This section is long enough that the comparison stopped early. What follows is partial, and the remainder is not necessarily unchanged.
2 unchanged sentences
Controls and Procedures
−Removed: Disclosure controls and procedures (as
−Removed: defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) are designed only to provide reasonable assurance that they will
−Removed: meet their objectives.
−Removed: Under the supervision and with the participation of our management, including our principal executive officer
−Removed: and principal financial officer, we conducted an evaluation of the effectiveness, as of December 31, 2019, of the design and
−Removed: operation of our disclosure controls and procedures, as such term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e).
−Removed: Based on this evaluation, our principal executive officer and principal financial officer have concluded that, as of such date,
−Removed: our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in our Exchange
−Removed: Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and
−Removed: forms, and that such information is accumulated and communicated to our management, including our principal executive officer and
−Removed: principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
+Added: Disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) are designed only to provide reasonable assurance that they will meet their objectives.
+Added: Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness, as of December 31, 2020, of the design and operation of our disclosure controls and procedures, as such term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e).
+Added: Based on this evaluation, our principal executive officer and principal financial officer have concluded that, as of such date, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Internal Control over Financial Reporting
−Removed: Management’s Report on Internal
−Removed: Control over Financial Reporting
−Removed: Our management is responsible for establishing
−Removed: and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and
−Removed: Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal
−Removed: executive officer and principal financial officer, and effected by our Board of Directors, management and other personnel, to provide
−Removed: reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
−Removed: purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:
+Added: Management’s Report on Internal Control over Financial Reporting
+Added: Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f).
+Added: Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal executive officer and principal financial officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:
(1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
1 unchanged sentence
(3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisitions, use or disposition of our assets that could have a material effect on the financial statements.
−Removed: Internal control over financial reporting
−Removed: has inherent limitations.
−Removed: Internal control over financial reporting is a process that involves human diligence and compliance and
−Removed: is subject to lapses in judgment and breakdowns resulting from human failures.
−Removed: Internal control over financial reporting also can
−Removed: be circumvented by collusion or improper management override.
−Removed: Because of such limitations, there is a risk that material misstatements
−Removed: may not be prevented or detected on a timely basis by internal control over financial reporting.
−Removed: However, these inherent limitations
−Removed: are known features of the financial reporting process.
−Removed: Therefore, it is possible to design into the process safeguards to reduce,
−Removed: though not eliminate, this risk.
−Removed: Our management assessed the effectiveness
−Removed: of our internal control over financial reporting as of December 31, 2019.
−Removed: In making the assessment, management used the criteria
−Removed: set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control - Integrated Framework
−Removed: Based on the results of this assessment,
−Removed: management (including our Chief Executive Officer and our Chief Financial Officer) has concluded that, as of December 31,
−Removed: 2019, our internal control over financial reporting was effective.
−Removed: Attestation Report of Registered
−Removed: Public Accounting Firm
−Removed: The effectiveness of our internal controls
−Removed: over financial reporting as of December 31, 2019 has been audited by our independent registered accounting firm, BDO USA,
−Removed: LLP, as stated in their attestation report, which is included on page F-3 herein.
−Removed: Changes in Internal Controls over
−Removed: Financial Reporting.
−Removed: There were no changes in our internal control
−Removed: over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially
−Removed: affect, our internal control over financial reporting.
+Added: Internal control over financial reporting has inherent limitations.
+Added: Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures.
+Added: Internal control over financial reporting also can be circumvented by collusion or improper management override.
+Added: Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting.
+Added: However, these inherent limitations are known features of the financial reporting process.
+Added: Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
+Added: Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2020.
+Added: In making the assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control - Integrated Framework (2013) .
+Added: Based on the results of this assessment, management (including our Chief Executive Officer and our Chief Financial Officer) has concluded that, as of December 31, 2020, our internal control over financial reporting was effective.
+Added: Changes in Internal Controls over Financial Reporting.
+Added: There were no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Other Information
Directors, Executive Officers and Corporate Governance
−Removed: The information required by this Item is
−Removed: incorporated herein by reference from our Proxy Statement for our 2020 Annual Meeting of Stockholders.
+Added: The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2021 Annual Meeting of Stockholders.
Executive Compensation
−Removed: The information required by this Item is
−Removed: incorporated herein by reference from our Proxy Statement for our 2020 Annual Meeting of Stockholders.
+Added: The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2021 Annual Meeting of Stockholders.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
−Removed: The information required by this Item is
−Removed: incorporated herein by reference from our Proxy Statement for our 2020 Annual Meeting of Stockholders.
+Added: The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2021 Annual Meeting of Stockholders.
Certain Relationships and Related Transactions, and Director Independence
−Removed: The information required by this Item is
−Removed: incorporated herein by reference from our Proxy Statement for our 2020 Annual Meeting of Stockholders.
+Added: The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2021 Annual Meeting of Stockholders.
Principal Accounting Fees and Services
−Removed: The information required by this Item is
−Removed: incorporated herein by reference from our Proxy Statement for our 2020 Annual Meeting of Stockholders.
+Added: The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2021 Annual Meeting of Stockholders.
Exhibits, Financial Statement Schedules.
(a) Financial Statements.
−Removed: The following financial statements are
−Removed: filed as part of this report:
−Removed: Reports of Independent Registered Public Accounting
+Added: The following financial statements are filed as part of this report:
+Added: Reports of Independent Registered Public Accounting Firms
Consolidated Balance Sheets
Consolidated Statements of Operations
−Removed: Consolidated Statements of Changes in Stockholders’
+Added: Consolidated Statements of Changes in Stockholders’ Equity
Consolidated Statements of Cash Flows
1 unchanged sentence
(b) Exhibits.
−Removed: Incorporated by Reference
−Removed: (Unless Otherwise Indicated)
Exhibit Title
Amended and Restated Certificate of Incorporation of the Registrant.
−Removed: July 15, 2011
First Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant.
−Removed: July 15, 2011
Second Amended and Restated Bylaws of the Registrant.
−Removed: October 31, 2013
Second Certificate of Amendment of Amended and Restated Certificate of Incorporation, as amended.
−Removed: March 14, 2014
Third Certificate of Amendment of Amended and Restated Certificate of Incorporation, as amended.
−Removed: April 27, 2015
+Added: Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Fortress Biotech, Inc.
+Added: Certificate of Amendment to the Certificate of Designations of Rights and Preferences of the Fortress Biotech, Inc.
+Added: 9.375% Series A Cumulative Preferred Stock under the Amended and Restated Certificate of Incorporation of Fortress Biotech, Inc.
Form of Common Stock Certificate.
−Removed: July 15, 2011
Certificate of Designation of Rights and Preferences 9.375% Series A Perpetual Preferred Stock.
−Removed: November 7, 2017
Description of Securities of Fortress Biotech, Inc.
Form of Stock Option Award Agreement.
−Removed: July 15, 2011
Amended and Restated Consulting Agreement, entered into as of January 1, 2019, by and between the Registrant and Eric Rowinsky.
−Removed: March 18, 2019
Form of Indemnification Agreement by and between the Registrant and its officers and directors.
−Removed: August 23, 2011
−Removed: Coronado Biosciences, Inc.
+Added: Fortress Biotech, Inc.
2012 Employee Stock Purchase Plan.
−Removed: July 13, 2012
−Removed: Promissory Note issued by Registrant to Israel Discount Bank of New York, dated February 13, 2014.
−Removed: February 18, 2014
−Removed: Assignment and Pledge of Money Market Account date February 13, 2014 in favor of Israel Discount Bank of New York.
−Removed: February 18, 2014
Restricted Stock Issuance Agreement, dated as of February 2, 2014, by and between the Registrant and Michael S.
−Removed: February 26, 2014
Restricted Stock Issuance Agreement, dated as of December 19, 2013, by and between the Registrant and Michael S.
−Removed: March 14, 2014
Restricted Stock Issuance Agreement, dated as of December 19, 2013, by and between the Registrant and Lindsay A.
Rosenwald, M.D.#
−Removed: March 14, 2014
Form of Coronado Biosciences, Inc.
2013 Stock Incentive Plan Award Agreement (2013 Stock Incentive Plan).
−Removed: March 14, 2014
−Removed: Form of Subscription Agreement
−Removed: November 10, 2014
−Removed: Note Purchase Agreement, dated February 27, 2015, by and between the Registrant and NSC Biotech Venture Fund.
−Removed: March 5, 2015
−Removed: Form of Subco Securities Purchase Agreement.
−Removed: March 5, 2015
−Removed: Form of Subco Warrant.
−Removed: March 5, 2015
−Removed: Form of Subco Promissory Note.
−Removed: March 5, 2015
Coronado Biosciences, Inc.
Deferred Compensation Plan for Directors, dated March 12, 2015.
−Removed: March 18, 2015
Fortress Biotech, Inc.
2013 Stock Incentive Plan, as amended.
−Removed: Fortress Biotech, Inc.
−Removed: Long-Term Incentive Plan.
+Added: Exhibit Title
Restricted Stock Unit Award Agreement between Fortress Biotech, Inc.
and George Avgerinos effective July 15, 2015.#
−Removed: July 17, 2015
−Removed: Amended and Restated Promissory Note issued by the Registrant to NSC Biotech Venture Fund I LLC, dated July 29, 2015.
−Removed: August 4, 2015
−Removed: Form of Fortress Biotech, Inc.
−Removed: Convertible Second Promissory Note.
−Removed: November 9, 2016
−Removed: Form of Common Stock Purchase Warrant.
−Removed: November 9, 2016
−Removed: Pledge and Security Agreement dated as of September 14, 2016 made by Fortress Biotech, Inc.
−Removed: and FBIO Acquisition, Inc.
−Removed: in favor of Opus Point Healthcare Innovations Fund, LP.
−Removed: November 9, 2016
−Removed: Placement Agency Agreement dated March 25, 2017, between Fortress Biotech, Inc., NAM Biotech Fund II, LLC- Series I and National Securities Corporation.
−Removed: Placement Agency Agreement dated March 25, 2017, between Fortress Biotech, Inc., NAM Special Situations Fund I QP, LLC –
−Removed: FBIO Series I and National Securities Corporation.
Form of Common Stock Purchase Warrant in favor of National Securities Corporation.
−Removed: Form of Note Purchase Agreement between Fortress Biotech, Inc., NAM Biotech Fund II, LLC –
−Removed: Series I and NAM Special Situations Fund I QP, LLC –
−Removed: FBIO Series I.
−Removed: Form of Promissory Note issued by Fortress Biotech, Inc.
−Removed: to NAM Biotech Fund II, LLC –
−Removed: Series I and NAM Special Situations Fund I QP, LLC –
−Removed: FBIO Series I.
Fortress Biotech, Inc.
2012 Employee Stock Purchase Plan, as amended.
−Removed: June 12, 2017
Fortress Biotech, Inc.
Amended and Restated Long-Term Incentive Plan.
−Removed: June 12, 2017
−Removed: Amended and Restated Credit Facility Agreement dated as of March 12, 2018, by and among Fortress Biotech, Inc.
−Removed: and Opus Healthcare Innovations Fund, LP.*
−Removed: March 16, 2018
Stock Purchase and Merger Agreement, dated as of November 12, 2018, by and between Avenue Therapeutics, Inc., InvaGen Pharmaceuticals Inc.
and Madison Pharmaceuticals Inc.
−Removed: November 16, 2018
Stockholders Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc., Avenue Therapeutics, Inc., Dr.
1 unchanged sentence
and InvaGen Pharmaceuticals Inc.
−Removed: November 16, 2018
Credit Agreement, dated as of November 12, 2018, by and between Avenue Therapeutics, Inc.
and InvaGen Pharmaceuticals Inc.
−Removed: November 16, 2018
Guaranty, dated as of November 12, 2018, by and between Fortress Biotech, Inc.
and InvaGen Pharmaceuticals Inc.
−Removed: November 16, 2018
Voting and Support Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc., Avenue Therapeutics, Inc., Dr.
1 unchanged sentence
and InvaGen Pharmaceuticals Inc.
−Removed: November 16, 2018
Waiver Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc., Avenue Therapeutics, Inc.
and InvaGen Pharmaceuticals Inc.
−Removed: November 16, 2018
Restrictive Covenant Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc.
and InvaGen Pharmaceuticals Inc.
−Removed: November 16, 2018
Indemnification Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc.
and InvaGen Pharmaceuticals Inc.
−Removed: November 16, 2018
−Removed: Stock Purchase Agreement by and among FBIO Acquisition, Inc., Fortress Biotech, Inc., and NHC Holdings, LLC, dated November 14, 2018.
−Removed: November 20, 2018
−Removed: Option and Stock Purchase Agreement by and among Caelum Biosciences, Inc., Alexion Pharmaceuticals, Inc., Fortress Biotech, Inc.,
−Removed: and the several shareholders of Caelum Biosciences, Inc., dated January 30, 2019.*
−Removed: January 31, 2019
−Removed: At Market Issuance Sales Agreement by and among the Registrant, Cantor Fitzgerald & Co., Oppenheimer & Co.
−Removed: Wainwright & Co., LLC, JonesTrading Institutional Services LLC and B.
−Removed: Riley FBR, Inc., dated June 30, 2019.
−Removed: June 28, 2019
+Added: Development, Option and Stock Purchase Agreement by and among Caelum Biosciences, Inc., Alexion Pharmaceuticals, Inc., Fortress Biotech, Inc., and the several shareholders of Caelum Biosciences, Inc., dated January 30, 2019.*
+Added: Amendment to the Fortress Biotech, Inc.
+Added: 2013 Stock Incentive Plan.#
+Added: Credit Agreement entered into by and among Fortress Biotech, Inc.
+Added: the lenders form time to time party thereto, and Oaktree Fund administration, LLC on August 27, 2020.
Subsidiaries of the Registrant.
−Removed: Filed herewith
Consent Independent Registered Public Accounting Firm.
−Removed: Filed herewith
Power of Attorney (included on the signature page of this Form 10-K).
−Removed: Filed herewith
Certification of Chairman, President and Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
−Removed: Filed herewith
Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
−Removed: Filed herewith
+Added: Exhibit Title
Certification of Chairman, President and Chief Executive Officer, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
−Removed: Filed herewith
Certification of the Chief Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
−Removed: Filed herewith
−Removed: XBRL Instance Document.
−Removed: Filed herewith
−Removed: XBRL Taxonomy Extension Schema Document.
−Removed: Filed herewith
−Removed: XBRL Taxonomy Extension Calculation Linkbase Document.
−Removed: Filed herewith
−Removed: XBRL Taxonomy Extension Definition Linkbase Document.
−Removed: Filed herewith
−Removed: XBRL Taxonomy Extension Label Linkbase Document.
−Removed: Filed herewith
−Removed: XBRL Taxonomy Extension Presentation Linkbase Document.
−Removed: Filed herewith
+Added: Inline XBRL Instance Document.*
+Added: Inline XBRL Taxonomy Extension Schema Document.*
+Added: Inline XBRL Taxonomy Extension Calculation Linkbase Document.*
+Added: Inline XBRL Taxonomy Extension Definition Linkbase Document.*
+Added: Inline XBRL Taxonomy Extension Label Linkbase Document.*
+Added: Inline XBRL Taxonomy Extension Presentation Linkbase Document.*
+Added: Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).*
# Management contract or compensatory plan.
8 unchanged sentences
Consolidated Statements of Operations
−Removed: Consolidated Statements of Changes in Stockholders’
+Added: Consolidated Statements of Changes in Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to the Consolidated Financial Statements
−Removed: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: Report of Independent Registered Public
−Removed: Accounting Firm
−Removed: Shareholders and Board of Directors
−Removed: Fortress Biotech, Inc.
−Removed: and subsidiaries
−Removed: New York, New York
−Removed: Opinion on the Consolidated Financial
−Removed: We have audited the accompanying consolidated
−Removed: balance sheets of Fortress Biotech, Inc.
−Removed: and subsidiaries (the “Company”) as of December 31, 2019 and 2018,
−Removed: the related consolidated statements of operations, stockholders’
−Removed: equity, and cash flows for each of the two years in the
−Removed: period ended December 31, 2019, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company
−Removed: and subsidiaries at December 31, 2019 and 2018, and the results of their operations and their cash flows for each of the two
−Removed: years in the period ended December 31, 2019 , in conformity with accounting principles generally accepted in the United
−Removed: States of America.
−Removed: We also have audited, in accordance with
−Removed: the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the Company’s internal
−Removed: control over financial reporting as of December 31, 2019, based on criteria established in Internal Control –
−Removed: Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and our
−Removed: report dated March 16, 2020 expressed an unqualified opinion thereon.
−Removed: Change in Accounting Principle
−Removed: As discussed in Note 2 to the
−Removed: consolidated financial statements, on January 1, 2019, the Company changed its method of accounting for leases due to
−Removed: the adoption of ASU 2016-02, Leases (ASC 842).
−Removed: Basis for Opinion
−Removed: These consolidated financial statements
−Removed: are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated
−Removed: financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight
−Removed: Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with
−Removed: the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
−Removed: the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: Our audits included performing procedures
−Removed: to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing
−Removed: procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and
−Removed: disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant
−Removed: estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: that our audits provide a reasonable basis for our opinion.
−Removed: We have served as the Company's auditor
−Removed: /s/ BDO USA, LLP
−Removed: Boston, Massachusetts
−Removed: March 16, 2020
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: Report of Independent Registered Public Accounting Firm
Shareholders and Board of Directors
2 unchanged sentences
New York, New York
−Removed: Opinion on Internal Control over Financial
−Removed: We have audited Fortress Biotech, Inc.
−Removed: and subsidiaries (the “Company’s”) internal control over financial reporting as of December 31, 2019, based
−Removed: on criteria established in Internal Control –
−Removed: Integrated Framework (2013) issued by the Committee of Sponsoring Organizations
−Removed: of the Treadway Commission (the “COSO criteria”).
−Removed: In our opinion, the Company maintained, in all material respects,
−Removed: effective internal control over financial reporting as of December 31, 2019, based on the COSO criteria.
−Removed: We also have audited, in accordance with
−Removed: the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidated balance
−Removed: sheets of the Company and subsidiaries as of December 31, 2019 and 2018, the related consolidated statements of operations,
−Removed: stockholders’
−Removed: equity, and cash flows for each of the two years in the period ended December 31, 2019, and the related
−Removed: notes and our report dated March 16, 2020 expressed an unqualified opinion thereon.
+Added: Opinion on the Consolidated Financial Statements
+Added: We have audited the accompanying consolidated balance sheets of Fortress Biotech, Inc.
+Added: and subsidiaries (the “Company”) as of December 31, 2020 and 2019, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2020, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2020 , in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
−Removed: The Company’s management is responsible
−Removed: for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control
−Removed: over financial reporting, included in the accompanying Item 9A, Management’s Report on Internal Control over Financial Reporting.
−Removed: Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
−Removed: We conducted our audit of internal control
−Removed: over financial reporting in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit
−Removed: to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material
−Removed: Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that
−Removed: a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the
−Removed: assessed risk.
−Removed: Our audit also included performing such other procedures as we considered necessary in the circumstances.
−Removed: that our audit provides a reasonable basis for our opinion.
−Removed: Definition and Limitations of Internal
−Removed: Control over Financial Reporting
−Removed: A company’s internal control over
−Removed: financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and
−Removed: the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
−Removed: A company’s
−Removed: internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records
−Removed: that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
−Removed: reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with
−Removed: generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with
−Removed: authorizations of management and directors of the company;
−Removed: and (3) provide reasonable assurance regarding prevention or timely
−Removed: detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the
−Removed: financial statements.
−Removed: Because of its inherent limitations, internal
−Removed: control over financial reporting may not prevent or detect misstatements.
−Removed: Also, projections of any evaluation of effectiveness
−Removed: to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree
−Removed: of compliance with the policies or procedures may deteriorate.
+Added: These consolidated financial statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical Audit Matter
+Added: The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved especially challenging, subjective, or complex judgments.
+Added: The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Accounting for Oaktree Note
+Added: As described in Note 2 and Note 10 to the consolidated financial statements, in August 2020, the Company entered into a $60.0 million senior secured credit agreement with Oaktree (“Note”).
+Added: In connection with the Oaktree Note, the Company issued warrants to Oaktree and certain of its affiliates to purchase up to 1,749,450 shares of common stock (see Note 14)
+Added: with a relative fair value of $4.4 million.
+Added: In accounting for the Oaktree Note, the Company analyzed the Note and warrants and their related features for the appropriate accounting of the arrangement, including assessment of potential embedded derivatives.
+Added: We identified the accounting for the Oaktree Note as a critical audit matter.
+Added: The principal considerations that led us to determine this matter was a critical audit matter included the inherent complexity in assessing the accounting for the Note and related embedded derivatives.
+Added: Auditing these elements required complex auditor judgment and an increased level of audit effort, including the need for specialized knowledge and skill in assessing these elements.
+Added: The procedures we performed to address this critical audit matter included:
+Added: ● Evaluating management’s accounting policies and practices including the appropriateness of
+Added: management’s evaluation of various terms and conditions in the debt agreement, and assessment of embedded derivatives.
+Added: ● Inspecting the underlying agreements and testing management’s evaluation and application of the relevant accounting guidance to the terms of the agreements.
+Added: ● Utilizing personnel with specialized knowledge and skill with complex debt instruments to assist in assessing the analysis and accounting for the Note and its features including the warrants.
+Added: We have served as the Company’s auditor since 2016.
/s/ BDO USA, LLP
4 unchanged sentences
Consolidated Balance Sheets
−Removed: ($ in thousands except for share and
−Removed: per share amounts)
+Added: ($ in thousands except for share and per share amounts)
Current assets
Cash and cash equivalents
−Removed: Accounts receivable (net of allowance for doubtful accounts of $100 and $0 at December 31, 2019 and December 31, 2018, respectively)
−Removed: Short-term investments (certificates of deposit)
+Added: Accounts receivable, net
Other receivables - related party
Prepaid expenses and other current assets
−Removed: Current assets held for sale
Total current assets
7 unchanged sentences
Accounts payable and accrued expenses
−Removed: Accounts payable and accrued expenses - related party
Interest payable
Interest payable - related party
−Removed: Notes payable, short-term (net of debt discount of $0 and $336 at December 31, 2019 and December 31, 2018, respectively)
−Removed: Partner company convertible note, short-term, at fair value
+Added: Income taxes payable
+Added: Notes payable, short-term
Operating lease liabilities, short-term
Derivative warrant liability
+Added: Partner company note payable, short-term
Total current liabilities
1 unchanged sentence
Operating lease liabilities, long-term
+Added: Partner company note payable, long-term
Other long-term liabilities
2 unchanged sentences
Stockholders’ equity
−Removed: Preferred stock, $.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 1,341,167 and 1,000,000 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively;
+Added: Cumulative redeemable perpetual preferred stock, $ .001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 and 1,341,167 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively;
liquidation value of $ 25.00 per share
−Removed: Common stock, $.001 par value, 100,000,000 shares authorized, 74,027,425 and 57,845,447 shares issued and outstanding as of December 31, 2019 and December 31, 2018, respectively
+Added: Common stock, $ .001 par value, 150,000,000 and 100,000,000 shares authorized, 94,877,492 and 74,027,425 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively
Common stock issuable, 0 and 251,337 shares as of December 31, 2020 and December 31, 2019, respectively
5 unchanged sentences
Total liabilities and stockholders' equity
−Removed: The accompanying notes
−Removed: are an integral part of these consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
FORTRESS BIOTECH, INC.
1 unchanged sentence
Consolidated Statements of Operations
−Removed: ($ in thousands except for share and
−Removed: per share amounts)
−Removed: For the Years Ended
+Added: ($ in thousands except for share and per share amounts)
+Added: Year Ended December 31,
Product revenue, net
−Removed: Revenue - from a related party
+Added: Revenue - related party
Operating expenses
1 unchanged sentence
Research and development
−Removed: Research and development –
−Removed: licenses acquired
−Removed: General and administrative
+Added: Research and development - licenses acquired
+Added: Selling, general and administrative
Total operating expenses
4 unchanged sentences
Change in fair value of derivative liability
−Removed: Change in fair value of subsidiary convertible note
Change in fair value of investments
1 unchanged sentence
Total other income (expense)
−Removed: Loss from continuing operations
−Removed: Discontinued operations:
−Removed: Gain from disposal of National
−Removed: Loss from discontinued operations, net of tax
−Removed: Total loss from discontinued operations
+Added: Loss before income tax expense
+Added: Income tax expense
net loss attributable to non-controlling interests
Net loss attributable to common stockholders
−Removed: Loss from continuing operations per common share - basic and diluted
−Removed: Loss from discontinued operations per common share - basic and diluted
+Added: Net loss per common share - basic and diluted
+Added: Net loss per common share attributable to non - controlling interests - basic and diluted
Net loss per common share attributable to common stockholders - basic and diluted
Weighted average common shares outstanding - basic and diluted
−Removed: The accompanying notes are an integral part
−Removed: of these consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
FORTRESS BIOTECH, INC.
AND SUBSIDIARIES
−Removed: Consolidated Statements of Changes in
−Removed: Stockholders’
+Added: Consolidated Statements of Changes in Stockholders’ Equity
($ in thousands except for share amounts)
6 unchanged sentences
Issuance of common stock under ESPP
−Removed: Issuance of subsidiaries' common shares for license expenses
−Removed: Partner company’s offering, net
−Removed: Partner company’s at-the-market offering, net
−Removed: Exercise of partner company’s warrants for cash
Issuance of common stock for at-the-market offering, net
−Removed: Contribution of capital for 2017 bonuses
−Removed: Common shares issuable for 2017 Subordinated Note Financing interest expense
−Removed: Common shares issued for 2017 Subordinated Note Financing interest expense
−Removed: Common shares issued for Opus interest expense
−Removed: Preferred A dividends declared and paid
−Removed: 2017 Preferred A offering cost adjustment
−Removed: Disposal of National
−Removed: Non-controlling interest in subsidiaries
−Removed: Net loss attributable to non-controlling interest
−Removed: Net loss attributable to common stockholders
−Removed: Balance at December 31, 2018
−Removed: Stock-based compensation expense
−Removed: Settlement of restricted stock units into common stock
−Removed: Issuance of common stock under ESPP
−Removed: Issuance of common stock for at-the-market offering, net
Issuance of Series A preferred stock for at-the-market offering, net
1 unchanged sentence
Preferred A dividends declared and paid
−Removed: Partner company’s offering, net
−Removed: Partner company’s at-the-market offering, net
+Added: Partner company’s offering, net
+Added: Partner company’s at-the-market offering, net
Issuance of partner company's common shares for license expenses
11 unchanged sentences
Balance at December 31, 2019
−Removed: The accompanying notes are an integral part
−Removed: of these consolidated financial statements.
+Added: The accompanying notes are an integral part of these consolidated financial statements.
FORTRESS BIOTECH, INC.
AND SUBSIDIARIES
+Added: Consolidated Statements of Changes in Stockholders’ Equity
+Added: ($ in thousands except for share amounts)
+Added: Series A Preferred Stock
+Added: Non-Controlling
+Added: Stockholders'
+Added: Balance at December 31, 2019
+Added: Stock-based compensation expense
+Added: Issuance of common stock related to equity plans
+Added: Issuance of common stock under ESPP
+Added: Issuance of common stock for at-the-market offering, net
+Added: Preferred A dividends declared and paid
+Added: Repurchase of Series A preferred stock, net
+Added: Retirement of Series A preferred stock
+Added: Issuance of Series A preferred stock for cash, net
+Added: Partner company’s offering, net
+Added: Partner companies' at-the-market offering, net
+Added: Partner company’s preferred stock offering, net
+Added: Issuance of common stock under partner company’s ESPP
+Added: Partner company’s dividends declared and paid
+Added: Partner company’s exercise of warrants for cash
+Added: Partner company’s exercise of options for cash
+Added: Reclass partner company's warrants from liability to equity
+Added: Issuance of partner company’s common shares for research and development expenses
+Added: Common shares issued for 2017 Subordinated Note Financing interest expense
+Added: Issuance of warrants in conjunction with Oaktree Note
+Added: Non-controlling interest in partner companies
+Added: Net loss attributable to non-controlling interest
+Added: Net loss attributable to common stockholders
+Added: Balance at December 31, 2020
+Added: The accompanying notes are an integral part of these consolidated financial statements.
+Added: FORTRESS BIOTECH, INC.
+Added: AND SUBSIDIARIES
Consolidated Statements of Cash Flows
($ in thousands)
−Removed: For the Years Ended
+Added: For the Year Ended
Cash Flows from Operating Activities:
−Removed: Net loss on discontinued operations
−Removed: Gain from disposal of National
−Removed: Loss from continuing operations
Reconciliation of net loss to net cash used in operating activities:
2 unchanged sentences
Amortization of debt discount
+Added: Non-cash interest
Amortization of product revenue license fee
1 unchanged sentence
Stock-based compensation expense
−Removed: Issuance of common stock for research and development-licenses acquired expense
+Added: Issuance of common stock for service
Issuance of partner company’s common shares for research and development expenses
1 unchanged sentence
Common shares issued for 2017 Subordinated Note Financing interest expense
−Removed: Common shares issuable for Opus interest expense
−Removed: Common shares issued for Opus interest expense
−Removed: Change in fair value of investments
+Added: Common shares issuable for 2019 Notes interest expense
+Added: Common shares issued for 2019 Notes interest expense
Change in fair value of derivative liability
−Removed: Change in fair value of partner company's convertible note
+Added: Change in fair value of investment
Gain on deconsolidation of Caelum
8 unchanged sentences
Interest payable - related party
+Added: Income taxes payable
Lease liabilities
Other long-term liabilities
−Removed: Net cash used in continuing operating activities
−Removed: Net cash used in discontinued operating activities
Net cash used in operating activities
2 unchanged sentences
Purchase of property and equipment
−Removed: Acquisition of intangible assets - Journey
+Added: Purchase of intangible asset
Purchase of short-term investment (certificates of deposit)
Redemption of short-term investment (certificates of deposit)
−Removed: Security deposits paid
Deconsolidation of Caelum
−Removed: Net cash provided by continuing investing activities
+Added: Net cash provided by (used in) continuing investing activities
Net cash provided by discontinued investing activities
−Removed: Net cash provided by investing activities
+Added: Net cash provided by (used in) investing activities
+Added: The accompanying notes are an integral part of these consolidated financial statements.
+Added: FORTRESS BIOTECH, INC.
+Added: AND SUBSIDIARIES
+Added: Consolidated Statements of Cash Flows
+Added: ($ in thousands)
+Added: For the Year Ended
Cash Flows from Financing Activities:
−Removed: Payment of Preferred A dividends
+Added: Payment of Series A preferred stock dividends
+Added: Purchase of treasury stock
+Added: Payment of costs related to purchase of treasury stock
Proceeds from issuance of Series A preferred stock
−Removed: Payment of cost related to issuance of Series A preferred stock
−Removed: Proceeds from issuance of Series A preferred stock for at-the-market offering
−Removed: Payment of cost related to issuance of Series A preferred stock for at-the-market offering
+Added: Payment of costs related to issuance of Series A preferred stock
Proceeds from issuance of common stock for at-the-market offering
−Removed: Payment of cost related to issuance of common stock for at-the-market offering
+Added: Payment of costs related to issuance of common stock for at-the-market offering
+Added: Proceeds from issuance of Series A preferred stock for at-the-market offering
+Added: Payment of costs related to issuance of Series A preferred stock for at-the-market offering
Proceeds from issuance of common stock under ESPP
−Removed: Proceeds from partner company's sale of stock
−Removed: Payment of costs related to partner company's sale of stock
−Removed: Proceeds from partner company's at-the-market offering
−Removed: Payment of costs related to partner company's at-the-market offering
+Added: Proceeds from partner companies' ESPP
+Added: Partner company’s dividends declared and paid
+Added: Proceeds from partner companies' sale of stock
+Added: Payment of costs related to partner companies' sale of stock
+Added: Proceeds from partner companies' at-the-market offering
+Added: Payment of costs related to partner companies' at-the-market offering
+Added: Proceeds from partner company's preferred stock offering
+Added: Payment of costs related to partner company's preferred stock offering
Proceeds from exercise of partner company’s warrants
+Added: Proceeds from exercise of partner company’s options
Payment of debt issuance costs associated with 2017 Subordinated Note Financing
−Removed: Proceeds from 2018 Venture Notes
Payment of debt issuance costs associated with 2018 Venture Notes
1 unchanged sentence
Payment of debt issuance costs associated with partner company's Horizon Notes
−Removed: Payment of partner company's Convertible Notes
−Removed: Net cash provided by continuing financing activities
−Removed: Net cash provided by discontinued financing activities
+Added: Proceeds from Oaktree Note
+Added: Payment of debt issuance costs associated with Oaktree Note
+Added: Repayment of 2017 Subordinated Note Financing
+Added: Repayment of 2018 Venture Notes
+Added: Repayment of 2019 Notes
+Added: Repayment of partner company's Horizon Notes
+Added: Repayment of IDB Note
+Added: Installment payment related to intangible asset
Net cash provided by financing activities
−Removed: Net increase (decrease) in cash and cash equivalents and restricted cash
+Added: Net increase in cash and cash equivalents and restricted cash
Cash and cash equivalents and restricted cash at beginning of period
Cash and cash equivalents and restricted cash at end of period
−Removed: For the Years Ended
Supplemental disclosure of cash flow information:
1 unchanged sentence
Cash paid for interest - related party
+Added: The accompanying notes are an integral part of these consolidated financial statements.
+Added: FORTRESS BIOTECH, INC.
+Added: AND SUBSIDIARIES
+Added: Consolidated Statements of Cash Flows
+Added: ($ in thousands)
+Added: Year Ended December 31,
Supplemental disclosure of non-cash financing and investing activities:
2 unchanged sentences
Issuance of partner company warrants in conjunction with Horizon Notes
−Removed: Common shares issued for 2017 Subordinated Note Financing interest expense
−Removed: Common shares issued for Opus debt
−Removed: Receivables of contribution of capital for 2017 bonuses
+Added: Issuance of warrants in conjunction with Oaktree Note
+Added: Common shares issued from 2017 Subordinated Note Financing interest expense
+Added: Common shares issued for 2019 Notes
Unpaid fixed assets
−Removed: Unpaid research and development licenses acquired
+Added: Partner company's unpaid intangible assets
+Added: Partner company's previous paid offering cost
+Added: Reclass partner company's warrants from liability to equity
+Added: Unpaid partner company’s offering cost
+Added: Unpaid partner company’s at-the-market offering cost
+Added: Unpaid partner company’s preferred stock offering cost
Unpaid debt offering cost
Unpaid at-the-market offering cost
−Removed: Unpaid Preferred A offering cost
−Removed: Unpaid partner company's offering cost
−Removed: Partner company's previous paid offering cost
−Removed: Partner company's unpaid intangible assets
−Removed: The accompanying notes are an integral part
−Removed: of these consolidated financial statements.
+Added: Unpaid Series A preferred stock offering cost
+Added: Unpaid research and development licenses acquired
+Added: Retirement of Series A preferred stock
+Added: The accompanying notes are an integral part of these consolidated financial statements.
FORTRESS BIOTECH, INC.
AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
+Added: Notes to the Consolidated Financial Statements
Organization and Description of Business
Fortress Biotech, Inc.
−Removed: (“Fortress”
−Removed: or the “Company”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing pharmaceutical
−Removed: and biotechnology products and product candidates, which the Company does at the Fortress level, at its majority-owned and majority-controlled
−Removed: subsidiaries and joint ventures, and at entities the Company founded and in which it maintains significant minority ownership positions.
−Removed: Fortress has a talented and experienced business development team, comprising scientists, doctors and finance professionals, who
−Removed: identify and evaluate promising products and product candidates for potential acquisition by new or existing partner companies.
−Removed: Fortress through its partner companies has executed such arrangements in partnership with some of the world’s foremost universities,
−Removed: research institutes and pharmaceutical companies, including City of Hope National Medical Center, Fred Hutchinson Cancer Research
−Removed: Jude Children’s Research Hospital, Dana-Farber Cancer Institute, Nationwide Children’s Hospital, Cincinnati
−Removed: Children’s Hospital Medical Center, Columbia University, the University of Pennsylvania, and AstraZeneca plc.
−Removed: Following the exclusive license or other
−Removed: acquisition of the intellectual property underpinning a product or product candidate, Fortress leverages its business, scientific,
−Removed: regulatory, legal and finance expertise to help the partners achieve their goals.
−Removed: Partner companies then assess a broad range of
−Removed: strategic arrangements to accelerate and provide additional funding to support research and development, including joint ventures,
−Removed: partnerships, out-licensings, and public and private financings;
−Removed: to date, three partner companies are publicly-traded, and two
−Removed: have consummated strategic partnerships with industry leaders Alexion Pharmaceuticals, Inc.
+Added: (“Fortress” or the “Company”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing pharmaceutical and biotechnology products and product candidates, which the Company does at the Fortress level, at its majority-owned and majority-controlled subsidiaries and joint ventures, and at entities the Company founded and in which it maintains significant minority ownership positions.
+Added: Fortress has a talented and experienced business development team, comprising scientists, doctors and finance professionals, who identify and evaluate promising products and product candidates for potential acquisition by new or existing partner companies.
+Added: Fortress through its partner companies has executed such arrangements in partnership with some of the world’s foremost universities, research institutes and pharmaceutical companies, including City of Hope National Medical Center, Fred Hutchinson Cancer Research Center, St.
+Added: Jude Children’s Research Hospital, Dana-Farber Cancer Institute, Nationwide Children's Hospital, Cincinnati Children's Hospital Medical Center, Columbia University, the University of Pennsylvania, and AstraZeneca plc.
+Added: Following the exclusive license or other acquisition of the intellectual property underpinning a product or product candidate, Fortress leverages its business, scientific, regulatory, legal and finance expertise to help the partners achieve their goals.
+Added: Partner companies then assess a broad range of strategic arrangements to accelerate and provide additional funding to support research and development, including joint ventures, partnerships, out-licensings, and public and private financings;
+Added: to date, three partner companies are publicly-traded, and two have consummated strategic partnerships with industry leaders Alexion Pharmaceuticals, Inc.
and InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Limited).
−Removed: Several of our partner companies possess
−Removed: licenses to product candidate intellectual property, including Aevitas Therapeutics, Inc.
−Removed: (“Aevitas”), Avenue
−Removed: Therapeutics, Inc.
−Removed: (“Avenue”), Baergic Bio, Inc.
−Removed: (“Baergic”), Caelum Biosciences, Inc.
−Removed: (“Caelum”),
−Removed: Cellvation, Inc.
−Removed: (“Cellvation”), Checkpoint Therapeutics, Inc.
−Removed: (“Checkpoint”), Cyprium Therapeutics, Inc.
−Removed: (“Cyprium”), Helocyte, Inc.
−Removed: (“Helocyte”), Hepla Sciences, Inc.
−Removed: (“Hepla”), Journey
−Removed: Medical Corporation (“Journey”
−Removed: or “JMC”), Mustang Bio, Inc.
−Removed: (“Mustang”) and Oncogenuity, Inc.
−Removed: (“Oncogenuity”).
+Added: Several of our partner companies possess licenses to product candidate intellectual property, including Aevitas Therapeutics, Inc.
+Added: (“Aevitas”), Avenue Therapeutics, Inc.
+Added: (“Avenue”), Baergic Bio, Inc.
+Added: (“Baergic”), Caelum Biosciences, Inc.
+Added: (“Caelum”), Cellvation, Inc.
+Added: (“Cellvation”), Checkpoint Therapeutics, Inc.
+Added: (“Checkpoint”), Cyprium Therapeutics, Inc.
+Added: (“Cyprium”), Helocyte, Inc.
+Added: (“Helocyte”), Journey Medical Corporation (“Journey” or “JMC”), Mustang Bio, Inc.
+Added: (“Mustang”) and Oncogenuity, Inc.
+Added: ("Oncogenuity").
Liquidity and Capital Resources
−Removed: Since inception, the Company’s operations
−Removed: have been financed primarily through the sale of equity and debt securities, from the sale of partner companies, the proceeds from
−Removed: the exercise of warrants and stock options.
−Removed: The Company has incurred losses from operations and negative cash flows from operating
−Removed: activities since inception and expects to continue to incur substantial losses for the next several years as it continues to fully
−Removed: develop and prepare regulatory filings and obtain regulatory approvals for its existing and new product candidates.
−Removed: The Company’s
−Removed: current cash and cash equivalents are sufficient to fund operations for at least the next 12 months.
−Removed: However, the Company will
−Removed: need to raise additional funding through strategic relationships, public or private equity or debt financings, sale of a partner
−Removed: company, grants or other arrangements to fully develop and prepare regulatory filings and obtain regulatory approvals for the existing
−Removed: and new product candidates, fund operating losses, and, if deemed appropriate, establish or secure through third parties manufacturing
−Removed: for the potential products, sales and marketing capabilities.
−Removed: If such funding is not available or not available on terms
−Removed: acceptable to the Company, the Company’s current development plan and plans for expansion of its general and administrative
−Removed: infrastructure will be curtailed.
−Removed: The Company also has the ability, subject to limitations imposed by Rule 144 of the Securities
−Removed: Act of 1933 and other applicable laws and regulations, to raise money from the sale of common stock of the public companies in
−Removed: which it has ownership positions.
−Removed: National Holdings Corporation
−Removed: During 2016, the Company purchased
−Removed: 56.6% of National Holdings Corporation, a diversified independent brokerage company (together with its subsidiaries, herein
−Removed: referred to as “NHLD”
−Removed: or “National”) through wholly owned subsidiary FBIO Acquisition, Inc.
−Removed: (“FBIO Acquisition”).
−Removed: The Company paid total consideration of $22.9 million or approximately 7.0 million shares
−Removed: at $3.25 per share in connection with this transaction.
−Removed: On November 14, 2018, the Company announced that it had reached
−Removed: an agreement with NHC Holdings, LLC (“NHC”) to sell all of its shares of National, representing 56.1% of the
−Removed: total outstanding shares of NHLD for $3.25 per share or total consideration of $22.9 million.
−Removed: Pursuant to the terms of the
−Removed: agreement with NHC the sale of the shares was subject to two closings.
−Removed: The first closing occurred on November 14, 2018
−Removed: in which the Company sold approximately 3.0 million of its shares in NHLD and received $9.8 million in proceeds.
−Removed: closing occurred on February 11, 2019 upon the receipt of FINRA approval of the sale in which the Company received $13.1
−Removed: million in proceeds for the sale of its remaining 4.0 million shares of NHLD to NHC and two other minority holders.
−Removed: December 31, 2018, the Company’s holding in National approximated 32.1% and was recorded on the consolidated
−Removed: balance sheets at fair value as a component of current assets held for sale.
−Removed: At December 31, 2019, the Company had no
−Removed: ownership interest in National.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
+Added: Since inception, the Company’s operations have been financed primarily through the sale of equity and debt securities, from the sale of partner companies, the proceeds from the exercise of warrants and stock options.
+Added: The Company has incurred losses from operations and negative cash flows from operating activities since inception and expects to continue to incur substantial losses for the next several years as it continues to fully develop and prepare regulatory filings and obtain regulatory approvals for its existing and new product candidates.
+Added: The Company’s current cash and cash equivalents are sufficient to fund operations for at least the next 12 months.
+Added: However, the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings, sale of a partner company, grants or other arrangements to fully develop and prepare regulatory filings and obtain regulatory approvals for the existing and new product candidates, fund operating losses, and, if deemed appropriate, establish or secure through third parties manufacturing for the potential products, sales and marketing capabilities.
+Added: If such funding is not available or not available on terms acceptable to the Company, the Company’s current development plan and plans for expansion of its selling, general and administrative infrastructure will be curtailed.
+Added: The Company also has the ability, subject to limitations imposed by Rule 144 of the Securities Act of 1933 and other applicable laws and regulations, to raise money from the sale of common stock of the public companies in which it has ownership positions.
+Added: In addition to the foregoing, the Company does not expect any material impact on its development timelines, revenue levels and its liquidity due to the worldwide spread of COVID-19 (except as may be implicated by the Material Adverse Effect claimed by InvaGen in connection with their agreement with Avenue).
+Added: However, the Company is continuing to assess the impact the spread of COVID-19 may have on its operations.
+Added: Avenue will also continue to assess the alleged Material Adverse Effect claimed by InvaGen.
Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
−Removed: The Company’s consolidated financial
−Removed: statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
−Removed: The Company’s consolidated financial statements include the accounts of the Company and the accounts of the Company’s
−Removed: subsidiaries, listed above.
+Added: The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
+Added: The Company’s consolidated financial statements include the accounts of the Company and the accounts of the Company’s subsidiaries, listed above.
All intercompany balances and transactions have been eliminated.
−Removed: The accompanying consolidated financial
−Removed: statements include the accounts of the Company’s subsidiaries.
−Removed: For consolidated entities where the Company owns less than
−Removed: 100% of the subsidiary, the Company records net loss attributable to non-controlling interests in its consolidated statements of
−Removed: operations equal to the percentage of the economic or ownership interest retained in such entities by the respective non-controlling
+Added: The accompanying consolidated financial statements include the accounts of the Company’s subsidiaries.
+Added: For consolidated entities where the Company owns less than 100% of the subsidiary, the Company records net loss attributable to non-controlling interests in its consolidated statements of operations equal to the percentage of the economic or ownership interest retained in such entities by the respective non-controlling parties.
The Company also consolidates subsidiaries in which it owns less than 50% of the subsidiary but maintains voting control.
−Removed: The Company continually assesses whether changes to existing relationships or future transactions may result in the consolidation
−Removed: or deconsolidation of partner companies.
+Added: The Company continually assesses whether changes to existing relationships or future transactions may result in the consolidation or deconsolidation of partner companies.
Use of Estimates
−Removed: The Company’s consolidated financial
−Removed: statements include certain amounts that are based on management’s best estimates and judgments.
−Removed: The Company’s significant
−Removed: estimates include, but are not limited to, useful lives assigned to long-lived assets, fair value of stock options and warrants,
−Removed: stock-based compensation, common stock issued to acquire licenses, investments, accrued expenses, provisions for income taxes and
−Removed: contingencies.
+Added: The Company’s consolidated financial statements include certain amounts that are based on management’s best estimates and judgments.
+Added: The Company’s significant estimates include, but are not limited to, useful lives assigned to long-lived assets, fair value of stock options and warrants, stock-based compensation, common stock issued to acquire licenses, investments, accrued expenses, provisions for income taxes and contingencies.
Due to the uncertainty inherent in such estimates, actual results may differ from these estimates.
Revenue Recognition
−Removed: Effective January 1, 2018, the Company began recognizing revenue
−Removed: under ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).
−Removed: The core principle of this
−Removed: revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in
−Removed: an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services.
+Added: The Company recognizes revenue under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).
+Added: The core principle of this revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services.
The following five steps are applied to achieve that core principle:
Identify the contract with the customer
−Removed: Identify the performance obligations in the
+Added: Identify the performance obligations in the contract
Determine the transaction price
−Removed: Allocate the transaction price to the performance
−Removed: obligations in the contract
−Removed: Recognize revenue when the company satisfies
−Removed: a performance obligation
−Removed: In order to identify the performance obligations in a contract
−Removed: with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service
−Removed: that is distinct.
−Removed: A performance obligation meets ASC 606’s definition of a “distinct”
−Removed: good or service (or bundle
−Removed: of goods or services) if both of the following criteria are met:
−Removed: The customer can benefit from the good or service either on
−Removed: its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being
−Removed: The entity’s promise to transfer the good or service to
−Removed: the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service
−Removed: is distinct within the context of the contract).
−Removed: If a good or service is not distinct, the good or service is
−Removed: combined with other promised goods or services until a bundle of goods or services is identified that is distinct.
−Removed: The transaction price is the amount of consideration to which
−Removed: an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected
−Removed: on behalf of third parties (for example, some sales taxes).
−Removed: The consideration promised in a contract with a customer may include
−Removed: fixed amounts, variable amounts, or both.
−Removed: Variable consideration is included in the transaction price only to the extent that it
−Removed: is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated
−Removed: with the variable consideration is subsequently resolved.
−Removed: The transaction price is allocated to each performance obligation
−Removed: on a relative standalone selling price basis.
−Removed: The transaction price allocated to each performance obligation is recognized when
−Removed: that performance obligation is satisfied, at a point in time or over time as appropriate.
−Removed: ASC 606 does not generally change the practice under which the
−Removed: Company recognizes product revenue from sales of Targadox®, Exelderm®, Luxamend®
−Removed: and Ceracade®.
−Removed: The Company’s
−Removed: performance obligation to deliver products is satisfied at the point in time that the goods are delivered to the customer, which
−Removed: is when the customer obtains title to and has the risks and rewards of ownership of the products.
−Removed: The Company has variable consideration in the form of rights
−Removed: of return, coupons, and price protection to customers.
−Removed: The Company uses an expected value method to estimate variable consideration
−Removed: and whether the transaction price is constrained.
−Removed: Payment is due within months of when the customer is invoiced, with discounts
−Removed: for prompt payment.
−Removed: Because the Company’s agreements for sales of product
−Removed: to its distributors can be cancelled early, prior to the termination date, they are deemed to have an expected duration of one
−Removed: year or less, and as such, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about
−Removed: its remaining performance obligations.
+Added: Allocate the transaction price to the performance obligations in the contract
+Added: Recognize revenue when the company satisfies a performance obligation
+Added: In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct.
+Added: A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met:
+Added: The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct).
+Added: The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract).
+Added: If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct.
+Added: The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes).
+Added: The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both.
+Added: Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
+Added: The transaction price is allocated to each performance obligation on a relative standalone selling price basis.
+Added: The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate.
+Added: The Company recognizes product revenue from sales of Ximino®, Targadox®, Exelderm®, Luxamend® and Ceracade®.
+Added: The Company’s performance obligation to deliver products is satisfied at the point in time that the goods are delivered to the customer, which is when the customer obtains title to and has the risks and rewards of ownership of the products.
+Added: The Company has variable consideration in the form of rights of return, coupons, and price protection to customers.
+Added: The Company uses an expected value method to estimate variable consideration and whether the transaction price is constrained.
+Added: Payment is due within months of when the customer is invoiced, with discounts for prompt payment.
+Added: The Company recorded expense related to returns reserve of $ 1.3 million and $ 2.9 million for the years ended December 31, 2020 and December 31, 2019, respectively.
+Added: Because the Company’s agreements for sales of product to its distributors can be cancelled early, prior to the termination date, they are deemed to have an expected duration of one year or less, and as such, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations.
Discontinued Operations
−Removed: At December 31, 2018, the Company
−Removed: determined that its National segment met the discontinued operations criteria set forth in Accounting Standards Codification (ASC)
−Removed: Subtopic 205-20-45, Presentation of Financial Statements , for the twelve months ended December 31, 2018.
−Removed: the National segment results have been classified as discontinued operations in the accompanying Consolidated Balance
−Removed: Sheets and Consolidated Statements of Operations.
−Removed: See Note 3 for more information relating to the Company’s discontinued
+Added: Pursuant to the discontinued operations criteria set forth in ASC Subtopic 205-20-45, Presentation of Financial Statements , proceeds received from the Company’s sale of its holdings in National Holding Corporation were classified as cash provided by discontinued investing activities in the Company’s cash flow statement for the year ended December 31, 2019.
+Added: See Note 3 for more information relating to the Company’s discontinued operations.
Fair Value Measurement
−Removed: The Company follows accounting guidance
−Removed: on fair value measurements for financial assets and liabilities measured at fair value on a recurring basis.
−Removed: Under the accounting
−Removed: guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer
−Removed: a liability in an orderly transaction between market participants at the measurement date.
−Removed: As such, fair value is a market-based
−Removed: measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
−Removed: The accounting guidance requires fair value
−Removed: measurements be classified and disclosed in one of the following three categories:
−Removed: Quoted prices in active markets for identical assets or
−Removed: Observable inputs other than Level 1 prices for similar
−Removed: assets or liabilities that are directly or indirectly observable in the marketplace.
−Removed: Unobservable inputs which are supported by little or no
−Removed: market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies,
−Removed: or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
−Removed: The fair value hierarchy also requires
−Removed: an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
−Removed: and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant
−Removed: to the fair value measurement.
