22 unchanged sentences
Changes in Internal Controls over Financial Reporting.
−Removed: 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.
+Added: In September 2021, a partner company email account was compromised by a third-party impersonator and payments intended for a vendor, approximating $9.5 million, were fraudulently re-directed into an individual bank account controlled by this third-party impersonator.
+Added: The impersonator had taken a number of steps to deceive our employees and reduce the likelihood of detection.
+Added: As a result of the foregoing, we identified a material weakness due to our internal controls having not been adequately designed to prevent or timely detect unauthorized cash disbursements.
+Added: Given the identification of the material weakness during September 2021, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2021, our disclosure controls and procedures were not effective at the reasonable assurance level.
+Added: In light of the above incident, our management took immediate action to remediate the material weakness, including enhancing and formalizing cash disbursement controls to prevent and timely detect unauthorized cash disbursements and significantly enhancing our information technology infrastructure and security measures.
+Added: Subsequent to the breach, management has remediated our controls and as of December 31, and we believe this material weakness has been remediated.
+Added: Except for the remediation efforts described above taken to address the material weakness, 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
+Added: Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
+Added: Not applicable.
Directors, Executive Officers and Corporate Governance
8 unchanged sentences
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2022 Annual Meeting of Stockholders.
−Removed: Exhibits, Financial Statement Schedules.
+Added: Exhibits and Financial Statement Schedules.
(a) Financial Statements.
The following financial statements are filed as part of this report:
−Removed: Reports of Independent Registered Public Accounting Firms
+Added: Reports of Independent Registered Public Accounting Firms (KPMG LLP, Short Hills, NJ;
+Added: Reports of Independent Registered Public Accounting Firms (BDO USA, Boston, MA;
Consolidated Balance Sheets
5 unchanged sentences
Exhibit Title
−Removed: Amended and Restated Certificate of Incorporation of the Registrant.
−Removed: First Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant.
−Removed: Second Amended and Restated Bylaws of the Registrant.
−Removed: Second Certificate of Amendment of Amended and Restated Certificate of Incorporation, as amended.
−Removed: Third Certificate of Amendment of Amended and Restated Certificate of Incorporation, as amended.
−Removed: Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Fortress Biotech, Inc.
+Added: Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 of the Registrant’s Form 10 (file No.
+Added: 000-54463) filed with the SEC on July 15, 2011).
+Added: First Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.2 of the Registrant’s Form 10 (file No.
+Added: 000-54463) filed with SEC on July 15, 2011) .
+Added: Second Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.7 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on October 31, 2013.
+Added: Second Certificate of Amendment of Amended and Restated Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.8 of the Registrant’s Annual Report on Form 10-K (file No.
+Added: 001-35366) filed with the SEC on March 14, 2014) .
+Added: Third Certificate of Amendment of Amended and Restated Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.9 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on April 27, 2015) .
+Added: Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Fortress Biotech, Inc (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on June 19, 2020).
Certificate of Amendment to the Certificate of Designations of Rights and Preferences of the Fortress Biotech, Inc.
−Removed: 9.375% Series A Cumulative Preferred Stock under the Amended and Restated Certificate of Incorporation of Fortress Biotech, Inc.
−Removed: Form of Common Stock Certificate.
−Removed: Certificate of Designation of Rights and Preferences 9.375% Series A Perpetual Preferred Stock.
−Removed: Description of Securities of Fortress Biotech, Inc.
−Removed: Form of Stock Option Award Agreement.
−Removed: Amended and Restated Consulting Agreement, entered into as of January 1, 2019, by and between the Registrant and Eric Rowinsky.
−Removed: Form of Indemnification Agreement by and between the Registrant and its officers and directors.
+Added: 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock under the Amended and Restated Certificate of Incorporation of Fortress Biotech, Inc (incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on June 19, 2020).
+Added: Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Fortress Biotech, Inc.
+Added: dated June 23, 2021, incorporated herein by reference to the Form 8-K filed on June 23, 2021 (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on June 23, 2020) .
+Added: Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 of the Registrant’s Form 10 (file No.
+Added: 000-54463) filed with the SEC on July 15, 2011) .
+Added: Certificate of Designation of Rights and Preferences 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 7, 2017) .
+Added: Description of Securities of Fortress Biotech, Inc (incorporated by reference to Exhibit 4.3 of the Registrant’s Annual Report on Form 10-K (file No.
+Added: 001-35366) filed with the SEC on March 31, 2021).
+Added: Form of Stock Option Award Agreement (incorporated by reference to Exhibit 10.9 of the Registrant’s Form 10 (file No.
+Added: 001-54463) filed with the SEC on July 15, 2011).
+Added: Amended and Restated Consulting Agreement, entered into as of January 1, 2019, by and between the Registrant and Eric Rowinsky (incorporated by reference to Exhibit 10.3 of the Registrant’s Annual Report on Form 10-K (file No.
+Added: 001-35366) filed with the SEC on March 18, 2019).
+Added: Form of Indemnification Agreement by and between the Registrant and its officers and directors (incorporated by reference to Exhibit 10.25 of the Registrant’s Form 10 (file No.
+Added: 000-54463) filed with the SEC on August 24, 2011).
+Added: Exhibit Title
Fortress Biotech, Inc.
−Removed: 2012 Employee Stock Purchase Plan.
+Added: 2012 Employee Stock Purchase Plan (incorporated by reference to Annex A of the Registrant’s Schedule 14A (file No.
+Added: 001-35366) filed with the SEC on July 13, 2012).
Restricted Stock Issuance Agreement, dated as of February 2, 2014, by and between the Registrant and Michael S.
+Added: Weiss (incorporated by reference to Exhibit 10.55 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on February 26, 2014).
Restricted Stock Issuance Agreement, dated as of December 19, 2013, by and between the Registrant and Michael S.
+Added: Weiss (incorporated by reference to Exhibit 10.57 of the Registrant’s Annual Report on Form 10-K (file No.
+Added: 001-35366) filed with the SEC on March 14, 2014).
Restricted Stock Issuance Agreement, dated as of December 19, 2013, by and between the Registrant and Lindsay A.
−Removed: Rosenwald, M.D.#
+Added: Rosenwald, M.D (incorporated by reference to Exhibit 10.58 of the Registrant’s Annual Report on Form 10-K (file No.
+Added: 001-35366) filed with the SEC on March 14, 2014).#
Form of Coronado Biosciences, Inc.
−Removed: 2013 Stock Incentive Plan Award Agreement (2013 Stock Incentive Plan).
+Added: 2013 Stock Incentive Plan Award Agreement (2013 Stock Incentive Plan) (incorporated by reference to Exhibit 10.60 of the Registrant’s Form S-8 (file No.
+Added: 333-194588) filed with the SEC on March 14, 2014).
Coronado Biosciences, Inc.
−Removed: Deferred Compensation Plan for Directors, dated March 12, 2015.
+Added: Deferred Compensation Plan for Directors, dated March 12, 2015 (incorporated by reference to Exhibit 10.67 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on March 18, 2015).
Fortress Biotech, Inc.
−Removed: 2013 Stock Incentive Plan, as amended.
−Removed: Exhibit Title
+Added: 2013 Stock Incentive Plan, as amended (incorporated by reference to Appendix A of the Registrant’s Schedule 14-A (file No.
+Added: 001-35366) filed with the SEC on June 4, 2015).
Restricted Stock Unit Award Agreement between Fortress Biotech, Inc.
−Removed: and George Avgerinos effective July 15, 2015.#
−Removed: Form of Common Stock Purchase Warrant in favor of National Securities Corporation.
+Added: and George Avgerinos effective July 15, 2015 (incorporated by reference to Exhibit 10.70 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on July 17, 2015).#
+Added: Form of Common Stock Purchase Warrant in favor of National Securities Corporation (incorporated by reference to Exhibit 10.35 of the Registrant’s Quarterly Report on Form 10-Q (file No.
+Added: 001-35366) filed with the SEC on May 10, 2017) .
Fortress Biotech, Inc.
−Removed: 2012 Employee Stock Purchase Plan, as amended.
+Added: 2012 Employee Stock Purchase Plan, as amended (incorporated by reference to Exhibit 10.38 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on June 12, 2017) .
Fortress Biotech, Inc.
−Removed: Amended and Restated Long-Term Incentive Plan.
+Added: Amended and Restated Long-Term Incentive Plan (incorporated by reference to Exhibit 10.39 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on June 12, 2017) .
Stock Purchase and Merger Agreement, dated as of November 12, 2018, by and between Avenue Therapeutics, Inc., InvaGen Pharmaceuticals Inc.
−Removed: and Madison Pharmaceuticals Inc.
+Added: and Madison Pharmaceuticals Inc (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
Stockholders Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc., Avenue Therapeutics, Inc., Dr.
Lucy Lu, M.D.
−Removed: and InvaGen Pharmaceuticals Inc.
+Added: and InvaGen Pharmaceuticals Inc (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
+Added: Exhibit Title
Credit Agreement, dated as of November 12, 2018, by and between Avenue Therapeutics, Inc.
−Removed: and InvaGen Pharmaceuticals Inc.
+Added: and InvaGen Pharmaceuticals Inc (incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
Guaranty, dated as of November 12, 2018, by and between Fortress Biotech, Inc.
−Removed: and InvaGen Pharmaceuticals Inc.
+Added: and InvaGen Pharmaceuticals Inc (incorporated by reference to Exhibit 10.4 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
Voting and Support Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc., Avenue Therapeutics, Inc., Dr.
Lucy Lu, M.D.
−Removed: and InvaGen Pharmaceuticals Inc.
+Added: and InvaGen Pharmaceuticals Inc (incorporated by reference to Exhibit 10.5 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
Waiver Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc., Avenue Therapeutics, Inc.
−Removed: and InvaGen Pharmaceuticals Inc.
+Added: and InvaGen Pharmaceuticals Inc (incorporated by reference to Exhibit 10.6 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
Restrictive Covenant Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc.
−Removed: and InvaGen Pharmaceuticals Inc.
+Added: and InvaGen Pharmaceuticals Inc (incorporated by reference to Exhibit 10.7 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
Indemnification Agreement, dated as of November 12, 2018, by and between Fortress Biotech, Inc.
−Removed: and InvaGen Pharmaceuticals Inc.
−Removed: 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: and InvaGen Pharmaceuticals Inc (incorporated by reference to Exhibit 10.8 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on November 16, 2018).
+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 (incorporated by reference to the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on January 31, 2019) .*
Amendment to the Fortress Biotech, Inc.
−Removed: 2013 Stock Incentive Plan.#
+Added: 2013 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on June 19, 2020) .#
Credit Agreement entered into by and among Fortress Biotech, Inc.
−Removed: the lenders form time to time party thereto, and Oaktree Fund administration, LLC on August 27, 2020.
+Added: the lenders from time to time party thereto, and Oaktree Fund administration, LLC on August 27, 2020 (incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q (file No.
+Added: 001-35366) filed with the SEC on November 9, 2020) .
+Added: Letter from BDO USA, LLP to the Securities and Exchange Commission dated September 22, 2021, incorporated by reference to the Form 8-K filed on September 24, 2021 (incorporated by reference to Exhibit 16.1 of the Registrant’s Current Report on Form 8-K (file No.
+Added: 001-35366) filed with the SEC on September 24, 2021).
Subsidiaries of the Registrant.
−Removed: Consent Independent Registered Public Accounting Firm.
+Added: Consent Independent Registered Accounting Firm (KPMG LLP, Short Hills, NJ).
+Added: Consent Independent Registered Accounting Firm ( BDO USA, LLP, Boston MA).
Power of Attorney (included on the signature page of this Form 10-K).
+Added: Exhibit Title
Certification of Chairman, President and Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
−Removed: Exhibit Title
Certification of Chairman, President and Chief Executive Officer, pursuant to 18 U.S.C.
15 unchanged sentences
Index to Consolidated Financial Statements
−Removed: Reports of Independent Registered Public Accounting Firm
+Added: Reports of Independent Registered Public Accounting Firms ( KPMG LLP , Short Hills, NJ ;
+Added: Reports of Independent Registered Public Accounting Firms (BDO USA LLP, Boston, MA;
Consolidated Balance Sheets
5 unchanged sentences
Report of Independent Registered Public Accounting Firm
−Removed: Shareholders and Board of Directors
+Added: To the Stockholders and the Board of Directors
Fortress Biotech, Inc.:
−Removed: and subsidiaries
−Removed: New York, New York
1 Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Fortress Biotech, Inc.
−Removed: 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”).
−Removed: 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.
+Added: and subsidiaries (the Company) as of December 31, 2021, the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for the year ended December 31, 2021, and the related notes (collectively, the consolidated financial statements).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021, and the results of its operations and its cash flows for the year ended December 31, 2021, in conformity with U.S.
+Added: generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.
+Added: Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
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.
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 the standards of the PCAOB.
+Added: We conducted our audit in accordance with the standards of the PCAOB.
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.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: 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: As part of our audit, 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.
Accordingly, we express no such opinion.
−Removed: 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: Our audit 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.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
−Removed: 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.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
+Added: Our audit 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 audit provides a reasonable basis for our opinion.
Critical Audit Matter
−Removed: 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 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:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
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.
−Removed: Accounting for Oaktree Note
−Removed: 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”).
−Removed: 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)
−Removed: with a relative fair value of $4.4 million.
−Removed: 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.
−Removed: We identified the accounting for the Oaktree Note as a critical audit matter.
−Removed: 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.
−Removed: 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.
−Removed: The procedures we performed to address this critical audit matter included:
−Removed: ● Evaluating management’s accounting policies and practices including the appropriateness of
−Removed: management’s evaluation of various terms and conditions in the debt agreement, and assessment of embedded derivatives.
−Removed: ● Inspecting the underlying agreements and testing management’s evaluation and application of the relevant accounting guidance to the terms of the agreements.
−Removed: ● 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: Evaluation of accrued coupon liability
+Added: As discussed in Note 2 and Note 11 of the consolidated financial statements, the Company accrues for coupons on products for certain qualified commercially-insured parties.
+Added: At December 31, 2021, the Company recorded $10.6 million in accrued coupon and rebates, which included the accrued coupon liability.
+Added: The Company estimates the amount of its expected coupon redemptions for product that is still in the distribution channel and records the estimate as a reduction of revenue in the period the related product revenue is recognized.
+Added: The Company’s accrued coupon liability is primarily based on historical company coupon redemption costs, cost per coupon claims, and estimates of product remaining in the distribution channel.
+Added: We identified the evaluation of the accrued coupon liability as a critical audit matter.
+Added: There was a high degree of auditor judgment required in the evaluation of certain assumptions used in the determination of the accrued coupon liability, including the estimation of product in the distribution channel, coupon redemption costs, and the cost per coupon claims.
+Added: The following are the primary procedures we performed to address this critical audit matter.
+Added: We evaluated the design of certain internal controls over the Company’s accrued coupon process, including a control over the assumptions.
+Added: We performed a risk assessment procedure to assess the sensitivity of changes in the estimate of distribution channel inventory on the accrued coupon liability.
+Added: We tested the sales data and coupon redemption data used by management to calculate coupon redemption costs and cost of coupon claims by comparing the data to historical information.
+Added: We also recalculated the coupon costs and the cost per coupon claim.
+Added: We developed an expectation of the coupon accrual liability based on an independent estimate of the product in the distribution channel and we compared our expectation to the Company’s coupon accrual liability.
We have served as the Company’s auditor since 2021.
+Added: Short Hills, New Jersey
+Added: March 28, 2022
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: Report of Independent Registered Public Accounting Firm
+Added: Shareholders and Board of Directors
+Added: Fortress Biotech, Inc.
+Added: and subsidiaries
+Added: New York, New York
+Added: Opinion on the Consolidated Financial Statements
+Added: We have audited the accompanying consolidated balance sheet of Fortress Biotech, Inc.
+Added: and subsidiaries (the “Company”) as of December 31, 2020, the related consolidated statements of operations, stockholders’ equity, and cash flows for the year 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 the results of its operations and its cash flows for the year ended December 31, 2020 , in conformity with accounting principles generally accepted in the United States of America.
+Added: Basis for Opinion
+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 audit.
+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 audit 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 audit 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 audit 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 audit 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 audit provides a reasonable basis for our opinion.
/s/ BDO USA, LLP
1 unchanged sentence
March 31, 2021
+Added: We have served as the Company’s auditor from 2016 to 2021.
FORTRESS BIOTECH, INC.
16 unchanged sentences
Accounts payable and accrued expenses
−Removed: Interest payable
−Removed: Interest payable - related party
+Added: Deferred revenue
Income taxes payable
−Removed: Notes payable, short-term
Operating lease liabilities, short-term
−Removed: Derivative warrant liability
−Removed: Partner company note payable, short-term
+Added: Partner company line of credit
+Added: Partner company installment payments - licenses, short-term (net of imputed interest of $ 490 and $ 778 as of December 31, 2021 and December 31, 2020, respectively)
Total current liabilities
−Removed: Notes payable, long-term (net of debt discount of $ 8,323 and $ 5,086 at December 31, 2020 and December 31, 2019, respectively)
+Added: Notes payable, long-term (net of debt discount of $ 7,063 and $ 8,323 as of December 31, 2021 and December 31, 2020, respectively)
Operating lease liabilities, long-term
−Removed: Partner company note payable, long-term
+Added: Partner company installment payments - licenses, long-term (net of imputed interest of $ 373 and $ 863 as of December 31, 2021 and December 31, 2020, respectively)
Other long-term liabilities
Total liabilities
−Removed: Commitments and contingencies
+Added: Commitments and contingencies (Note 16)
Stockholders’ equity
−Removed: 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;
−Removed: liquidation value of $ 25.00 per share
−Removed: 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
−Removed: Common stock issuable, 0 and 251,337 shares as of December 31, 2020 and December 31, 2019, respectively
+Added: Cumulative redeemable perpetual preferred stock, $ .001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively, liquidation value of $ 25.00 per share
+Added: Common stock, $ .001 par value, 170,000,000 shares authorized, 101,435,505 shares issued and outstanding as of December 31, 2021;
+Added: 150,000,000 shares authorized, 94,877,492 shares issued and outstanding as of December 31, 2020, respectively
Additional paid-in-capital
11 unchanged sentences
Product revenue, net
+Added: Collaboration revenue
Revenue - related party
4 unchanged sentences
Selling, general and administrative
+Added: Wire transfer fraud loss
Total operating expenses
3 unchanged sentences
Interest expense and financing fee
−Removed: Change in fair value of derivative liability
Change in fair value of investments
−Removed: Gain on deconsolidation of Caelum
+Added: Change in fair value of derivative liability
Total other income (expense)
17 unchanged sentences
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
−Removed: Issuance of Series A preferred stock for at-the-market offering, net
−Removed: Issuance of Series A preferred stock for cash, net
−Removed: Preferred A dividends declared and paid
−Removed: Partner company’s offering, net
−Removed: Partner company’s at-the-market offering, net
−Removed: Issuance of partner company's common shares for license expenses
−Removed: Issuance of partner company's common shares for research and development expenses
−Removed: Issuance of partner company warrants in conjunction with Horizon Notes
−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 issuable for Opus interest expense
−Removed: Common shares issued for Opus interest expense
−Removed: Common shares issued for Opus debt
−Removed: Non-controlling interest in subsidiaries
−Removed: Deconsolidation of Caelum non-controlling interest
−Removed: Net loss attributable to non-controlling interest
−Removed: Net loss attributable to common stockholders
−Removed: Balance at December 31, 2019
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
−Removed: FORTRESS BIOTECH, INC.
