1 unchanged sentence
Evaluation of disclosure controls and procedures
−Removed: Our management evaluated the effectiveness of our disclosure controls and procedures (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) or 15d-15(e)) as of the end of the period covered by this 2022 10-K Report.
−Removed: Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that, as of December 31, 2022, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms, and (ii) is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
−Removed: Changes in internal control over financial reporting
−Removed: There was no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
−Removed: Inherent limitations on effectiveness of controls
−Removed: Our management does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud.
−Removed: A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
−Removed: Further, the design of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be considered relative to their costs.
−Removed: Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, misstatements, errors, and instances of fraud, if any, within our company have been or will be prevented or detected.
−Removed: Further, internal controls may become inadequate because of changes in conditions, or through the deterioration of the degree of compliance with policies or procedures.
−Removed: Management’s report on internal control over financial reporting
−Removed: Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined under Exchange Act Rules 13a-15(f) and 15d-15(f).
−Removed: Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S.
−Removed: Internal control over financial reporting includes those policies and procedures that:
−Removed: pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
−Removed: provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors;
−Removed: provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.
−Removed: Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2022.
−Removed: In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control— Integrated Framework (2013).
−Removed: Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of its internal control over financial reporting.
−Removed: Based on management’s assessment, we believe that our internal controls over financial reporting were effective as of December 31, 2022.
−Removed: This 2022 10-K Report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting.
−Removed: Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to the rules of the SEC that permit the Company to provide only management’s report in this 2022 10-K Report.
+Added: Our management evaluated the effectiveness of
+Added: our disclosure controls and procedures (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) or 15d-15(e)) as of the end
+Added: of the period covered by this 2023 10-K Report.
+Added: Based on that evaluation, our Principal Executive Officer and Principal Financial Officer
+Added: concluded that, as of December 31, 2023, our disclosure controls and procedures were effective to ensure that information required to
+Added: be disclosed by us in the reports we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within
+Added: the time periods specified in the SEC rules and forms, and (ii) is accumulated and communicated to our management, including our Principal
+Added: Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
+Added: Changes in internal control over financial
+Added: There was no change in our internal control
+Added: over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
+Added: our internal control over financial reporting.
+Added: Inherent limitations on effectiveness of
+Added: Our management does not expect that our disclosure
+Added: controls and procedures or our internal controls will prevent all error and all fraud.
+Added: A control system, no matter how well conceived
+Added: and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
+Added: Further, the design
+Added: of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be considered relative
+Added: to their costs.
+Added: Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance
+Added: that all control issues, misstatements, errors, and instances of fraud, if any, within our company have been or will be prevented or
+Added: Further, internal controls may become inadequate because of changes in conditions, or through the deterioration of the degree
+Added: of compliance with policies or procedures.
+Added: Management’s report on internal control
+Added: over financial reporting
+Added: Our management is responsible for establishing
+Added: and maintaining adequate internal control over financial reporting, as defined under Exchange Act Rules 13a-15(f) and 15d-15(f).
+Added: internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
+Added: reporting and the preparation of financial statements for external purposes in accordance with U.S.
+Added: Internal control over financial
+Added: reporting includes those policies and procedures that:
+Added: ● pertain to the maintenance of records that in reasonable
+Added: detail accurately and fairly reflect the transactions and dispositions of our assets;
+Added: ● provide reasonable assurance that transactions are recorded
+Added: as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our
+Added: receipts and expenditures are being made only in accordance with authorizations of our management and directors;
+Added: ● provide reasonable assurance regarding prevention or timely
+Added: detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.
+Added: Our management assessed the effectiveness
+Added: of our internal control over financial reporting as of December 31, 2023.
+Added: In making this assessment, our management used the
+Added: criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control —
+Added: Integrated Framework (2013).
+Added: Management’s assessment included an evaluation of the design of our internal control over
+Added: financial reporting and testing of the operational effectiveness of its internal control over financial reporting.
+Added: management’s assessment, we believe that our internal controls over financial reporting were effective as of December 31,
+Added: This 2023 10-K Report does not include an attestation
+Added: report of the Company’s registered public accounting firm regarding internal control over financial reporting.
+Added: report was not subject to attestation by the Company’s registered public accounting firm pursuant to the rules of the SEC that
+Added: permit the Company to provide only management’s report in this 2023 10-K Report.
Other information
−Removed: Disclosure regarding foreign jurisdictions that prevent inspections
−Removed: Directors, executive officers, and corporate governance
−Removed: The information required by this Item relating to our directors and corporate governance is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
+Added: Effective March 22, 2024, Tommy G.
+Added: Thompson resigned as the Company’s
+Added: Executive Chairman of the Board and was reappointed as the Company’s Chairman of the Board.
+Added: Disclosure regarding foreign jurisdictions
+Added: that prevent inspections
+Added: Directors, executive officers, and
+Added: corporate governance
+Added: This information will be contained in our definitive proxy statement for
+Added: our 2024 Annual Meeting of Stockholders, to be filed with the SEC not later than 120 days after the end of our fiscal year covered by
+Added: this report, and incorporated herein by reference or, alternatively, by amendment to this Form 10-K under cover of Form 10-K/A no later
+Added: than the end of such 120 day period.
Executive compensation
−Removed: The information required by this Item is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
−Removed: Security ownership of certain beneficial owners and management and related stockholder matters
−Removed: The information required by this Item is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
−Removed: Certain relationships and related transactions, and director independence
−Removed: The information required by this Item is incorporated herein by reference to the definitive Proxy Statements to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
+Added: This information will be contained in our definitive proxy statement for
+Added: our 2024 Annual Meeting of Stockholders, to be filed with the SEC not later than 120 days after the end of our fiscal year covered by
+Added: this report, and incorporated herein by reference or, alternatively, by amendment to this Form 10-K under cover of Form 10-K/A no later
+Added: than the end of such 120 day period.
+Added: Security ownership of certain beneficial
+Added: owners and management and related stockholder matters
+Added: This information will be contained in our definitive proxy statement for
+Added: our 2024 Annual Meeting of Stockholders, to be filed with the SEC not later than 120 days after the end of our fiscal year covered by
+Added: this report, and incorporated herein by reference or, alternatively, by amendment to this Form 10-K under cover of Form 10-K/A no later
+Added: than the end of such 120 day period.
+Added: Certain relationships and related
+Added: transactions, and director independence
+Added: This information will be contained in our definitive proxy statement for
+Added: our 2024 Annual Meeting of Stockholders, to be filed with the SEC not later than 120 days after the end of our fiscal year covered by
+Added: this report, and incorporated herein by reference or, alternatively, by amendment to this Form 10-K under cover of Form 10-K/A no later
+Added: than the end of such 120 day period.
Principal accountant fees and services
−Removed: The information required by this Item is incorporated herein by reference to the definitive Proxy Statements to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
−Removed: Exhibits and financial statement schedules
−Removed: Financial statements and financial statements schedules
−Removed: Financial Statements are listed in the Index to Financial Statements on page F-1 of this 2022 10-K Report.
−Removed: No financial statement schedules are included because such schedules are not applicable, are not required, or because required information is included in the consolidated financial statements or notes thereto.
+Added: This information will be contained in our definitive proxy statement
+Added: for our 2024 Annual Meeting of Stockholders, to be filed with the SEC not later than 120 days after the end of our fiscal year covered
+Added: by this report, and incorporated herein by reference or, alternatively, by amendment to this Form 10-K under cover of Form 10-K/A no
+Added: later than the end of such 120 day period.
+Added: Exhibits and financial statement
+Added: (a) Financial statements and financial statements schedules
+Added: (1) Financial Statements are listed in the Index to Financial Statements
+Added: on page F-1 of this 2023 10-K Report.
+Added: (2) No financial statement schedules are included because such schedules
+Added: are not applicable, are not required, or because required information is included in the
+Added: consolidated financial statements or notes thereto.
Agreement and Plan of Reorganization, dated July 6, 2009, among Croff Enterprises, Inc., AMHN Acquisition Corp., America’s Minority Health Network, Inc., and the Major Shareholders(1)
16 unchanged sentences
Certificate of Designation, Preferences and Rights of Series A Preferred Stock (11)
+Added: Fourth Amendment to Bylaws of the Company, dated June 29, 2023 (13)
Form of Certificate of Common Stock (14)
26 unchanged sentences
Lease, dated October 5, 2018, by and between 951 Yamato Acquisition Company, LLC and TherapeuticsMD, Inc.
−Removed: Executive Employment Agreement, dated as of August 3, 2021, by and between TherapeuticsMD, Inc.
−Removed: and Hugh O’Dowd ( 28 )
−Removed: TherapeuticsMD, Inc.
−Removed: Inducement Grant Restricted Stock Unit Agreement, dated as of August 31, 2021, by and between TherapeuticsMD, Inc.
−Removed: and Hugh O’Dowd ( 29 )
−Removed: Employment Agreement, dated June 1, 2020, between the Company and James C.
−Removed: D’Arecca ( 6)
−Removed: Amendment to Employment Agreement, dated October 15, 2021, between TherapeuticsMD, Inc.
−Removed: D’Arecca ( 3 0 )
−Removed: Executive Employment Agreement, dated October 15, 2021, by and between TherapeuticsMD, Inc.
−Removed: and Mark Glickman ( 3 1 )
−Removed: TherapeuticsMD, Inc.
−Removed: Inducement Grant Restricted Stock Unit Agreement, dated October 15, 2021, by and between TherapeuticsMD, Inc.
−Removed: and Mark Glickman ( 3 2 )
−Removed: Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and Michael Donegan ( 2 4 )
−Removed: Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and Robert G.
−Removed: Finizio ( 2 4 )
−Removed: Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and John C.K.
−Removed: Milligan, IV ( 2 4 )
−Removed: Amendment, dated April 8, 2021, to the Amended and Restated Employment Agreement, dated as of November 24, 2020, by and between TherapeuticsMD, Inc.
−Removed: and John C.K.
−Removed: Milligan, IV ( 26 )
−Removed: Employment Agreement, October 30, 2019, between the Company and Edward J.
−Removed: Borkowski ( 20)
−Removed: Amendment to Employment Agreement between the Company and Edward J.
−Removed: Borkowski ( 20)
License and Supply Agreement, dated June 6, 2019, by and between TherapeuticsMD, Inc.
2 unchanged sentences
and each of its executive officers and directors (25)
−Removed: Controlled Equity Offering SM Sales Agreement, dated November 27, 2020, by and between TherapeuticsMD, Inc.
−Removed: and Cantor Fitzgerald & Co.
−Removed: Controlled Equity OfferingSM Sales Agreement, dated March 3, 2021, by and between TherapeuticsMD, Inc.
−Removed: and Cantor Fitzgerald & Co.
2022 Executive Retention and Performance Bonus Plan.
2 unchanged sentences
and Rubric Capital Management LP, dated July 29, 2022 (11)
−Removed: S u bscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TOA Talents, LLC, dated July 29, 2022 (37)
+Added: Subscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TOA Talents, LLC, dated July 29, 2022 (11)
Subscription Agreement between TherapeuticsMD, Inc.
22 unchanged sentences
and MCD Consulting Management Services, LLC, dated February 21, 2023 (34)
+Added: Subscription Agreement, dated May 1, 2023, between TherapeuticsMD, Inc.
+Added: and Rubric Capital Management LP (35)
+Added: Master Services Agreement, dated August 15, 2023, between TherapeuticsMD, Inc.
+Added: and JZ Advisory Group (36)
Subsidiaries of the Company
+Added: Consent of Berkowitz Pollack Brant
Consent of Grant Thornton LLP
3 unchanged sentences
Section 1350 Certification of Chief Financial Officer
+Added: TherapeuticsMD, Inc.
+Added: Policy on Recoupment of Incentive Compensation
Inline XBRL Document Set for the consolidated financial statements and accompanying notes in Part IV, Item 15(a), “Financial Statements and Financial Statements Schedules” of this Annual Report on Form 10-K
1 unchanged sentence
* Indicates a contract with management or compensatory plan or arrangement.
−Removed: Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission.
−Removed: Confidential treatment has been granted with respect to this omitted information.
−Removed: Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(2).
−Removed: The omitted information is not material and would likely cause competitive harm to the Company if publicly disclosed.
−Removed: Certain of the exhibits and schedules to this exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K.
−Removed: The Company agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request.
+Added: ** Certain confidential material contained in the document has been omitted
+Added: and filed separately with the Securities and Exchange Commission.
+Added: Confidential treatment
+Added: has been granted with respect to this omitted information.
+Added: *** Portions of this exhibit have been redacted in compliance with Regulation
+Added: S-K Item 601(b)(2).
+Added: The omitted information is not material and would likely cause competitive
+Added: harm to the Company if publicly disclosed.
+Added: + Certain of the exhibits and
+Added: schedules to this exhibit have been omitted in accordance with Item 601(a)(5) of Regulation
+Added: The Company agrees to furnish a copy of all omitted exhibits and schedules to the SEC
+Added: upon its request.
† Filed herewith.
†† Furnished herewith.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on July 10, 2009 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on June 14, 2010 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-K for the year ended December 31, 2007 filed with the Commission on May 1, 2008 and incorporated herein by reference (SEC File No.
+Added: (1) Filed as an exhibit to Form 8-K filed with the Commission on July
+Added: 10, 2009 and incorporated herein by reference (SEC File No.
+Added: (2) Filed as an exhibit to Form 8-K filed with
+Added: the Commission on June 14, 2010 and incorporated herein by reference (SEC File No.