−Removed: The Company’s assessment of the significance of a particular input to the fair value measurement
−Removed: in its entirety requires management to make judgments and consider factors specific to the asset or liability.
−Removed: Certain of the Company’s financial
−Removed: instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due
−Removed: to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
+Added: The Company follows accounting guidance on fair value measurements for financial assets and liabilities measured at fair value on a recurring basis.
+Added: Under the accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
+Added: As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
+Added: The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories:
+Added: Quoted prices in active markets for identical assets or liabilities.
+Added: Observable inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
+Added: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
+Added: The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
+Added: Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
+Added: The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
+Added: Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.
Segment Reporting
−Removed: The Company operates in two operating and
−Removed: reportable segments, Dermatology Product Sales and Pharmaceutical and Biotechnology Product Development.
−Removed: The Company evaluates
−Removed: the performance of each segment based on operating profit or loss.
−Removed: There is no inter-segment allocation of interest expense and
−Removed: income taxes.
+Added: The Company operates in two operating and reportable segments, Dermatology Product Sales and Pharmaceutical and Biotechnology Product Development.
+Added: The Company evaluates the performance of each segment based on operating profit or loss.
+Added: There is no inter-segment allocation of interest expense and income taxes.
Cash and Cash Equivalents
−Removed: The Company considers highly liquid investments
−Removed: with a maturity of three months or less when purchased to be cash equivalents.
−Removed: Cash and cash equivalents at December 31, 2019
−Removed: and at December 31, 2018 consisted of cash and certificates of deposit in institutions in the United States.
−Removed: Balances at certain
−Removed: institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S.
+Added: The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.
+Added: Cash and cash equivalents at December 31, 2020 and at December 31, 2019 consisted of cash and certificates of deposit in institutions in the United States.
+Added: Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S.
government agency securities.
Short-term Investments
−Removed: The Company classifies its certificates
−Removed: of deposit as cash and cash equivalents or held to maturity in accordance with the Financial Accounting Standards Board ("FASB")
−Removed: Accounting Standards Codification (“ASC”) 320, Investments - Debt and Equity Securities .
−Removed: The Company considers
−Removed: all short-term investments with an original maturity in excess of three months when purchased to be short-term investments.
−Removed: investments consist of short-term FDIC insured certificates of deposit with a maturity of more than three months and less than
−Removed: twelve months, carried at amortized cost using the effective interest method.
−Removed: The cost of the Company’s certificates of deposit
−Removed: approximated fair value.
−Removed: The Company reassesses the appropriateness of the classification of its investments at the end of each
−Removed: reporting period.
−Removed: At December 31, 2019, the Company
−Removed: had approximately $15.0 million in certificates of deposit, which the Company classified as cash and cash equivalents.
−Removed: no short term investments classified as held-to-maturity as of December 31, 2019.
−Removed: At December 31, 2018, the Company had
−Removed: approximately $27.6 million in certificates of deposit.
−Removed: The Company classified $10.0 million as cash and cash equivalents and classified
−Removed: $17.6 million as short-term investments (certificates of deposits) held-to-maturity as of December 31, 2018.
−Removed: This classification
−Removed: was based upon management’s determination that it has the positive intent and ability to hold the securities until their
−Removed: maturity dates, as its investments mature within one year and the underlying cash invested in these securities is not required
−Removed: for current operations.
+Added: The Company classifies its certificates of deposit as cash and cash equivalents or held to maturity in accordance with ASC 320, Investments - Debt and Equity Securities .
+Added: The Company reassesses the appropriateness of the classification of its investments at the end of each reporting period.
+Added: At December 31, 2020, the Company had approximately $ 76.8 million and $ 15.0 million, respectively, in certificates of deposit, which the Company classified as cash and cash equivalents.
+Added: There were no short term investments classified as held-to-maturity as of December 31, 2020.
Property and Equipment
−Removed: Computer equipment, furniture &
−Removed: fixtures and machinery & equipment are recorded at cost and depreciated using the straight-line method over the estimated
−Removed: useful life of each asset.
−Removed: Leasehold improvements are amortized over the shorter of the estimated useful lives or the term of the
−Removed: respective leases.
−Removed: Impairment of Long-Lived Assets
−Removed: The Company reviews long-lived assets,
−Removed: including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying
−Removed: amount of the assets may not be fully recoverable.
−Removed: Factors that the Company considers in deciding when to perform an impairment
−Removed: review include significant underperformance of the business in relation to expectations, significant negative industry or economic
−Removed: trends, and significant changes or planned changes in the use of the assets.
−Removed: If an impairment review is performed to evaluate a
−Removed: long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use
−Removed: and eventual disposition of the long-lived asset to its carrying value.
−Removed: An impairment loss would be recognized when estimated undiscounted
−Removed: future cash flows expected to result from the use of an asset are less than its carrying amount.
−Removed: The impairment loss would be based
−Removed: on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows.
+Added: Computer equipment, furniture & fixtures and machinery & equipment are recorded at cost and depreciated using the straight-line method over the estimated useful life of each asset.
+Added: Leasehold improvements are amortized over the shorter of the estimated useful lives or the term of the respective leases.
+Added: In connection with Mustang’s cell processing facility, Mustang incurred costs for the design and construction of the facility and the purchase of equipment;
+Added: $ 0.5 million and $ 1.2 million are recorded in fixed assets – construction in process on the balance sheet at December 31, 2020 and 2019, respectively.
+Added: Upon completion of the facility’s construction, all costs associated with the buildout will be recorded as leasehold improvements and amortized over the shorter of the estimated useful lives or the term of the respective leases, upon the improvement being placed in service.
Restricted Cash
−Removed: The Company records cash held in trust
−Removed: or pledged to secure certain debt obligations as restricted cash.
−Removed: As of December 31, 2019, and 2018, the Company has $16.6
−Removed: million and $16.1 million, respectively, of restricted cash collateralizing a note payable of $14.9 million in 2019 and 2018, and
−Removed: certain pledges to secure letters of credit in connection with certain office leases of $1.7 million and $1.2 million in 2019 and
−Removed: 2018, respectively.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The following table provides a reconciliation
−Removed: of cash, cash equivalents, and restricted cash from the consolidated balance sheets to the consolidated statements of cash flows
−Removed: for the years ended December 31, 2019, and 2018 ($ in thousands).
+Added: The Company records cash held in trust or pledged to secure certain debt obligations as restricted cash.
+Added: As of December 31, 2020, the Company had $ 1.6 million of restricted cash representing pledges to secure letters of credit in connection with certain office leases.
+Added: As of December 31, 2019, the Company had $ 16.6 million of restricted cash collateralizing a note payable of $ 15.0 million and $ 1.6 million in certain pledges to secure letters of credit in connection with certain office leases.
+Added: The following table provides a reconciliation of cash, cash equivalents, and restricted cash from the consolidated balance sheets to the consolidated statements of cash flows for the years ended 2020, and 2019:
+Added: ($ in thousands)
Cash and cash equivalents
1 unchanged sentence
Total cash and cash equivalents and restricted cash
−Removed: Inventories comprise finished goods, which
−Removed: are valued at the lower of cost or market, on a first-in, first-out basis.
−Removed: The Company evaluates the carrying value of inventories
−Removed: on a regular basis, taking into account anticipated future sales compared with quantities on hand, and the remaining shelf life
−Removed: of goods on hand.
−Removed: Accounts Receivable
−Removed: Accounts receivable consists of amounts
−Removed: due to the Company for product sales of JMC.
−Removed: The Company’s accounts receivable reflects discounts for estimated early payment
−Removed: and for product estimated returns.
−Removed: Accounts receivable are stated at amounts due from customers, net of an allowance for doubtful
−Removed: Accounts that are outstanding longer than the contractual payment terms are considered past due.
−Removed: The Company determines
−Removed: its allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable
−Removed: are past due and the customer’s current ability to pay its obligation to the Company.
−Removed: The Company writes off accounts
−Removed: receivable when they become uncollectible.
−Removed: The allowance for product estimated returns were $5.4 million and $3.1 million at December 31,
−Removed: 2019 and 2018, respectively.
−Removed: The Company recorded expense related to returns reserve of $2.9 million and $2.4 million for the years
−Removed: ended December 31, 2019 and 2018, respectively.
+Added: Inventories comprise finished goods, which are valued at the lower of cost and net realizable value, on a first-in, first-out basis.
+Added: The Company evaluates the carrying value of inventories on a regular basis, taking into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand.
+Added: Accounts Receivable, net
+Added: Accounts receivable consists of amounts due to the Company for product sales of JMC.
+Added: The Company’s accounts receivable reflects discounts for estimated early payment and for product estimated returns.
+Added: Accounts receivable are stated at amounts due from customers, net of an allowance for doubtful accounts that are outstanding longer than the contractual payment terms are considered past due.
+Added: The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due and the customer’s current ability to pay its obligation to the Company.
+Added: The Company writes off accounts receivable when they become uncollectible.
+Added: For the years ended December 31, 2020 and 2019 the allowance for doubtful accounts was approximately $ 0.1 million and $ 0.1 million, respectively.
+Added: The allowance for product estimated returns were $ 4.6 million and $ 5.4 million at December 31, 2020 and 2019, respectively, representing constrained revenue.
Investments at Fair Value
−Removed: The Company elects the fair value option
−Removed: for its long-term investments at fair value (see Note 6).
−Removed: The decision to elect the fair value option, which is irrevocable once
−Removed: elected, is determined on an instrument by instrument basis and applied to an entire instrument.
−Removed: The net gains or losses, if any,
−Removed: on an investment for which the fair value option has been elected are recognized as a change in fair value of investments on the
−Removed: Consolidated Statements of Operations.
−Removed: The Company elected the fair value option,
−Removed: instead of the equity method, for its investment in National as of December 31, 2018 (see Note 3).
−Removed: The Company has various processes and controls
−Removed: in place to ensure that fair value is reasonably estimated.
−Removed: While the Company believes its valuation methods are appropriate and
−Removed: consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain
−Removed: financial instruments could result in a different estimate of fair value at the reporting date.
−Removed: Fair Value Option
−Removed: As permitted under the FASB, ASC 825, Financial
−Removed: Instruments, (“ASC 825”), the Company has elected the fair value option to account for the Helocyte and Caelum
−Removed: convertible notes.
−Removed: In accordance with ASC 825, the Company records these convertible notes at fair value with changes in fair value
−Removed: recorded in the Consolidated Statement of Operations.
−Removed: As a result of applying the fair value option, direct costs and fees related
−Removed: to the Helocyte and Caelum convertible notes were recognized in earnings as incurred and were not deferred.
−Removed: During 2018, the Helocyte
−Removed: convertible notes matured and the Company repaid the principal amount due of approximately $4.4 million.
−Removed: During 2019, Caelum’s
−Removed: convertible notes were converted into Common shares of Caelum (see Note 10).
+Added: The Company elects the fair value option for its long-term investments at fair value (see Note 6).
+Added: The decision to elect the fair value option, which is irrevocable once elected, is determined on an instrument by instrument basis and applied to an entire instrument.
+Added: The net gains or losses, if any, on an investment for which the fair value option has been elected are recognized as a change in fair value of investments on the Consolidated Statements of Operations.
+Added: The Company has various processes and controls in place to ensure that fair value is reasonably estimated.
+Added: While the Company believes its valuation methods are appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date.
Accounting for Warrants at Fair Value
−Removed: The Company classifies as liabilities any
−Removed: contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs
−Removed: and if that event is outside the control of the Company) or (ii) give the counterparty a choice of net-cash settlement or
−Removed: settlement in shares (physical settlement or net-share settlement).
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The fair value of warrants that include
−Removed: price protection reset provision features are deemed to be “down-round protection”
−Removed: and, therefore, do not meet the
−Removed: scope exception for treatment as a derivative under ASC 815, Derivatives and Hedging , since “down-round protection”
−Removed: is not an input into the calculation of the fair value of warrants and cannot be considered “indexed to the Company’s
−Removed: own stock”
−Removed: which is a requirement for the scope exception as outlined under ASC 815.
−Removed: The accounting treatment of derivative
−Removed: financial instruments requires that the Company record the warrants at their fair values as of the inception date of the agreement
−Removed: and at fair value as of each subsequent balance sheet date.
−Removed: Any change in fair value is recorded as non-operating, non-cash income
−Removed: or expense for each reporting period at each balance sheet date.
−Removed: The Company reassesses the classification of its derivative instruments
−Removed: at each balance sheet date.
−Removed: If the classification changes as a result of events during the period, the contract is reclassified
−Removed: as of the date of the event that caused the reclassification.
−Removed: The Company assessed the classification
−Removed: of warrants issuable in connection with 2018 Venture Notes and determined that the Cyprium Contingently Issuable Warrants met the
−Removed: criteria for liability classification.
−Removed: Accordingly, the Company classified the Cyprium Contingently Issuable Warrants as a liability
−Removed: at their fair value and shall adjust the instruments to fair value at each balance sheet date until the warrants are issued.
−Removed: change in the fair value of the Cyprium Contingently Issuable Warrants shall be recognized as “change in the fair value of
−Removed: derivative liabilities”
−Removed: in the Consolidated Statements of Operations.
+Added: The Company classifies as liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement).
+Added: The accounting treatment of derivative financial instruments requires that the Company record the warrants at their fair values as of the inception date of the agreement and at fair value as of each subsequent balance sheet date.
+Added: Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance sheet date.
+Added: The Company reassesses the classification of its derivative instruments at each balance sheet date.
+Added: If the classification changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification.
+Added: The Company assessed the classification of warrants issuable in connection with 2018 Venture Notes and determined that the Cyprium Contingently Issuable Warrants met the criteria for liability classification.
+Added: Accordingly, the Company classified the Cyprium Contingently Issuable Warrants as a liability at their fair value and adjusted the instruments to fair value at each balance sheet date until the warrants were issued.
+Added: Any change in the fair value of the Cyprium Contingently Issuable Warrants is recognized as “change in the fair value of derivative liabilities” in the Consolidated Statements of Operations.
+Added: During the year ended December 31, 2020, Cyprium raised approximately $ 8.0 million in Cumulative Redeemable Perpetual Preferred Shares (“Cyprium Offering,” see Note 14).
+Added: The Cyprium Offering coupled with the repayment of the 2018 Venture Debt (see Note 10), triggered the issuance of the Cyprium Warrant, in that a price per share could be established.
+Added: As such these events resulted in Cyprium recording the Cyprium Warrant as issued rather than contingently issuable.
Opus Credit Facility, with Detachable Warrants
−Removed: The Company accounts for the Opus Credit
−Removed: Facility with detachable warrants in accordance with ASC 470, Debt .
−Removed: The Company assessed the classification of its common
−Removed: stock purchase warrants as of the date of the transaction and determined that such instruments meet the criteria for equity classification.
−Removed: The warrants are reported on the Consolidated Balance Sheets as a component of additional paid in capital within stockholders’
−Removed: The Company recorded the related issue
−Removed: costs and value ascribed to the warrants as a debt discount of the Opus Credit Facility.
−Removed: The discount is amortized utilizing the
−Removed: effective interest method over the term of the Opus Credit Facility.
−Removed: The unamortized discount, if any, upon repayment of the Opus
−Removed: Credit Facility will be expensed to interest expense.
−Removed: In accordance with ASC Subtopic 470-20, the Company determined the weighted
−Removed: average effective interest rate of the debt was approximately 16% at December 31, 2019.
−Removed: The Company has also evaluated the
−Removed: Opus Credit Facility and warrants in accordance with the provisions of ASC 815, Derivatives and Hedging , including consideration
−Removed: of embedded derivatives requiring bifurcation.
−Removed: As of December 31, 2019, Opus dissolved
−Removed: and is in the process of distributing its assets among its Limited Partners.
−Removed: While this dissolution will not impact any of the
−Removed: terms under the Opus Credit Facility the Company is working with Opus to amend and restate the relevant documentation, in order
−Removed: to memorialize the distribution of assets.
+Added: The Company accounted for the Opus Credit Facility (see Note 10) with detachable warrants in accordance with ASC 470, Debt .
+Added: The Company assessed the classification of its common stock purchase warrants as of the date of the transaction and determined that such instruments met the criteria for equity classification.
+Added: The warrants were reported on the Consolidated Balance Sheets as a component of additional paid in capital within stockholders’ equity.
+Added: The Company recorded the related issue costs and value ascribed to the warrants as a debt discount of the Opus Credit Facility.
+Added: The discount was amortized utilizing the effective interest method over the term of the Opus Credit Facility.
+Added: The unamortized discount, if any, upon repayment of the Opus Credit Facility would be expensed to interest expense.
+Added: In accordance with ASC Subtopic 470-20, the Company determined the weighted average effective interest rate of the debt was approximately 16 % at December 31, 2019.
+Added: The Company also evaluated the Opus Credit Facility and warrants in accordance with the provisions of ASC 815, Derivatives and Hedging , including consideration of embedded derivatives requiring bifurcation.
+Added: As of December 31, 2019, Opus dissolved and distributed its assets among its Limited Partners.
+Added: The dissolution did not impact any of the terms under the Opus Credit Facility.
+Added: During the year ended December 31, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $ 9.0 million balance previously outstanding under the Opus Credit Facility/2019 Notes (see Note 10).
Issuance of Debt and Equity
−Removed: The Company issues complex financial instruments
−Removed: which include both equity and debt features.
−Removed: The Company analyzes each instrument under ASC 480, Distinguishing Liabilities
−Removed: from Equity, ASC 815, Derivatives and Hedging and, ASC 470, Debt , in order to establish whether such instruments
−Removed: include any embedded derivatives.
+Added: The Company issues complex financial instruments which include both equity and debt features.
+Added: The Company analyzes each instrument under ASC 480, Distinguishing Liabilities from Equity, ASC 815, Derivatives and Hedging and, ASC 470, Debt , in order to establish whether such instruments include any embedded derivatives.
+Added: The Company accounted for the Oaktree Note with detachable warrants in accordance with ASC 470, Debt .
+Added: The Company assessed the classification of its common stock purchase warrants as of the date of the transaction and determined that such instruments met the criteria for equity classification.
+Added: The note proceeds were allocated between the Oaktree Note and the warrants on a relative fair value basis.
+Added: The warrants were reported on the Consolidated Balance Sheets as a component of additional paid in capital within stockholders’ equity.
+Added: The Company recorded the related issue costs and value ascribed to the warrants as a debt discount of the Oaktree Note.
+Added: The discount was amortized utilizing the effective interest method over the term of the Oaktree Note.
+Added: The unamortized discount, if any, upon repayment of the Oaktree Note would be expensed to interest expense.
+Added: In accordance with ASC Subtopic 470-20, the Company determined the weighted average effective interest rate of the debt was approximately 15.13 % at December 31, 2020.
+Added: The Company also evaluated the Oaktree Note and warrants in accordance with the provisions of ASC 815, Derivatives and Hedging , including consideration of embedded derivatives requiring bifurcation.
Long-Lived Assets
−Removed: Long-lived assets, primarily fixed assets,
−Removed: are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets might not
−Removed: be recoverable.
+Added: Long-lived assets, primarily fixed assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets might not be recoverable.
The Company will perform a periodic assessment of assets for impairment in the absence of such information or indicators.
−Removed: Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset,
−Removed: a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that
−Removed: the carrying amount of an asset or group of assets is not recoverable.
−Removed: For long-lived assets to be held and used, the Company would
−Removed: recognize an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the
−Removed: impairment loss based on the difference between the carrying amount and estimated fair value.
−Removed: As of December 31, 2019 and
−Removed: 2018 there were no indicators of impairment.
+Added: Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable.
+Added: For long-lived assets to be held and used, the Company would recognize an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and estimated fair value.
+Added: As of December 31, 2020 and 2019 there were no indicators of impairment.
Research and Development
−Removed: Research and development costs are expensed
−Removed: Advance payments for goods and services that will be used in future research and development activities are expensed
−Removed: when the activity has been performed or when the goods have been received rather than when the payment is made.
−Removed: Upfront and milestone
−Removed: payments due to third parties that perform research and development services on the Company’s behalf will be expensed as
−Removed: services are rendered or when the milestone is achieved.
−Removed: Research and development costs primarily
−Removed: consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation,
−Removed: payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to
−Removed: third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants,
−Removed: the cost of acquiring and manufacturing clinical trial materials, and costs associated with regulatory filings, laboratory costs
−Removed: and other supplies.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: In accordance with ASC 730-10-25-1, Research
−Removed: and Development , costs incurred in obtaining technology licenses are charged to research and development expense if the technology
−Removed: licensed has not reached commercial feasibility and has no alternative future use.
−Removed: Such licenses purchased by the Company require
−Removed: substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility
−Removed: and has no alternative future use.
−Removed: Accordingly, the total purchase price for the licenses acquired during the period was reflected
−Removed: as research and development - licenses acquired on the Consolidated Statements of Operations for the years ended December 31,
−Removed: 2019 and 2018.
+Added: Research and development costs are expensed as incurred.
+Added: Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
+Added: Upfront and milestone payments due to third parties that perform research and development services on the Company’s behalf will be expensed as services are rendered or when the milestone is achieved.
+Added: Research and development costs primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, and costs associated with regulatory filings, laboratory costs and other supplies.
+Added: In accordance with ASC 730-10-25-1, Research and Development , costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use.
+Added: Such licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and has no alternative future use.
+Added: Accordingly, the total purchase price for the licenses acquired during the period was reflected as research and development - licenses acquired on the Consolidated Statements of Operations for the years ended December 31, 2020 and 2019.
Contingencies
−Removed: The Company records accruals for contingencies
−Removed: and legal proceedings expected to be incurred in connection with a loss contingency when it is probable that a liability has been
−Removed: incurred and the amount can be reasonably estimated.
−Removed: If a loss contingency is not probable but
−Removed: is reasonably possible, or is probable but cannot be estimated, the nature of the contingent liability, together with an estimate
−Removed: of the range of possible loss if determinable and material, would be disclosed.
−Removed: Effective January 1, 2019, the Company
−Removed: accounts for its leases under ASC 842, Leases .
−Removed: Under this guidance, arrangements meeting the definition of a lease
−Removed: are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset
−Removed: and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the
−Removed: Company’s incremental borrowing rate.
−Removed: Lease liabilities are increased by interest and reduced by payments each period, and
−Removed: the right-of-use asset is amortized over the lease term.
−Removed: For operating leases, interest on the lease liability and the amortization
−Removed: of the right-of-use asset result in straight-line rent expense over the lease term.
−Removed: For finance leases, interest on the lease liability
−Removed: and the amortization of the right-of-use asset results in front-loaded expense over the lease term.
−Removed: Variable lease expenses are
−Removed: recorded when incurred.
−Removed: In calculating the right-of-use asset and
−Removed: lease liability, the Company elects to combine lease and non-lease components.
−Removed: The Company continues to account for leases in the
−Removed: prior period financial statements under ASC Topic 840.
+Added: The Company records accruals for contingencies and legal proceedings expected to be incurred in connection with a loss contingency when it is probable that a liability has been incurred and the amount can be reasonably estimated.
+Added: If a loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, the nature of the contingent liability, together with an estimate of the range of possible loss if determinable and material, would be disclosed.
+Added: Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases .
+Added: Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company's incremental borrowing rate.
+Added: Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term.
+Added: For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term.
+Added: For finance leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term.
+Added: Variable lease expenses are recorded when incurred.
+Added: In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components.
+Added: The Company continues to account for leases in the prior period consolidated financial statements under ASC Topic 840, Leases .
Stock-Based Compensation
−Removed: The Company expenses stock-based compensation
−Removed: to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards and
−Removed: forfeiture rates.
−Removed: For stock-based compensation awards to
−Removed: non-employees, prior to the adoption of ASU 2018-07 on January 1, 2019, the Company remeasured the fair value of the non-employee
−Removed: awards at each reporting period prior to vesting and finally at the vesting date of the award.
−Removed: Changes in the estimated fair value
−Removed: of these non-employee awards were recognized as compensation expense in the period of change.
−Removed: Subsequent to the adoption of ASU
−Removed: 2018-07, the Company recognizes non-employees compensation costs over the requisite service period based on a measurement of fair
−Removed: value for each stock award at the time the award is granted.
−Removed: The Company estimates the fair value of
−Removed: stock option grants using the Black-Scholes option pricing model or 409A valuations, as applicable.
−Removed: The assumptions used in calculating
−Removed: the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application
−Removed: of management’s judgment.
−Removed: The Company records income taxes using
−Removed: the asset and liability method.
−Removed: Deferred income tax assets and liabilities are recognized for the future tax effects attributable
−Removed: to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective
−Removed: income tax bases, and operating loss and tax credit carryforwards.
−Removed: The Company establishes a valuation allowance if management
−Removed: believes it is more likely than not that the deferred tax assets will not be recovered based on an evaluation of objective verifiable
−Removed: For tax positions that are more likely than not of being sustained upon audit, the Company recognizes the largest amount
−Removed: of the benefit that is greater than 50% likely of being realized.
−Removed: For tax positions that are not more likely than not of being
−Removed: sustained upon audit, the Company does not recognize any portion of the benefit.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
+Added: The Company expenses stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards and forfeitures, which are recorded upon occurence.
+Added: For stock-based compensation awards to non-employees, prior to the adoption of ASU 2018-07 on January 1, 2019, the Company remeasured the fair value of the non-employee awards at each reporting period prior to vesting and finally at the vesting date of the award.
+Added: Changes in the estimated fair value of these non-employee awards were recognized as compensation expense in the period of change.
+Added: Subsequent to the adoption of ASU 2018-07, the Company recognizes non-employees compensation costs over the requisite service period based on a measurement of fair value for each stock award at the time the award is granted.
+Added: The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model.
+Added: The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.
+Added: The Company accounts for income taxes under ASC 740, Income Taxes (“ASC 740”).
+Added: ASC 740 requires the recognition of deferred tax assets and liabilities for both the expected impact of differences between the financial statement and tax basis of assets and liabilities and for the expected future tax benefit to be derived from tax loss and tax credit carry forwards.
+Added: ASC 740 additionally requires a valuation allowance to be established when it is more likely than not that all or a portion of deferred tax assets will not be realized.
+Added: ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
+Added: For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities.
+Added: ASC 740 also provides guidance on de-recognition, classification, interest and penalties, accounting in interim period, disclosure and transition.
+Added: Based on the Company’s evaluation, it has been concluded that there are no significant uncertain tax positions requiring recognition in the Company’s financial statements.
+Added: The 2017 through 2019 tax years are the only periods subject to examination upon filing of appropriate tax returns.
+Added: The Company believes that its income tax positions and deductions would be sustained on audit and does not anticipate any adjustments that would result in a material change to its financial position.
+Added: The Company’s policy for recording interest and penalties associated with audits is to record such expense as a component of income tax expense.
+Added: There were no amounts accrued for penalties or interest as of or during the years ended December 31, 2020 and 2019.
+Added: Management is currently unaware of any issues under review that could result in significant payments, accruals or material deviations from its position.
Non-Controlling Interests
−Removed: Non-controlling interests in consolidated
−Removed: entities represent the component of equity in consolidated entities held by third parties.
−Removed: Any change in ownership of a subsidiary
−Removed: while the controlling financial interest is retained is accounted for as an equity transaction between the controlling and non-controlling
+Added: Non-controlling interests in consolidated entities represent the component of equity in consolidated entities held by third parties.
+Added: Any change in ownership of a subsidiary while the controlling financial interest is retained is accounted for as an equity transaction between the controlling and non-controlling interests.
Comprehensive Loss
−Removed: The Company’s comprehensive loss
−Removed: is equal to its net loss for all periods presented.
−Removed: Reclassifications
−Removed: Certain prior period amounts may have been
−Removed: reclassified to conform to the current year presentation.
+Added: The Company’s comprehensive loss is equal to its net loss for all periods presented.
Recently Adopted Accounting Pronouncements
−Removed: In June 2018, the FASB issued ASU
−Removed: 2018-07, “Improvements to Nonemployee Share-Based Payment Accounting”
−Removed: , which simplifies the accounting for share-based
−Removed: payments granted to nonemployees for goods and services.
−Removed: Under the ASU, most of the guidance on such payments to nonemployees would
−Removed: be aligned with the requirements for share-based payments granted to employees.
−Removed: The changes take effect for public companies for
−Removed: fiscal years starting after December 15, 2018, including interim periods within that fiscal year.
−Removed: For all other entities,
−Removed: the amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning
−Removed: after December 15, 2020.
−Removed: Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606.
−Removed: Company adopted ASU No.
+Added: In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820), - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement , which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements.
+Added: This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.
+Added: Early adoption is permitted upon issuance of the update.
+Added: The Company adopted ASU No.
2018-13 as of January 1, 2020.
−Removed: The adoption of this update did not have a material impact on
−Removed: the Company’s financial statements.
−Removed: In July 2017, the FASB issued ASU
−Removed: 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic
−Removed: Accounting for Certain Financial Instruments with Down Round Features;
−Removed: Replacement of the Indefinite Deferral for
−Removed: Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests
−Removed: with a Scope Exception .
−Removed: Part I of this update addresses the complexity of accounting for certain financial instruments
−Removed: with down round features.
−Removed: Down round features are features of certain equity-linked instruments (or embedded features) that result
−Removed: in the strike price being reduced on the basis of the pricing of future equity offerings.
−Removed: Current accounting guidance creates cost
−Removed: and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features
−Removed: that require fair value measurement of the entire instrument or conversion option.
−Removed: Part II of this update addresses the difficulty
−Removed: of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB
−Removed: Accounting Standards Codification.
−Removed: This pending content is the result of the indefinite deferral of accounting requirements about
−Removed: mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests.
−Removed: The amendments in Part II of this update do not have an accounting effect.
−Removed: This ASU is effective for fiscal years, and interim
−Removed: periods within those years, beginning after December 15, 2018.
−Removed: The adoption of this ASU on January 1, 2019, did not have
−Removed: a material impact on the Company’s financial statements.
−Removed: In February 2016, the FASB issued
−Removed: ASU 2016-02, Leases (Topic 842) in order to increase transparency and comparability among organizations by, among
−Removed: other provisions, recognizing lease assets and lease liabilities on the balance sheet for those leases classified as operating
−Removed: leases under previous GAAP.
−Removed: For public companies, ASU 2016-02 is effective for fiscal years beginning after December 15, 2018
−Removed: (including interim periods within those periods) using a modified retrospective approach and early adoption is permitted.
−Removed: In transition, entities may also elect a package of practical expedients that must be applied in its entirety to all leases commencing
−Removed: before the adoption date, unless the lease is modified, and permits entities to not reassess (a) the existence of a lease,
−Removed: (b) lease classification or (c) determination of initial direct costs, as of the adoption date, which effectively allows
−Removed: entities to carryforward accounting conclusions under previous U.S.
−Removed: In July 2018, the FASB issued ASU 2018-11,
−Removed: Leases (Topic 842):
−Removed: Targeted Improvements , which provides entities an optional transition method to apply the guidance under
−Removed: Topic 842 as of the adoption date, rather than as of the earliest period presented.
−Removed: The Company adopted Topic 842 on January 1,
−Removed: 2019, using the optional transition method by recording a right of use asset of $23.0 million, a lease liability of $26.8 million
−Removed: and eliminated deferred rent of approximately $3.8 million;
−Removed: there was no effect on opening retained earnings, and the Company continues
−Removed: to account for leases in the prior period financial statements under ASC Topic 840.
−Removed: In adopting the new standard, the Company elected
−Removed: to apply the practical expedients regarding the identification of leases, lease classification, indirect costs, and the combination
−Removed: of lease and non-lease components.
−Removed: the Financial Accounting Standards Board (“FASB”) issued an Accounting Standards
−Removed: Update (“ASU”) 2017-09, Compensation-Stock Compensation (Topic 718):
−Removed: Scope of Modification
−Removed: Accounting , which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification.
−Removed: Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification
−Removed: of the award (as equity or liability) changes as a result of the change in terms or conditions.
−Removed: The new standard was effective
−Removed: on January 1, 2018;
−Removed: however, early adoption is permitted.
+Added: The adoption of this update did not have a material impact on the Company’s consolidated financial statements.
+Added: In June 2018, the FASB issued ASU 2018-07, “Improvements to Nonemployee Share-Based Payment Accounting” , which simplifies the accounting for share-based payments granted to nonemployees for goods and services.
+Added: Under the ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees.
+Added: The changes take effect for public companies for fiscal years starting after December 15, 2018, including interim periods within that fiscal year.
+Added: For all other entities, the amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020.
+Added: Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606.
The Company adopted ASU No.
2018-07 as of January 1, 2019.
−Removed: The adoption of this update did not impact the Company’s financial statements.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: In January 2017,
−Removed: the FASB issued an ASU 2017-01, “
−Removed: Business Combinations
−Removed: (Topic 805) Clarifying the Definition of a Business ”.
−Removed: The amendments in this ASU clarify the definition
−Removed: of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted
−Removed: for as acquisitions (or disposals) of assets or businesses.
−Removed: The definition of a business affects many areas of accounting
−Removed: including acquisitions, disposals, goodwill, and consolidation.
−Removed: The guidance is effective for annual periods beginning after December 15,
−Removed: 2017, including interim periods within those periods.
−Removed: The Company adopted ASU 2017-01 on January 1, 2018.
−Removed: of this update did not impact the Company’s financial statements.
+Added: The adoption of this update did not have a material impact on the Company’s consolidated financial statements.
+Added: In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815):
+Added: Accounting for Certain Financial Instruments with Down Round Features;
+Added: Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception .
+Added: Part I of this update addresses the complexity of accounting for certain financial instruments with down round features.
+Added: Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings.
+Added: Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option.
+Added: Part II of this update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification.
+Added: This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests.
+Added: The amendments in Part II of this update do not have an accounting effect.
+Added: This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018.
+Added: The adoption of this ASU on January 1, 2019, did not have a material impact on the Company's consolidated financial statements.
+Added: In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) in order to increase transparency and comparability among organizations by, among other provisions, recognizing lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous GAAP.
+Added: For public companies, ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 (including interim periods within those periods) using a modified retrospective approach and early adoption is permitted.
+Added: In transition, entities may also elect a package of practical expedients that must be applied in its entirety to all leases commencing before the adoption date, unless the lease is modified, and permits entities to not reassess (a) the existence of a lease, (b) lease classification or (c) determination of initial direct costs, as of the adoption date, which effectively allows entities to carryforward accounting conclusions under previous U.S.
+Added: In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842):
+Added: Targeted Improvements , which provides entities an optional transition method to apply the guidance under Topic 842 as of the adoption date, rather than as of the earliest period presented.
+Added: The Company adopted Topic 842 on January 1, 2019, using the optional transition method by recording a right of use asset of $ 23.0 million, a lease liability of $ 26.8 million and eliminated deferred rent of approximately $ 3.8 million;
+Added: there was no effect on opening retained earnings, and the Company continues to account for leases in the prior period financial statements under ASC Topic 840.
+Added: In adopting the new standard, the Company elected to apply the practical expedients regarding the identification of leases, lease classification, indirect costs, and the combination of lease and non-lease components.
Recent Accounting Pronouncements
−Removed: June 2016, the FASB issued ASU 2016-13, “Financial Instruments –
−Removed: Credit Losses”
−Removed: The ASU sets forth
−Removed: a “current expected credit loss”
−Removed: (CECL) model which requires the Company to measure all expected credit losses for
−Removed: financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable
−Removed: This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets
−Removed: measured at amortized cost and applies to some off-balance sheet credit exposures.
−Removed: This ASU is effective for fiscal years beginning
−Removed: after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted.
−Removed: the FASB issued the final ASU to delay adoption for smaller reporting companies to calendar year 2023.
−Removed: Company is currently assessing the impact of the adoption of this ASU on its financial statements .
−Removed: In August 2018, the FASB issued ASU
−Removed: 2018-13, Fair Value Measurement (Topic 820), - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value
−Removed: Measurement , which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with
−Removed: the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements.
−Removed: This guidance is effective
−Removed: for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.
−Removed: Early adoption is permitted
−Removed: upon issuance of the update.
−Removed: The Company does not expect the adoption of this guidance to have a material impact on its financial
−Removed: December 2019, the FASB issued ASU No.
−Removed: 2019-12, “Income Taxes (Topic 740):
−Removed: Simplifying the Accounting for Income
−Removed: Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes.
−Removed: 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance
−Removed: to improve consistent application.
−Removed: This guidance is effective for fiscal years, and interim periods within those fiscal years,
−Removed: beginning after December 15, 2020, with early adoption permitted.
−Removed: The Company is currently evaluating the impact of this standard
−Removed: on its consolidated financial statements and related disclosures.
+Added: In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses” .
+Added: The ASU sets forth a “current expected credit loss” (CECL) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts.
+Added: This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures.
+Added: This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted.
+Added: Recently, the FASB issued the final ASU to delay adoption for smaller reporting companies to calendar year 2023.
+Added: The Company is currently assessing the impact of the adoption of this ASU on its consolidated financial statements.
+Added: In December 2019, the FASB issued ASU No.
+Added: 2019-12, “Income Taxes (Topic 740):
+Added: Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes.
+Added: ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application.
+Added: This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
+Added: The Company adopted the new guidance in the first quarter of 2021 and the adoption of this guidance did not to have a material impact on the financial statements.
Discontinued Operations
−Removed: As of December 31, 2018, the Company
−Removed: recorded its investment in National at fair value of $13.1 million or $3.25 per share.
−Removed: This holding is reported on the Company’s
−Removed: Consolidated Balance Sheets as current assets held for sale on December 31, 2018.
−Removed: Pursuant to the terms of the NHC agreement
−Removed: the Company also recorded a net gain of $2.3 million related to the transactions which is included in discontinued operations in
−Removed: the consolidated statement of operations for the twelve months ended December 31, 2018.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The following is a summary of revenue and
−Removed: expenses of National for the year ended December 31, 2018:
−Removed: ($ in thousands)
−Removed: Operating expenses
−Removed: Commissions, compensation and fees
−Removed: Clearing fees
−Removed: Communications
−Removed: Licenses and registration
−Removed: Professional fees
−Removed: Depreciation and amortization
−Removed: Other administrative expenses
−Removed: Total operating expenses
−Removed: Gain from operations
−Removed: Other income (expense)
−Removed: Change in fair value of warrants
−Removed: Total other (expense) income
−Removed: Loss from discontinued operations before income taxes
−Removed: Income tax expense
−Removed: Loss from discontinued operations
−Removed: Gain from disposal of National
−Removed: Total loss from discontinued operations, net of tax
−Removed: In connection with this sale, the Company
−Removed: classified the assets and liabilities related to NHLD, included on its consolidated balance sheet as of December 31, 2018,
−Removed: as held for sale as presented in the table below:
−Removed: ($ in thousands)
−Removed: Current assets
−Removed: Current assets held for sale
−Removed: Total current assets held for sale
−Removed: Total assets held for sale
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The table below depicts the cash flows
−Removed: from the transaction for the year ended December 31, 2018:
+Added: On November 14, 2018, the Company announced that it had reached an agreement with NHC Holdings, LLC (“NHC”) to sell all of its shares of National Holdings Corporation, a diversified independent brokerage company (together with its subsidiaries, herein referred to as “NHLD” or “National”) for total consideration of $ 22.9 million.
+Added: Pursuant to the terms of the agreement with NHC the sale of the shares was subject to two closings.
+Added: The first closing occurred on November 14, 2018 in which the Company sold approximately 3.0 million of its shares in NHLD and received $ 9.8 million in proceeds.
+Added: The second closing occurred on February 11, 2019 upon the receipt of FINRA approval of the sale in which the Company received $ 13.1 million in proceeds for the sale of its remaining 4.0 million shares of NHLD to NHC and two other minority holders.
+Added: At December 31, 2019, the Company had no ownership interest in National.
+Added: The table below depicts the cash flows from the transaction for the year ended December 31, 2019:
+Added: For the Year Ended
($ in thousands)
−Removed: Operating activities
−Removed: Effect of elimination entry with discontinued operations presentation
−Removed: Total cash used in discontinued operating activities
Investing activities
3 unchanged sentences
Agreement with Alexion
−Removed: In January 2019, Caelum, a subsidiary
−Removed: of the Company, entered into a Development, Option and Stock Purchase Agreement (the “
−Removed: DOSPA ”)
−Removed: and related documents by and among Caelum, Alexion Therapeutics, Inc.
−Removed: Alexion ”),
−Removed: the Company and Caelum security holders parties thereto (including Fortress, the “
−Removed: Sellers ”).
+Added: In January 2019, Caelum, a subsidiary of the Company at that time, entered into a Development, Option and Stock Purchase Agreement (the "DOSPA") and related documents by and among Caelum, Alexion Therapeutics, Inc.
+Added: ("Alexion"), the Company and Caelum security holders parties thereto (including Fortress, the "Sellers").
Under the terms of the agreement, Alexion purchased a 19.9 % minority equity interest in Caelum for $ 30 million.
−Removed: Additionally, Alexion
−Removed: has agreed to make potential payments to Caelum upon the achievement of certain developmental milestones, in exchange for which
−Removed: Alexion obtained a contingent exclusive option to acquire the remaining equity in Caelum.
−Removed: The agreement also provides
−Removed: for potential additional payments, in the event Alexion exercises the purchase option, for up to $500 million, which
−Removed: includes an upfront option exercise payment and potential regulatory and commercial milestone payments.
−Removed: The Company deconsolidated its holdings
−Removed: in Caelum immediately prior to the execution of the DOSPA.
−Removed: Following the DOSPA execution,
−Removed: the Company owns approximately 40% of the issued and outstanding capital stock of Caelum.
−Removed: The following table provides a
−Removed: summary of the assets and liabilities of Caelum impacted by the deconsolidation:
+Added: Additionally, Alexion has agreed to make potential payments to Caelum upon the achievement of certain developmental milestones, in exchange for which Alexion obtained a contingent exclusive option to acquire the remaining equity in Caelum.
+Added: The agreement also provides for potential additional payments, in the event Alexion exercises the purchase option, for up to $ 500 million, which includes an upfront option exercise payment and potential regulatory and commercial milestone payments.
+Added: Alexion’s 19.9 % ownership does not participate in the potential additional payments.
+Added: The Company deconsolidated its holdings in Caelum immediately prior to the execution of the DOSPA.
+Added: Following the DOSPA execution, the Company owns approximately 40 % of the issued and outstanding capital stock of Caelum.
+Added: The following table provides a summary of the assets and liabilities of Caelum impacted by the deconsolidation:
($ in thousands)
11 unchanged sentences
Net liability impacted by deconsolidation
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: In connection with this transaction the
−Removed: Company recorded a gain resulting from the deconsolidation of Caelum on its consolidated financial statements for the year ended
−Removed: December 31, 2019:
+Added: In connection with this transaction the Company recorded a gain resulting from the deconsolidation of Caelum on its consolidated financial statements for the year ended December 31, 2019:
+Added: deconsolidation of
($ in thousands)
−Removed: deconsolidation
Fair value of Caelum
3 unchanged sentences
Gain on deconsolidation of Caelum
+Added: In December 2019, following FDA feedback which resulted in the redesign and expansion of Caelum’s planned clinical development program for CAEL-101, Caelum entered into an Amended and Restated DOSPA (“A&R DOSPA”), which amended the terms of the existing agreement with Alexion.
+Added: The amendment modified the terms of Alexion’s option to acquire the remaining equity in Caelum based on data from the expanded Phase II/III trials.
+Added: The amendment also modified the development-related milestone events associated with the initial $ 30.0 million in contingent payments, provided for an additional $ 20.0 million in upfront funding, as well as funding of $ 60.0 million in exchange for an additional equity interest in Caelum at fair value upon achievement of a specific development-related milestone event.
+Added: On December 12, 2020, AstraZeneca (“AZ”) announced its intention to acquire Alexion, with the acquisition expected to close by the third quarter of 2021, as the acquisition is subject to approval by both AZ and Alexion shareholders, as well as certain regulatory approvals, share listing approvals, and other customary closing conditions.
+Added: The acquisition of Alexion by AZ triggers the Change of Control clause in the A&R DOSPA, such that Alexion’s purchase option expires on the date that is six months after the closing of any Change of Control.
Agreement with InvaGen
−Removed: On November 12, 2018, the Company’s
−Removed: partner company Avenue entered into a Stock Purchase and Merger Agreement (“SPMA”) with InvaGen Pharmaceuticals Inc.
−Removed: (“InvaGen”) and Madison Pharmaceuticals Inc., a newly formed, wholly-owned subsidiary of InvaGen.
−Removed: Pursuant to the SPMA,
−Removed: and following approval by Avenue’s stockholders on February 8, 2019, InvaGen purchased a number of shares of Avenue
−Removed: common stock representing 33.3% of Avenue’s fully diluted capital stock for net proceeds to Avenue of $31.5 million (after
−Removed: deducting fees and other offering-related costs).
−Removed: Upon the achievement of certain closing
−Removed: conditions (including most notably U.S.
−Removed: Food and Drug Administration approval for IV Tramadol, Avenue’s product candidate), InvaGen
−Removed: will be obligated to acquire Avenue via reverse subsidiary merger (the “Merger Transaction”).
−Removed: Under the Merger Transaction, InvaGen
−Removed: will pay $180 million (subject to certain potential reductions) to the holders of Avenue’s capital stock (other than InvaGen
−Removed: Subject to the terms and conditions described
−Removed: in the SPMA, InvaGen may also provide interim financing to Avenue in an amount of up to $7.0 million during the time period
−Removed: between February 8, 2019 and the Merger Transaction.
−Removed: Any amounts drawn on the interim financing will be deducted from the
−Removed: aggregate consideration payable to Company stockholders by virtue of the Merger Transaction.
−Removed: Prior to the closing of the Merger Transaction,
−Removed: Avenue will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) with a trust company as rights agent,
−Removed: pursuant to which holders of common shares of Avenue, other than InvaGen (each, a “Holder”), will be entitled to receive
−Removed: on Contingent Value Right (“CVR”) for each share held immediately prior to the Merger Transaction.
−Removed: Each CVR represents the right of its holder
−Removed: to receive a contingent cash payment pursuant to the CVR Agreement upon the achievement of certain milestones.
−Removed: If, during the period
−Removed: commencing on the day following the closing of the Merger Transaction until December 31, 2028, IV Tramadol generates
−Removed: at least $325 million or more in Net Sales (as defined in the CVR Agreement) in a calendar year, each Holder shall be entitled
−Removed: to receive their pro rata share of (i) if the product generated less than $400 million in Net Sales during such calendar year,
−Removed: 10% of Gross Profit (as defined in the CVR Agreement), (ii) if the product generated between $400 million and $500 million
−Removed: in Net Sales during such calendar year, 12.5% of Gross Profit, or (iii) if the product generated more than $500 million in
−Removed: Net Sales during such calendar year, 15% of Gross Profit.
−Removed: Additionally, at any time beginning on January 1, 2029 that IV Tramadol
−Removed: has generated at least $1.5 billion in aggregate Net Sales, then with respect to each calendar year in which IV Tramadol generates
−Removed: $100 million or more in Net Sales, each Holder shall be entitled to receive their pro rata share of an amount equal to 20% of the
−Removed: Gross Profit generated by IV Tramadol.
−Removed: These additional payments will terminate on the earlier of December 31, 2036 and the
−Removed: date (which may be extended by up to 6 months) that any person has received approval from the FDA for an Abbreviated New Drug Application
−Removed: or an FDA AP-rated 505(b)(2) NDA using IV Tramadol.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: Property and Equipment
−Removed: Fortress’
+Added: On November 12, 2018, Avenue entered into a Stock Purchase and Merger Agreement (the “Avenue SPMA”) with InvaGen Pharmaceuticals Inc.
+Added: (“InvaGen”), and Madison Pharmaceuticals Inc.
+Added: (the “Merger Sub”), under which Avenue would be sold to InvaGen in a two-stage transaction.
+Added: The first stage of the strategic transaction between InvaGen and Avenue closed in February 2019.
+Added: InvaGen acquired approximately 5.8 million shares of Avenue’s common stock at $ 6.00 per share for total gross consideration of $ 35.0 million, representing a 33.3 % stake in Avenue’s capital stock on a fully diluted basis.
+Added: At the second stage closing, InvaGen would acquire the remaining shares of Avenue’s common stock, pursuant to a reverse triangular merger with Avenue remaining as the surviving entity.
+Added: The second stage closing is subject to the satisfaction of certain closing conditions, including conditions pertaining to the FDA approval, labeling, scheduling and the absence of any Risk Evaluation and Mitigation Strategy or similar restrictions in effect with respect to IV Tramadol, as well as the expiration of any waiting period applicable to the acquisition under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR”).
+Added: In October 2020, InvaGen communicated to Avenue that it believes a Material Adverse Effect (as defined in the Avenue SPMA) has occurred due to the impact of the COVID-19 pandemic on potential commercialization and projected sales of IV Tramadol, which means it is possible InvaGen could attempt to avoid its obligation to consummate the second stage closing under the Avenue SPMA, terminate the Avenue SPMA, and/or pursue monetary claims against Avenue and/or Fortress.
+Added: Avenue disagrees with InvaGen’s assertion that a Material Adverse Effect has occurred and has advised InvaGen of this position.
+Added: In February 2020, the U.S.
+Added: Food and Drug Administration (“FDA”) accepted the submission of Avenue’s’ New Drug Application (“NDA”) for IV Tramadol for review and assigned a Prescription Drug User Fee Act (“PDUFA”) date of October 10, 2020.
+Added: In October 2020, Avenue announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding Avenue’s NDA for IV Tramadol.
+Added: The FDA held a Type A meeting with Avenue in November 2020 to discuss the issues outlined in the CRL.
+Added: On February 12, 2021 Avenue resubmitted its NDA to the FDA for IV Tramadol.
+Added: The NDA resubmission followed the receipt of the official minutes from Avenue’s Type A meeting with the FDA.
+Added: The NDA resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation.
+Added: On February 26, 2021, Avenue received an acknowledgement letter from the FDA that Avenue’s resubmission of its NDA is a complete, class 1 response to the CRL, and a PDUFA goal date was set for April 12, 2021.
+Added: In connection with the resubmission of Avenue’s NDA, InvaGen communicated to Avenue that it believes the proposed label for IV Tramadol under certain circumstances would constitute a Material Adverse Effect on the purported basis that the proposed label for IV Tramadol would make the product commercially unviable, and in addition that the indiciation that the FDA approves may fail to satisfy a condition precedent to InvaGen’s obligation to consummate the second stage closing of the Avenue SPMA.
+Added: Avenue has notified InvaGen that it disagrees with InvaGen’s assertions.
+Added: Nevertheless, InvaGen may seek to avoid its obligation to consummate the second stage closing under the Avenue SPMA, terminate the Avenue SPMA, and/or pursue monetary claims against Avenue and/or Fortress.
+Added: Over the past several months, Avenue has communicated with InvaGen relating to InvaGen’s assertions.
+Added: Nevertheless, InvaGen has communicated to Avenue its desire to consider all options on the proposed merger, including the option to not consummate the merger.
+Added: This indicates that InvaGen may attempt to avoid its obligations under the Avenue SPMA to consummate the merger, terminate the Avenue SPMA, and/or pursue monetary claims against Avenue and/or Fortress.
+Added: As a result, the possible timing and likelihood of the completion of the merger are uncertain, and, accordingly, there can be no assurance that such transaction will be completed on the expected terms, anticipated schedule, or at all.
+Added: During the pendency of any dispute regarding these matters, Avenue may be, and so long as the Avenue SPMA remains in place Avenue will be, prohibited from engaging in a change-of-control transaction, selling its rights to IV Tramadol or effecting an equity or debt financing, in each case without the prior written consent of InvaGen.
+Added: Subject to the terms and conditions described in the Avenue SPMA, InvaGen may also provide interim financing to Avenue in an amount of up to $ 7.0 million during the time period between February 8, 2019 and the Merger Transaction.
+Added: Any amounts drawn on the interim financing will be deducted from the aggregate consideration payable to Company stockholders by virtue of the Merger Transaction.
+Added: There have been no amounts drawn upon this interim financing as of December 31, 2020.