−Removed: AND SUBSIDIARIES
−Removed: Consolidated Statements of Changes in Stockholders’ Equity
−Removed: ($ in thousands except for share amounts)
−Removed: Series A Preferred Stock
−Removed: Non-Controlling
−Removed: Stockholders'
−Removed: Balance at December 31, 2019
−Removed: Stock-based compensation expense
Issuance of common stock related to equity plans
1 unchanged sentence
Issuance of common stock for at-the-market offering, net
−Removed: Preferred A dividends declared and paid
+Added: Payment of Series A perpetual preferred stock dividends
Repurchase of Series A preferred stock, net
16 unchanged sentences
Balance at December 31, 2020
+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: Payment of Series A perpetual preferred stock dividends
+Added: Partner company’s offering, net
+Added: Partner companies' at-the-market offering, net
+Added: Partner company’s exercise of options for cash
+Added: Issuance of common stock under partner company’s ESPP
+Added: Partner company’s dividends declared and paid
+Added: Issuance of partner company’s common shares for research and development expenses
+Added: Common shares issued for dividend on partner company's convertible preferred shares
+Added: Conversion of partner company convertible preferred shares
+Added: Conversion of partner company derivative warrant liabilities
+Added: Non-controlling interest in subsidiaries
+Added: Net loss attributable to non-controlling interest
+Added: Net loss attributable to common stockholders
+Added: Balance at December 31, 2021
The accompanying notes are an integral part of these consolidated financial statements.
3 unchanged sentences
($ in thousands)
−Removed: For the Year Ended
+Added: Year Ended December 31,
Cash Flows from Operating Activities:
3 unchanged sentences
Amortization of debt discount
+Added: Accretion of partner company convertible preferred shares
Non-cash interest
+Added: Prepayment penalty of Oaktree Note
Amortization of product revenue license fee
3 unchanged sentences
Issuance of partner company’s common shares for research and development expenses
−Removed: Common shares issuable for 2017 Subordinated Note Financing interest expense
+Added: Common shares issued for dividend on partner company's convertible preferred shares
Common shares issued for 2017 Subordinated Note Financing interest expense
−Removed: Common shares issuable for 2019 Notes interest expense
−Removed: Common shares issued for 2019 Notes interest expense
−Removed: Change in fair value of derivative liability
−Removed: Change in fair value of investment
−Removed: Gain on deconsolidation of Caelum
+Added: Change in fair value of investment in Caelum
+Added: Change in fair value of partner company derivative liability
Research and development-licenses acquired, expense
4 unchanged sentences
Accounts payable and accrued expenses
−Removed: Accounts payable and accrued expenses - related party
Interest payable
Interest payable - related party
+Added: Deferred revenue
Income taxes payable
6 unchanged sentences
Purchase of intangible asset
−Removed: Purchase of short-term investment (certificates of deposit)
−Removed: Redemption of short-term investment (certificates of deposit)
−Removed: Deconsolidation of Caelum
−Removed: Net cash provided by (used in) continuing investing activities
−Removed: Net cash provided by discontinued investing activities
+Added: Proceeds from sale of Caelum
Net cash provided by (used in) investing activities
4 unchanged sentences
($ in thousands)
−Removed: For the Year Ended
+Added: Year Ended December 31,
Cash Flows from Financing Activities:
−Removed: Payment of Series A preferred stock dividends
+Added: Payment of Series A perpetual preferred stock dividends
Purchase of treasury stock
Payment of costs related to purchase of treasury stock
−Removed: Proceeds from issuance of Series A preferred stock
−Removed: Payment of costs related to issuance of Series A preferred stock
−Removed: Proceeds from issuance of common stock for at-the-market offering
−Removed: Payment of costs related to issuance of common stock for at-the-market offering
−Removed: Proceeds from issuance of Series A preferred stock for at-the-market offering
−Removed: Payment of costs related to issuance of Series A preferred stock for at-the-market offering
+Added: Proceeds from issuance of Series A perpetual preferred stock
+Added: Payment of costs related to issuance of Series A perpetual preferred stock
+Added: Proceeds from issuance of common stock for at-the-market offering, net
Proceeds from issuance of common stock under ESPP
1 unchanged sentence
Partner company’s dividends declared and paid
−Removed: Proceeds from partner companies' sale of stock
−Removed: Payment of costs related to partner companies' sale of stock
−Removed: Proceeds from partner companies' at-the-market offering
−Removed: Payment of costs related to partner companies' at-the-market offering
+Added: Proceeds from partner companies' sale of stock, net
+Added: Proceeds from partner companies' at-the-market offering, net
Proceeds from partner company's preferred stock offering
Payment of costs related to partner company's preferred stock offering
−Removed: Proceeds from exercise of partner company’s warrants
−Removed: Proceeds from exercise of partner company’s options
+Added: Proceeds from exercise of partner companies’ equity grants
Payment of debt issuance costs associated with 2017 Subordinated Note Financing
Payment of debt issuance costs associated with 2018 Venture Notes
−Removed: Proceeds from partner company's Horizon Notes
−Removed: Payment of debt issuance costs associated with partner company's Horizon Notes
Proceeds from Oaktree Note
Payment of debt issuance costs associated with Oaktree Note
+Added: Repayment of Oaktree Note
Repayment of 2017 Subordinated Note Financing
3 unchanged sentences
Repayment of IDB Note
−Removed: Installment payment related to intangible asset
+Added: Repayment of partner company installment payments - licenses
+Added: Proceeds from partner company convertible preferred shares, net
+Added: Proceeds from partner's company line of credit
+Added: Repayment of partner's company line of credit
Net cash provided by financing activities
5 unchanged sentences
Cash paid for interest - related party
+Added: Cash paid for tax
The accompanying notes are an integral part of these consolidated financial statements.
6 unchanged sentences
Settlement of restricted stock units into common stock
−Removed: Common shares issuable for license acquired
−Removed: Issuance of partner company warrants in conjunction with Horizon Notes
Issuance of warrants in conjunction with Oaktree Note
Common shares issued from 2017 Subordinated Note Financing interest expense
−Removed: Common shares issued for 2019 Notes
Unpaid fixed assets
+Added: Conversion of partner company convertible preferred shares
+Added: Conversion of partner company derivative warrant liabilities
Partner company's unpaid intangible assets
−Removed: Partner company's previous paid offering cost
Reclass partner company's warrants from liability to equity
−Removed: Unpaid partner company’s offering cost
Unpaid partner company’s at-the-market offering cost
Unpaid partner company’s preferred stock offering cost
+Added: Unpaid partner company’s debt offering cost
+Added: Unpaid partner company’s offering cost
+Added: Partner company derivative warrant liability associated with partner company convertible preferred shares
Unpaid debt offering cost
Unpaid at-the-market offering cost
−Removed: Unpaid Series A preferred stock offering cost
+Added: Retirement of Series A perpetual preferred stock
Unpaid research and development licenses acquired
−Removed: Retirement of Series A preferred stock
+Added: Lease liabilities arising from obtaining right-of-use assets
The accompanying notes are an integral part of these consolidated financial statements.
7 unchanged sentences
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.
−Removed: 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: 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, Mayo Foundation for Medical Education and Research, AstraZeneca plc and Dr.
+Added: Reddy’s Laboratories, Ltd.
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.
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;
−Removed: to date, three partner companies are publicly-traded, and two have consummated strategic partnerships with industry leaders Alexion Pharmaceuticals, Inc.
+Added: to date, four partner companies are publicly-traded, and three have consummated strategic partnerships with industry leaders Alexion Pharmaceuticals, Inc.
and InvaGen Pharmaceuticals, Inc.
−Removed: (a subsidiary of Cipla Limited).
+Added: (a subsidiary of Cipla Limited) and Sentynl Therapeutics, Inc.
+Added: On October 6, 2021, AstraZeneca plc (“AstraZeneca”) (acquiror of Alexion) purchased 100 % of our partner company Caelum Biosciences, Inc.
+Added: (“Caelum”) for approximately $ 150 million upfront and up to $ 350 million in contingent regulatory and sales milestone payments.
Several of our partner companies possess licenses to product candidate intellectual property, including Aevitas Therapeutics, Inc.
−Removed: (“Aevitas”), Avenue Therapeutics, Inc.
−Removed: (“Avenue”), Baergic Bio, Inc.
−Removed: (“Baergic”), Caelum Biosciences, Inc.
−Removed: (“Caelum”), Cellvation, Inc.
+Added: (“Aevitas”), Baergic Bio, Inc.
+Added: (“Baergic”), Caelum, Cellvation, Inc.
(“Cellvation”), Checkpoint Therapeutics, Inc.
2 unchanged sentences
(“Helocyte”), Journey Medical Corporation (“Journey” or “JMC”), Mustang Bio, Inc.
−Removed: (“Mustang”) and Oncogenuity, Inc.
−Removed: ("Oncogenuity").
+Added: (“Mustang”) Oncogenuity, Inc.
+Added: ("Oncogenuity"), and UR-1 Therapeutics, Inc.
Liquidity and Capital Resources
−Removed: 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: Since inception, the Company’s operations have been financed primarily through the sale of equity and debt securities, from the sale of partner companies, and the proceeds from the exercise of warrants and stock options.
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.
The Company’s current cash and cash equivalents are sufficient to fund operations for at least the next 12 months.
−Removed: 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.
−Removed: 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: However, the Company will need to raise additional funding through strategic relationships, public or private equity or debt financings, sale of a partner companies, grants or other arrangements to 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 plans, and plans for expansion of its general and administrative infrastructure may be curtailed.
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.
−Removed: 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).
−Removed: However, the Company is continuing to assess the impact the spread of COVID-19 may have on its operations.
−Removed: Avenue will also continue to assess the alleged Material Adverse Effect claimed by InvaGen.
+Added: In addition to the foregoing, the Company experienced minimal impact on its development timelines, revenue levels and its liquidity due to the worldwide spread of COVID-19.
Summary of Significant Accounting Policies
9 unchanged sentences
The Company’s consolidated financial statements include certain amounts that are based on management’s best estimates and judgments.
−Removed: 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.
+Added: The Company’s significant estimates include, but are not limited to, provisions for product returns, coupons, rebates, chargebacks, discounts, allowances and distribution fees paid by Journey to certain wholesalers, inventory realization, useful lives assigned to long-lived assets and amortizable intangible 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: The Company recognizes revenue under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).
+Added: The Company records revenue in accordance with the provisions of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).
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.
−Removed: The following five steps are applied to achieve that core principle:
−Removed: Identify the contract with the customer
−Removed: Identify the performance obligations in the contract
−Removed: Determine the transaction price
−Removed: Allocate the transaction price to the performance obligations in the contract
−Removed: Recognize revenue when the company satisfies a performance obligation
−Removed: 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.
−Removed: 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:
−Removed: 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).
−Removed: 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).
−Removed: 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.
−Removed: 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 Company’s revenues primarily result from contracts with customers, which are generally short-term and have a single performance obligation — the delivery of product.
+Added: The Company’s performance obligation to deliver products is satisfied when the goods are received by the customer, which is the point at which the customer obtains title to, and accepts the risks and rewards of ownership of, the products.
+Added: The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods to a customer.
The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both.
−Removed: 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.
−Removed: The transaction price is allocated to each performance obligation on a relative standalone selling price basis.
−Removed: 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.
−Removed: The Company recognizes product revenue from sales of Ximino®, Targadox®, Exelderm®, Luxamend® and Ceracade®.
−Removed: 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.
−Removed: The Company has variable consideration in the form of rights of return, coupons, and price protection to customers.
−Removed: The Company uses an expected value method to estimate variable consideration and whether the transaction price is constrained.
−Removed: Payment is due within months of when the customer is invoiced, with discounts for prompt payment.
−Removed: 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.
−Removed: 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.
−Removed: Discontinued Operations
−Removed: 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.
−Removed: See Note 3 for more information relating to the Company’s discontinued operations.
+Added: Many of the Company’s products sold are subject to trade discounts, rebates, coupons and right of return.
+Added: Revenues are recorded net of provisions for variable consideration, including discounts, rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotional programs and other sales allowances.
+Added: Accruals for these provisions are presented in the consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash).
+Added: Amounts recorded for revenue deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates and assumptions.
+Added: The following section briefly describes the nature of the Company’s provisions for variable consideration and how such provisions are estimated.
+Added: Gross-to-Net Sales Accruals — The Company records gross-to-net sales accruals for government rebates, chargebacks, wholesaler distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts.
+Added: Trade Discounts and Other Sales Allowances — The Company provides trade discounts and allowances to its wholesale customers for sales order management, data, and distribution services.
+Added: The Company also provides for prompt pay discounts if payment is received within the payment term days which generally range from 30 to 75 days .
+Added: These discounts and allowances are recorded at the time of sale based on the customer’s contracted rate and have been recorded as a reduction of revenue and a reduction to accounts receivables.
+Added: Wholesaler fees — The Company pays administrative and other fees to certain wholesale customers consistent with pharmaceutical industry practices.
+Added: The Company records a provision for these fees based on contracted rates and historical redemption rates.
+Added: Assumptions used to establish the provision include level of wholesaler inventories, contract sales volumes and average contract pricing.
+Added: The Company regularly reviews the information related to these estimates and adjust the provision accordingly.
+Added: Product Returns — Consistent with industry practice, the Company offers customers a right to return any unused product.
+Added: Such right of return commences six months prior to the product expiration date and ends one year after the product expiration date.
+Added: Products returned for expiration are reimbursed at current or contracted price, less 5%.
+Added: The Company estimates the amount of its product sales that may be returned by its customers and accrues this estimate as a reduction of revenue in the period the related product revenue is recognized.
+Added: The Company currently estimates product return reserves using available industry data and its own sales information, including its visibility and estimates into the inventory remaining in the distribution channel.
+Added: The Company bases its product returns allowance on estimated on-hand inventories in the sales channels, measured end-customer demand, actual returns history and other factors, such as the trend experience for lots where product is still being returned, as applicable.
+Added: If the historical data the Company uses to calculate these estimates does not properly reflect future returns, then a change in the allowance would be made in the period in which such a determination is made and revenues in that period could be materially affected.
+Added: Under this methodology, the Company tracks actual returns by individual production lots.
+Added: Returns on closed lots, that is, lots no longer eligible for return credits, are analyzed to determine historical returns experience.
+Added: Returns on open lots, that is, lots still eligible for return credits, are monitored and compared with historical return trend rates.
+Added: Any changes from the historical trend rates are considered in determining the current sales return allowance.
+Added: Government Chargebacks — Chargebacks for fees and discounts to indirect qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified U.S.
+Added: Department of Veterans Affairs hospitals and 340B entities at prices lower than the list prices charged to customers who purchase product directly from the Company.
+Added: Customers charge the Company for the difference between what they pay for the product and the statutory selling price to the qualified government entity.
+Added: These allowances are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net.
+Added: The chargeback amount from our direct customers is generally determined at the time of our direct customers’ resale to the qualified government healthcare provider, and the Company generally issues credits for such amounts within a few weeks of our direct customer’s notification to the Company of the resale.
+Added: The allowance for chargebacks is based on expected sell-through levels by our direct customers to indirect customers, as well as estimated wholesaler inventory levels.
+Added: Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare.
+Added: These accruals are recorded in the same period that the related revenue is recognized, resulting in a reduction of product revenue.
+Added: For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap, for whom the Company will owe an additional liability under the Medicare Part D program.
+Added: For Medicaid programs, the Company estimates the portion of sales attributed to Medicaid patients and records a liability for the rebates to be paid to the respective state Medicaid programs.
+Added: The Company’s liability for these rebates consists of invoices received for:
+Added: claims from prior quarters that have not been paid or for which an invoice has not yet been received;
+Added: estimates of claims for the current quarter;
+Added: and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.
+Added: Wholesaler Chargeback Accruals — The Company sells a portion of its products indirectly through wholesaler distributors to contracted customers commonly referred to as “indirect customers.” The Company enters into specific agreements with these indirect customers to establish pricing for its products, and in-turn, the indirect customers independently select a wholesaler from which to purchase the products.
+Added: Because the price paid by the indirect customers is lower than the price paid by the wholesaler (wholesale acquisition cost, or “WAC”), the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and WAC.
+Added: The Company’s provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels as well as historical chargeback rates.
+Added: The Company continually monitors its reserve for chargebacks and adjusts the reserve accordingly when expected chargebacks differ from actual experience.
+Added: Coupons — The Company offers coupons on products for qualified commercially-insured parties with prescription drug co-payments.
+Added: Such product sales flow through both traditional wholesaler and specialty pharmacy channels.
+Added: Approximately 85 % of the Company's product revenues are sold through the specialty pharmacy channel, which has a shorter cycle from the Company’s sales date to the fulfilment of the prescription by the specialty pharmacy customer, resulting in less inventory in this channel.
+Added: Coupons are processed and redeemed at the time of prescription fulfilment by the pharmacy, and the Company is charged for the coupons redeemed monthly.