+Added: (3) Filed as an exhibit to Form 10-K for the year ended December 31,
+Added: 2007 filed with the Commission on May 1, 2008 and incorporated herein by reference (SEC File
+Added: (4) Filed as an exhibit to Form 8-K filed with the Commission on July
+Added: 21, 2011 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form
+Added: 8-K filed with the Commission on March 10, 2022 and incorporated herein by reference (SEC File No.
+Added: (6) Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2010
+Added: filed with the Commission on August 3, 2010 and incorporated herein by reference (SEC File
+Added: (7) Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2023
+Added: filed with the Commission on August 14, 2023 and incorporated herein by reference (SEC File
+Added: (8) Filed as an exhibit to Definitive 14C Information Statement filed
+Added: with the Commission on June 29, 2010 and incorporated herein by reference (SEC File No.
+Added: (9) Filed as an exhibit to Form 8-K filed with the Commission on December
+Added: 22, 2015 and incorporated herein by reference (SEC File No.
+Added: (10) Filed as an exhibit to Form 8-K filed with the Commission on June 3,
+Added: 2022 and incorporated herein by reference (SEC File No.
+Added: (11) Filed as an exhibit to Form 8-K filed with the Commission on August
+Added: 1, 2022 and incorporated herein by reference (SEC File No.
+Added: (12) Filed as an exhibit to Form 8-K filed with the Commission on May 9, 2022 and incorporated herein by reference (SEC File No.
(13) Filed as an exhibit to Form 8-K filed with the Commission on July 6, 2023 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2010 filed with the Commission on August 3, 2010 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2020 filed with the Commission on August 7, 2020 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Definitive 14C Information Statement filed with the Commission on June 29, 2010 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on December 22, 2015 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form S-3 filed with the Commission on January 25, 2013 and incorporated hereby by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-K for the year ended December 31, 2019 filed with the Commission on February 24, 2020 and incorporated herein by reference (SEC File No.
+Added: (14) Filed as an exhibit to Form S-3 filed
+Added: with the Commission on January 25, 2013 and incorporated hereby by reference (SEC File No.
+Added: Filed as an exhibit to Form 10-K for the year ended December 31, 2022 filed with the Commission on April 7, 2023 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 8-K filed with the Commission on October 11, 2011 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form S-8 filed with the Commission on June 21, 2019 and incorporated herein by reference (SEC File No.
+Added: (18) Filed as an appendix to the Definitive Proxy Statement filed with the Commission on April 14, 2021 and incorporated herein by
+Added: reference (SEC File No.
(19) Filed as an exhibit to Form 8-K filed with the Commission on August 22, 2013 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Registration Statement on Form S-8 filed with the Commission on October 15, 2013 and incorporated herein by reference (SEC File No.
−Removed: Filed as an appendix to the Definitive Proxy Statement filed with the Commission on May 4, 2020 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on February 27, 2023 and incorporated herein by reference (SEC File No.
+Added: (20) Filed as an exhibit to Registration Statement on Form S-8 filed
+Added: with the Commission on October 15, 2013 and incorporated herein by reference (SEC File No.
+Added: (21) Filed as an appendix to the Definitive Proxy Statement filed with
+Added: the Commission on May 4, 2020 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 8-K filed with the Commission on February 24, 2012 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 8-K filed with the Commission on February 6, 2013 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2020 filed with the Commission on August 7, 2020 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 10-Q filed with the Commission on November 9, 2020 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 10-K for the year ended December 31, 2020 filed with the Commission on March 4, 2021 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2019 filed with the Commission on August 9, 2019 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2018 filed with the Commission on November 8, 2018 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2019 filed with the Commission on November 8, 2019 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on November 27, 2020 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Registration Statement on Form S-3 filed with the Commission on March 4, 2021 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on April 12, 2021 and incorporated herein by reference (File No.
−Removed: Filed as an appendix to the Definitive Proxy Statement filed with the Commission on April 14, 2021 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on August 9, 2021 and incorporated herein by reference (File No.
−Removed: Filed as exhibit to Form S-8 filed with the Commission on August 31, 2021 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarterly period ended September 30, 2021 filed with the Commission on November 11, 2021 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form S-8 filed with the Commission on October 15, 2021 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form S-8 filed with the Commission on October 15, 2021 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on March 10, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 10-K for the year ended December 31, 2021, filed with the Commission on March 23, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2022, filed with the Commission on May 16, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on June 3, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on August 1, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on May 9, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on October 3, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on October 31, 2022 and incorporated herein by reference (File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on December 5, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2019 filed with the Commission on August 9, 2019 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form
+Added: 10-K for the year ended December 31, 2021, filed with the Commission on March 23, 2022 and incorporated herein by reference (SEC
+Added: Filed as an exhibit to Form 8-K filed with the Commission on October
+Added: 3, 2022 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on October
+Added: 31, 2022 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on December
+Added: 5, 2022 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on February
+Added: 27, 2023 and incorporated herein by reference (SEC SEC File No.
+Added: Filed as an appendix to the Definitive Proxy Statement filed with
+Added: the Commission on May 17, 2023 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form 10-Q for the quarter ended September
+Added: 30, 2023, filed with the Commission on November 14, 2023 and incorporated herein by reference (SEC File No.
Form 10-K summary
−Removed: Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this 2022 10-K Report to be signed on its behalf by the undersigned, thereunto duly authorized, on April 7, 2023
+Added: Pursuant to the requirements of Section 13 or 15(d) of the Securities
+Added: Exchange Act of 1934, the registrant has duly caused this 2023 10-K Report to be signed on its behalf by the undersigned, thereunto duly
+Added: authorized, on March 29, 2024.
THERAPEUTICSMD, INC.
1 unchanged sentence
Chief Executive Officer
−Removed: /s/ Michael C.
−Removed: Principal Financial and Accounting Officer
−Removed: Pursuant to the requirements of the Securities Exchange Act of 1934, this 2022 10-K Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated on April 7, 2023.
+Added: Pursuant to the requirements of Section 13 or 15(d) of the Securities
+Added: Exchange Act of 1934, the registrant has duly caused this 2023 10-K Report to be signed on its behalf by the undersigned, thereunto duly
+Added: authorized, on March 29, 2024.
/s/ Marlan D.
1 unchanged sentence
(Principal Executive Officer)
−Removed: /s/ Michael C.
+Added: /s/ Joseph Ziegler
Principal Financial and Accounting Officer
+Added: Joseph Ziegler
/s/ Cooper C.
4 unchanged sentences
INDEX TO FINANCIAL STATEMENTS
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID Number 52) F-2
Report of Independent Registered Public Accounting Firm (PCAOB ID Number
−Removed: Consolidated Balance Sheets
−Removed: Consolidated Statements of Operations
−Removed: Consolidated Statements of Stockholders’ E quity ( Deficit)
−Removed: Consolidated Statements of Cash Flows
−Removed: Notes to Consolidated Financial Statements
−Removed: Report of Independent Registered Public Accounting Firm
−Removed: Board of Directors and Stockholders
−Removed: TherapeuticsMD, Inc.
+Added: Consolidated Balance Sheets F-5
+Added: Consolidated Statements of Operations F-6
+Added: Consolidated Statements of Stockholders’ Equity (Deficit) F-7
+Added: Consolidated Statements of Cash Flows F-8
+Added: Notes to Consolidated Financial Statements F-9
+Added: REPORT OF INDEPENDENT REGISTERED
+Added: PUBLIC ACCOUNTING FIRM
+Added: To the Board of Directors and
+Added: Stockholders of TherapeuticsMD, Inc.
+Added: and Subsidiaries
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of TherapeuticsMD, Inc.
−Removed: (a Nevada corporation) and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the two years in the period ended December 31, 2022, and the related notes collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
−Removed: Going concern
−Removed: The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern.
−Removed: As discussed in Note 1 to the financial statements, the Company has recently changed its business strategy to become a royalty company.
−Removed: The Company has limited experience operating as a royalty company and may need to raise additional capital to fund its operations until the Company becomes cash flow positive.
−Removed: These conditions, along with other matters as set forth in Note 1, raise substantial doubt about the Company’s ability to continue as a going concern.
−Removed: Management’s plans in regard to these matters are also described in Note 1.
−Removed: The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: We have audited the accompanying consolidated
+Added: balance sheet of TherapeuticsMD, Inc.
+Added: and Subsidiaries (the “Company”) as of December 31, 2023, and the related consolidated
+Added: statement of operations, stockholders’ equity, and cash flows for the year then ended, and the related notes (collectively referred
+Added: to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all
+Added: material respects, the financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows
+Added: for the year then ended, in conformity with accounting principles generally accepted in the United States of America.
+Added: Substantial Doubt about the Company’s
+Added: Ability to Continue as a Going Concern
+Added: The accompanying consolidated financial statements
+Added: have been prepared assuming that the Company will continue as a going concern.
+Added: As discussed in Note 1 to the consolidated financial statements,
+Added: the recent change in operations and negative cash flow position along with other conditions as set forth in Note 1, raise substantial
+Added: doubt about the Company’s ability to continue as a going concern.
+Added: Management’s plans in regard to these matters are also described
+Added: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
−Removed: These financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
−Removed: 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.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
−Removed: 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: These consolidated financial statements are the
+Added: responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial
+Added: statements based on our audit.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
+Added: (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
+Added: rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audit in accordance with the
+Added: standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
+Added: financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we
+Added: 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
+Added: of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s
+Added: 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 financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the 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 financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical audit matter
−Removed: Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: We determined that there are no critical audit matters.
−Removed: /s/ GRANT THORNTON LLP
+Added: Our audit included performing procedures to assess
+Added: the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
+Added: that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
+Added: consolidated financial statements.
+Added: Our audit also included evaluating the accounting principles used and significant estimates made by
+Added: management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audit provides
+Added: a reasonable basis for our opinion.
+Added: Critical Audit Matters
+Added: The critical audit matters communicated below
+Added: are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated
+Added: to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the consolidated financial statements and
+Added: (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of critical audit matters does not alter
+Added: in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit
+Added: matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
+Added: Acquisition of Net Working Capital
+Added: As described further in Note 1 to the consolidated
+Added: financial statements, the Company determined the acquisition of net working capital by Mayne Pharma, LLC in accordance with the Transaction
+Added: The Transaction Agreement included significant estimates, which are subject to change for a period of up to two years.
+Added: Company received financial claims from Mayne Pharma, LLC related to this agreement for amounts owed under the provisions of the Transaction
+Added: Agreement related to distributor fees, rebates and returns of licensed products.
+Added: The Company does not believe these claims are substantiated
+Added: and thus, did not record an amount due to the licensee as of December 31, 2023.
+Added: We identified the acquisition of net working capital as
+Added: a critical audit matter.
+Added: The principal consideration for our determination that the acquisition of net working capital pursuant to the
+Added: provisions of the Transaction Agreement as a critical audit matter is due to the significant estimates and judgements required by management
+Added: when determining the inputs and assumptions utilized in the development of the initial net working capital calculation included in the
+Added: Transaction Agreement.
+Added: The subjectivity of the estimates increases the level of estimation uncertainty, auditor judgement and level of
+Added: effort required to evaluate management’s evidence supporting the projected final net working capital acquisition amount as it relates
+Added: to the allowance for returns, rebates and distributor fees, including assumptions that no further liability will be incurred.
+Added: Our audit procedures perform ed
+Added: to address the critical matter included, among others:
+Added: the letter sent to the licensee in response to financial claims.
+Added: original Transaction Agreement and subsequent amendments.
+Added: the rebates and returns analysis performed by the Company, assess method utilized, calculation,
+Added: and conclusion reached for reasonableness.
+Added: /s/ Berkowitz Pollack Brant, Advisors + CPAs
We have served as the Company’s auditor since 2023.
+Added: West Palm Beach, FL
+Added: March 29, 2024
+Added: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
+Added: Board of Directors and Shareholders
+Added: TherapeuticsMD, Inc.
+Added: on the financial statements
+Added: We have audited
+Added: the accompanying consolidated balance sheet of TherapeuticsMD, Inc.
+Added: (a Nevada corporation) and subsidiaries (the “Company”)
+Added: as of December 31, 2022, the related consolidated statements of operations, stockholders’ (deficit) equity, and cash flows for
+Added: the year then ended, and the related notes collectively referred to as the “financial statements”).
+Added: In our opinion, the financial
+Added: statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022, and the results of
+Added: its operations and its cash flows for the year ended December 31, 2022, in conformity with accounting principles generally accepted in
+Added: the United States of America.
+Added: The accompanying
+Added: consolidated financial statements have been prepared assuming the Company will continue as a going concern.
+Added: As discussed in Note 1 to
+Added: the financial statements, the Company has recently changed its business strategy to become a royalty company.
+Added: The Company has limited
+Added: experience operating as a royalty company and may need to raise additional capital to fund its operations until the Company becomes cash
+Added: flow positive.
+Added: These conditions, along with other matters as set forth in Note 1, raise substantial doubt about the Company’s ability
+Added: to continue as a going concern.
+Added: Management’s plans in regard to these matters are also described in Note 1.
+Added: The financial statements
+Added: do not include any adjustments that might result from the outcome of this uncertainty.
+Added: These financial
+Added: statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s
+Added: financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board
+Added: (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: our audit in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable
+Added: assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not
+Added: 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
+Added: are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
+Added: on the effectiveness of the Company’s internal control over financial reporting.
+Added: Accordingly, we express no such opinion.
+Added: included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,
+Added: and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts
+Added: and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates
+Added: made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audit provides a
+Added: reasonable basis for our opinion.
+Added: as the Company’s auditor from 2015 to 2023.