+Added: Prior to the closing of the Merger Transaction, Avenue will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) with a trust company as rights agent, pursuant to which holders of common shares of Avenue, other than InvaGen (each, a “Holder”), will be entitled to receive on Contingent Value Right (“CVR”) for each share held immediately prior to the Merger Transaction.
+Added: Each CVR represents the right of its holder to receive a contingent cash payment pursuant to the CVR Agreement upon the achievement of certain milestones.
+Added: If, during the period commencing on the day following the closing of the Merger Transaction until December 31, 2028, IV Tramadol generates at least $ 325 million or more in Net Sales (as defined in the CVR Agreement) in a calendar year, each Holder shall be entitled to receive their pro rata share of (i) if the product generated less than $ 400 million in Net Sales during such calendar year, 10 % of Gross Profit (as defined in the CVR Agreement), (ii) if the product generated between $ 400 million and $ 500 million in Net Sales during such calendar year, 12.5 % of Gross Profit, or (iii) if the product generated more than $ 500 million in Net Sales during such calendar year, 15 % of Gross Profit.
+Added: Additionally, at any time beginning on January 1, 2029 that IV Tramadol has generated at least $ 1.5 billion in aggregate Net Sales, then with respect to each calendar year in which IV Tramadol generates $ 100 million or more in Net Sales, each Holder shall be entitled to receive their pro rata share of an amount equal to 20 % of the Gross Profit generated by IV Tramadol.
+Added: These additional payments will terminate on the earlier of December 31, 2036 and the date (which may be extended by up to 6 months) that any person has received approval from the FDA for an Abbreviated New Drug Application or an FDA AP-rated 505(b)(2) NDA using IV Tramadol.
Property and Equipment
−Removed: consisted of the following:
+Added: Fortress’ property and equipment consisted of the following:
($ in thousands)
−Removed: Useful Life (Years)
Computer equipment
6 unchanged sentences
Property and equipment, net
−Removed: Relates to the Mustang cell processing
−Removed: Depreciation expenses of Fortress’
−Removed: property and equipment for the years ended December 31, 2019 and 2018 was $1.9 million and $1.4 million, respectively, and
−Removed: was recorded in research and development, manufacturing and general and administrative expense in the Consolidated Statements of
+Added: Relates to the Mustang cell processing facility.
+Added: Depreciation expenses of Fortress’ property and equipment for the years ended December 31, 2020 and 2019 was $ 2.3 million and $ 1.9 million, respectively, and was recorded in research and development, and selling, general and administrative expense in the Consolidated Statements of Operations.
Fair Value Measurements
−Removed: Certain of the Company’s financial
−Removed: instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due
−Removed: to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.
+Added: Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable, accrued expenses and other current liabilities.
Fair Value of Caelum
−Removed: The Company valued its investment in Caelum
−Removed: in accordance with ASC Topic 820, Fair Value Measurements and Disclosures , and estimated the fair value to be $11.1 million
−Removed: based on a per share value of $1.543.
−Removed: The following inputs were utilized to derive the value:
−Removed: risk free rate of return of 1.6%,
−Removed: volatility of 70% and a discount for lack of marketability of 28.7%.
−Removed: In connection with the DOSPA Caelum’s
−Removed: convertible notes automatically converted into common shares of Caelum and the warrant liability payable to the placement agent
−Removed: in connection with the placement of the convertible notes was also issued (see Note 10).
+Added: The Company values its investment in Caelum in accordance with ASC Topic 820, Fair Value Measurements and Disclosures , and as of December 31, 2020, estimated the fair value to be $ 17.6 million based on a per share value of $ 2.43 .
+Added: As of December 31, 2020, the following inputs were utilized to derive the value:
+Added: risk free rate of return of 0.36 %, volatility of 70 % and a discount for lack of marketability of 21.0 % to 31.0 % based on maturity dates of various scenerios.
+Added: Further, the Company considered the impact of the acquisition of Alexion by AZ, which if consummated, will shorten the timeframe in which the option will be exercised in accordance with the A&R DOSPA.
+Added: As of December 31, 2019, the estimated fair value of the Company’s investment in Caelum was $ 11.1 million based on a per share value of $ 1.54 .
+Added: As of December 31, 2019, the following inputs were utilized to derive the value:
+Added: risk free rate of return of 1.6 %, volatility of 70 % and a discount for lack of marketability of 28.7 %.
Caelum Warrant Liability
−Removed: The fair value of Caelum's warrant liability,
−Removed: which was issued in connection with Caelum’s convertible note, was written up to the full value of the liability at December 31,
−Removed: 2018 due to the conversion of the notes in January 2019 (see Note 4).
−Removed: The fair value at December 31, 2018 was measured
−Removed: using a Monte Carlo simulation valuation methodology.
−Removed: A summary of the weighted average (in aggregate) significant unobservable
−Removed: inputs (Level 3 inputs) used in measuring Caelum’s warrant liabilities that are categorized within Level 3 of the fair value
−Removed: hierarchy as of December 31, 2018 are as follows:
−Removed: December 31, 2018
+Added: The fair value of Caelum's warrant liability, which was issued in connection with Caelum’s convertible note, was written up to the full value of the liability prior to the conversion of the notes in January 2019 (see Note 10).
+Added: The fair value was measured using a Monte Carlo simulation valuation methodology.
+Added: A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring Caelum’s warrant liabilities that are categorized within Level 3 of the fair value hierarchy as of January 2019 was as follows:
Risk-free interest rate
−Removed: 2.905% –
+Added: 2.905 % - 2.909
Expected dividend yield
1 unchanged sentence
Expected volatility
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: ($ in thousands)
+Added: In connection with the DOSPA Caelum's convertible notes automatically converted into common shares of Caelum and the warrant liability payable to the placement agent in connection with the placement of the convertible notes was also issued (see Note 10).
Fair Value of
−Removed: Warrant Liability
−Removed: Ending balance at January 1, 2018
−Removed: Change in fair value of derivative liability
−Removed: Ending balance at December 31, 2018
+Added: ($ in thousands)
+Added: Beginning balance at January 1, 2019
Issuance of warrant due to conversion of note
1 unchanged sentence
Caelum Convertible Notes
−Removed: Caelum’s convertible debt was measured
−Removed: at fair value using the Monte Carlo simulation valuation methodology.
−Removed: A summary of the weighted average (in aggregate) significant
−Removed: unobservable inputs (Level 3 inputs) used in measuring Caelum’s convertible debt that is categorized within Level 3.
−Removed: December 31, 2018, conversion of the Caelum Convertible Notes was probable and as such the fair value approximated cost.
−Removed: Caelum Convertible Notes were converted during 2019.
−Removed: For the year ended December 31, 2018 the following inputs were utilized
−Removed: to derive the notes’
−Removed: December 31, 2018
+Added: Caelum’s convertible debt was measured at fair value using the Monte Carlo simulation valuation methodology.
+Added: A summary of the weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring Caelum’s convertible debt that is categorized within Level 3.
+Added: As of December 31, 2018, conversion of the Caelum Convertible Notes was probable and as such the fair value approximated cost.
+Added: The Caelum Convertible Notes were converted during 2019.
+Added: As of January 2019 the following inputs were utilized to derive the notes’ fair value:
Risk-free interest rate
2 unchanged sentences
Expected volatility
−Removed: ($ in thousands)
Notes, at fair
−Removed: Ending balance at December 31, 2017
+Added: ($ in thousands)
+Added: Beginning balance at January 1, 2019
Change in fair value of convertible notes
Ending balance at December 31, 2019
−Removed: Conversion of the convertible notes
−Removed: Ending balance at December 31, 2019
Cyprium Warrant Liability
−Removed: The fair value of the Cyprium Contingently
−Removed: Issuable Warrants in connection with the 2018 Venture Debt was determined by applying management’s estimate of the probability
−Removed: of issuance of the Contingently Issuable Warrants together with an option-pricing model, with the following key assumptions:
+Added: The fair value of the Cyprium Contingently Issuable Warrants in connection with the 2018 Venture Debt was determined by applying management’s estimate of the probability of issuance of the Contingently Issuable Warrants together with an option-pricing model, with the following key assumptions:
Risk-free interest rate
3 unchanged sentences
Probability of issuance of the warrant
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
+Added: Issuable Warrant
($ in thousands)
−Removed: Cyprium Contingently
−Removed: Issuable Warrant Liability
−Removed: Ending balance at January 1, 2019
−Removed: Issuance of warrant due to probability of financing
+Added: Beginning balance at January 1, 2019
+Added: Change in fair value
Ending balance at December 31, 2019
−Removed: The following tables classify into the
−Removed: fair value hierarchy of Fortress’
−Removed: financial instruments, measured at fair value on a recurring basis on the Consolidated
−Removed: Balance Sheets as of December 31, 2019 and 2018:
+Added: Change in fair value
+Added: Reclass partner company's warrants from liability to equity
+Added: Ending balance at December 31, 2020
+Added: The following tables classify into the fair value hierarchy of Fortress’ financial instruments, measured at fair value on a recurring basis on the Consolidated Balance Sheets as of December 31, 2020 and 2019:
Fair Value Measurement as of December 31, 2020
3 unchanged sentences
($ in thousands)
−Removed: Warrant liabilities
+Added: Fair value of investment in Caelum
Fair Value Measurement as of December 31, 2019
1 unchanged sentence
Warrant liabilities
−Removed: Caelum Convertible Note, at fair value
−Removed: The table below provides a roll forward
−Removed: of the changes in fair value of Level 3 financial instruments for the years ended December 31, 2019 and 2018:
+Added: The table below provides a roll forward of the changes in fair value of Level 3 financial instruments for the years ended December 31, 2020 and 2019:
+Added: Investment in
($ in thousands)
Balance at December 31, 2019
−Removed: Conversion of convertible notes
−Removed: Issuance of warrant
−Removed: Contingent warrant liability
−Removed: Fair value of investment
+Added: Change in fair value
+Added: Reclass partner company's warrants from liability to equity
+Added: Change in fair value of investments
Balance at December 31, 2020
−Removed: Convertible Notes at fair value
+Added: Caelum Convertible
($ in thousands)
Balance at December 31, 2018
−Removed: Payment of convertible note
−Removed: Disposal of National
−Removed: Change in fair value of investments
−Removed: Change in fair value of convertible notes
−Removed: Change in fair value of derivative liabilities
+Added: Conversion of convertible notes
+Added: Issuance of warrant
+Added: Fair value of investment
+Added: Change in fair value of derivative liability
Balance at December 31, 2019
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
Licenses Acquired
−Removed: In accordance with ASC 730-10-25-1, Research
−Removed: and Development , costs incurred in obtaining technology licenses are charged to research and development expense if the technology
−Removed: licensed has not reached commercial feasibility and has no alternative future use.
−Removed: The licenses purchased by the Company require
−Removed: substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility
−Removed: and has no alternate use.
−Removed: As such, for the years ended December 31, 2019 and 2018, the total purchase price of licenses acquired,
−Removed: totaling approximately $6.1 million and $4.1 million, respectively, was classified as research and development-licenses acquired
−Removed: in the Consolidated Statements of Operations.
−Removed: For the years ended December 31, 2019 and 2018, the Company’s
−Removed: research and development-licenses acquired are comprised of the following:
−Removed: For the Years Ended
+Added: In accordance with ASC 730-10-25-1, Research and Development , costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use.
+Added: The licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and has no alternate use.
+Added: As such, for the years ended December 31, 2020 and 2019, the total purchase price of licenses acquired, totaling approximately $ 2.8 million and $ 6.1 million, respectively, was classified as research and development-licenses acquired in the Consolidated Statements of Operations.
+Added: For the years ended December 31, 2020 and 2019, the Company’s research and development-licenses acquired are comprised of the following:
+Added: For the Year Ended
($ in thousands)
Partner companies:
−Removed: License Agreement with Revogenex Ireland
−Removed: In 2015, the Company purchased an exclusive
−Removed: license to IV Tramadol for the U.S.
−Removed: market from Revogenex, a privately held company in Dublin, Ireland, for an upfront fee
−Removed: of $3.0 million.
+Added: License Agreement with University of Massachusetts
+Added: On December 17, 2020, Aevitas entered into an exclusive license agreement (the “UMass license”) with the University of Massachusetts to obtain an exclusive license to the University’s intellectual property rights which relate to gene therapy for Factor H deficiency.
+Added: For the year ended December 31, 2020, Aevitas recorded $ 0.1 million in connection with the execution of the UMass License.
+Added: Development milestone payments totaling approximately $ 1.0 million in the aggregate are due upon achievement of each milestone.
+Added: Four net sales milestones totaling $ 4.0 million are due on licensed products as are high single digit royalties due on aggregate, annual, worldwide net sales of licensed products.
+Added: License Agreement with Revogenex Ireland Ltd
+Added: In 2015, the Company purchased an exclusive license to IV Tramadol for the U.S.
+Added: market from Revogenex, a privately held company in Dublin, Ireland, for an upfront fee of $ 3.0 million.
The Company then assigned all of its right, title and interest to the exclusive license to Avenue.
−Removed: a centrally acting synthetic opioid analgesic for moderate to moderately severe pain and is available as immediate release or extended-release
−Removed: tablets in the United States.
−Removed: Under the terms of the license agreement assumed by Avenue, Revogenex is eligible to receive additional
−Removed: milestone payments upon the achievement of certain development milestones.
−Removed: As of December 31, 2019, one remaining development
−Removed: milestone of $3.0 million for approval of IV Tramadol by the FDA has not been achieved.
−Removed: In addition, royalty payments ranging from
−Removed: high single digit to low double digits royalty payments are due on net sales of the approved product.
−Removed: For the year ended December 31, 2019
−Removed: Avenue recorded $1.0 million in connection with the filing of its NDA for IV Tramadol to treat moderate to moderately severe postoperative
+Added: Under the terms of the license agreement assumed by Avenue, Revogenex is eligible to receive additional milestone payments upon the achievement of certain development milestones.
+Added: As of December 31, 2020, one remaining development milestone of $ 3.0 million for approval of IV Tramadol by the FDA has not been achieved.
+Added: In addition, royalty payments ranging from high single digit to low double digits are due on net sales of the approved product.
No expense was recorded in connection with this agreement in 2020.
+Added: For the year ended December 31, 2019, Avenue recorded $ 1.0 million in connection with the filing of its NDA for IV Tramadol.
AstraZeneca AB License Agreement
−Removed: On December 17, 2019, Baergic entered
−Removed: into two license agreements:
−Removed: (i) a License Agreement (the “AZ License”) with AstraZeneca AB (“AZ”)
−Removed: to acquire an exclusive license to patent and related intellectual property rights pertaining to their proprietary compound Gamma-aminobutyric
−Removed: acid receptor A alpha 2 & 3 (GABAA α2,3) positive allosteric modulators (collectively, the “AZ IP”);
−Removed: and (ii) an Exclusive License Agreement (the “Cincinnati License”) with Cincinnati Children’s Hospital Medical
−Removed: Center (“Cincinnati”) to acquire patent and related intellectual property rights pertaining to a GABA inhibitor program
−Removed: for neurological disorders (the “Cincinnati IP”).
−Removed: Pursuant to the terms of the AZ License,
−Removed: Baergic paid an upfront fee of $3.0 million, and issued 2,492,192 common shares equal to 19.95% of Baergic to AZ as consideration
−Removed: for AZ License.
−Removed: In connection with the issuance of the shares, Baergic also provided AZ with anti-dilution protection up to $75
−Removed: Baergic valued the stock grant to AZ utilizing a discounted cash flow model to determine the weighted market value of
−Removed: invested capital, discounted by a lack of marketability of 44.6%, weighted average cost of capital of 20.5%, and net of debt utilized,
−Removed: resulting in a value of $0.029 per share or $0.1 million on December 31, 2019.
−Removed: Development milestone payments totaling
−Removed: approximately $75 million in the aggregate are due upon achievement of each milestone.
−Removed: Three net sales milestones totaling $130
−Removed: million are due on licensed products as are high single digit royalties due on aggregate, annual, worldwide net sales of licensed
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: Cincinnati Children’s License
−Removed: Pursuant to the terms of the Cincinnati
−Removed: License, Baergic agreed to pay an upfront fee of $0.2 million as well as $30,000 for reimbursement of past patent expenses and
−Removed: issued 624,922 common shares equal to 5% of Baergic, to Cincinnati as consideration for the License.
−Removed: In connection with the issuance
−Removed: of the shares, Baergic also provided Cincinnati with anti-dilution protection up to $15M.
−Removed: Baergic valued the stock grant to Cincinnati
−Removed: utilizing a discounted cash flow model to determine the weighted market value of invested capital, discounted by a lack of marketability
−Removed: of 44.6%, weighted average cost of capital of 20.5%, and net of debt utilized, resulting in a value of $0.029 per share or $0.1
−Removed: million on December 31, 2019.
−Removed: Two development milestone payments of approximately
−Removed: $6.5 million are payable upon milestone achievements.
−Removed: Four net sales milestones totaling $21 million are due on licensed products
−Removed: as are low single digit royalties due on aggregate, annual, worldwide net sales of licensed products.
−Removed: License Agreement with Columbia University
−Removed: In January 2017, Caelum entered into
−Removed: an exclusive license agreement with Columbia University (“Columbia”) to secure worldwide license rights to CAEL-101,
−Removed: a chimeric fibril-reactive monoclonal antibody (mAb) being evaluated in a Phase 1a/1b study for the treatment of amyloid light
−Removed: chain (“AL”) amyloidosis.
−Removed: Under the terms of the agreement, Columbia is eligible to receive additional milestone payments
−Removed: of up to $5.5 million upon the achievement of certain development milestones, in addition to royalty payments for sales of the
−Removed: CAEL-101 is a novel antibody being developed for patients with AL Amyloidosis, a rare systemic disorder caused by an abnormality
−Removed: of plasma cells in the bone marrow.
−Removed: For the year ended December 31, 2018,
−Removed: Caelum recorded expense of $0.3 million in connection with its license for CAEL-101 from Columbia University.
−Removed: In January 2019,
−Removed: in connection with the Alexion DOSPA the Company ceased to consolidate Caelum (see Note 4).
−Removed: University of Texas Health Science Center
−Removed: at Houston License Agreement
−Removed: In October 2016, Cellvation entered
−Removed: into a license agreement with the University of Texas Health Science Center at Houston (“University of Texas”) for
−Removed: the treatment of traumatic brain injury using Autologous Bone Marrow Mononuclear Cells (the “Initial TBI License”)
−Removed: for an upfront cash fee of approximately $0.3 million and the issuance of 500,000 common shares representing 5% of the outstanding
−Removed: shares of Cellvation.
−Removed: An additional 9 development milestones approximating $6.2 million are due in connection with the development
−Removed: of adult indications, and an additional 8 development milestones approximating $6.0 million are due in connection with the development
−Removed: of pediatric indications, as well as single digit royalty net sales and royalty milestones are due for the term of the contract.
+Added: On December 17, 2019, Baergic entered into two license agreements:
+Added: (i) a License Agreement (the “AZ License”) with AstraZeneca AB (“AZ”) to acquire an exclusive license to patent and related intellectual property rights pertaining to their proprietary compound Gamma-aminobutyric acid receptor A alpha 2 & 3 (GABAA α2,3) positive allosteric modulators (collectively, the “AZ IP”);
+Added: and (ii) an Exclusive License Agreement (the “Cincinnati License”) with Cincinnati Children’s Hospital Medical Center (“Cincinnati”) to acquire patent and related intellectual property rights pertaining to a GABA inhibitor program for neurological disorders (the “Cincinnati IP”).
+Added: Pursuant to the terms of the AZ License, Baergic paid an upfront fee of $ 3.0 million and issued 2,492,192 common shares equal to 19.95 % of Baergic to AZ as consideration for AZ License.
+Added: In connection with the issuance of the shares, Baergic also provided AZ with anti-dilution protection up to $ 75 million.
+Added: Baergic valued the stock grant to AZ utilizing a discounted cash flow model to determine the weighted market value of invested capital, discounted by a lack of marketability of 44.6 %, weighted average cost of capital of 20.5 %, and net of debt utilized, resulting in a value of $ 0.029 per share or $ 0.1 million on December 31, 2019.
+Added: Development milestone payments totaling approximately $ 75 million in the aggregate are due upon achievement of each milestone.
+Added: Three net sales milestones totaling $ 130 million are due on licensed products as are high single digit royalties due on aggregate, annual, worldwide net sales of licensed products.
+Added: For the years ended December 31, 2020 and 2019, Baergic recorded expense of approximately $ 9,000 and nil , respectively, in connection with its licenses with AZ.
+Added: Cincinnati Children’s License Agreement
+Added: Pursuant to the terms of the Cincinnati License, Baergic paid an upfront fee of $ 0.2 million as well as $ 30,000 for reimbursement of past patent expenses and issued 624,922 common shares equal to 5 % of Baergic to Cincinnati as consideration for the license.
+Added: In connection with the issuance of the shares, Baergic also provided Cincinnati with anti-dilution protection up to $ 15.0 million.
+Added: Baergic valued the stock grant to Cincinnati utilizing a discounted cash flow model to determine the weighted market value of invested capital, discounted by a lack of marketability of 44.6 %, weighted average cost of capital of 20.5 %, and net of debt utilized, resulting in a value of $ 0.029 per share or $ 0.1 million on December 31, 2019.
+Added: Two development milestone payments of approximately $ 6.5 million are payable upon milestone achievements.
+Added: Four net sales milestones totaling $ 21.0 million are due on licensed products as are low single digit royalties due on aggregate, annual, worldwide net sales of licensed products.
+Added: For the years ended December 31, 2020 and 2019, Baergic recorded expense of approximately $ 2,000 and nil , respectively, in connection with its Cincinnati License.
+Added: University of Texas Health Science Center at Houston License Agreement
+Added: In October 2016, Cellvation entered into a license agreement with the University of Texas Health Science Center at Houston (“University of Texas”) for the treatment of traumatic brain injury using Autologous Bone Marrow Mononuclear Cells (the “Initial TBI License”) for an upfront cash fee of approximately $ 0.3 million and the issuance of 500,000 common shares representing 5 % of the outstanding shares of Cellvation.
+Added: An additional 9 development milestones approximating $ 6.2 million are due in connection with the development of adult indications, and an additional 8 development milestones approximating $ 6.0 million are due in connection with the development of pediatric indications, as well as single digit royalty net sales and royalty milestones are due for the term of the contract.
An additional minimum annual royalty ranging from $ 50,000 to $ 0.2 million is due, depending on the age of the license.
−Removed: In addition, Cellvation entered into a
−Removed: secondary license with the University of Texas for a method and apparatus for conditioning cell populations for cell therapies
−Removed: (the “Second TBI License”).
−Removed: Cellvation paid an upfront fee of $50,000 in connection with the Second TBI License, and
−Removed: a minimum annual royalty of $0.1 million is payable beginning in the year after first commercial sale occurs (which minimum annual
−Removed: royalty is creditable against actual royalties paid under the Second TBI License.
−Removed: Additional payments of $0.3 million
−Removed: are due for the completion of certain development milestones and single digit royalties upon the achievement of net sales.
−Removed: In connection
−Removed: with the two University of Texas licenses, Cellvation granted each of two University of Texas researchers acting as consultants
−Removed: to Cellvation 500,000 shares of Cellvation common stock.
−Removed: For the years ended December 31, 2019
−Removed: and 2018, Cellvation recorded expense of approximately nil and $1,000, respectively, in connection with its licenses with the University
−Removed: Dana-Farber Cancer Institute License
−Removed: In March 2015, Checkpoint entered
−Removed: into an exclusive license agreement with Dana-Farber Cancer Institute (“Dana-Farber”) to develop a portfolio of fully
−Removed: human immuno-oncology targeted antibodies.
−Removed: The portfolio of antibodies licensed from Dana-Farber include antibodies targeting PD-L1,
−Removed: GITR and CAIX.
−Removed: Under the terms of the agreement, Checkpoint paid Dana-Farber an up-front licensing fee of $1.0 million in 2015
−Removed: and, on May 11, 2015, granted Dana-Farber 500,000 shares of Checkpoint common stock, valued at $32,500 or $0.065 per share.
−Removed: The agreement included an anti-dilution clause that maintained Dana-Farber’s ownership at 5% until such time that Checkpoint
−Removed: raised $10.0 million in cash in exchange for common shares.
−Removed: Pursuant to this provision, on September 30, 2015, Checkpoint
−Removed: granted to Dana-Farber an additional 136,830 shares of common stock valued at approximately $0.6 million and the anti-dilution
−Removed: clause thereafter expired.
−Removed: Dana-Farber is eligible to receive payments of up to an aggregate of approximately $21.5 million for
−Removed: each licensed product upon Checkpoint’s successful achievement of certain clinical development, regulatory and first commercial
−Removed: sale milestones.
−Removed: In addition, Dana-Farber is eligible to receive up to an aggregate of $60.0 million upon Checkpoint’s successful
−Removed: achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered low to
−Removed: mid-single digit percentage of net sales.
−Removed: Dana-Farber receives an annual license maintenance fee of $50,000, which is creditable
−Removed: against milestone payments or royalties due to Dana-Farber.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: For the year ended December 31, 2018,
−Removed: Checkpoint expensed a non-refundable milestone payment of $1.0 million upon the twelfth patient dosed in a Phase 1 clinical study
−Removed: of its anti-PD-LI antibody, cosibelimab (formerly referred to as CK-301), which is included in the Statements of Operations for
−Removed: the year ended December 31, 2018.
−Removed: In connection with the license agreement
−Removed: with Dana-Farber, Checkpoint entered into a collaboration agreement with TGTX, which was amended and restated in June 2019,
−Removed: to develop and commercialize the anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies,
−Removed: while Checkpoint retains the right to develop and commercialize these antibodies in the field of solid tumors.
−Removed: Michael Weiss, Chairman
−Removed: of the Board of Directors of Checkpoint is also the Executive Chairman, President and Chief Executive Officer and a stockholder
+Added: In addition, Cellvation entered into a secondary license with the University of Texas for a method and apparatus for conditioning cell populations for cell therapies (the “Second TBI License”).
+Added: Cellvation paid an upfront fee of $ 50,000 in connection with the Second TBI License, and a minimum annual royalty of $ 0.1 million is payable beginning in the year after first commercial sale occurs (which minimum annual royalty is creditable against actual royalties paid under the Second TBI License).
+Added: Additional payments of $ 0.3 million are due for the completion of certain development milestones and single digit royalties upon the achievement of net sales.
+Added: In connection with the two University of Texas licenses, Cellvation granted each of two University of Texas researchers acting as consultants to Cellvation 500,000 shares of Cellvation common stock.
+Added: For the years ended December 31, 2020 and 2019, Cellvation recorded expense of approximately $ 1,000 and nil , respectively, in connection with its licenses with the University of Texas.
+Added: Dana-Farber Cancer Institute License Agreement
+Added: In March 2015, Checkpoint entered into an exclusive license agreement with Dana-Farber Cancer Institute (“Dana-Farber”) to develop a portfolio of fully human immuno-oncology targeted antibodies.
+Added: The portfolio of antibodies licensed from Dana-Farber include antibodies targeting PD-L1, GITR and CAIX.
+Added: Under the terms of the agreement, Checkpoint paid Dana-Farber an up-front licensing fee of $ 1.0 million in 2015 and, on May 11, 2015, granted Dana-Farber 500,000 shares of Checkpoint common stock, valued at $ 32,500 or $ 0.065 per share.
+Added: The agreement included an anti-dilution clause that maintained Dana-Farber’s ownership at 5 % until such time that Checkpoint raised $ 10.0 million in cash in exchange for common shares.
+Added: Pursuant to this provision, on September 30, 2015, Checkpoint granted to Dana-Farber an additional 136,830 shares of common stock valued at approximately $ 0.6 million and the anti-dilution clause thereafter expired.
+Added: Dana-Farber is eligible to receive payments of up to an aggregate of approximately $ 21.5 million for each licensed product upon Checkpoint’s successful achievement of certain clinical development, regulatory and first commercial sale milestones.
+Added: In addition, Dana-Farber is eligible to receive up to an aggregate of $ 60.0 million upon Checkpoint’s successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered low to mid-single digit percentage of net sales.
+Added: Dana-Farber receives an annual license maintenance fee of $ 50,000 , which is creditable against future milestone payments or royalties.
+Added: The portfolio of antibodies licensed from Dana-Farber include antibodies targeting PD-L1, GITR and CAIX.
+Added: In connection with the license agreement with Dana-Farber, Checkpoint entered into a collaboration agreement with TGTX, which was amended and restated in June 2019, to develop and commercialize the anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies, while Checkpoint retains the right to develop and commercialize these antibodies in the field of solid tumors.
+Added: Michael Weiss, Chairman of the Board of Directors of Checkpoint is also the Executive Chairman, President and Chief Executive Officer and a stockholder of TGTX.
Under the terms of the original agreement, TGTX paid Checkpoint $ 0.5 million, representing an upfront licensing fee.
−Removed: the signing of the amended and restated collaboration agreement in June 2019, TGTX paid Checkpoint an additional $1.0 million
−Removed: upfront licensing fee.
−Removed: Checkpoint is eligible to receive substantive potential milestone payments for the anti-PD-L1 program of
−Removed: up to an aggregate of approximately $28.6 million upon TGTX’s successful achievement of certain clinical development, regulatory
−Removed: and first commercial sale milestones.
−Removed: This is comprised of up to approximately $9.4 million upon TGTX’s successful completion
−Removed: of clinical development milestones, and up to approximately $19.2 million upon regulatory filings and first commercial sales in
−Removed: specified territories.
−Removed: Checkpoint is also eligible to receive substantive potential milestone payments for the anti-GITR antibody
−Removed: program of up to an aggregate of approximately $21.5 million upon TGTX’s successful achievement of certain clinical development,
−Removed: regulatory and first commercial sale milestones.
−Removed: This is comprised of up to approximately $7.0 million upon TGTX’s successful
−Removed: completion of clinical development milestones, and up to approximately $14.5 million upon first commercial sales in specified territories.
−Removed: In addition, Checkpoint is eligible to receive up to an aggregate of $60.0 million upon TGTX’s successful achievement of
−Removed: certain sales milestones based on aggregate net sales for both programs, in addition to royalty payments based on a tiered low
−Removed: double-digit percentage of net sales.
−Removed: Checkpoint also receives an annual license maintenance fee, which is creditable against milestone
−Removed: payments or royalties due to Checkpoint.
−Removed: TGTX also pays Checkpoint for its out-of-pocket costs of material used by TGTX for their
−Removed: development activities.
−Removed: During the year ended December 31, 2019 and 2018, the Company recognized approximately $1.6 million
−Removed: and $3.0 million, respectively in revenue from its collaboration agreement with TGTX on the Consolidated Statements of Operations.
+Added: Upon the signing of the amended and restated collaboration agreement in June 2019, TGTX paid Checkpoint an additional $ 1.0 million upfront licensing fee.
+Added: Checkpoint is eligible to receive substantive potential milestone payments for the anti-PD-L1 program of up to an aggregate of approximately $ 27.6 million upon TGTX’s successful achievement of certain clinical development, regulatory and first commercial sale milestones.
+Added: This is comprised of up to approximately $ 8.4 million upon TGTX's successful completion of clinical development milestones, and up to approximately $ 19.2 million upon regulatory filings and first commercial sales in specified territories.
+Added: Checkpoint is also eligible to receive substantive potential milestone payments for the anti-GITR antibody program of up to an aggregate of approximately $ 21.5 million upon TGTX's successful achievement of certain clinical development, regulatory and first commercial sale milestones.
+Added: This is comprised of up to approximately $ 7.0 million upon TGTX’s successful completion of clinical development milestones, and up to approximately $ 14.5 million upon first commercial sales in specified territories.
+Added: In addition, Checkpoint is eligible to receive up to an aggregate of $ 60.0 million upon TGTX’s successful achievement of certain sales milestones based on aggregate net sales for both programs, in addition to royalty payments based on a tiered low double-digit percentage of net sales.
+Added: Checkpoint also receives an annual license maintenance fee, which is creditable against future milestone payments or royalties.
+Added: TGTX also pays Checkpoint for its out-of-pocket costs of material used by TGTX for their development activities.
+Added: For the years ended December 31, 2020 and 2019, Checkpoint recognized approximately $ 1.0 million and $ 1.6 million, respectively, in revenue related to the collaboration agreement in the Consolidated Statements of Operations.
+Added: The revenue for the year ended December 31, 2020 included a milestone of $ 925,000 upon the 12 th patient dosed in a phase 1 clinical trial for the anti-PD-L1 antibody cosibelimab during March 2020.
Adimab, LLC Collaboration Agreement
−Removed: In October 2015, Fortress entered
−Removed: into a collaboration agreement with Adimab to discover and optimize antibodies using their proprietary core technology platform.
−Removed: Under this agreement, Adimab optimized cosibelimab, Checkpoint’s anti-PD-L1 antibody which it originally licensed from Dana-Farber.
−Removed: In January 2019, Fortress transferred the rights to the optimized antibody to Checkpoint, and Checkpoint entered into a collaboration
−Removed: agreement directly with Adimab on the same day.
−Removed: Under the terms of the agreement, Adimab is eligible to receive payments up to
−Removed: an aggregate of approximately $7.1 million upon the Checkpoint’s successful achievement of certain clinical development and
−Removed: regulatory milestones, of which $4.8 million are due upon various filings for regulatory approvals to commercialize the product.
+Added: In October 2015, Fortress entered into a collaboration agreement with Adimab to discover and optimize antibodies using their proprietary core technology platform.
+Added: Under this agreement, Adimab optimized cosibelimab, Checkpoint's anti-PD-L1 antibody which it originally licensed from Dana-Farber.
+Added: In January 2019, Fortress transferred the rights to the optimized antibody to Checkpoint, and Checkpoint entered into a collaboration agreement directly with Adimab on the same day.
+Added: Under the terms of the agreement, Adimab is eligible to receive payments up to an aggregate of approximately $ 7.1 million upon the Checkpoint's successful achievement of certain clinical development and regulatory milestones, of which $ 4.8 million are due upon various filings for regulatory approvals to commercialize the product.
In addition, Adimab is eligible to receive royalty payments based on a tiered low single digit percentage of net sales.
1 unchanged sentence
License Agreement
−Removed: In March 2015, the Company entered
−Removed: into an exclusive license agreement with NeuPharma, Inc.
−Removed: (“NeuPharma”) to develop and commercialize novel irreversible,
−Removed: 3rd generation epidermal growth factor receptor (“EGFR”) inhibitors including CK-101, on a worldwide basis (other than
−Removed: certain Asian countries).
+Added: In March 2015, the Company entered into an exclusive license agreement with NeuPharma, Inc.
+Added: (“NeuPharma”) to develop and commercialize novel irreversible, 3rd generation epidermal growth factor receptor (“EGFR”) inhibitors including CK-101, on a worldwide basis (other than certain Asian countries).
On the same date, the Company assigned all of its right and interest in the EGFR inhibitors to Checkpoint.
−Removed: Under the terms of the agreement, Checkpoint paid NeuPharma an up-front licensing fee of $1.0 million in 2015, and NeuPharma is
−Removed: eligible to receive payments of up to an aggregate of approximately $40.0 million upon Checkpoint’s successful achievement
−Removed: of certain clinical development and regulatory milestones in up to three indications, of which $22.5 million are due upon various
−Removed: regulatory approvals to commercialize the products.
−Removed: In addition, NeuPharma is eligible to receive payments of up to an aggregate
−Removed: of $40 million upon Checkpoint’s successful achievement of certain sales milestones based on aggregate net sales, in addition
−Removed: to royalty payments based on a tiered mid to high-single digit percentage of net sales.
−Removed: In September 2016, Checkpoint dosed
−Removed: the first patient in a Phase 1/2 clinical study of CK-101, which is currently ongoing as of December 31, 2019.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial Statements
−Removed: Teva Pharmaceutical Industries Ltd.
−Removed: License Agreement (through its subsidiary, Cephalon, Inc.)
−Removed: In December 2015, Fortress entered into a license agreement
−Removed: with Teva Pharmaceutical Industries Ltd.
−Removed: through its subsidiary, Cephalon, Inc.
−Removed: (“Cephalon”).
−Removed: This agreement
−Removed: was assigned to Checkpoint by the Company on the same date.
−Removed: Under the terms of the license agreement, Checkpoint obtained an exclusive,
−Removed: worldwide license to Cephalon’s patents relating to CEP-8983 and its small molecule prodrug, CEP-9722, a PARP inhibitor,
−Removed: which Checkpoint referred to as CK-102.
−Removed: Checkpoint paid Cephalon an up-front licensing fee of $0.5 million.
−Removed: In August 2018,
−Removed: Checkpoint gave notice to Cephalon of its intention to terminate the license agreement, which became effective in February 2019.
+Added: Under the terms of the agreement, Checkpoint paid NeuPharma an up-front licensing fee of $ 1.0 million in 2015, and NeuPharma is eligible to receive payments of up to an aggregate of approximately $ 40.0 million upon Checkpoint’s successful achievement of certain clinical development and regulatory milestones in up to three indications, of which $ 22.5 million are due upon various regulatory approvals to commercialize the products.
+Added: In addition, NeuPharma is eligible to receive payments of up to an aggregate of $ 40 million upon Checkpoint’s successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered mid to high-single digit percentage of net sales.
Jubilant Biosys Limited License Agreement
−Removed: In May 2016, Checkpoint entered into
−Removed: a license agreement with Jubilant Biosys Limited (“Jubilant”), whereby Checkpoint obtained an exclusive, worldwide
−Removed: license (the “Jubilant License”) to Jubilant’s family of patents covering compounds that inhibit BRD4, a member
−Removed: of the BET domain for cancer treatment, including CK-103.
−Removed: Under the terms of the Jubilant License, Checkpoint paid Jubilant an
−Removed: up-front licensing fee of $2.0 million, and Jubilant is eligible to receive payments up to an aggregate of approximately $89.0
−Removed: million upon Checkpoint’s successful achievement of certain preclinical, clinical development, and regulatory milestones,
−Removed: of which $59.5 million are due upon various regulatory approvals to commercialize the products.
−Removed: In addition, Jubilant is eligible
−Removed: to receive payments up to an aggregate of $89.0 million upon Checkpoint’s successful achievement of certain sales milestones
−Removed: based on aggregate net sales, in addition to royalty payments based on a tiered low to mid-single digit percentage of net sales.
−Removed: In connection with the Jubilant License,
−Removed: Checkpoint entered into a sublicense agreement with TGTX (the “Sublicense Agreement”), a related party, to develop
−Removed: and commercialize the compounds licensed in the field of hematological malignancies, with Checkpoint retaining the right to develop
−Removed: and commercialize these compounds in the field of solid tumors.
−Removed: Michael Weiss, Chairman of the Board of Directors of Checkpoint
−Removed: and the Company’s Executive Vice Chairman, Strategic Development, is also the Executive Chairman, President and Chief Executive
−Removed: Officer and a stockholder of TGTX.
−Removed: Under the terms of the Sublicense Agreement, TGTX paid Checkpoint $1.0 million, representing
−Removed: an upfront licensing fee, recorded as collaboration revenue –
−Removed: related party and Checkpoint is eligible to receive substantive
−Removed: potential milestone payments up to an aggregate of approximately $87.2 million upon TGTX’s successful achievement of clinical
−Removed: development and regulatory milestones.
−Removed: Such potential milestone payments may approximate $25.5 million upon TGTX’s successful
−Removed: completion of three clinical development milestones for two licensed products, and up to approximately $61.7 million upon the achievement
−Removed: of five regulatory approvals and first commercial sales in specified territories for two licensed products.
−Removed: In addition, Checkpoint
−Removed: is eligible to receive potential milestone payments up to an aggregate of $89.0 million upon TGTX’s successful achievement
−Removed: of three sales milestones based on aggregate net sales by TGTX, for two licensed products, in addition to royalty payments based
−Removed: on a mid-single digit percentage of net sales by TGTX.
−Removed: TGTX also pays Checkpoint for 50% of IND enabling costs and patent
−Removed: The Company recognized $0.1 million and $0.4 million in revenue related to this arrangement during the year ended December 31,
−Removed: 2019 and 2018, respectively.
−Removed: The collaborations with TGTX each contain
−Removed: single material performance obligations under Topic 606, which is the granting of a license that is functional intellectual property.
−Removed: Checkpoint’s performance obligation was satisfied at the point in time when TGTX had the ability to use and benefit from
−Removed: the right to use the intellectual property.
−Removed: The performance obligations of the original agreements were satisfied prior to the
−Removed: adoption of Topic 606.
+Added: In May 2016, Checkpoint entered into a license agreement with Jubilant Biosys Limited (“Jubilant”), whereby Checkpoint obtained an exclusive, worldwide license (the “Jubilant License”) to Jubilant’s family of patents covering compounds that inhibit BRD4, a member of the BET domain for cancer treatment, including CK-103.
+Added: Under the terms of the Jubilant License, Checkpoint paid Jubilant an up-front licensing fee of $ 2.0 million, and Jubilant is eligible to receive payments up to an aggregate of approximately $ 89.0 million upon Checkpoint’s successful achievement of certain preclinical, clinical development, and regulatory milestones, of which $ 59.5 million are due upon various regulatory approvals to commercialize the products.
+Added: In addition, Jubilant is eligible to receive payments up to an aggregate of $ 89.0 million upon Checkpoint’s successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered low to mid-single digit percentage of net sales.
+Added: In connection with the Jubilant License, Checkpoint entered into a sublicense agreement with TGTX (the “Sublicense Agreement”), a related party, to develop and commercialize the compounds licensed in the field of hematological malignancies, with Checkpoint retaining the right to develop and commercialize these compounds in the field of solid tumors.
+Added: Under the terms of the Sublicense Agreement, TGTX paid Checkpoint $ 1.0 million, representing an upfront licensing fee, recorded as collaboration revenue – related party and Checkpoint is eligible to receive substantive potential milestone payments up to an aggregate of approximately $ 87.2 million upon TGTX’s successful achievement of clinical development and regulatory milestones.
+Added: Such potential milestone payments may approximate $ 25.5 million upon TGTX’s successful completion of three clinical development milestones for two licensed products, and up to approximately $ 61.7 million upon the achievement of five regulatory approvals and first commercial sales in specified territories for two licensed products.
+Added: In addition, Checkpoint is eligible to receive potential milestone payments up to an aggregate of $ 89.0 million upon TGTX’s successful achievement of three sales milestones based on aggregate net sales by TGTX, for two licensed products, in addition to royalty payments based on a mid-single digit percentage of net sales by TGTX.
+Added: TGTX also pays Checkpoint for 50 % of IND enabling costs and patent expenses.
+Added: Checkpoint recognized $ 0.1 million and $ 0.1 million in revenue related to this arrangement during the year ended December 31, 2020 and 2019, respectively.
+Added: The collaborations with TGTX each contain single material performance obligations under Topic 606, which is the granting of a license that is functional intellectual property.
+Added: Checkpoint's performance obligation was satisfied at the point in time when TGTX had the ability to use and benefit from the right to use the intellectual property.
+Added: The performance obligations of the original agreements were satisfied prior to the adoption of Topic 606.
The performance obligation of the amendment to the collaboration agreement was satisfied in June 2019.
−Removed: The milestone payments are based on successful
−Removed: achievement of clinical development, regulatory, and sales milestones.
−Removed: Because these payments are contingent on the occurrence
−Removed: of a future event, they represent variable consideration and are constrained and included in the transaction price only when it
−Removed: is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
−Removed: The sales-based royalty
−Removed: payments are recognized as revenue when the subsequent sales occur.
−Removed: Checkpoint also receives variable consideration for certain
−Removed: research and development, out-of-pocket material costs and patent maintenance related activities that are dependent upon the Company’s
−Removed: actual expenditures under the collaborations and are constrained and included in the transaction price only when it is probable
−Removed: that a significant reversal in the amount of cumulative revenue recognized will not occur.
−Removed: Revenue is recognized approximately
−Removed: when the amounts become due because it relates to an already satisfied performance obligation.
−Removed: For the year ended December 31,
−Removed: 2019, Checkpoint did not receive any milestone or royalty payments.
−Removed: License Agreement with the Eunice
−Removed: Kennedy Shriver National Institute of Child Health and Human Development
−Removed: In March 2017, Cyprium and the Eunice
−Removed: Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the National Institutes
−Removed: of Health (“NIH”), entered into a Cooperative Research and Development Agreement to advance the clinical development
−Removed: of Phase 3 candidate CUTX-101 (copper histidinate injection) for the treatment of Menkes disease.
−Removed: Cyprium and NICHD also entered
−Removed: into a worldwide, exclusive license agreement to develop and commercialize AAV-based ATP7A gene therapy for use in combination
−Removed: with CUTX-101 for the treatment of Menkes disease and related copper transport disorders .
−Removed: Cyprium made an upfront payment
−Removed: of $0.1 million to NICHD upon execution of the exclusive license.
−Removed: NICHD is eligible to receive payments of up to an aggregate of
−Removed: approximately $1.7 million upon Cyprium’s successful achievement of certain clinical development and regulatory milestones
−Removed: for each licensed product, in addition to $1 million upon first commercial sale of a product candidate.
−Removed: In addition, in the event
−Removed: Cyprium sells a Priority Review Voucher that it receives from the FDA in connection with the approval of one of its product candidates
−Removed: (a “PRV”) to a third party, it is obligated to pay to NIH 20% of the proceeds that it receives from such third party
−Removed: with respect to the first PRV sold, and 15% of the proceeds with respect to the second PRV sold.
−Removed: In the alternative, in the event
−Removed: Cyprium redeems a PRV in connection with seeking priority review for one of its product candidates, Cyprium will be obligated to
−Removed: pay NIH $15 million.
+Added: The milestone payments are based on successful achievement of clinical development, regulatory, and sales milestones.
+Added: Because these payments are contingent on the occurrence of a future event, they represent variable consideration and are constrained and included in the transaction price only when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
+Added: The sales-based royalty payments are recognized as revenue when the subsequent sales occur.
+Added: Checkpoint also receives variable consideration for certain research and development, out-of-pocket material costs and patent maintenance related activities that are dependent upon the Company's actual expenditures under the collaborations and are constrained and included in the transaction price only when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
+Added: Revenue is recognized approximately when the amounts become due because it relates to an already satisfied performance obligation.
+Added: For the year ended December 31, 2020, Checkpoint recognized the achievement of a clinical development milestone under its collaboration agreement with TGTX based upon their dosing of a 12th patient in a phase 1 clinical trial of cosibelimab.
+Added: For the year ended December 31, 2019, Checkpoint did no t receive any milestone or royalty payments.
+Added: License Agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development
+Added: In March 2017, Cyprium and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the National Institutes of Health (“NIH”), entered into a Cooperative Research and Development Agreement to advance the clinical development of Phase 3 candidate CUTX-101 (copper histidinate injection) for the treatment of Menkes disease.
+Added: Cyprium and NICHD also entered into a worldwide, exclusive license agreement to develop and commercialize AAV-based ATP7A gene therapy for use in combination with CUTX-101 for the treatment of Menkes disease and related copper transport disorders .
+Added: Cyprium made an upfront payment of $ 0.1 million to NICHD upon execution of the exclusive license.
+Added: NICHD is eligible to receive payments of up to an aggregate of approximately $ 1.7 million upon Cyprium’s successful achievement of certain clinical development and regulatory milestones for each licensed product, in addition to $ 1 million upon first commercial sale of a product candidate.
+Added: In addition, in the event Cyprium sells a Priority Review Voucher that it receives from the FDA in connection with the approval of one of its product candidates (a "PRV") to a third party, it is obligated to pay to NIH 20 % of the proceeds that it receives from such third party with respect to the first PRV sold, and 15 % of the proceeds with respect to the second PRV sold.
+Added: In the alternative, in the event Cyprium redeems a PRV in connection with seeking priority review for one of its product candidates, Cyprium will be obligated to pay NIH $ 15 million.
For the years ended December 31, 2020 and 2019, no expense was recorded in connection with this license.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
License Agreement with the City of Hope
−Removed: Helocyte entered into the original license
−Removed: agreement with City of Hope National Medical Center (“COH”) on March 31, 2015, to secure:
−Removed: (i) an exclusive
−Removed: worldwide license for two immunotherapies for Cytomegalovirus (“CMV”) control in the post-transplant setting (known
−Removed: as Triplex and PepVax).
+Added: Helocyte entered into the original license agreement with City of Hope National Medical Center (“COH”) on March 31, 2015, to secure:
+Added: (i) an exclusive worldwide license for two immunotherapies for Cytomegalovirus (“CMV”) control in the post-transplant setting (known as Triplex and PepVax).
In consideration for the license and option, Helocyte made an upfront payment of $ 0.2 million.
−Removed: In March 2016,
−Removed: Helocyte entered into amended and restated license agreements for each of its PepVax and Triplex immunotherapies programs with
−Removed: its licensor COH.
−Removed: The amended and restated licenses expand the intellectual property and other rights granted to Helocyte by COH
−Removed: in the original license agreement without modifying the financial terms.
−Removed: In 2018, Helocyte discontinued the development of PepVax
−Removed: and terminated the related license and clinical trial agreements with COH.
−Removed: If Helocyte successfully develops and commercializes
−Removed: Triplex, COH is eligible to receive up to $3.7 million related to three financial milestones, $7.5 million in development milestones
−Removed: for the remaining two development milestones and up to $26.0 million in three milestones related to net sales for each licensed
+Added: In March 2016, Helocyte entered into amended and restated license agreements for each of its PepVax and Triplex immunotherapies programs with its licensor COH.
+Added: The amended and restated licenses expand the intellectual property and other rights granted to Helocyte by COH in the original license agreement without modifying the financial terms.
+Added: In 2018, Helocyte discontinued the development of PepVax and terminated the related license and clinical trial agreements with COH.
+Added: If Helocyte successfully develops and commercializes Triplex, COH is eligible to receive up to $ 3.7 million related to three financial milestones, $ 7.5 million in development milestones for the remaining two development milestones and up to $ 26.0 million in three milestones related to net sales for each licensed product.
To date Helocyte has completed a Phase 2 clinical trial program for Triplex.
−Removed: In April 2015, Helocyte secured the
−Removed: exclusive worldwide rights to an immunotherapy for the prevention of congenital CMV:
−Removed: ConVax (formerly Pentamer) from COH for an
−Removed: upfront payment of $45,000.
−Removed: If Helocyte successfully develops and commercializes Pentamer, COH could receive up to $5.5 million
−Removed: for the achievement of four development milestones, $26.0 million for three sales milestones, single digit royalties based on net
−Removed: sales reduced by certain factors and a minimum annual royalty of $0.75 million per year following a first marketing approval.
−Removed: For the twelve months ended December 31,
−Removed: 2019 and 2018, Helocyte recorded nil and $1.5 million respectively in research and development - licenses acquired on the Consolidated
−Removed: Statement of Operations in connection with this license.
−Removed: The expense recorded in 2018 was in connection to the achievement of the
−Removed: development milestone related to the completion of the Phase 2 clinical study for Triplex.
−Removed: License with the National Institute
−Removed: of Allergy and Infectious Disease (NIAD)
−Removed: In December 2019, Helocyte entered
−Removed: into a non-exclusive license agreement with the National Institute of Allergy and Infectious Disease (a division of the National
−Removed: Institutes of Health (“NIAID”)) for the use of certain material pertaining to one of its product candidates.
−Removed: agreed to pay an upfront fee of $0.5 million, which is payable in three separate installments, as well as a minimum annual royalty
−Removed: Additional payments of up to $1,050,000 in the aggregate are due upon the achievement of four developmental milestones,
−Removed: and royalties in the low single digits are due on net sales of licensed products.
−Removed: For the twelve
−Removed: months ended December 31, 2019 and 2018, Helocyte recorded $0.5 million and nil, respectively, in research and
−Removed: development - licenses acquired on the Consolidated Statement of Operations in connection with this license.
−Removed: For the years ended December 31, 2019
−Removed: and 2018 Mustang recorded the following expense in research and development –
−Removed: licenses acquired:
+Added: In April 2015, Helocyte secured the exclusive worldwide rights to an immunotherapy for the prevention of congenital CMV:
+Added: ConVax (formerly Pentamer) from COH for an upfront payment of $ 45,000 .