+Added: The majority of coupon liability at the end of the period represents coupons that have been redeemed and for which the Company has been billed, and an accrual for expected redemptions for product in the distribution channel.
+Added: This element of the liability requires the Company to estimate the distribution channel inventory at period end, the expected redemption rates, and the cost per coupon claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period.
+Added: The estimate of product remaining in the distribution channel is comprised of actual inventory at the wholesaler as well as an estimate of inventory at the specialty pharmacies, which the Company estimates based upon historical ordering patterns, which consist of reordering approximately every two weeks.
+Added: The estimated redemption rate is based on historical redemptions as a percentage of units sold.
+Added: The cost per coupon is based on the coupon rate .
+Added: Managed Care Rebates — The Company offers managed care rebates to certain providers.
+Added: The Company calculates rebate payment amounts due under this program based on actual qualifying products and applies a contractual discount rate.
+Added: The accrual is based on an estimate of claims that the Company expects to receive and inventory in the distribution channel.
+Added: The accrual is recognized at the time of sale, resulting in a reduction of product revenue.
+Added: Collaboration Revenue
+Added: Our collaboration revenue includes service revenue, license fees and future contingent milestone-based payments.
+Added: We recognize collaboration revenue for contracted R&D services performed for our customers over time.
+Added: We measure our progress using an input method based on the effort we expend or costs we incur toward the satisfaction of our performance obligation.
+Added: We estimate the amount of effort we expend, including the time it will take us to complete the activities, or the costs we may incur in a given period, relative to the estimated total effort or costs to satisfy the performance obligation.
+Added: This results in a percentage that we multiply by the transaction price to determine the amount of revenue we recognize each period.
+Added: This approach requires us to make estimates and use judgement.
+Added: If our estimates or judgements change over the course of the collaboration, they may affect the timing and amount of revenue that we recognize in the current and future periods.
+Added: Reclassifications
+Added: Certain comparative figures have been reclassified to conform to the current year presentation.
+Added: The Company reclassified certain return reserves related to sales allowances of $4.6 million from accounts receivable to current liabilities on the consolidated balance sheet at December 31, 2020.
+Added: This reclassification was deemed to be immaterial.
Fair Value Measurement
16 unchanged sentences
The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.
−Removed: 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.
−Removed: Balances at certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S.
−Removed: government agency securities.
−Removed: Short-term Investments
−Removed: 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 .
−Removed: The Company reassesses the appropriateness of the classification of its investments at the end of each reporting period.
−Removed: 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.
−Removed: There were no short term investments classified as held-to-maturity as of December 31, 2020.
+Added: Cash and cash equivalents at December 31, 2021 and 2020, 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.
Property and Equipment
4 unchanged sentences
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.
+Added: Intangible Assets
+Added: Intangible assets are reported at cost, less accumulated amortization and impairments.
+Added: Intangible assets with finite lives are amortized over their estimated useful lives, which represents the estimated life of the product.
+Added: Amortization is calculated primarily using the straight-line method.
+Added: During the ordinary course of business, the Company has entered into certain licenses and asset purchase agreements.
+Added: Potential milestone payments for achieving sales targets or regulatory development milestones are recorded when it is probable of achievement.
+Added: Upon a milestone payment being achieved, the milestone payment will be capitalized and amortized over the remaining useful life for approved products and expensed for milestones prior to FDA approval.
+Added: Royalty payments are recorded as cost of goods sold as sales are recognized.
Restricted Cash
The Company records cash held in trust or pledged to secure certain debt obligations as restricted cash.
−Removed: 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.
−Removed: 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: As of December 31, 2021 and 2020, the Company had $ 2.2 million and $ 1.6 million, respectively, of restricted cash representing pledges to secure letters of credit in connection with certain office leases.
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 2021 and 2020:
−Removed: ($ in thousands)
Cash and cash equivalents
3 unchanged sentences
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: Included in inventories is the acquired Qbrezxa finished goods inventory which includes a fair value step-up of $ 6.5 million.
+Added: The $ 6.5 million was fully expensed within cost of sales for the year ended December 31, 2021, as the inventory was sold to customers.
Accounts Receivable, net
5 unchanged sentences
For the years ended December 31, 2021 and 2020, the allowance for doubtful accounts was approximately $ 0.1 million and $ 0.1 million, respectively.
−Removed: 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
4 unchanged sentences
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.
−Removed: Accounting for Warrants at Fair Value
−Removed: 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).
−Removed: 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.
−Removed: Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance sheet date.
−Removed: The Company reassesses the classification of its derivative instruments at each balance sheet date.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: During the year ended December 31, 2020, Cyprium raised approximately $ 8.0 million in Cumulative Redeemable Perpetual Preferred Shares (“Cyprium Offering,” see Note 14).
−Removed: 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.
−Removed: As such these events resulted in Cyprium recording the Cyprium Warrant as issued rather than contingently issuable.
−Removed: Opus Credit Facility, with Detachable Warrants
−Removed: The Company accounted for the Opus Credit Facility (see Note 10) with detachable warrants in accordance with ASC 470, Debt .
−Removed: 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.
−Removed: The warrants were reported on the Consolidated Balance Sheets as a component of additional paid in capital within stockholders’ equity.
−Removed: The Company recorded the related issue costs and value ascribed to the warrants as a debt discount of the Opus Credit Facility.
−Removed: The discount was amortized utilizing the effective interest method over the term of the Opus Credit Facility.
−Removed: The unamortized discount, if any, upon repayment of the Opus Credit Facility would be expensed to interest expense.
−Removed: 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.
−Removed: 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.
−Removed: As of December 31, 2019, Opus dissolved and distributed its assets among its Limited Partners.
−Removed: The dissolution did not impact any of the terms under the Opus Credit Facility.
−Removed: 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
4 unchanged sentences
The note proceeds were allocated between the Oaktree Note and the warrants on a relative fair value basis.
−Removed: The warrants were reported on the Consolidated Balance Sheets as a component of additional paid in capital within stockholders’ equity.
The Company recorded the related issue costs and value ascribed to the warrants as a debt discount of the Oaktree Note.
−Removed: The discount was amortized utilizing the effective interest method over the term of the Oaktree Note.
−Removed: The unamortized discount, if any, upon repayment of the Oaktree Note would be expensed to interest expense.
−Removed: 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.
−Removed: 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.
−Removed: Long-Lived Assets
+Added: The discount is being amortized utilizing the effective interest method over the term of the Oaktree Note which is approximately 16.08 % at December 31, 2021.
+Added: Impairment of Long-Lived Assets
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.
10 unchanged sentences
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.
−Removed: 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
1 unchanged sentence
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.
−Removed: Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases .
+Added: The Company accounts for its leases under ASC 842, Leases .
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.
6 unchanged sentences
Stock-Based Compensation
−Removed: 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.
−Removed: 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.
−Removed: Changes in the estimated fair value of these non-employee awards were recognized as compensation expense in the period of change.
−Removed: 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 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 occurrence.
The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model.
12 unchanged sentences
Management is currently unaware of any issues under review that could result in significant payments, accruals or material deviations from its position.
+Added: Earnings Per Share
+Added: Basic net income (loss) per share of common stock is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the reporting period.
+Added: Diluted earnings per share is calculated by dividing net income by the weighted-average number of shares of common stock outstanding during the reporting period after giving effect to dilutive potential common shares for stock options and restricted stock units, determined using the treasury stock method.
Non-Controlling Interests
1 unchanged sentence
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.
+Added: On March 31, 2021, the Company adopted a sequencing policy under ASC 815-40-35 Derivatives and Hedging (“ASC 815”) whereby in the event that reclassification of contracts from equity to assets or liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares as a result of certain securities convertible or exchangeable for a potentially indeterminable number of shares, shares will be allocated on the basis of the earliest issuance date of potentially dilutive instruments, with the earliest grants receiving the first allocation of shares.
+Added: Pursuant to ASC 815, grants or issuances of securities or options to the Company’s non-employees, employees or directors are not subject to the sequencing policy.
Comprehensive Loss
1 unchanged sentence
Recently Adopted Accounting Pronouncements
−Removed: 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: In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) .
+Added: This ASU reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange.
+Added: This ASU provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic.
+Added: It specifically addresses:
+Added: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange;
+Added: (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange;
+Added: and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange.
+Added: This ASU will be effective for all entities for fiscal years beginning after December 15, 2021.
+Added: An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments.
+Added: Early adoption is permitted, including adoption in an interim period.
+Added: The adoption of ASU 2021-04 is not expected to have a material impact on the Company’s consolidated financial statements or disclosures.
+Added: In August 2020, the FASB issued ASU No.
+Added: 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40):
+Added: Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity , which simplifies accounting for convertible instruments by removing major separation models required under current GAAP.
+Added: The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas.
This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2023.
−Removed: Early adoption is permitted upon issuance of the update.
−Removed: The Company adopted ASU No.
−Removed: 2018-13 as of January 1, 2020.
−Removed: The adoption of this update did not have a material impact on the Company’s consolidated financial statements.
−Removed: 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.
−Removed: 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.
−Removed: The changes take effect for public companies for fiscal years starting after December 15, 2018, including interim periods within that fiscal year.
−Removed: 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.
−Removed: Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606.
−Removed: The Company adopted ASU No.
−Removed: 2018-07 as of January 1, 2019.
−Removed: The adoption of this update did not have a material impact on the Company’s consolidated financial statements.
−Removed: 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):
−Removed: Accounting for Certain Financial Instruments with Down Round Features;
−Removed: Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception .
−Removed: Part I of this update addresses the complexity of accounting for certain financial instruments with down round features.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−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 periods within those years, beginning after December 15, 2018.
−Removed: The adoption of this ASU on January 1, 2019, did not have a material impact on the Company's consolidated financial statements.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842):
−Removed: 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.
−Removed: 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;
−Removed: 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.
−Removed: 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.
−Removed: Recent Accounting Pronouncements
−Removed: In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses” .
−Removed: 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.
−Removed: 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.
−Removed: This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years, with early adoption permitted.
−Removed: Recently, the FASB issued the final ASU to delay adoption for smaller reporting companies to calendar year 2023.
−Removed: The Company is currently assessing the impact of the adoption of this ASU on its consolidated financial statements.
+Added: Early adoption will be permitted.
+Added: The Company is currently evaluating the impact of this standard on its consolidated financial statements.
In December 2019, the FASB issued ASU No.
3 unchanged sentences
This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted.
−Removed: 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.
−Removed: Discontinued Operations
−Removed: 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.
−Removed: Pursuant to the terms of the agreement with NHC the sale of the shares was subject to two closings.
−Removed: 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.
−Removed: 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.
−Removed: At December 31, 2019, the Company had no ownership interest in National.
−Removed: The table below depicts the cash flows from the transaction for the year ended December 31, 2019:
−Removed: For the Year Ended
−Removed: ($ in thousands)
−Removed: Investing activities
−Removed: Proceeds from sale of National
−Removed: Total cash provided by discontinued investing activities
+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 consolidated financial statements.
+Added: In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses .
+Added: The ASU sets forth a current expected credit loss 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.
Collaboration and Stock Purchase Agreements
−Removed: Agreement with Alexion
−Removed: 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.
−Removed: ("Alexion"), the Company and Caelum security holders parties thereto (including Fortress, the "Sellers").
−Removed: Under the terms of the agreement, Alexion purchased a 19.9 % minority equity interest in Caelum for $ 30 million.
−Removed: 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.
−Removed: 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.
−Removed: Alexion’s 19.9 % ownership does not participate in the potential additional payments.
−Removed: The Company deconsolidated its holdings in Caelum immediately prior to the execution of the DOSPA.
−Removed: Following the DOSPA execution, the Company owns approximately 40 % of the issued and outstanding capital stock of Caelum.
−Removed: The following table provides a summary of the assets and liabilities of Caelum impacted by the deconsolidation:
−Removed: ($ in thousands)
−Removed: Current assets
−Removed: Cash and cash equivalents
−Removed: Prepaid expenses and other current assets
−Removed: Total current assets
−Removed: Current liabilities
−Removed: Accounts payable and accrued expenses
−Removed: Interest payable
−Removed: Interest payable - related party
−Removed: Note payable - related party
−Removed: Warrant liability
−Removed: Total current liabilities
−Removed: Net liability impacted by deconsolidation
−Removed: 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:
−Removed: deconsolidation of
−Removed: ($ in thousands)
−Removed: Fair value of Caelum
−Removed: Net liabilities deconsolidated
−Removed: Non-controlling interest share
−Removed: Write off of MSA fees due Fortress
−Removed: Gain on deconsolidation of Caelum
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: Agreement with AstraZeneca’s Alexion
+Added: In January 2019, Caelum, a subsidiary of the Company at that time, entered into a Development, Option and Stock Purchase Agreement (as amended, the "DOSPA") and related documents by and among Caelum, AstraZeneca as successor-in-interest to Alexion Therapeutics, Inc., the Company and Caelum’s other equity holders as parties thereto
+Added: (such equity holders, including Fortress, the "Sellers").
+Added: Under the terms of the agreement, AstraZeneca obtained a minority interest in Caelum and a contingent exclusive option to acquire the remaining equity in Caelum.
+Added: On September 28, 2021 AstraZeneca notified Caelum of its intention to exercise its purchase option, and on October 5, 2021 AstraZeneca acquired Caelum.
+Added: The Company received 42.4 % of the distribution of proceeds from the option exercise price of $ 150 million, approximately $ 56.9 million, which is net of the 10 % , 24-month escrow holdback and other miscellaneous transaction expenses.
+Added: The Sellers currently remain eligible to receive up to an additional $ 350 million in contingent regulatory and commercial milestone payments, of which Fortress is eligible to receive 42.4 % or approximately $ 148.6 million.
+Added: Agreement with Sentynl
+Added: On February 24, 2021, Cyprium entered into a development and contingent asset purchase agreement with Sentynl.
+Added: Pursuant to the terms of the agreement, Sentynl paid Cyprium an upfront fee of $ 8.0 million specifically earmarked to complete the CUTX-101 development program for the treatment of Menkes disease, through the filing of Cyprium’s New Drug Application (“NDA”) with the U.S.
+Added: Food and Drug Administration (“FDA”).
+Added: Cyprium also remains eligible to receive up to an additional $ 12.0 million payable as follows:
+Added: (i) $ 3.0 million upon acceptance by the FDA of the NDA for review;
+Added: and (ii) $ 9.0 million upon FDA approval of the NDA and transfer of CUTX-101 to Sentynl.
+Added: The Company will recognize revenue associated with these future milestones based upon achievement.
+Added: At December 31, 2021, none of these future milestones was deemed probable.
+Added: Following the transfer of CUTX-101 to Sentynl (if any), Cyprium would remain eligible to receive up to $ 255.0 million in additional sales milestone payments (payable pursuant to five milestones), as well as royalties on CUTX-101 net sales ranging from mid-single digits up to the mid-twenties.
+Added: Cyprium would retain 100 % ownership over any FDA Priority Review Voucher that may be issued at NDA approval for CUTX-101.
+Added: The Company determined that this agreement falls within the scope of ASC 606-10-15-3 and ASC 808-10-15-5A Revenue from Collaborative Arrangements (“ASC 808”) and as such the Company will recognize revenue in connection with achievement of two future development milestone payments.
+Added: In connection with the $ 8.0 million upfront payment to Sentynl, the Company is recognizing revenue using an input method based upon the costs incurred to date in relation to the total estimated costs to complete the development activities.
+Added: Accordingly, revenue is being recognized over the period in which the development activities are expected to occur.
+Added: For the year ended December 31, 2021, the Company recognized revenue of $ 5.4 million.
+Added: No revenue was recognized in connection with this agreement in 2020.
Agreement with InvaGen
1 unchanged sentence
(“InvaGen”), and Madison Pharmaceuticals Inc.
−Removed: (the “Merger Sub”), under which Avenue would be sold to InvaGen in a two-stage transaction.
−Removed: The first stage of the strategic transaction between InvaGen and Avenue closed in February 2019.
+Added: (the “Merger Sub”), which contemplated:
+Added: (i) the purchase by InvaGen of a 33.3 % stake in Avenue and;
+Added: (ii) the contingent sale of Avenue to InvaGen.
+Added: The first stage stock purchase closed in February 2019:
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.
−Removed: 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.
−Removed: 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”).
−Removed: 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.
−Removed: Avenue disagrees with InvaGen’s assertion that a Material Adverse Effect has occurred and has advised InvaGen of this position.
−Removed: In February 2020, the U.S.
−Removed: 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.
−Removed: In October 2020, Avenue announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding Avenue’s NDA for IV Tramadol.
−Removed: The FDA held a Type A meeting with Avenue in November 2020 to discuss the issues outlined in the CRL.
−Removed: On February 12, 2021 Avenue resubmitted its NDA to the FDA for IV Tramadol.
−Removed: The NDA resubmission followed the receipt of the official minutes from Avenue’s Type A meeting with the FDA.
−Removed: The NDA resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation.
−Removed: 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.
−Removed: 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.
−Removed: Avenue has notified InvaGen that it disagrees with InvaGen’s assertions.
−Removed: 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.
−Removed: Over the past several months, Avenue has communicated with InvaGen relating to InvaGen’s assertions.
−Removed: Nevertheless, InvaGen has communicated to Avenue its desire to consider all options on the proposed merger, including the option to not consummate the merger.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Any amounts drawn on the interim financing will be deducted from the aggregate consideration payable to Company stockholders by virtue of the Merger Transaction.
−Removed: There have been no amounts drawn upon this interim financing as of December 31, 2020.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: Under a contingent second stage closing, InvaGen may have acquired the remaining shares of Avenue’s capital stock (in some cases compulsorily and in some cases at InvaGen’s option), pursuant to a reverse triangular merger with Avenue remaining as the surviving entity.
+Added: On November 1, 2021, Avenue delivered InvaGen notice of termination of the Avenue SPMA, meaning that the second stage acquisition of Avenue by InvaGen pursuant to the Avenue SPMA is no longer possible.
+Added: Inventory consisted of the following:
+Added: ($ in thousands)
+Added: Raw materials
+Added: Finished goods
+Added: Total inventories
+Added: The acquired Qbrezxa finished goods inventory includes a fair value step-up of $ 6.5 million, which was fully expensed within cost of sales for the year ended December 31, 2021 as the inventory was sold to customers.