Miami, Florida
6 unchanged sentences
Current assets:
+Added: Cash and cash equivalents
Restricted cash
+Added: Royalty receivable, current portion
Prepaid and other current assets
3 unchanged sentences
License rights and other intangible assets, net
−Removed: Right of use assets
Royalty receivable, long term
Other non-current assets
−Removed: Non-current assets of discontinued operations
−Removed: Liabilities and stockholders' equity (deficit):
+Added: Right of use assets
+Added: Liabilities and stockholders’ equity:
Current liabilities:
−Removed: Current maturities of long-term debt
Accounts payable
7 unchanged sentences
Stockholders’ equity (deficit):
−Removed: Preferred stock, par value $ 0.001 ;
−Removed: 10,000 shares authorized
Common stock, par value $ 0.001 ;
−Removed: 12,000 shares authorized, 9,498 and 8,598
−Removed: (adjusted for the 50-for-1 reverse stock split ) issued and outstanding as of December 31, 2022 and 2021, respectively
+Added: 32,000 and 12,000 shares authorized, 11,532 and 9,498 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively
Additional paid-in capital
Accumulated deficit
−Removed: Total stockholders' equity (deficit)
−Removed: Total liabilities and stockholders' equity (deficit)
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
+Added: The accompanying notes are an integral part of
+Added: these consolidated financial statements.
TherapeuticsMD, Inc.
2 unchanged sentences
(In thousands, except per share amounts)
−Removed: Year ended December 31,
−Removed: Product revenue, net
−Removed: License revenue
+Added: Years ended December 31,
+Added: Revenue, net:
+Added: License and service revenue
Total revenue, net
1 unchanged sentence
Operating expenses:
−Removed: Selling and marketing
−Removed: General and administrative
−Removed: Research and development
−Removed: Restructuring expense
+Added: Selling, general and administrative
+Added: Depreciation & amortization
+Added: Restructuring
Total operating expenses
Income (loss) from operations
−Removed: Other (expense) income:
−Removed: Other (expense) income, net
−Removed: Total other (expense) income, net
+Added: Other income (expense):
+Added: Miscellaneous income (expense)
+Added: Total other income (loss), net
Income (loss) from continuing operations before income taxes
−Removed: Provision for income taxes
+Added: Benefit (provision) for income taxes
Net income (loss) from continuing operations
4 unchanged sentences
Discontinued operations, net
−Removed: Net income (loss)
+Added: Net income (loss) per common share, basic
Income (loss) per common share, diluted:
1 unchanged sentence
Discontinued operations, net
−Removed: Net income (loss)
+Added: Net income (loss) per common share, diluted
Weighted average common shares, basic
Weighted average common shares, diluted
−Removed: Comprehensive income (loss):
Net income (loss)
1 unchanged sentence
Comprehensive income (loss):
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
+Added: The accompanying notes are an integral part of
+Added: these consolidated financial statements.
TherapeuticsMD, Inc.
and Subsidiaries
−Removed: Consolidated Statements of Stockholders' (Deficit) Equity
+Added: Consolidated Statements of Stockholders’ (Deficit)
(In thousands)
Balance, December 31, 2021
−Removed: Shares issued for sale of common stock, net of cost
−Removed: Shares issued for exercise of warrants, net of cashless
−Removed: Shares issued for exercise of options
−Removed: Shares issued for vested restricted and performance stock units
−Removed: Shares issued for sale of common stock related to employee stock purchase plan
−Removed: Share-based payment award compensation costs
−Removed: Balance, December 31, 2021
+Added: $ ( 1,051,360 )
Shares issued for sale of common stock, net of cost
2 unchanged sentences
Shares issued for vested restricted and performance stock units
−Removed: Shares issued for sale of common stock related to
−Removed: employee stock purchase plan
+Added: Shares issued for sale of common stock related to employee stock purchase plan
Share-based payment award compensation costs
Balance, December 31, 2022
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
+Added: Shares issued for vested restricted stock units
+Added: Share-based compensation
+Added: Shares issued for sale of common stock related to private placement sale
+Added: Balance, December 31, 2023
+Added: $ ( 949,641 )
+Added: The accompanying notes are an integral part of
+Added: these consolidated financial statements.
TherapeuticsMD, Inc.
2 unchanged sentences
(In thousands)
−Removed: Year ended December 31,
+Added: Years ended December 31,
Cash flows from operating activities:
Net income (loss)
−Removed: Loss from discontinued operations, net of tax
+Added: Income (loss) from discontinued operations, net of tax
Net income (loss) from continuing operations
−Removed: Adjustments to reconcile net income (loss) to net cash used in continuing operating activities:
+Added: Adjustments to reconcile net income (loss) to net cash provided by (used in) continuing operating
Depreciation and amortization
7 unchanged sentences
Total adjustments
−Removed: Net cash used in continuing operating activities
+Added: Net cash provided by (used in) continuing operating activities
Cash flows from continuing investing activities:
−Removed: Payment for patent related costs
−Removed: Purchase of fixed assets
−Removed: Net cash provided by (used in) continuing investing activities
+Added: Receipts (payment) for patents
+Added: Net cash used in continuing investing activities
Cash flows from continuing financing activities:
Proceeds from sale of common stock, net of costs
−Removed: Proceeds from exercise of options and warrants
−Removed: Proceeds from sale of common stock related to employee stock
−Removed: purchase plan
+Added: Proceeds from sale of common stock related to employee stock purchase plan
Repayments of debt
4 unchanged sentences
Payment of debt financing fees
−Removed: Net cash (used in) provided by continuing financing activities
+Added: Net cash provided by (used in) continuing financing activities
Discontinued operations:
11 unchanged sentences
Warrants issued in relation to debt financing agreement
−Removed: The accompanying notes are an integral part of these consolidated financial statements.
+Added: The accompanying notes are an integral part of
+Added: these consolidated financial statements.
TherapeuticsMD, Inc.
3 unchanged sentences
TherapeuticsMD, Inc.
−Removed: (the “Company”), a Nevada corporation, and its consolidated subsidiaries are referred to collectively in this Annual Report on Form 10-K (“2022 10-K Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 2022 10-K Report includes our trademarks, trade names and service marks, such as TherapeuticsMD ® , vitaMedMD ® , BocaGreenMD ® , vitaCare TM , IMVEXXY ® , BIJUVA ® and ANNOVERA ® , which are protected under applicable intellectual property laws and are the property of, or licensed to, the Company.
−Removed: Solely for convenience, trademarks, trade names and service marks referred to in this 2022 10-K Report may appear without the ® , TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks.
−Removed: We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.
−Removed: TherapeuticsMD was previously a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
−Removed: In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
−Removed: On December 30, 2022 (the “Closing Date”), the Company completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, pursuant to which the Company and its subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD® and vitaMedMD® brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma the Company’s exclusive license to commercialize ANNOVERA (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith.
−Removed: Pursuant to a License Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Mayne License Agreement”), the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.
−Removed: Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time, milestone payments to the Company of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million.
−Removed: Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
−Removed: The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.
−Removed: Mayne Pharma will pay to the Company minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below.
−Removed: Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.
−Removed: Pursuant to a Transaction Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Transaction Agreement”), the Company sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including, with the Populations Council’s consent, the Company’s exclusive license from the Population Council to commercialize ANNOVERA (the “Transferred Assets”).
−Removed: The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the
−Removed: Mayne License Agreement, as amended.
−Removed: The acquisition of net working capital was determined in accordance with the Transaction Agreement and included significant estimates which could change materially for a period of up to two years following the Closing Date.
−Removed: On the Closing Date, the Company and Mayne Pharma entered into Amendment No.
+Added: (the “Company”), a Nevada
+Added: corporation, and its consolidated subsidiaries are referred to collectively in this Annual Report on Form 10-K (“2023 10-K
+Added: Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 2023 10-K Report
+Added: includes trademarks, trade names and service marks, such as TherapeuticsMD ® , vitaMedMD ® ,
+Added: BocaGreenMD ® , vitaCareTM, IMVEXXY ® , and BIJUVA ® , which are protected under applicable
+Added: intellectual property laws and are the property of, or licensed by or to, us.
+Added: Solely for convenience, trademarks, trade names and
+Added: service marks referred to in this 2023 10-K Report may appear without the ® , TM or SM symbols, but such references
+Added: are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the
+Added: right of the applicable licensor to these trademarks, trade names and service marks.
+Added: We do not intend our use or display of other
+Added: parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a
+Added: relationship with, or endorsement or sponsorship of us by, these other parties.
+Added: TherapeuticsMD was previously a women’s healthcare company with
+Added: a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
+Added: In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed
+Added: to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
+Added: On December 30, 2022 (the “Closing
+Added: Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company
+Added: (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, in which we and our subsidiaries
+Added: (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under
+Added: the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and
+Added: territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA ® (together with the Licensed
+Added: Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain
+Added: other assets to Mayne Pharma in connection therewith.
+Added: In a License Agreement, dated December 4, 2022, between TherapeuticsMD
+Added: and Mayne Pharma (the “Mayne License Agreement”), we granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable,
+Added: perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the
+Added: Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable
+Added: license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization
+Added: in the United States and its possessions and territories.
+Added: Under the Mayne License Agreement, Mayne Pharma will pay us
+Added: one-time milestone payments of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a
+Added: calendar year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar
+Added: year reach $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year
+Added: reach $ 300.0 million.
+Added: Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty
+Added: rate of 8.0 % on the first $ 80.0 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain
+Added: adjustments, for a period of 20 years following the Closing Date.
+Added: The royalty rate will decrease to 2.0 % on a Product-by-Product
+Added: basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version
+Added: of a Product launching in the United States.
+Added: Mayne Pharma will pay us minimum annual royalties of $ 3.0 million per year for 12
+Added: years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below.
+Added: the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully
+Added: paid-up and royalty free license for the Licensed Products.
+Added: Under the Transaction Agreement, dated December 4, 2022, between TherapeuticsMD
+Added: and Mayne Pharma (the “Transaction Agreement”), we sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize
+Added: the Products in the United States, including, with the Population Council’s consent, our exclusive license from the Population Council
+Added: to commercialize ANNOVERA (the “Transferred Assets”).
+Added: The total consideration from Mayne Pharma to TherapeuticsMD for
+Added: the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License
+Added: Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the
+Added: acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments,
+Added: (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement
+Added: Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as
+Added: The acquisition of net working capital was determined in accordance with the Transaction Agreement and included significant
+Added: estimates which could change materially for a period of up to two years following the Closing Date.
+Added: On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment
1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”).
−Removed: Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay the Company approximately $ 1.0 million in prepaid royalties on the Closing Date.
−Removed: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.
−Removed: In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement (see vitaCare divestiture below), including the Company’s minimum payment obligations thereunder.
−Removed: As part of the transformation that included Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
−Removed: Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
−Removed: Additional disclosures regarding discontinued operations are provided in Note 2.
−Removed: The Company also has license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S.
−Removed: In July 2018, we entered into a license and supply agreement (the “Knight License Agreement”) with Knight Therapeutics Inc.
−Removed: (“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
−Removed: In June 2019, we entered into an exclusive license and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.
−Removed: In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.
−Removed: In connection with the Company’s transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr.
−Removed: Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 31, 2022.
−Removed: Severance obligations for all employees other than executive officers were paid in full in January 2023 and severance obligations for terminated executive officers will be paid in accordance with their employment agreements and separation agreements as previously disclosed.
−Removed: As of December 31, 2022, we employed 1 full-time employee primarily engaged in an executive position.
−Removed: We have also entered into consulting agreements with certain former members of our management team who support our relationship with current partners and assist with certain financial, legal and regulatory matters and the continued wind-down of our historical business operations.
+Added: Pursuant to the Mayne License Agreement Amendment,
+Added: Mayne Pharma agreed to pay us approximately $ 1.0 million in prepaid royalties on the Closing Date.
+Added: The prepaid royalties reduced the first
+Added: four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257 thousand
+Added: per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty
+Added: payment was paid to us.
+Added: We and Mayne Pharma settled the $ 1.5 million of consideration due to Mayne for the assumed obligations under a
+Added: long-term services agreement (see the section entitled “vitaCare Divestiture” below for a discussion of the long-term services
+Added: agreement), including our minimum payment obligations thereunder.
+Added: As the parties agreed, during the second quarter of 2023, Mayne Parma
+Added: held back our royalty payment of $ 0.6 million and we funded an additional $ 0.9 million in August 2023 to settle the original $ 1.5 million
+Added: As part of the transformation that included the Mayne License Agreement,
+Added: historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in
+Added: our consolidated financial statements.
+Added: Assets and liabilities associated with the commercial business are classified as assets and liabilities
+Added: of discontinued operations in our consolidated balance sheets.
+Added: Additional disclosures regarding discontinued operations are provided in
+Added: We also have license agreements with strategic partners to commercialize
+Added: IMVEXXY and BIJUVA outside of the U.S.
+Added: ● In July 2018, we entered into a license and supply agreement
+Added: (the “Knight License Agreement”) with Knight Therapeutics Inc.
+Added: (“Knight”) pursuant to which we granted Knight
+Added: an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
+Added: September 2019, we entered into an exclusive license and supply agreement (the “Theramex
+Added: License Agreement”) with Theramex HQ UK Limited (“Theramex”) to commercialize
+Added: IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.
+Added: In 2021, Theramex secured
+Added: regulatory approval for BIJUVA in certain European countries and began commercialization
+Added: efforts in those countries.
+Added: In connection with our transformation into a pharmaceutical royalty
+Added: company, the termination of our executive management team (except for Mr.
+Added: Marlan Walker, our former General Counsel and current Chief
+Added: Executive Officer) and all other employees was completed by December 31, 2022.