+Added: If Helocyte successfully develops and commercializes Pentamer, COH could receive up to $ 5.5 million for the achievement of four development milestones, $ 26.0 million for three sales milestones, single digit royalties based on net sales reduced by certain factors and a minimum annual royalty of $ 0.75 million per year following a first marketing approval.
+Added: For the year ended December 31, 2020 and 2019, Helocyte recorded nil and nil respectively in research and development - licenses acquired on the Consolidated Statement of Operations in connection with this license.
+Added: License with the National Institute of Allergy and Infectious Disease (NIAD)
+Added: In December 2019, Helocyte entered into a non-exclusive license agreement with the National Institute of Allergy and Infectious Disease (a division of the National Institutes of Health (“NIAID”)) for the use of certain material pertaining to one of its product candidates.
+Added: Helocyte agreed to pay an upfront fee of $ 0.5 million, which is payable in three separate installments, as well as a minimum annual royalty of $ 55,000 .
+Added: Additional payments of up to $ 1,050,000 in the aggregate are due upon the achievement of four developmental milestones, and royalties in the low single digits are due on net sales of licensed products.
+Added: For the year ended December 31, 2020 and 2019, Helocyte recorded nil and $ 0.5 million, respectively, in research and development - licenses acquired on the Consolidated Statement of Operations in connection with this license.
+Added: For the years ended December 31, 2020 and 2019 Mustang recorded the following expense in research and development – licenses acquired:
+Added: For the Year Ended December 31,
($ in thousands)
−Removed: For the Years Ended
−Removed: MB-102 (CD 123 CAR T for AML)
−Removed: Nationwide Children's Hospital
−Removed: MB-108 (C134 Oncolytic Virus for GBM)
−Removed: MB-104 (CS1 CAR T for Multiple Myeloma and Light Chain Amyloidosis)
−Removed: MB-105 (PSCA CAR T for Prostate & Pancreatic Cancers)
−Removed: MB-107 (XSCID)
−Removed: MB-105 (PSCA CAR T for Prostate & Pancreatic Cancers)
−Removed: MB-103 (HER2 CAR T for GBM & Metastatic Breast Cancer to Brain)
−Removed: MB-107 (XSCID)
−Removed: Manufacturing License
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
+Added: City of Hope National Medical Center
+Added: CD123 (MB-102) 3
+Added: IL13Rα2 (MB-101) 3
+Added: HER2 (MB-103) 1
+Added: PSCA (MB-105) 3
+Added: Fred Hutch - CD20 (MB-106) 2
+Added: Nationwide Children’s Hospital - C134 (MB-108)
+Added: CSL Behring (Calimmune)
+Added: SIRION LentiBOOST TM
License Agreement with City of Hope
−Removed: In March 2015, Mustang entered into
−Removed: an exclusive license agreement with COH to acquire intellectual property rights pertaining to CAR T (the “COH License”).
−Removed: Pursuant to the COH License, Mustang paid COH an upfront fee of $2.0 million in April 2015 (included in research and development-licenses
−Removed: acquired expenses on the Consolidated Statement of Operations) and granted COH 1.0 million shares of Mustang’s Class A
−Removed: Common Stock, representing 10% ownership of Mustang.
−Removed: Additional payments totaling $2.0 million are due upon the completion of two
−Removed: financial milestones, and payments totaling $14.5 million are due upon the completion of six development goals.
−Removed: Future mid-single
−Removed: digit royalty payments are due on net sales of licensed products, with a minimum annual royalty of $1.0 million.
−Removed: In February 2017, the Company and
−Removed: COH amended and restated the Original Agreement by entering into three separate amended and restated exclusive license agreements,
−Removed: one relating to CD123 (MB-102), one relating to IL13Rα2 (MB-101) and one relating to the Spacer technology, that amended
−Removed: the Original Agreement in certain other respects, and collectively replace the Original Agreement in its entirety.
−Removed: The total potential
−Removed: consideration payable to COH by the Company, in equity or cash, did not, in the aggregate, change materially from the Original
+Added: In March 2015, Mustang entered into an exclusive license agreement with COH to acquire intellectual property rights pertaining to chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) technologies (the “COH License”).
+Added: Pursuant to the COH License, Mustang paid COH an upfront fee of $ 2.0 million in April 2015 (included in research and development-licenses acquired expenses on the Consolidated Statement of Operations) and granted COH 1.0 million shares of Mustang’s Class A Common Stock, representing 10 % ownership of Mustang.
+Added: Additional payments totaling $ 2.0 million are due upon the completion of two financial milestones, and payments totaling $ 14.5 million are due upon the completion of six development goals.
+Added: Future mid-single digit royalty payments are due on net sales of licensed products, with a minimum annual royalty of $ 1.0 million.
+Added: In February 2017, the Company and COH amended and restated the COH License by entering into three separate amended and restated exclusive license agreements, one relating to CD123 (MB-102), one relating to IL13Rα2 (MB-101) and one relating to the Spacer technology, that amended the COH License in certain other respects, and collectively replace the COH License in its entirety.
+Added: The total potential consideration payable to COH by the Company, in equity or cash, did not, in the aggregate, change materially from the COH License.
CD123 License with City of Hope (MB-102)
−Removed: Pursuant to the CD123 License, Mustang
−Removed: and COH acknowledge that an upfront fee was paid under the Original License.
−Removed: In addition, an annual maintenance fee will continue
−Removed: COH is eligible to receive up to approximately $14.5 million in milestone payments upon and subject to the achievement
−Removed: of certain milestones.
+Added: Pursuant to the CD123 License, Mustang and COH acknowledge that an upfront fee was paid under the COH License.
+Added: In addition, an annual maintenance fee will continue to apply.
+Added: COH is eligible to receive up to approximately $ 14.5 million in milestone payments upon and subject to the achievement of certain milestones.
Royalty payments in the mid-single digits are due on net sales of licensed products.
−Removed: Mustang is obligated
−Removed: to pay COH a percentage of certain revenues received in connection with a sublicense in the mid-teens to mid-thirties, depending
−Removed: on the timing of the sublicense in the development of any product.
−Removed: In addition, equity grants made under the Original License were
−Removed: acknowledged, and the anti-dilution provisions of the Original License were carried forward.
−Removed: For the year ended December 31,
−Removed: 2019, Mustang expensed a non-refundable milestone payment of $0.3 million upon the twelfth patient dosed in a Phase 1 clinical
−Removed: study of CD123.
+Added: Mustang is obligated to pay COH a percentage of certain revenues received in connection with a sublicense in the mid-teens to mid-thirties, depending on the timing of the sublicense in the development of any product.
+Added: In addition, equity grants made under the COH License were acknowledged, and the anti-dilution provisions of the COH License were carried forward.
+Added: For the year ended December 31, 2020, Mustang expensed a non-refundable milestone payment of $ 0.3 million in connection with their public underwritten offerings.
+Added: For the year ended December 31, 2019, Mustang expensed a non-refundable milestone payment of $ 0.3 million upon the twelfth patient dosed in a Phase 1 clinical study of CD123.
+Added: Nationwide Children’s Hospital License Agreement (MB-108)
+Added: In February 2019, Mustang announced that it partnered and entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital (“Nationwide”) to develop their C134 oncolytic virus (MB-108) for the treatment of glioblastoma multiforme (“GBM”).
+Added: Mustang intends to combine MB-108 with MB-101 (IL13Rα2-specific CAR T) to potentially enhance efficacy in treating GBM.
There were no expenses recorded in 2020 in connection with this license.
−Removed: Nationwide Children’s Hospital
−Removed: License Agreement (MB-108)
−Removed: In February 2019, Mustang announced
−Removed: that it partnered and entered into an exclusive worldwide license agreement with Nationwide Children’s Hospital (“Nationwide”)
−Removed: to develop their C134 oncolytic virus (MB-108) for the treatment of glioblastoma multiforme (“GBM”).
−Removed: Mustang intends
−Removed: to combine MB-108 with MB-101 (IL13Rα2-specific CAR T) to potentially enhance efficacy in treating GBM.
−Removed: For the year ended
−Removed: December 31, 2019, Mustang paid $0.2 million in consideration for the license to exclusive, worldwide rights to develop and
−Removed: commercialize products that incorporate data, know-how and/or MB-108 that were developed at Nationwide.
−Removed: Additional payments are
−Removed: due to Nationwide upon achievement of development and commercialization milestones totaling $152.8 million.
−Removed: Royalty payments in
−Removed: the low-single digits are due on net sales of licensed products.
−Removed: CS1 Technology License with City of
−Removed: Hope (MB-104)
−Removed: 2017, Mustang entered into an exclusive license agreement with the COH for the use of CS1 specific CAR T technology (CS1
−Removed: Technology) to be directed against multiple myeloma.
−Removed: Pursuant to the Agreement, Mustang paid an upfront fee of $0.6 million
−Removed: on July 3, 2017, and owes an annual maintenance fee of $50,000, which began in 2019.
−Removed: Additional payments of up to $14.9
−Removed: million are due upon and subject to the achievement of ten development milestones, and royalty payments in the mid-single
−Removed: digits are due on net sales of licensed products.
−Removed: During the year ended December 31, 2019, Mustang expensed a
−Removed: non-refundable milestone payment of $0.2 million upon the first patient dosed in a Phase 1 clinical study of CS1.
−Removed: no expenses recorded in 2018 in connection with this license.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: PSCA Technology License with City of
−Removed: Hope (MB-105)
−Removed: 2017, Mustang entered into an exclusive license agreement with the COH for the use of prostate stem cell antigen
−Removed: (“PSCA”) CAR T technology (“PSCA Technology”) to be used in the treatment of prostate cancer.
−Removed: Pursuant to the Agreement, Mustang paid an upfront fee of $0.3 million on July 3, 2017, and owes an annual maintenance
−Removed: fee of $50,000, which began in 2019.
−Removed: Additional payments of up to $14.9 million are due upon and subject to the
−Removed: achievement of ten development milestones, and royalty payments in the mid-single digits are due on net sales of licensed
−Removed: During the years ended December 31, 2019 and 2018, Mustang recorded an expense of $0.2 million and nil,
−Removed: respectively, in connection with the acquisition of this license.
−Removed: CSL Behring License (MB-107)
−Removed: On August 23,
−Removed: 2019, Mustang entered into a license agreement with CSL Behring (“CSL Behring License”) for the
−Removed: Cytegrity TM stable producer cell line for the production of MB-107 lentiviral gene therapy.
−Removed: Cytegrity™
−Removed: stable producer cell line will be used to produce the viral vector for Mustang Bio’s MB-107 lentiviral gene therapy
−Removed: program for the treatment of XSCID.
−Removed: Mustang licensed MB-107 from St.
+Added: For the year ended December 31, 2019, Mustang paid $ 0.2 million in consideration for the license to exclusive, worldwide rights to develop and commercialize products that incorporate data, know-how and/or patents related to MB-108 that were developed at Nationwide.
+Added: Additional payments are due to Nationwide upon achievement of development and commercialization milestones totaling $ 152.8 million.
+Added: Royalty payments in the low-single digits are due on net sales of licensed products.
+Added: CS1 License with City of Hope (MB-104)
+Added: On May 31, 2017, Mustang entered into an exclusive license agreement with the COH for the use of CS1-specific CAR T technology to be directed against multiple myeloma.
+Added: Pursuant to the agreement, Mustang paid an upfront fee of $ 0.6 million on July 3, 2017, and owes an annual maintenance fee of $ 50,000 , which began in 2019.
+Added: Additional payments of up to $ 14.9 million are due upon and subject to the achievement of ten development milestones, and royalty payments in the mid-single digits are due on net sales of licensed products.
+Added: During the year ended December 31, 2020, Mustang expensed a non-refundable milestone payment of $ 0.2 million in connection with this license for the issuance of the first patent related to the CS1 technology.
+Added: During the year ended December 31, 2019, Mustang expensed a non-refundable milestone payment of $ 0.2 million upon the first patient dosed in a Phase 1 clinical study of the CS1 CAR T.
+Added: PSCA License with City of Hope (MB-105)
+Added: On May 31, 2017, Mustang entered into an exclusive license agreement with the COH for the use of prostate stem cell antigen (“PSCA”) CAR T technology to be used in the treatment of prostate cancer.
+Added: Pursuant to the agreement, Mustang paid an upfront fee of $ 0.3 million on July 3, 2017, and owes an annual maintenance fee of $ 50,000 , which began in 2019.
+Added: Additional payments of up to $ 14.9 million are due upon and subject to the achievement of ten development milestones, and royalty payments in the mid-single digits are due on net sales of licensed products.
+Added: During the years ended December 31, 2020 and 2019, Mustang recorded an expense of $ 0.2 million and nil , respectively, in connection with the acquisition of this license.
+Added: CSL Behring (Calimmune) License (MB-107)
+Added: On August 23, 2019, Mustang entered into a non-exclusive license agreement with CSL Behring (Calimmune, Inc.) (“Calimmune License”) for the Cytegrity TM stable producer cell line for the production of viral vector for Mustang’s lentiviral gene therapy program for the treatment of XSCID.
+Added: Mustang had previously licensed the XSCID gene therapy program from St.
Jude in August 2018.
−Removed: Mustang paid $0.2 million in
−Removed: consideration for the license.
−Removed: CSL Behring is eligible to receive additional payments totaling $1.2 million upon the
−Removed: achievement of three development and commercialization milestones.
−Removed: Royalty payments in the low-single digits are due on net
−Removed: sales of licensed products.
−Removed: Upon the execution of the CSL Behring License, Mustang recorded research and development expense
−Removed: of $0.2 million in the statement of operations for the year ended December 31, 2019.
−Removed: License with University of California
−Removed: On March 17, 2017, Mustang entered
−Removed: into an exclusive license agreement with the Regents of the University of California (“UCLA License”) to acquire intellectual
−Removed: property rights in patent applications related to the engineered anti-prostate stem cell antigen antibodies for cancer targeting
−Removed: and detection.
−Removed: Pursuant to the UCLA Agreement, Mustang paid UCLA an upfront fee of $0.2 million on April 25, 2017.
−Removed: maintenance fees also apply;
−Removed: additional payments are due upon achievement of certain development milestones totaling $14.3 million,
−Removed: and royalty payments in the mid-single digits are due on net sales of licensed products.
−Removed: In September 2019, COH commenced
−Removed: its Phase 1 clinical trial resulting in the achievement of a development milestone and as a result Mustang recorded an expense
−Removed: of $0.3 million.
+Added: Mustang paid $ 0.2 million in consideration for the Calimmune license.
+Added: CSL Behring is eligible to receive additional payments totaling $ 1.2 million upon the achievement of three development and commercialization milestones.
+Added: Royalty payments in the low-single digits are due on net sales of licensed products.
+Added: Upon the execution of the Calimmune License, Mustang expensed a non-refundable milestone payment of $ 0.2 million and $ 0.2 million in the Consolidated Statement of Operations for the years ended December 31, 2020 and 2019, respectively.
+Added: University of California License
+Added: On March 17, 2017, Mustang entered into an exclusive license agreement with the Regents of the University of California (“UCLA License”) to acquire intellectual property rights in patent applications related to the engineered anti-prostate stem cell antigen antibodies for cancer targeting and detection.
+Added: Pursuant to the UCLA License, Mustang paid UCLA an upfront fee of $ 0.2 million on April 25, 2017.
+Added: Annual maintenance fees also apply;
+Added: additional payments are due upon achievement of certain development milestones totaling $ 14.3 million, and royalty payments in the mid-single digits are due on net sales of licensed products.
+Added: In September 2019, COH commenced its Phase 1 clinical trial resulting in the achievement of a development milestone, and as a result Mustang recorded an expense of $ 0.3 million.
There were no expenses recorded in 2020 in connection with this license.
−Removed: HER2 Technology License with City of
−Removed: Hope (MB-103)
−Removed: 2017, Mustang entered into an exclusive license agreement with the COH for the use of human epidermal growth factor receptor
−Removed: 2 (“HER2”) CAR T technology (“HER2 Technology”), which will be applied in the treatment of
−Removed: glioblastoma multiforme.
−Removed: Pursuant to the Agreement, Mustang paid an upfront fee of $0.6 million and owes an annual
−Removed: maintenance fee of $50,000, which began in 2019.
−Removed: Additional payments of up to $14.9 million are due upon and subject to the
−Removed: achievement of ten development milestones, and royalty payments in the mid-single digits are due on net sales of licensed
−Removed: During the years ended December 31, 2019 and 2018, Mustang recorded an expense of nil and $0.2 million,
−Removed: respectively, in connection with the acquisition of this license as well as the achievement of a milestone during 2018.
−Removed: Jude Children’s Research Hospital
−Removed: License Agreement (MB-107)
−Removed: On August 2, 2018, Mustang entered
−Removed: into an exclusive worldwide license agreement with St.
−Removed: Jude for the development of a first-in-class ex vivo lentiviral gene
−Removed: therapy for the treatment of X-linked severe combined immunodeficiency (“XSCID”).
−Removed: Mustang paid $1.0 million in consideration
−Removed: for the exclusive license in addition to an annual maintenance fee of $0.1 million (which began in 2019).
−Removed: Jude is eligible
−Removed: to receive payments totaling $13.5 million upon the achievement of five development and commercialization milestones.
−Removed: Royalty payments
−Removed: in the mid-single digits are due on net sales of licensed products.
−Removed: During the years ended December 31, 2019 and 2018 Mustang
−Removed: recorded an expense of nil and $1.0 million, respectively, in connection with the acquisition of this license.
+Added: HER2 License with City of Hope (MB-103)
+Added: On May 31, 2017, Mustang entered into an exclusive license agreement with the COH for the use of human epidermal growth factor receptor 2 (“HER2”) CAR T technology (“HER2 Technology”), which will be applied in the treatment of glioblastoma multiforme.
+Added: Pursuant to the agreement, Mustang paid an upfront fee of $ 0.6 million and owes an annual maintenance fee of $ 50,000 , which began in 2019.
+Added: Additional payments of up to $ 14.9 million are due upon and subject to the achievement of ten development milestones, and royalty payments in the mid-single digits are due on net sales of licensed products.
+Added: During the year ended December 31, 2020, Mustang recorded a non-refundable milestone payment of $ 0.5 million in connection with the twelfth patient treated in the Phase 1 clinical study of HER2 CAR T technology at COH.
+Added: For the year ended December 31, 2019, Mustang expensed a non-refundable milestone payment of $ 0.2 million upon the first patient dosed in the Phase 1 clinical study of HER2.
+Added: Jude Children’s Research Hospital License (MB-107 and MB-207)
+Added: On August 2, 2018, Mustang entered into an exclusive worldwide license agreement with St.
+Added: Jude for the development of a first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (“XSCID”).
+Added: Mustang paid $ 1.0 million in consideration for the exclusive license in addition to an annual maintenance fee of $ 0.1 million (which began in 2019).
+Added: Jude is eligible to receive payments totaling $ 13.5 million upon the achievement of five development and commercialization milestones.
+Added: Royalty payments in the mid-single digits are due on net sales of licensed products.
+Added: During the years ended December 31, 2020 and 2019 Mustang did no t record any expenses in connection with this license.
Manufacturing License with City of Hope
−Removed: On January 3, 2018, Mustang entered
−Removed: into a non-exclusive license agreement with COH to acquire patent and licensed know-how rights related to developing, manufacturing,
−Removed: and commercializing licensed products.
−Removed: The Company paid $75,000 in consideration for the licenses to the patent rights and the
−Removed: licensed know-how in addition to an annual maintenance fee.
−Removed: Royalty payments in the low-single digits are due on net sales of licensed
−Removed: During the years ended December 31, 2019 and 2018, respectively, Mustang recorded an expense of nil and $0.1 million,
−Removed: respectively, in connection with the acquisition of this license.
−Removed: IL13Rα2 License with City of Hope
−Removed: Pursuant to the IL13Rα2 License,
−Removed: Mustang and COH acknowledge that an upfront fee was paid under the Original License.
−Removed: In addition, an annual maintenance fee will
−Removed: continue to apply.
−Removed: COH is eligible to receive up to approximately $14.5 million in milestone payments upon and subject to the achievement
−Removed: of certain milestones.
+Added: On January 3, 2018, Mustang entered into a non-exclusive license agreement with COH to acquire patent and licensed know-how rights related to developing, manufacturing, and commercializing licensed products.
+Added: The Company paid $ 0.1 million in consideration for the licenses to the patent rights and the licensed know-how in addition to an annual maintenance fee.
+Added: Royalty payments in the low-single digits are due on net sales of licensed products.
+Added: During the years ended December 31, 2020 and 2019, respectively, Mustang recorded no expense in connection with the COH license.
+Added: IL13Rα2 License with City of Hope (MB-101)
+Added: Pursuant to the IL13Rα2 License, Mustang and COH acknowledge that an upfront fee was paid under the Original License.
+Added: In addition, an annual maintenance fee will continue to apply.
+Added: COH is eligible to receive up to approximately $ 14.5 million in milestone payments upon and subject to the achievement of certain milestones.
Royalty payments in the mid-single digits are due on net sales of licensed products.
−Removed: Mustang is obligated
−Removed: to pay COH a percentage of certain revenues received in connection with a sublicense in the mid-teens to mid-thirties, depending
−Removed: on the timing of the sublicense in the development of any product.
−Removed: In addition, equity grants made under the Original License were
−Removed: acknowledged, and the anti-dilution provisions of the Original License were carried forward.
−Removed: During the years ended December 31,
−Removed: 2019 and 2018, Mustang recorded no expense in connection with the IL13Rα2 License.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
+Added: Mustang is obligated to pay COH a percentage of certain revenues received in connection with a sublicense in the mid-teens to mid-thirties, depending on the timing of the sublicense in the development of any product.
+Added: In addition, equity grants made under the Original License were acknowledged, and the anti-dilution provisions of the Original License were carried forward.
+Added: For the year ended, December 31, 2020, Mustang expensed a non-refundable milestone payment of $ 0.3 million in connection with their public underwritten offerings.
+Added: There was no expense recorded for the year ended December 31, 2019.
Spacer License with City of Hope
−Removed: Pursuant to the Spacer License, Mustang
−Removed: and COH acknowledge that an upfront fee was paid under the Original License.
−Removed: In addition, an annual maintenance fee will continue
−Removed: No royalties are due if the Spacer technology is used in conjunction with a CD123 CAR or an IL13Rα2 CAR, and royalty
−Removed: payments in the low single digits are due on net sales of licensed products if the Spacer technology is used in conjunction with
−Removed: other intellectual property.
−Removed: Mustang is obligated to pay COH a percentage (in the mid-thirties) of certain revenues received in
−Removed: connection with a sublicense.
−Removed: In addition, equity grants made under the Original License were acknowledged, and the anti-dilution
−Removed: provisions of the Original License were carried forward.
−Removed: During the years ended December 31, 2019 and 2018, Mustang recorded
−Removed: no expense in connection with the Spacer License.
+Added: Pursuant to the Spacer License, Mustang and COH acknowledge that an upfront fee was paid under the Original License.
+Added: In addition, an annual maintenance fee will continue to apply.
+Added: No royalties are due if the Spacer technology is used in conjunction with a CD123 CAR or an IL13Rα2 CAR, and royalty payments in the low single digits are due on net sales of licensed products if the Spacer technology is used in conjunction with other intellectual property.
+Added: Mustang is obligated to pay COH a percentage (in the mid-thirties) of certain revenues received in connection with a sublicense.
+Added: In addition, equity grants made under the Original License were acknowledged, and the anti-dilution provisions of the Original License were carried forward.
+Added: For the year ended December 31, 2020, Mustang expensed a non-refundable milestone payment of $ 0.3 million in connection with their public underwritten offerings.
+Added: There was no expense recorded for the year ended December 31, 2019.
IV/ICV Agreement with City of Hope
−Removed: On February 17, 2017, Mustang entered
−Removed: into an exclusive license agreement (the “IV/ICV Agreement”) with COH to acquire intellectual property rights in patent
−Removed: applications related to the intraventricular and intracerebroventricular methods of delivering T cells that express CARs.
−Removed: to the IV/ICV Agreement, Mustang paid COH an upfront fee of $0.1 million in March 2017.
−Removed: COH is eligible to receive up to approximately
−Removed: $0.1 million in milestone payments upon the achievement of a certain milestone as well as an annual maintenance fee.
−Removed: Royalty payments
−Removed: in the low-single digits are due on net sales of licensed products and services.
−Removed: During the years ended December 31, 2019
−Removed: and 2018 Mustang recorded no expense in connection with the IV/ICV Agreement.
−Removed: Fred Hutchinson Cancer Research Center
−Removed: License (MB-106)
−Removed: On July 3, 2017, Mustang entered into
−Removed: an exclusive, worldwide licensing agreement with Fred Hutchinson Cancer Research Center (“Fred Hutch”) for the use
−Removed: of a CAR T therapy related to autologous T cells engineered to express a CD20-specific chimeric antigen receptor (“CD20 Technology
−Removed: License”).
−Removed: Pursuant to the CD20 Technology License, Mustang paid Fred Hutch an upfront fee of $0.3 million and will owe an
−Removed: annual maintenance fee of $50,000 on each anniversary of the license until the achievement by Mustang of regulatory approval of
−Removed: a licensed product using CD20 Technology.
−Removed: Additional payments are due for the achievement of certain development milestones totaling
−Removed: $39.1 million and royalty payments in the mid-single digits are due on net sales of licensed products.
−Removed: During the years ended December 31,
−Removed: 2019 and 2018 Mustang recorded no expense in connection with the CD20 Technology License.
+Added: On February 17, 2017, Mustang entered into an exclusive license agreement (the “IV/ICV Agreement”) with COH to acquire intellectual property rights in patent applications related to the intraventricular and intracerebroventricular methods of delivering T cells that express CARs.
+Added: Pursuant to the IV/ICV Agreement, Mustang paid COH an upfront fee of $ 0.1 million in March 2017.
+Added: COH is eligible to receive up to approximately $ 0.1 million in milestone payments upon the achievement of a certain milestone as well as an annual maintenance fee.
+Added: Royalty payments in the low-single digits are due on net sales of licensed products and services.
+Added: During the years ended December 31, 2020 and 2019, Mustang recorded no expense in connection with the IV/ICV Agreement.
+Added: Fred Hutchinson Cancer Research Center License (MB-106)
+Added: On July 3, 2017, Mustang entered into an exclusive, worldwide licensing agreement with Fred Hutchinson Cancer Research Center (“Fred Hutch”) for the use of a CAR T therapy related to autologous T cells engineered to express a CD20-specific chimeric antigen receptor (“CD20 Technology License”).
+Added: Pursuant to the CD20 Technology License, Mustang paid Fred Hutch an upfront fee of $ 0.3 million and will owe an annual maintenance fee of $ 50,000 on each anniversary of the license until the achievement by Mustang of regulatory approval of a licensed product using CD20 Technology.
+Added: Additional payments are due for the achievement of certain development milestones totaling $ 39.1 million and royalty payments in the mid-single digits are due on net sales of licensed products.
+Added: During the years ended December 31, 2020 and 2019 Mustang recorded expenses totaling $ 0.3 million and nil , respectively, in connection with the CD20 Technology License.
Harvard College License
−Removed: On November 20, 2017, Mustang entered
−Removed: into an exclusive, worldwide license agreement with President and Fellows of Harvard College (the “Harvard Agreement”)
−Removed: for the use of gene editing, via the use of CRISPR/Cas9, to be used in enhancing the efficacy of chimeric antigen receptor T (CAR
−Removed: T) cell therapies for solid tumor indications and to generate universal off the shelf CAR T cell therapies for both liquid and
−Removed: solid tumor indications.
−Removed: Pursuant to the Harvard Agreement, Mustang paid Harvard College an upfront fee of $0.3 million and will
−Removed: owe an annual maintenance fee of $25,000 and $50,000 for calendar years 2018 and 2019, respectively, and $100,000 for each subsequent
−Removed: calendar year during the term of the agreement.
−Removed: Additional payments are due for the achievement of seven development milestones
−Removed: totaling $16.7 million and royalty payments in the low-single digits are due on the net sales of licensed products.
−Removed: years ended December 31, 2019 and 2018 Mustang recorded no expense in connection with the Harvard College License.
−Removed: In November 2019, Mustang terminated
−Removed: the Harvard Agreement.
−Removed: Licenses with the University of North
−Removed: On November 30, 2017, Tamid entered
−Removed: into three exclusive AAV gene therapies licensing arrangements with the University of North Carolina at Chapel Hill (“UNC”).
−Removed: The preclinical product candidates acquired through these licenses target ocular manifestations of Mucopolysaccharidosis type
−Removed: 1 (MPS1), dysferlinopathies and corneal transplant rejections.
−Removed: The three therapies were developed in the lab of Matthew Hirsch,
−Removed: Ph.D., Assistant Professor, Ophthalmology at the UNC Gene Therapy center.
−Removed: In December 2019, Tamid discontinued
−Removed: the development the development of all three candidates and terminated the related licenses and clinical trial agreements with
+Added: On November 20, 2017, Mustang entered into an exclusive, worldwide license agreement with President and Fellows of Harvard College (the “Harvard Agreement”) for the use of gene editing, via the use of CRISPR/Cas9, to be used in enhancing the efficacy of chimeric antigen receptor T (CAR T) cell therapies for solid tumor indications and to generate universal off the shelf CAR T cell therapies for both liquid and solid tumor indications.
+Added: Pursuant to the Harvard Agreement, Mustang paid Harvard College an upfront fee of $ 0.3 million and will owe an annual maintenance fee of $ 25,000 and $ 50,000 for calendar years 2018 and 2019, respectively, and $ 100,000 for each subsequent calendar year during the term of the agreement.
+Added: Additional payments are due for the achievement of seven development milestones totaling $ 16.7 million and royalty payments in the low-single digits are due on the net sales of licensed products.
+Added: During the years ended December 31, 2020 and 2019, Mustang recorded no expense in connection with the Harvard Agreement.
+Added: Mustang terminated the Harvard Agreement in January 2020.
+Added: SIRION Biotech GmbH - LentiBOOST TM (MB-207)
+Added: In October, 2020, Mustang announced a worldwide licensing agreement with SIRION Biotech (“SIRION”) for the rights to SIRION’s LentiBOOST TM technology for the development of MB-207, Mustang’s lentiviral gene therapy for the treatment of previously transplanted patients with X-linked severe combined immunodeficiency (the “SIRION Technology License”).
+Added: Pursuant to the SIRION Technology License, which requires payment in Euro, the Company paid SIRION a one-time upfront fee of $ 0.1 million (€ 0.1 million) during 2020.
+Added: In addition, five future development milestone payments totaling up to approximately $ 5.6 million (€ 4.7 million) in the aggregate are due upon achievement of certain milestones.
+Added: Additional milestone payments totaling up to $ 4.1 million (€ 3.5 million) in the aggregate are due in connection with the achievement of three commercial milestones and low- to mid-single digit royalties are due on aggregate cumulative worldwide net sales of licensed products.
+Added: For the year ended December 31, 2020, Mustang expensed an up-front payment of $ 0.1 million.
+Added: There was no expense recorded for the year ended December 31, 2019.
+Added: Effective May 6, 2020, Oncogenuity entered into a license agreement with the Trustees of Columbia University in the City of New York (“Columbia”) to develop novel oligonucleotides for the treatment of genetically driven cancers (the “Columbia License”).
+Added: The proprietary platform produces oligomers, known as “ONCOlogues.”
+Added: As consideration for the Columbia License, Oncogenuity paid an upfront fee of $ 0.3 million, and Fortress transferred to Columbia 1,000,000 shares of Oncogenuity common stock, representing 10.00 % ownership of Oncogenuity.
+Added: In connection with the share transfer, Oncogenuity also provided Columbia with limited anti-dilution protection.
+Added: Oncogenuity valued the stock grant to Columbia utilizing a discounted cash flow model to determine the weighted market value of invested capital, discounted by a lack of marketability of 41.7 %, weighted average cost of capital of 20.5 %, and net of debt utilized, resulting in a value of $ 0.021 per share or $ 21,000 for the year ended December 31, 2020.
+Added: Since a portion of the acquisition of the license was settled through the transfer of shares of Oncogenuity's common stock, this transaction fell within the scope of ASC Topic 718 , Compensation-Stock Compensation , since equity was transferred in exchange for goods (the license).
+Added: Specifically, Oncogenuity recorded the cost of the license as a non-employee share based payment, measured at the grant date fair value of the common stock.
+Added: The common shares were equity-classified.
+Added: The anti-dilution provision was concluded to represent a performance condition tied to a future liquidity event, which was not considered as probable to occur at December 31, 2020, because it was deemed outside of Oncogenuity’s control.
+Added: Development milestone payments totaling up to approximately $ 18.0 million in the aggregate are due upon achievement of certain milestones in connection with the initial indication.
+Added: Additional milestone payments totaling up to $ 15.3 million in the aggregate are due in connection with product development milestones for subsequent indications.
+Added: A $ 15.0 million sales milestone is due upon the achievement of a licensed product sales threshold, and low- to mid-single digit royalties are due on aggregate cumulative worldwide net sales of licensed products.
+Added: For the year ended December 31, 2020, Oncogenuity recorded expense of $ 0.3 million in research and development - licenses acquired in the Company’s Consolidated Statement of Operations.
+Added: Licenses with the University of North Carolina
+Added: On November 30, 2017, Tamid entered into three exclusive AAV gene therapies licensing arrangements with the University of North Carolina at Chapel Hill (“UNC”).
+Added: The preclinical product candidates acquired through these licenses target ocular manifestations of Mucopolysaccharidosis type 1 (MPS1), dysferlinopathies and corneal transplant rejections.
+Added: The three therapies were developed in the lab of Matthew Hirsch, Ph.D., Assistant Professor, Ophthalmology at the UNC Gene Therapy center.
+Added: In December 2019, Tamid discontinued the development of all three candidates and terminated the related licenses and clinical trial agreements with UNC.
For the years ended December 31, 2020 and 2019, Tamid recorded no expense in connection with these licenses.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
Sponsored Research and Clinical Trial Agreements
−Removed: On January 25, 2018, Aevitas entered
−Removed: into a Sponsored Research Agreement with the University of Massachusetts (“UMass SRA”) for certain continued research
−Removed: and development activities related to the development of adeno-associated virus (“AAV”) gene therapies in complement-mediated
+Added: For the Year Ended December 31,
+Added: ($ in thousands)
+Added: UMass - adeno-associated virus ("AAV")
+Added: On January 25, 2018, Aevitas entered into a Sponsored Research Agreement with the University of Massachusetts (“UMass SRA”) for certain continued research and development activities related to the development of adeno-associated virus (“AAV”) gene therapies in complement-mediated diseases.
The total amount to be funded by Aevitas under the UMass SRA is $ 0.8 million.
−Removed: Pursuant to the terms of the UMass SRA,
−Removed: Aevitas paid $0.8 million which was due upon execution.
−Removed: For the years ended December 31, 2019 and 2018, Aevitas recorded expense
−Removed: of approximately nil and $0.8 million, respectively, in connection with the UMass SRA.
−Removed: The expense was recorded in research and
−Removed: development expenses in the Company’s Consolidated Statements of Operations.
−Removed: On July 24, 2018, Aevitas entered
−Removed: into a Sponsored Research Agreement with the Trustees of the University of Pennsylvania (“UPenn SRA”) for certain continued
−Removed: research and development activities related to the development of AAV gene therapies in complement-mediated diseases.
−Removed: amount to be funded by Aevitas under the UPenn SRA is $2.0 million.
−Removed: Pursuant to the terms of the UPenn SRA, Aevitas paid $0.3 million
−Removed: which was due upon execution.
−Removed: For the years ended December 31, 2019 and 2018, Aevitas recorded expense of approximately $1.1
−Removed: million and $0.5 million, respectively, in connection with the UPenn SRA.
−Removed: The expense was recorded in research and development
−Removed: expenses in the Company’s Consolidated Statements of Operations.
−Removed: On September 1, 2019, Aevitas entered
−Removed: into a Sponsored Research Arrangement (“SRA”) with Duke University School of Medicine (“Duke”).
−Removed: the year ended December 31, 2019, Aevitas recorded approximately $0.1 million for the purpose of conducting a study to identify
−Removed: a dose range for AAV8 vectors in Dry Age-related Macular Degeneration (“Dry AMD”) in research and development expense
−Removed: on the consolidated statement of operations.
−Removed: No expense related to this SRA was recorded in 2018.
−Removed: On March 12, 2018, Caelum entered
−Removed: into a Sponsored Research Agreement with Columbia University to conduct preclinical research in connection with CAEL-101.
−Removed: cost of the study approximates $0.1 million.
−Removed: For the year ended December 31, 2018, Caelum recorded expense of approximately
−Removed: $0.1 million in connection with the agreement in research and development expense in the Company’s Consolidated Statements
−Removed: of Operations.
−Removed: In January 2019, in connection with the Alexion DOSPA the Company ceased to consolidate Caelum (see Note 4).
−Removed: In October 2016, Cellvation entered
−Removed: research funding agreement with the University of Texas in connection with the license for a method and apparatus for conditioning
−Removed: cell populations for cell therapies.
−Removed: In connection with this agreement Cellvation agreed to fund $0.8 million of research quarterly
−Removed: through March 31, 2018.
+Added: Pursuant to the terms of the UMass SRA, Aevitas paid $ 0.8 million which was due upon execution.
+Added: On May 31, 2020, a First Amendment to the UMass SRA was signed and the total amount to be funded was $ 0.7 million, including $ 0.4 million due within 30 days of execution.
+Added: For the years ended December 31, 2020 and 2019, Aevitas recorded expense of approximately $ 0.4 million and nil , respectively, in connection with the UMass SRA.
+Added: The expense was recorded in research and development expenses in the Company’s Consolidated Statement of Operations.
+Added: On July 24, 2018, Aevitas entered into a Sponsored Research Agreement with the Trustees of the University of Pennsylvania (“UPenn SRA”) for certain continued research and development activities related to the development of AAV gene therapies in complement-mediated diseases.
+Added: The total amount to be funded by Aevitas under the UPenn SRA is $ 2.0 million.
+Added: Pursuant to the terms of the UPenn SRA, Aevitas paid $ 0.3 million which was due upon execution.
+Added: For the years ended December 31, 2020 and 2019, Aevitas recorded expense of approximately $ 0.6 million and $ 1.1 million, respectively, in connection with the UPenn SRA.
+Added: The expense was recorded in research and development expenses in the Company’s Consolidated Statement of Operations.
+Added: On September 1, 2019, Aevitas entered into a Sponsored Research Arrangement (“SRA”) with Duke University School of Medicine (“Duke”).
+Added: For the years ended December 31, 2020 and 2019, Aevitas recorded approximately nil and $ 0.1 million, respectively, for the purpose of conducting a study to identify a dose range for AAV8 vectors in Dry Age-related Macular Degeneration (“Dry AMD”) in research and development expense on the Consolidated Statement of Operations.
+Added: In October 2016, Cellvation entered research funding agreement with the University of Texas in connection with the license for a method and apparatus for conditioning cell populations for cell therapies.
+Added: In connection with this agreement Cellvation agreed to fund $ 0.8 million of research quarterly through March 31, 2018.
The agreement was revised effective May 1, 2017, with quarterly payments extended through December 31, 2018.
−Removed: For the years ended December 31, 2019 and 2018, Cellvation recorded an expense of $0.1 million and $0.3 million, respectively,
−Removed: representing amounts due under this arrangement.
−Removed: In connection with its license agreement
−Removed: with NeuPharma, Checkpoint entered into a Sponsored Research Agreement with NeuPharma for certain research and development activities.
−Removed: Effective January 11, 2016, TGTX, a related party, agreed to assume all costs associated with this Sponsored Research Agreement
−Removed: and paid Checkpoint for all amounts previously paid by the Company.
−Removed: For the year ended December 31, 2019 and 2018, approximately
−Removed: nil and $35,000, respectively, was recognized in revenue from a related party in connection with the Sponsored Research Agreement
−Removed: in the Consolidated Statements of Operations.
−Removed: PepVax Clinical Research and Support Agreements
−Removed: March 2016, Helocyte entered into an Investigator-Initiated Clinical Research Support Agreement, as amended, with the
−Removed: COH, to support a Phase 2 clinical study of its PepVax immunotherapy for CMV control in allogeneic stem cell transplant
−Removed: recipients (“PepVax Research Agreement”).
−Removed: The Phase 2 study is additionally supported by grants from the National
−Removed: Institutes of Health/National Cancer Institute (“NCI”).
−Removed: During 2018, Helocyte elected to discontinue the further
−Removed: development of its HLA-restricted, single-antigen PepVax program and as such ceased to incur costs associated with this
−Removed: For the years ended December 31, 2019 and 2018, Helocyte recorded nil and $0.1 million, respectively, in
−Removed: connection with the PepVax Research Agreement, recorded in research and development expenses in the Company’s
−Removed: Consolidated Statements of Operations.
−Removed: In 2018 Helocyte discontinued the development of PepVax and terminated this
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: ConVax (Pentamer) Sponsored Research
−Removed: On May 1, 2017,
−Removed: Helocyte and COH entered in a Sponsored Research Agreement for preclinical studies in connection with the development of ConVax.
−Removed: In June 2017, Helocyte made an upfront payment of $1.5 million to fund the development plan, the payment was recorded as
−Removed: a prepayment on the Consolidated Balance Sheets.
−Removed: For the years ended December 31, 2019 and 2018, Helocyte recorded approximately
−Removed: nil and $1.3 million, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations.
−Removed: This agreement expired during 2018.
−Removed: For the years ended December 31, 2019
−Removed: and 2018 Mustang recorded the following expense in research and development for sponsored research and clinical trial agreements:
+Added: For the years ended December 31, 2020 and 2019, Cellvation recorded an expense of nil and $ 0.1 million, respectively, representing amounts due under this arrangement.
+Added: For the years ended December 31, 2020 and 2019 Mustang recorded the following expense in research and development for sponsored research and clinical trial agreements:
+Added: For the Year Ended December 31,
($ in thousands)
−Removed: For the Years Ended
−Removed: CAR T development (multiple programs)
−Removed: MB-102 (CD123 CAR T for AML)
−Removed: MB-101 (IL13Rα2 CAR T for Glioblastoma)
−Removed: Manufacturing License
−Removed: MB-107 (XSCID)
−Removed: MB-106 (CD20 CAR T for GBM & Metastatic Breast Cancer to Brain)
−Removed: Beth Israel Deaconess Medical Center
−Removed: CRISPR (multiple programs)
+Added: City of Hope National Medical Center
+Added: CD123 (MB-102)
+Added: IL13Rα2 (MB-101)
+Added: Manufacturing
+Added: HER2 (MB-103)
+Added: PSCA (MB-105)
+Added: Beth Israel Deaconess Medical Center - CRISPR
+Added: Jude Children's Research Hospital - XSCID (MB-107)
+Added: Fred Hutchinson Cancer Research Center - CD20 (MB-106)
City of Hope Sponsored Research Agreement
−Removed: In March 2015, in connection with
−Removed: Mustang’s license with COH for the development of CAR T, Mustang entered into a Sponsored Research Agreement in which Mustang
−Removed: will fund continued research in the amount of $2.0 million per year, payable in four equal annual installments, until 2020.
−Removed: research covered under this arrangement is for IL13Rα2 (MB-101), CD123 (MB-102) and the Spacer technology.
−Removed: For the years
−Removed: ended December 31, 2019 and 2018, Mustang incurred expense of $2.0 million and $2.0 million, respectively and recorded as
−Removed: research and development expense in the Company’s Consolidated Statement of Operations.
−Removed: CD123 (MB-102) Clinical Research Support
−Removed: On February 17, 2017, Mustang entered
−Removed: into a Clinical Research Support Agreement for CD123.
−Removed: Pursuant to the terms of this agreement, Mustang made an upfront payment
−Removed: of approximately $20,000 and will contribute an additional $0.1 million per patient in connection with the on-going investigator-initiated
+Added: In March 2015, in connection with Mustang’s license with COH for the development of CAR T, Mustang entered into a Sponsored Research Agreement in which Mustang will fund continued research in the amount of $ 2.0 million per year, payable in four equal annual installments, until 2020.
+Added: The research covered under this arrangement is for IL13Rα2 (MB-101), CD123 (MB-102) and the Spacer technology.
+Added: For the years ended December 31, 2020 and 2019, Mustang incurred expense of $ 0.5 million and $ 2.0 million, respectively and recorded as research and development expense in the Company’s Consolidated Statement of Operations.
+Added: CD123 (MB-102) Clinical Research Support Agreement
+Added: On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for CD123.
+Added: Pursuant to the terms of this agreement, Mustang made an upfront payment of approximately $ 20,000 and will contribute an additional $ 0.1 million per patient in connection with the on-going investigator-initiated study.
Further, Mustang agreed to fund approximately $ 0.2 million over three years pertaining to the clinical development of CD123.
−Removed: For the years ended December 31, 2019 and 2018 Mustang recorded approximately $1.2 million and $0.8 million, respectively,
−Removed: in research and development expenses in the Company’s Consolidated Statements of Operations.
−Removed: IL13Rα2 (MB-101) Clinical Research
−Removed: Support Agreement
−Removed: Also, on February 17, 2017, Mustang
−Removed: entered into a Clinical Research Support Agreement for IL13Rα2 (“IL13Rα2 CRA”).
−Removed: Pursuant to the terms of
−Removed: this agreement Mustang made an upfront payment of approximately $9,300 and will contribute an additional $0.1 million per patient
−Removed: in connection with the on-going investigator-initiated study.
−Removed: Further, Mustang agreed to fund approximately $0.2 million over three
−Removed: years pertaining to the clinical development of IL13Rα2.
−Removed: For the years ended December 31, 2019 and 2018, Mustang recorded
−Removed: approximately $0.9 million and $1.1 million, respectively, in research and development expenses under the IL13Rα2 CRA in
−Removed: the Company’s Consolidated Statements of Operations.
+Added: For the years ended December 31, 2020 and 2019, Mustang recorded approximately $ 0.4 million and $ 1.2 million, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations.
+Added: CS1(MB-104) Clinical Research Support Agreement
+Added: In June 2020, Mustang entered into a clinical research and support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled:
+Added: "Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CS1-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients with CS1+ Multiple Myeloma."
+Added: The CAR T being studied under this protocol has been designated by Mustang as MB-104.
+Added: Under the terms of the agreement Mustang will reimburse COH for costs associated with this trial not to exceed $ 2.4 million.
+Added: The agreement will expire upon the delivery of the final study report or earlier.
+Added: During the year ended December 31, 2020, Mustang recorded approximately $ 0.9 million in research and development expenses in the Company’s Consolidated Statement of Operations pursuant to this agreement.
+Added: IL13Rα2 (MB-101) Clinical Research Support Agreements
+Added: On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for IL13Rα2 (the “IL13Rα2 GBM CRA”).
+Added: Pursuant to the terms of this agreement Mustang made an upfront payment of approximately $ 9,300 and will contribute an additional $ 0.1 million per patient in connection with the on-going investigator-initiated study.
+Added: Further, Mustang agreed to fund approximately $ 0.2 million over three years pertaining to the clinical development of IL13Rα2.
+Added: In October 2020, Mustang entered into a Clinical Research Support Agreement for the IL13Rα2 directed CAR T program for adult patients with Leptomeningeal Glioblastoma, Ependymoma or Medulloblastoma (the “IL13Rα2 Leptomeningeal CRA”).
+Added: Pursuant to the terms of the IL13Rα2 Leptomeningeal CRA, Mustang made an upfront payment of $ 29,375 and will contribute an additional $ 0.1 million per patient in connection with the on-going investigator-initiated study.
+Added: Further, the Company agreed to fund approximately $ 0.2 million annually pertaining to the clinical development of IL13Rα2.
+Added: For the years ended December 31, 2020 and 2019, Mustang recorded approximately $ 0.5 million and $ 0.9 million, respectively, in research and development expenses under the IL13Rα2 CRAs in the Company’s Consolidated Statement of Operations.
+Added: HER2 (MB-103) Clinical Research Support Agreement
+Added: In September 2020, Mustang entered into a clinical research support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled:
+Added: “Phase I Study of Cellular Immunotherapy using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients with Recurrent/Refractory Malignant Glioma.” The CAR T being studied under this protocol has been designated as MB-103.
+Added: Under the terms of the agreement Mustang will pay COH $ 29,375 upon execution and will reimburse COH for costs associated with this trial not to exceed $ 3.0 million.
+Added: The agreement will expire upon the delivery of a final study report or earlier.
+Added: For the year ended December 31, 2020, Mustang recorded $ 1.5 million in research and development expenses in the Company’s Consolidated Statement of Operations pursuant to this agreement.
+Added: PSCA (MB-105) Clinical Research Support Agreement
+Added: In October 2020, Mustang entered into a clinical research support agreement with COH in connection with an Investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled:
+Added: “A Phase 1b study to evaluate PSCA-specific chimeric antigen receptor (CAR)-T cells for patients with metastatic castration resistant prostate cancer.” The CAR T being studied under this protocol has been designated as MB-105.
+Added: Under the terms of the agreement Mustang will pay COH $ 33,000 upon execution and will reimburse COH for costs associated with this trial not to exceed $ 2.3 million.
+Added: The agreement will expire upon the delivery of a final study report or earlier.
+Added: For the year ended December 31, 2020, Mustang recorded $ 0.2 million in research and development expenses in the Company’s Consolidated Statement of Operations pursuant to this agreement.
City of Hope Sponsored Research Agreement - Manufacturing
−Removed: On January 3, 2018, Mustang entered
−Removed: into a Sponsored Research Agreement with COH to optimize and develop CAR T cell processing procedures.
−Removed: Pursuant to the SRA, the
−Removed: Company will fund continued research in the amount of $0.9 million for the program, which has an initial term of two (2) years.
−Removed: For the years ended December 31, 2019 and 2018 Mustang recorded approximately $0.5 million and $0.5 million, respectively,
−Removed: in research and development expenses in the Company’s Consolidated Statements of Operations.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: CRISPR Sponsored Research Agreement
−Removed: with Beth Israel Deaconess Medical Center, Inc.
−Removed: On November 28, 2017, Mustang entered
−Removed: into a Sponsored Research Agreement with Beth Israel Deaconess Medical Center Inc.
−Removed: (“BIDMC”) to perform research relating
−Removed: to gene editing, via the use of CRISPR/Cas9, to be used in enhancing the efficacy of chimeric antigen receptor T (CAR T) cell therapies
−Removed: for solid tumor indications and to generate universal off the shelf CAR T cell therapies for both liquid and solid tumor indications.
+Added: On January 3, 2018, Mustang entered into a Sponsored Research Agreement (“SRA”) with COH to optimize and develop CAR T cell processing procedures.
+Added: Pursuant to the SRA, Mustang funded continued research in the amount of $ 0.9 million for the program, with an initial term of two (2) years.
+Added: The SRA expired in January 2020.
+Added: For the years ended December 31, 2020 and 2019, Mustang recorded approximately nil and $ 0.5 million, respectively, in research and development expenses in the Company’s Consolidated Statements of Operations.
+Added: CRISPR Sponsored Research Agreement with Beth Israel Deaconess Medical Center, Inc.
+Added: On November 28, 2017, Mustang entered into a Sponsored Research Agreement with Beth Israel Deaconess Medical Center Inc.
+Added: (“BIDMC”) to perform research relating to gene editing, via the use of CRISPR/Cas9, to be used in enhancing the efficacy of CAR T cell therapies for solid tumor indications and to generate universal off the shelf CAR T cell therapies for both liquid and solid tumor indications.
Mustang agreed to fund approximately $ 0.8 million over a three-year period.
−Removed: Mustang recorded $0.1 million and $0.1 million in 2019
−Removed: and 2018, respectively, related to this agreement in research and development expenses in the Company’s Consolidated Statements
−Removed: of Operations.
−Removed: The CRISPR license was terminated in 2019, see Note 7.
−Removed: CD20 (MB-106) Clinical Trial Agreement
−Removed: with Fred Hutch
−Removed: Also, on July 3, 2017, in conjunction
−Removed: with the CD20 Technology License from Fred Hutch, Mustang entered into an investigator-initiated clinical trial agreement (“CD20
−Removed: CTA”) to provide partial funding for a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20
−Removed: Technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas.
−Removed: In connection with the CD20 CTA, Mustang agreed
−Removed: to fund up to $5.3 million of costs associated with the clinical trial, which commenced during the fourth quarter of 2017.