+Added: For additional information on Journey’s acquisition of Qbrexza, please refer to Note 9.
Property and Equipment
12 unchanged sentences
Fair Value Measurements
−Removed: 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.
−Removed: Fair Value of Caelum
−Removed: 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 .
−Removed: As of December 31, 2020, the following inputs were utilized to derive the value:
−Removed: 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.
−Removed: 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.
−Removed: 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: Fair Value of Investment in Caelum
+Added: The Company valued 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 .
As of December 31, 2020, the following inputs were utilized to derive the value:
−Removed: risk free rate of return of 1.6 %, volatility of 70 % and a discount for lack of marketability of 28.7 %.
−Removed: Caelum Warrant Liability
−Removed: 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).
−Removed: The fair value was measured using a Monte Carlo simulation valuation methodology.
−Removed: 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:
−Removed: Risk-free interest rate
−Removed: 2.905 % - 2.909
−Removed: Expected dividend yield
−Removed: Expected term in years
−Removed: Expected volatility
−Removed: 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).
−Removed: Fair Value of
+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 scenarios.
+Added: Further, the Company considered the impact of the acquisition of Alexion by AZ, which upon consummation would shorten the timeframe in which the option could be exercised in accordance with the A&R DOSPA.
+Added: Upon AstraZeneca’s notification of their intent to acquire Caelum in September 2021, the Company increase the carrying value of its investment in Caelum to 42.4 % of the distribution of proceeds from the option exercise price of $ 150 million, or $ 56.9 million.
+Added: Fortress received the funds at the acquisition close in October 2021.
+Added: The following table classifies Fortress’ financial instruments, measured at fair value on a recurring basis, into the fair value hierarchy on the Consolidated Balance Sheet as of December 31, 2020:
+Added: Fair Value Measurement as of December 31, 2020
($ in thousands)
−Removed: Beginning balance at January 1, 2019
−Removed: Issuance of warrant due to conversion of note
−Removed: Ending balance at December 31, 2019
−Removed: Caelum Convertible Notes
−Removed: Caelum’s convertible debt was measured at fair value using the Monte Carlo simulation valuation methodology.
−Removed: 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.
−Removed: As of December 31, 2018, conversion of the Caelum Convertible Notes was probable and as such the fair value approximated cost.
−Removed: The Caelum Convertible Notes were converted during 2019.
−Removed: As of January 2019 the following inputs were utilized to derive the notes’ fair value:
+Added: Fair value of investment in Caelum
+Added: Journey Placement Agent Warrant Liability
+Added: The fair value of Journey’s contingently issuable Placement Agent Warrants in connection with Journey’s preferred offering (see Note 10), 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 Journey’s warrant liability that are categorized within Level 3 of the fair value hierarchy was as follows:
Risk-free interest rate
2 unchanged sentences
Expected volatility
−Removed: Notes, at fair
−Removed: ($ in thousands)
−Removed: Beginning balance at January 1, 2019
−Removed: Change in fair value of convertible notes
−Removed: Ending balance at December 31, 2019
+Added: Upon the closing of the Journey Initial Public Offering (“Journey IPO”) (see note 14), Journey issued the Placement Agent Warrants to purchase 5 % of the shares of Journey common stock into which the Journey Preferred Stock converted.
+Added: The Placement Agent Warrants have a term of 5 years .
+Added: At December 31,2021, Journey issued 111,567 shares of Journey common stock related to the conversion of all of the placement agent warrants.
+Added: Journey Contingent Payment Warrant
+Added: In connection with the Journey license, collaboration, and assignment agreement (the “DFD Agreement”) to obtain the global rights for the development and commercialization of DFD-29 with Dr.
+Added: Reddy’s Laboratories, Ltd (“DRL”) (see Note 7), Journey agreed to pay DRL additional consideration upon either an IPO of the Company’s common stock or an acquisition of the Company, the agreement further specifies that only one payment can be made.
+Added: The contingent payment associated with an IPO of Journey’s common stock is deemed to be achieved if upon the completion of an IPO Journey’s market capitalization on a fully diluted basis is $ 150 million or greater at the close of business on the date of such Journey IPO.
+Added: The payment due for the achievement of the IPO criteria is a follows:
+Added: (a) issue to DRL a number of shares of Journey’s common stock equal to $ 5.0 million as calculated using a fifteen (15) day volume weighted average price (“VWAP”) of Journey’s closing price, measured fifteen (15) days following the Journey IPO;
+Added: or (b) make a cash payment to DRL equal to $ 5.0 million.
+Added: As a result of Journey’s IPO on November 16, 2021, the Company issued 545,131 unregistered shares of Journey common stock to DRL, calculated using a 15-day VWAP of $ 9.1721 per share.
+Added: The restrictions on the unregistered shares of common stock are governed by the terms set forth in the DFD-29 Agreement and applicable securities laws.
Cyprium Warrant Liability
−Removed: 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:
+Added: The fair value of the Cyprium Contingently Issuable Warrants in connection with the 2018 Venture Debt (see Note 10) 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
2 unchanged sentences
Expected volatility
−Removed: Probability of issuance of the warrant
−Removed: Issuable Warrant
−Removed: ($ in thousands)
−Removed: Beginning balance at January 1, 2019
−Removed: Change in fair value
−Removed: Ending balance at December 31, 2019
−Removed: Change in fair value
−Removed: Reclass partner company's warrants from liability to equity
−Removed: Ending balance at December 31, 2020
−Removed: 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:
−Removed: Fair Value Measurement as of December 31, 2020
−Removed: ($ in thousands)
−Removed: Fair value of investment in Caelum
−Removed: Fair Value Measurement as of December 31, 2019
−Removed: ($ in thousands)
−Removed: Fair value of investment in Caelum
−Removed: Fair Value Measurement as of December 31, 2019
−Removed: ($ in thousands)
−Removed: Warrant liabilities
The table below provides a roll forward of the changes in fair value of Level 3 financial instruments for the years ended December 31, 2021 and 2020:
1 unchanged sentence
($ in thousands)
+Added: Balance at January 1, 2020
+Added: Change in fair value of investment in Caelum
Balance at December 31, 2020
−Removed: Change in fair value
−Removed: Reclass partner company's warrants from liability to equity
−Removed: Change in fair value of investments
+Added: Change in fair value of investment in Caelum
+Added: Sale of Caelum
Balance at December 31, 2021
−Removed: Caelum Convertible
($ in thousands)
Balance at December 31, 2019
−Removed: Conversion of convertible notes
−Removed: Issuance of warrant
−Removed: Fair value of investment
+Added: Change in fair value
+Added: Reclass partner company's warrants from liability to equity
+Added: Balance at December 31, 2020
+Added: Journey contingent payment liability
+Added: Journey placement agent warrant
Change in fair value of derivative liability
+Added: Conversion of partner company derivative liabilities
Balance at December 31, 2021
4 unchanged sentences
For the years ended December 31, 2021 and 2020, the Company’s research and development-licenses acquired are comprised of the following:
−Removed: For the Year Ended
+Added: Year Ended December 31,
($ in thousands)
Partner companies:
−Removed: License Agreement with University of Massachusetts
−Removed: 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.
−Removed: For the year ended December 31, 2020, Aevitas recorded $ 0.1 million in connection with the execution of the UMass License.
−Removed: Development milestone payments totaling approximately $ 1.0 million in the aggregate are due upon achievement of each milestone.
−Removed: 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.
−Removed: License Agreement with Revogenex Ireland Ltd
−Removed: In 2015, the Company purchased an exclusive license to IV Tramadol for the U.S.
−Removed: market from Revogenex, a privately held company in Dublin, Ireland, for an upfront fee of $ 3.0 million.
−Removed: The Company then assigned all of its right, title and interest to the exclusive license to Avenue.
−Removed: 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.
−Removed: 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.
−Removed: In addition, royalty payments ranging from high single digit to low double digits are due on net sales of the approved product.
−Removed: No expense was recorded in connection with this agreement in 2020.
−Removed: For the year ended December 31, 2019, Avenue recorded $ 1.0 million in connection with the filing of its NDA for IV Tramadol.
−Removed: AstraZeneca AB License Agreement
−Removed: On December 17, 2019, Baergic entered into two license agreements:
−Removed: (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”);
−Removed: 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”).
−Removed: 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.
−Removed: In connection with the issuance of the shares, Baergic also provided AZ with anti-dilution protection up to $ 75 million.
−Removed: 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.
−Removed: Development milestone payments totaling approximately $ 75 million in the aggregate are due upon achievement of each milestone.
−Removed: 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.
−Removed: 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.
−Removed: Cincinnati Children’s License Agreement
−Removed: 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.
−Removed: In connection with the issuance of the shares, Baergic also provided Cincinnati with anti-dilution protection up to $ 15.0 million.
−Removed: 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.
−Removed: Two development milestone payments of approximately $ 6.5 million are payable upon milestone achievements.
−Removed: 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.
−Removed: 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.
−Removed: University of Texas Health Science Center at Houston License Agreement
−Removed: 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.
−Removed: 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.
−Removed: 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 secondary license with the University of Texas for a method and apparatus for conditioning cell populations for cell therapies (the “Second TBI License”).
−Removed: 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).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Dana-Farber Cancer Institute License Agreement
−Removed: 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.
−Removed: The portfolio of antibodies licensed from Dana-Farber include antibodies targeting PD-L1, 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 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 raised $ 10.0 million in cash in exchange for common shares.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Dana-Farber receives an annual license maintenance fee of $ 50,000 , which is creditable against future milestone payments or royalties.
−Removed: The portfolio of antibodies licensed from Dana-Farber include antibodies targeting PD-L1, GITR and CAIX.
−Removed: 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.
−Removed: 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.
−Removed: Under the terms of the original agreement, TGTX paid Checkpoint $ 0.5 million, representing an upfront licensing fee.
−Removed: Upon the signing of the amended and restated collaboration agreement in June 2019, TGTX paid Checkpoint an additional $ 1.0 million upfront licensing fee.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Checkpoint also receives an annual license maintenance fee, which is creditable against future milestone payments or royalties.
−Removed: TGTX also pays Checkpoint for its out-of-pocket costs of material used by TGTX for their development activities.
−Removed: 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.
−Removed: 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.
−Removed: Adimab, LLC Collaboration Agreement
−Removed: In October 2015, Fortress entered 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 agreement directly with Adimab on the same day.
−Removed: 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.
−Removed: In addition, Adimab is eligible to receive royalty payments based on a tiered low single digit percentage of net sales.
−Removed: NeuPharma, Inc.
−Removed: License Agreement
−Removed: In March 2015, the Company entered into an exclusive license agreement with NeuPharma, Inc.
−Removed: (“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).
−Removed: 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 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.
−Removed: 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.
−Removed: Jubilant Biosys Limited License Agreement
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: TGTX also pays Checkpoint for 50 % of IND enabling costs and patent expenses.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The performance obligations of the original agreements were satisfied prior to the adoption of Topic 606.
−Removed: The performance obligation of the amendment to the collaboration agreement was satisfied in June 2019.
−Removed: The milestone payments are based on successful achievement of clinical development, regulatory, and sales milestones.
−Removed: 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.
−Removed: The sales-based royalty payments are recognized as revenue when the subsequent sales occur.
−Removed: 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.
−Removed: Revenue is recognized approximately when the amounts become due because it relates to an already satisfied performance obligation.
−Removed: 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.
−Removed: For the year ended December 31, 2019, Checkpoint did no t receive any milestone or royalty payments.
−Removed: License Agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development
−Removed: 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.
−Removed: 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 .
−Removed: Cyprium made an upfront payment 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 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.
−Removed: 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.
−Removed: 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.
−Removed: For the years ended December 31, 2020 and 2019, no expense was recorded in connection with this license.
−Removed: License Agreement with the City of Hope
−Removed: Helocyte entered into the original license agreement with City of Hope National Medical Center (“COH”) on March 31, 2015, to secure:
−Removed: (i) an exclusive worldwide license for two immunotherapies for Cytomegalovirus (“CMV”) control in the post-transplant setting (known as Triplex and PepVax).
−Removed: In consideration for the license and option, Helocyte made an upfront payment of $ 0.2 million.
−Removed: In March 2016, Helocyte entered into amended and restated license agreements for each of its PepVax and Triplex immunotherapies programs with its licensor COH.
−Removed: 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.
−Removed: In 2018, Helocyte discontinued the development of PepVax and terminated the related license and clinical trial agreements with COH.
−Removed: 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.
−Removed: To date Helocyte has completed a Phase 2 clinical trial program for Triplex.
−Removed: In April 2015, Helocyte secured the exclusive worldwide rights to an immunotherapy for the prevention of congenital CMV:
−Removed: ConVax (formerly Pentamer) from COH for an upfront payment of $ 45,000 .
−Removed: 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.
−Removed: 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.
−Removed: License with the National Institute of Allergy and Infectious Disease (NIAD)
−Removed: 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.
−Removed: 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 .
−Removed: 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.
−Removed: 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: On June 29, 2021, Journey entered into a license, collaboration, and assignment agreement (the “DFD Agreement”) to obtain the global rights for the development and commercialization of DFD-29 with DRL.
+Added: Journey paid $ 10.0 million, of which $ 2.0 million was paid upon execution and $ 8.0 million was paid on September 29, 2021.
+Added: Additional contingent regulatory and commercial milestone payments totaling up to $ 163.0 million are also payable.
+Added: Royalties ranging from approximately 10 % to approximately 15 % are payable on net sales of the DFD-29 product.
+Added: Additionally, Journey is required to fund and oversee the Phase 3 clinical trials at a cost approximating $ 24.0 million, based upon the current development plan and budget.
+Added: The DFD Agreement also included contingent payments to be made to DRL in the event of a Journey IPO or the sale of Journey, See Note 6.
+Added: The fair value of the contingent payment was deemed to be $ 3.8 million, and was recorded in research and development, licenses acquired expense for the year ended December 31, 2021.
+Added: In connection with the closing of Journey’s IPO on November 16, 2021, Journey issued 545,131 unregistered shares of Journey Medical Inc.
+Added: common stock to DRL to settle the obligation, calculated using a 15 -day volume weighted average price (“VWAP”) of $ 9.1721 per share.
For the years ended December 31, 2021 and 2020 Mustang recorded the following expense in research and development – licenses acquired:
6 unchanged sentences
PSCA (MB-105)
−Removed: Fred Hutch - CD20 (MB-106) 2
−Removed: Nationwide Children’s Hospital - C134 (MB-108)
−Removed: CSL Behring (Calimmune)
−Removed: SIRION LentiBOOST TM
−Removed: License Agreement with City of Hope
−Removed: 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”).
−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 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.
−Removed: 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.
−Removed: Future mid-single 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 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.
−Removed: 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.
−Removed: CD123 License with City of Hope (MB-102)
−Removed: Pursuant to the CD123 License, Mustang and COH acknowledge that an upfront fee was paid under the COH License.
−Removed: In addition, an annual maintenance fee will continue to apply.
−Removed: COH is eligible to receive up to approximately $ 14.5 million in milestone payments upon and subject to the achievement of certain milestones.
−Removed: Royalty payments in the mid-single digits are due on net sales of licensed products.
−Removed: 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.
−Removed: In addition, equity grants made under the COH License were acknowledged, and the anti-dilution provisions of the COH License were carried forward.
−Removed: 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.
−Removed: 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.
−Removed: Nationwide Children’s Hospital License Agreement (MB-108)
−Removed: 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”).
−Removed: Mustang intends to combine MB-108 with MB-101 (IL13Rα2-specific CAR T) to potentially enhance efficacy in treating GBM.
−Removed: There were no expenses recorded in 2020 in connection with this license.
−Removed: 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.
−Removed: Additional payments are due to Nationwide upon achievement of development and commercialization milestones totaling $ 152.8 million.
−Removed: Royalty payments in the low-single digits are due on net sales of licensed products.
−Removed: CS1 License with City of Hope (MB-104)
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: PSCA License with City of Hope (MB-105)
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: CSL Behring (Calimmune) License (MB-107)
−Removed: 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.
−Removed: Mustang had previously licensed the XSCID gene therapy program from St.
−Removed: Jude in August 2018.
−Removed: Mustang paid $ 0.2 million in consideration for the Calimmune license.
−Removed: CSL Behring is eligible to receive additional payments totaling $ 1.2 million upon the achievement of three development and commercialization milestones.
−Removed: Royalty payments in the low-single digits are due on net sales of licensed products.
−Removed: 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.
−Removed: University of California License
−Removed: 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.
−Removed: Pursuant to the UCLA License, Mustang paid UCLA an upfront fee of $ 0.2 million on April 25, 2017.
−Removed: Annual maintenance fees also apply;
−Removed: 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.
−Removed: 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.
−Removed: There were no expenses recorded in 2020 in connection with this license.
−Removed: HER2 License with City of Hope (MB-103)
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Jude Children’s Research Hospital License (MB-107 and MB-207)
−Removed: On August 2, 2018, Mustang entered into an exclusive worldwide license agreement with St.
−Removed: Jude for the development of a first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (“XSCID”).
−Removed: 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).
−Removed: Jude is eligible to receive payments totaling $ 13.5 million upon the achievement of five development and commercialization milestones.
−Removed: Royalty payments in the mid-single digits are due on net sales of licensed products.
−Removed: During the years ended December 31, 2020 and 2019 Mustang did no t record any expenses in connection with this license.
−Removed: Manufacturing License with City of Hope
−Removed: 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.
−Removed: 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.
−Removed: Royalty payments in the low-single digits are due on net sales of licensed products.
−Removed: During the years ended December 31, 2020 and 2019, respectively, Mustang recorded no expense in connection with the COH license.
−Removed: IL13Rα2 License with City of Hope (MB-101)
−Removed: Pursuant to the IL13Rα2 License, Mustang and COH acknowledge that an upfront fee was paid under the Original License.
−Removed: In addition, an annual maintenance fee will continue to apply.
−Removed: COH is eligible to receive up to approximately $ 14.5 million in milestone payments upon and subject to the achievement of certain milestones.
−Removed: Royalty payments in the mid-single digits are due on net sales of licensed products.