+Added: Severance obligations for all employees other than executive
+Added: officers were paid in full in January 2023 and severance obligations for terminated executive officers were paid in accordance with their
+Added: employment agreements and separation agreements as previously disclosed.
+Added: As of December 31, 2022 and 2023, we employed one full-time employee
+Added: primarily engaged in an executive position.
+Added: We have engaged external consultants who support our relationship with
+Added: current partners and assist with certain financial, legal, and regulatory matters and the continued wind-down of our historical business
+Added: On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would
+Added: serve as our Principal Financial and Accounting Officer.
+Added: On August 17, 2023 Michael C.
+Added: Donegan notified us of his decision to resign from
+Added: the positions of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023.
+Added: Ziegler succeeded Mr.
+Added: Donegan as Principal Financial and Accounting Officer as of the date of Mr.
+Added: Donegan’s resignation.
vitaCare Divestiture
−Removed: On April 14, 2022, we completed the divestiture of vitaCare Prescription Services, Inc.
−Removed: (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”).
−Removed: We received net proceeds of $ 142.6 million, net of transaction costs of $ 7.2 million, and we recognized a gain on sale of business of $ 143.4 million.
−Removed: Included in the net proceeds amount was $ 11.3 million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”), which is recorded as restricted cash in the consolidated balance sheets.
−Removed: The restricted cash was held by an escrow agent and was be released to us in March 2023.
−Removed: Additionally, we may receive up to an additional $ 7.0 million in earn-out consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement.
−Removed: We will record the contingent consideration at the settlement amount when the consideration is realized or realizable.
−Removed: The Purchase Agreement contains customary representations and warranties, covenants, and indemnities of the parties thereto.
−Removed: The commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction.
−Removed: In addition, under the Mayne License Agreement Amendment, Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to us by $ 1.5 million in consideration of Mayne Pharma assuming our obligations under the long-term services agreement related to vitaCare.
−Removed: The divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when the Company changed its business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for 2022 and 2021.
−Removed: With multiple variant strains of the SARS-Cov-2 virus and the COVID-19 disease that it causes (collectively, “COVID-19”) still circulating, we continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic.
−Removed: The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict.
−Removed: As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain and difficult to predict.
−Removed: Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future.
+Added: On April 14, 2022, we completed the divestiture of our former subsidiary
+Added: vitaCare Prescription Services, Inc.
+Added: (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital
+Added: stock (the “vitaCare Divestiture”).
+Added: We received net proceeds of $ 142.6 million, after deducting transaction costs of $ 7.2
+Added: million, and we recognized a gain on sale of business of $ 143.4 million.
+Added: Included in the net proceeds amount was $ 11.3 million of customary
+Added: holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”) which we received in 2023.
+Added: Additionally,
+Added: the Purchase Agreement provides that we may receive up to an additional $ 7.0 million in earn-out consideration, contingent upon vitaCare’s
+Added: financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement;
+Added: however, we do not believe this
+Added: earnout will be realized.
+Added: We will record the contingent consideration at the settlement amount if and when the consideration is realized
+Added: or realizable.
+Added: The Purchase Agreement contains customary representations and warranties,
+Added: covenants, and indemnities of the parties thereto.
+Added: The commitments under a long-term services agreement related to vitaCare were transferred
+Added: to Mayne Pharma as part of the Mayne Transaction.
+Added: The divestiture of vitaCare was determined to be a component of discontinued
+Added: operations in December 2022, when we changed our business by becoming a royalty company and as a result vitaCare activities were reclassified
+Added: to discontinued operations for 2023 and 2022.
Going concern
−Removed: On December 4, 2022, we entered into agreements with Mayne Pharma pursuant to which we granted Mayne Pharma an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products (in the United States and its possessions and territories), (ii) assign to Mayne Pharma the Company’s exclusive license to commercialize ANNOVERA in the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma.
−Removed: The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the License Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the License Agreement, as amended.
−Removed: On the Closing Date, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of the Company’s subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.
−Removed: Following the transaction with Mayne Pharma, our primary source of revenue will be from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
+Added: On December 4, 2022, we entered into agreements with Mayne Pharma pursuant
+Added: to which we granted Mayne Pharma an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products (in
+Added: the United States and its possessions and territories), (ii) assign to Mayne Pharma our exclusive license to commercialize ANNOVERA in
+Added: the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma.
+Added: The total consideration from Mayne Pharma to the TherapeuticsMD for
+Added: the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement
+Added: consisted of (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition
+Added: of net working capital subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties
+Added: in connection with the Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne
+Added: License Agreement, as amended.
+Added: On the Closing Date, we repaid all obligations under the Financing
+Added: Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders
+Added: from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”)
+Added: and the Financing Agreement was terminated.
+Added: Following the transaction with Mayne Pharma, our primary source of
+Added: revenue is from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
We may need to raise additional capital to provide additional liquidity to fund our operations until we become cash flow positive.
−Removed: To address our capital needs, we may pursue various equity and debt financing and other alternatives.
−Removed: The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering.
−Removed: Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock, and our available authorized shares.
−Removed: Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock and our available authorized shares.
−Removed: To the extent that we raise additional capital through the sale of such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders.
−Removed: If we are not successful in obtaining additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge, consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us.
−Removed: If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA are delayed, if the net working capital settlement with Mayne Pharma under the Transaction Agreement, or if we are unsuccessful with future financings and or the continued impact of the COVID-19 pandemic or the supply chains related to the third-party contract manufacturers is worse than we anticipate, our existing cash reserves would be insufficient to satisfy our liquidity.
−Removed: The presence of these projected factors in conjunction with the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
−Removed: The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
+Added: address our capital needs, we may pursue various equity and debt financing and other alternatives.
+Added: The equity financing alternatives may
+Added: include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders,
+Added: or other institutional counterparties or an underwritten public equity or equity-linked securities offering.
+Added: Our ability to sell equity
+Added: securities may be limited by market conditions, including the market price of our common stock, and our available authorized shares.
+Added: To the extent that we raise additional capital through the sale of
+Added: such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include
+Added: liquidation or other preferences that adversely affect the rights of our existing stockholders.
+Added: If we are not successful in obtaining
+Added: additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge,
+Added: consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us.
+Added: On May 1, 2023, we entered into a Subscription Agreement (the “Subscription
+Added: Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or more
+Added: of its affiliates, up to an aggregate of 5,000,000 shares of our common stock, par value $ 0.001 per share (our “Common Stock”),
+Added: from time to time during the term of the Subscription Agreement in separate draw-downs at our election.
+Added: On June 29, 2023, we issued and
+Added: sold 312,525 shares of Common Stock at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement.
+Added: We received gross proceeds
+Added: of $ 1.15 million from the draw down, before expenses.
+Added: On November 15,
+Added: 2023 Rubric drew down an additional 1,000,000 shares of Common Stock at a price per share equal to $ 2.28 .
+Added: We received gross proceeds of
+Added: $ 2.0 million from the drawdown, before expenses.
+Added: In February 2024, the Company received Mayne Pharma’s
+Added: calculation of allowance for payer rebates and wholesale distributor fees which differed significantly from the Company’s
+Added: estimate of the allowances.
+Added: The Company believes its estimated allowances for payer rebates and wholesale distributor fees are
+Added: reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement.
+Added: Given the recent receipt of
+Added: Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this
+Added: As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any
+Added: additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor
+Added: As of December 31, 2023, the Company believes no additional accrual
+Added: is required for amounts that may be owed for the allowance for returns under the Transaction Agreement.
+Added: The Company has not recorded any
+Added: contingent gains or receivables for any such allowances.
+Added: Management continues to monitor the unresolved and pending net working capital
+Added: items as changes to estimated amounts owed or amounts due from Mayne Pharma that may be material.
+Added: If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA
+Added: grow more slowly than expected or decline, if the net working capital settlement with Mayne Pharma under the Transaction Agreement
+Added: is greater than our current estimates, if we are unsuccessful with future financings or if the supply chains related to the
+Added: third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our
+Added: liquidity requirements.
+Added: The potential impact of these factors in conjunction with the uncertainty of the capital markets raises
+Added: substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial
+Added: The accompanying consolidated financial statements do not include any
+Added: adjustments that might be necessary if we are unable to continue as a going concern.
Basis of presentation
−Removed: The consolidated financial statements and related notes include our parent company and all wholly-owned subsidiaries.
−Removed: The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S.
−Removed: Our fiscal year-end is as of and for the year ended December 31 st for each year presented.
+Added: The consolidated financial statements and related notes include our
+Added: parent company and all wholly owned subsidiaries.
+Added: The consolidated financial statements are prepared in accordance with accounting principles
+Added: generally accepted in the Unites States of America (“U.S.
+Added: Our fiscal year-end is as of and for the year ended December
+Added: 31st for each year presented.
All intercompany transactions among our businesses have been eliminated.
−Removed: As part of the transformation as a result of Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
−Removed: Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
−Removed: Additional disclosures regarding discontinued operations are provided in Note 2.
−Removed: Certain amounts in the n otes to the consolidated financial statements may not add due to rounding, and all percentages have been calculated using unrounded amounts.
+Added: As part of the transformation and as a result of the vitaCare divestiture
+Added: and the Mayne Transaction, historical results of commercial operations for all periods prior to the Closing Date have been reflected as
+Added: discontinued operations in the consolidated financial statements.
+Added: Assets and liabilities associated with the commercial business are classified
+Added: as assets and liabilities of discontinued operations in the consolidated balance sheet.
+Added: Additional disclosures regarding discontinued
+Added: operations are provided in Note 2 of these consolidated financial statements.
+Added: Certain amounts in the notes to the consolidated financial statements
+Added: may not add due to rounding.
+Added: Certain prior period amounts have been reclassified to conform to current-period presentation.
New accounting standards
Adoption of new accounting standards
−Removed: New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on the Company’s consolidated financial statements or processes.
−Removed: Accounting standards issued but not yet adopted
−Removed: Reference Rate Reform (Topic 848):
−Removed: Facilitation of the Effects of Reference Rate Reform on Financial Reporting and Scope.
−Removed: These ASUs provide optional guidance for a limited period of time to ease potential accounting impacts associated with transitioning away from reference rates that are expected to be discontinued, such as London Interbank Offered Rate (LIBOR).
−Removed: These ASUs include practical expedients for contract modifications due to reference rate reform.
−Removed: Generally, contract modifications related to reference rate reform may be considered an event that does not require remeasurement or reassessment of a previous accounting determination at the modification date.
−Removed: These ASUs were effective upon issuance and may be applied prospectively to contract modifications made or evaluated on or before December 31, 2022.
−Removed: We paid off our debt as of December 30, 2022, and as a result the adoption of this guidance will not have an impact on our financial statements and, to the extent we enter into new debt agreements, we will apply such guidance to those contracts.
−Removed: Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on the Company’s consolidated financial statements or processes.
+Added: In December 2023, the Financial Accounting Standards Board (“FASB”)
+Added: issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures.” ASU 2023-09 enhances the transparency
+Added: and decision usefulness of income tax disclosures by requiring consistent categories and greater disaggregation of information in the
+Added: rate reconciliation and income taxes paid disaggregated by jurisdiction.
+Added: ASU 2023-09 will be effective for the Company in its income tax
+Added: disclosure included in its 2025 Annual Report on Form 10-K and will be applied on a prospective basis.
+Added: However, retrospective application
+Added: is permitted.
+Added: Early adoption is also permitted.
+Added: The Company is evaluating the impact of ASU 2023-09 on the Company's income tax disclosures
+Added: and on its consolidated financial statements.
Discontinued Operations
−Removed: Discontinued operations comprise activities that were disposed of at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes and represent a business shift having a major effect on the Company’s operations and financial results according to Accounting Standard Codification (“ASC”) Topic 205, Presentation of Financial Statements.
−Removed: An adjustment has been made to the consolidated statements of operations for the twelve months ended December 31, 2022 and 2021 to reclassify commercial activities and vitaCare activities to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results.
−Removed: No amounts for shared general and administrative operating support expense were allocated to discontinued operations.
−Removed: As required by the terms of our Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings.
−Removed: As a result, interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax.
−Removed: Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2022 and 2021.
+Added: Discontinued operations comprise activities that were disposed of at
+Added: the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting
+Added: purposes and represent a business shift having a major effect on the Company’s operations and financial results according to Accounting
+Added: Standard Codification (“ASC”) Topic 205, Presentation of Financial Statements.
+Added: An adjustment has been made to the consolidated
+Added: statements of operations for the twelve months ended December 31, 2023 and 2022 to reclassify commercial activities and vitaCare activities
+Added: to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s
+Added: operations and financial results.
+Added: No amounts for shared general and administrative operating support expense were allocated to discontinued
+Added: As required by the terms of the Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding
+Added: debt borrowings.
+Added: As a result, interest expense and amortization of deferred financing costs as well as expense for accretion of Series
+Added: A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax.
+Added: Additionally,
+Added: the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated
+Added: balance sheet as of December 31, 2023 and 2022.
For additional information, see Note 2 - Discontinued Operations.
Estimates and assumptions
−Removed: The preparation of consolidated financial statements in conformity to U.S.
−Removed: GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.
−Removed: We evaluate our estimated assumptions based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
−Removed: Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions.
+Added: The preparation of consolidated financial statements in conformity
+Added: GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure
+Added: of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the
+Added: reporting period.
+Added: We evaluate our estimated assumptions based on historical experience and on various other assumptions that are believed
+Added: to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are
+Added: not readily apparent from other sources.
+Added: Actual results may differ, at times in material amounts, from these estimates under different
+Added: assumptions or conditions.