−Removed: the years ended December 31, 2019 and 2018 Mustang recorded $0.8 million and $1.3 million of expense, respectively, related
−Removed: to this agreement in research and development expenses in the Company’s Consolidated Statements of Operations.
−Removed: MB-107 (XSCID)
−Removed: Non-Interventional Services Agreement with St.
−Removed: In December 2019, Mustang entered
−Removed: into a Non-Interventional Services Agreement with Children’s CGMP, LLC (“CGMP”), an affiliate of St.
−Removed: Jude Children’s
−Removed: Research Hospital, pursuant to which CGMP provides lentiviral vector for non-clinical XSCID research purposes, as well as related
−Removed: advisory services.
−Removed: Mustang agreed to fund approximately $0.8 million upon execution of the agreement, which was recorded in research
−Removed: and development expenses for the year ended December 31, 2019 in the Company’s Consolidated Statements of Operations.
−Removed: On November 30, 2017, in connection
−Removed: with its three separate license agreements with UNC, Tamid entered into a Sponsored Research Agreement with UNC (“UNC SRA”)
−Removed: for certain continued research and development activities related to Nanodysferlin for treatment of Dysferlinopathy, and AAV-HLA-G
−Removed: for corneal transplant rejection.
+Added: Mustang recorded nil and $ 0.1 million in 2020 and 2019, respectively, related to this agreement in research and development expenses in the Company’s Consolidated Statements of Operations.
+Added: In January 2019, Mustang terminated the SRA with BIDMC due to the departure of key personnel from BIDMC.
+Added: CD20 (MB-106) Clinical Trial Agreement with Fred Hutch
+Added: On July 3, 2017, in conjunction with the CD20 Technology License from Fred Hutch, Mustang entered into an investigator-initiated clinical trial agreement (“CD20 CTA”) to provide partial funding for a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20 Technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas.
+Added: In connection with the CD20 CTA, Mustang agreed to fund up to $ 5.3 million of costs associated with the clinical trial, which commenced during the fourth quarter of 2017.
+Added: In November 2020, the CD20 CTA was amended to include additional funding of approximately $ 0.8 million for the treatment of five patients with chronic lymphocytic leukemia.
+Added: For the years ended December 31, 2020 and 2019 Mustang recorded $ 1.8 million and $ 0.6 million of expense, respectively, related to this agreement in research and development expenses in the Company’s Consolidated Statements of Operations.
+Added: CD20 (MB-106) Sponsored Research Agreement – Manufacturing with Fred Hutch
+Added: On March 17, 2018, Mustang entered into a Sponsored Research Agreement (“SRA”) with Fred Hutch related to developing and optimizing processes and systems associated with CD20 cell processing.
+Added: Pursuant to the SRA, Mustang funded research in the amount of $ 0.6 million during the term of the SRA, which expired in March 2019.
+Added: For the years ended December 31, 2020 and 2019, Mustang recorded expense of nil and $ 0.2 million, respectively, in research and development expenses in the Statements of Operations pursuant to the terms of this agreement.
+Added: XSCID (MB-107) Data Transfer Agreement with St.
+Added: In June 2020, Mustang entered into a Data Transfer Agreement with St.
+Added: Jude under which Mustang will reimburse St.
+Added: Jude for costs associated with St.
+Added: Jude’s clinical trial for the treatment of infants with XSCID.
+Added: Pursuant to the terms of this agreement and for the year ended December 31, 2020, Mustang paid an upfront fee of $ 1.1 million, which was recorded in research and development expenses in the Company’s Consolidated Statement of Operations.
+Added: Mustang will continue to reimburse St.
+Added: Jude for costs incurred in connection with this trial.
+Added: MB-107 (XSCID) Non-Interventional Services Agreement with Children’s CGMP
+Added: In December 2019, Mustang entered into a Non-Interventional Services Agreement with Children's CGMP, LLC ("Children’s"), an affiliate of St.
+Added: Jude Children's Research Hospital, pursuant to which Children’s provides lentiviral vector for non-clinical XSCID research purposes, as well as related advisory services.
+Added: Mustang agreed to fund approximately $ 0.8 million upon execution of the agreement, which was recorded in research and development expenses for the year ended December 31, 2019 in the Company's Consolidated Statement of Operations.
+Added: Columbia Sponsored Research Agreement
+Added: Pursuant to the terms of the Columbia License, Oncogenuity will make semi-annual research payments to Columbia over a five year period ending in November 2024;
+Added: such payments not to exceed $ 4.8 million.
+Added: For the year ended December 31, 2020, Oncogenuity recorded expense of $ 0.5 million in research and development in the Company’s Consolidated Statements of Operations.
+Added: No expense was recorded in 2019.
+Added: University of Oxford Sponsorship Agreement
+Added: On December 16, 2020 Oncogenuity entered into an agreement with The Chancellor Masters and Scholars of the University of Oxford (“Oxford”).
+Added: Under the terms of the agreement Oxford will engage in preclinical development of antisense oligonulcleotides as a therapy in certain indications.
+Added: In connection with the agreement Oncogenuity agreed to fund research for approximately 18 months for up to of $ 0.6 million ( £ 0.4 million).
+Added: Oncogenuity made an up-front payment of $ 0.1 million ( £ 0.1 million) in January 2021.
+Added: On November 30, 2017, in connection with its three separate license agreements with UNC, Tamid entered into a Sponsored Research Agreement with UNC (“UNC SRA”) for certain continued research and development activities related to Nanodysferlin for treatment of Dysferlinopathy, and AAV-HLA-G for corneal transplant rejection.
Total amount to be funded by Tamid under the UNC SRA is $ 2.3 million over a term of three years .
Pursuant to the terms of the UNC SRA, Tamid paid $ 0.8 million which was due upon execution.
−Removed: For the years ended December 31,
−Removed: 2019 and 2018, Tamid recorded expense of nil and $0.7 million respectively in connection with the UNC SRA.
−Removed: The expense was recorded
−Removed: in research and development expenses in the Company’s Consolidated Statements of Operations.
−Removed: Effective December 2019,
−Removed: Tamid returned the license to UNC and ceased to incur costs associated with the development of products under this license.
−Removed: On July 22, 2019 Journey purchased
−Removed: Ximino®, a minocycline hydrochloride used to treat acne from a third party.
−Removed: Pursuant to the terms and conditions of the Asset
−Removed: Purchase Agreement (“APA”), total consideration for the APA is $9.4 million, comprised of an upfront payment of $2.4
−Removed: million payable within 60 days after execution on September 22, 2019.
−Removed: The remaining four payments totaling $7.0 million are
−Removed: due in consecutive years commencing on the second anniversary of execution of the APA.
−Removed: In addition, Journey is obligated to pay
−Removed: royalties in the mid-single digits based on net sales of Ximino, subject to specified reductions.
−Removed: The Company, in accordance with ASU 2017-01,
−Removed: Business Combinations (Topic 805):
−Removed: Clarifying the Definition of a Business , determined the purchase of Ximino did not constitute
−Removed: the purchase of a business, and therefore recorded the purchase price of Ximino as an asset, to be amortized over the life of the
−Removed: product, which is deemed to be seven years.
−Removed: In addition, the Company determined pursuant to ASC 450, Contingencies, that
−Removed: royalty payments in connection with the APA will be recorded when they become payable with a corresponding charge to cost of goods
−Removed: In accordance with the terms of the APA
−Removed: Journey will incur interest expense in the event of payment default.
−Removed: As such per ASC 835-30 Interest-Imputed Interest, Journey
−Removed: recorded an initial discount for imputed interest of $2.3 million.
−Removed: As of December 31, 2019, Journey recorded an intangible
−Removed: asset related to this transaction of $7.1 million which was recorded on the consolidated balance sheet of Fortress.
−Removed: On August 31, 2018, JMC entered into
−Removed: an agreement with a third party to acquire the exclusive rights to Exelderm®, a topical antifungal available in a cream and
−Removed: This acquisition was recorded as an intangible asset and expense will be recognized over the expected life of Exelderm®
−Removed: JMC commenced the sale of Exelderm®
−Removed: in September 2018 and accordingly commenced the amortization of this cost.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: In January 2016, JMC entered into
−Removed: a licensing agreement with a third party to distribute its prescription wound cream Luxamend ®
−Removed: and paid an upfront fee of $50,000.
−Removed: Additionally, in January 2016, JMC entered into a licensing agreement with a third party to distribute its prescription emollient
−Removed: Ceracade ®
−Removed: for the treatment of various types of dermatitis and paid an upfront fee of $0.3 million.
−Removed: JMC commenced the sale
−Removed: of both of these products during the year ended December 31, 2016 and accordingly commenced the amortization of these costs
−Removed: over their respective three year estimated useful life.
−Removed: In March 2015, JMC entered into a
−Removed: license and supply agreement to acquire the rights to distribute Targadox®
−Removed: a dermatological product for the treatment of acne.
+Added: For the years ended December 31, 2020 and 2019, Tamid recorded expense of nil and nil respectively in connection with the UNC SRA.
+Added: The expense was recorded in research and development expenses in the Company’s Consolidated Statements of Operations.
+Added: Effective December 2019, Tamid returned the license to UNC and ceased to incur costs associated with the development of products under this license.
+Added: On December 18, 2020, Journey entered an Asset Purchase Agreement with a third party (the “Anti-itch Product Agreement”) for a topical product that is indicated to treat scabies and skin itch conditions (“Anti-itch Product”).
+Added: Pursuant to the terms and conditions of the Anti-itch Product Agreement, Journey agreed to pay $ 4.0 million, comprised of a non-refundable deposit of $ 0.2 million upon the execution of the term sheet, a cash upfront payment of $ 1.8 million on January 1, 2021 and additional future payments of $ 0.5 million on April 1, 2021, $ 0.5 million on July 1, 2021, and $ 1.0 million on January 1, 2022.
+Added: There are no subsequent milestone payments or royalties beyond the aforementioned payments.
+Added: Commercial launch of this product is expected in the third quarter of 2021.
+Added: The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805):
+Added: Clarifying the Definition of a Business , determined the purchase of the Anti-itch Product did not constitute the purchase of a business, and therefore recorded the purchase price of the Anti-itch Product as an asset, to be amortized over the life of the product, which is deemed to be three years .
+Added: On July 29, 2020, Journey entered into a License and Supply Agreement with a third party to acquire intellectual property rights to an oral acne product that is indicated for the treatment of severe acne (the “Isotretinoin Agreement”).
+Added: Pursuant to the terms and conditions of the Isotretinoin Agreement, Journey agreed to pay $ 5.0 million, comprised of an upfront payment of $ 1.0 million paid upon execution with remaining payments due as follows:
+Added: $ 0.5 million upon achievement of a regulatory approval milestone and $ 0.5 million upon the delivery of the first order and $ 3.0 million due in $ 1.0 million installments, on the 18-month anniversary, the 24-month anniversary and the 36-month anniversary of execution of the Isotretinoin Agreement.
+Added: Three additional milestone payments totaling $ 17.0 million are contingent upon the achievement of certain net sales milestones.
+Added: Royalties in the low-double digits based on net sales, subject to specified reductions are also due.
+Added: Commercial launch of this product is expected in the second quarter of 2021.
+Added: The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805):
+Added: Clarifying the Definition of a Business , determined the purchase of the Isotretinoin Agreement did not constitute the purchase of a business, and therefore recorded the purchase price of the Isotretinoin Agreement as an asset, to be amortized over the life of the product, which is deemed to be five years .
+Added: On July 22, 2019 Journey purchased Ximino®, a minocycline hydrochloride used to treat acne from a third party.
+Added: Pursuant to the terms and conditions of the Asset Purchase Agreement (“APA”), total consideration for the APA is $ 9.4 million, comprised of an upfront payment of $ 2.4 million payable within 60 days after execution on September 22, 2019.
+Added: The remaining four payments totaling $ 7.0 million are due in consecutive years commencing on the second anniversary of execution of the APA.
+Added: In addition, Journey is obligated to pay royalties in the mid-single digits based on net sales of Ximino, subject to specified reductions.
+Added: The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805):
+Added: Clarifying the Definition of a Business , determined the purchase of Ximino did not constitute the purchase of a business, and therefore recorded the purchase price of Ximino as an asset, to be amortized over the life of the product, which is deemed to be seven years .
+Added: In addition, the Company determined pursuant to ASC 450, Contingencies, that royalty payments in connection with the APA will be recorded when they become payable with a corresponding charge to cost of goods sold.
+Added: In accordance with the terms of the APA Journey will incur interest expense in the event of payment default.
+Added: As such per ASC 835-30 Interest-Imputed Interest, Journey recorded an initial discount for imputed interest of $ 2.3 million.
+Added: As of December 31, 2019, Journey recorded an intangible asset related to this transaction of $ 7.1 million which was recorded on the Consolidated Balance Sheet of Fortress.
+Added: On August 31, 2018, JMC entered into an agreement with a third party to acquire the exclusive rights to Exelderm®, a topical antifungal available in a cream and solution.
+Added: This acquisition was recorded as an intangible asset and expense will be recognized over the expected life of Exelderm® of 3 years .
+Added: JMC commenced the sale of Exelderm® in September 2018 and accordingly commenced the amortization of this cost.
+Added: In January 2016, JMC entered into a licensing agreement with a third party to distribute its prescription wound cream Luxamend ® and paid an upfront fee of $ 50,000 .
+Added: Additionally, in January 2016, JMC entered into a licensing agreement with a third party to distribute its prescription emollient Ceracade ® for the treatment of various types of dermatitis and paid an upfront fee of $ 0.3 million.
+Added: JMC commenced the sale of both of these products during the year ended December 31, 2016 and accordingly commenced the amortization of these costs over their respective three year estimated useful life.
+Added: In March 2015, JMC entered into a license and supply agreement to acquire the rights to distribute Targadox® a dermatological product for the treatment of acne.
JMC made an upfront payment of $ 1.3 million.
Further payments will be made based on a revenue sharing arrangement.
−Removed: FDA approval for the manufacturing of this product in July 2016 and commenced sales of this product in October 2016.
−Removed: The table below provides a summary of intangible
−Removed: assets as of December 31, 2019 and 2018, respectively:
+Added: JMC received FDA approval for the manufacturing of this product in July 2016 and commenced sales of this product in October 2016.
+Added: The table below provides a summary of intangible assets as of December 31, 2020 and 2019, respectively:
+Added: Estimated Useful
($ in thousands)
+Added: Lives (Years)
December 31, 2020
December 31, 2019
−Removed: Intangible assets –
−Removed: asset purchases
+Added: Total Intangible assets – asset purchases
Accumulated amortization
Net intangible assets
−Removed: The table below provides a summary for
−Removed: the years ended December 31, 2019 and 2018, of recognized expense related to product licenses, which was recorded in costs
−Removed: of goods sold on the Consolidated Statement of Operations (see Note 19):
+Added: The table below provides a summary for the years ended December 31, 2020 and 2019, of recognized expense related to product licenses, which was recorded in costs of goods sold on the Consolidated Statement of Operations (see Note 19):
($ in thousands)
−Removed: Beginning balance at January 1, 2018
−Removed: Amortization expense
−Removed: Ending balance at December 31, 2018
+Added: Beginning balance at December 31, 2018
Purchase of Ximino 1
Amortization expense
+Added: Beginning balance at December 31, 2019
+Added: Isotretinoin Agreement 2
+Added: Anti-itch product license acquisition 3
+Added: Amortization expense
Ending balance at December 31, 2020
−Removed: Includes an upfront payment of $2.4 million and four
−Removed: payments totaling $7.0 million due in consecutive years commencing on the second anniversary of the execution of the APA.
−Removed: payments were discounted by $2.3 million as a result of the long-term nature of such payments.
−Removed: The future amortization of these intangible
−Removed: assets is as follows ($ in thousands):
−Removed: Exelderm®
+Added: Includes an upfront payment of $ 2.4 million and four payments totaling $ 7.0 million due in consecutive years commencing on the second anniversary of the execution of the APA.
+Added: Such payments were discounted by $ 2.3 million as a result of the long-term nature of such payments.
+Added: Includes an upfront payment of $ 1.0 million and a milestone payment of $ 0.5 million in 2020 and three payments totaling $ 3.5 million due at various points between 2021 through 2023.
+Added: Such payments were discounted by $ 0.3 million as a result of the long-term nature of such payments.
+Added: As of December 31, 2020, this asset has not yet been placed in service, therefore no amortization expense was recognized on this asset for the year ended December 31, 2020.
+Added: Journey expects the asset to be placed in service in the first half of 2021.
+Added: Once the asset is placed in service Journey will amortize the asset over five years , which represents its expected useful life.
+Added: Includes an upfront payment of $ 0.2 million and three payments totaling $ 2.8 million in 2021 and $ 1.0 million in 2022.
+Added: Such payments were discounted by $ 0.1 million as a result of the long-term nature of such payments.
+Added: As of December 31, 2020, this asset has not yet been placed in service, therefore no amortization expense was recognized on this asset for the year ended December 31, 2020.
+Added: The Company expects to launch this asset in Q3 2021.
+Added: Once the asset is placed in service Journey will amortize the asset over three years , which represents its expected useful life.
+Added: The future amortization of these intangible assets is as follows:
+Added: ($ in thousands)
Year Ended December 31, 2021
3 unchanged sentences
Year Ended December 31, 2025
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
+Added: Intangible assets not yet placed in service
Debt and Interest
−Removed: Total debt consists of the following as
−Removed: of December 31, 2019 and December 31, 2018:
+Added: Total debt consists of the following:
($ in thousands)
11 unchanged sentences
September - 2021
−Removed: O pus Credit Facility 1
September - 2021
−Removed: M ustang Horizon Notes 2
+Added: Mustang Horizon Notes 2
October - 2022
−Removed: C aelum Convertible Note, at fair value 4
−Removed: January - 2019
−Removed: C aelum Convertible Note, at fair value 4
−Removed: C aelum Convertible Note, at fair value 4
+Added: August - 2025
Total notes payable
1 unchanged sentence
Total notes payable
−Removed: Classified as short-term on the Company's Consolidated Balance Sheet as of December 31, 2018.
−Removed: Classified as long-term on the Company's Consolidated Balance Sheet as of December 31, 2019.
+Added: Formerly the Opus Credit Facility (see Note 17).
Interest rate is 9.0 % plus one-month LIBOR Rate in excess of 2.5 %;
+Added: at December 31, 2019, $ 1.2 million is included in Notes payable, short-term on the Consolidated Balance Sheet.
As a result of a one year maturity date extension, the interest rate of 9.0 % takes effect in year 4 of the note.
−Removed: These notes converted in January 2019 with Caelum's execution of the DOSPA with Alexion (see Note 4).
−Removed: Maturity was extended into 2021 in January 2020.
−Removed: On February 13, 2014, the Company
−Removed: executed a promissory note in favor of IDB in the amount of $15.0 million (the “IDB Note”).
−Removed: The Company borrowed $14.0
−Removed: million against this note and used it to repay its prior loan from Hercules Technology Growth Capital, Inc.
−Removed: The Company may
−Removed: request revolving advances under the IDB Note in a minimum amount of $0.1 million (or the remaining amount of the undrawn balance
−Removed: under the IDB Note if such amount is less than $0.1 million).
−Removed: All amounts advanced under the IDB Note are due in full at the earlier
−Removed: (i) August 1, 2020, as extended or (ii) on the IDB’s election following the occurrence and continuation
−Removed: of an event of default.
−Removed: The unpaid principal amount of each advance shall bear interest at a rate per annum equal to the rate payable
−Removed: on the Company’s money market account plus a margin of 150 basis points.
+Added: At December 31, 2019, $ 6.0 million is included in Notes payable, short-term on the Consolidated Balance Sheet.
+Added: On August 27, 2020 (the “Closing Date”), Fortress, as borrower, entered into a $ 60.0 million senior secured credit agreement (the “Oaktree Agreement”) with Oaktree.
+Added: The Company borrowed the full $ 60.0 million in connection with the terms of the Oaktree Note on the Closing Date and used the bulk of the proceeds to repay its outstanding debt to other lenders (2017 Subordinated Notes, 2018 Venture Notes and 2019 Notes (previously the “Opus Credit Facility”)).
+Added: The Oaktree Note bears interest at a fixed annual rate of 11.0 %, payable quarterly and maturing on the fifth anniversary of the Closing Date, August 27, 2025 , the (“Maturity Date”).
+Added: The Company is required to make quarterly interest-only payments until the Maturity Date, at which point the outstanding principal amount is due.
+Added: The Company may voluntarily prepay the Oaktree Note at any time subject to a Prepayment Fee.
+Added: The Company is also required to make mandatory prepayments of the Oaktree Note under various circumstances.
+Added: No amounts paid or prepaid may be reborrowed without Oaktree consent.
+Added: The Oaktree Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, affiliate transactions, investments, acquisitions, mergers, dispositions, prepayment of permitted indebtedness, and dividends and other distributions, subject to certain exceptions.
+Added: These affirmative and negative covenants apply in different instances to Fortress itself, its private subsidiaries, its public subsidiaries, or certain combinations of the foregoing.
+Added: The limitations on dividends and other distributions have the practical effect of preventing any further issuances by the Company or its private subsidiaries of equity securities with cash dividends or redemption features.
+Added: In addition, the Oaktree Agreement contains certain financial covenants, including, among other things, (i) maintenance of minimum liquidity and (ii) a minimum revenue test that requires Journey’s annual revenue to be equal to or to exceed annual revenue projections set forth in the agreement.
+Added: Failure by the Company or Journey, as applicable, to comply with the financial covenants will result in an event of default, subject to certain cure rights of the Company.
+Added: The Company was in compliance with all applicable covenants under the Oaktree Note as of December 31, 2020.
+Added: The Oaktree Agreement contains customary events of default, in certain circumstances subject to customary cure periods.
+Added: These events of default apply in different instances to Fortress itself, its private subsidiaries, its public subsidiaries, or a certain combination of the foregoing.
+Added: Following an event of default and any cure period, if applicable, the Agent will have the right upon notice to accelerate all amounts outstanding under the Oaktree Agreement, in addition to other remedies available to the lenders as secured creditors of the Company.
+Added: The Oaktree Agreement grants a security interest in favor of the Agent, for the benefit of the lenders, in substantially all of the Company’s assets (consisting principally of the Company’s shareholdings in, and in some cases debt owing from, its partner companies) as collateral securing the Company’s obligations under the Oaktree Agreement, except for:
+Added: (i) certain interests in controlled foreign corporation subsidiaries of the Company;
+Added: (ii) the Company’s holdings in Avenue;
+Added: and (iii) those portions of the Company’s holdings in certain subsidiaries (plus Caelum) that are encumbered by pre-existing equity pledges to certain of the Company’s officers.
+Added: None of Fortress’ subsidiaries or partner companies is a party to the Oaktree Agreement, and the collateral package does not include the asets of any such subsidiaries or partner companies.
+Added: Pursuant to the terms of the Oaktree Agreement, on the Closing Date the Company paid Oaktree an upfront commitment fee equal to 3 % of the $ 60.0 million, or $ 1.8 million.
+Added: In addition, the Company paid a $ 35,000 Agency fee to the Agent, which was due on the Closing Date and will be due annually, together with fees of $ 2.5 million directly to third parties involved in the transaction.
+Added: In connection with the Oaktree Note, the Company issued warrants to Oaktree and certain of its affiliates to purchase up to 1,749,450 shares of common stock of the Company (see Note 14) with a relative fair value of $ 4.4 million.
+Added: As of December 31, 2020, the Company recorded the fees totaling $ 8.7 million ($ 1.8 million to Oaktree, $ 2.5 million of expenses paid to third-parties and $ 4.4 million representing the relative fair value of the Oaktree Warrants) to debt discount.
+Added: These costs will be amortized over the term of the Oaktree Note.
+Added: On February 13, 2014, the Company executed a promissory note in favor of IDB in the amount of $ 15.0 million (the “IDB Note”).
+Added: The Company borrowed $ 14.0 million against this note and used it to repay its prior loan from Hercules Technology Growth Capital, Inc.
+Added: The Company could request revolving advances under the IDB Note in a minimum amount of $ 0.1 million (or the remaining amount of the undrawn balance under the IDB Note if such amount were less than $ 0.1 million).
+Added: All amounts advanced under the IDB Note were due in full at the earlier of:
+Added: (i) August 1, 2020, as extended or (ii) on the IDB’s election following the occurrence and continuation of an event of default.
+Added: The unpaid principal amount of each advance shall bear interest at a rate per annum equal to the rate payable on the Company’s money market account plus a margin of 150 basis points.
The interest rate at December 31, 2019 was 2.25 %.
The IDB Note contains various representations and warranties customary for financings of this type.
−Removed: The obligations of the Company under the
−Removed: IDB Note are collateralized by a security interest in, a general lien upon, and a right of set-off against the Company’s
−Removed: money market account of $15.0 million, which is recorded as restricted cash in the Company’s consolidated balance sheets,
−Removed: pursuant to the Assignment and Pledge of Money Market Account, dated as of February 13, 2014 (the “Pledge Agreement”).
−Removed: Pursuant to the Pledge Agreement, the Bank may, after the occurrence and continuation of an event of default under the IDB Note,
−Removed: recover from the money market account all amounts outstanding under the IDB Note.
−Removed: The Pledge Agreement contains various representations,
−Removed: warranties, and covenants customary for pledge agreements of this type.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: The Company will default on the IDB Note
−Removed: if, among other things, it fails to pay outstanding principal or interest when due.
−Removed: Following the occurrence of an event of default
−Removed: under the IDB Note, the Bank may:
−Removed: (i) declare the entire outstanding principal balance of the IDB Note, together with all
−Removed: accrued interest and other sums due under the IDB Note, to be immediately due and payable;
−Removed: (ii) exercise its right of setoff
−Removed: against any money, funds, credits or other property of any nature in possession of, under control or custody of, or on deposit
+Added: The obligations of the Company under the IDB Note were collateralized by a security interest in, a general lien upon, and a right of set-off against the Company’s money market account of $ 15.0 million, which was recorded as restricted cash in the Company's Consolidated Balance Sheets, pursuant to the Assignment and Pledge of Money Market Account, dated as of February 13, 2014 (the “Pledge Agreement”).
+Added: Pursuant to the Pledge Agreement, the Bank may, after the occurrence and continuation of an event of default under the IDB Note, recover from the money market account all amounts outstanding under the IDB Note.
+Added: The Pledge Agreement contained various representations, warranties, and covenants customary for pledge agreements of this type.
+Added: The Company could default on the IDB Note if, among other things, it failed to pay outstanding principal or interest when due.
+Added: Following the occurrence of an event of default under the IDB Note, the Bank may:
+Added: (i) declare the entire outstanding principal balance of the IDB Note, together with all accrued interest and other sums due under the IDB Note, to be immediately due and payable;
+Added: (ii) exercise its right of setoff against any money, funds, credits or other property of any nature in possession of, under control or custody of, or on deposit with IDB;
(iii) terminate the commitments of IDB;
−Removed: and (iv) liquidate the money market account to reduce the Company’s
−Removed: obligations to IDB.
−Removed: On September 18, 2017, the maturity
−Removed: on the IDB Note was extended to August 1, 2020.
+Added: and (iv) liquidate the money market account to reduce the Company’s obligations to IDB.
+Added: On September 18, 2017, the maturity on the IDB Note was extended to August 1, 2020 .
In January 2020, the maturity on the IDB Note was extended to August 1, 2021 .
−Removed: The Company applied the 10% cash flow test pursuant to ASC 470 to calculate the difference between the present value of the
−Removed: amended IDB Note’s cash flows and the present value of the original remaining cash flow and concluded that the results didn't
−Removed: exceed the 10% factor, the debt modification is not considered substantially different and did not apply extinguishment accounting,
−Removed: rather accounting for the modification on a prospective basis pursuant to ASC 470.
−Removed: The Company only pays interest on the IDB Note
−Removed: through maturity.
−Removed: At December 31, 2019 and 2018, the
−Removed: Company had approximately $14.9 million outstanding under its promissory note with IDB.
−Removed: Helocyte Convertible Notes
−Removed: During 2016 Helocyte entered into an agreement
−Removed: with Aegis Capital Corp.
−Removed: (“Aegis”) to raise up to $5.0 million in convertible notes.
−Removed: The notes had an initial term
−Removed: of 18 months, which could be extended at the option of the holder, on one or more occasions, for up to 180 days and accrue simple
−Removed: interest at the rate of 5% per annum for the first 12 months and 8% per annum simple interest thereafter.
−Removed: The notes are guaranteed
−Removed: The outstanding principal and interest of the notes automatically converts into the type of equity securities sold
−Removed: by Helocyte in the next sale of equity securities in which Helocyte realizes aggregate gross cash proceeds of at least $10.0 million
−Removed: (before commissions or other expenses and excluding conversion of the notes) at a conversion price equal to the lesser of (a) the
−Removed: lowest price per share at which equity securities of Helocyte are sold in such sale less a 33% discount and (b) a per share
−Removed: price based on a pre-offering valuation of $50.0 million divided by the number of common shares outstanding on a fully-diluted
−Removed: The outstanding principal and interest of the notes may be converted at the option of the holder in any sale of equity securities
−Removed: that does not meet the $10.0 million threshold for automatic conversion using the same methodology.
−Removed: The notes also automatically
−Removed: convert upon a “Sale”
−Removed: of Helocyte, defined as (a) a transaction or series of related transactions where one or
−Removed: more non-affiliates acquires (i) capital stock of Helocyte or any surviving successor entity possessing the voting power to
−Removed: elect a majority of the board of directors or (ii) a majority of the outstanding capital stock of Helocyte or the surviving
−Removed: successor entity (b) the sale, lease or other disposition of all or substantially all of Helocyte’s assets or any other
−Removed: transaction resulting in substantially all of Helocyte’s assets being converted into securities of another entity or cash.
−Removed: Upon a Sale of Helocyte, the outstanding principal and interest of the notes automatically converts into common shares at a price
−Removed: equal to the lesser of (a) a discount to the price per share being paid in the Sale of Helocyte equal to 33% or (b) a
−Removed: conversion price per share based on a pre-sale valuation of $50.0 million divided by the fully-diluted common stock of Helocyte
−Removed: immediately prior to the Sale of Helocyte (excluding the notes).
−Removed: As of December 31, 2016, Helocyte
−Removed: realized net proceeds in its four separate closings of $3.9 million after paying Aegis, its placement fee of $0.4 million, or approximately
−Removed: 10% of the net proceeds, and legal fees of approximately $0.1 million.
−Removed: Additionally, Aegis received warrants (“Helocyte Warrants”)
−Removed: to purchase the number of shares of Helocyte’s common stock equal to $0.4 million, divided by the price per share at which
−Removed: any note sold to investors first converts into Helocyte’s common stock.
−Removed: The warrants are issued at each closing.
−Removed: Warrants, which were recorded as a liability in accordance with ASC 815, have a five-year term and have a per share exercise price
−Removed: equal to 110% of the price per share at which any note sold to investors first converts into Helocyte’s common stock.
−Removed: Offering expired on December 31, 2016.
−Removed: Due to the complexity and number of embedded
−Removed: features within each convertible note, and as permitted under accounting guidance, the Company elected to account for the convertible
−Removed: notes and all the embedded features under the fair value option.
−Removed: During the twelve months ended December 31,
−Removed: 2018, the Helocyte Convertible Notes matured, and were all repaid in full.
−Removed: Opus Credit Facility Agreement
−Removed: On September 14, 2016, Fortress entered
−Removed: into a Credit Facility Agreement (the “Opus Credit Facility”) with Opus Point Healthcare Innovations Fund, LP (“OPHIF”).
−Removed: Since Fortress’s Chairman, President and Chief Executive Officer (Lindsay A.
−Removed: Rosenwald) and Fortress’s Executive Vice
−Removed: President, Strategic Development (Michael S.
−Removed: Weiss), are Co-Portfolio Managers and Partners of Opus Point Partners Management,
−Removed: LLC (“Opus”), an affiliate of OPHIF, all of the disinterested directors of Fortress’s board of directors approved
−Removed: the terms of the Credit Facility Agreement and accompanying Pledge and Security Agreement and forms of Note and Warrant (collectively,
−Removed: the “Financing Documents”).
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: Pursuant to the Opus Credit Facility, Fortress was eligible
−Removed: to borrow up to a maximum aggregate amount of $25.0 million from OPHIF and any other lender that joins the Credit Facility Agreement
−Removed: from time to time (OPHIF and each subsequent lender, a “Lender”) under one or more convertible secured promissory
−Removed: notes (each a “Note”) from September 14, 2016 until September 1, 2017 (the “Commitment Period”).
−Removed: All amounts borrowed under the Credit Facility Agreement were required to be paid in full by September 14, 2018 (the “Maturity
−Removed: Date”), however Fortress had the right to prepay the Notes at any time without penalty.
−Removed: Pursuant to the Opus Credit Facility and
−Removed: form of Note, each Note will bear interest at 12% per annum and interest will be paid quarterly in arrears commencing on December 1,
−Removed: 2016 and on the first business day of each September, December, March and June thereafter until the Maturity Date.
−Removed: the occurrence and continuance of an event of default (as specified in Credit Facility Agreement and form of Note), each Note will
−Removed: bear interest at 14% and be payable on demand.
−Removed: The Lenders may elect to convert the principal and interest of the Notes at any
−Removed: time into shares of Fortress’s common stock (“Common Stock”) at a conversion price of $10.00 per share.
−Removed: are secured by shares of capital stock currently held by Fortress in certain Fortress Companies as set forth in the Pledge and
−Removed: Security Agreement entered into between Fortress, its wholly owned subsidiary, FBIO Acquisition, Inc., and OPHIF (as collateral
−Removed: agent on behalf of all the Lenders) on September 14, 2016 (the “Pledge and Security Agreement”).
−Removed: Fortress may terminate the Opus Credit
−Removed: Facility upon notice to the Lenders and payment of all outstanding obligations under the Credit Facility Agreement.
−Removed: Notwithstanding
−Removed: any early termination of the Credit Facility Agreement, within 15 days after termination of the Commitment Period, Fortress will
−Removed: issue each Lender warrants (each a “Warrant”) pursuant to the terms of the Credit Facility Agreement and form of Warrant
−Removed: to purchase their pro rata share of (a) 1,500,000 shares of Common Stock;
−Removed: and (b) that number of shares of Common Stock
−Removed: equal to the product of (i) 1,000,000, times (ii) the principal amount of all Notes divided by 25,000,000.
−Removed: will have a five-year term and will be exercisable at a price of $3.00 per share.
−Removed: On March 12, 2018, the Company and
−Removed: OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”).
−Removed: The A&R Opus Credit Facility
−Removed: extended the maturity date of the notes issued under the Opus Credit Facility from September 14, 2018 by one year to September 14,
−Removed: In September 2019 the A&R Opus Credit Facility was amended to extend the maturity of the notes under the Opus Credit
−Removed: Facility from September 14, 2019 to September 14, 2021.
−Removed: The A&R Opus Credit Facility also permits the Company to
−Removed: make portions of interest and principal repayments in the form of shares of the Company’s common stock and/or in common stock
−Removed: of the Company’s publicly traded subsidiaries, subject to certain conditions.
−Removed: Fortress retains the ability to prepay the
−Removed: Notes at any time without penalty.
−Removed: The notes payable under the A&R Opus Credit Facility continue to bear interest at 12% per
+Added: The Company applied the 10% cash flow test pursuant to ASC 470 to calculate the difference between the present value of the amended IDB Note’s cash flows and the present value of the original remaining cash flow and concluded that the results didn't exceed the 10% factor, the debt modification is not considered substantially different and therefore did not apply extinguishment accounting, rather it accounted for the modification on a prospective basis pursuant to ASC 470.
+Added: The Company only paid interest on the IDB Note through maturity.
+Added: During August 2020, the Company repaid the IDB Note utilizing the cash collateral securing the IDB Note, which was classified as restricted cash on the Company’s Consolidated Balance Sheet.
+Added: At December 31, 2020 and 2019, the Company had approximately nil and $ 14.9 million, respectively, outstanding under its promissory note with IDB.
+Added: 2019 Notes (formerly the Opus Credit Facility)
+Added: On September 14, 2016, Fortress entered into a Credit Facility Agreement (the “Opus Credit Facility”) with Opus Point Healthcare Innovations Fund, LP (“OPHIF”).
+Added: Since Fortress’s Chairman, President and Chief Executive Officer (Lindsay A.
+Added: Rosenwald) and Fortress’s Executive Vice President, Strategic Development (Michael S.
+Added: Weiss), are Co-Portfolio Managers and Partners of Opus Point Partners Management, LLC (“Opus”), an affiliate of OPHIF, all of the disinterested directors of Fortress’s board of directors approved the terms of the Credit Facility Agreement and accompanying Pledge and Security Agreement and forms of Note and Warrant (collectively, the “Financing Documents”).
+Added: Pursuant to the Opus Credit Facility, Fortress was eligible to borrow up to a maximum aggregate amount of $ 25.0 million from OPHIF and any other lender that joins the Credit Facility Agreement from time to time (OPHIF and each subsequent lender, a “Lender”) under one or more convertible secured promissory notes (each a “Note”) from September 14, 2016 until September 1, 2017 (the “Commitment Period”).
+Added: All amounts borrowed under the Credit Facility Agreement were required to be paid in full by September 14, 2018 (the “Maturity Date”), however Fortress had the right to prepay the Notes at any time without penalty.
+Added: Pursuant to the Opus Credit Facility and form of Note, each Note will bear interest at 12 % per annum and interest will be paid quarterly in arrears commencing on December 1, 2016 and on the first business day of each September, December, March and June thereafter until the Maturity Date.
+Added: Upon the occurrence and continuance of an event of default (as specified in Credit Facility Agreement and form of Note), each Note will bear interest at 14 % and be payable on demand.
+Added: The Lenders may elect to convert the principal and interest of the Notes at any time into shares of Fortress’s common stock (“Common Stock”) at a conversion price of $ 10.00 per share.
+Added: All Notes are secured by shares of capital stock currently held by Fortress in certain Fortress Companies as set forth in the Pledge and Security Agreement entered into between Fortress, its wholly owned subsidiary, FBIO Acquisition, Inc., and OPHIF (as collateral agent on behalf of all the Lenders) on September 14, 2016 (the “Pledge and Security Agreement”).
+Added: Fortress may terminate the Opus Credit Facility upon notice to the Lenders and payment of all outstanding obligations under the Credit Facility Agreement.
+Added: Notwithstanding any early termination of the Credit Facility Agreement, within 15 days after termination of the Commitment Period, Fortress will issue each Lender warrants (each a “Warrant”) pursuant to the terms of the Credit Facility Agreement and form of Warrant to purchase their pro rata share of (a) 1,500,000 shares of Common Stock;
+Added: and (b) that number of shares of Common Stock equal to the product of (i) 1,000,000 , times (ii) the principal amount of all Notes divided by 25,000,000 .
+Added: The Warrants will have a five-year term and will be exercisable at a price of $ 3.00 per share.
+Added: On March 12, 2018, the Company and OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”).
+Added: The A&R Opus Credit Facility extended the maturity date of the notes issued under the Opus Credit Facility from September 14, 2018 by one year to September 14, 2019.
+Added: In September 2019 the A&R Opus Credit Facility was amended to extend the maturity of the notes under the Opus Credit Facility from September 14, 2019 to September 14, 2021.
+Added: The A&R Opus Credit Facility also permits the Company to make portions of interest and principal repayments in the form of shares of the Company’s common stock and/or in common stock of the Company’s publicly traded subsidiaries, subject to certain conditions.
+Added: Fortress retains the ability to prepay the Notes at any time without penalty.
+Added: The notes payable under the A&R Opus Credit Facility continue to bear interest at 12 % per annum.
The A&R Opus Credit Facility was accounted for as a debt modification for the year ended December 31, 2018.
−Removed: July 18, 2019, Fortress issued 396,825 common shares of Fortress at $1.26 per share to Dr.
−Removed: The shares were
−Removed: issued as a prepayment by Fortress of $500,000 of debt owed to Dr.
+Added: On July 18, 2019, Fortress issued 396,825 common shares of Fortress at $ 1.26 per share to Dr.
+Added: The shares were issued as a prepayment by Fortress of $ 500,000 of debt owed to Dr.
Rosenwald that was held in the name of OPHIF.
−Removed: The prepayment
−Removed: was made in the form of Fortress common stock, measured at the closing price on July 18, 2019, under that certain A&R
−Removed: Opus Credit Facility.
−Removed: As of December 31, 2019 and 2018,
−Removed: $9.0 million and $9.5 million, respectively, was outstanding under the Opus Credit Facility.
−Removed: Also, as of December 31, 2019
−Removed: Opus dissolved and is in the process of distributing its assets among its Limited Partners.
−Removed: While this dissolution will not impact
−Removed: any of the terms under the Opus Credit Facility the Company is working with Opus to amend and restate the relevant documentation,
−Removed: in order memorialize the distribution of assets.
+Added: The prepayment was made in the form of Fortress common stock, measured at the closing price on July 18, 2019, under that certain A&R Opus Credit Facility.
+Added: Effective December 31, 2019, OPHIF dissolved and distributed it assets among its limited partners.
+Added: Following the distribution, the $ 9.0 million facility comprised of separate notes (collectively, the “2019 Notes”) held by DAK Capital Inc.
+Added: ($ 3.8 million);
+Added: Fortress’ Chairman, President and Chief Executive Officer Lindsay A.
+Added: Rosenwald, M.D.
+Added: ($ 0.3 million);
+Added: Fortress's Executive Vice President, Strategic Development Michael S.
+Added: Weiss ($ 2.0 million);
+Added: and various entities and individuals affiliated with Dr.
+Added: Rosenwald and Mr.
+Added: Weiss ($ 2.9 million).
+Added: The terms of the 2019 Notes did not change in connection with such reallocations.
+Added: In August, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $ 9.0 million balance previously outstanding under the 2019 Notes.
+Added: As of December 31, 2020 and 2019, nil and $ 9.0 million, respectively, was outstanding under the 2019 Notes.
IDB Letters of Credit
−Removed: The Company has several letters of credit
−Removed: (“LOC”) with IDB securing rent deposits for lease facilities totaling approximately $1.1 million.
−Removed: The LOC’s are
−Removed: secured by cash, which is included in restricted cash.
+Added: The Company has several letters of credit (“LOC”) with IDB securing rent deposits for lease facilities totaling approximately $ 1.6 million.
+Added: The LOC’s are secured by cash, which is included in restricted cash on the Company’s Consolidated Balance Sheet .
Interest paid on the letters of credit is 2 % per annum.
2017 Subordinated Note Financing
−Removed: On March 31, 2017, the Company entered
−Removed: into Note Purchase Agreements (the “Purchase Agreements”) with NAM Biotech Fund II, LLC I (“NAM Biotech Fund”)
−Removed: and NAM Special Situations Fund I QP, LLC (“NAM Special Situations Fund”), both of which are accredited investors,
−Removed: and sold subordinated promissory notes (the “Notes”) of the Company (the “2017 Subordinated Note Financing”)
−Removed: in the aggregate principal amount of $3.25 million.
+Added: On March 31, 2017, the Company entered into Note Purchase Agreements (the “Purchase Agreements”) with NAM Biotech Fund II, LLC I (“NAM Biotech Fund”) and NAM Special Situations Fund I QP, LLC (“NAM Special Situations Fund”), both of which are accredited investors, and sold subordinated promissory notes (the “Notes”) of the Company (the “2017 Subordinated Note Financing”) in the aggregate principal amount of $ 3.25 million.
The Notes bear interest at the rate of 8 % per annum;
−Removed: additionally, the Notes
−Removed: accrue paid-in-kind interest at the rate of 7% per annum, which will be paid quarterly in shares of the Company’s common
−Removed: stock and/or shares of common stock of one of the Company’s subsidiaries that are publicly traded, in accordance with the
−Removed: terms of the Notes.
−Removed: Each Note is due on the third anniversary of its issuance, provided that the Company may extend the maturity
−Removed: date for two one-year periods in its sole discretion.
−Removed: The 2017 Subordinated Note Financing is for a maximum of $40.0 million (which
−Removed: the Company may, in its sole discretion, increase to $50.0 million).
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: National Securities Corporation (“NSC”),
−Removed: a subsidiary of National and a related party, (see Note 17), pursuant to a Placement Agency Agreement entered into between the
−Removed: Company, NAM Biotech Fund and NSC (the “NAM Placement Agency Agreement”) and a Placement Agency Agreement entered into
−Removed: between the Company, NAM Special Situations Fund and NSC (together with the NAM Placement Agency Agreement, the “Placement
−Removed: Agency Agreements”) acts as placement agent in the 2017 Subordinated Note Financing.
−Removed: Pursuant to the terms of the Placement
−Removed: Agency Agreements, NSC receives (in addition to reimbursement of certain expenses) an aggregate cash fee equal to 10% of the aggregate
−Removed: sales price of the Notes sold in the 2017 Subordinated Note Financing to NAM Biotech Fund and NAM Special Situations Fund.
−Removed: Placement Agent also receives warrants equal to 10% of the aggregate principal amount of the Notes sold in the 2017 Subordinated
−Removed: Note Financing divided by the closing share price of the Company’s common stock on the date of closing (the “Placement
−Removed: Agent Warrants”).
−Removed: The Placement Agent Warrants are exercisable immediately at such closing share price for a period of five
−Removed: The Placement Agent will have a right of first offer for a period of 12 months for any proposed issuance of the Company’s
−Removed: capital stock in a private financing, subject to certain exceptions, and will also have the right to participate as an investor
−Removed: in subsequent financings.
−Removed: On March 31, 2017, the Company held
−Removed: its first closing of the 2017 Subordinated Note Financing and received gross proceeds of $3.2 million.
−Removed: NSC received a cash fee
−Removed: of approximately $0.3 million and warrant to purchase 87,946 shares of the Company’s common stock at an exercise price of
−Removed: per share $3.70.
−Removed: On May 1, 2017, the Company held a
−Removed: second closing of the 2017 Subordinated Note Financing and received gross proceeds of $8.6 million, before expenses.
−Removed: a placement agent fee of approximately $0.9 million in the second closing and warrants to purchase 234,438 shares of the Company’s
−Removed: common stock at an exercise price of $3.65 per share.
−Removed: On May 31, 2017, the Company held
−Removed: a third closing of the 2017 Subordinated Note Financing and received gross proceeds of $5.3 million, before expenses.
−Removed: a placement agent fee of approximately $0.5 million in the third closing and warrants to purchase 147,806 shares of the Company’s
−Removed: common stock at an exercise price of $3.61 per share.
−Removed: On June 30, 2017, the Company held
−Removed: a fourth closing of the 2017 Subordinated Note Financing and received gross proceeds of $1.8 million, before expenses.
−Removed: a placement agent fee of approximately $0.2 million in the fourth closing and warrants to purchase 38,315 shares of the Company’s
−Removed: common stock at an exercise price of $4.75 per share.
−Removed: On August 31, 2017, the Company held
−Removed: a fifth closing of the 2017 Subordinated Note Financing and received gross proceeds of $3.0 million, before expenses.
−Removed: a placement agent fee of approximately $0.3 million in the fifth closing and warrants to purchase 63,526 shares of the Company’s
−Removed: common stock at an exercise price of $4.75 per share.
−Removed: On September 30, 2017, the Company
−Removed: held a sixth closing of the 2017 Subordinated Note Financing and received gross proceeds of $6.4 million, before expenses.
−Removed: received a placement agent fee of approximately $0.6 million in the sixth closing and warrants to purchase 144,149 shares of the
−Removed: Company’s common stock at an exercise price of $4.42 per share.
−Removed: Caelum Convertible Notes
−Removed: On July 31, 2017 Caelum through National
−Removed: Securities Corporation (“NSC”
−Removed: or “Placement Agent”), a subsidiary of National offered up to $10 million,
−Removed: convertible promissory notes (the “Caelum Convertible Notes”) to accredited investors (as defined under the U.S.
−Removed: securities laws).
−Removed: Under the terms of the offering the Placement Agent received a 10% selling commission, payable by Caelum and
−Removed: deducted from the gross proceeds (see Note 17).
−Removed: During the year ended December 31,
−Removed: 2017, Caelum raised $9.9 million in the offering, in three separate closings and paid a placement fee equal to 10% of the proceeds
−Removed: of the sale or $0.9 million.
−Removed: Additionally NSC received warrants to purchase a number of shares the Caelum’s Common Stock
−Removed: equal to 10% of the aggregate amount of shares underlying the Notes with a per share exercise price equal to 110% of the per share
−Removed: conversion price of the Notes;
−Removed: provided, however, that if no Note converts, the exercise price will be $75 million dollars divided
−Removed: by the total number of fully-diluted shares of Common Stock outstanding immediately prior to exercise of the warrant, giving effect
−Removed: to the assumed conversion of all options, warrants, and convertible securities of the Company.
−Removed: The notes convert upon a qualified financing
−Removed: in which Caelum raises gross proceeds of at least $10 million as follows:
−Removed: the lesser of (a) a discount to the price per common
−Removed: share being paid in the Sale of the Company equal to 20% or (b) a conversion price per share based on a pre-sale valuation
−Removed: of $75,000,000 divided by the number of common shares outstanding at that time assuming the hypothetical conversion or exercise
−Removed: of any convertible securities, options, warrants and other rights to acquire common shares of the Company.
−Removed: The Company elected
−Removed: the fair value option to account for this note.
−Removed: On January 30, 2019 Caelum entered
−Removed: into a DOSPA and related documents by and among Caelum, Alexion, Fortress and the Caelum security holders’
−Removed: parties thereto
−Removed: (including Fortress, the “Sellers”) (see Note 4).
−Removed: The first of four transactional components of the DOSPA is the purchase
−Removed: by Alexion of a number of shares of Caelum preferred stock equal to 19.9% of Caelum’s total capitalization for consideration
−Removed: of $30 million.
−Removed: This transaction caused the Caelum convertible notes to convert into 1,870,412,shares of Caelum preferred Class B
−Removed: Based on this transaction, the notes were written down to par value of $9.9 million and the related warrant liability was
−Removed: written up to the full value of $1.0 million at December 31, 2018 (see Note 6).
−Removed: Further, the Alexion transaction resulted
−Removed: in the automatic conversion of the notes, as such on January 30, 2019 the notes were converted into equity.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
+Added: additionally, the Notes accrue paid-in-kind interest at the rate of 7 % per annum, which will be paid quarterly in shares of the Company’s common stock and/or shares of common stock of one of the Company’s subsidiaries that are publicly traded, in accordance with the terms of the Notes.
+Added: Each Note is due on the third anniversary of its issuance, provided that the Company may extend the maturity date for two one-year periods in its sole discretion.
+Added: The 2017 Subordinated Note Financing is for a maximum of $ 40.0 million (which the Company may, in its sole discretion, increase to $ 50.0 million).
+Added: National Securities Corporation (“NSC”), a subsidiary of National and a related party, (see Note 17), pursuant to a Placement Agency Agreement entered into between the Company, NAM Biotech Fund and NSC (the “NAM Placement Agency Agreement”) and a Placement Agency Agreement entered into between the Company, NAM Special Situations Fund and NSC (together with the NAM Placement Agency Agreement, the “Placement Agency Agreements”) acts as placement agent in the 2017 Subordinated Note Financing.
+Added: Pursuant to the terms of the Placement Agency Agreements, NSC receives (in addition to reimbursement of certain expenses) an aggregate cash fee equal to 10 % of the aggregate sales price of the Notes sold in the 2017 Subordinated Note Financing to NAM Biotech Fund and NAM Special Situations Fund.
+Added: The Placement Agent also receives warrants equal to 10 % of the aggregate principal amount of the Notes sold in the 2017 Subordinated Note Financing divided by the closing share price of the Company’s common stock on the date of closing (the “Placement Agent Warrants”).
+Added: The Placement Agent Warrants are exercisable immediately at such closing share price for a period of five years .
+Added: The Placement Agent will have a right of first offer for a period of 12 months for any proposed issuance of the Company’s capital stock in a private financing, subject to certain exceptions, and will also have the right to participate as an investor in subsequent financings.
+Added: On March 31, 2017, the Company held its first closing of the 2017 Subordinated Note Financing and received gross proceeds of $ 3.2 million.