−Removed: 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.
−Removed: In addition, equity grants made under the Original License were acknowledged, and the anti-dilution provisions of the Original License were carried forward.
−Removed: 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.
−Removed: There was no expense recorded for the year ended December 31, 2019.
−Removed: Spacer License with City of Hope
−Removed: Pursuant to the Spacer License, Mustang and COH acknowledge that an upfront fee was paid under the Original License.
−Removed: In addition, an annual maintenance fee will continue to apply.
−Removed: 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.
−Removed: Mustang is obligated to pay COH a percentage (in the mid-thirties) of certain revenues received in connection with a sublicense.
−Removed: In addition, equity grants made under the Original License were acknowledged, and the anti-dilution provisions of the Original License were carried forward.
−Removed: 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.
−Removed: There was no expense recorded for the year ended December 31, 2019.
−Removed: IV/ICV Agreement with City of Hope
−Removed: 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.
−Removed: Pursuant 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 $ 0.1 million in milestone payments upon the achievement of a certain milestone as well as an annual maintenance fee.
−Removed: Royalty payments in the low-single digits are due on net sales of licensed products and services.
−Removed: During the years ended December 31, 2020 and 2019, Mustang recorded no expense in connection with the IV/ICV Agreement.
−Removed: Fred Hutchinson Cancer Research Center License (MB-106)
−Removed: 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”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Harvard College License
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: During the years ended December 31, 2020 and 2019, Mustang recorded no expense in connection with the Harvard Agreement.
−Removed: Mustang terminated the Harvard Agreement in January 2020.
−Removed: SIRION Biotech GmbH - LentiBOOST TM (MB-207)
−Removed: 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”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: For the year ended December 31, 2020, Mustang expensed an up-front payment of $ 0.1 million.
−Removed: There was no expense recorded for the year ended December 31, 2019.
−Removed: 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”).
−Removed: The proprietary platform produces oligomers, known as “ONCOlogues.”
−Removed: 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.
−Removed: In connection with the share transfer, Oncogenuity also provided Columbia with limited anti-dilution protection.
−Removed: 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.
−Removed: 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).
−Removed: 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.
−Removed: The common shares were equity-classified.
−Removed: 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.
−Removed: 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.
−Removed: Additional milestone payments totaling up to $ 15.3 million in the aggregate are due in connection with product development milestones for subsequent indications.
−Removed: 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.
−Removed: 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.
−Removed: Licenses with the University of North Carolina
−Removed: On November 30, 2017, Tamid entered 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 1 (MPS1), dysferlinopathies and corneal transplant rejections.
−Removed: The three therapies were developed in the lab of Matthew Hirsch, Ph.D., Assistant Professor, Ophthalmology at the UNC Gene Therapy center.
−Removed: In December 2019, Tamid discontinued the development of all three candidates and terminated the related licenses and clinical trial agreements with UNC.
−Removed: For the years ended December 31, 2020 and 2019, Tamid recorded no expense in connection with these licenses.
+Added: Fred Hutchinson Cancer Research Center - CD20 (MB-106)
+Added: Leiden University Medical Centre (MB-110)
+Added: CSL Behring (Calimmune) (MB-107)
+Added: SIRION Biotech LentiBOOST TM (MB-207)
+Added: Partner Companies
+Added: The Company’s partner companies have entered into various license agreements with other medical centers.
+Added: These license agreements include upfront payments which are expensed and various d evelopmental milestone payments due upon achievement of various milestones which in the aggregate are approximately $ 480.4 million, of which $ 335.4 million relates to Mustang agreements.
+Added: The license agreements also have sales-based milestone payments that total approximately $ 226.1 million.
+Added: The agreements also include royalty payments on any future sales .
Sponsored Research and Clinical Trial Agreements
−Removed: For the Year Ended December 31,
−Removed: ($ in thousands)
−Removed: UMass - adeno-associated virus ("AAV")
−Removed: 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.
−Removed: 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, Aevitas paid $ 0.8 million which was due upon execution.
−Removed: 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.
−Removed: 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.
−Removed: The expense was recorded in research and development expenses in the Company’s Consolidated Statement of Operations.
−Removed: 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.
−Removed: The total 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 which was due upon execution.
−Removed: 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.
−Removed: The expense was recorded in research and development expenses in the Company’s Consolidated Statement of Operations.
−Removed: On September 1, 2019, Aevitas entered into a Sponsored Research Arrangement (“SRA”) with Duke University School of Medicine (“Duke”).
−Removed: 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.
−Removed: 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.
−Removed: In connection with this agreement Cellvation agreed to fund $ 0.8 million of research quarterly through March 31, 2018.
−Removed: The agreement was revised effective May 1, 2017, with quarterly payments extended through December 31, 2018.
−Removed: 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.
−Removed: 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 years ended December 31, 2021 and 2020, the Company recorded $ 7.8 million and $ 9.2 million, respectively, in research and development expenses in the Company’s Consolidated Statement of Operations pursuant to the terms of various sponsored research and clinical trial agreements.
+Added: The breakout of this expense by partner company is as follows:
For the Year Ended December 31,
($ in thousands)
−Removed: City of Hope National Medical Center
−Removed: CD123 (MB-102)
−Removed: IL13Rα2 (MB-101)
−Removed: Manufacturing
−Removed: HER2 (MB-103)
−Removed: PSCA (MB-105)
−Removed: Beth Israel Deaconess Medical Center - CRISPR
−Removed: Jude Children's Research Hospital - XSCID (MB-107)
−Removed: Fred Hutchinson Cancer Research Center - CD20 (MB-106)
−Removed: City of Hope Sponsored Research Agreement
−Removed: 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.
−Removed: The research covered under this arrangement is for IL13Rα2 (MB-101), CD123 (MB-102) and the Spacer technology.
−Removed: 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.
−Removed: CD123 (MB-102) Clinical Research Support Agreement
−Removed: On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for CD123.
−Removed: 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.
−Removed: 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, 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.
−Removed: CS1(MB-104) Clinical Research Support Agreement
−Removed: 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:
−Removed: "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."
−Removed: The CAR T being studied under this protocol has been designated by Mustang as MB-104.
−Removed: Under the terms of the agreement Mustang will reimburse COH for costs associated with this trial not to exceed $ 2.4 million.
−Removed: The agreement will expire upon the delivery of the final study report or earlier.
−Removed: 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.
−Removed: IL13Rα2 (MB-101) Clinical Research Support Agreements
−Removed: On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for IL13Rα2 (the “IL13Rα2 GBM CRA”).
−Removed: 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.
−Removed: Further, Mustang agreed to fund approximately $ 0.2 million over three years pertaining to the clinical development of IL13Rα2.
−Removed: 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”).
−Removed: 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.
−Removed: Further, the Company agreed to fund approximately $ 0.2 million annually pertaining to the clinical development of IL13Rα2.
−Removed: 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.
−Removed: HER2 (MB-103) Clinical Research Support Agreement
−Removed: 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:
−Removed: “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.
−Removed: 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.
−Removed: The agreement will expire upon the delivery of a final study report or earlier.
−Removed: 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.
−Removed: PSCA (MB-105) Clinical Research Support Agreement
−Removed: 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:
−Removed: “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.
−Removed: 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.
−Removed: The agreement will expire upon the delivery of a final study report or earlier.
−Removed: 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.
−Removed: City of Hope Sponsored Research Agreement - Manufacturing
−Removed: On January 3, 2018, Mustang entered into a Sponsored Research Agreement (“SRA”) with COH to optimize and develop CAR T cell processing procedures.
−Removed: 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.
−Removed: The SRA expired in January 2020.
−Removed: 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.
−Removed: CRISPR Sponsored Research Agreement with Beth Israel Deaconess Medical Center, Inc.
−Removed: On November 28, 2017, Mustang entered into a Sponsored Research Agreement with Beth Israel Deaconess Medical Center Inc.
−Removed: (“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.
−Removed: Mustang agreed to fund approximately $ 0.8 million over a three-year period.
−Removed: 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.
−Removed: In January 2019, Mustang terminated the SRA with BIDMC due to the departure of key personnel from BIDMC.
−Removed: CD20 (MB-106) Clinical Trial Agreement with Fred Hutch
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: CD20 (MB-106) Sponsored Research Agreement – Manufacturing with Fred Hutch
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: XSCID (MB-107) Data Transfer Agreement with St.
−Removed: In June 2020, Mustang entered into a Data Transfer Agreement with St.
−Removed: Jude under which Mustang will reimburse St.
−Removed: Jude for costs associated with St.
−Removed: Jude’s clinical trial for the treatment of infants with XSCID.
−Removed: 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.
−Removed: Mustang will continue to reimburse St.
−Removed: Jude for costs incurred in connection with this trial.
−Removed: MB-107 (XSCID) Non-Interventional Services Agreement with Children’s CGMP
−Removed: In December 2019, Mustang entered into a Non-Interventional Services Agreement with Children's CGMP, LLC ("Children’s"), an affiliate of St.
−Removed: 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.
−Removed: 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.
−Removed: Columbia Sponsored Research Agreement
−Removed: 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;
−Removed: such payments not to exceed $ 4.8 million.
−Removed: 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.
−Removed: No expense was recorded in 2019.
−Removed: University of Oxford Sponsorship Agreement
−Removed: On December 16, 2020 Oncogenuity entered into an agreement with The Chancellor Masters and Scholars of the University of Oxford (“Oxford”).
−Removed: Under the terms of the agreement Oxford will engage in preclinical development of antisense oligonulcleotides as a therapy in certain indications.
−Removed: In connection with the agreement Oncogenuity agreed to fund research for approximately 18 months for up to of $ 0.6 million ( £ 0.4 million).
−Removed: Oncogenuity made an up-front payment of $ 0.1 million ( £ 0.1 million) in January 2021.
−Removed: 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.
−Removed: Total amount to be funded by Tamid under the UNC SRA is $ 2.3 million over a term of three years .
−Removed: 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, 2020 and 2019, Tamid recorded expense of nil and nil respectively in connection with the UNC SRA.
−Removed: The expense was recorded in research and development expenses in the Company’s Consolidated Statements of Operations.
−Removed: Effective December 2019, Tamid returned the license to UNC and ceased to incur costs associated with the development of products under this license.
−Removed: 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: On March 31, 2021, Journey executed an Asset Purchase Agreement (the “Qbrexza APA”) with Dermira, Inc.
+Added: a subsidiary of Eli Lilly and Company (“Dermira”).
+Added: Pursuant to the terms of the agreement, Journey acquired the rights to Qbrexza® (glycoprronium), a prescription cloth towelette to treat primary axillary hyperhidrosis in patients nine years of age or older.
+Added: Upon HSR acceptance, which was received on May 13, 2021, Journey paid the upfront fee of $ 12.5 million to Dermira.
+Added: In addition, Dermira is eligible to receive up to $ 144 million in the aggregate upon the achievement of certain sales milestones.
+Added: The royalty structure for the agreement is tiered with royalties for the first two years ranging from approximately 40 % to 30 %.
+Added: Thereafter for a period of eight years royalties are approximately 12.0 % to 19.0 %.
+Added: Royalty amounts are subject to 50 % diminution in the event of loss of exclusivity due to the introduction of an authorized generic.
+Added: Upon closing of the Qbrexza® purchase, Journey became substituted for Dermira as the plaintiff in U.S.
+Added: patent litigation commenced by Dermira on October 21, 2020 in the U.S.
+Added: District Court of Delaware (the “Patent Litigation”) against Perrigo Pharma International DAC (“Perrigo”) alleging infringement of certain patents covering Qbrexza® (the “Qbrexza® Patents”), which are included among the proprietary rights to Qbrexza®.
+Added: The Patent Litigation was initiated following the submission by Perrigo, in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), of an Abbreviated New Drug Application (“ANDA”).
+Added: The ANDA seeks approval to market a generic version of Qbrexza® prior to the expiration of the Qbrexza® Patents and alleges that the Qbrexza® Patents are invalid.
+Added: Perrigo is subject to a 30-month stay preventing it from selling a generic version, but that stay is set to expire on March 9, 2023.
+Added: Trial in the Patent Litigation is scheduled for September 19, 2022.
+Added: The Company cannot make any predictions about the final outcome of this matter or the timing thereof.
+Added: The purchase price of $ 12.5 million included the asset Qbrexza as well as finished goods and raw material inventory.
+Added: Journey also has the obligation to accept any product returns related to sales made by Dermira.
+Added: Journey allocated the upfront payment to inventory since the fair value of the inventory and Qbrexza rights exceeded the purchase price.
+Added: The future contingent milestone payments, if achieved, will be recorded to intangible asset and amortized over the seven-year life of the asset commencing on the closing date.
+Added: In 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”).
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.
There are no subsequent milestone payments or royalties beyond the aforementioned payments.
−Removed: Commercial launch of this product is expected in the third quarter of 2021.
−Removed: The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805):
−Removed: 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 .
−Removed: 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”).
−Removed: 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:
−Removed: $ 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: Commercial launch of this product is expected in the first half of 2022.
+Added: On July 29, 2020, Journey entered into a license and supply agreement for Accutane® (“Accutane Agreement”) with DRL.
+Added: Pursuant to the Accutane Agreement, Journey agreed to pay $ 5.0 million, comprised of an upfront payment of $ 1.0 million paid upon execution, with additional milestone payments totaling $ 4.0 million.
Three additional milestone payments totaling $ 17.0 million are contingent upon the achievement of certain net sales milestones.
Royalties in the low-double digits based on net sales, subject to specified reductions are also due.
−Removed: Commercial launch of this product is expected in the second quarter of 2021.
−Removed: The Company, in accordance with ASU 2017-01, Business Combinations (Topic 805):
−Removed: 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 .
−Removed: On July 22, 2019 Journey purchased Ximino®, a minocycline hydrochloride used to treat acne from a third party.
−Removed: 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.
−Removed: The remaining four payments totaling $ 7.0 million are due in consecutive years commencing on the second anniversary of execution of the APA.
−Removed: In addition, Journey is obligated to pay 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, Business Combinations (Topic 805):
−Removed: 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 .
−Removed: 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.
−Removed: In accordance with the terms of the APA Journey will incur interest expense in the event of payment default.
−Removed: As such per ASC 835-30 Interest-Imputed Interest, Journey recorded an initial discount for imputed interest of $ 2.3 million.
−Removed: 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.
−Removed: 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.
−Removed: This acquisition was recorded as an intangible asset and expense will be recognized over the expected life of Exelderm® of 3 years .
−Removed: JMC commenced the sale of Exelderm® in September 2018 and accordingly commenced the amortization of this cost.
−Removed: 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 .
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: JMC made an upfront payment of $ 1.3 million.
−Removed: Further payments will be made based on a revenue sharing arrangement.
−Removed: JMC received FDA approval for the manufacturing of this product in July 2016 and commenced sales of this product in October 2016.
+Added: The term of the agreement is ten years and renewable upon mutual agreement.
+Added: Journey is required to pay royalties during the term of the agreement.
+Added: The agreement contains customary representations, warranties, and indemnities.
+Added: Each party may also terminate the agreement for material breach by the other party or for certain bankruptcy or insolvency related events and Journey may terminate for upon 180 days written notice to the other party.
The table below provides a summary of intangible assets as of December 31, 2021 and 2020, respectively:
10 unchanged sentences
Beginning balance at December 31, 2019
−Removed: Purchase of Ximino 1
−Removed: Amortization expense
−Removed: Beginning balance at December 31, 2019
−Removed: Isotretinoin Agreement 2
Anti-itch product license acquisition 2
1 unchanged sentence
Ending balance at December 31, 2020
−Removed: 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.
−Removed: Such payments were discounted by $ 2.3 million as a result of the long-term nature of such payments.
+Added: Exelderm milestone
+Added: Amortization expense
+Added: Ending balance at December 31, 2021
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.
Such payments were discounted by $ 0.3 million as a result of the long-term nature of such payments.
−Removed: 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.
−Removed: Journey expects the asset to be placed in service in the first half of 2021.
−Removed: Once the asset is placed in service Journey will amortize the asset over five years , which represents its expected useful life.
Includes an upfront payment of $ 0.2 million and three payments totaling $ 2.8 million in 2021 and $ 1.0 million in 2022.
1 unchanged sentence
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.
−Removed: The Company expects to launch this asset in Q3 2021.
+Added: The Company expects to launch this asset in the first half of 2022.
Once the asset is placed in service Journey will amortize the asset over three years , which represents its expected useful life.
5 unchanged sentences
Year ended December 31, 2025
−Removed: Year Ended December 31, 2025
−Removed: Intangible assets not yet placed in service
+Added: Assets not yet placed in service:
+Added: Anti-itch product license acquisition
Debt and Interest
2 unchanged sentences
Interest rate
−Removed: 2017 Subordinated Note Financing 3
−Removed: 2017 Subordinated Note Financing 3
−Removed: 2017 Subordinated Note Financing 3
−Removed: 2017 Subordinated Note Financing 3
−Removed: August - 2022
−Removed: 2017 Subordinated Note Financing 3
−Removed: September - 2022
−Removed: 2018 Venture Notes 4
−Removed: August - 2021
−Removed: 2018 Venture Notes 4
−Removed: September - 2021
−Removed: September - 2021
−Removed: Mustang Horizon Notes 2
−Removed: October - 2022
+Added: Total notes payable - Oaktree Note
August - 2025
−Removed: Total notes payable
Discount on notes payable
+Added: Repayment of Oaktree Note
Total notes payable
−Removed: Formerly the Opus Credit Facility (see Note 17).
−Removed: Interest rate is 9.0 % plus one-month LIBOR Rate in excess of 2.5 %;
−Removed: at December 31, 2019, $ 1.2 million is included in Notes payable, short-term on the Consolidated Balance Sheet.
−Removed: 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: At December 31, 2019, $ 6.0 million is included in Notes payable, short-term on the Consolidated Balance Sheet.
−Removed: 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.
−Removed: 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: On August 27, 2020 (the “Closing Date”), Fortress, as borrower, entered into a $ 60.0 million senior secured credit agreement with Oaktree (the “Oaktree Agreement” and the debt thereunder, the “Oaktree Note”) .
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”).
3 unchanged sentences
No amounts paid or prepaid may be reborrowed without Oaktree consent.