Cash and Restricted Cash
−Removed: We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $ 0.25 million per bank.
−Removed: We have never experienced any losses related to these funds.
−Removed: Restricted cash is comprised of escrowed funds deposited with a bank relating to the vitaCare Divestiture.
−Removed: All restrictions were lifted in March 2023 and it is no longer restricted, see Note 15.
−Removed: Accounts receivable and allowance for doubtful accounts
−Removed: Accounts receivable are customer obligations due under normal trade terms and are measured at amortized cost.
−Removed: We historically extended credit on an unsecured basis to most of our customers based on an evaluation of a customer’s financial condition, and collateral was not required.
−Removed: Our accounts receivable concentration of credit risk is primarily limited to customers who are drug wholesalers and retail pharmacy distributors.
−Removed: We review accounts receivable for uncollectible and delinquent accounts and credit card chargebacks, and we provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, reasonable supportable forecasts, and existing economic conditions, and we record an allowance that presents the net amount expected to be collected.
−Removed: We write off uncollectible and delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers.
−Removed: We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts.
−Removed: To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required.
−Removed: Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current COVID-19 pandemic, or other customer-specific factors.
−Removed: Although we have historically not experienced significant credit losses, it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade receivables in the future.
−Removed: On December 30, 2022, Mayne Pharma acquired our accounts receivable balance of approximately $ 29.3 million which is subject to certain working capital adjustments.
−Removed: Inventories are valued at the lower of cost or net realizable value.
−Removed: Our pharmaceutical products are valued using first in first out method and our vitamins are valued using the average-cost method.
−Removed: We review inventories for excess and obsolescence, and we write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value.
−Removed: Obsolescence may occur due to product expiring, product improvements rendering previous versions obsolete, or decreases in demand for our products.
−Removed: On December 30, 2022, Mayne Pharma acquired our inventory balance of approximately $ 8.4 million , which is subject to certain net working capital adjustments.
+Added: For the purpose of the statements of cash flows, all highly liquid
+Added: investments with an original maturity of three months or less are considered to be cash equivalents.
+Added: The carrying value of these
+Added: investments approximates fair value.
+Added: We maintain cash at financial institutions that at times may exceed
+Added: the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $ 0.25 million per bank.
+Added: We have never experienced any
+Added: losses related to these funds.
+Added: Restricted cash was comprised of escrowed funds deposited with a bank
+Added: relating to the vitaCare Divestiture.
+Added: All restrictions were lifted in March 2023.
Fair Value Measurements
−Removed: Fair value is the price to sell an asset or transfer a liability and therefore represents an exit price in the principal market (or in the absence of a principal market, the most advantageous market).
−Removed: It represents a market-based measurement that contemplates a hypothetical transaction between market participants at the measurement date.
−Removed: The unique characteristics of an asset or liability and the availability of observable prices affect the number of valuation approaches and/or techniques used in a fair value analysis.
−Removed: We measure fair value using observable and unobservable inputs.
−Removed: We give the highest priority to quoted prices (unadjusted) in active markets for identical assets or liabilities (Level 1 inputs) and the lowest priority to unobservable inputs (Level 3 inputs).
+Added: Fair value is the price to sell an asset or transfer a liability and
+Added: therefore represents an exit price in the principal market (or in the absence of a principal market, the most advantageous market).
+Added: represents a market-based measurement that contemplates a hypothetical transaction between market participants at the measurement date.
+Added: The unique characteristics of an asset or liability and the availability
+Added: of observable prices affect the number of valuation approaches and/or techniques used in a fair value analysis.
+Added: We measure fair value
+Added: using observable and unobservable inputs.
+Added: We give the highest priority to quoted prices (unadjusted) in active markets for identical assets
+Added: or liabilities (Level 1 inputs) and the lowest priority to unobservable inputs (Level 3 inputs).
We apply the following fair value hierarchy:
−Removed: Level 1 - Quoted prices (unadjusted) in active markets for identical assets and liabilities.
−Removed: Level 2 - Quoted prices in non-active markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices;
−Removed: and inputs that are not directly observable but are corroborated by observable market data.
+Added: ● Level 1 - Quoted prices (unadjusted) in active markets for
+Added: identical assets and liabilities.
+Added: ● Level 2 - Quoted prices in non-active markets or in active
+Added: markets for similar assets or liabilities, observable inputs other than quoted prices;
+Added: and inputs that are not directly observable but
+Added: are corroborated by observable market data.
● Level 3 - Inputs that are unobservable.
−Removed: The carrying amount of our cash, restricted cash, accounts receivable, accounts payable and accrued expenses approximate their fair value because of the short-term maturity of such instruments, which are considered Level 1 under the fair value hierarchy.
−Removed: Fixed assets are carried at cost less accumulated depreciation and amortization.
−Removed: We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred.
−Removed: We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three to seven years .
−Removed: Leasehold improvements are depreciated over the shorter of their useful life or the term of the lease.
−Removed: Long-lived assets held and used by us, including fixed assets, are assessed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
−Removed: We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development.
−Removed: We begin to capitalize software development costs when both the preliminary project stage is completed, and it is probable that the software will be used as intended.
+Added: The carrying amount of our cash, restricted cash, accounts receivable,
+Added: accounts payable and accrued expenses approximate their fair value because of the short-term maturity of such instruments, which are considered
+Added: Level 1 under the fair value hierarchy.
+Added: Fixed assets are carried at cost less accumulated depreciation and
+Added: amortization.
+Added: We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs
+Added: to operating expenses as incurred.
+Added: We compute depreciation using the straight-line method over the estimated useful lives of the related
+Added: assets, which range from three to seven years .
+Added: Leasehold improvements are depreciated over the shorter of their useful life or the term
+Added: of the lease.
+Added: Long-lived assets held and used by us, including fixed assets, are assessed for impairment whenever events or changes in
+Added: circumstances indicate that the carrying amount of an asset may not be recoverable.
+Added: We capitalize software and software development costs incurred to create
+Added: and acquire computer software for internal use, principally related to software coding and application development.
+Added: We begin to capitalize
+Added: software development costs when both the preliminary project stage is completed, and it is probable that the software will be used as
Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software.
−Removed: Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five to seven years .
−Removed: License rights and other intangibles assets
−Removed: We record license rights and other intangible assets at cost, which includes external costs, consisting primary of legal costs, incurred in securing our patents and trademarks.
−Removed: License rights cost related to ANNOVERA were amortized until December 30, 2022 over the useful life over which the license rights would contribute directly or indirectly to our cash flows.
−Removed: The cost was amortized using the straight-line method as the pattern of economic benefit could not be reliably determined.
−Removed: On December 30, 2022, we assigned our ANNOVERA license to Mayne Pharma and included the remaining ANNOVERA license cost of $ 30.2 million in our calculation of the gain on sale of assets.
−Removed: In addition, amortization of license rights of $ 3.0 million for years 2022 and 2021 was reclassified to discontinued operations.
−Removed: Intangible assets subject to amortization, such as patents, are amortized over the useful life of the patent using the straight-line method.
−Removed: If the patent is not granted, we write off any capitalized patent costs at that time.
+Added: Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five
+Added: to seven years .
+Added: License rights and other
+Added: intangibles assets
+Added: We record license rights and other intangible assets at cost, which
+Added: includes external costs, consisting primary of legal costs, incurred in securing our patents and trademarks.
+Added: License rights costs related to ANNOVERA were amortized until December
+Added: 30, 2022 over the useful life over which the license rights would contribute directly or indirectly to our cash flows.
+Added: The cost was amortized
+Added: using the straight-line method as the pattern of economic benefit could not be reliably determined.
+Added: On December 30, 2022, we assigned
+Added: our ANNOVERA license to Mayne Pharma and included the remaining ANNOVERA license cost of $ 30.2 million in our calculation of the gain
+Added: on sale of assets.
+Added: In addition, amortization of license rights of $ 3.0 million for 2022 was reclassified to discontinued operations.
+Added: Intangible assets subject to amortization, such as patents, are amortized
+Added: over the useful life of the patent using the straight-line method.
+Added: If the patent is not granted, we write off any capitalized patent costs
+Added: at that time.
Intangible assets not subject to amortization, such as trademarks, are perpetual and have indefinite lives.
−Removed: We review license rights and other intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to their remaining useful lives.
−Removed: We assess other intangible assets not subject to amortization for potential impairment at least annually during the fourth quarter of each year, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of the intangible assets below their carrying value.
+Added: We review license rights and other intangible assets subject to amortization
+Added: on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to their remaining useful
+Added: We assess other intangible assets not subject to amortization for potential impairment at least annually during the fourth quarter
+Added: of each year, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of the
+Added: intangible assets below their carrying value.
Segment reporting
−Removed: We manage and operate as one business, which prior to December 2022 was focused on creating and commercializing products targeted exclusively for women and after we signed Mayne License Agreement, is focused on collecting royalties from licensing our products.
+Added: We manage and operate as one business, which prior to December 2022
+Added: was focused on creating and commercializing products targeted exclusively for women and after we signed Mayne License Agreement, is focused
+Added: on collecting royalties from licensing our products.
Our business is led by our chief executive officer.
−Removed: We do not operate separate lines of business with respect to any of our products, and we do not prepare discrete financial information with respect to separate products.
+Added: We do not operate separate lines
+Added: of business with respect to any of our products, and we do not prepare discrete financial information with respect to separate products.
Accordingly, we view our business as one reportable operating segment.
Revenue recognition
−Removed: We determine the amount of revenue to be recognized through application of the following steps:
+Added: We determine the amount of revenue to be recognized through application
+Added: of the following steps:
● Identification of the contract with a customer;
3 unchanged sentences
● Recognition of revenue when or as we satisfy the performance obligations.
−Removed: Essentially all of our revenue is generated through contracts with our customers.
−Removed: A performance obligation is a promise in a contract to transfer a product or service to a customer.
−Removed: A good or service is considered to be transferred when the customer receives the goods or service or obtains control, and we treat shipping as a fulfillment activity rather than as a separate obligation.
−Removed: We generally recognize revenue at a point in time when all of our performance obligations under the terms of a contract are satisfied.
−Removed: Revenue is recognized upon transfer of control of promised products or services in an amount that reflects the consideration we expect to receive in exchange
−Removed: for those products or services.
+Added: A performance obligation is a promise in a contract to transfer a product
+Added: or service to a customer.
+Added: A good or service is considered to be transferred when the customer receives the goods or service or obtains
+Added: control, and we treat shipping as a fulfillment activity rather than as a separate obligation.
+Added: We generally recognize revenue at a point
+Added: in time when all of our performance obligations under the terms of a contract are satisfied.
+Added: Revenue is recognized upon transfer of control
+Added: of promised products or services in an amount that reflects the consideration we expect to receive in exchange for those products or services.
The collectability of consideration on the contract is reasonably assured before revenue is recognized.
−Removed: To the extent that customer payment has been received before all recognition criteria are met, these revenues are initially deferred in other accruals on the balance sheet and the revenue is recognized in the period that all recognition criteria have been met.
−Removed: Prescription products
−Removed: On December 30, 2022, we granted an exclusive license to commercialize our prescription products and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, which resulted in a business shift that had a major effect on our operations and financial results.
−Removed: As part of the transformation that included the Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
−Removed: As of December 31, 2022, we are no longer directly engaged in the sale of prescription products.
−Removed: Prior to the business shift in December 2022, prescription products were sold at fixed wholesale acquisition cost, or WAC, determined based on our list price.
−Removed: However, the total transaction price was variable as it was calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees.
−Removed: These estimates were based on the amounts earned or to be claimed on the related sales and were classified as reductions of accounts receivable (if the amount was payable to the customer) or a current liability (if the amount was payable to a party other than a customer).
−Removed: To determine the transaction price, we estimated the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration.
−Removed: The estimated amount of variable consideration was included in the transaction price only to the extent that it was probable that a significant reversal in the amount of cumulative product revenue recognized would not occur when the uncertainty associated with the variable consideration was subsequently resolved.
−Removed: In determining amounts of variable consideration to include in a contract’s transaction price, we relied on our historical experience and other evidence that supported our qualitative assessment of whether product revenue would be subject to a significant reversal.
−Removed: We considered all the facts and circumstances associated with both the risk of a product revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur.
−Removed: Actual amounts of consideration ultimately received could differ from our estimates.
−Removed: If actual results in the future varied from our original estimates, we would adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.
−Removed: We accepted returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration.
−Removed: ANNOVERA can not be returned before the expiration date and expired ANNOVERA can be returned up to 12 months past the expiration date.
−Removed: Our prescription vitamins, IMVEXXY and BIJUVA have a shelf life of 24 months from the date of manufacture and ANNOVERA currently has a shelf life of 18 months from the date of manufacture.
−Removed: We did not allow product returns for prescription products that have been dispensed to a patient.
−Removed: We estimated the amount of our product sales that could be returned by our customers and recorded this estimate as a reduction of product revenue in the period the related product revenue was recognized.
−Removed: Where historical rates of return existed, we used history as a basis to establish a returns reserve for products shipped to wholesalers.
−Removed: For newly launched products, for which the right of return existed but for which we did not have history of product returns, we estimated returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel.
−Removed: At the end of each reporting period, sometimes we constrained product revenue, if necessary, for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products being shipped, price changes of competitive products and any introductions of generic products.
−Removed: We recognized the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration.
−Removed: Since our returns primarily consisted of expired and short dated products that would not be resold, we did not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of product revenue is deferred due to the anticipated return).
−Removed: We offered various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty.
−Removed: We estimated the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which was reviewed and adjusted, if necessary, on a quarterly basis.