+Added: NSC received a cash fee of approximately $ 0.3 million and warrant to purchase 87,946 shares of the Company’s common stock at an exercise price of per share $ 3.70 .
+Added: On May 1, 2017, the Company held a second closing of the 2017 Subordinated Note Financing and received gross proceeds of $ 8.6 million, before expenses.
+Added: NSC received a placement agent fee of approximately $ 0.9 million in the second closing and warrants to purchase 234,438 shares of the Company’s common stock at an exercise price of $ 3.65 per share.
+Added: On May 31, 2017, the Company held a third closing of the 2017 Subordinated Note Financing and received gross proceeds of $ 5.3 million, before expenses.
+Added: NSC received a placement agent fee of approximately $ 0.5 million in the third closing and warrants to purchase 147,806 shares of the Company’s common stock at an exercise price of $ 3.61 per share.
+Added: On June 30, 2017, the Company held a fourth closing of the 2017 Subordinated Note Financing and received gross proceeds of $ 1.8 million, before expenses.
+Added: NSC received a placement agent fee of approximately $ 0.2 million in the fourth closing and warrants to purchase 38,315 shares of the Company’s common stock at an exercise price of $ 4.75 per share.
+Added: On August 31, 2017, the Company held a fifth closing of the 2017 Subordinated Note Financing and received gross proceeds of $ 3.0 million, before expenses.
+Added: NSC received a placement agent fee of approximately $ 0.3 million in the fifth closing and warrants to purchase 63,526 shares of the Company’s common stock at an exercise price of $ 4.75 per share.
+Added: On September 30, 2017, the Company held a sixth closing of the 2017 Subordinated Note Financing and received gross proceeds of $ 6.4 million, before expenses.
+Added: NSC received a placement agent fee of approximately $ 0.6 million in the sixth closing and warrants to purchase 144,149 shares of the Company’s common stock at an exercise price of $ 4.42 per share.
+Added: In August, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $ 28.4 million balance previously outstanding under the 2017 Subordinated Note Financing.
+Added: As of December 31, 2020 and 2019, nil and $ 28.4 million, respectively, was outstanding under the 2017 Subordinated Note Financing.
2018 Venture Notes
−Removed: During the year ended December 31,
−Removed: 2018, the Company closed a private placement of promissory notes for an aggregate of $21.7 million (the “2018 Venture Notes”)
−Removed: The Company intends to use the proceeds from the 2018 Venture Notes to acquire and license medical technologies and
−Removed: products through existing or recently formed Company subsidiaries.
+Added: During the year ended December 31, 2018, the Company closed a private placement of promissory notes for an aggregate of $ 21.7 million (the “2018 Venture Notes”) through NSC.
+Added: The Company intends to use the proceeds from the 2018 Venture Notes to acquire and license medical technologies and products through existing or recently formed Company subsidiaries.
The Company may also use the proceeds to finance its subsidiaries.
−Removed: The notes mature 36 months from issuance, provided that during the first 24 months the Company may extend the maturity date by
+Added: The notes mature 36 months from issuance, provided that during the first 24 months the Company may extend the maturity date by six months.
No principal amount will be due for the first 24 months (or the first 30 months if the maturity date is extended).
Thereafter, the note will be repaid at the rate of 1/12 of the principal amount per month for a period of 12 months.
−Removed: the note is 8% payable quarterly during the first 24 months (or the first 30 months if the note is extended) and monthly during
−Removed: the last 12 months.
−Removed: NSC acted as the sole placement agent for
−Removed: the 2018 Venture Notes.
−Removed: The Company paid NSC a fee of $1.7 million during the three months ended March 31, 2018 in connection
−Removed: with its placement of the 2018 Venture Notes.
−Removed: The 2018 Venture Notes allows the Company
−Removed: to transfer a portion of the proceeds from the 2018 Venture Notes to a Fortress subsidiary upon the completion by such subsidiary
−Removed: of an initial public offering in which it raises sufficient equity capital so that it has cash equal to five times the amount of
−Removed: the portion of the proceeds of the 2018 Venture Notes so transferred (the “SubCo Funding Threshold”).
−Removed: Through December 31, 2019, the Company
−Removed: has transferred $3.8 million to Aevitas, $1.6 million to Tamid, $2.2 Million to Cyprium and $2.0 million to Cellvation.
−Removed: Notwithstanding
−Removed: such transfers, the Company continues to hold such debt balances as liabilities on its own balance sheet on a consolidated basis,
−Removed: until such time as the SubCo Funding Threshold is met with respect to a particular subsidiary.
−Removed: In connection with this transfer NSC received
−Removed: warrants to purchase each such subsidiary’s stock equal to 25% of that subsidiary’s proceeds of the 2018 Venture Notes
−Removed: divided by the lowest price at which the subsidiary sells its equity in its first third party equity financing.
−Removed: The warrants issued
−Removed: have a term of 10 years and an exercise price equal to the par value of the Fortress subsidiary’s common stock.
−Removed: As of December 31,
−Removed: 2019, the warrants were contingently issuable as neither an initial public offering nor a third-party financing had occurred at
−Removed: any such subsidiary.
+Added: Interest on the note is 8 % payable quarterly during the first 24 months (or the first 30 months if the note is extended) and monthly during the last 12 months .
+Added: NSC acted as the sole placement agent for the 2018 Venture Notes.
+Added: The Company paid NSC a fee of $ 1.7 million during the three months ended March 31, 2018 in connection with its placement of the 2018 Venture Notes.
+Added: The 2018 Venture Notes allows the Company to transfer a portion of the proceeds from the 2018 Venture Notes to a Fortress subsidiary upon the completion by such subsidiary of an initial public offering in which it raises sufficient equity capital so that it has cash equal to five times the amount of the portion of the proceeds of the 2018 Venture Notes so transferred (the “SubCo Funding Threshold”).
+Added: Through December 31, 2019, the Company had transferred $ 3.8 million to Aevitas, $ 1.6 million to Tamid, $ 2.2 Million to Cyprium and $ 2.0 million to Cellvation.
+Added: Notwithstanding such transfers, the Company continued to hold such debt balances as liabilities on its own balance sheet on a consolidated basis, until such time as the SubCo Funding Threshold is met with respect to a particular subsidiary.
+Added: In connection with this transfer NSC received warrants to purchase each such subsidiary’s stock equal to 25 % of that subsidiary’s proceeds of the 2018 Venture Notes divided by the lowest price at which the subsidiary sells its equity in its first third party equity financing.
+Added: The warrants issued have a term of 10 years and an exercise price equal to the par value of the Fortress subsidiary’s common stock.
+Added: As of December 31, 2019, the warrants were contingently issuable as neither an initial public offering nor a third-party financing had occurred at any such subsidiary.
+Added: In August, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $ 21.7 million balance previously outstanding under the 2018 Venture Notes.
+Added: As of December 31, 2020 and 2019, nil and $ 21.7 million, respectively, was outstanding under the 2018 Venture Notes.
Mustang Horizon Notes
−Removed: On March 29, 2019 (the “Closing
−Removed: Date”), Mustang entered into a $20.0 million Loan Agreement with Horizon Technology Finance Corporation (“Horizon”),
−Removed: herein referred to as the “Mustang Horizon Notes”.
−Removed: In accordance with the Loan Agreement, $15.0 million of the $20.0
−Removed: million loan was funded on the Closing Date, with the remaining $5.0 million fundable upon Mustang achieving certain predetermined
−Removed: Each advance under the Mustang Horizon
−Removed: Notes will mature 42 months from the first day of the month following the funding of the advance.
−Removed: The first three advances will
−Removed: mature on October 1, 2022 (the “Loan Maturity Date”).
−Removed: Each advance accrues interest at a per annum rate of interest
−Removed: equal to 9.00% plus the amount by which the one-month LIBOR Rate, as reported in the Wall Street Journal, exceeds 2.50%.
−Removed: Agreement provides for interest-only payments commencing May 1, 2019, through and including October 1, 2020.
−Removed: The interest-only
−Removed: period may be extended to April 1, 2021, if the Company satisfies the Interest Only Extension Milestone (as defined in the
−Removed: Loan Agreement).
−Removed: Thereafter, commencing May 1, 2021, amortization payments will be payable monthly in eighteen installments
−Removed: of principal and interest.
−Removed: At its option, upon ten business days’
−Removed: prior written notice to Horizon, the Company may prepay
−Removed: all or any portion greater than or equal to $500,000 of each of the outstanding advances by paying the entire principal balance
−Removed: (or portion thereof) and all accrued and unpaid interest, subject to a prepayment charge of 4.0% of the then outstanding principal
−Removed: balance of each advance if such advance is prepaid on or before the Loan Amortization Date (as defined in the Loan Agreement),
−Removed: 3% if such advance is prepaid after the Loan Amortization Date applicable to such Loan, but on or prior to twelve months following
−Removed: the Loan Amortization Date, and 2% thereafter.
−Removed: In addition, a final payment equal to $250,000 for each advance (i.e., $750,000
−Removed: in aggregate with respect to the initial $15.0 million) is due on the maturity date or other date of payment in full.
−Removed: Amounts outstanding
−Removed: during an event of default shall be payable on demand and shall accrue interest at an additional rate of 5.0% per annum of the
−Removed: past due amount outstanding.
−Removed: Each advance of the loan is secured by
−Removed: a lien on substantially all of the assets of Mustang, other than Intellectual Property and Excluded Collateral (in each case as
−Removed: defined in the Loan Agreement), and contains customary covenants and representations, including a liquidity covenant, financial
−Removed: reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions,
−Removed: taxes, corporate changes, deposit accounts, and subsidiaries.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: The events of default under the Loan Agreement
−Removed: include, among other things, without limitation, and subject to customary grace periods, (1) Mustang’s failure to make
−Removed: any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) the Mustang’s
−Removed: breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse change,
−Removed: (4) Mustang making a false or misleading representation or warranty in any material respect, (5) the Mustang’s
−Removed: insolvency or bankruptcy, (6) certain attachments or judgments on the Mustang’s assets, (7) the occurrence of any
−Removed: material default under certain agreements or obligations of Mustang involving indebtedness in excess of $250,000, or (8) failing
−Removed: to maintain certain minimum monthly cash balances which range from approximately $8 to $13 million over the term of the loan ($13.0
−Removed: million as of December 31, 2019).
−Removed: If an event of default occurs, Horizon is entitled to take enforcement action, including
−Removed: acceleration of amounts due under the Loan Agreement.
−Removed: The Loan Agreement also contains warrant
−Removed: coverage of 5% of the total amount funded.
−Removed: Four warrants (the “Warrants”) were issued by Mustang to Horizon to purchase
−Removed: a combined 288,184 shares of Mustang’s common stock with an exercise price of $3.47 and a fair value of $0.9 million.
−Removed: Warrant is exercisable for ten years from the date of issuance.
−Removed: Horizon may exercise the Warrant either by (a) cash or check
−Removed: or (b) through a net issuance conversion.
−Removed: The shares of the Company’s common stock will, upon request by Horizon, be
−Removed: registered and freely tradable following a period of six months after issuance.
−Removed: Mustang paid Horizon an initial commitment
−Removed: fee of $0.2 million and reimbursed Horizon for $30,000 of legal fees in connection with the Loan Agreement.
−Removed: Mustang incurred approximately
−Removed: $1.2 million of legal and other direct costs in connection with the Loan Agreement.
−Removed: All fees, warrants and costs paid to Horizon
−Removed: and all direct costs incurred by Mustang are recognized as a debt discount to the funded loans and are amortized to interest expense
−Removed: using the effective interest method over the term of the Loan Agreement.
+Added: On March 29, 2019 (the "Closing Date"), Mustang entered into a $ 20.0 million Loan Agreement with Horizon Technology Finance Corporation ("Horizon"), herein referred to as the "Mustang Horizon Notes".
+Added: In accordance with the Loan Agreement, $ 15.0 million of the $ 20.0 million loan was funded on the Closing Date, with the remaining $ 5.0 million fundable upon Mustang achieving certain predetermined milestones.
+Added: Each advance under the Mustang Horizon Notes will mature 42 months from the first day of the month following the funding of the advance.
+Added: The first three advances will mature on October 1, 2022 (the "Loan Maturity Date").
+Added: Each advance accrues interest at a per annum rate of interest equal to 9.00 % plus the amount by which the one-month LIBOR Rate, as reported in the Wall Street Journal, exceeds 2.50 %.
+Added: The Loan Agreement provides for interest-only payments commencing May 1, 2019, through and including October 1, 2020.
+Added: The interest-only period may be extended to April 1, 2021, if the Company satisfies the Interest Only Extension Milestone (as defined in the Loan Agreement).
+Added: Thereafter, commencing May 1, 2021, amortization payments will be payable monthly in eighteen installments of principal and interest.
+Added: At its option, upon ten business days' prior written notice to Horizon, the Company may prepay all or any portion greater than or equal to $ 500,000 of each of the outstanding advances by paying the entire principal balance (or portion thereof) and all accrued and unpaid interest, subject to a prepayment charge of 4.0 % of the then outstanding principal balance of each advance if such advance is prepaid on or before the Loan Amortization Date (as defined in the Loan Agreement), 3 % if such advance is prepaid after the Loan Amortization Date applicable to such Loan, but on or prior to twelve months following the Loan Amortization Date, and 2 % thereafter.
+Added: In addition, a final payment equal to $ 250,000 for each advance (i.e., $ 750,000 in aggregate with respect to the initial $ 15.0 million) is due on the maturity date or other date of payment in full.
+Added: Amounts outstanding during an event of default shall be payable on demand and shall accrue interest at an additional rate of 5.0 % per annum of the past due amount outstanding.
+Added: Each advance of the loan is secured by a lien on substantially all of the assets of Mustang, other than Intellectual Property and Excluded Collateral (in each case as defined in the Loan Agreement), and contains customary covenants and representations, including a liquidity covenant, financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries.
+Added: The events of default under the Loan Agreement include, among other things, without limitation, and subject to customary grace periods, (1) Mustang's failure to make any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) the Mustang's breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse change, (4) Mustang making a false or misleading representation or warranty in any material respect, (5) the Mustang's insolvency or bankruptcy, (6) certain attachments or judgments on the Mustang's assets, (7) the occurrence of any material default under certain agreements or obligations of Mustang involving indebtedness in excess of $ 250,000 , or (8) failing to maintain certain minimum monthly cash balances which range from approximately $ 8 to $ 13 million over the term of the loan ($ 13.0 million as of December 31, 2019).
+Added: If an event of default occurs, Horizon is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement.
+Added: The Loan Agreement also contains warrant coverage of 5 % of the total amount funded.
+Added: Four warrants (the "Warrants") were issued by Mustang to Horizon to purchase a combined 288,184 shares of Mustang's common stock with an exercise price of $ 3.47 and a fair value of $ 0.9 million.
+Added: The Warrants are exercisable for ten years from the date of issuance.
+Added: Horizon may exercise the Warrant either by (a) cash or check or (b) through a net issuance conversion.
+Added: The shares of the Company's common stock will, upon request by Horizon, be registered and freely tradable following a period of six months after issuance.
+Added: Mustang paid Horizon an initial commitment fee of $ 0.2 million and reimbursed Horizon for $ 30,000 of legal fees in connection with the Loan Agreement.
+Added: Mustang incurred approximately $ 1.2 million of legal and other direct costs in connection with the Loan Agreement.
+Added: All fees, warrants and costs paid to Horizon and all direct costs incurred by Mustang are recognized as a debt discount to the funded loans and are amortized to interest expense using the effective interest method over the term of the Loan Agreement.
+Added: On September 30, 2020, Mustang repaid the amount outstanding under the Horizon Notes in full, which was comprised of $ 15.0 million face value of the outstanding notes, $ 0.1 million in accrued and unpaid interest, a $ 0.8 million final payment fee and prepayment penalties of $ 0.6 million.
Interest Expense
−Removed: The following table shows the details of
−Removed: interest expense for all debt arrangements during the periods presented.
−Removed: Interest expense includes contractual interest and amortization
−Removed: of the debt discount and amortization of fees represents fees associated with loan transaction costs, amortized over the life of
−Removed: For the Years Ended December 31,
+Added: The following table shows the details of interest expense for all debt arrangements during the periods presented.
+Added: Interest expense includes contractual interest and amortization of the debt discount and amortization of fees represents fees associated with loan transaction costs, amortized over the life of the loan:
+Added: Year Ended December 31,
($ in thousands)
2017 Subordinated Note Financing 1
−Removed: Opus Credit Facility
2018 Venture Notes 1
−Removed: Helocyte Convertible Note
−Removed: Caelum Convertible Note
Mustang Horizon Notes 1,3
+Added: Oaktree Note 1
Note Payable 2
Total Interest Expense and Financing Fee
−Removed: Amortization of fees.
+Added: Note 1:For the year ended December 31, 2020, includes $ 1.2 million expense of unamortized debt discount fees for the 2017 Subordinated Note Financing, $ 0.3 million for the 2018 Venture Notes and $ 1.8 million for the Mustang Horizon Notes.
Imputed interest expense related to Ximino purchase (see Note 9).
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
+Added: Includes $ 0.6 million of prepayment penalties included in interest expense for the Mustang Horizon Notes.
Accrued Liabilities and other Long-Term Liabilities
−Removed: Accrued expenses and other long-term liabilities
−Removed: consisted of the following:
+Added: Accrued expenses and other long-term liabilities consisted of the following:
($ in thousands)
1 unchanged sentence
Professional fees
−Removed: Salaries, bonuses and related benefits
+Added: Salaries, bonus and related benefits
Research and development
Research and development - manufacturing
−Removed: Research and development - clinical supplies
Research and development - license maintenance fees
Research and development - milestones
−Removed: Falk Pharma milestone
Accrued royalties payable
−Removed: Accrued coupon expense
+Added: Accrued coupon funding expense
Total accrued expenses
1 unchanged sentence
Deferred rent and long-term lease abandonment charge 1
−Removed: Long-term note payable 2
−Removed: Total other long-term liabilities
−Removed: As of December 31, 2019, balance consists of deferred
−Removed: charges related to build-out of the New York facility, and as of December 31, 2018, balance consists of deferred rent and
−Removed: deferred build out charges.
−Removed: As of December 31, 2019, Journey recorded a note
−Removed: payable, net of an imputed interest discount of $2.3 million, of $4.7 million in connection with its acquisition of Ximino, see
−Removed: The imputed interest discount was calculating utilizing an 11.96% effective interest rate based upon a non-investment
−Removed: grade “CCC”
−Removed: rate over a five-year period.
−Removed: Amortization of interest discount was $0.3 million for the year
−Removed: ended December 31, 2019.
+Added: Partner company note payable, long-term
+Added: Ximino agreement 2
+Added: Isotretinoin agreement 3
+Added: Anti-itch product agreement 4
+Added: Total other long-term liabilities and partner company note payable, long-term
+Added: Balance consists of deferred charges related to build-out of the New York facility
+Added: As of December 31, 2019, Journey recorded a note payable, net of an imputed interest discount of $ 2.3 million, of $ 4.7 million in connection with its acquisition of Ximino, see Note 9.
+Added: The imputed interest discount was calculating utilizing an 11.96 % effective interest rate based upon a non-investment grade “CCC” rate over a five-year period.
+Added: Amortization of interest discount was $ 0.6 million and $ 0.3 million for the years ended December 31, 2020 and 2019, respectively.
+Added: At December 31, 2020, $ 2.0 million was classified as Partner company note payable, short-term on the Company’s Consolidated Balance Sheet.
+Added: As of December 31, 2020, Journey recorded a note payable, net of an imputed interest discount of $ 0.3 million, of $ 3.7 million in connection with its acquisition of the Isotretinoin agreement, see Note 9.
+Added: The imputed interest discount was calculated utilizing a 4.00 % effective rate, which represents the market rate for an asset-backed three year loan, secured by receivables.
+Added: Amortization of interest discount was $ 0.1 million for the year ended December 31, 2020.
+Added: At December 31, 2020, $ 0.5 million of note payable was classified as Partner company note payable, short-term on the Company’s Consolidated Balance Sheet.
+Added: As of December 31, 2020, Journey recorded a note payable, net of an imputed interest discount of $ 0.1 million, of $ 3.7 million in connection with its acquisition of an anti-itch product, see Note 9.
+Added: The imputed interest discount was calculated utilizing a 4.25 % effective rate, which represents the market rate for an asset-backed three year loan, secured by receivables.
+Added: Amortization of interest discount was negligible for the year ended December 31, 2020.
+Added: As of December 31, 2020, $ 2.8 million of note payable was classified as Partner company note payable, short-term on the Company’s Consolidated Balance Sheet.
Non-Controlling Interests
−Removed: Non-controlling interests in consolidated
−Removed: entities are as follows:
−Removed: For the twelve months ended
+Added: Non-controlling interests in consolidated entities are as follows:
+Added: For the year ended
As of December 31, 2020
1 unchanged sentence
As of December 31, 2020
+Added: Net loss attributable to
+Added: Non-controlling interests
+Added: Non-controlling
($ in thousands)
NCI equity share
−Removed: Net loss attributable to non-
−Removed: controlling interests
non-controlling interests
in consolidated entities
−Removed: Non-controlling
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: For the twelve months ended
+Added: Acquisition Corp VIII
+Added: For the year ended
As of December 31, 2019
1 unchanged sentence
As of December 31, 2019
+Added: Net loss attributable to
+Added: Non-controlling interests
+Added: Non-controlling
($ in thousands)
NCI equity share
−Removed: Net loss attributable to non-
−Removed: controlling interests
non-controlling interests
in consolidated entities
−Removed: Non-controlling
−Removed: Checkpoint is consolidated with Fortress’
−Removed: operations because Fortress maintains voting control through its ownership of Checkpoint’s Class A Common Shares which provide super-majority voting rights.
−Removed: Avenue and Mustang are consolidated with Fortress’
−Removed: operations because Fortress maintains voting control through its ownership of Preferred Class A Shares which provide super-majority voting rights.
−Removed: Effective January 30, 2019, Caelum ceased to be a controlled Fortress entity and as such is no longer consolidated.
+Added: Checkpoint is consolidated with Fortress’ operations because Fortress maintains voting control through its ownership of Checkpoint’s Class A Common Shares which provide super-majority voting rights.
+Added: Avenue and Mustang are consolidated with Fortress’ operations because Fortress maintains voting control through its ownership of Preferred Class A Shares which provide super-majority voting rights.
Net Loss per Common Share
−Removed: The Company calculates loss per share using
−Removed: the two-class method, which is an earnings allocation formula that determines earnings per share for Common Stock and participating
−Removed: securities, if any, according to dividends declared and non-forfeitable participation rights in undistributed earnings.
−Removed: method, all earnings (distributed and undistributed) are allocated to Common Stock and participating securities, if any, based
−Removed: on their respective rights to receive dividends.
−Removed: Holders of restricted Common Stock were entitled to all cash dividends, when and
−Removed: if declared, and such dividends are non-forfeitable.
−Removed: The participating securities do not have a contractual obligation to share
−Removed: in any losses of the Company.
−Removed: As a result, net losses are not allocated to the participating securities for any periods presented.
−Removed: Basic net loss per share is calculated
−Removed: by dividing the net loss by the weighted-average number of shares of Common Stock outstanding during the period, without consideration
−Removed: for Common Stock equivalents.
−Removed: Diluted net loss per share is computed by dividing the net loss by the weighted-average number of
−Removed: Common Stock and Common Stock equivalents outstanding for the period.
−Removed: Included in Common Stock issued and outstanding
−Removed: as of December 31, 2019 and 2018 were 12,625,144 and 11,174,113 shares of unvested restricted stock, which is excluded from
−Removed: the weighted average Common Stock outstanding since its effect would be dilutive.
−Removed: The Company’s potential dilutive
−Removed: securities which consist of unvested restricted stock, unvested restricted stock units, options, and warrants have been excluded
−Removed: from the computation of diluted net loss per share as the effect would be to reduce the net loss per share.
−Removed: Therefore, the weighted-average
−Removed: Common Stock outstanding used to calculate both basic and diluted net loss per share is the same.
−Removed: The following shares of potentially dilutive
−Removed: securities, weighted during the years ended December 31, 2019 and 2018 have been excluded from the computations of diluted
−Removed: weighted average shares outstanding as the effect of including such securities would be antidilutive:
−Removed: For the Years Ended
+Added: Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of Common Stock outstanding during the period, without consideration for Common Stock equivalents.
+Added: Diluted net loss per share is computed by dividing the net loss by the weighted-average number of Common Stock and Common Stock equivalents outstanding for the period.
+Added: The following shares of potentially dilutive securities, weighted during the years ended December 31, 2020 and 2019 have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive:
+Added: Year Ended December 31,
Warrants to purchase Common Stock
−Removed: Opus warrants to purchase Common Stock
Options to purchase Common Stock
2 unchanged sentences
Unvested Restricted Stock Units
−Removed: Stockholders’
−Removed: The Company’s Certificate of Incorporation,
−Removed: as amended, authorizes the Company to issue 100,000,000 shares of $0.001 par value Common Stock of which 74,027,425 and 57,845,447
−Removed: shares are outstanding at December 31, 2019 and 2018, respectively.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: The terms, rights, preference and privileges
−Removed: of the Common Stock are as follows:
+Added: Stockholders’ Equity
+Added: At the Company’s 2020 Annual Meeting of Stockholders held on June 17, 2020, its stockholders approved an amendment to its certificate of incorporation to increase the number of authorized shares of common stock available to issue by 50,000,000 to 150,000,000 with a par value of $ 0.001 per share.
+Added: The amendment was filed with the Secretary of State of the State of Delaware on June 18, 2020.
+Added: 94,877,492 and 74,027,425 shares of common stock are outstanding at December 31, 2020 and 2019, respectively.
+Added: The terms, rights, preference and privileges of the Common Stock are as follows:
Voting Rights
−Removed: Each holder of Common Stock is entitled
−Removed: to one vote per share of Common Stock held on all matters submitted to a vote of the stockholders, including the election of directors.
−Removed: The Company’s certificate of incorporation and bylaws do not provide for cumulative voting rights.
−Removed: Subject to preferences that may be applicable
−Removed: to any then outstanding preferred stock, the holders of the Company’s outstanding shares of Common Stock are entitled to
−Removed: receive dividends, if any, as may be declared from time to time by the Company’s Board of Directors out of legally available
−Removed: In the event of the Company’s liquidation,
−Removed: dissolution or winding up, holders of Common Stock will be entitled to share ratably in the net assets legally available for distribution
−Removed: to stockholders after the payment of all of the Company’s debts and other liabilities, subject to the satisfaction of any
−Removed: liquidation preference granted to the holders of any outstanding shares of Preferred Stock.
+Added: Each holder of Common Stock is entitled to one vote per share of Common Stock held on all matters submitted to a vote of the stockholders,f including the election of directors.
+Added: The Company’s certificate of incorporation and bylaws do not provide for cumulative voting rights.
+Added: Subject to preferences that may be applicable to any then outstanding preferred stock, the holders of the Company’s outstanding shares of Common Stock are entitled to receive dividends, if any, as may be declared from time to time by the Company’s Board of Directors out of legally available funds.
+Added: In the event of the Company’s liquidation, dissolution or winding up, holders of Common Stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of the Company’s debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares of Preferred Stock.
Rights and Preference
−Removed: Holders of the Company’s Common Stock
−Removed: have no preemptive, conversion or subscription rights, and there is no redemption or sinking fund provisions applicable to the
−Removed: Common Stock.
−Removed: The rights, preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected
−Removed: by, the rights of the holders of shares of any series of the Company’s preferred stock that are or may be issued.
+Added: Holders of the Company’s Common Stock have no preemptive, conversion or subscription rights, and there is no redemption or sinking fund provisions applicable to the Common Stock.
+Added: The rights, preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of the Company’s preferred stock that are or may be issued.
Fully Paid and Nonassessable
−Removed: All of the Company’s outstanding
−Removed: shares of Common Stock are fully paid and nonassessable.
+Added: All of the Company’s outstanding shares of Common Stock are fully paid and nonassessable.
Series A Preferred Stock
−Removed: On October 26, 2017, the Company designated
−Removed: 5,000,000 shares of $0.001 par value preferred stock as Series A Preferred Stock.
−Removed: As of December 31, 2019, and
−Removed: 2018, 1,341,167 and 1,000,000 shares, respectively, of Series A Preferred Stock were issued and outstanding.
−Removed: The terms, rights, preference and privileges
−Removed: of the Series A Preferred Stock are as follows:
+Added: On October 26, 2017, the Company designated 5,000,000 shares of $ 0.001 par value preferred stock as Series A Preferred Stock.
+Added: As of December 31, 2020, and 2019, 3,427,138 and 1,341,167 shares, respectively, of Series A Preferred Stock were issued and outstanding.
+Added: The terms, rights, preference and privileges of the Series A Preferred Stock are as follows:
Voting Rights
−Removed: Except as may be otherwise required by
−Removed: law, the voting rights of the holders of the Series A Preferred Stock are limited to the affirmative vote or consent of the
−Removed: holders of at least two-thirds of the votes entitled to be cast by the holders of the Series A Preferred Stock outstanding
−Removed: at the time in connection with the:
−Removed: (1) authorization or creation, or increase in the authorized or issued amount of, any
−Removed: class or series of capital stock ranking senior to the Series A Preferred Stock with respect to payment of dividends or the
−Removed: distribution of assets upon liquidation, dissolution or winding up or reclassification of any of the Company’s authorized
−Removed: capital stock into such shares, or creation, authorization or issuance of any obligation or security convertible into or evidencing
−Removed: the right to purchase any such shares;
−Removed: or (2) amendment, alteration, repeal or replacement of the Company’s certificate
−Removed: of incorporation, including by way of a merger, consolidation or otherwise in which the Company may or may not be the surviving
−Removed: entity, so as to materially and adversely affect and deprive holders of Series A Preferred Stock of any right, preference,
−Removed: privilege or voting power of the Series A Preferred Stock.
−Removed: Dividends on Series A Preferred Stock
−Removed: accrue daily and will be cumulative from, and including, the date of original issue and shall be payable quarterly every March 31,
−Removed: June 30, September 30, and December 31, at the rate of 9.375% per annum of its liquidation preference, which is
−Removed: equivalent to $2.34375 per annum per share.
−Removed: The first dividend on Series A Preferred Stock sold in the offering was payable
−Removed: on December 31, 2017 (in the amount of $0.299479 per share) to the holders of record of the Series A Preferred Stock
−Removed: at the close of business on December 15, 2017 and thereafter for each subsequent quarter in the amount of $0.5839375 per share.
−Removed: The Company recorded approximately $2.6 million and $2.3 million of dividends in Additional Paid in Capital on the Consolidated
−Removed: Balance Sheets as of December 31, 2019 and 2018, respectively.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
+Added: Except as may be otherwise required by law, the voting rights of the holders of the Series A Preferred Stock are limited to the affirmative vote or consent of the holders of at least two-thirds of the votes entitled to be cast by the holders of the Series A Preferred Stock outstanding at the time in connection with the:
+Added: (1) authorization or creation, or increase in the authorized or issued amount of, any class or series of capital stock ranking senior to the Series A Preferred Stock with respect to payment of dividends or the distribution of assets upon liquidation, dissolution or winding up or reclassification of any of the Company’s authorized capital stock into such shares, or creation, authorization or issuance of any obligation or security convertible into or evidencing the right to purchase any such shares;
+Added: or (2) amendment, alteration, repeal or replacement of the Company’s certificate of incorporation, including by way of a merger, consolidation or otherwise in which the Company may or may not be the surviving entity, so as to materially and adversely affect and deprive holders of Series A Preferred Stock of any right, preference, privilege or voting power of the Series A Preferred Stock.
+Added: Dividends on Series A Preferred Stock accrue daily and will be cumulative from, and including, the date of original issue and shall be payable monthly at the rate of 9.375 % per annum of its liquidation preference, which is equivalent to $ 2.34375 per annum per share.
+Added: The first dividend on Series A Preferred Stock sold in the offering was payable on December 31, 2017 (in the amount of $ 0.299479 per share) to the holders of record of the Series A Preferred Stock at the close of business on December 15, 2017 and thereafter for each subsequent quarter in the amount of $ 0.5839375 per share.
+Added: The Company recorded approximately $ 6.5 million and $ 2.6 million of dividends in Additional Paid in Capital on the Consolidated Balance Sheets as of December 31, 2020 and 2019, respectively.
No Maturity Date or Mandatory Redemption
−Removed: The Series A Preferred Stock has no
−Removed: maturity date, and the Company is not required to redeem the Series A Preferred Stock.
−Removed: Accordingly, the Series A Preferred
−Removed: Stock will remain outstanding indefinitely unless the Company decides to redeem it pursuant to its optional redemption right or
−Removed: its special optional redemption right in connection with a Change of Control (as defined below), or under the circumstances set
−Removed: forth below under “Limited Conversion Rights Upon a Change of Control”
−Removed: and elect to convert such Series A Preferred
+Added: The Series A Preferred Stock has no maturity date, and the Company is not required to redeem the Series A Preferred Stock.
+Added: Accordingly, the Series A Preferred Stock will remain outstanding indefinitely unless the Company decides to redeem it pursuant to its optional redemption right or its special optional redemption right in connection with a Change of Control (as defined below), or under the circumstances set forth below under “Limited Conversion Rights Upon a Change of Control” and elect to convert such Series A Preferred Stock.
The Company is not required to set aside funds to redeem the Series A Preferred Stock.
Optional Redemption
−Removed: The Series A Preferred Stock may be
−Removed: redeemed in whole or in part (at the Company’s option) any time on or after December 15, 2022, upon not less than 30
−Removed: days nor more than 60 days’
−Removed: written notice by mail prior to the date fixed for redemption thereof, for cash at a redemption
−Removed: price equal to $25.00 per share, plus any accumulated and unpaid dividends to, but not including, the redemption date.
+Added: The Series A Preferred Stock may be redeemed in whole or in part (at the Company’s option) any time on or after December 15, 2022, upon not less than 30 days nor more than 60 days ’ written notice by mail prior to the date fixed for redemption thereof, for cash at a redemption price equal to $ 25.00 per share, plus any accumulated and unpaid dividends to, but not including, the redemption date.
Special Optional Redemption
−Removed: Upon the occurrence a Change of Control
−Removed: (as defined below), the Company may redeem the shares of Series A Preferred Stock, at its option, in whole or in part, within
−Removed: one hundred twenty (120) days of any such Change of Control, for cash at $25.00 per share, plus accumulated and unpaid dividends
−Removed: (whether or not declared) to, but excluding, the redemption date.
−Removed: If, prior to the Change of Control conversion date, the Company
−Removed: has provided notice of its election to redeem some or all of the shares of Series A Preferred Stock (whether pursuant to the
−Removed: Company’s optional redemption right described above under “Optional Redemption”
−Removed: or this special optional redemption
−Removed: right), the holders of shares of Series A Preferred Stock will not have the Change of Control conversion right with respect
−Removed: to the shares of Series A Preferred Stock called for redemption.
−Removed: If the Company elects to redeem any shares of the Series A
−Removed: Preferred Stock as described in this paragraph, the Company may use any available cash to pay the redemption price.
−Removed: A “Change of Control”
−Removed: to occur when, after the original issuance of the Series A Preferred Stock, the following have occurred and are continuing:
−Removed: the acquisition by any person, including any syndicate or group deemed to be a “person”
−Removed: under Section 13(d)(3) of the Exchange Act of beneficial ownership, directly or indirectly, through a purchase, merger or other acquisition transaction or series of purchases, mergers or other acquisition transactions of the Company’s stock entitling that person to exercise more than 50% of the total voting power of all the Company’s stock entitled to vote generally in the election of the Company’s directors (except that such person will be deemed to have beneficial ownership of all securities that such person has the right to acquire, whether such right is currently exercisable or is exercisable only upon the occurrence of a subsequent condition);
+Added: Upon the occurrence a Change of Control (as defined below), the Company may redeem the shares of Series A Preferred Stock, at its option, in whole or in part, within one hundred twenty (120) days of any such Change of Control, for cash at $ 25.00 per share, plus accumulated and unpaid dividends (whether or not declared) to, but excluding, the redemption date.
+Added: If, prior to the Change of Control conversion date, the Company has provided notice of its election to redeem some or all of the shares of Series A Preferred Stock (whether pursuant to the Company’s optional redemption right described above under “Optional Redemption” or this special optional redemption right), the holders of shares of Series A Preferred Stock will not have the Change of Control conversion right with respect to the shares of Series A Preferred Stock called for redemption.
+Added: If the Company elects to redeem any shares of the Series A Preferred Stock as described in this paragraph, the Company may use any available cash to pay the redemption price.
+Added: A “Change of Control” is deemed to occur when, after the original issuance of the Series A Preferred Stock, the following have occurred and are continuing:
+Added: ● the acquisition by any person, including any syndicate or group deemed to be a “person” under Section 13(d)(3) of the Exchange Act of beneficial ownership, directly or indirectly, through a purchase, merger or other acquisition transaction or series of purchases, mergers or other acquisition transactions of the Company’s stock entitling that person to exercise more than 50% of the total voting power of all the Company’s stock entitled to vote generally in the election of the Company’s directors (except that such person will be deemed to have beneficial ownership of all securities that such person has the right to acquire, whether such right is currently exercisable or is exercisable only upon the occurrence of a subsequent condition);
● following the closing of any transaction referred to in the bullet point above, neither the Company nor the acquiring or surviving entity has a class of common equity securities (or American Depositary Receipts representing such securities) listed on the NYSE, the NYSE American LLC or the Nasdaq Stock Market, or listed or quoted on an exchange or quotation system that is a successor to the NYSE, the NYSE American LLC or the Nasdaq Stock Market.
Conversion, Exchange and Preemptive Rights
−Removed: Except as described below under “Limited
−Removed: Conversion Rights upon a Change of Control,”
−Removed: the Series A Preferred Stock is not subject to preemptive rights or convertible
−Removed: into or exchangeable for any other securities or property at the option of the holder.
−Removed: Limited Conversion Rights upon a Change
−Removed: Upon the occurrence of a Change of Control,
−Removed: each holder of shares of Series A Preferred Stock will have the right (unless, prior to the Change of Control Conversion Date,
−Removed: the Company has provided or provides irrevocable notice of its election to redeem the Series A Preferred Stock as described
−Removed: above under “Optional Redemption,”
−Removed: or “Special Optional Redemption”) to convert some or all of the shares
−Removed: of Series A Preferred Stock held by such holder on the Change of Control Conversion Date, into the Common Stock Conversion
−Removed: Consideration, which is equal to the lesser of:
−Removed: the quotient obtained by dividing (i) the sum of the $25.00 liquidation preference per share of Series A Preferred Stock plus the amount of any accumulated and unpaid dividends (whether or not declared) to, but not including, the Change of Control Conversion Date (unless the Change of Control Conversion Date is after a record date for a Series A Preferred Stock dividend payment and prior to the corresponding Dividend Payment Date, in which case no additional amount for such accumulated and unpaid dividend will be included in this sum) by (ii) the Common Stock Price (such quotient, the “Conversion Rate”);
+Added: Except as described below under “Limited Conversion Rights upon a Change of Control,” the Series A Preferred Stock is not subject to preemptive rights or convertible into or exchangeable for any other securities or property at the option of the holder.
+Added: Limited Conversion Rights upon a Change of Control
+Added: Upon the occurrence of a Change of Control, each holder of shares of Series A Preferred Stock will have the right (unless, prior to the Change of Control Conversion Date, the Company has provided or provides irrevocable notice of its election to redeem the Series A Preferred Stock as described above under “Optional Redemption,” or “Special Optional Redemption”) to convert some or all of the shares of Series A Preferred Stock held by such holder on the Change of Control Conversion Date, into the Common Stock Conversion Consideration, which is equal to the lesser of:
+Added: ● the quotient obtained by dividing (i) the sum of the $ 25.00 liquidation preference per share of Series A Preferred Stock plus the amount of any accumulated and unpaid dividends (whether or not declared) to, but not including, the Change of Control Conversion Date (unless the Change of Control Conversion Date is after a record date for a Series A Preferred Stock dividend payment and prior to the corresponding Dividend Payment Date, in which case no additional amount for such accumulated and unpaid dividend will be included in this sum) by (ii) the Common Stock Price (such quotient, the “Conversion Rate”);
● 13.05483 shares of common stock, subject to certain adjustments.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: In the case of a Change of Control pursuant
−Removed: to which the Company’s common stock will be converted into cash, securities or other property or assets, a holder of Series A
−Removed: Preferred Stock will receive upon conversion of such Series A Preferred Stock the kind and amount of Alternative Form Consideration
−Removed: which such holder would have owned or been entitled to receive upon the Change of Control had such holder held a number of shares
−Removed: of the Company’s common stock equal to the Common Stock Conversion Consideration immediately prior to the effective time
−Removed: of the Change of Control.
−Removed: Notwithstanding the foregoing, the holders
−Removed: of shares of Series A Preferred Stock will not have the Change of Control Conversion Right if the acquiror has shares listed
−Removed: or quoted on the NYSE, the NYSE American LLC or Nasdaq Stock Market or listed or quoted on an exchange or quotation system that
−Removed: is a successor to the NYSE, the NYSE American LLC or Nasdaq Stock Market, and the Series A Preferred Stock becomes convertible
−Removed: into or exchangeable for such acquiror’s listed shares upon a subsequent Change of Control of the acquiror.
+Added: In the case of a Change of Control pursuant to which the Company’s common stock will be converted into cash, securities or other property or assets, a holder of Series A Preferred Stock will receive upon conversion of such Series A Preferred Stock the kind and amount of Alternative Form Consideration which such holder would have owned or been entitled to receive upon the Change of Control had such holder held a number of shares of the Company’s common stock equal to the Common Stock Conversion Consideration immediately prior to the effective time of the Change of Control.
+Added: Notwithstanding the foregoing, the holders of shares of Series A Preferred Stock will not have the Change of Control Conversion Right if the acquiror has shares listed or quoted on the NYSE, the NYSE American LLC or Nasdaq Stock Market or listed or quoted on an exchange or quotation system that is a successor to the NYSE, the NYSE American LLC or Nasdaq Stock Market, and the Series A Preferred Stock becomes convertible into or exchangeable for such acquiror’s listed shares upon a subsequent Change of Control of the acquiror.
Liquidation Preference
−Removed: In the event the Company liquidates, dissolves
−Removed: or is wound up, holders of the Series A Preferred Stock will have the right to receive $25.00 per share, plus any accumulated
−Removed: and unpaid dividends to, but not including, the date of payment, before any payment is made to the holders of the Company’s
−Removed: common stock.
−Removed: The Series A Preferred Stock will
−Removed: rank, with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution
−Removed: or winding up, (1) senior to all classes or series of the Company’s common stock and to all other equity securities
−Removed: issued by the Company other than equity securities referred to in clauses (2) and (3);
−Removed: (2) on a par with all equity securities
−Removed: issued by the Company with terms specifically providing that those equity securities rank on a par with the Series A Preferred
−Removed: Stock with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution
−Removed: or winding up;
−Removed: (3) junior to all equity securities issued by the Company with terms specifically providing that those equity
−Removed: securities rank senior to the Series A Preferred Stock with respect to rights to the payment of dividends and the distribution
−Removed: of assets upon the Company liquidation, dissolution or winding up;
−Removed: and (4) junior to all of the Company’s existing and
−Removed: future indebtedness.
+Added: In the event the Company liquidates, dissolves or is wound up, holders of the Series A Preferred Stock will have the right to receive $ 25.00 per share, plus any accumulated and unpaid dividends to, but not including, the date of payment, before any payment is made to the holders of the Company’s common stock.
+Added: The Series A Preferred Stock will rank, with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution or winding up, (1) senior to all classes or series of the Company’s common stock and to all other equity securities issued by the Company other than equity securities referred to in clauses (2) and (3);
+Added: (2) on a par with all equity securities issued by the Company with terms specifically providing that those equity securities rank on a par with the Series A Preferred Stock with respect to rights to the payment of dividends and the distribution of assets upon the Company’s liquidation, dissolution or winding up;
+Added: (3) junior to all equity securities issued by the Company with terms specifically providing that those equity securities rank senior to the Series A Preferred Stock with respect to rights to the payment of dividends and the distribution of assets upon the Company liquidation, dissolution or winding up;
+Added: and (4) junior to all of the Company’s existing and future indebtedness.
Stock-Based Compensation
−Removed: As of December 31, 2019, the Company
−Removed: had four equity compensation plans:
+Added: As of December 31, 2020, the Company had four equity compensation plans:
the Fortress Biotech, Inc.
−Removed: 2007 Stock Incentive Plan (the “2007 Plan”), the
−Removed: Fortress Biotech, Inc.
−Removed: 2013 Stock Incentive Plan, as amended (the “2013 Plan”), the Fortress Biotech, Inc.
−Removed: 2012 Employee Stock Purchase Plan (the “ESPP”) and the Fortress Biotech, Inc.
−Removed: Long Term Incentive Plan (“LTIP”).
−Removed: In 2007, the Company’s Board of Directors adopted and stockholders approved the 2007 Plan authorizing the Company to grant
−Removed: up to 6,000,000 shares of Common Stock to eligible employees, directors, and consultants in the form of restricted stock, stock
−Removed: options and other types of grants.
−Removed: In 2013, the Company’s Board of Directors adopted and stockholders approved the 2013 Plan
−Removed: authorizing the Company to grant up to 2,300,000 shares of Common Stock to eligible employees, directors, and consultants in the
−Removed: form of restricted stock, stock options and other types of grants.
−Removed: In 2015, the Company’s Board of Directors and stockholders
−Removed: approved an increase of 7,700,000 shares for the 2013 Plan bringing the total number of shares approved under this plan to 10,000,000,
−Removed: with the aggregate total of authorized shares available for grants under the 2007 Plan and the 2013 Plan of up to 16,000,000 shares.
−Removed: An aggregate 13,750,535 shares were granted under both the Company’s 2007 and 2013 plans, net of cancellations, and 2,249,465
−Removed: shares were available for issuance as of December 31, 2019.
−Removed: Certain partner companies have their own
−Removed: equity compensation plan under which shares are granted to eligible employees, directors and consultants in the form of restricted
−Removed: stock, stock options, and other types of grants of stock of the respective partner company’s common stock.
−Removed: The table below
−Removed: provides a summary of those plans as of December 31, 2019:
+Added: 2007 Stock Incentive Plan (the “2007 Plan”), the Fortress Biotech, Inc.
+Added: 2013 Stock Incentive Plan, as amended (the “2013 Plan”), the Fortress Biotech, Inc.
+Added: 2012 Employee Stock Purchase Plan (the “ESPP”) and the Fortress Biotech, Inc.
+Added: Long Term Incentive Plan (“LTIP”).
+Added: In 2007, the Company’s Board of Directors adopted and stockholders approved the 2007 Plan authorizing the Company to grant up to 6,000,000 shares of Common Stock to eligible employees, directors, and consultants in the form of restricted stock, stock options and other types of grants.
+Added: In 2013, the Company’s Board of Directors adopted and stockholders approved the 2013 Plan authorizing the Company to grant up to 2,300,000 shares of Common Stock to eligible employees, directors, and consultants in the form of restricted stock, stock options and other types of grants.
+Added: In 2015, the Company’s Board of Directors and stockholders approved an increase of 7,700,000 shares for the 2013 Plan and in 2020, the Company’s Board of Directors and stockholders approved an increase of 3,000,000 shares bringing the total number of shares approved under this plan to 13,000,000 , with the aggregate total of authorized shares available for grants under the 2007 Plan and the 2013 Plan of up to 19,000,000 shares.
+Added: An aggregate 14,721,911 shares were granted under both the Company’s 2007 and 2013 plans, net of cancellations, and 4,278,089 shares were available for issuance as of December 31, 2020.
+Added: Certain partner companies have their own equity compensation plan under which shares are granted to eligible employees, directors and consultants in the form of restricted stock, stock options, and other types of grants of stock of the respective partner company’s common stock.
+Added: The table below provides a summary of those plans as of December 31, 2020:
Shares available at
17 unchanged sentences
2016 Incentive Plan
+Added: Oncogenuity, Inc.
FBIO Acquisition Corp.
+Added: VII 2017 Incentive Plan
+Added: FBIO Acquisition Corp.
V 2017 Incentive Plan
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated
−Removed: Financial Statements
−Removed: The purpose of the Company’s and partner company’s
−Removed: equity compensation plans is to provide for equity awards as part of an overall compensation package of performance-based rewards
−Removed: to attract and retain qualified personnel.
−Removed: Such awards include, without limitation, options, stock appreciation rights, sales
−Removed: or bonuses of restricted stock, restricted stock units or dividend equivalent rights, and an award may consist of one such security
−Removed: or benefit, or two or more of them in any combination or alternative.
−Removed: Vesting of awards may be based upon the passage of time,
−Removed: the occurrence of one or more events, or the satisfaction of performance criteria or other conditions.
−Removed: Incentive and non-statutory stock options
−Removed: are granted pursuant to option agreements adopted by the plan administrator.
−Removed: Options generally have 10-year contractual terms and
−Removed: vest in three equal annual installments commencing on the grant date.
−Removed: The Company estimates the fair value of
−Removed: stock option grants using a Black-Scholes option pricing model.
+Added: The purpose of the Company’s and partner company’s equity compensation plans is to provide for equity awards as part of an overall compensation package of performance-based rewards to attract and retain qualified personnel.
+Added: Such awards include, without limitation, options, stock appreciation rights, sales or bonuses of restricted stock, restricted stock units or dividend equivalent rights, and an award may consist of one such security or benefit, or two or more of them in any combination or alternative.
+Added: Vesting of awards may be based upon the passage of time, the occurrence of one or more events, or the satisfaction of performance criteria or other conditions.
+Added: Incentive and non-statutory stock options are granted pursuant to option agreements adopted by the plan administrator.
+Added: Options generally have 10-year contractual terms and vest in three equal annual installments commencing on the grant date.
+Added: The Company estimates the fair value of stock option grants using a Black-Scholes option pricing model.
In applying this model, the Company uses the following assumptions:
1 unchanged sentence
The risk-free interest rate is based on the yields of United States Treasury securities with maturities similar to the expected term of the options for each option group.
−Removed: As the Company has a limited trading history for its Common Stock, the expected stock price volatility for its Common Stock was estimated by incorporating two years of the Company’s historical volatility and the average historical price volatility for industry peers based on daily price observations over a period equivalent to the expected term of the stock option grants.
−Removed: Industry peers consist of several public companies in the biopharmaceutical industry similar in size, stage of life cycle and financial leverage.
−Removed: The Company’s historical volatility is weighted with that of the peer group and that combined historical volatility is weighted 80% with a 20% weighting of the Company’s implied volatility, which is obtained from traded options of the Company’s stock.
−Removed: The Company intends to continue to consistently apply this process using the same or similar public companies until it has sufficient historical information regarding the volatility of its Common Stock that is consistent with the expected life of the options.
−Removed: Should circumstances change such that the identified companies are no longer similar to the Company, more suitable companies whose share prices are publicly available would be utilized in the calculation.
+Added: ● Volatility :
+Added: The Company utilizes the trading history of its Common Stock to determine the expected stock price volatility for its Common Stock.
● Expected Term :
−Removed: Due to the limited exercise history of the Company’s stock options, the Company determined the expected term based on the Simplified Method under SAB 107 and the expected term for non-employees is the remaining contractual life for both options and warrants.
+Added: Due to the limited exercise history of the Company’s stock options, the Company determined the expected term based on the Simplified Method under SAB 107 and the expected term for non-employees is the remaining contractual life for both options and warrants.
● Expected Dividend Rate :
The Company has not paid and does not anticipate paying any cash dividends in the near future on its common stock.
−Removed: The fair value of each option award was
−Removed: estimated on the grant date using the Black-Scholes option-pricing model and expensed under the straight-line method.
−Removed: The following table summarizes the stock-based
−Removed: compensation expense from stock option, employee stock purchase programs and restricted Common Stock awards and warrants for the
−Removed: years ended December 31, 2019 and 2018:
−Removed: For the Years Ended
+Added: The fair value of each option award was estimated on the grant date using the Black-Scholes option-pricing model and expensed under the straight-line method.