+Added: AstraZeneca’s notification of its intent to acquire Caelum, received on September 28, 2021, is defined in the Oaktree Agreement as a monetization event and as such, triggered a $ 10 million prepayment and an applicable prepayment fee of $ 0.5 million.
+Added: The prepayment fee of $ 0.5 million is included in interest expense for the year ended December 31, 2021.
+Added: The Company paid the $ 10.5 million on October 12, 2021.
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.
11 unchanged sentences
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.
−Removed: 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: None of Fortress’ subsidiaries or partner companies is a party to the Oaktree Agreement, and the collateral package does not include the assets of any such subsidiaries or partner companies.
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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: These costs will be amortized over the term of the Oaktree Note.
−Removed: On February 13, 2014, the Company executed a promissory note in favor of IDB in the amount of $ 15.0 million (the “IDB Note”).
−Removed: The Company borrowed $ 14.0 million against this note and used it to repay its prior loan from Hercules Technology Growth Capital, Inc.
−Removed: 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).
−Removed: All amounts advanced under the IDB Note were due in full at the earlier of:
−Removed: (i) August 1, 2020, as extended or (ii) on the IDB’s election following the occurrence and continuation 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 on the Company’s money market account plus a margin of 150 basis points.
−Removed: The interest rate at December 31, 2019 was 2.25 %.
−Removed: The IDB Note contains various representations and warranties customary for financings of this type.
−Removed: 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”).
−Removed: 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.
−Removed: The Pledge Agreement contained various representations, warranties, and covenants customary for pledge agreements of this type.
−Removed: The Company could default on the IDB Note if, among other things, it failed to pay outstanding principal or interest when due.
−Removed: Following the occurrence of an event of default under the IDB Note, the Bank may:
−Removed: (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;
−Removed: (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;
−Removed: (iii) terminate the commitments of IDB;
−Removed: and (iv) liquidate the money market account to reduce the Company’s obligations to IDB.
−Removed: On September 18, 2017, the maturity on the IDB Note was extended to August 1, 2020 .
−Removed: 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 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.
−Removed: The Company only paid interest on the IDB Note through maturity.
−Removed: 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.
−Removed: At December 31, 2020 and 2019, the Company had approximately nil and $ 14.9 million, respectively, outstanding under its promissory note with IDB.
−Removed: 2019 Notes (formerly the Opus Credit Facility)
−Removed: On September 14, 2016, Fortress entered 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 President, Strategic Development (Michael S.
−Removed: 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”).
−Removed: 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”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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”).
−Removed: Fortress may terminate the Opus Credit Facility upon notice to the Lenders and payment of all outstanding obligations under the Credit Facility Agreement.
−Removed: 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;
−Removed: 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 .
−Removed: The Warrants 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 OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Fortress retains the ability to prepay the Notes at any time without penalty.
−Removed: The notes payable under the A&R Opus Credit Facility continue to bear interest at 12 % per annum.
−Removed: The A&R Opus Credit Facility was accounted for as a debt modification for the year ended December 31, 2018.
−Removed: On July 18, 2019, Fortress issued 396,825 common shares of Fortress at $ 1.26 per share to Dr.
−Removed: The shares were issued as a prepayment by Fortress of $ 500,000 of debt owed to Dr.
−Removed: Rosenwald that was held in the name of OPHIF.
−Removed: 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.
−Removed: Effective December 31, 2019, OPHIF dissolved and distributed it assets among its limited partners.
−Removed: Following the distribution, the $ 9.0 million facility comprised of separate notes (collectively, the “2019 Notes”) held by DAK Capital Inc.
−Removed: ($ 3.8 million);
−Removed: Fortress’ Chairman, President and Chief Executive Officer Lindsay A.
−Removed: Rosenwald, M.D.
−Removed: ($ 0.3 million);
−Removed: Fortress's Executive Vice President, Strategic Development Michael S.
−Removed: Weiss ($ 2.0 million);
−Removed: and various entities and individuals affiliated with Dr.
−Removed: Rosenwald and Mr.
−Removed: Weiss ($ 2.9 million).
−Removed: The terms of the 2019 Notes did not change in connection with such reallocations.
−Removed: 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.
−Removed: As of December 31, 2020 and 2019, nil and $ 9.0 million, respectively, was outstanding under the 2019 Notes.
+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, and 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: 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, to be amortized over the term of the Oaktree Note.
+Added: For the years ended December 31, 2021 and 2020, the Company amortized $ 1.3 million and $ 0.4 million, respectively, of debt discount associated with the Oaktree Note.
+Added: Debt Repayment
+Added: In August 2020, in connection with the Oaktree Note, the Company repaid the following indebtedness:
+Added: the 2018 Venture Notes in the amount of $ 21.7 million, 2019 Notes (formerly the Opus Credit Facility) in the amount of $ 9.0 million and the 2017 Subordinated Notes in the amount of $ 28.4 million.
+Added: Additionally the Company repaid its IDB Note of $ 14.0 million by utilizing the restricted cash securing the note.
+Added: For the year ended December 31, 2020, the Company incurred interest expense related to the accelerated amortization of the debt discount associated with the aforementioned debt payoff.
+Added: Interest expense included $ 1.2 million 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 expensed at the time of the debt repayment.
+Added: Mustang Horizon Notes
+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.
IDB Letters of Credit
−Removed: The Company has several letters of credit (“LOC”) with IDB securing rent deposits for lease facilities totaling approximately $ 1.6 million.
+Added: The Company has several letters of credit (“LOC”) with IDB securing rent deposits for lease facilities totaling approximately $ 2.2 million and $ 1.6 million as of December 31, 2021 and December 31, 2020, respectively.
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.
−Removed: 2017 Subordinated Note Financing
−Removed: 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.
−Removed: The Notes bear interest at the rate of 8 % per annum;
−Removed: 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.
−Removed: 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.
−Removed: 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).
−Removed: 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.
−Removed: 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.
−Removed: 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”).
−Removed: The Placement Agent Warrants are exercisable immediately at such closing share price for a period of five years .
−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 capital stock in a private financing, subject to certain exceptions, and will also have the right to participate as an investor in subsequent financings.
−Removed: On March 31, 2017, the Company held its first closing of the 2017 Subordinated Note Financing and received gross proceeds of $ 3.2 million.
−Removed: 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 .
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: As of December 31, 2020 and 2019, nil and $ 28.4 million, respectively, was outstanding under the 2017 Subordinated Note Financing.
−Removed: 2018 Venture Notes
−Removed: 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.
−Removed: 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.
−Removed: 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 six months.
−Removed: No principal amount will be due for the first 24 months (or the first 30 months if the maturity date is extended).
−Removed: 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: 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 .
−Removed: NSC acted as the sole placement agent for 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 with its placement of the 2018 Venture Notes.
−Removed: 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”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: As of December 31, 2020 and 2019, nil and $ 21.7 million, respectively, was outstanding under the 2018 Venture Notes.
−Removed: Mustang Horizon Notes
−Removed: 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".
−Removed: 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.
−Removed: Each advance under the Mustang Horizon Notes will mature 42 months from the first day of the month following the funding of the advance.
−Removed: The first three advances will mature on October 1, 2022 (the "Loan Maturity Date").
−Removed: 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 %.
−Removed: The Loan Agreement provides for interest-only payments commencing May 1, 2019, through and including October 1, 2020.
−Removed: 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).
−Removed: Thereafter, commencing May 1, 2021, amortization payments will be payable monthly in eighteen installments of principal and interest.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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).
−Removed: If an event of default occurs, Horizon is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement.
−Removed: The Loan Agreement also contains warrant coverage of 5 % of the total amount funded.
−Removed: 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.
−Removed: The Warrants are exercisable for ten years from the date of issuance.
−Removed: Horizon may exercise the Warrant either by (a) cash or check or (b) through a net issuance conversion.
−Removed: 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.
−Removed: 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.
−Removed: Mustang incurred approximately $ 1.2 million of legal and other direct costs in connection with the Loan Agreement.
−Removed: 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.
−Removed: 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.
+Added: Journey 8 % Cumulative Convertible Class A Preferred Offering
+Added: In March 2021, Journey commenced an offering of 8 % Cumulative Convertible Class A Preferred Stock (“Journey Preferred Offering”) in an aggregate minimum amount of $ 12.5 million and an aggregate maximum amount of $ 30.0 million.
+Added: The Journey Preferred Offering terminated on July 18, 2021.
+Added: Journey issued an aggregate of 758,680 Class A Preferred shares at a price of $ 25.00 per share, for gross proceeds of $ 19.0 million.
+Added: Following the payment of placement agent fees of $ 1.9 million, and other expenses of $ 0.1 million, Journey received $ 17.0 million of net proceeds.
+Added: The Journey Preferred Stock automatically converts into Journey’s Common Stock upon a sale of Journey or a financing in an amount of at least $ 25.0 million within a year of the closing date of the Journey Preferred Offering (extendable by another six months at Journey’s option) at a discount of 15 % to the per share qualified stock price.
+Added: On November 12, 2021 the Journey IPO was completed, resulting in the conversion of all of the Journey Preferred Stock into 2,231,346 shares of Journey common stock (see Note 14).
+Added: The Company evaluated the terms of the Journey Preferred Offering under ASC 480, Distinguishing Liabilities from Equity , and determined the instrument met the criteria to be recorded as a liability.
+Added: The value at conversion does not vary with the value of Journey’s common shares, therefore the settlement provision would not be considered a conversion feature.
+Added: Accordingly, the Company determined liability classification is appropriate and as such, this instrument was accounted for as a liability, until it converted into Journey common stock upon completion of the Journey IPO.
+Added: Dividends on the Journey Preferred Stock were paid quarterly in shares of Fortress common stock based upon a 7.5 % discount to the average trading price over the 10-day period preceding the dividend payment date.
+Added: Dividends paid on the Journey Preferred Stock was recorded as interest expense on the consolidated statements of operations.
+Added: For the year ended December 31, 2021, the Company issued 253,815 shares of common stock representing dividends paid of $ 0.8 million from issuance through conversion.
+Added: As consideration for the foregoing, Journey issued to Fortress 81,985 shares of its common stock at the Journey IPO price of $ 10.00 .
+Added: In connection with the Journey Preferred Offering, Journey issued upon the closing of the Journey IPO to the placement agent (“the Placement Agent Warrants”) to purchase 5 % of the shares of Journey common stock into which the Journey Preferred Stock converted.
+Added: The Placement Agent Warrants have a term of 5 years .
+Added: At December 31,2021 Journey issued 111,567 shares of Journey common stock related to the conversion of all of the placement agent warrants.
+Added: Journey East West Bank Working Capital Line of Credit
+Added: On March 31, 2021, Journey entered into an agreement with East West Bank (“EWB”) in which EWB agreed to provide a $ 7.5 million working capital line of credit.
+Added: The line of credit is secured by Journey’s receivables and cash.
+Added: Interest on the line is the greater of 4.25% or the Prime Rate plus 1% .
+Added: The agreement matures in 36 months .
+Added: The outstanding balance of the working capital line of credit was $ 0.8 million at December 31, 2021.
Interest Expense
7 unchanged sentences
Oaktree Note 2
−Removed: Note Payable 2
+Added: Partner company convertible preferred shares
+Added: Partner company dividend payable
+Added: Partner company installment payments - licenses 3
Total Interest Expense and Financing Fee
−Removed: 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.
−Removed: Imputed interest expense related to Ximino purchase (see Note 9).
−Removed: Includes $ 0.6 million of prepayment penalties included in interest expense for the Mustang Horizon Notes.
−Removed: Accrued Liabilities and other Long-Term Liabilities
−Removed: Accrued expenses and other long-term liabilities consisted of the following:
+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 expensed at the time of debt repayment on September 30, 2020.
+Added: Includes $ 0.5 million prepayment fee for the Oaktree Note included in interest expense in 2021 and $ 0.6 million of prepayment penalties included in interest expense for the Mustang Horizon Notes in 2020 .
+Added: Imputed interest expense related to Ximino, Accutane and Anti-itch product license acquisition (see Note 9).
+Added: Accounts Payable and Accrued Expenses
+Added: Accounts payable and accrued expenses consisted of the following:
($ in thousands)
+Added: Accounts Payable
Accrued expenses:
6 unchanged sentences
Accrued royalties payable
−Removed: Accrued coupon funding expense
−Removed: Total accrued expenses
−Removed: Other long-term liabilities:
−Removed: Deferred rent and long-term lease abandonment charge 1
−Removed: Partner company note payable, long-term
−Removed: Ximino agreement 2
−Removed: Isotretinoin agreement 3
−Removed: Anti-itch product agreement 4
−Removed: Total other long-term liabilities and partner company note payable, long-term
−Removed: Balance consists of deferred charges related to build-out of the New York facility
−Removed: 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.
−Removed: 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.
−Removed: Amortization of interest discount was $ 0.6 million and $ 0.3 million for the years ended December 31, 2020 and 2019, respectively.
−Removed: At December 31, 2020, $ 2.0 million was classified as Partner company note payable, short-term on the Company’s Consolidated Balance Sheet.
−Removed: 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.
−Removed: 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.
−Removed: Amortization of interest discount was $ 0.1 million for the year ended December 31, 2020.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Amortization of interest discount was negligible for the year ended December 31, 2020.
−Removed: 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.
+Added: Accrued coupon and rebates
+Added: Income taxes payable
+Added: Return reserve
+Added: Total accounts payable and accrued expenses
Non-Controlling Interests
11 unchanged sentences
in consolidated entities
−Removed: Acquisition Corp VIII
For the Year Ended
18 unchanged sentences
Options to purchase Common Stock
−Removed: Convertible preferred stock
Unvested Restricted Stock
1 unchanged sentence
Stockholders’ Equity
−Removed: 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.
−Removed: The amendment was filed with the Secretary of State of the State of Delaware on June 18, 2020.
−Removed: 94,877,492 and 74,027,425 shares of common stock are outstanding at December 31, 2020 and 2019, respectively.
+Added: The Company’s Certificate of Incorporation, as amended, authorizes the Company to issue 170,000,000 shares of $ 0.001 par value Common Stock of which 101,435,505 shares of common stock are outstanding as of December 31, 2021.
+Added: As of December 31, 2020, 150,000,000 shares were authorized and 94,877,492 shares of common stock were outstanding.
The terms, rights, preference and privileges of the Common Stock are as follows:
Voting Rights
−Removed: 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: 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, including the election of directors.
The Company’s certificate of incorporation and bylaws do not provide for cumulative voting rights.
6 unchanged sentences
All of the Company’s outstanding shares of Common Stock are fully paid and nonassessable.
−Removed: Series A Preferred Stock
−Removed: On October 26, 2017, the Company designated 5,000,000 shares of $ 0.001 par value preferred stock as Series A Preferred Stock.
−Removed: 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: Series A Cumulative Redeemable Perpetual Preferred Stock
+Added: On October 26, 2017, the Company designated 5,000,000 shares of $ 0.001 par value preferred stock as Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”).
+Added: As of December 31, 2021 and 2020, 3,427,138 shares of Series A Preferred Stock were issued and outstanding.
The terms, rights, preference and privileges of the Series A Preferred Stock are as follows:
43 unchanged sentences
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.
−Removed: 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: An aggregate 16,506,003 shares have been granted under both the Company’s 2007 and 2013 plans, net of cancellations, and 2,493,997 shares were available for issuance as of December 31, 2021.
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.
19 unchanged sentences
2016 Incentive Plan
−Removed: Oncogenuity, Inc.
FBIO Acquisition Corp.
1 unchanged sentence
FBIO Acquisition Corp.
−Removed: V 2017 Incentive Plan
+Added: VIII 2017 Incentive Plan
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.
17 unchanged sentences
($ in thousands)
−Removed: Employee awards
+Added: Employee and non-employee awards
Executive awards of Fortress Companies' stock
−Removed: Non-employee awards
Partner Companies:
6 unchanged sentences
contractual life
+Added: Number of shares
exercise price
3 unchanged sentences
Options vested and expected to vest at December 31, 2021
+Added: Options vested and exercisable at December 31, 2021
During the years ended December 31, 2021 and 2020, there were no exercises of stock options.
2 unchanged sentences
Stock-based compensation expense from restricted stock awards and restricted stock units for the years ended December 31, 2021 and 2020 was $ 19.5 million and $ 12.5 million, respectively.
+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 milestone will be achieved.
During 2021, the Company granted 2.3 million restricted shares of its Common Stock to executives and directors of the Company and 1.4 million restricted stock units to employees and non-employees of the Company.
1 unchanged sentence
The 2021 restricted stock awards and restricted stock unit awards vest upon both the passage of time as well as meeting certain performance criteria.
−Removed: Restricted stock awards and restricted stock unit awards are expensed under the straight-line method over the vesting period.
−Removed: 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.
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.
1 unchanged sentence
The 2020 restricted stock awards and restricted stock unit awards vest upon both the passage of time as well as meeting certain performance criteria.
−Removed: Restricted stock awards and restricted stock unit awards are expensed under the straight-line method over the vesting period.
−Removed: 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.
The following table summarizes Fortress restricted stock awards and restricted stock units activities, excluding activities related to Fortress subsidiaries:
38 unchanged sentences
in connection with a consulting agreement the Company issued warrants to purchase 100,000 shares of common stock.
−Removed: 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: The relative fair value of the Oaktree warrants was recorded to debt discount and is being amortized over the term of the Oaktree Note (see Note 10).
As of December 31, 2021, the Company had no unrecognized stock-based compensation expense related to warrants.
7 unchanged sentences
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 2021 and 2020.
−Removed: The shares are subject to repurchase by the Company until both of the following conditions are met:
−Removed: (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 shares will vest in full once both of the following conditions are met:
+Added: (i) the Company’s market capitalization has increased 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).
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.
1 unchanged sentence
For the year ended December 31, 2021 and 2020, the Company recorded stock compensation expense of approximately $ 3.8 million and $ 2.5 million, respectively related to the LTIP grants on the Consolidated Statements of Operations.
−Removed: Capital Raise
−Removed: 2019 Common Stock At the Market Offering
−Removed: 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.
−Removed: Wainwright & Co.
−Removed: Inc., Jones Trading Institutional Services LLC and B.
−Removed: Riley, as selling agents, governing potential sales of the Company’s common stock.