−Removed: We recorded distributor fees based on amounts stated in contracts.
−Removed: We estimated chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience.
−Removed: We provided discounts to our customers for prompt payment.
−Removed: Consumer rebates and coupons costs, distribution fees, chargebacks and discounts were deducted from gross product revenue at the time the product revenue was recognized.
−Removed: For our prescription products, we offered a co-pay assistance program for eligible enrolled patients whose out of pocket costs were reduced to a more affordable price.
−Removed: This allowed patients to access the product at a reasonable cost and was in line with our responsible pricing approach.
−Removed: We reimbursed pharmacies for this discount through third-party vendors.
−Removed: The variable consideration was estimated based on contract prices, the estimated percentage of patients that would utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance.
−Removed: Payers could change coverage levels for our prescription products positively or negatively, at any time up to the time that we have formally
−Removed: contracted coverage with the payer.
−Removed: As such, the net transaction price of our prescription products was susceptible to such changes in coverage levels, which was outside the influence of the Company.
−Removed: As a result, we constrain ed variable consideration for our prescription products to an amount that would not result in a significant product revenue reversal in future periods.
−Removed: Our ability to estimate the net transaction price for our prescription products was constrained by our estimates of the amount to be paid for the co-pay assistance program which was directly related to the level of prescriptions paid for by insurance.
−Removed: As such, we record ed an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses.
−Removed: We re-evaluate d variable consideration each reporting period.
+Added: To the extent that customer payment
+Added: has been received before all recognition criteria are met, these revenues are initially deferred in other accruals on the balance sheet
+Added: and the revenue is recognized in the period that all recognition criteria have been met.
License revenue
−Removed: License arrangements may consist of non-refundable upfront license fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product royalty payments.
+Added: License arrangements may consist of non-refundable upfront license
+Added: fees, exclusive licensed rights to patented or patent pending technology, and various performance or sales milestones and future product
+Added: royalty payments.
Some of these arrangements may include multiple performance obligations.
−Removed: Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use functional intellectual property is transferred to the customer.
−Removed: On December 30, 2022, we and closed the Mayne Transaction pursuant to which we sold to Mayne Pharma the exclusive license rights in our product ANNOVERA and granted an exclusive license in other products, including IMVEXXY and BIJUVA (together, the three products being the “Licensed Products” - see Note 1).
−Removed: Under the terms of the Mayne License Agreement, we received $ 140 million at closing and we are eligible to receive additional payments in the aggregate of up to an additional $ 30 million, based on the achievement of sales milestones (collectively, the “Milestone Amounts”).
−Removed: The proceeds at closing were allocated between consideration for the sale of ANNOVERA and the initial license fee for the Licensed Products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal (see Note 2), while the license grant of the other products were recognized under the provisions of ASC 606, Revenue from Contracts with Customers, as a license of functional intellectual property.
−Removed: The proceeds were allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products.
−Removed: The Milestone Amounts will be recognized, as applicable, in subsequent periods based on actual product sales that exceed the respective net sales milestones as such variable consideration is constrained by the occurrence of the subsequent sales.
−Removed: Our royalty revenue in 2022 related to royalties provided for under the Mayne License Agreement based on Mayne Pharma’s sales of the licensed products subject to that agreement.
−Removed: Under the Mayne License Agreement, the Company is entitled to earn royalties on net sales of all of the Licensed Products at a royalty rate of (i) 8 % on the first $ 80 million of net sales of the Licensed Products and (ii) 7.5 % on net sales of all of the Licensed Products after the first $ 80 million of net sales.
−Removed: The royalty rate is subject to a 2 % reduction upon the earlier to occur of (i) the expiration or revocation of the last valid claim covering a Licensed Product, and (ii) a generic product launch (a “LOE”).
−Removed: We are entitled to minimum annual royalties beginning with the year ending December 31, 2023 ($ 3 million annual minimum) and continuing with 3 % annual increases through the year ending December 31, 2034 (the “Minimum Annual Royalty”).
−Removed: The total Minimum Annual Royalty we are entitled to is $ 42.6 million, and this total amount was allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products.
−Removed: The portion allocated to consideration for the sale of ANNOVERA was attributed towards the gain on disposal of that asset.
−Removed: For the remaining portion allocated to the license grants for the other products, we determined that the minimum guarantee underlying the Minimum Annual Royalty should be treated as fixed consideration and recognized under ASC 606 at the point in time when the license was transferred.
−Removed: Since the Minimum Annual Royalty will be received in annual installments through 2034, we determined the transaction price allocated under ASC 606 contained a significant financing component, and we therefore determined the initial royalty revenue and corresponding receivable based on the present value of the allocated Minimum Annual Royalty.
−Removed: The present value was calculated using a discount rate of 10.45 %, based on the credit characteristics of Mayne Pharma and the timing of future payments, and the value will be accreted to full value through the earlier of January 1, 2034 or a LOE.
−Removed: This royalty receivable is a contract asset as of December 31, 2022, and is further subject to offset by Mayne Pharma (see N.
+Added: Non-refundable up-front fees that are not contingent
+Added: on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use
+Added: functional intellectual property is transferred to the customer.
+Added: On December 30, 2022, we granted an exclusive license to commercialize
+Added: our prescription products and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, which resulted
+Added: in a business shift that had a major effect on our operations and financial results.
+Added: As part of the transformation that included the Mayne
+Added: License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated
+Added: financial statements for all periods prior to the Closing Date.
+Added: As of December 31, 2022, we are no longer directly engaged in the sale
+Added: of prescription products.
+Added: Under the terms of the Mayne License Agreement, we received $ 140 million
+Added: at closing and we are eligible to receive additional payments in the aggregate of up to an additional $ 30 million, based on the achievement
+Added: of sales milestones (collectively, the “Milestone Amounts”).
+Added: The proceeds at closing were allocated between consideration
+Added: for the sale of ANNOVERA and the initial license fee for the Licensed Products, as the sale of ANNOVERA was accounted for under ASC 610-20,
+Added: Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal (see Note 2), while the license grant of
+Added: the other products were recognized under the provisions of ASC 606, Revenue from Contracts with Customers, as a license of functional
+Added: intellectual property.
+Added: The proceeds were allocated among the Licensed Products on the relative net present value of forecasted future
+Added: product sales from those products.
+Added: The Milestone Amounts will be recognized, as applicable, in subsequent periods based on actual product
+Added: sales that exceed the respective net sales milestones as such variable consideration is constrained by the occurrence of the subsequent
+Added: Our royalty revenue in 2023 primarily related to royalties provided
+Added: for under the Mayne License Agreement based on Mayne Pharma’s sales of the licensed products subject to that agreement.
+Added: Mayne License Agreement, the Company is entitled to earn royalties on net sales of all of the Licensed Products at a royalty rate of (i)
+Added: 8 % on the first $ 80 million of net sales of the Licensed Products and (ii) 7.5 % on net sales of all of the Licensed Products after the
+Added: first $ 80 million of net sales.
+Added: The royalty rate is subject to a 2 % reduction upon the earlier to occur of (i) the expiration or revocation
+Added: of the last valid claim covering a Licensed Product, and (ii) a generic product launch (a “LOE”).
+Added: We are entitled to minimum
+Added: annual royalties beginning with the year ending December 31, 2023 ($ 3 million annual minimum) and continuing with 3 % annual increases
+Added: through the year ending December 31, 2034 (the “Minimum Annual Royalty”).
+Added: The total Minimum Annual Royalty we are entitled
+Added: to is $ 42.6 million, and this total amount was allocated among the Licensed Products on the relative net present value of forecasted future
+Added: product sales from those products.
+Added: The portion allocated to consideration for the sale of ANNOVERA was attributed towards the gain on
+Added: disposal of that asset.
+Added: For the remaining portion allocated to the license grants for the other products, we determined that the minimum
+Added: guarantee underlying the Minimum Annual Royalty should be treated as fixed consideration and recognized under ASC 606 at the point in
+Added: time when the license was transferred.
+Added: Since the Minimum Annual Royalty will be received in annual installments through 2034, we determined
+Added: the transaction price allocated under ASC 606 contained a significant financing component, and we therefore determined the initial royalty
+Added: revenue and corresponding receivable based on the present value of the allocated Minimum Annual Royalty.
+Added: The present value was calculated
+Added: using a discount rate of 10.45 %, based on the credit characteristics of Mayne Pharma and the timing of future payments, and the value
+Added: will be accreted to full value through the earlier of January 1, 2034 or a LOE.
+Added: This royalty receivable is a contract asset as of December
+Added: 31, 2022 and 2023, and is further subject to offset by Mayne Pharma (see L.
Contract Assets and Liabilities below).
−Removed: Royalty revenue earned in excess of the Minimum Annual Royalty will be recognized under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following:
−Removed: 1) when the subsequent sale occurs or 2) when the performance obligation to which some or all of the sales-based royalty has been allocated has been satisfied (or partially satisfied).
−Removed: We applied the royalty recognition constraint required under the guidance for sales-based royalties, which requires a sales-based royalty to be recorded no sooner than the underlying sale.
−Removed: Therefore, royalties on sales of products commercialized by Mayne Pharma will be recognized in the subsequent periods that the Licensed Products are sold.
−Removed: In 2021, we received milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets.
−Removed: In 2022 and 2021, we recorded BIJUVA sales of $ 1.4 million made through the Theramex License Agreement which was recorded as license revenue.
+Added: Royalty revenue earned in excess of the Minimum Annual Royalty will
+Added: be recognized under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the
+Added: 1) when the subsequent sale occurs or 2) when the performance obligation to which some or all of the sales-based royalty has
+Added: been allocated has been satisfied (or partially satisfied).
+Added: We applied the royalty recognition constraint required under the guidance
+Added: for sales-based royalties, which requires a sales-based royalty to be recorded no sooner than the underlying sale.
+Added: Therefore, royalties
+Added: on sales of products commercialized by Mayne Pharma will be recognized in the subsequent periods that the Licensed Products are sold.
+Added: In 2023, we recorded BIJUVA license sales of $ 0.3 million made through
+Added: the Theramex License Agreement and $ 1.0 million pertaining to our licensed products with Mayne Pharma, which was recognized as license
+Added: Additionally, we recognized $ 0.5 million in other income pertaining to royalty sales of ANNOVERA.
Cost of revenue
−Removed: Cost of revenue includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs and product shipping and handling costs.
−Removed: Costs related to the Population Council License Agreement, which were based on our net sales of ANNOVERA, and amortization of license rights were reclassified to discontinued operations for 2022 and 2021 as a result of the transaction with Mayne Pharma.
−Removed: Contract Assets and Liabilities
−Removed: Contract assets as of December 31, 2022, include royalties recognized from the Minimum Annual Royalty (see L.
+Added: Cost of revenue includes the cost of inventory, manufacturing, manufacturing
+Added: overhead and supply chain costs and product shipping and handling costs.
+Added: Costs related to the Population Council License Agreement, which
+Added: were based on our net sales of ANNOVERA, and amortization of license rights were reclassified to discontinued operations for 2022 as a
+Added: result of the transaction with Mayne Pharma.
+Added: Contract Assets and
+Added: Contract assets totaling $ 21.6 million as of December 31, 2023, include
+Added: royalties recognized from the Minimum Annual Royalty (see J.
Revenue Recognition above).
−Removed: Pursuant to the Mayne License Agreement, this asset was reduced in December 2022 by $ 1.5 million in consideration for Mayne Pharma assuming an obligation payable to vitaCare, and will be further reduced, other than from future payments on receivables from Mayne Pharma, for $ 1.0 million in prepaid royalties that we received from Mayne Pharma on the closing date.
−Removed: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable to us under the Minimum Annual Royalty by an amount equal to $ 257,250 per quarter plus interest calculated at 19 % per annum.
−Removed: Research and development
−Removed: Research and development expenses included internal R&D activities, costs of services of third-party contract research organizations (“CROs”) and usage of their clinical research sites, manufacturing, scale-up and validation costs, and other activities.
−Removed: Internal R&D activity expenses included laboratory supplies, salaries, benefits, and share-based payment award compensation costs.
−Removed: CRO activity expenses included preclinical laboratory experiments and clinical trial studies.
−Removed: Other activity expenses included regulatory consulting and other costs.
−Removed: These consulting expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs which were reclassified to discontinued operations for 2022 and 2021 as a result of the transaction with Mayne Pharma.
−Removed: As of December 31, 2022, we do no t have any ongoing research and development activities.
−Removed: Share-based payment awards
−Removed: We account for share-based payment awards on a fair value basis of the equity instrument issued.
−Removed: Under fair value accounting, the grant-date fair value of the share-based payment award is amortized as compensation expense, on a straight-line basis, over the service period (generally, the vesting period) for both graded and cliff vesting awards.
+Added: Share-based payment
+Added: We account for share-based payment awards on a fair value basis of
+Added: the equity instrument issued.
+Added: Under fair value accounting, the grant-date fair value of the share-based payment award is amortized as
+Added: compensation expense, on a straight-line basis, over the service period (generally, the vesting period) for both graded and cliff vesting
We have elected to account for forfeitures as they occur.
1 unchanged sentence
On May 6, 2022, we completed a reverse stock split of our Common Stock.
−Removed: As a result, outstanding shares of our Common Stock were split at a ratio of 50- for-1 (the “Reverse Stock Split”) with any fractional shares resulting from the Reserve Stock Split rounded up to the next whole share of Common Stock.
−Removed: The number of authorized shares of Common Stock was also correspondingly reduced from 600.0 million shares to 12.0 million shares to give effect to the Reverse Stock Split.