+Added: The following table summarizes the stock-based compensation expense from stock option, employee stock purchase programs and restricted Common Stock awards and warrants for the years ended December 31, 2020 and 2019
+Added: Year Ended December 31,
($ in thousands)
Employee awards
+Added: Executive awards of Fortress Companies' stock
Non-employee awards
1 unchanged sentence
Total stock-based compensation expense
−Removed: For the years ended December 31, 2019
−Removed: and 2018, $2.8 million and $5.3 million was included in research and development expenses, and $10.4 million and $9.7 million was
−Removed: included in general and administrative expenses, respectively.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The following table summarizes Fortress
−Removed: stock option activities excluding activities related to partner companies:
−Removed: exercise price
−Removed: Total weighted
−Removed: intrinsic value
+Added: For the years ended 2020 and 2019, $ 3.2 million and $ 2.8 million was included in research and development expenses, and $ 10.3 million and $ 10.4 million was included in selling, general and administrative expenses, respectively.
+Added: The following table summarizes Fortress stock option activities excluding activities related to partner companies:
Weighted average
+Added: Weighted average
+Added: weighted average
contractual life
+Added: exercise price
+Added: intrinsic value
Options vested and expected to vest at December 31, 2018
1 unchanged sentence
Options vested and expected to vest at December 31, 2020
−Removed: Options vested and exercisable
−Removed: During the years ended December 31,
−Removed: 2019 and 2018, there were no exercises of stock options.
−Removed: As of December 31, 2019, the Company
−Removed: had no unrecognized stock-based compensation expense related to options.
+Added: During the years ended December 31, 2020 and 2019, there were no exercises of stock options.
+Added: As of December 31, 2020, the Company had no unrecognized stock-based compensation expense related to options.
Restricted Stock
−Removed: Stock-based compensation expense from restricted
−Removed: stock awards and restricted stock units for the years ended December 31, 2019 and 2018 was $11.5 million and $13.9 million,
−Removed: respectively.
−Removed: During 2019, the Company granted 1,546,408
−Removed: restricted shares of its Common Stock to executives and directors of the Company and 290,000 restricted stock units to employees
−Removed: and non-employees of the Company.
−Removed: The fair value of the restricted stock awards issued during 2019 of $1.4 million and the fair
−Removed: value of the restricted stock unit awards issued during 2019 of $0.4 million were estimated on the grant date using the Company’s
−Removed: stock price as of the grant date.
−Removed: The 2019 restricted stock awards and restricted stock unit awards vest upon both the passage
−Removed: of time as well as meeting certain performance criteria.
−Removed: Restricted stock awards and restricted stock unit awards are expensed
−Removed: under the straight-line method over the vesting period.
−Removed: During 2018, the Company granted 1,721,802
−Removed: restricted shares of its Common Stock to executives and directors of the Company and 490,000 restricted stock units to employees
−Removed: and non-employees of the Company.
−Removed: The fair value of the restricted stock awards issued during 2018 of $6.6 million and the fair
−Removed: value of the restricted stock unit awards issued during 2018 of $1.8 million were estimated on the grant date using the Company’s
−Removed: stock price as of the grant date.
−Removed: The 2018 restricted stock awards and restricted stock unit awards vest upon both the passage
−Removed: of time as well as meeting certain performance criteria.
−Removed: Restricted stock awards and restricted stock unit awards are expensed
−Removed: under the straight-line method over the vesting period.
−Removed: The following table summarizes Fortress
−Removed: restricted stock awards and restricted stock units activities, excluding activities related to Fortress subsidiaries:
+Added: Stock-based compensation expense from restricted stock awards and restricted stock units for the years ended December 31, 2020 and 2019 was $ 12.5 million and $ 11.5 million, respectively.
+Added: During 2020, the Company granted 1.9 million restricted shares of its Common Stock to executives and directors of the Company and 0.6 million restricted stock units to employees and non-employees of the Company.
+Added: The fair value of the restricted stock awards issued during 2020 of $ 4.8 million and the fair value of the restricted stock unit awards issued during 2020 of $ 2.4 million were estimated on the grant date using the Company’s stock price as of the grant date.
+Added: The 2020 restricted stock awards and restricted stock unit awards vest upon both the passage of time as well as meeting certain performance criteria.
+Added: Restricted stock awards and restricted stock unit awards are expensed under the straight-line method over the vesting period.
+Added: Expense for awards with performance-based vesting criteria will be measured and recorded if and when it becomes probable that the milstone will be achieved.
+Added: During 2019, the Company granted 1.5 million restricted shares of its Common Stock to executives and directors of the Company and 0.3 million restricted stock units to employees and non-employees of the Company.
+Added: The fair value of the restricted stock awards issued during 2019 of $ 1.4 million and the fair value of the restricted stock unit awards issued during 2019 of $ 0.4 million were estimated on the grant date using the Company’s stock price as of the grant date.
+Added: The 2019 restricted stock awards and restricted stock unit awards vest upon both the passage of time as well as meeting certain performance criteria.
+Added: Restricted stock awards and restricted stock unit awards are expensed under the straight-line method over the vesting period.
+Added: Expense for awards with performance-based vesting criteria will be measured and recorded if and when it becomes probable that the milstone will be achieved.
+Added: The following table summarizes Fortress restricted stock awards and restricted stock units activities, excluding activities related to Fortress subsidiaries:
average grant
+Added: Number of shares
Unvested balance at December 31, 2018
6 unchanged sentences
Restricted stock granted
−Removed: Restricted stock forfeited
Restricted stock vested
3 unchanged sentences
Unvested balance at December 31, 2020
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The total fair value of restricted
−Removed: stock units and awards that vested during the years ended December 31, 2019 and 2018 was $2.0 million and $3.3 million,
−Removed: respectively.
−Removed: As of December 31, 2019, the Company had unrecognized stock-based compensation expense related to all
−Removed: unvested restricted stock and restricted stock unit awards of $11.9 million and $1.8 million, respectively, which is expected
−Removed: to be recognized over the remaining weighted-average vesting period of 4.8 years and 2.1 years, respectively.
−Removed: does not include 227,083 restricted stock units and 395,869 restricted stock awards as of December 31, 2019 which are
−Removed: performance-based and vest upon achievement of certain corporate milestones.
−Removed: Stock-based compensation for these awards will
−Removed: be measured and recorded if and when it is probable that the milestone will be achieved.
+Added: The total fair value of restricted stock units and awards that vested during the years ended December 31, 2020 and 2019 was $ 2.0 million and $ 2.0 million, respectively.
+Added: As of December 31, 2020, the Company had unrecognized stock-based compensation expense related to all unvested restricted stock and restricted stock unit awards of $ 12.6 million and $ 3.1 million, respectively, which is expected to be recognized over the remaining weighted-average vesting period of 4.1 years and 2.8 years, respectively.
+Added: This amount does not include 0.1 million restricted stock units as of December 31, 2020 which are performance-based and vest upon achievement of certain corporate milestones.
+Added: Stock-based compensation for these awards will be measured and recorded if and when it is probable that the milestone will be achieved.
Deferred Compensation Plan
−Removed: On March 12, 2015, the Company’s
−Removed: Compensation Committee approved the Deferred Compensation Plan allowing all non-employee directors the opportunity to defer all
−Removed: or a portion of their fees or compensation, including restricted stock and restricted stock units.
−Removed: During the year ended December 31,
−Removed: 2019 and 2018, certain non-employee directors elected to defer an aggregate of 230,000 and 230,000 restricted stock awards, respectively,
−Removed: under this plan.
+Added: On March 12, 2015, the Company’s Compensation Committee approved the Deferred Compensation Plan allowing all non-employee directors the opportunity to defer all or a portion of their fees or compensation, including restricted stock and restricted stock units.
+Added: During the year ended December 31, 2020 and 2019, certain non-employee directors elected to defer an aggregate of 230,000 and 230,000 restricted stock awards, respectively, under this plan.
Employee Stock Purchase Plan
−Removed: Eligible employees can purchase the Company’s
−Removed: Common Stock at the end of a predetermined offering period at 85% of the lower of the fair market value at the beginning or end
−Removed: of the offering period.
+Added: Eligible employees can purchase the Company’s Common Stock at the end of a predetermined offering period at 85 % of the lower of the fair market value at the beginning or end of the offering period.
The ESPP is compensatory and results in stock-based compensation expense.
−Removed: As of December 31, 2019, 454,515 shares
−Removed: have been purchased and 545,485 shares are available for future sale under the Company’s ESPP.
−Removed: The Company recognized share-based
−Removed: compensation expense of $0.1 million and $0.2 million for the years ended December 31, 2019 and 2018, respectively.
−Removed: The following table summarizes Fortress
−Removed: warrant activities, excluding activities related to partner companies:
−Removed: Number of shares
−Removed: Weighted average
−Removed: exercise price
+Added: As of December 31, 2020, 577,301 shares have been purchased and 422,699 shares are available for future sale under the Company’s ESPP.
+Added: The Company recognized share-based compensation expense of $ 0.1 million and $ 0.1 million for the years ended December 31, 2020 and 2019, respectively.
+Added: The following table summarizes Fortress warrant activities, excluding activities related to partner companies:
Total weighted
−Removed: average intrinsic
Weighted average
+Added: Weighted average
contractual life
+Added: exercise price
Outstanding as of December 31, 2018
2 unchanged sentences
Exercisable as of December 31, 2020
−Removed: All stock-based expense in connection with
−Removed: these warrants has been recognized prior to January 1, 2017.
−Removed: Long-Term Incentive Program (“LTIP”)
−Removed: On July 15, 2015, the stockholders
−Removed: approved the LTIP for the Company’s Chairman, President and Chief Executive Officer, Dr.
−Removed: Rosenwald, and Executive Vice
−Removed: Chairman, Strategic Development, Mr.
−Removed: The LTIP consists of a program to grant equity interests in the Company and in
−Removed: the Company’s subsidiaries, and a performance-based bonus program that is designed to result in performance-based compensation
−Removed: that is deductible without limit under Section 162(m) of the Internal Revenue Code of 1986, as amended.
−Removed: On January 1, 2019 and 2018, the Compensation
−Removed: Committee granted 648,204 and 586,429 shares each to Dr.
+Added: During 2020, in connection with the issuance of the Oaktree Note, the Company issued warrants to purchase 1,749,450 shares of common stock;
+Added: in connection with a consulting agreement the Company issued warrants to purchase 100,000 shares of common stock.
+Added: The relative fair value of the Oaktree warrants was recorded to debt discount and will be amortized over the term of the Oaktree Note (see Note 10).
+Added: As of December 31, 2020, the Company had no unrecognized stock-based compensation expense related to warrants.
+Added: Long-Term Incentive Program (“LTIP”)
+Added: On July 15, 2015, the stockholders approved the LTIP for the Company’s Chairman, President and Chief Executive Officer, Dr.
+Added: Rosenwald, and Executive Vice Chairman, Strategic Development, Mr.
+Added: The LTIP consists of a program to grant equity interests in the Company and in the Company’s subsidiaries, and a performance-based bonus program that is designed to result in performance-based compensation that is deductible without limit under Section 162(m) of the Internal Revenue Code of 1986, as amended.
+Added: On January 1, 2020 and 2019, the Compensation Committee granted 801,536 and 648,204 shares each to Dr.
Rosenwald and Mr.
Weiss, respectively.
−Removed: These equity grants,
−Removed: made in accordance with the LTIP, represent 1% of total outstanding shares of the Company as of the dates of such grants and were
−Removed: granted in recognition of their performance in 2018 and 2017.
−Removed: The shares are subject to repurchase by the Company until both of
−Removed: the following conditions are met:
−Removed: (i) the Company’s market capitalization increases by a minimum of $100.0 million,
−Removed: and (ii) the employee is either in the service of the Company as an employee or as a Board member (or both) on the tenth anniversary
−Removed: of the LTIP, or the eligible employee has had an involuntary separation from service (as defined in the LTIP).
−Removed: The Company’s
−Removed: repurchase option on such shares will also lapse upon the occurrence of a corporate transaction (as defined in the LTIP) if the
−Removed: eligible employee is in service on the date of the corporate transaction.
−Removed: The fair value of each grant on the grant date was approximately
−Removed: $0.6 million for the 2019 grant and $2.3 million for the 2018 grant.
−Removed: For the year ended December 31, 2019 and 2018, the Company
−Removed: recorded expense of approximately $1.4 million and $1.3 million, respectively related to the LTIP grants on the Consolidated Statements
−Removed: of Operations.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: For their service in 2017, Dr.
−Removed: Weiss received bonuses of $500,000 each, paid in cash during the quarter ended June 30, 2018 (the “LTIP
−Removed: Annual Cash Bonus”).
−Removed: Rosenwald and Mr.
−Removed: Weiss waived their right to the LTIP Annual Cash Bonus.
−Removed: treated this transaction as a capital contribution, which is reflected on the Consolidated Statement of Changes in Stockholders’
−Removed: Equity for the year ended December 31, 2018.
−Removed: In lieu of the LTIP Annual Cash Bonus, on July 3, 2018 the Company’s
−Removed: Board granted Dr.
−Removed: Rosenwald and Mr.
−Removed: Weiss each a restricted stock award for the number of shares of the Company’s
−Removed: common stock with a fair market value equal to the LTIP Annual Cash Bonus, measured at the date of such consent;
−Removed: such number of
−Removed: shares as calculated at the $3.04 closing trading price of the Company’s common stock, equal to 164,473 shares each.
−Removed: fair value of each grant on the grant date was approximately $0.5 million.
−Removed: For the years ended December 31, 2019 and 2018,
−Removed: the Company recorded expense of approximately $0.3 million and $0.1 million, respectively, related to these grants on the Consolidated
−Removed: Statements of Operations.
+Added: These equity grants, made in accordance with the LTIP, represent 1 % of total outstanding shares of the Company as of the dates of such grants and were granted in recognition of their performance in 2019 and 2018.
+Added: The shares are subject to repurchase by the Company until both of the following conditions are met:
+Added: (i) the Company’s market capitalization increases by a minimum of $ 100.0 million, and (ii) the employee is either in the service of the Company as an employee or as a Board member (or both) on the tenth anniversary of the LTIP, or the eligible employee has had an involuntary separation from service (as defined in the LTIP).
+Added: The Company’s repurchase option on such shares will also lapse upon the occurrence of a corporate transaction (as defined in the LTIP) if the eligible employee is in service on the date of the corporate transaction.
+Added: The fair value of each grant on the grant date was approximately $ 2.1 million for the 2020 grant and $ 0.6 million for the 2019 grant.
+Added: For the year ended December 31, 2020 and 2019, the Company recorded stock compensation expense of approximately $ 2.5 million and $ 1.4 million, respectively related to the LTIP grants on the Consolidated Statements of Operations.
Capital Raise
−Removed: At the Market Offering
−Removed: On August 17, 2016, the Company entered
−Removed: into an Amended and Restated At Market Issuance Sales Agreement, or Sales Agreement, with MLV & Co.
−Removed: LLC, or MLV, and FBR
−Removed: Capital Markets & Co., or FBR (“ATM”).
−Removed: On August 18, 2016, the Company filed a Registration Statement
−Removed: on Form S-3, which became effective on December 1, 2016 and permits the Company to issue and sell shares of its common
−Removed: stock having an aggregate offering price of up to $53.0 million from time to time through MLV and FBR, as sales agents under the
−Removed: Sales Agreement.
+Added: 2019 Common Stock At the Market Offering
+Added: On June 28, 2019, the Company entered into an At Market Issuance Sales Agreement (“2019 Common ATM”), with Cantor Fitzgerald & Co., Oppenheimer & Co., Inc., H.C.
+Added: Wainwright & Co.
+Added: Inc., Jones Trading Institutional Services LLC and B.
+Added: Riley, as selling agents, governing potential sales of the Company’s common stock.
+Added: For the years ended December 31, 2020 and 2019, the Company issued approximately 17.4 million and 3.8 million shares of common stock, respectively, for gross proceeds of $ 47.5 million and $ 5.6 million, respectively, at an average selling price of $ 2.73 and $ 1.49 , respectively.
+Added: Under the 2019 Common ATM, the Company pays the agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock, and in connection with these sales, with respect to the years ended December 31, 2020 and 2019, the Company paid aggregate fees of approximately $ 1.4 million and $ 0.2 million, respectively.
+Added: Common Stock At the Market Offering
+Added: On August 17, 2016, the Company entered into an Amended and Restated At Market Issuance Sales Agreement, or Sales Agreement, with MLV & Co.
+Added: LLC, or MLV, and FBR Capital Markets & Co., or FBR (“ATM”).
+Added: On August 18, 2016, the Company filed a Registration Statement on Form S-3, which became effective on December 1, 2016 and permits the Company to issue and sell shares of its common stock having an aggregate offering price of up to $ 53.0 million from time to time through MLV and FBR, as sales agents under the Sales Agreement.
The Sales Agreement terminated on August 17, 2019 .
−Removed: Pursuant to the terms of the ATM, for the
−Removed: year ended December 31, 2019 and 2018, the Company issued approximately 8.0 million and 2.9 million shares of common stock,
−Removed: respectively, at an average price of $1.88 and $2.50 per share, respectively, for gross proceeds of $15.1 million and $7.3 million,
−Removed: respectively.
−Removed: In connection with these sales, the Company paid aggregate fees of approximately $0.3 million and $0.3 million, respectively.
−Removed: 2018 9.375% Series A Cumulative
−Removed: Redeemable Perpetual Preferred Stock At the Market Offering
−Removed: On April 5, 2018, the Company entered
−Removed: into an At Market Sales Agreement (the “2018 Preferred ATM”), with B.
−Removed: Riley, National Securities Corporation, LifeSci
−Removed: Capital LLC, Maxim Group LLC and Noble Capital Markets, Inc.
−Removed: as selling agents, governing the issuance of the Company’s
−Removed: 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (“Perpetual Preferred Stock”).
−Removed: For the year ended
−Removed: December 31, 2019, the Company issued 39,292 shares of Perpetual Preferred Stock for gross proceeds $0.8 million at an average
−Removed: selling price of $20.67.
+Added: Pursuant to the terms of the ATM, for the year ended December 31, 2019, the Company issued approximately 8.0 million shares of common stock, respectively, at an average price of $ 1.88 per share for gross proceeds of $ 15.1 million.
+Added: In connection with these sales, the Company paid aggregate fees of approximately $ 0.3 million, respectively.
+Added: 2019 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock Offering
+Added: In November 2019, the Company completed an underwritten public offering of 262,500 shares of its 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock, (Nasdaq:
+Added: FBIOP) (the "Preferred Stock"), (plus a 45-day option to purchase up to an additional 39,375 shares, which was exercised in November, 2019) at a price of $ 20 per share for gross proceeds of approximately $ 6.0 million, before deducting underwriting discounts and commissions and offering expenses.
+Added: On February 14, 2020, the Company announced the closing of an underwritten public offering, whereby it sold 625,000 shares of its Preferred Stock, (plus a 45-day option to purchase up to an additional 93,750 shares, which was exercised in February 2020) at a price of $ 20.00 per share for gross proceeds of approximately $ 14.4 million, before deducting underwriting discounts and commissions and offering expenses of approximately $ 1.3 million.
+Added: On May 29, 2020, the Company closed on an underwritten public offering whereby it sold 555,556 shares of its Preferred Stock, (plus a 45-day option to purchase up to an additional 83,333 shares, which was exercised in May 2020) at a price of $ 18.00 per share for gross proceeds of approximately $ 11.5 million, before deducting underwriting discounts and commissions and offering expenses of approximately $ 1.1 million.
+Added: On August 26, 2020, the Company closed on an underwritten public offering whereby it sold 666,666 shares of its Preferred Stock, (plus a 45-day option to purchase up to an additional 66,666 shares, which was exercised in August 2020) at a price of $ 18.00 per share for gross proceeds of approximately $ 13.2 million, before deducting underwriting discounts and commissions and offering expenses of approximately $ 1.1 million.
+Added: 2018 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock At the Market Offering
+Added: On April 5, 2018, the Company entered into an At Market Sales Agreement (the “2018 Preferred ATM”), with B.
+Added: Riley, National Securities Corporation, LifeSci Capital LLC, Maxim Group LLC and Noble Capital Markets, Inc.
+Added: as selling agents, governing the issuance of the Company’s 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock (“Perpetual Preferred Stock”).
+Added: For the year ended December 31, 2019, the Company issued 39,292 shares of Perpetual Preferred Stock for gross proceeds $ 0.8 million at an average selling price of $ 20.67 .
No shares of Perpetual Preferred Stock were issued in 2018.
−Removed: Under the 2018 Preferred ATM, the Company
−Removed: pays the agents a commission rate of up to 7.0% of the gross proceeds from the sale of any shares of Perpetual Preferred Stock,
−Removed: and in connection with these sales, with respect to the year ended December 31, 2019, the Company paid aggregate fees of approximately
−Removed: The above-mentioned shares of Perpetual
−Removed: Preferred Stock were sold under the 2016 Shelf.
+Added: Under the 2018 Preferred ATM, the Company pays the agents a commission rate of up to 7.0 % of the gross proceeds from the sale of any shares of Perpetual Preferred Stock, and in connection with these sales, with respect to the year ended December 31, 2019, the Company paid aggregate fees of approximately $ 24,000 .
+Added: The above-mentioned shares of Perpetual Preferred Stock were sold under the 2016 Shelf.
The 2016 Shelf expired on December 1, 2019 .
−Removed: 2019 Common Stock At the Market Offering
−Removed: On June 28, 2019, the Company entered
−Removed: into an At Market Issuance Sales Agreement (“2019 Common ATM”), with Cantor Fitzgerald & Co., Oppenheimer &
−Removed: Co., Inc., H.C.
+Added: The 2019 offerings of both common stock and preferred stock were sold under the Company’s shelf registration statement on Form S-3 originally filed on July 6, 2018 and declared effective July 23, 2019 (the “2019 Shelf”).
+Added: The shares of common stock were sold under the Company’s shelf registration statement on Form S-3 originally filed on July 6, 2018 and declared effective July 23, 2019 (the “2019 Shelf”) through May 27, 2020.
+Added: On May 18, 2020, the Company filed a new shelf registration statement on Form S-3, which was declared effective on May 26, 2020 (the "2020 Shelf").
+Added: In connection with the 2020 Shelf, the Company entered into an At Market Issuance Sales Agreement ("2020 Common ATM"), with Cantor Fitzgerald & Co., Oppenheimer & Co., Inc., H.C.
Wainwright & Co.
−Removed: Inc., Jones Trading Institutional Services LLC and B.
−Removed: Riley, as selling agents,
−Removed: governing potential sales of the Company’s common stock.
−Removed: For the year ended December 31, 2019, the Company issued approximately
−Removed: 3.8 million shares of common stock for gross proceeds of $5.6 million at an average selling price of $1.49.
−Removed: Under the 2019 Common
−Removed: ATM, the Company pays the agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock,
−Removed: and in connection with these sales, with respect to the year ended December 31, 2019, the Company paid aggregate fees of approximately
−Removed: $0.2 million.
−Removed: 2019 9.375% Series A Cumulative
−Removed: Redeemable Perpetual Preferred Stock Offering
−Removed: In November 2019, the Company completed
−Removed: an underwritten public offering of 262,500 shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock,
−Removed: (plus a 45-day option to purchase up to an additional 39,375 shares, which was exercised in November, 2019) at a price of $20 per
−Removed: share for gross proceeds of approximately $6.0 million, before deducting underwriting discounts and commissions and offering expenses.
−Removed: (See Note 21.)
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The 2019 offerings of both common stock
−Removed: and preferred stock were sold under the Company’s shelf registration statement on Form S-3 originally filed on July 6,
−Removed: 2018 and declared effective July 23, 2019 (the “2019 Shelf”).
−Removed: Approximately $38.3 million of securities remain
−Removed: available for sale under the 2019 Shelf at December 31, 2019.
+Added: Riley and Dawson James Securities, Inc., as selling agents, governing potential sales of the Company's common stock.
+Added: ATM sales commencing on June 1, 2020 were made under the 2020 Shelf as were Perpetual Preferred Offerings.
+Added: Approximately $ 26.7 million of securities remain available for sale under the 2020 Shelf at December 31, 2020.
+Added: Cyprium 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock Offering
+Added: On August 28, 2020, Cyprium closed on an underwritten public offering whereby it sold 255,400 shares of its 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock (“Cyprium Perpetual Preferred Stock” or “Cyprium PPS”), plus an overallotment of an additional 64,600 shares, which was exercised on September 18, 2020, at a price of $ 25.00 per share for gross proceeds of $ 8.0 million, before deducting underwriting discounts and commissions and offering expenses of approximately $ 0.9 million (the “Cyprium Offering”).
+Added: Pursuant to the terms of the Cyprium PPS, shareholders on the record date are entitled to receive a monthly cash dividend of $ 0.19531 per share which yields an annual dividend of $ 2.34375 per share.
+Added: The Cyprium PPS will automatically be redeemed upon the first (and only the first) bona fide, arm’s-length sale of a Priority Review Voucher (a “PRV”) issued by the FDA in connection with the approval of CUTX-101, Cyprium’s lead product candidate.
+Added: Upon the PRV sale, each share of Cyprium PPS will be automatically redeemed in exchange for a payment equal to twice (2x) the $ 25.00 liquidation preference, plus accumulated and unpaid dividends to, but excluding, the redemption date.
+Added: An optional exchange to Company Preferred Stock is available after 24 months from the issuance date so long as a sale of the PRV has not occurred.
+Added: Additionally, if a PRV Sale has not occurred by September 30, 2024 the Cyprium PPS is either automatically exchanged for Company Preferred Stock or cash at the discretion of Fortress.
+Added: The Cyprium PPS is fully and unconditionally guaranteed by Fortress.
+Added: Cyprium paid an initial dividend of $ 49,883 ($ 0.19531 per share) to shareholders of record on September 30, 2020.
+Added: Cyprium paid $ 0.2 million in dividends for the year ended December 31, 2020.
Checkpoint Therapeutics, Inc.
−Removed: In November 2017, the Checkpoint filed
−Removed: a shelf registration statement on Form S-3 (No.
−Removed: 333-221493) (the "Checkpoint S-3"), which was declared effective
−Removed: in December 2017.
+Added: In November 2017, the Checkpoint filed a shelf registration statement on Form S-3 (No.
+Added: 333-221493) (the "Checkpoint 2017 S-3"), which was declared effective in December 2017.
Under the Checkpoint S-3, Checkpoint may sell up to a total of $ 100 million of its securities.
−Removed: In connection
−Removed: with the Checkpoint S-3, Checkpoint entered into an At-the-Market Issuance Sales Agreement (the "Checkpoint ATM") with
−Removed: Cantor Fitzgerald & Co., Ladenburg Thalmann & Co.
+Added: In connection with the Checkpoint S-3, Checkpoint entered into an At-the-Market Issuance Sales Agreement (the "Checkpoint 2017 ATM") with Cantor Fitzgerald & Co., Ladenburg Thalmann & Co.
Wainwright & Co., LLC (each an "Agent"
and collectively, the "Agents"), relating to the sale of shares of common stock.
−Removed: Under the Checkpoint ATM, Checkpoint
−Removed: pays the Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock.
−Removed: During the year ended December 31,
−Removed: 2019, Checkpoint sold a total of 2,273,189 shares of common stock under the ATM for aggregate total gross proceeds of approximately
−Removed: $8.0 million at an average selling price of $3.52 per share, resulting in net proceeds of approximately $7.8 million after deducting
−Removed: commissions and other transaction costs.
−Removed: During the year ended December 31,
−Removed: 2018, Checkpoint sold a total of 1,841,774 shares of common stock under the Checkpoint ATM for aggregate total gross proceeds of
−Removed: approximately $8.0 million at an average selling price of $4.33 per share, resulting in net proceeds of approximately $7.7 million
−Removed: after deducting commissions and other transactions costs.
−Removed: In November 2019, Checkpoint completed
−Removed: an underwritten public offering of 15,400,000 shares of its common stock at a price of $1.27 per share for gross proceeds of approximately
−Removed: $19.6 million.
−Removed: Total net proceeds from the offering were approximately $17.6 million, net of underwriting discounts and offering
−Removed: expenses of approximately $2.0 million.
−Removed: In March 2018, Checkpoint completed
−Removed: an underwritten public offering of 5,290,000 shares of its common stock at a price of $4.35 per share for gross proceeds of approximately
−Removed: $23.0 million.
−Removed: Total net proceeds from the offering were approximately $20.8 million, net of underwriting discounts and offering
−Removed: expenses of approximately $2.2 million.
−Removed: Approximately $41.4 million of the shelf
−Removed: remains available for sale under the Checkpoint S-3, following the offerings noted above.
+Added: Under the Checkpoint 2017 ATM, Checkpoint pays the Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock.
+Added: The Checkpoint 2017 S-3 expired in December 2020.
+Added: During the year ended December 31, 2020, Checkpoint sold a total of 5,104,234 shares of common stock under the Checkpoint ATM for aggregate total gross proceeds of approximately $ 12.8 million at an average selling price of $ 2.50 per share, resulting in net proceeds of approximately $ 12.4 million after deducting commissions and other transaction costs.
+Added: During the year ended December 31, 2019, Checkpoint sold a total of 2,273,189 shares of common stock under the Checkpoint ATM for aggregate total gross proceeds of approximately $ 8.0 million at an average selling price of $ 3.52 per share, resulting in net proceeds of approximately $ 7.8 million after deducting commissions and other transaction costs.
+Added: In September 2020, Checkpoint completed an underwritten public offering in which it sold 7,321,429 shares of its common stock at a price of $ 2.80 per share for gross proceeds of approximately $ 20.5 million.
+Added: Total net proceeds from the offering were approximately $ 18.9 million, net of underwriting discounts and offering expenses of approximately $ 1.6 million.
+Added: The shares were sold under the Checkpoint 2017 S-3.
+Added: In November 2019, Checkpoint completed an underwritten public offering of 15,400,000 shares of its common stock at a price of $ 1.27 per share for gross proceeds of approximately $ 19.6 million.
+Added: Total net proceeds from the offering were approximately $ 17.6 million, net of underwriting discounts and offering expenses of approximately $ 2.0 million.
+Added: The shares were sold under the Checkpoint 2017 S-3.
+Added: In November 2020, Checkpoint filed a shelf registration statement on Form S-3 (the “Checkpoint 2020 S-3”), which was declared effective in December 2020.
+Added: Under the Checkpoint 2020 S-3, Checkpoint may sell up to a total of $ 100 million of its securities.
+Added: In connection with the Checkpoint S-3, Checkpoint entered into an ATM (the "Checkpoint 2020 ATM") with Cantor Fitzgerald & Co., Ladenburg Thalmann & Co.
+Added: Wainwright & Co., LLC (each an “Agent” and collectively, the “Agents”), relating to the sale of shares of common stock.
+Added: Under the ATM, Checkpoint pays the Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock.
+Added: As of December 31, 2020, approximately $ 83.6 million of the shelf remains available for sale under the Checkpoint 2020 S-3.
Mustang Bio, Inc.
−Removed: July 13, 2018, Mustang filed a shelf registration statement No.
−Removed: 333-226175 on Form S-3, as amended on July 20,
−Removed: 2018 (the "2018 Mustang S-3"), which was declared effective in August 2018.
−Removed: Under the 2018 Mustang S-3, Mustang
−Removed: may sell up to a total of $75.0 million of its securities.
−Removed: In connection with the 2018 Mustang S-3, Mustang entered into an At-the-Market
−Removed: Issuance Sales Agreement (the "Mustang ATM") with B.
−Removed: Riley FBR, Inc., Cantor Fitzgerald & Co., National
−Removed: Securities Corporation, and Oppenheimer & Co.
+Added: On July 13, 2018, Mustang filed a shelf registration statement No.
+Added: 333-226175 on Form S-3 , as amended on July 20, 2018 (the "2018 Mustang S-3"), which was declared effective in August 2018.
+Added: Under the 2018 Mustang S-3, Mustang may sell up to a total of $ 75.0 million of its securities.
+Added: In connection with the 2018 Mustang S-3, Mustang entered into an At-the-Market Issuance Sales Agreement (the "Mustang ATM") with B.
+Added: Riley Securities, Inc.
+Added: Riley FBR, Inc.), Cantor Fitzgerald & Co., National Securities Corporation, and Oppenheimer & Co.
(each an "Agent"
−Removed: and collectively, the "Agents"),
−Removed: relating to the sale of shares of common stock.
−Removed: Under the Mustang ATM, Mustang pays the Agents a commission rate of up to 3.0%
−Removed: of the gross proceeds from the sale of any shares of common stock.
−Removed: During the year ended December 31, 2019, Mustang
−Removed: issued approximately 3.5 million shares of common stock under the Mustang ATM at an average price of $6.42 per share for gross
−Removed: proceeds of $22.5 million.
−Removed: In connection with these sales, Mustang paid aggregate fees of approximately $0.5 million, for net proceeds
−Removed: of approximately $22.0 million.
−Removed: No sales were made under the Mustang ATM in 2018.
−Removed: In April 2019, Mustang completed an
−Removed: underwritten public offering of 6,875,000 shares of its common stock, (plus a 30-day option to purchase up to an additional 1,031,250
−Removed: shares of common stock, which was exercised in May 2019) at a price of $4.00 per share for gross proceeds of approximately
−Removed: $31.6 million, before deducting underwriting discounts and commissions and offering expenses.
−Removed: The shares were sold under the 2018
+Added: and collectively, the "Agents"), relating to the sale of shares of common stock.
+Added: Under the Mustang ATM, Mustang pays the Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock.
+Added: During the year ended December 31, 2020, Mustang issued approximately 17.6 million shares of common stock at an average price of $ 3.40 per share for gross proceeds of $ 59.8 million under the Mustang ATM.
+Added: In connection with these sales, Mustang paid aggregate fees of approximately $ 1.1 million for net proceeds of approximately $ 58.7 million.
+Added: During the year ended December 31, 2019, Mustang issued approximately 3.5 million shares of common stock at an average price of $ 6.42 per share for gross proceeds of $ 22.5 million under the Mustang ATM.
+Added: In connection with these sales, Mustang paid aggregate fees of approximately $ 0.5 million for net proceeds of approximately $ 22.0 million.
+Added: On June 11, 2020, Mustang entered into an underwriting agreement (the “Mustang Underwriting Agreement”) with Cantor Fitzgerald & Co., as representative of the underwriters named therein (each, an “Underwriter” and collectively with Cantor Fitzgerald & Co., the “Underwriters”).
+Added: In connection with the Mustang Underwriting Agreement, Mustang issued 10,769,231 shares of common stock (plus a 30-day option to purchase up to an additional 1,615,384 shares of common stock, of which 686,373 were exercised) at a price of $ 3.25 per share for gross proceeds of approximately $ 37.2 million, before deducting underwriting discounts and commissions and offering expenses.
+Added: In connection with the public offering, Mustang paid aggregate fees of approximately $ 2.4 million for net proceeds of approximately $ 34.8 million.
+Added: The shares were sold under the Mustang S-3 registrations filed with the Securities and Exchange Commission.
+Added: The offering closed on June 15, 2020, and the over-allotment closed on June 25, 2020.
+Added: In April 2019, Mustang completed an underwritten public offering of 6,875,000 shares of its common stock, (plus a 30-day option to purchase up to an additional 1,031,250 shares of common stock, which was exercised in May 2019) at a price of $ 4.00 per share for gross proceeds of approximately $ 31.6 million, before deducting underwriting discounts and commissions and offering expenses.
+Added: The shares were sold under the 2018 Mustang S-3.
Mustang paid aggregate fees of approximately $ 2.1 million and received approximately $ 29.5 million of net proceeds.
−Removed: On August 16, 2019, Mustang filed
−Removed: a shelf registration statement No.
−Removed: 333-233350 on Form S-3 (the “2019 Mustang S-3”), which was declared effective
−Removed: on September 30, 2019.
+Added: On October 23, 2020, Mustang filed a shelf registration statement No.
+Added: 333-249657 on Form S-3 (the "2020 Mustang S-3"), which was declared effective on December 4, 2020.
Under the 2020 Mustang S-3, Mustang may sell up to a total of $ 100.0 million of its securities.
−Removed: December 31, 2019, no sales were made under Mustang’s 2019 S-3 and approximately $20.9 million of the 2018 Mustang S-3
−Removed: remains available for sale.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
+Added: As of December 31, 2020, approximately $ 85.7 million of the 2020 Mustang S-3 remains available for sales of securities.
+Added: On August 16, 2019, Mustang filed a shelf registration statement No.
+Added: 333-233350 on Form S-3 (the "2019 Mustang S-3"), which was declared effective on September 30, 2019.
+Added: Under the 2019 Mustang S-3, Mustang may sell up to a total of $ 75.0 million of its securities.
+Added: As of December 31, 2020, the 2019 S-3 is no longer available for sales of securities.
Commitments and Contingencies
−Removed: On October 3, 2014, the Company entered
−Removed: into a 15-year lease for office space at 2 Gansevoort Street, New York, NY 10014, at an average annual rent of $2.5 million.
−Removed: Company took possession of this space, which serves as its principal executive offices, in December 2015, and took occupancy
−Removed: in April 2016.
+Added: On October 3, 2014, the Company entered into a 15 -year lease for office space at 2 Gansevoort Street, New York, NY 10014, at an average annual rent of $ 2.5 million.
+Added: The Company took possession of this space, which serves as its principal executive offices, in December 2015, and took occupancy in April 2016.
Total rent expense, over the full term of the lease for this space will approximate $ 40.7 million.
−Removed: In conjunction
−Removed: with the lease, the Company entered into Desk Space Agreements with two related parties:
−Removed: OPPM and TGTX, to occupy 10% and 45%,
−Removed: respectively, of the office space that requires them to pay their share of the average annual rent of $0.3 million and $1.1 million,
−Removed: respectively.
+Added: In conjunction with the lease, the Company entered into Desk Space Agreements with two related parties:
+Added: OPPM and TGTX, to occupy 10 % and 45 %, respectively, of the office space that requires them to pay their share of the average annual rent of $ 0.3 million and $ 1.1 million, respectively.
The total net rent expense will approximate $ 16.0 million over the lease term.
−Removed: These initial rent allocations will
−Removed: be adjusted periodically for each party based upon actual percentage of the office space occupied.
−Removed: Additionally, the Company has
−Removed: reserved the right to execute desk space agreements with other third parties and those arrangements will also affect the cost of
−Removed: the lease actually borne by us.
−Removed: In October 2015, the Company entered
−Removed: into a 5-year lease for approximately 6,100 square feet of office space in Waltham, MA at an average annual rent of approximately
−Removed: $0.2 million.
+Added: These initial rent allocations will be adjusted periodically for each party based upon actual percentage of the office space occupied.
+Added: Additionally, the Company has reserved the right to execute desk space agreements with other third parties and those arrangements will also affect the cost of the lease actually borne by us.
+Added: In October 2015, the Company entered into a 5-year lease for approximately 6,100 square feet of office space in Waltham, MA at an average annual rent of approximately $ 0.2 million.
The Company took occupancy of this space in January 2016.
−Removed: In June 2017, Journey extended its
−Removed: lease for 2,295 square feet of office space in Scottsdale, AZ by one year, at an average annual rent of approximately $55,000.
+Added: In December 2020, we amended our lease and entered into a new two-year extension of the same office space in Waltham, MA at an average annual rent of $ 0.2 million.
+Added: The term of this amended lease commences on April 1, 2021 and will expire on March 31, 2023 .
+Added: In June 2017, Journey extended its lease for 2,295 square feet of office space in Scottsdale, AZ by one year , at an average annual rent of approximately $ 55,000 .
Journey originally took occupancy of this space in November 2014.
−Removed: In August 2018, Journey amended their lease and entered
−Removed: into a new two-year extension for 3,681 square feet of office space in the same location in Scottsdale, AZ at an annual rate of
−Removed: approximately $94,000.
+Added: In August 2018, Journey amended their lease and entered into a new two-year extension for 3,681 square feet of office space in the same location in Scottsdale, AZ at an annual rate of approximately $ 94,000 .
The term of this amended lease commenced on December 1, 2018 and will expire on November 30, 2020 .
−Removed: On October 27, 2017, Mustang entered
−Removed: into a lease agreement with WCS - 377 Plantation Street, Inc., a Massachusetts nonprofit corporation (“Landlord”).
−Removed: Pursuant to the terms of the lease agreement, Mustang agreed to lease 27,043 square feet from the Landlord, located at 377 Plantation
−Removed: Street in Worcester, MA (the “Facility”), through November 2026, subject to additional extensions at Mustang’s
+Added: In August 2020, Journey amended their lease and entered into a new 25-month extension of the same office space in Scottsdale, AZ at an average annual rent of $ 0.1 million.
+Added: The term of this amended lease commenced on December 1, 2020 and will expire on December 31, 2022 .
+Added: On October 27, 2017, Mustang entered into a lease agreement with WCS - 377 Plantation Street, Inc., a Massachusetts nonprofit corporation (“Landlord”).
+Added: Pursuant to the terms of the lease agreement, Mustang agreed to lease 27,043 square feet from the Landlord, located at 377 Plantation Street in Worcester, MA (the “Facility”), through November 2026, subject to additional extensions at Mustang’s option.
Base rent, net of abatements of $ 0.6 million over the lease term, totals approximately $ 3.6 million, on a triple-net basis.
−Removed: The terms of the lease also require that
−Removed: Mustang post an initial security deposit of $0.8 million, in the form of $0.5 million letter of credit and $0.3 million in cash,
−Removed: which increased to $1.3 million ($1.0 million letter of credit, $0.3 million in cash) on November 1, 2019.
−Removed: After the fifth
−Removed: lease year, the letter of credit obligation is subject to reduction.
−Removed: The Facility began operations for the production
−Removed: of personalized CAR T and gene therapies in 2018.
−Removed: The Company leases copiers under agreements
−Removed: classified as operating leases that expire on various dates through 2021.
−Removed: Most of the Company’s lease liabilities
−Removed: result from the lease of its New York City, NY office, which expires in 2031 and Mustang’s Worcester, MA cell processing
−Removed: facility lease, which expires in 2026.
−Removed: Such leases do not require any contingent rental payments, impose any financial restrictions,
−Removed: or contain any residual value guarantees.
−Removed: Certain of the Company’s leases include renewal options and escalation clauses;
−Removed: renewal options have not been included in the calculation of the lease liabilities and right of use assets as the Company is not
−Removed: reasonably certain to exercise the options.
−Removed: The Company does not act as a lessor or have any leases classified as financing
−Removed: At December 31, 2019, the Company had operating lease liabilities of $25.5 million and right of use assets of $21.5
−Removed: million, which were included in the consolidated balance sheet.
−Removed: During the year ended December 31,
−Removed: 2019, the Company recorded $3.2 million as lease expense to current period operations.
+Added: The terms of the lease also require that Mustang post an initial security deposit of $ 0.8 million, in the form of $ 0.5 million letter of credit and $ 0.3 million in cash, which increased to $ 1.3 million ($ 1.0 million letter of credit, $ 0.3 million in cash) on November 1, 2019.
+Added: After the fifth lease year, the letter of credit obligation is subject to reduction.
+Added: The Facility began operations for the production of personalized CAR T and gene therapies in 2018.
+Added: The Company leases copiers under agreements classified as operating leases that expire on various dates through 2024.
+Added: Most of the Company’s lease liabilities result from the lease of its New York City, NY office, which expires in 2031 and Mustang’s Worcester, MA cell processing facility lease, which expires in 2026 .
+Added: Such leases do not require any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees.
+Added: Certain of the Company’s leases include renewal options and escalation clauses;
+Added: renewal options have not been included in the calculation of the lease liabilities and right of use assets as the Company is not reasonably certain to exercise the options.
+Added: The Company does not act as a lessor or have any leases classified as financing leases.
+Added: At December 31, 2020, the Company had operating lease liabilities of $ 24.7 million and right of use assets of $ 20.5 million, which were included in the Consolidated Balance Sheet.
+Added: During the years ended December 31, 2020 and 2019, the Company recorded $ 3.2 million and $ 3.2 million, respectively, as lease expense to current period operations.
+Added: Year Ended December 31,
($ in thousands)
2 unchanged sentences
Variable lease cost
−Removed: Total lease cost
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The following tables summarize quantitative
−Removed: information about the Company’s operating leases, under the adoption of Topic 842 :
+Added: Total lease expense
+Added: The following tables summarize quantitative information about the Company’s operating leases, under the adoption of ASC Topic 842 , Leases :
+Added: Year Ended December 31,
($ in thousands)
Operating cash flows from operating leases
−Removed: Weighted-average remaining lease term –
−Removed: operating leases
−Removed: Weighted-average discount rate –
−Removed: operating leases
+Added: Right-of-use assets exchanged for new operating lease liabilities
+Added: Weighted-average remaining lease term – operating leases (years)
+Added: Weighted-average discount rate – operating leases
($ in thousands)
4 unchanged sentences
Year Ended December 31, 2025
+Added: Total operating lease liabilities
present value discount
−Removed: Operating lease liabilities
−Removed: The Company recognizes rent expense on
−Removed: a straight-line basis over the non-cancellable lease term.
−Removed: Rent expense for the years ended December 31, 2019 and 2018 was
−Removed: $2.1 million and $1.7 million, respectively.
+Added: Net operating lease liabilities, short-term and long-term
+Added: The Company recognizes rent expense on a straight-line basis over the non-cancellable lease term.
+Added: Rent expense for the years ended December 31, 2020 and 2019 was $ 2.0 million and $ 2.1 million, respectively.
Indemnification
−Removed: In accordance with its certificate of incorporation,
−Removed: bylaws and indemnification agreements, the Company has indemnification obligations to its officers and directors for certain events
−Removed: or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity.
−Removed: There have been
−Removed: no claims to date, and the Company has director and officer insurance to address such claims.
−Removed: Pursuant to agreements with clinical
−Removed: trial sites, the Company provides indemnification to such sites in certain conditions.
+Added: In accordance with its certificate of incorporation, bylaws and indemnification agreements, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity.
+Added: There have been no claims to date, and the Company has director and officer insurance to address such claims.
+Added: Pursuant to agreements with clinical trial sites, the Company provides indemnification to such sites in certain conditions.
Legal Proceedings
−Removed: Fortress Biotech, Inc.
−Removed: In the ordinary course of business, the
−Removed: Company and its subsidiaries may be subject to both insured and uninsured litigation.
−Removed: Suits and claims may be brought against the
−Removed: Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical
−Removed: trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc.,
−Removed: and seeking resulting alleged damages.
−Removed: Falk Pharma, GmbH v.
−Removed: Biotech, Inc.
−Removed: (Frankfurt am Main Regional Court, Ref.
−Removed: 3-06 0 28/16).
−Removed: Falk Pharma, GmbH (“Dr.
−Removed: Pharma”) and Fortress were among the parties to that certain Collaboration Agreement dated March 20, 2012, whereby they
−Removed: agreed to collaborate to develop a product for treatment of Crohn’s disease.
−Removed: A dispute arose between Dr.
−Removed: and Fortress with respect to their relative rights and obligations under the Collaboration Agreement;
−Removed: specifically, Dr.
−Removed: Pharma contended that it had fulfilled its contractual obligations to Fortress and is entitled to the final milestone payment due
−Removed: under the Collaboration Agreement - EUR 2.5 million.
−Removed: Fortress contended that no such payment is due because a condition of the
−Removed: EUR 2.5 million payment was the delivery of a Clinical Study Report that addressed the primary and secondary objectives of a Phase
−Removed: II trial, and Fortress contended that Dr.
−Removed: Falk Pharma failed to deliver such a Clinical Study Report.
−Removed: filed a lawsuit against Fortress in the above-referenced Court in Frankfurt, Germany to recover the EUR 2.5 million plus interest
−Removed: and attorneys’
−Removed: fees, and Fortress filed an answer to the complaint, denying that it had any liability to Dr.
−Removed: On July 27, 2017, Fortress received a judgment from the court in Frankfurt awarding the full amount (EUR 2.5 million) plus
−Removed: interest to Dr.
−Removed: Fortress appealed the decision to the Higher Regional Court of Frankfurt on August 28, 2017,
−Removed: and the initial response of Dr.
−Removed: Falk Pharma to the appeal was filed on February 16, 2018.
−Removed: At an appellate hearing in
−Removed: the Higher Regional Court on June 12, 2018, the court issued an oral ruling upholding the lower court’s judgment and
−Removed: indicating that an impending written, enforceable judgment would do the same.
−Removed: On July 12, 2018, the Higher Regional Court
−Removed: approved and recorded terms of settlement between Fortress and Dr.
−Removed: Falk Pharma pursuant to which Fortress paid $3.3 million
−Removed: Falk Pharma during the calendar year of 2018, and approximately $39,500 to the court in mandated administrative fees.
−Removed: The final $300,000 was paid during calendar year 2019.
−Removed: No remaining liability exists at December 31, 2019.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
+Added: In the ordinary course of business, the Company and its subsidiaries may be subject to both insured and uninsured litigation.
+Added: Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages.
+Added: In November 2020, a purported securities class action complaint was filed in the U.S.
+Added: District Court for the Eastern District of New York, putatively on behalf of all shareholders who purchased or otherwise acquired Fortress securities between December 11, 2019 and October 9, 2020 (the “Class Period”), and who were allegedly damaged in connection therewith.
+Added: The case is captioned Cushman v.
+Added: Fortress Biotech, Inc., et al.
+Added: 1:20-cv-05767, and names as defendants the Company and two of our officers.
+Added: The complaint alleges that, throughout the Class Period, the Company made false and/or misleading statements and/or failed to disclose various facts and circumstances with respect to a New Drug Application filed by Avenue Therapeutics, Inc., our partner company, regarding IV Tramadol, Avenue’s lead product candidate.
+Added: The complaint alleges violations of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, and seeks damages as well as attorneys’ fees, expert fees and other costs.
+Added: The action is in the early stages of litigation, and the Company intends to vigorously contest the claims.
Employee Benefit Plan
−Removed: On January 1, 2008, the Company adopted
−Removed: a defined contribution 401(k) plan which allows employees to contribute up to a percentage of their compensation, subject
−Removed: to IRS limitations and provides for a discretionary Company match up to a maximum of 4% of employee compensation.
−Removed: For the years
−Removed: ended December 31, 2019 and 2018, the Company paid a matching contribution of $0.4 million and $0.2 million, respectively.
+Added: On January 1, 2008, the Company adopted a defined contribution 401(k) plan which allows employees to contribute up to a percentage of their compensation, subject to IRS limitations and provides for a discretionary Company match up to a maximum of 4 % of employee compensation.
+Added: For the years ended December 31, 2020 and 2019, the Company paid a matching contribution of $ 0.5 million and $ 0.4 million, respectively.
Related Party Transactions
−Removed: The Company’s Chairman, President
−Removed: and Chief Executive Officer, individually and through certain trusts over which he has voting and dispositive control, beneficially
−Removed: owned approximately 11.6% and 13.1% of the Company’s issued and outstanding Common Stock as of December 31, 2019 and
−Removed: 2018, respectively.
−Removed: The Company’s Executive Vice Chairman, Strategic Development individually owns approximately 12.7% and
−Removed: 15.2% of the Company’s issued and outstanding Common Stock at December 31, 2019 and 2018, respectively.
−Removed: For the years ended December 31, 2019
−Removed: and 2018, the Company’s CEO and Executive Vice Chairman received nil and $500,000 each, respectively.
−Removed: For their service in
−Removed: 2017, the Company’s CEO and Executive Vice Chairman received bonuses of $500,000 each, paid in cash during the quarter ended
−Removed: June 30, 2018.
−Removed: The bonus recipients waived their right to a cash bonus from the Company.
−Removed: The Company treated this transaction
−Removed: as a capital contribution, which is reflected on the Consolidated Statement of Changes in Stockholders’
−Removed: Equity for the year
−Removed: ended December 31, 2018.
+Added: The Company’s Chairman, President and Chief Executive Officer, individually and through certain trusts over which he has voting and dispositive control, beneficially owned approximately 9.9 % and 11.6 % of the Company’s issued and outstanding Common Stock as of December 31, 2020 and 2019, respectively.
+Added: The Company’s Executive Vice Chairman, Strategic Development individually owns approximately 10.8 % and 12.7 % of the Company’s issued and outstanding Common Stock at December 31, 2020 and 2019, respectively.