−Removed: 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.
−Removed: 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: Capital Raises
+Added: On July 23, 2021, the Company filed a shelf registration statement 333-255185 on Form S-3, which was declared effective on July 30, 2021 (the "2021 Shelf").
+Added: No securities have been drawn down under the 2021 Shelf.
+Added: Common Stock At the Market Offering and 2020 Shelf
+Added: On May 18, 2020, the Company filed a 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"), governing potential sales of the Company's common stock.
+Added: ATM activity since June 1, 2020 were made under the 2020 Shelf.
+Added: For the year ended December 31, 2021, the Company issued approximately 3.1 million shares of common stock at an average price of $ 3.05 per share for gross proceeds of $ 9.4 million.
+Added: In connection with these sales, the Company paid aggregate fees of $ 0.3 million.
+Added: Approximately $ 17.4 million of securities remain available for sale under the 2020 Shelf at December 31, 2021.
+Added: On July 23, 2021, the Company filed shelf registration statement 333-255185 on Form S-3, which was declared effective on July 30, 2021 (the “2021 Shelf”).
+Added: No securities have been drawn down under the 2021 Shelf.
2019 Common Stock At the Market Offering
−Removed: On August 17, 2016, the Company entered into an Amended and Restated At Market Issuance Sales Agreement, or Sales Agreement, with MLV & Co.
−Removed: LLC, or MLV, and FBR Capital Markets & Co., or FBR (“ATM”).
−Removed: 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.
−Removed: The Sales Agreement terminated on August 17, 2019 .
−Removed: 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.
−Removed: In connection with these sales, the Company paid aggregate fees of approximately $ 0.3 million, respectively.
+Added: On June 28, 2019, the Company entered into an At Market Issuance Sales Agreement (“2019 Common ATM”) governing potential sales of the Company’s common stock.
+Added: Under the 2019 Common ATM, the Company paid the agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock.
+Added: For the year ended December 31, 2020, the Company issued approximately 17.4 million shares of common stock, at an average selling price of $ 2.73 per share for gross proceeds of $ 47.5 million.
+Added: In connection with these sales, the Company paid aggregate fees of approximately $ 1.4 million.
2019 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock Offering
−Removed: 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:
−Removed: 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.
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.
1 unchanged sentence
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.
−Removed: 2018 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock At the Market Offering
−Removed: On April 5, 2018, the Company entered into an At Market Sales Agreement (the “2018 Preferred ATM”), with B.
−Removed: Riley, National Securities Corporation, LifeSci Capital LLC, Maxim Group LLC and Noble Capital Markets, Inc.
−Removed: as selling agents, governing the issuance of the Company’s 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock (“Perpetual Preferred Stock”).
−Removed: 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 .
−Removed: No shares of Perpetual Preferred Stock were issued in 2018.
−Removed: 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 .
−Removed: The above-mentioned shares of Perpetual Preferred Stock were sold under the 2016 Shelf.
−Removed: The 2016 Shelf expired on December 1, 2019 .
−Removed: 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”).
−Removed: 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.
−Removed: 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").
−Removed: 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.
−Removed: Wainwright & Co.
−Removed: Riley and Dawson James Securities, Inc., as selling agents, governing potential sales of the Company's common stock.
−Removed: ATM sales commencing on June 1, 2020 were made under the 2020 Shelf as were Perpetual Preferred Offerings.
−Removed: Approximately $ 26.7 million of securities remain available for sale under the 2020 Shelf at December 31, 2020.
−Removed: Cyprium 9.375 % Series A Cumulative Redeemable Perpetual Preferred Stock Offering
−Removed: 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”).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Cyprium PPS is fully and unconditionally guaranteed by Fortress.
−Removed: Cyprium paid an initial dividend of $ 49,883 ($ 0.19531 per share) to shareholders of record on September 30, 2020.
−Removed: Cyprium paid $ 0.2 million in dividends for the year ended December 31, 2020.
−Removed: Checkpoint Therapeutics, Inc.
−Removed: In November 2017, the Checkpoint filed a shelf registration statement on Form S-3 (No.
+Added: All of the Company’s Perpetual Preferred Offerings were made under the 2020 Shelf.
+Added: Journey’s common stock began trading on the Nasdaq Capital Market on November 12, 2021 under the ticker symbol “DERM.” On November 16, 2021, Journey completed an initial public offering (the “Journey IPO”) whereby it sold 3,520,000 shares of its common stock at a price of $ 10.00 per share for gross proceeds of $ 35.2 million, before deducting underwriting discounts and other offering costs of $ 4.6 million for net proceeds of $ 30.6 million.
+Added: In March 2021, Journey commenced an offering of 8 % Cumulative Convertible Class A Preferred Stock (“Journey Preferred Offering”) in an aggregate minimum amount of $ 12.5 million and an aggregate maximum amount of $ 30.0 million.
+Added: The Journey Preferred Offering terminated on July 18, 2021.
+Added: Journey issued an aggregate of 758,680 Class A Preferred shares at a price of $ 25.00 per share, for gross proceeds of $ 19.0 million.
+Added: Following the payment of placement agent fees of $ 1.9 million, and other expenses of $ 0.1 million, Journey received $ 17.0 million in net proceeds.
+Added: Due to the Journey IPO in November 2021 as noted above, the Journey Preferred Stock converted into 2,231,346 shares of Journey common stock.
+Added: In November 2017, Checkpoint filed a shelf registration statement on Form S-3 (No.
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 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.
−Removed: Wainwright & Co., LLC (each an "Agent"
−Removed: and collectively, the "Agents"), relating to the sale of shares of common stock.
+Added: In connection with the Checkpoint S-3, Checkpoint entered into an At-the-Market Issuance Sales Agreement (the "Checkpoint 2017 ATM") relating to the sale of shares of common stock.
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.
The Checkpoint 2017 S-3 expired in December 2020.
−Removed: 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.
−Removed: 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.
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.
Total net proceeds from the offering were approximately $ 18.9 million, net of underwriting discounts and offering expenses of approximately $ 1.6 million.
−Removed: The shares were sold under the Checkpoint 2017 S-3.
−Removed: 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.
−Removed: Total net proceeds from the offering were approximately $ 17.6 million, net of underwriting discounts and offering expenses of approximately $ 2.0 million.
−Removed: The shares were sold under the Checkpoint 2017 S-3.
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.
Under the Checkpoint 2020 S-3, Checkpoint may sell up to a total of $ 100 million of its securities.
−Removed: In connection with the Checkpoint S-3, Checkpoint entered into an ATM (the "Checkpoint 2020 ATM") with Cantor Fitzgerald & Co., Ladenburg Thalmann & Co.
−Removed: Wainwright & Co., LLC (each an “Agent” and collectively, the “Agents”), relating to the sale of shares of common stock.
−Removed: 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: In connection with the Checkpoint 2020 S-3, Checkpoint entered into an ATM (the “Checkpoint 2020 ATM”) with the Agents relating to the sale of shares of Checkpoint’s common stock.
+Added: Under the Checkpoint 2020 ATM, Checkpoint pays the Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of Checkpoint’s common stock.
+Added: During the year ended December 31, 2020, Checkpoint sold a total of 5,104,234 shares of common stock under the Checkpoint 2017 ATM and Checkpoint 2020 ATM combined 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, 2021, Checkpoint sold a total of 11,899,983 shares of common stock under the Checkpoint 2020 ATM for aggregate total gross proceeds of approximately $ 41.3 million at an average selling price of $ 3.47 per share, resulting in net proceeds of approximately $ 40.4 million after deducting commissions and other transaction costs.
As of December 31, 2021, approximately $ 54.6 million of the shelf remains available for sale under the Checkpoint 2020 S-3.
−Removed: Mustang Bio, Inc.
+Added: Pursuant to the Founders Agreement, Checkpoint issued to Fortress 2.5 % of the aggregate number of shares of Checkpoint common stock issued in the offerings noted above.
+Added: Accordingly, Checkpoint issued 297,490 shares and 310,625 shares to Fortress for the year ended December 31, 2021 and 2020, respectively.
+Added: On April 23, 2021, Mustang filed a shelf registration statement No.
+Added: 333-255476 on Form S-3 (the “Mustang 2021 S-3”), which was declared effective on May 24, 2021.
+Added: Under the Mustang 2021 S-3, Mustang may sell up to a total of $ 200 million of its securities.
+Added: As of December 31, 2021, $ 200 million of the Mustang 2021 S-3 remains available for sales of securities.
On July 13, 2018, Mustang filed a shelf registration statement No.
1 unchanged sentence
Under the 2018 Mustang S-3, Mustang 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 Issuance Sales Agreement (the "Mustang ATM") with B.
−Removed: Riley Securities, Inc.
−Removed: Riley FBR, Inc.), Cantor Fitzgerald & Co., National Securities Corporation, and Oppenheimer & Co.
−Removed: (each an "Agent"
−Removed: and collectively, the "Agents"), relating to the sale of shares of common stock.
+Added: In connection with the 2018 Mustang S-3, Mustang entered into an At-the-Market Issuance Sales Agreement (the "Mustang ATM") relating to the sale of shares of common stock.
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.
−Removed: 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.
−Removed: In connection with these sales, Mustang paid aggregate fees of approximately $ 1.1 million for net proceeds of approximately $ 58.7 million.
+Added: On December 31, 2020, the ATM Agreement was amended to add H.C.
+Added: Wainwright & Co., LLC as an Agent.
+Added: During the year ended December 31, 2021, the Company issued approximately 19.4 million shares of common stock at an average price of $ 3.70 per share for gross proceeds of $ 71.9 million under the ATM Agreement.
+Added: In connection with these sales, the Company paid aggregate fees of approximately $ 1.3 million for net proceeds of approximately $ 70.6 million.
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.
In connection with these sales, Mustang paid aggregate fees of approximately $ 1.1 million for net proceeds of approximately $ 58.7 million.
−Removed: 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: 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.
+Added: Under the 2020 Mustang S-3, Mustang may sell up to a total of $ 100.0 million of its securities.
+Added: On June 11, 2020, Mustang entered into an underwriting agreement (the “Mustang Underwriting Agreement”).
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.
2 unchanged sentences
The offering closed on June 15, 2020, and the over-allotment closed on June 25, 2020.
−Removed: 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.
−Removed: The shares were sold under the 2018 Mustang S-3.
−Removed: Mustang paid aggregate fees of approximately $ 2.1 million and received approximately $ 29.5 million of net proceeds.
−Removed: On October 23, 2020, Mustang filed a shelf registration statement No.
−Removed: 333-249657 on Form S-3 (the "2020 Mustang S-3"), which was declared effective on December 4, 2020.
−Removed: Under the 2020 Mustang S-3, Mustang may sell up to a total of $ 100.0 million of its securities.
−Removed: As of December 31, 2020, approximately $ 85.7 million of the 2020 Mustang S-3 remains available for sales of securities.
−Removed: On August 16, 2019, Mustang filed a shelf registration statement No.
−Removed: 333-233350 on Form S-3 (the "2019 Mustang S-3"), which was declared effective on September 30, 2019.
−Removed: Under the 2019 Mustang S-3, Mustang may sell up to a total of $ 75.0 million of its securities.
−Removed: As of December 31, 2020, the 2019 S-3 is no longer available for sales of securities.
+Added: Pursuant to the terms of the Second Amended and Restated Founders Agreement, Mustang issued to Fortress 2.5 % of the aggregate number of shares of Mustang common stock issued in the offerings noted above.
+Added: Accordingly, Mustang issued 576,157 shares of common stock and recorded 107,022 shares issuable to Fortress for the year ended December 31, 2021 and issued 730,795 common shares to Fortress for the year ended December 31, 2020.
+Added: In November 2021, Avenue, pursuant to an underwritten public offering, sold 2,238,805 shares of its common stock at a price of $ 1.34 per share for gross proceeds of approximately $ 3.0 million.
+Added: After deducting underwriting discounts and commissions and other expenses, net proceeds to Avenue from this underwritten public offering were $ 2.6 million.
+Added: In December 2021, Avenue, pursuant to an underwritten public offering, sold 1,910,100 shares of its common stock at a price of $ 1.07 per share for gross proceeds of approximately $ 2.0 million.
+Added: After deducting underwriting discounts and commissions and other expenses, net proceeds to Avenue from this underwritten public offering were $ 1.8 million.
+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 $ 0.7 million in dividends for the year ended December 31, 2021, and $ 0.2 million in dividends for the year ended December 31, 2020, including the initial dividend of $ 49,883 ($ 0.19531 per share) paid to shareholders of record on September 30, 2020.
Commitments and Contingencies
23 unchanged sentences
The Facility began operations for the production of personalized CAR T and gene therapies in 2018.
−Removed: The Company leases copiers under agreements classified as operating leases that expire on various dates through 2024.
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 .
3 unchanged sentences
The Company does not act as a lessor or have any leases classified as financing leases.
−Removed: 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: At December 31, 2021, the Company had operating lease liabilities of $ 23.1 million and right of use assets of $ 19.0 million, which are included in the Company’s Consolidated Balance Sheet.
During the years ended December 31, 2021 and 2020, the Company recorded $ 3.3 million and $ 3.2 million, respectively, as lease expense to current period operations.
26 unchanged sentences
There have been no claims to date, and the Company has director and officer insurance to address such claims.
−Removed: Pursuant to agreements with clinical trial sites, the Company provides indemnification to such sites in certain conditions.
+Added: The Company and its partner companies also provide indemnification of contractual counterparties without limitation to clinical sites, service providers and licensors.
Legal Proceedings
1 unchanged sentence
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.
−Removed: In November 2020, a purported securities class action complaint was filed in the U.S.
−Removed: 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.
−Removed: The case is captioned Cushman v.
−Removed: Fortress Biotech, Inc., et al.
−Removed: 1:20-cv-05767, and names as defendants the Company and two of our officers.
−Removed: 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.
−Removed: 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.
−Removed: The action is in the early stages of litigation, and the Company intends to vigorously contest the claims.
+Added: On March 31, 2021 Journey executed an Asset Purchase Agreement (the “Qbrexza APA”) with Dermira, Inc., a subsidiary of Eli Lilly and Company (“Dermira”), and the transaction closed on May 14, 2021.
+Added: Pursuant to the terms of the agreement, Journey acquired the rights to Qbrexza® (glycoprronium), a prescription cloth towelette to treat primary axillary hyperhidrosis in patients nine years of age or older.
+Added: Upon closing of the Qbrexza purchase, Journey became substituted for Dermira as the plaintiff in, and is currently vigorously litigating, U.S.
+Added: patent litigation commenced by Dermira on October 21, 2020 in the U.S.
+Added: District Court of Delaware (the “Perrigo Patent Litigation”) against Perrigo Pharma International DAC (“Perrigo”) (N/K/A Padagis Israel Pharmaceuticals Ltd.) alleging infringement of certain patents covering Qbrexza (the “Qbrexza Patents”), which are included among the proprietary rights to Qbrexza that Journey acquired pursuant to the Qbrexza APA.
+Added: The Perrigo Patent Litigation was initiated following the submission by Perrigo, in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), of an Abbreviated New Drug Application, or ANDA.
+Added: The ANDA seeks approval to market a generic version of Qbrexza prior to the expiration of the Qbrexza Patents and alleges that the Qbrexza Patents are invalid.
+Added: Perrigo is subject to a 30-month stay preventing it from selling a generic version, but that stay is set to expire on March 9, 2023.
+Added: Trial in the Perrigo Patent Litigation is scheduled for September 19, 2022.
+Added: Journey cannot make any predictions about the final outcome of this matter or the timing thereof.
+Added: On March 4, 2022, Journey filed a complaint against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd.
+Added: District Court of Delaware (the “Teva Patent Litigation”) alleging infringement of certain patents covering Qbrexza (the “Qbrexza Patents”), which are included among the proprietary rights to Qbrexza that were acquired pursuant to the Qbrexza APA.
+Added: The Teva Patent Litigation was initiated following the submission by Teva, in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), of an Abbreviated New Drug Application, or ANDA.
+Added: The ANDA seeks approval to market a generic version of Qbrexza prior to the expiration of the Qbrexza Patents and alleges that the Qbrexza Patents are invalid.
+Added: Teva is subject to a 30-month stay preventing it from selling a generic version.
+Added: The stay should expire no earlier than August 8, 2024.
+Added: Trial in the Teva Patent Litigation has not yet been scheduled.
+Added: The Company cannot make any predictions about the final outcome of this matter or the timing thereof.
+Added: In January 2022, Journey acquired Amzeeq (minocycline) topical foam, 4%, and Zilxi (minocycline) topical foam, 1.5%, two FDA-Approved Topical Minocycline Products and Molecule Stabilizing Technology (MST)™ from VYNE Therapeutics, Inc.
+Added: Upon completion of the acquisition from VYNE, Journey became substituted for VYNE as the plaintiff in U.S.
+Added: patent litigation commenced by VYNE on August 9, 2021 in the U.S.
+Added: District Court of Delaware (the “Padagis Patent Litigation”) against Padagis Israel Pharmaceuticals Ltd.
+Added: (F/K/A Perrigo Israel Pharmaceuticals Ltd.) (“Padagis”) alleging infringement of certain patents covering Amzeeq® (the “Amzeeq® Patents”), which are included among the proprietary rights to Amzeeq® that were acquired pursuant to the APA.
+Added: The Padagis Patent Litigation was initiated following the submission by Padagis, in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), of an Abbreviated New Drug Application (the “ANDA”).
+Added: The ANDA seeks approval to market a generic version of Amzeeq® prior to the expiration of the Amzeeq® Patents and alleges that the Amzeeq® Patents are invalid.
+Added: Padagis is subject to a 30-month stay preventing it from selling a generic version, but that stay is set to expire on December 30, 2023.
+Added: Journey is seeking, among other relief, an order that the effective date of any United States Food and Drug Administration approval of Padagis’ ANDA be no earlier than the expiration of the patents listed in the Orange Book, the latest of which expires on September 8, 2037, and such further and other relief as the court may deem appropriate.
+Added: Trial in the Padagis Patent Litigation is scheduled for July 10, 2023.
+Added: Journey cannot make any predictions about the final outcome of this matter or the timing thereof.