−Removed: Additionally, all rights to receive shares of Common Stock under outstanding warrants, options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) were adjusted to give effect of the Reverse Stock Split.
−Removed: Furthermore, remaining shares of Common Stock available for future issuance under share-based payment award plans and our employee stock purchase plan were adjusted to give effect of the Reverse Stock Split.
−Removed: Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders was not required for our Board of Directors (the “Board”) to effectuate the Reverse Stock Split.
−Removed: All historical number of shares of Common Stock and per share data have been adjusted to give effect to the Reverse Stock Split.
−Removed: Additionally, since the Common Stock par value was unchanged, historical amounts for Common Stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split.
+Added: As a result, shares of our outstanding Common Stock were split at a ratio of 50-for-1 (the “Reverse Stock Split”) with any
+Added: fractional shares resulting from the Reserve Stock Split rounded up to the next whole share of Common Stock.
+Added: The number of authorized
+Added: shares of Common Stock was also correspondingly reduced from 600.0 million shares to 12.0 million shares to give effect to the Reverse
+Added: Additionally, all rights to receive shares of Common Stock under outstanding warrants, options, restricted stock units (“RSUs”)
+Added: and performance stock units (“PSUs”) were adjusted to give effect of the Reverse Stock Split.
+Added: Furthermore, remaining shares
+Added: of Common Stock available for future issuance under share-based payment award plans and our employee stock purchase plan were adjusted
+Added: to give effect of the Reverse Stock Split.
+Added: Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders
+Added: was not required for our Board of Directors (the “Board”) to effectuate the Reverse Stock Split.
+Added: All historical numbers of shares of Common Stock and per share data
+Added: have been adjusted to give effect to the Reverse Stock Split.
+Added: Additionally, since the Common Stock par value was unchanged, historical
+Added: amounts for Common Stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split.
+Added: Increase of authorized shares
+Added: On June 26, 2023, at our combined 2022 and 2023 Annual Meeting, our
+Added: stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase the number of authorized shares of
+Added: Common Stock from 12 million shares to 32 million shares.
Income taxes are accounted for under the asset and liability method.
−Removed: Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and income tax credit carryforwards.
−Removed: Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
−Removed: The effect on deferred tax assets and liabilities of a change in income tax rates is recorded as a component of the income tax provision in the period that includes the enactment date.
−Removed: Regular assessments are made on the likelihood that our deferred tax assets will be recovered from our future taxable income.
−Removed: Our evaluation is based on estimates, assumptions, and includes an analysis of available positive and negative evidence, giving weight based on the evidence’s relative objectivity.
−Removed: Sources of positive evidence include estimates of future taxable income, future reversal of existing
−Removed: taxable temporary differences, taxable income in carryback years, and available tax planning strategies.
−Removed: Sources of negative evidence include current and cumulative losses in recent years, losses expected in early future years, any history of operating losses or tax credit carryforwards expiring unused, and unsettled circumstances that, if unfavorably resolved, would adversely affect future profit levels.
−Removed: The remaining carrying value of our deferred tax assets, after recording the valuation allowance on our deferred tax assets, is based on our present belief that it is more likely than not that we will be able to generate sufficient future taxable income to utilize such deferred tax assets.
−Removed: The amount of the remaining deferred tax assets considered recoverable could be adjusted if our estimates of future taxable income during the carryforward period change favorably or unfavorably.
−Removed: To the extent we believe that it is more likely than not that some or all the remaining deferred tax assets will not be realized, we must establish a valuation allowance against those deferred tax assets, resulting in additional income tax expense in the period such determination is made.
−Removed: To the extent a valuation allowance currently exists, we will continue to monitor all positive and negative evidence until we believe it is more likely than not that it is no longer necessary, resulting in an income tax benefit in the period such determination is made.
−Removed: Our policy is to recognize both interest and penalties related to uncertain tax positions as part of the income tax provision.
−Removed: Significant judgment is required in evaluating our tax positions, and in determining our provisions for income taxes, our deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets.
−Removed: We establish reserves when, despite our belief that the income tax return positions are fully supportable, certain positions are likely to be challenged and we may ultimately not prevail in defending those positions.
−Removed: Earnings per common share
−Removed: Basic earnings or loss per common share is computed by dividing net income or loss available to common stockholders by the sum of the weighted average number of shares of common stock.
−Removed: Diluted earnings per common share is computed by dividing net income available to common stockholders by the sum of the weighted average number of shares of common stock and the number of additional shares of common stock that would have been outstanding if our outstanding potentially dilutive securities had been issued.
−Removed: Potentially dilutive securities include awards of non-vested or vested and not settled restricted stock units, performance stock units where the performance requirements have been met and not settled, warrants and options.
−Removed: The dilutive effect of potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method, except if its impact is anti-dilutive.
−Removed: Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities.
+Added: Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
+Added: the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating loss and income
+Added: tax credit carryforwards.
+Added: Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable
+Added: income in the years in which those temporary differences are expected to be recovered or settled.
+Added: The effect on deferred tax assets and
+Added: liabilities of a change in income tax rates is recorded as a component of the income tax provision in the period that includes the enactment
+Added: Regular assessments are made on the likelihood that our deferred tax
+Added: assets will be recovered from our future taxable income.
+Added: Our evaluation is based on estimates, assumptions, and includes an analysis of
+Added: available positive and negative evidence, giving weight based on the evidence’s relative objectivity.
+Added: Sources of positive evidence
+Added: include estimates of future taxable income, future reversal of existing taxable temporary differences, taxable income in carryback years,
+Added: and available tax planning strategies.
+Added: Sources of negative evidence include current and cumulative losses in recent years, losses expected
+Added: in early future years, any history of operating losses or tax credit carryforwards expiring unused, and unsettled circumstances that,
+Added: if unfavorably resolved, would adversely affect future profit levels.
+Added: The remaining carrying value of our deferred tax assets, after recording
+Added: the valuation allowance on our deferred tax assets, is based on our present belief that it is more likely than not that we will be able
+Added: to generate sufficient future taxable income to utilize such deferred tax assets.
+Added: The amount of the remaining deferred tax assets considered
+Added: recoverable could be adjusted if our estimates of future taxable income during the carryforward period change favorably or unfavorably.
+Added: To the extent we believe that it is more likely than not that some or all the remaining deferred tax assets will not be realized, we must
+Added: establish a valuation allowance against those deferred tax assets, resulting in additional income tax expense in the period such determination
+Added: To the extent a valuation allowance currently exists, we will continue to monitor all positive and negative evidence until we
+Added: believe it is more likely than not that it is no longer necessary, resulting in an income tax benefit in the period such determination
+Added: Our policy is to recognize both interest and penalties related to uncertain
+Added: tax positions as part of the income tax provision.
+Added: Significant judgment is required in evaluating our tax positions, and in determining
+Added: our provisions for income taxes, our deferred tax assets and liabilities and any valuation allowance recorded against our net deferred
+Added: We establish reserves when, despite our belief that the income tax return positions are fully supportable, certain positions
+Added: are likely to be challenged and we may ultimately not prevail in defending those positions.
+Added: Earnings per common
+Added: Basic earnings or loss per common share is computed by dividing net
+Added: income or loss available to common stockholders by the sum of the weighted average number of shares of common stock.
+Added: Diluted earnings
+Added: per common share is computed by dividing net income available to common stockholders by the sum of the weighted average number of shares
+Added: of common stock and the number of additional shares of common stock that would have been outstanding if our outstanding potentially dilutive
+Added: securities had been issued.
+Added: Potentially dilutive securities include awards of non-vested or vested and not settled restricted stock units,
+Added: performance stock units where the performance requirements have been met and not settled, warrants and options.
+Added: The dilutive effect of
+Added: potentially dilutive securities is reflected in diluted earnings per common share by application of the treasury stock method, except
+Added: if its impact is anti-dilutive.
+Added: Under the treasury stock method, an increase in the fair market value of our common stock can result in
+Added: a greater dilutive effect from potentially dilutive securities.
We determine if an arrangement is a lease at inception.
−Removed: Determining whether a contract contains a lease includes judgment regarding whether the contract conveys the right to control the use of identified property or equipment for a period of time in exchange for consideration.
−Removed: We account for our lease-related assets and liabilities based on their classification as operating leases or finance leases, following the relevant accounting guidance.
−Removed: For all the lessee arrangements, we have elected an accounting policy to combine non-lease components with the related-lease components and treat the combined items as a lease for accounting purposes.
−Removed: We measure lease related assets and liabilities based on the present value of lease payments, including in-substance fixed payments, variable payments that depend on an index or rate measured at the commencement date, and the amount we believe is probable we will pay the lessor under residual value guarantees when applicable.
−Removed: We discount lease payments based on our estimated incremental borrowing rate at lease commencement (or modification), which is primarily based on our estimated credit rating, the lease term at commencement, and the contract currency of the lease arrangement.
−Removed: We have elected to exclude short-term leases (leases with an original lease term less than one year) from the measurement of lease-related assets and liabilities.
−Removed: We test right-of-use asset in an operating or finance lease at the asset group level (because these assets are long-lived nonfinancial assets and should be accounted for the same way as other long-lived nonfinancial assets) whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
+Added: whether a contract contains a lease includes judgment regarding whether the contract conveys the right to control the use of identified
+Added: property or equipment for a period of time in exchange for consideration.
+Added: We account for our lease-related assets and liabilities based on their
+Added: classification as operating leases or finance leases, following the relevant accounting guidance.
+Added: For all the lessee arrangements, we
+Added: have elected an accounting policy to combine non-lease components with the related-lease components and treat the combined items as a
+Added: lease for accounting purposes.
+Added: We measure lease related assets and liabilities based on the present value of lease payments, including
+Added: in-substance fixed payments, variable payments that depend on an index or rate measured at the commencement date, and the amount we believe
+Added: is probable we will pay the lessor under residual value guarantees when applicable.
+Added: We discount lease payments based on our estimated
+Added: incremental borrowing rate at lease commencement (or modification), which is primarily based on our estimated credit rating, the lease
+Added: term at commencement, and the contract currency of the lease arrangement.
+Added: We have elected to exclude short-term leases (leases with an
+Added: original lease term less than one year) from the measurement of lease-related assets and liabilities.
+Added: We test right-of-use assets in an operating or finance lease at the asset group level (because these assets are long-lived nonfinancial
+Added: assets and should be accounted for the same way as other long-lived nonfinancial assets) whenever events or changes in circumstances indicate
+Added: that the carrying amount of an asset may not be recoverable.
+Added: We sublease our unoccupied facilities to third parties.
+Added: Any impairment
+Added: to the associated right-of-use asset, leasehold improvements, or other assets as a result of the sublease is recognized in the period
+Added: when a decision to sublease is made and recorded in our consolidated statement of operations.
+Added: We recognize sublease income on a straight-line
+Added: basis over the sublease term.
Loss Contingencies
−Removed: In determining whether an accrual for a loss contingency is required, we first assess the likelihood of occurrence of the future event or events that will confirm the loss.
−Removed: When a loss is probable (the future event or events are likely to occur) and the amount of the loss can be reasonably estimated, the estimated loss is accrued.
−Removed: If the reasonable estimate of the loss is a range and an amount within the range appears to be a better estimate than any other amount within the range, that amount should be accrued.
−Removed: However, if no amount within the range is a better estimate, the minimum amount in the range should be accrued.
−Removed: When a loss is reasonably possible (the chance of the future event or events occurring is more than remote but less than likely), no accrual is recognized .
+Added: In determining whether an accrual for a loss contingency is required,
+Added: we first assess the likelihood of occurrence of the future event or events that will confirm the loss.
+Added: When a loss is probable (the future
+Added: event or events are likely to occur) and the amount of the loss can be reasonably estimated, the estimated loss is accrued.
+Added: If the reasonable
+Added: estimate of the loss is a range and an amount within the range appears to be a better estimate than any other amount within the range,
+Added: that amount should be accrued.
+Added: However, if no amount within the range is a better estimate, the minimum amount in the range should be
+Added: When a loss is reasonably possible (the chance of the future event or events occurring is more than remote but less than likely),
+Added: no accrual is recognized.
+Added: See Note 8 for more information.
Restructuring charges
−Removed: During the year ended December 31, 2022, the Company initiated and completed a restructuring plan that resulted in a reduction of its workforce to one employee.
−Removed: One-time termination benefits include severance, continuation of health insurance coverage, and other benefits for a specified period of time, as well as contract terminations and fixed assets write-downs, which resulted in $ 15.7 million of restructuring costs for the year ended December 31, 2022.
−Removed: These costs have been recognized in the accompanying consolidated statement of operations as follows (in thousands):
+Added: During the year ended December 31, 2022, the Company initiated and
+Added: completed a restructuring plan that resulted in a reduction of its workforce to one employee.
+Added: One-time termination benefits include severance,
+Added: continuation of health insurance coverage, and other benefits for a specified period of time, as well as contract terminations and fixed
+Added: assets write-downs, which resulted in $ 15.7 million of restructuring costs for the year ended December 31, 2022.
+Added: There were no restructuring
+Added: costs incurred during the year ended December 31, 2023.
+Added: Restructuring costs have been recognized in the accompanying consolidated statement
+Added: of operations as follows (in thousands):
Executive termination benefits
5 unchanged sentences
Total restructuring expenses - discontinued operations
−Removed: At December 31, 2022, $ 9.3 million related to restructuring costs was included in accrued expenses and other current liabilities and $ 6.2 million was included in current liabilities of discontinued operations in the accompanying consolidated balance sheets.
+Added: At December 31, 2023 and 2022 respectively, $ 2.5 million and $ 6.2 million
+Added: of restructuring costs were included in current liabilities of discontinued operations in the accompanying consolidated balance sheets.