Shared Services Agreement with TGTX
−Removed: In July 2015, TGTX and the Company
−Removed: entered into an arrangement to share the cost of certain research and development employees.
−Removed: The Company’s Executive Vice
−Removed: Chairman, Strategic Development, is Executive Chairman and Interim Chief Executive Officer of TGTX.
−Removed: Under the terms of the Agreement,
−Removed: TGTX will reimburse the Company for the salary and benefit costs associated with these employees based upon actual hours worked
−Removed: on TGTX related projects.
−Removed: In connection with the shared services agreement, the Company invoiced TGTX $0.5 million and $1.3 million,
−Removed: and received payments of $0.5 million and $1.3 million for the years ended December 31, 2019 and 2018, respectively.
−Removed: Desk Share Agreements with TGTX and
−Removed: In September 2014, the Company entered
−Removed: into Desk Share Agreements with TGTX and Opus Point Partners Management, LLC (“OPPM”) to occupy 40% and 20% of the
−Removed: New York, NY office space that requires TGTX and OPPM to pay their share of the average annual rent.
−Removed: These initial rent allocations
−Removed: will be adjusted periodically for each party based upon actual percentage of the office space occupied.
−Removed: Additionally, the Company
−Removed: has reserved the right to execute desk share agreements with other third parties and those arrangements will also affect the cost
−Removed: of the lease actually borne by the Company.
+Added: In July 2015, TGTX and the Company entered into an arrangement to share the cost of certain research and development employees.
+Added: The Company’s Executive Vice Chairman, Strategic Development, is Executive Chairman and Interim Chief Executive Officer of TGTX.
+Added: Under the terms of the Agreement, TGTX will reimburse the Company for the salary and benefit costs associated with these employees based upon actual hours worked on TGTX related projects.
+Added: In connection with the shared services agreement, the Company invoiced TGTX $ 0.6 million and $ 0.5 million, and received payments of $ 0.5 million and $ 0.5 million for the years ended December 31, 2020 and 2019, respectively.
+Added: Desk Share Agreements with TGTX and OPPM
+Added: In September 2014, the Company entered into Desk Share Agreements with TGTX and Opus Point Partners Management, LLC (“OPPM”) to occupy 40 % and 20 % of the New York, NY office space that requires TGTX and OPPM to pay their share of the average annual rent.
+Added: These initial rent allocations will be adjusted periodically for each party based upon actual percentage of the office space occupied.
+Added: Additionally, the Company has reserved the right to execute desk share agreements with other third parties and those arrangements will also affect the cost of the lease actually borne by the Company.
Each initial Desk Share Agreement has a term of five years .
−Removed: The Company took possession
−Removed: of the New York, NY office space in December 2015, commenced build out of the space shortly thereafter and took occupancy
−Removed: of the space in April 2016.
−Removed: The Desk Share Agreement was amended in May 2016, adjusting the initial rent allocations
−Removed: to 45% for TGTX and 10% for OPPM.
−Removed: In connection with the Company’s
−Removed: Desk Space Agreements for the New York, NY office space, for the year ended December 31, 2019 and 2018, the Company had paid
−Removed: $2.6 million and $2.7 million in rent, respectively, and invoiced TGTX and OPPM approximately $1.3 million and $1.0 million and
−Removed: $180,000 and $217,000, respectively, for their prorated share of the rent base.
−Removed: At December 31, 2019, the amount due related
−Removed: to this arrangement from TGTX and OPPM approximated $114,000 and $400,000, respectively.
−Removed: As of July 1, 2018, TGTX employees
−Removed: began to occupy desks in the Waltham, MA office under the Desk Share Agreement.
−Removed: TGTX began to pay their share of the rent based
−Removed: on actual percentage of the office space occupied on a month by month basis.
−Removed: For the years ended December 31, 2019 and 2018,
−Removed: the Company had paid approximately $240,000 and $223,000 in rent for the Waltham, MA office, and invoiced TGTX approximately $109,000
−Removed: and $47,000, respectively.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: As of December 31, 2019, the Company
−Removed: had paid a total of $2.8 million in rent under the Desk Share Agreements for both the New York, NY office and the Waltham, MA office
−Removed: combined, and invoiced TGTX and OPPM approximately $1.4 million and $180,000, respectively, for their prorated shares of the rents.
−Removed: Checkpoint Collaborative Agreements
−Removed: Checkpoint has entered into various agreements
−Removed: with TGTX to develop and commercialize certain assets in connection with its licenses, including a collaboration agreement for
−Removed: some of the Dana Farber licensed antibodies, a sponsored research agreement for compounds licensed from NeuPharma, and a sublicense
−Removed: agreement for the Jubilant family of patents.
−Removed: Checkpoint believes that by partnering with TGTX to develop these compounds in therapeutic
−Removed: areas outside of its business focus, it may substantially offset its preclinical costs and milestone costs related to the development
−Removed: and marketing of these compounds in solid tumor indications.
−Removed: Opus Credit Facility
−Removed: On September 14, 2016, the Company
−Removed: and Opus Point Health Innovations Fund (“OPHIF”) entered into a Credit Facility Agreement (the “Opus Credit Facility”).
−Removed: Fortress’s Chairman, President and Chief Executive Officer (Lindsay A.
−Removed: Rosenwald) and Fortress’s Executive Vice President,
−Removed: Strategic Development (Michael Weiss), are Co-Portfolio Managers and Partners of OPPM, an affiliate of OPHIF.
−Removed: As such, all of the
−Removed: disinterested directors of Fortress’s board of directors approved the terms of the Opus Credit Facility and related agreements.
−Removed: On March 12, 2018, the Company and
−Removed: OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”).
−Removed: The A&R Opus Credit Facility
−Removed: extends the maturity date of the notes issued under the Opus Credit Facility from September 14, 2018 by one year to September 14,
−Removed: The A&R Opus Credit Facility also permits the Company to make portions of interest and principal repayments in the form
−Removed: of shares of the Company’s common stock and/or in common stock of the Company’s publicly traded subsidiaries, subject
−Removed: to certain conditions.
−Removed: On September 13, 2019, the Company and OPHIF extended the maturity dates of the notes from September 14,
−Removed: 2019 by two years to September 14, 2021.
−Removed: Fortress retains the ability to prepay the Notes at any time without penalty.
−Removed: notes payable under the A&R Opus Credit Facility continue to bear interest at 12% per annum.
−Removed: July 18, 2019, the Company prepaid $500,000 of debt owed under the A&R Opus Credit Facility by issuing 396,825 shares
−Removed: of Fortress common stock at $1.26 per share (the closing price on July 18, 2019) to Dr.
−Removed: The notes payable under the A&R Opus
−Removed: Credit Facility continue to bear interest at 12% per annum.
−Removed: For the years ended December 31, 2019 and 2018, the Company paid
−Removed: cash for interest expense of $0.5 million and $0.3 million, respectively (see Note 10).
−Removed: Checkpoint Public Offering of Common
−Removed: NSC, a subsidiary of National (of which
−Removed: the Company owned 32.1% as of December 31, 2018), served as an underwriter in connection with Checkpoint’s 2018 equity
−Removed: offering, which closed on March 12, 2018.
−Removed: As the underwriter, NSC received a fee of approximately $1.8 million, or 8% on the
−Removed: gross proceeds raised of $23.0 million.
+Added: The Company took possession of the New York, NY office space in December 2015, commenced build out of the space shortly thereafter and took occupancy of the space in April 2016.
+Added: The Desk Share Agreement was amended in May 2016, adjusting the initial allocations to 45 % for TGTX and 10 % for OPPM.
+Added: The Desk Share Agreement was amended again in 2020, adjusting the rent allocations to 65 % for TGTX and 0 % for OPPM.
+Added: In connection with the Company’s Desk Space Agreements for the New York, NY office space, for the years ended December 31, 2020 and 2019, the Company had paid $ 2.6 million and $ 2.6 million in rent, respectively, and invoiced TGTX and OPPM approximately $ 1.6 million and $ 1.3 million and nil and $ 0.2 million respectively, for their prorated share of the rent base.
+Added: At December 31, 2020, the amount due related to this arrangement from TGTX and OPPM approximated nil and $ 0.4 million, respectively.
+Added: As of July 1, 2018, TGTX employees began to occupy desks in the Waltham, MA office under the Desk Share Agreement.
+Added: TGTX began to pay their share of the rent based on actual percentage of the office space occupied on a month by month basis.
+Added: For the years ended December 31, 2020 and 2019, the Company had paid approximately $ 0.3 million and $ 0.2 million in rent for the Waltham, MA office, and invoiced TGTX approximately $ 0.1 million and $ 0.1 million, respectively.
+Added: As of December 31, 2020 and 2019, the Company had paid a total of $ 2.9 million and $ 2.8 million, respectively, in rent under the Desk Share Agreements for both the New York, NY office and the Waltham, MA office combined, and invoiced TGTX approximately $ 1.7 million and $ 1.4 million, respectively, for their prorated share of the rents.
+Added: Checkpoint Collaborative Agreements with TGTX
+Added: Checkpoint has entered into various agreements with TGTX to develop and commercialize certain assets in connection with its licenses, including a collaboration agreement for some of the Dana Farber licensed antibodies, and a sublicense agreement for the Jubilant family of patents.
+Added: Checkpoint believes that by partnering with TGTX to develop these compounds in therapeutic areas outside of its business focus, it may substantially offset its preclinical costs and milestone costs related to the development and marketing of these compounds in solid tumor indications.
+Added: 2019 Notes (formerly the Opus Credit Facility)
+Added: On September 14, 2016, the Company and Opus Point Health Innovations Fund (“OPHIF”) entered into a Credit Facility Agreement (the “Opus Credit Facility”).
+Added: Fortress’s Chairman, President and Chief Executive Officer (Lindsay A.
+Added: Rosenwald) and Fortress’s Executive Vice President, Strategic Development (Michael Weiss), are Co-Portfolio Managers and Partners of OPPM, an affiliate of OPHIF.
+Added: As such, all of the disinterested directors of Fortress’s board of directors approved the terms of the Opus Credit Facility and related agreements.
+Added: On March 12, 2018, the Company and OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”).
+Added: The A&R Opus Credit Facility extended the maturity date of the notes issued under the Opus Credit Facility from September 14, 2018 by one year to September 14, 2019 .
+Added: On September 13, 2019, the Company and OPHIF extended the maturity dates of the notes from September 14, 2019 by two years to September 14, 2021 .
+Added: Fortress retained the ability to prepay the Notes at any time without penalty.
+Added: The notes payable under the A&R Opus Credit Facility bear interest at 12 % per annum.
+Added: Effective December 31, 2019, OPHIF dissolved and distributed it assets among its limited partners.
+Added: Following the distribution, the $ 9.0 million facility comprised of separate notes (collectively, the “2019 Notes”) held by DAK Capital Inc.
+Added: ($ 3.8 million);
+Added: Fortress’ Chairman, President and Chief Executive Officer Lindsay A.
+Added: Rosenwald, M.D.
+Added: ($ 0.3 million);
+Added: Fortress's Executive Vice President, Strategic Development Michael S.
+Added: Weiss ($ 2.0 million);
+Added: and various entities and individuals affiliated with Dr.
+Added: Rosenwald and Mr.
+Added: Weiss ($ 2.9 million).
+Added: The terms of the 2019 Notes did not change in connection with such reallocations.
+Added: During the year ended December 31, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $ 9.0 million balance previously outstanding under the 2019 Notes.
+Added: For the year ended December 31, 2020, in connection with the 2019 Notes pay off, the Company paid $ 0.5 million in interest on the portion of the 2019 Notes held by the Company's Chairman, President and Chief Executive Officer and the Company's Executive Vice President, Strategic Development.
2018 Venture Notes
−Removed: For the year ended December 31, 2018,
−Removed: the Company raised approximately $21.7 million in promissory notes.
−Removed: National Securities Corporation (“NSC”), a wholly
−Removed: owned subsidiary of National, and a related party as a result of the Company’s ownership of National, acted as the sole placement
−Removed: agent for the 2018 Venture Notes.
−Removed: The Company paid NSC a fee of $1.7 million during the year ended December 31, 2018, in connection
−Removed: with the 2018 Venture Notes.
−Removed: At December 31, 2018, the fee, which was recorded as debt discount on the Company’s Consolidated
−Removed: Balance Sheet and will be amortized over the life of the 2018 Venture Notes.
−Removed: In November 2018, the Company announced that
−Removed: it had an agreement to sell its majority holding in National, the sale was completed in February of 2019, see Note 3.
+Added: For the year ended December 31, 2018, the Company raised approximately $ 21.7 million in promissory notes.
+Added: National Securities Corporation (“NSC”), a wholly owned subsidiary of National, and a related party as a result of the Company’s ownership of National, acted as the sole placement agent for the 2018 Venture Notes.
+Added: In November 2018, the Company announced that it had an agreement to sell its majority holding in National, the sale was completed in February of 2019, see Note 3.
+Added: During the year ended December 31, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $ 21.7 million balance previously outstanding under the 2018 Venture Notes.
2017 Subordinated Note Financing
−Removed: On March 17, 2017, the Company and
−Removed: NSC, a subsidiary of National, (entered into placement agency agreements with NAM Biotech Fund and NAM Special Situation Fund in
−Removed: connection with the sale of subordinated promissory notes (see Note 10).
−Removed: Pursuant to the terms of the agreements, NSC received
−Removed: a placement agent fee in cash of 10% of the debt raised and warrants equal to 10% of the aggregate principal amount of debt raised
−Removed: divided by the closing share price of the Company’s common stock on the date of closing.
−Removed: For the year ended December 31, 2017,
−Removed: NSC earned a placement agent fee of $2.8 million and a Placement Agent Warrant to purchase 716,180 shares of the Company’s
−Removed: common stock, all of which are outstanding, with exercise prices ranging from $3.61 to $4.75.
−Removed: In November 2018, the Company
−Removed: announced that it had an agreement to sell its majority holding in National, of which NSC is a wholly owned subsidiary, the sale
−Removed: was completed in February of 2019, see Note 3.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: Caelum Convertible Notes
−Removed: On July 31, 2017 Caelum, through NSC,
−Removed: a subsidiary of National, offered up to $10 million, convertible promissory notes to accredited investors (as defined under the
−Removed: Federal securities laws).
−Removed: Caelum raised $9.9 million in the offering, in three separate closings and paid a placement fee
−Removed: equal to NSC of 10% of the proceeds of the sale or $1.0 million.
−Removed: Additionally NSC received warrants to purchase a number of shares
−Removed: the Caelum’s Common Stock equal to 10% of the aggregate amount of shares underlying the Notes with a per share exercise price
−Removed: equal to 110% of the per share conversion price of the Notes;
−Removed: provided, however, that if no Note converts, the exercise price will
−Removed: be $75 million dollars divided by the total number of fully-diluted shares of Common Stock outstanding immediately prior to exercise
−Removed: of the warrant, giving effect to the assumed conversion of all options, warrants, and convertible securities of the Company (see
−Removed: In January 2019, as a result of the Caelum strategic financing these notes were converted pursuant to the terms
−Removed: of the note agreement.
−Removed: In November 2018, the Company announced
−Removed: that it had an agreement to sell its majority holding in National, of which NSC is a wholly owned subsidiary, the sale was completed
−Removed: in February of 2019, see Note 3.
−Removed: On June 26, 2017, Avenue completed
−Removed: an IPO in which NSC acted as co-manager and earned fees and commissions of approximately $2.3 million that were deducted from the
−Removed: In November 2018, the Company announced that it had an agreement to sell its majority holding in National, of which
−Removed: NSC is a wholly owned subsidiary, the sale was completed in February of 2019, see Note 3.
−Removed: Founders Agreement and Management Services
−Removed: The Company has entered into Founders Agreements
−Removed: with each of the Fortress subsidiaries listed in the table below.
−Removed: Pursuant to each Founders Agreement, in exchange for the time
−Removed: and capital expended in the formation of each partner company and the identification of specific assets the acquisition of which
−Removed: result in the formation of a viable emerging growth life science company, the Company will loan each such partner company an amount
−Removed: representing the up-front fee required to acquire assets.
−Removed: Each Founders Agreement has a term of 15 years, which upon expiration
−Removed: automatically renews for successive one-year periods unless terminated by the Company or a Change in Control (as defined in the
−Removed: Founders Agreement) occurs.
−Removed: In connection with each Founders Agreement the Company receives 250,000 Class A Preferred shares
−Removed: (except for that with Checkpoint, in which the Company holds Class A Common Stock).
−Removed: The Class A Preferred Stock (Class A
−Removed: Common Stock with respect to Checkpoint) is identical to common stock other than as to voting rights, conversion rights and the
−Removed: PIK Dividend right (as described below).
−Removed: Each share of Class A Preferred Stock (Class A Common Stock with respect to
−Removed: Checkpoint) is entitled to vote the number of votes that is equal to one and one-tenth (1.1) times a fraction, the numerator of
−Removed: which is the sum of (A) the shares of outstanding common stock and (B) the whole shares of common stock into which the
−Removed: shares of outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) are convertible and the
−Removed: denominator of which is the number of shares of outstanding Class A Preferred Stock (Class A Common Stock with respect
−Removed: to Checkpoint).
−Removed: Thus, the Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) will at all times
−Removed: constitute a voting majority.
−Removed: Each share of Class A Preferred Stock (Class A Common Stock with respect to Checkpoint)
−Removed: is convertible, at the holder’s option, into one fully paid and nonassessable share of common stock of such partner company,
−Removed: subject to certain adjustments.
−Removed: The holders of Class A Preferred Stock (and the Class A Common Stock with respect to
−Removed: Checkpoint), as a class, are entitled receive on each effective date or “Trigger Date”
−Removed: (defined as the date that the
−Removed: Company first acquired, whether by license or otherwise, ownership rights to a product) of each agreement (each a “PIK Dividend
−Removed: Payment Date”) until the date all outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint)
−Removed: is converted into common stock or redeemed (and the purchase price is paid in full), pro rata per share dividends paid in additional
−Removed: fully paid and nonassessable shares of common stock (“PIK Dividends”) such that the aggregate number of shares of common
−Removed: stock issued pursuant to such PIK Dividend is equal to two and one-half percent (2.5%) of such partner company’s fully-diluted
−Removed: outstanding capitalization on the date that is one (1) business day prior to any PIK Dividend Payment Date.
−Removed: The Company has
−Removed: reached agreements with several of the partner companies to change the PIK Dividend Interest Payment Date to January 1 of
−Removed: each year - a change that has not and will not result in the issuance of any additional partner company common stock beyond that
−Removed: amount to which the Company would otherwise be entitled absent such change(s).
−Removed: The Company owns 100% of the Class A Preferred
−Removed: Stock (Class A Common Stock with respect to Checkpoint) of each partner company that has a Founders Agreement with the Company.
−Removed: As additional consideration under the Founders
−Removed: Agreement, each partner company with which the Company has entered into a Founders Agreement will also:
−Removed: (i) pay an equity
−Removed: fee in shares of the common stock of such partner company, payable within five (5) business days of the closing of any equity
−Removed: or debt financing for each partner company or any of its respective subsidiaries that occurs after the effective date of the Founders
−Removed: Agreement and ending on the date when the Company no longer has majority voting control in such partner company’s voting
−Removed: equity, equal to two and one-half (2.5%) of the gross amount of any such equity or debt financing;
−Removed: and (ii) pay a cash fee
−Removed: equal to four and one-half percent (4.5%) of such partner company’s annual net sales, payable on an annual basis, within
−Removed: ninety (90) days of the end of each calendar year.
−Removed: In the event of a Change in Control, each such partner company will pay a one-time
−Removed: change in control fee equal to five (5x) times the product of (A) net sales for the twelve (12) months immediately preceding
−Removed: the change in control and (B) four and one-half percent (4.5%).
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The following table summarizes, by subsidiary,
−Removed: the effective date of the Founders Agreements and PIK dividend or equity fee payable to the Company in accordance with the terms
−Removed: of the Founders Agreements, Exchange Agreements and the subsidiaries’
−Removed: certificates of incorporation.
−Removed: Partner company
−Removed: Effective Date 1
+Added: On March 17, 2017, the Company and NSC entered into placement agency agreements with NAM Biotech Fund and NAM Special Situation Fund in connection with the sale of subordinated promissory notes (see Note 10).
+Added: Pursuant to the terms of the agreements, NSC received a placement agent fee in cash of 10 % of the debt raised and warrants equal to 10 % of the aggregate principal amount of debt raised divided by the closing share price of the Company’s common stock on the date of closing.
+Added: For the year ended December 31, 2017, NSC earned a placement agent fee of $ 2.8 million and a Placement Agent Warrant to purchase 716,180 shares of the Company’s common stock, all of which are outstanding, with exercise prices ranging from $ 3.61 to $ 4.75 .
+Added: During the year ended December 31, 2020, the Company used certain proceeds from the Oaktree Note to pay off the $ 28.4 million balance previously outstanding under the 2017 Subordinated Note Financing.
+Added: Avenue Credit Facility Agreement
+Added: On June 12, 2020, Avenue, the Company and InvaGen entered into a Facility Agreement (“Avenue Facility Agreement”), under which, beginning on October 1, 2020, Avenue may borrow up to $ 2.0 million collectively from the Company and InvaGen, subject to certain conditions set forth therein.
+Added: The Company’s commitment amount is $ 0.8 million, and InvaGen’s is $ 1.2 million, and a 7 % per annum interest rate applies (payable on the last day of each fiscal quarter).
+Added: Repayment of the loan is due upon the earliest to occur of:
+Added: (i) the Second Stage Closing Date, as defined in the Avenue SPMA;
+Added: (ii) April 29, 2021;
+Added: and (iii) the date that is 30 days following the termination of the Avenue SPMA.
+Added: As of December 31, 2020, there have been no amounts drawn by Avenue on the Avenue Facility Agreement.
+Added: Founders Agreement and Management Services Agreement
+Added: The Company has entered into Founders Agreements with each of the Fortress partner companies listed in the table below.
+Added: Pursuant to each Founders Agreement, in exchange for the time and capital expended in the formation of each partner company and the identification of specific assets the acquisition of which result in the formation of a viable emerging growth life science company, the Company will loan each such partner company an amount representing the up-front fee required to acquire assets.
+Added: Each Founders Agreement has a term of 15 years , which upon expiration automatically renews for successive one-year periods unless terminated by the Company or a Change in Control (as defined in the Founders Agreement) occurs.
+Added: In connection with each Founders Agreement the Company receives 250,000 Class A Preferred shares (except for that with Checkpoint, in which the Company holds Class A Common Stock).
+Added: The Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is identical to common stock other than as to voting rights, conversion rights and the PIK Dividend right (as described below).
+Added: Each share of Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is entitled to vote the number of votes that is equal to one and one-tenth (1.1) times a fraction, the numerator of which is the sum of (A) the shares of outstanding common stock and (B) the whole shares of common stock into which the shares of outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) are convertible and the denominator of which is the number of shares of outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint).
+Added: Thus, the Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) will at all times constitute a voting majority.
+Added: Each share of Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is convertible, at the holder’s option, into one fully paid and nonassessable share of common stock of such partner company, subject to certain adjustments.
+Added: The holders of Class A Preferred Stock (and the Class A Common Stock with respect to Checkpoint), as a class, are entitled receive on each effective date or “Trigger Date” (defined as the date that the Company first acquired, whether by license or otherwise, ownership rights to a product) of each agreement (each a “PIK Dividend Payment Date”) until the date all outstanding Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) is converted into common stock or redeemed (and the purchase price is paid in full), pro rata per share dividends paid in additional fully paid and nonassessable shares of common stock (“PIK Dividends”) such that the aggregate number of shares of common stock issued pursuant to such PIK Dividend is equal to two and one-half percent ( 2.5 %) of such partner company’s fully-diluted outstanding capitalization on the date that is one (1) business day prior to any PIK Dividend Payment Date.
+Added: The Company has reached agreements with several of the partner companies to change the PIK Dividend Interest Payment Date to January 1 of each year - a change that has not and will not result in the issuance of any additional partner company common stock beyond that amount to which the Company would otherwise be entitled absent such change(s).
+Added: The Company owns 100 % of the Class A Preferred Stock (Class A Common Stock with respect to Checkpoint) of each partner company that has a Founders Agreement with the Company.
+Added: As additional consideration under the Founders Agreement, each partner company with which the Company has entered into a Founders Agreement will also:
+Added: (i) pay an equity fee in shares of the common stock of such partner company, payable within five (5) business days of the closing of any equity or debt financing for each partner company or any of its respective subsidiaries that occurs after the effective date of the Founders Agreement and ending on the date when the Company no longer has majority voting control in such partner company’s voting equity, equal to two and one-half ( 2.5 %) of the gross amount of any such equity or debt financing;
+Added: and (ii) pay a cash fee equal to four and one-half percent ( 4.5 %) of such partner company’s annual net sales, payable on an annual basis, within ninety (90) days of the end of each calendar year.
+Added: In the event of a Change in Control, each such partner company will pay a one-time change in control fee equal to five (5x) times the product of (A) net sales for the twelve (12) months immediately preceding the change in control and (B) four and one-half percent ( 4.5 %).
+Added: The following table summarizes, by subsidiary, the effective date of the Founders Agreements and PIK dividend or equity fee payable to the Company in accordance with the terms of the Founders Agreements, Exchange Agreements and the partner companies’ certificates of incorporation.
PIK Dividend as
−Removed: capitalization
Class of Stock
+Added: Fortress Partner Company
+Added: Effective Date 1
+Added: capitalization
March 20, 2015
3 unchanged sentences
October 31, 2016
+Added: January 1, 2017
December 17, 2019 5
1 unchanged sentence
July 28, 2017
−Removed: November 30, 2017 3
−Removed: Represents the effective date of each subsidiary’s Founders Agreement.
−Removed: Instead of a PIK dividend, Checkpoint pays the Company an annual equity fee in shares of Checkpoint’s common stock equal to 2.5% of Checkpoint’s fully diluted outstanding capitalization, pursuant to its Founders Agreement.
−Removed: Represents the Trigger Date.
+Added: April 22, 2020 5
+Added: Represents the effective date of each subsidiary’s Founders Agreement.
+Added: Each PIK dividend and equity fee is payable on the annual anniversary of the effective date of the original Founders Agreement or has since been amended to January 1 of each calendar year.
Pursuant to the terms of the agreement between Avenue and InvaGen Pharmaceuticals, Inc.
−Removed: during the term of the SPMA PIK dividends will not be paid or accrued.
−Removed: The following table summarizes, by subsidiary,
−Removed: the PIK dividend or equity fee recorded by the Company in accordance with the terms of the Founders Agreements, Exchange Agreements
−Removed: and the subsidiaries’
−Removed: certificates of incorporation for the years ended December 31, 2019 and 2018 ($ in thousands):
+Added: during the term of the Avenue SPMA PIK dividends will not be paid or accrued.
+Added: Instead of a PIK dividend, Checkpoint pays the Company an annual equity fee in shares of Checkpoint’s common stock equal to 2.5 % of Checkpoint’s fully diluted outstanding capitalization.
+Added: Effective January 31, 2019 the Caelum Founders Agreement and MSA with Fortress were terminated in conjunction with the execution of the DOSPA between Caelum and Alexion (See Note 4).
+Added: Represents the Trigger Date, the date that the Fortress partner company first acquires, whether by license or otherwise, ownership rights in a product.
+Added: The following table summarizes, by subsidiary, the PIK dividend or equity fee recorded by the Company in accordance with the terms of the Founders Agreements, Exchange Agreements and the partner companies’ certificates of incorporation for the years ended December 31, 2020 and 2019 ($ in thousands):
Partner company
3 unchanged sentences
Pursuant to the terms of the Amended and Restated Mutual Conditional Termination Agreement between Fortress and Caelum, the Founders Agreement dated January 1, 2017 was terminated upon signing of the DOSPA with Alexion on January 30, 2019.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
Management Services Agreements
−Removed: The Company has entered into Management
−Removed: Services Agreements (the “MSAs”) with certain of its partner companies.
−Removed: Pursuant to each MSA, the Company’s management
−Removed: and personnel provide advisory, consulting and strategic services to each partner company that has entered into an MSA with Fortress
−Removed: for a period of five (5) years.
−Removed: Such services may include, without limitation, (i) advice and assistance concerning any
−Removed: and all aspects of each such partner company’s operations, clinical trials, financial planning and strategic transactions
−Removed: and financings and (ii) conducting relations on behalf of each such partner company with accountants, attorneys, financial
−Removed: advisors and other professionals (collectively, the “Services”).
−Removed: Each such partner company is obligated to utilize
−Removed: clinical research services, medical education, communication and marketing services and investor relations/public relation services
−Removed: of companies or individuals designated by Fortress, provided those services are offered at market prices.
−Removed: However, such partner
−Removed: companies are not obligated to take or act upon any advice rendered from Fortress, and the Company shall not be liable to any such
−Removed: partner company for its actions or inactions based upon the Company’s advice.
−Removed: The Company and its affiliates, including all
−Removed: members of Fortress’
−Removed: Board of Directors, have been contractually exempted from fiduciary duties to each such partner company
−Removed: relating to corporate opportunities.
−Removed: The following table summarizes, by partner
−Removed: company, the effective date of the MSA and the annual consulting fee payable by the subsidiary to the Company in quarterly installments
−Removed: ($ in thousands):
−Removed: Fortress partner
+Added: The Company has entered into Management Services Agreements (the “MSAs”) with certain of its partner companies.
+Added: Pursuant to each MSA, the Company’s management and personnel provide advisory, consulting and strategic services to each partner company that has entered into an MSA with Fortress for a period of five (5) years.
+Added: Such services may include, without limitation, (i) advice and assistance concerning any and all aspects of each such partner company’s operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of each such partner company with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”).
+Added: Each such partner company is obligated to utilize clinical research services, medical education, communication and marketing services and investor relations/public relation services of companies or individuals designated by Fortress, provided those services are offered at market prices.
+Added: However, such partner companies are not obligated to take or act upon any advice rendered from Fortress, and the Company shall not be liable to any such partner company for its actions or inactions based upon the Company’s advice.
+Added: The Company and its affiliates, including all members of Fortress’ Board of Directors, have been contractually exempted from fiduciary duties to each such partner company relating to corporate opportunities.
+Added: The following table summarizes, by partner company, the effective date of the MSA and the annual consulting fee payable by the subsidiary to the Company in quarterly installments ($ in thousands):
+Added: Year Ended December 31,
+Added: Fortress partner company
Effective Date
−Removed: (Income)/Expense
March 20, 2015
7 unchanged sentences
November 30, 2017
+Added: Oncogenuity 3
+Added: February 10, 2017
+Added: Fortress - MSA Income
Consolidated (Income)/Expense
Pursuant to the terms of the agreement between Avenue and InvaGen Pharmaceuticals, Inc.
−Removed: during the term of the SPMA fees under the MSA will not be due or accrued.
+Added: during the term of the Avenue SPMA fees under the MSA will not be due or accrued.
+Added: In December 2019, Tamid discontinued development and terminated its’ licenses and clinical trial agreements with UNC.
+Added: Oncogenuity license was purchased in the year ended December 31, 2020.
Fees and Stock Grants Received by Fortress
−Removed: Fees recorded in connection with the Company’s
−Removed: agreements with its subsidiaries are eliminated in consolidation.
−Removed: These include management services fees, issuance of common shares
−Removed: of partner companies in connection with third party raises and annual stock dividend or issuances on the anniversary date of respective
−Removed: Founders Agreements.
−Removed: Deferred income taxes reflect the net tax
−Removed: effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes
−Removed: and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
−Removed: The components of the income tax provision
−Removed: (benefit) are as follows:
−Removed: For the years ended December 31,
+Added: Fees recorded in connection with the Company’s agreements with its subsidiaries are eliminated in consolidation.
+Added: These include management services fees, issuance of common shares of partner companies in connection with third party raises and annual stock dividend or issuances on the anniversary date of respective Founders Agreements.
+Added: Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
+Added: The components of the income tax provision (benefit) are as follows:
+Added: For the Year Ended December 31,
($ in thousands)
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: The Company has incurred net operating
−Removed: losses since inception.
−Removed: The Company has not reflected any benefit of such net operating loss carryforwards (“NOL”)
−Removed: in the accompanying consolidated financial statements and has established a valuation allowance of $168.2 million against its net
−Removed: deferred tax assets.
−Removed: Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts
−Removed: of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating
−Removed: losses and tax credit carryforwards.
−Removed: The significant components of the Company’s
−Removed: deferred taxes consist of the following:
+Added: For the years ended December 31, 2020 and 2019, income tax expense was $ 0.1 million and nil , respectively, resulting in an effective income tax rate of 0.13 % and 0 %.
+Added: The increase in income tax expense in 2020 is due to additional state tax return filings.
+Added: The Company has incurred net operating losses since inception.
+Added: The Company has not reflected any benefit of such net operating loss carryforwards (“NOL”) in the accompanying consolidated financial statements and has established a valuation allowance of $ 203.9 million against its net deferred tax assets.
+Added: Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
+Added: The significant components of the Company’s deferred taxes consist of the following:
As of December 31,
9 unchanged sentences
Unrealized gain/loss on investments
−Removed: Business interest expense deduction limit
+Added: Reserve on Sales Return, Discount and Bad Debt
Total deferred tax assets
2 unchanged sentences
Deferred tax liabilities:
−Removed: Unrealized gain/loss on investment
Right of use asset
−Removed: Gain / loss on Deconsolidation of Caelum
+Added: Fair Value adjustment on investment in Caelum
Basis in subsidiary
Total deferred tax assets, net
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: A reconciliation of the statutory tax rates
−Removed: and the effective tax rates is as follows:
+Added: A reconciliation of the statutory tax rates and the effective tax rates is as follows:
For the Year Ended December 31,
5 unchanged sentences
Stock based compensation shortfall
−Removed: Change in federal rate
Change in state rate
−Removed: Intercompany elimination adjustments
Deconsolidation of Caelum
−Removed: Change in fair value of warrants
Change in valuation allowance
1 unchanged sentence
Effective income tax rate
−Removed: The Company files a consolidated income
−Removed: tax return with subsidiaries for which the Company has an 80% or greater ownership interest.
−Removed: subsidiaries for which the Company
−Removed: does not have an 80% or more ownership are not included in the Company’s consolidated income tax group and file their own
−Removed: separate income tax return.
−Removed: As a result, certain corporate entities included in these financial statements are not able to combine
−Removed: or offset their taxable income or losses with other entities' tax attributes.
−Removed: ASC 740 requires a valuation allowance
−Removed: to reduce the deferred tax assets reported if, based on the weight of all positive and negative evidence, it is more likely than
−Removed: not that some portion, or all, of the deferred tax assets will not be realized.
−Removed: Realization of the deferred tax assets is substantially
−Removed: dependent on the Company’s ability to generate sufficient taxable income within certain future periods.
−Removed: Management has considered
−Removed: the Company’s history of cumulative tax and book losses incurred since inception, and the other positive and negative evidence,
−Removed: and has concluded that it is more likely than not that the Company will not realize the benefits of the net deferred tax assets
−Removed: as of December 31, 2019 and 2018.
−Removed: Accordingly, a full valuation allowance has been established against the net deferred tax
−Removed: assets as of December 31, 2019 and 2018.
+Added: The Company files a consolidated income tax return with subsidiaries for which the Company has an 80 % or greater ownership interest.
+Added: subsidiaries for which the Company does not have an 80 % or more ownership are not included in the Company’s consolidated income tax group and file their own separate income tax return.
+Added: As a result, certain corporate entities included in these financial statements are not able to combine or offset their taxable income or losses with other entities’ tax attributes.
+Added: ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of all positive and negative evidence, it is more likely than not that some portion, or all, of the deferred tax assets will not be realized.
+Added: Realization of the deferred tax assets is substantially dependent on the Company’s ability to generate sufficient taxable income within certain future periods.
+Added: Management has considered the Company’s history of cumulative tax and book losses incurred since inception, and the other positive and negative evidence, and has concluded that it is more likely than not that the Company will not realize the benefits of the net deferred tax assets as of December 31, 2020 and 2019.
+Added: Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2020 and 2019.
The valuation allowance increased by a net $ 35.7 million during the current year.
−Removed: The Company has incurred net
−Removed: operating losses (“NOLs”) since inception.
−Removed: At December 31, 2019, the Company had federal NOLs of $445.9
−Removed: million, which will begin to expire in the year 2026, state NOLs of $487.0 million, which will begin to expire in 2022,
−Removed: federal income tax credits of $12.4 million, which will begin to expire in 2028, and state R&D tax credits of $0.4
−Removed: million, which will begin to expire in 2033.
−Removed: The utilization of the Company’s NOLs and tax credit carryovers are
−Removed: subject to annual Internal Revenue Code Section 382 limitations (“382 Limitations”).
−Removed: Based on the analysis
−Removed: of the NOLs and tax credit carryovers subject to the 382 Limitations, the Company has concluded that the 382 Limitations
−Removed: would not prevent the Company from utilizing all of its NOLs and tax credit carryovers before expiration.
−Removed: On November 14, 2018, the Company
−Removed: entered into a stock purchase agreement with B.
−Removed: Riley Financial, Inc.
−Removed: Riley”) to sell approximately 7.0 million
−Removed: shares of the common stock of National, representing approximately 56.1% of National’s outstanding common stock and the Company’s
−Removed: entire economic interest in National.
−Removed: The first closing occurred on November 14, 2018 in which the Company sold approximately
−Removed: 3.0 million of its shares in NHLD and received $9.8 million in proceeds.
−Removed: The second closing occurred on February 11, 2019
−Removed: upon the receipt of FINRA approval of the sale in which the Company received $13.1 million in proceeds for the sale of its remaining
−Removed: 4.0 million shares of NHLD to NHC and two other minority holders and received.
−Removed: The Company has written off National’s deferred
−Removed: tax assets and the corresponding allowance as of December 31, 2018.
−Removed: In January 2019, in connection with the
−Removed: Alexion DOSPA, the Company ceased to consolidate Caelum (see Note 4).
−Removed: As a result of the deconsolidation of Caelum, the Company
−Removed: has eliminated Caelum’s deferred tax assets and the valuation allowance for a net tax expense charge or benefit of zero for
−Removed: the year ended December 31, 2019.
−Removed: As of December 31, 2019, the Company
−Removed: had no unrecognized tax benefits and does not anticipate any significant change to the unrecognized tax benefit balance.
−Removed: would classify interest and penalties related to uncertain tax positions as income tax expense, if applicable.
−Removed: There was no interest
−Removed: expense or penalties related to unrecognized tax benefits recorded through December 31, 2019.
−Removed: The NOLs from tax years 2006
−Removed: through 2018 remain open to examination (and adjustment) by the Internal Revenue Service and state taxing authorities.
−Removed: federal tax years ending December 31, 2016, 2017 and 2018 are open for assessment of federal taxes.
−Removed: The expiration of the
−Removed: statute of limitations related to the various state income and franchise tax returns varies by state.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
+Added: The Company has incurred net operating losses (“NOLs”) since inception.
+Added: At December 31, 2020, the Company had federal NOLs of $ 525.7 million, which will begin to expire in the year 2026 , state NOLs of $ 648.2 million, which will begin to expire in 2022 , and federal income tax credits of $ 15.4 million and state income tax credits of $ 1.2 million, which will begin to expire in 2028 .
+Added: Approximately $ 284.8 million of the federal NOLs and $ 4.5 million of the state NOLs can be carried forward indefinitely.
+Added: Under the provisions of Section 382 of the Internal Revenue Code, a corporation that undergoes an “ownership change”, as defined therein, is subject to limiatations on its use of pre-change NOLs and income tax credits carryforwards to offset future tax liabilities.
+Added: The Company is currently evaluating the impact of Section 382 on its tax attributes.
+Added: The Company has recorded a full valuation allowance on all of its deferred tax assets as it believes that it is more likely than not that the deferred tax assets will not be realized regardless of whether an “ownership change” has occurred.
+Added: As of December 31, 2020, th Company had no unrecognized tax benefits and does not anticipate any significant change to the unrecognized tax benefit balance.
+Added: The Company would classify interest and penalties related to uncertain tax positions as income tax expense, if applicable.
+Added: There was no interest expense or penalties related to unrecognized tax benefits recorded through December 31, 2020.
+Added: The NOLs from tax years 2008 through 2019 remain open to examination (and adjustment) by the Internal Revenue Service and state taxing authorities.
+Added: In addition, federal tax years ending December 31, 2017, 2018 and 2019 are open for assessment of federal taxes.
+Added: The expiration of the statute of limitations related to the various state income and franchise tax returns varies by state.
+Added: In January 2019, in connection with the Alexion DOSPA, the Company ceased to consolidate Caelum (see Note 4).
+Added: As a result of the deconsolidation of Caelum, the Company has eliminated Caelum’s deferred tax assets and the valuation allowance for a net tax expense charge or benefit of zero for the year ended December 31, 2019.
+Added: Coronavirus Aid, Relief and Economic Security Act ("CARES Act")
+Added: In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act ("CARES Act") was signed into law on March 27, 2020.
+Added: The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer's social security payments, net operating loss utilization and carryback periods and modifications to the net interest deduction limitations.
+Added: The CARES Act did not have a material impact on the Company’s income tax provision for 2020.
+Added: The Company will continue to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows.
+Added: On December 27, 2020, the President of the United States signed the Consolidated Appropriations Act, 2021 (“Consolidated Appropriations Act”) into law.
+Added: The Consolidated Appropriations Act is intended to enhance and expand certain provisions of the CARES Act, allows for the deductions of expenses related to the Paycheck Protection Program funds received by companies, and provides an update to meals and entertainment expensing for 2021.
+Added: The Consolidated Appropriations Act did not have a material impact to the Company’s income tax provision for 2020.
Segment Information
−Removed: The Company operates in two reportable
−Removed: segments, Dermatology Product Sales and Pharmaceutical and Biotechnology Product Development.
−Removed: The accounting policies of the Company’s
−Removed: segments are the same as those described in Note 2.
−Removed: Prior to the sale of National the Company operated in three segments, one which
−Removed: included National, see Note 3.
−Removed: The following tables summarize, for the periods indicated, operating results, from continued operations
−Removed: by reportable segment ($ in thousands):
−Removed: Pharmaceutical and
+Added: The Company operates in two reportable segments, Dermatology Product Sales and Pharmaceutical and Biotechnology Product Development.
+Added: The accounting policies of the Company’s segments are the same as those described in Note 2.
+Added: The following tables summarize, for the periods indicated, operating results from continued operations by reportable segment:
+Added: Pharmaceutical
Biotechnology
+Added: ($ in thousands)
Year Ended December 31, 2020
−Removed: Product Development
Direct cost of goods
2 unchanged sentences
General and administrative
−Removed: Segment gain (loss) from operations
+Added: Other expense
+Added: Income tax expense
+Added: Segment income (loss)
Segment assets
2 unchanged sentences
Total segment assets
−Removed: Pharmaceutical and
+Added: Pharmaceutical
Biotechnology
+Added: ($ in thousands)
Year Ended December 31, 2019
−Removed: Product Development
Direct cost of goods
2 unchanged sentences
General and administrative
−Removed: Other expense
−Removed: Segment gain (loss) from operations
+Added: Segment income (loss)
Segment assets
4 unchanged sentences
Disaggregation of Total Revenues
−Removed: The Company has five marketed products,
−Removed: Targadox®, Ximino®, Exelderm®, Luxamend®
−Removed: and Ceracade®.
−Removed: Substantially all of the Company’s product revenues
−Removed: are recorded in the U.S.
−Removed: Substantially all of the Company’s collaboration revenues are from its collaboration with TGTX.
−Removed: Revenues by product and collaborator are summarized as follows ($ in thousands):
+Added: The Company has five marketed products, Targadox®, Ximino®, Exelderm®, Luxamend® and Ceracade®.
+Added: Substantially all of the Company’s product revenues are recorded in the U.S.
+Added: Substantially all of the Company’s collaboration revenues are from its collaboration with TGTX.
+Added: The table below summarizes the Company’s revenue for the years ended December 31, 2020 and 2019:
Year Ended December 31,
−Removed: Targadox®
−Removed: Other Branded Revenue 1
−Removed: Total product revenues
−Removed: Total Revenue
−Removed: $6.9M in other branded revenue in 2019 includes $3.6M in Ximino Sales.
−Removed: Ximino was sold for five months starting in August 2019.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Notes to the Consolidated Financial
−Removed: Collaboration Revenue
−Removed: The Company recognized collaboration and
−Removed: license agreement revenues of $1.7 million and $3.5 million during the year ended December 31, 2019 and 2018, respectively.
+Added: ($ in thousands)
+Added: Product revenue, net
+Added: Revenue – related party
Significant Customers
−Removed: For the year ended December 31, 2019,
−Removed: two of the Company’s Dermatology Products customers each accounted for more than 10.0% of its total gross product revenue,
−Removed: accounting for approximately 50% and 10%, respectively.
−Removed: The revenue from these customers is captured in the product revenue, net
−Removed: line item within the Consolidated Statements of Operations.
−Removed: For the year ended December 31, 2018,
−Removed: two of the Company’s Dermatology Products customers each accounted for more than 10.0% of its total gross product revenue,
−Removed: accounting for approximately 48.5% and 10.6%, respectively.
−Removed: The revenue from these customers is captured in the product revenue,
−Removed: net line item within the Consolidated Statements of Operations.
−Removed: At December 31, 2019, two of the Company’s Dermatology
−Removed: Products customers accounted for more than 10% of its total accounts receivable balance at 21% and 18% respectively.
−Removed: At December 31, 2018, one of the Company’s Dermatology
−Removed: Products customers accounted for 79.1% of its total accounts receivable balance.
−Removed: Net Revenue from Pharmaceutical and Biotechnology
−Removed: Product Development represents collaboration revenue from TGTX in connection with Checkpoint, which is classified as related party
+Added: For the year ended December 31, 2020, none of the Company’s Dermatology Products customers accounted for more than 10.0% of its total gross product revenue.
+Added: For the year ended December 31, 2019, two of the Company’s Dermatology Products customers each accounted for more than 10.0% of its total gross product revenue, accounting for approximately 50 % and 10 %, respectively.
+Added: The revenue from these customers is captured in the product revenue, net line item within the Consolidated Statements of Operations.
+Added: At December 31, 2020, one of the Company’s Dermatology Products customers accounted for 12 % of its total accounts receivable balance.
+Added: At December 31, 2019, two of the Company’s Dermatology Products customers accounted for more than 10% of its total accounts receivable balance at 21 % and 18 %, respectively.
+Added: Included in Product revenue, net, for the years ended December 31, 2020 and 2019 was $ 1.4 million and nil , respectively, of revenue that was constrained in a prior period.
+Added: Revenue – related party represents collaboration revenue from TGTX in connection with Checkpoint.
Subsequent Events
−Removed: February 11, 2020, the Company announced the pricing of an underwritten public offering, whereby it sold 625,000 shares
−Removed: of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, (plus a 45-day option to purchase up to an
−Removed: additional 93,750 shares, which was exercised in February 2020) at a price of $20.00 per share for gross proceeds of
−Removed: approximately $14.4 million, before deducting underwriting discounts and commissions and offering expenses.
−Removed: The above-mentioned shares of Perpetual Preferred Stock were
−Removed: sold under the 2019 Fortress Shelf.
−Removed: Pursuant to the requirements of Section 13
−Removed: or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
−Removed: the undersigned, thereunto duly authorized.
+Added: On February 24, 2021, Cyprium announced the execution of an asset purchase agreement with Sentynl Therapeutics, Inc.
+Added: (“Sentynl”), a U.S.-based specialty pharmaceutical company owned by the Zydus Group.
+Added: The asset purchase agreement commits Sentynl to an upfront cash payment to Cyprium of $ 8.0 million for development, a $ 3.0 million cash milestone payment at NDA acceptance, the purchase price of $ 9.0 million, as well as potential sales milestones totaling $ 255.0 million.
+Added: Royalties on CUTX-101 net sales range from the mid-single digits up to the mid-twenties are also payable.
+Added: Cyprium will retain development responsibility of CUTX-101 through approval of the NDA by the FDA, and Sentynl will be responsible for commercialization of CUTX-101 as well as progressing newborn screening activities.
+Added: Continued development of CUTX-101 will be overseen by a Joint Steering Committee consisting of representatives from Cyprium and Sentynl.
+Added: Cyprium will retain 100 % ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
+Added: On February 12, 2021, Avenue resubmitted its NDA to the FDA for IV Tramadol.
+Added: The NDA for IV Tramadol was resubmitted following the receipt of official minutes from a Type A meeting with the FDA, which was conducted following a CRL issued by the FDA in October 2020.
+Added: The resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation.
+Added: On February 26, 2021, Avenue received an acknowledgement letter from the FDA that Avenue’s resubmission of its NDA is a complete, class 1 response to the CRL, and a Prescription Drug User Fee Act goal date has been set for April 12, 2021.
+Added: 8 % Cumulative Convertible Class A Preferred Offering
+Added: In March 2021, our partner company Journey is conducting an offering to accredited investors of 8 % Cumulative Convertible Class A Preferred Stock in an aggregate minimum amount of $ 12.5 million and an aggregate maximum amount of $ 30.0 million, which may be increased if Journey and the placement agent agree to do so.
+Added: Dividends on the Journey preferred stock will be paid quarterly in shares of the Company’s common based upon a 7.5 % discount to the average trading price over the 10-day period preceding the dividend payment date.
+Added: The approximate number of shares issuable as a dividend per quarter, based upon the Company’s common stock price as of March 26, 2021, would be 72,849 shares if the minimum amount is raised and 174,838 if the maximum amount is raised.
+Added: In addition, if the Journey preferred stock has not been converted into Journey common stock upon a sale of Journey or a financing of Journey in an amount of at least $ 25.0 million within a year of the closing (extendable by another six months at Journey’s option), the Journey preferred stock will be exchanged for shares of the Company’s common stock, also based upon a 7.5 % discount to the average Company common stock trading price over the 10-day period preceding such exchange.
+Added: The approximate number of the Company’s common shares issuable upon such exchange would be approximately 3.4 million shares if the minimum amount is sold and 8.1 million if the maximum amount is sold, in each case based upon the Company’s common stock price as of March 26, 2021.
+Added: The Company will be obligated to file one or more registration statements covering the issuance of shares that result from such dividends/exchange.
+Added: As consideration for the foregoing Journey will issue to the Company additional shares of Journey common stock, debt securities, or a combination of the foregoing.
+Added: From the initial closing on March 31, 2021, the Company raised gross proceeds of $ 12.5 million.
+Added: Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Fortress Biotech, Inc.
3 unchanged sentences
Rosenwald, M.D.
−Removed: Chairman, President and Chief Executive Officer (Principal Executive Officer)
+Added: Chairman, President and Chief Executive Officer
+Added: (Principal Executive Officer)
POWER OF ATTORNEY
−Removed: We, the undersigned directors and/or executive
−Removed: officers of Fortress Biotech, Inc., hereby severally constitute and appoint Lindsay A.
−Removed: Rosenwald, M.D., acting singly, his
−Removed: or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her in any and
−Removed: all capacities, to sign any and all amendments to this Annual Report on Form 10-K and to file the same, with all exhibits
−Removed: thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact
−Removed: and agent full power and authority to do and perform each and every act and thing necessary or appropriate to be done in connection
−Removed: therewith, as fully for all intents and purposes as he or she might or could do in person, hereby approving, ratifying and confirming
−Removed: all that said attorney-in-fact and agent, or his substitute, may lawfully do or cause to be done by virtue hereof.
−Removed: Pursuant to the requirements of the Securities
−Removed: Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities
−Removed: and on the dates indicated.
+Added: We, the undersigned directors and/or executive officers of Fortress Biotech, Inc., hereby severally constitute and appoint Lindsay A.
+Added: Rosenwald, M.D., acting singly, his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing necessary or appropriate to be done in connection therewith, as fully for all intents and purposes as he or she might or could do in person, hereby approving, ratifying and confirming all that said attorney-in-fact and agent, or his substitute, may lawfully do or cause to be done by virtue hereof.
+Added: Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
/s/ Lindsay A.
22 unchanged sentences
March 31, 2021
+Added: March 31, 2021
+Added: March 31, 2021
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.