Employee Benefit Plan
9 unchanged sentences
In connection with the shared services agreement, the Company invoiced TGTX $ 0.4 million and $ 0.6 million, and received payments of $ 0.4 million and $ 0.5 million for the years ended December 31, 2021 and 2020, respectively.
−Removed: Desk Share Agreements with TGTX and OPPM
−Removed: 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.
−Removed: These initial rent allocations will be adjusted periodically for each party based upon actual percentage of the office space occupied.
−Removed: 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.
+Added: Shared Services Agreement with Journey
+Added: On November 12, 2021, Journey and the Company entered into an arrangement to share the cost of certain legal, finance, regulatory, and research and development employees.
+Added: The Company’s Executive Chairman and Chief Executive Officer is the Executive Chairman of Journey.
+Added: Under the terms of the Agreement, Journey will reimburse the Company for the salary and benefit costs associated with these employees based upon actual hours worked on Journey related projects following the completion of their initial public offering.
+Added: For the year ended December 31, 2021, the Company’s employees have provided services to Journey totaling approximately $ 0.6 million.
+Added: Upon completion of Journey’s initial public offering in November 2021 (see Note 14) $ 0.5 million was converted into 52,438 shares of Journey common stock at the initial public offering price of $ 10.00 per share.
+Added: Desk Share Agreement with TGTX
+Added: The Desk Share Agreement with TGTX, as amended, requires TGTX to pay 65 % of the average annual rent.
+Added: Additionally, the Company has reserved the right to execute desk share agreements with other third parties and those arrangements will 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 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.
−Removed: The Desk Share Agreement was amended in May 2016, adjusting the initial allocations to 45 % for TGTX and 10 % for OPPM.
−Removed: The Desk Share Agreement was amended again in 2020, adjusting the rent allocations to 65 % for TGTX and 0 % for OPPM.
−Removed: 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.
−Removed: At December 31, 2020, the amount due related to this arrangement from TGTX and OPPM approximated nil and $ 0.4 million, respectively.
+Added: In connection with the Company’s Desk Share Agreement with TGTX for the New York, NY office space, for the years ended December 31, 2021 and 2020, the Company had paid $ 2.7 million and $ 2.6 million in rent, respectively, and invoiced TGTX approximately $ 1.5 million and $ 1.6 million respectively, for their prorated share of the rent base.
+Added: At December 31, 2021, there were no amounts due from TGTX related to this arrangement.
As of July 1, 2018, TGTX employees began to occupy desks in the Waltham, MA office under the Desk Share Agreement.
1 unchanged sentence
For the years ended December 31, 2021 and 2020, the Company had paid approximately $ 0.2 million and $ 0.3 million in rent for the Waltham, MA office, and invoiced TGTX approximately $ 0.1 million and $ 0.1 million, respectively.
−Removed: 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.
Checkpoint Collaborative Agreements with TGTX
1 unchanged sentence
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: Journey Promissory Note
+Added: On September 30, 2021, the Company increased the Journey promissory note by $ 9.5 million in response to a cyber incident that occurred at Journey and resulted in $ 9.5 million of fraudulent payments.
+Added: The $ 9.5 million contribution was approved by the boards of directors of both the Company and Journey, and ensured that Journey’s accounts payable function continued to operate smoothly.
+Added: This contribution, along with the $ 5.2 million already outstanding under the Journey Promissory Note, converted into 1,476,044 shares of Journey common stock upon completion of Journey’s initial public offering in November 2021 (see Note 14) at the initial public offering price of $ 10.00 per share.
+Added: The amounts associated with the Journey Promissory Note are eliminated in the consolidated balance sheets.
2019 Notes (formerly the Opus Credit Facility)
−Removed: On September 14, 2016, the Company 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, Strategic Development (Michael Weiss), are Co-Portfolio Managers and Partners of OPPM, an affiliate of OPHIF.
−Removed: As such, all of the 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 OPHIF amended and restated the Opus Credit Facility (the “A&R Opus Credit Facility”).
−Removed: 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 .
−Removed: 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 .
−Removed: Fortress retained the ability to prepay the Notes at any time without penalty.
−Removed: The notes payable under the A&R Opus Credit Facility bear interest at 12 % per annum.
−Removed: Effective December 31, 2019, OPHIF dissolved and distributed it assets among its limited partners.
−Removed: Following the distribution, the $ 9.0 million facility comprised of separate notes (collectively, the “2019 Notes”) held by DAK Capital Inc.
−Removed: ($ 3.8 million);
−Removed: Fortress’ Chairman, President and Chief Executive Officer Lindsay A.
−Removed: Rosenwald, M.D.
−Removed: ($ 0.3 million);
−Removed: Fortress's Executive Vice President, Strategic Development Michael S.
−Removed: Weiss ($ 2.0 million);
−Removed: and various entities and individuals affiliated with Dr.
−Removed: Rosenwald and Mr.
−Removed: Weiss ($ 2.9 million).
−Removed: The terms of the 2019 Notes did not change in connection with such reallocations.
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.
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.
−Removed: 2018 Venture Notes
−Removed: For the year ended December 31, 2018, the Company raised approximately $ 21.7 million in promissory notes.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 2017 Subordinated Note Financing
−Removed: 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).
−Removed: 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.
−Removed: 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 .
−Removed: 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.
−Removed: Avenue Credit Facility Agreement
−Removed: 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.
−Removed: 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).
−Removed: Repayment of the loan is due upon the earliest to occur of:
−Removed: (i) the Second Stage Closing Date, as defined in the Avenue SPMA;
−Removed: (ii) April 29, 2021;
−Removed: and (iii) the date that is 30 days following the termination of the Avenue SPMA.
−Removed: As of December 31, 2020, there have been no amounts drawn by Avenue on the Avenue Facility Agreement.
Founders Agreement and Management Services Agreement
17 unchanged sentences
Class of Stock
−Removed: Fortress Partner Company
+Added: Partner Company
Effective Date 1
capitalization
−Removed: March 20, 2015
+Added: July 28, 2017
February 17, 2015
+Added: December 17, 2019 4
+Added: October 31, 2016
March 17, 2015
March 13, 2017
−Removed: October 31, 2016
−Removed: January 1, 2017
−Removed: December 17, 2019 5
March 20, 2015
−Removed: July 28, 2017
+Added: March 13, 2015
April 22, 2020 4
+Added: November 7, 2017 4
Represents the effective date of each subsidiary’s Founders Agreement.
3 unchanged sentences
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.
−Removed: 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).
Represents the Trigger Date, the date that the Fortress partner company first acquires, whether by license or otherwise, ownership rights in a product.
4 unchanged sentences
Includes 2022 PIK dividend accrued for the year ended December 31, 2021, as Type 1 subsequent event.
−Removed: 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.
Management Services Agreements
7 unchanged sentences
Year Ended December 31,
−Removed: Fortress partner company
+Added: Partner company
Effective Date
−Removed: March 20, 2015
+Added: July 28, 2017
February 17, 2015
March 9, 2017
−Removed: March 17, 2015
October 31, 2016
1 unchanged sentence
March 13, 2017
−Removed: July 28, 2017
−Removed: November 30, 2017
−Removed: Oncogenuity 3
+Added: March 20, 2015
+Added: March 13, 2015
February 10, 2017
−Removed: Fortress - MSA Income
+Added: November 7, 2017
Consolidated (Income)/Expense
1 unchanged sentence
during the term of the Avenue SPMA fees under the MSA will not be due or accrued.
−Removed: In December 2019, Tamid discontinued development and terminated its’ licenses and clinical trial agreements with UNC.
−Removed: Oncogenuity license was purchased in the year ended December 31, 2020.
Fees and Stock Grants Received by Fortress
2 unchanged sentences
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.
−Removed: The components of the income tax provision (benefit) are as follows:
−Removed: For the Year Ended December 31,
+Added: The components of the income tax provision are as follows:
+Added: For the years ended December 31,
($ in thousands)
−Removed: 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: For the years ended December 31, 2021 and 2020, income tax expense was $ 0.5 million and $ 0.1 million, respectively, resulting in an effective income tax rate of 0 % and 0 %.
The increase in income tax expense in 2021 is due to additional state tax return filings.
14 unchanged sentences
Unrealized gain/loss on investments
+Added: Business interest limitation
Reserve on Sales Return, Discount and Bad Debt
4 unchanged sentences
Right of use asset
−Removed: Fair Value adjustment on investment in Caelum
Basis in subsidiary
+Added: Fair Value adjustment on investment in Caelum
Total deferred tax assets, net
8 unchanged sentences
Change in state rate
−Removed: Deconsolidation of Caelum
Change in valuation allowance
12 unchanged sentences
Approximately $ 409.7 million of the federal NOLs and $ 3.1 million of the state NOLs can be carried forward indefinitely.
−Removed: 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.
−Removed: The Company is currently evaluating the impact of Section 382 on its tax attributes.
+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 limitations on its use of pre-change NOLs and income tax credits carryforwards to offset future tax liabilities.
+Added: It appears the Company underwent previous ownership changes potentially limiting its use of tax attributes.
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.
−Removed: 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: As of December 31, 2021, the Company had no unrecognized tax benefits and does not anticipate any significant change to the unrecognized tax benefit balance.
The Company would classify interest and penalties related to uncertain tax positions as income tax expense, if applicable.
3 unchanged sentences
The expiration of the statute of limitations related to the various state income and franchise tax returns varies by state.
−Removed: In January 2019, in connection with the Alexion DOSPA, the Company ceased to consolidate Caelum (see Note 4).
−Removed: 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.
Coronavirus Aid, Relief and Economic Security Act ("CARES Act")
1 unchanged sentence
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.
−Removed: The CARES Act did not have a material impact on the Company’s income tax provision for 2020.
+Added: The CARES Act did not have a material impact on the Company’s income tax provision for 2021 or 2020.
The Company will continue to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows.
1 unchanged sentence
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.
−Removed: The Consolidated Appropriations Act did not have a material impact to the Company’s income tax provision for 2020.
+Added: The Consolidated Appropriations Act did not have a material impact to the Company’s income tax provision for 2021 or 2020.
Segment Information
4 unchanged sentences
Biotechnology
−Removed: ($ in thousands)
Year Ended December 31, 2021
−Removed: Direct cost of goods
−Removed: Sales and marketing costs
+Added: Cost of goods - product revenue
Research and development
−Removed: General and administrative
+Added: Selling, general and administrative
+Added: Wire transfer fraud loss
+Added: Income tax expense
+Added: Pharmaceutical
+Added: Biotechnology
+Added: Year Ended December 31, 2020
+Added: Cost of goods - product revenue
+Added: Research and development
+Added: Selling, general and administrative
Other expense
1 unchanged sentence
Segment income (loss)
−Removed: Segment assets
+Added: The following tables summarize, for the periods indicated, total assets by reportable segment:
+Added: Pharmaceutical
+Added: ($ in thousands)
+Added: Biotechnology
+Added: December 31, 2021
Intangible assets, net
2 unchanged sentences
Pharmaceutical
−Removed: Biotechnology
($ in thousands)
−Removed: Year Ended December 31, 2019
−Removed: Direct cost of goods
−Removed: Sales and marketing costs
−Removed: Research and development
−Removed: General and administrative
−Removed: Segment income (loss)
−Removed: Segment assets
+Added: Biotechnology
+Added: December 31, 2020
Intangible assets, net
3 unchanged sentences
Disaggregation of Total Revenues
−Removed: The Company has five marketed products, Targadox®, Ximino®, Exelderm®, Luxamend® and Ceracade®.
−Removed: Substantially all of the Company’s product revenues are recorded in the U.S.
−Removed: Substantially all of the Company’s collaboration revenues are from its collaboration with TGTX.
+Added: Journey has the following actively marketed products, Qbrexza®, Accutane®, Targadox®, Ximino®, Exelderm®, and Luxamend®.
+Added: All of Journey’s product revenues are recorded in the U.S.
+Added: The Company’s collaboration revenue is from Cyprium’s agreement with Sentynl (see Note 3).
+Added: The Company’s related party revenue is from Checkpoint’s collaborations with TGTX (see Note 17).
The table below summarizes the Company’s revenue for the years ended December 31, 2021 and 2020:
Year Ended December 31,
−Removed: ($ in thousands)
−Removed: Product revenue, net
+Added: Other branded revenue
+Added: Collaboration revenue
Revenue – related party
Significant Customers
−Removed: 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.
−Removed: 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.
−Removed: The revenue from these customers is captured in the product revenue, net line item within the Consolidated Statements of Operations.
−Removed: At December 31, 2020, one of the Company’s Dermatology Products customers accounted for 12 % of its total accounts receivable balance.
−Removed: 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.
−Removed: 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.
−Removed: Revenue – related party represents collaboration revenue from TGTX in connection with Checkpoint.
+Added: For the years ended December 31, 2021, none of the Company’s Dermatology Products customers accounted for more than 10.0% of its total gross product revenue.
+Added: At December 31, 2021, two of Journey’s customers accounted for more than 10% of its total accounts receivable balance at 16.3% and 12.9%.
+Added: As of December 31, 2020, one of the Company’s Dermatology Products customers accounted for 12 % of its total accounts receivable balance.
Subsequent Events
−Removed: On February 24, 2021, Cyprium announced the execution of an asset purchase agreement with Sentynl Therapeutics, Inc.
−Removed: (“Sentynl”), a U.S.-based specialty pharmaceutical company owned by the Zydus Group.
−Removed: 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.
−Removed: Royalties on CUTX-101 net sales range from the mid-single digits up to the mid-twenties are also payable.
−Removed: 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.
−Removed: Continued development of CUTX-101 will be overseen by a Joint Steering Committee consisting of representatives from Cyprium and Sentynl.
−Removed: Cyprium will retain 100 % ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
−Removed: On February 12, 2021, Avenue resubmitted its NDA to the FDA for IV Tramadol.
−Removed: 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.
−Removed: The resubmission included revised language relating to the proposed product label and a report relating to terminal sterilization validation.
−Removed: 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.
−Removed: 8 % Cumulative Convertible Class A Preferred Offering
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Company will be obligated to file one or more registration statements covering the issuance of shares that result from such dividends/exchange.
−Removed: 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.
−Removed: From the initial closing on March 31, 2021, the Company raised gross proceeds of $ 12.5 million.
+Added: VYNE Therapeutics Product Acquisition (“VYNE Product Acquisition”)
+Added: On January 13, 2022 Journey entered into a definitive agreement with VYNE Therapeutics, Inc.
+Added: (“VYNE”) to acquire its Molecule Stabilizing Technology (“MST”)™ franchise for an upfront payment of $ 20.0 million and an additional $ 5.0 million on the one (1)-year anniversary of the closing.
+Added: The agreement also provides for contingent net sales milestone payments.
+Added: The Company acquired Amzeeq (minocycline) topical foam, 4%, and Zilxi (minocycline) topical foam, 1.5%, two FDA-Approved Topical Minocycline Products and Molecule Stabilizing Technology (MST)™.
+Added: Maruho Milestone Payment
+Added: On February 11, 2022, Journey announced that its exclusive out-licensing partner in Japan received manufacturing and marketing approval in Japan for Rapifort® Wipes 2.5% (Japanese equivalent to U.S.
+Added: FDA approved Qbrexza®) for the treatment of primary axillary hyperhidrosis, triggering a net $ 2.5 million milestone payment to Journey.
+Added: The net payment reflects a milestone payment of $ 10 million to Journey from their exclusive licensing partner in Japan, Maruho Co., Ltd.
+Added: (“Maruho”), offset by a $ 7.5 million payment to Dermira, Inc., pursuant to the terms of the Asset Purchase Agreement between Journey and Dermira Inc.
+Added: In conjunction with the terms of the licensing agreement with Maruho, the milestone payment was due from Maruho within 30 days of the approval.
+Added: Journey acquired global rights to Qbrexza® from Dermira Inc.
+Added: Amendment to the East West Bank Working Capital Line of Credit
+Added: On January 12, 2022, Journey entered into a third amendment (the “Amendment”) of its loan and security agreement with East West Bank, which increased the borrowing capacity of Journey’s revolving line of credit to $ 10.0 million, from $ 7.5 million, and added a term loan not to exceed $ 20.0 million.
+Added: Both the revolving line of credit and the term loan mature on January 12, 2026 .
+Added: The term loan includes two tranches, the first of which is a $ 15.0 million term loan and the second of which is a $ 5.0 million term loan.
+Added: On January 12, 2022, Journey borrowed $ 15.0 million against the first tranche of the term loan to facilitate the VYNE Product Acquisition.
+Added: The term loan bears interest on its outstanding daily balance at a floating rate equal to 1.73 % above the prime rate and is payable monthly, on the first calendar day each month.
+Added: The term loans contain an interest only payment period through January 12, 2024, with an extension through July 12, 2024 if certain covenants are met, after which the outstanding balance of each term loan is payable in equal monthly installments of principal, plus all accrued interest, through the term loan maturity date.
+Added: Journey may prepay all or any part of the term loan without penalty or premium, but may not re-borrow any amount, once repaid.
+Added: Any outstanding borrowing against the revolving line of credit bears interest at a floating rate equal to 0.70 % above the prime rate.
+Added: The Amendment includes customary financial covenants such as collateral ratios and minimum liquidity provisions as well as audit provisions.
+Added: Runway Growth Capital LLC Debt Facility
+Added: On March 8, 2022, Mustang announced completion of a $ 75 million long-term debt facility with Runway Growth Capital LLC (“Runway”).
+Added: Of the $ 75 million, $ 30 million was funded upon closing, and the additional $ 45 million available under the facility may be funded upon Mustang’s achieving certain predetermined milestones.
+Added: The loan will be repaid in sixty monthly payments consisting of 24 month ly payments of interest only, followed by 36 month ly payments of principal and accrued interest, payable monthly in arrears, with all repayments ending on the same date as the initial tranche.
+Added: The interest-only period may be extended to 36 months contingent upon Mustang achieving certain milestones.
+Added: In connection with the debt financing, Mustang issued to Runway warrants to purchase up to 748,036 of its common shares at an exercise price of $ 0.8021 per share.
+Added: Proceeds from the facility will be used to support the ongoing clinical development of key investigational product candidates within Mustang’s pipeline and for general working capital purposes.
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.
37 unchanged sentences
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.