+Added: At December 31, 2022, $ 9.3 million related to restructuring costs was included in accrued expenses and other current liabilities.
Reclassification of prior year presentation
−Removed: Certain prior year amounts have been reclassified for consistency with the current year presentation.
−Removed: An adjustment has been made to the consolidated statements of operations for 2022 and 2021 to reclassify commercial operations and vitaCare operations to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results.
+Added: Certain prior year amounts have been reclassified for consistency with
+Added: the current year presentation.
Discontinued Operations
−Removed: We changed our business in 2022, by out-licensing our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma.
−Removed: This plan represented a strategic shift having a major effect on the Company's operations and financial results.
−Removed: Upon the completion of the Company’s restructuring and ultimate conversion from a commercial pharmaceutical company to a licensing only company with the consummation of the Mayne Transaction, the Company classified all direct revenues, costs and expenses related to commercial operations, within income (loss) from discontinued operations, net of tax, in the consolidated statements of operations for all periods presented.
−Removed: No amounts for shared general and administrative operating support expense were allocated to discontinued operations.
−Removed: As required by the terms of our Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings, and as a result interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax (as disclosed below).
−Removed: Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2022 and 2021.
−Removed: The total consideration from Mayne Pharma was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of $ 12.1 million for the acquisition of net working capital subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million for prepaid royalties in connection with the License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the License Agreement, as amended.
−Removed: The Company’s es timate of net working capital at closing was determined in accordance with the Transaction Agreement which establishes the process for the determination of final net working capital.
−Removed: The determination of net working capital include s significant estimates which could change materially for a period of up to two years following the Closing Date .
−Removed: On March 29, 2023, the Company received Mayne Pharma’s closing net working capital calculation which differed significantly from the Company’s estimate of closing net working capital.
−Removed: The Company believes that its estimate of net working capital is reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement.
−Removed: Given the recent receipt of Mayne Pharma’s calculation and the nature of the estimates involved , the outcome of this matter is uncertain at this point.
−Removed: As a result , the Company cannot reasonably estimate a range of loss, and accordingly , the Company has not accrued any additional liability ass ociated with Mayne Pharma’s calculation.
−Removed: The proceeds at closing were allocated separately to the sale of ANNOVERA and the license grant related to the other products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal.
−Removed: We recognized $ 70.0 million in revenue from transaction with Mayne Pharma, which represented license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products as well as present value of future minimum royalty payments (as discussed in Note 1).
−Removed: The Company classified the $ 143.4 million gain on the sale of the vitaCare business and $ 62.0 gain on sale of ANNOVERA, net of transaction costs in discontinued operations.
−Removed: The Company recorded a restructuring expense of $ 15.7 million, for the year ended December 31, 2022 for contract terminations, severance, and fixed asset write-downs, of which $ 6.2 million was recorded in discontinued operations.
−Removed: The following table presents results of discontinued operations (in thousands):
−Removed: Year ended December 31,
+Added: As discussed in Note 1, we changed our business in 2022 by
+Added: licensing our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize
+Added: our IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and
+Added: assigning our exclusive license to commercialize ANNOVERA to Mayne Pharma.
+Added: This plan represented a strategic shift having a major effect
+Added: on our operations and financial results.
+Added: Upon our conversion from a commercial pharmaceutical company to a licensing only company with
+Added: the consummation of the Mayne Transaction, we classified all direct revenues, costs and expenses related to commercial operations, within
+Added: income (loss) from discontinued operations, net of tax, in the consolidated statements of operations for all periods presented.
+Added: no t allocated any amounts for shared general and administrative operating support expense to discontinued operations.
+Added: As required by the
+Added: terms of the Financing Agreement, proceeds from the Mayne Transaction and the vitaCare Divestiture were used to fully repay our outstanding
+Added: debt borrowings, and as a result interest expense and amortization of deferred financing costs as well as expense for accretion of Series
+Added: A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax (as disclosed
+Added: Additionally, the related assets and liabilities have been
+Added: reported as assets and liabilities of discontinued operations in our consolidated balance sheet as of December 31, 2023 and 2022.
+Added: The total consideration from Mayne Pharma consisted of (i)
+Added: a cash payment of $ 140.0 million at closing, (ii) a cash payment of $ 12.1 million for the acquisition of net working capital subject to
+Added: certain adjustments, (iii) a cash payment of approximately $ 1.0 million for prepaid royalties in connection with the Mayne License Agreement
+Added: Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
+Added: Our estimate of net working capital at closing was determined in accordance
+Added: with the Transaction Agreement which establishes the process for the determination of final net working capital.
+Added: The determination of
+Added: final net working capital includes significant estimates which could change materially for a period of up to two years following the Closing
+Added: The following table presents results of discontinued operations
+Added: (in thousands):
+Added: Years ended December 31,
Product revenue, net
Cost of goods sold
+Added: Gross profit (loss)
Operating expenses:
5 unchanged sentences
Loss from discontinued operations
−Removed: Other (expense) income:
+Added: Other income (expense):
Gain on sale of vitaCare
3 unchanged sentences
Expense for accretion of Series A Preferred Stock
−Removed: Other income, net
+Added: Loss on disposal of assets
+Added: Other expense, net
Total other income (expense), net
Loss before from income taxes
−Removed: Provision for income taxes
+Added: Benefit (provision) for income taxes
Net income (loss) from discontinued operations
−Removed: The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations as of December 31, 2022 and December 31, 2021 (in thousands):
+Added: The following table presents the carrying amounts of the classes of
+Added: assets and liabilities of discontinued operations (in thousands):
As of December 31,
1 unchanged sentence
Accounts receivable
−Removed: Prepaid and other current assets
−Removed: Total current assets
−Removed: Fixed assets, net
−Removed: License rights and other intangible assets, net
Current liabilities:
1 unchanged sentence
Accrued expenses and other current liabilities
−Removed: Total current liabilities
−Removed: Prepaid and other current assets
−Removed: Our prepaid and other current assets consisted of the following (in thousands):
−Removed: As of December 31,
−Removed: Paragraph IV legal proceeding costs
+Added: Total liabilities
+Added: Prepaid and other current
+Added: Our prepaid and other current assets consisted of the following
+Added: (in thousands):
+Added: Capitalized legal
Prepaid and other current assets
Our fixed assets, net consisted of the following (in thousands):
−Removed: As of December 31,
Furniture and fixtures
4 unchanged sentences
Fixed assets, net
−Removed: We recorded depreciation expense of $ 0.6 million for 2022 and $ 0.4 million for 2021.
+Added: We recorded in continuing operations, depreciation expense of $ 0.1
+Added: million for 2023 and $ 0.6 million for 2022.
Licensed rights and other intangible assets
−Removed: The following provides information about our license rights and other intangible assets, net (in thousands):
+Added: The following provides information about our license rights and other
+Added: intangible assets, net (in thousands):
As of December 31, 2023
As of December 31, 2022
−Removed: Intangible assets
−Removed: subject to amortization:
+Added: Intangible assets subject to amortization:
Hormone therapy drug patents
−Removed: Hormone therapy drug patents applied
−Removed: and pending approval
−Removed: Intangible assets
−Removed: subject to amortization
+Added: Hormone therapy drug patents applied and pending approval
+Added: Intangible assets subject to amortization
Intangible assets not subject to amortization:
1 unchanged sentence
Intangible assets, net
−Removed: We recorded, in continuing operations, amortization expense related to patents of $ 0.6 million for 2022 and $ 0.3 million for 2021.We recorded amortization expense related to the exclusive license rights agreement with Population Council of $ 3.0 million for 2022 and 2021, which was reclassified to discontinued operations after we completed transaction with Mayne Pharma in December 2022, which are excluded from the table above.
−Removed: Our intangible assets subject to amortization are expected to be amortized as follows (in thousands):
+Added: We recorded, in continuing operations, amortization expense related
+Added: to patents of $ 0.8 million for 2023, of which $ 0.5 million is accelerated amortization as a result of a review of our intangible assets,
+Added: and $ 0.6 million for 2022.
+Added: We recorded amortization expense related to the exclusive license rights agreement with Population Council
+Added: of $ 3.0 million for 2022, which was reclassified to discontinued operations after we completed transaction with Mayne Pharma in December
+Added: 2022, and excluded from the table above.
+Added: Our intangible assets subject to amortization are expected to be amortized
+Added: as follows (in thousands):
Year ending December 31,
−Removed: We use a combination of qualitative and quantitative factors to assess licensed rights and intangible assets for impairment.
−Removed: As a result of performing these assessments, we determined that no impairment existed as of December 31, 2022 or 2021, therefore, no write downs were recorded to our licensed rights and other intangible assets.
+Added: We use a combination of qualitative and quantitative factors to assess
+Added: licensed rights and intangible assets for impairment.
+Added: In the year ending December 31, 2023, we have not impaired any of our hormone therapy
+Added: drug patent assets.
Accrued expenses and other current liabilities
−Removed: Other accrued expenses and other current liabilities consisted of the following (in thousands):
+Added: Other accrued expenses and other current liabilities consisted of the
+Added: following (in thousands):
As of December 31,
5 unchanged sentences
Prepaid royalty
+Added: Other accrued expenses and current liabilities
Accrued expenses and other current liabilities
−Removed: We expense advertising costs when incurred, which amounted to $ 13.2 million and $ 39.7 million for 2022 and 2021, respectively, which was reclassified to discontinued operations as a result of business shift following transaction with Mayne Pharma.
−Removed: Our debt consisted of the following (in thousands):
−Removed: As of December 31,
−Removed: Financing Agreement
−Removed: deferred financing fees
−Removed: Current maturities of long-term debt
−Removed: Long-term debt
+Added: We expense advertising costs when incurred, which amounted to
+Added: $ 13.2 million for 2022, which was reclassified to discontinued operations as a result of our business shift following the Mayne
+Added: We incurred no advertising costs in 2023.
Financing agreement
−Removed: We were party to a Financing Agreement with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent”), various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors.
−Removed: On December 30, 2022, we repaid all obligations under the Financing Agreement and the Financing Agreement was terminated.
−Removed: The Financing Agreement was entered into in April 2019, and it provided us with up to a $ 300.0 million first lien secured term loan credit facility.
−Removed: The credit facility provided for availability to us in three tranches:
−Removed: (i) $ 200.0 million was drawn upon entering into the Financing Agreement;
−Removed: (ii) $ 50.0 million was drawn in February 2020 and (iii) $ 50.0 million was previously available to us in the Administrative Agent’s sole and absolute discretion either contemporaneously with the delivery of our financial statements for the quarterly period ended June 30, 2020 or at such earlier date as the Administrative Agent may have consented to.
−Removed: In the third quarter of 2020, the Administrative Agent terminated the undrawn $ 50.0 million tranche under the Financing Agreement, therefore, such amount was no longer available to us to borrow.
−Removed: In connection with the initial borrowing under the Financing Agreement, we paid, for the benefit of the lenders, a facility fee equal to 2.5 % of the initial amount borrowed and were required to pay such a facility fee in connection with subsequent borrowings under the Financing Agreement.
−Removed: Borrowings under the Financing Agreement accrued interest at either (i) 3-month LIBOR plus 7.75 %, subject to a LIBOR floor of 2.70 % or (ii) the prime rate plus 6.75 %, subject to a prime rate floor of 5.2 % as selected by us.
−Removed: As of December 30, 2022, our interest rate was 10.45 %.
−Removed: Interest on amounts borrowed under the Financing Agreement was due and payable quarterly in arrears.
−Removed: In addition, we were required to pay an annual administrative fee, and other fees and expenses.
−Removed: In August 2020, we entered into Amendment No.
−Removed: 5 to the Financing Agreement (“Amendment No.
−Removed: 5”) pursuant to which, among other amendments, the covenant in the Financing Agreement regarding our achievement of minimum consolidated net revenue attributable to commercial sales of our IMVEXXY, BIJUVA and ANNOVERA products were adjusted in order to reflect the impact of COVID-19 on our business.
−Removed: In lieu of a cash amendment fee, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 95,042 shares of our common stock with an exercise price of $ 79 per share and a ten-year term (the “Lender Warrants”).
−Removed: The Lender Warrants were issued pursuant to an exemption from registration under the Securities Act of 1933, as amended, and no registration rights were issued.
−Removed: The estimated fair value of the Lender Warrants was $ 7.4 million and was recorded as deferred financing cost since Amendment No.
−Removed: 5 was accounted for as a debt modification.
−Removed: In November 2020, in connection with Amendment No.
−Removed: 6 to the Financing Agreement (“Amendment No.
−Removed: 6”), we amended the Lender Warrants to provide for an adjustment to the exercise price if we conduct certain dilutive issuances prior to December 31, 2020, or if the volume-weighted average price of our common stock for the fifteen trading days ending December 31, 2020 was lower than the then current exercise price.
−Removed: Also, in November 2020, we concluded an underwritten public offering of our common stock and received consideration of $ 59.5 per share, after deducting for underwriting discounts and commissions.
−Removed: This offering of our common stock automatically triggered the down round provision to the exercise price of the Lender Warrants, which lowered the exercise price from $ 79 to $ 59.5 per share.
−Removed: The estimated fair value of the adjustment to the exercise price of Lender Warrants was $ 0.2 million and was recorded as deferred financing cost since Amendment No.
−Removed: 6 was accounted for as a debt modification.
−Removed: No other amendment financing fees were paid.
−Removed: In January 2021, we entered into Amendment No.
−Removed: 7 to the Financing Agreement (“Amendment No.
−Removed: 7”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA for the fiscal quarters ending March 31, 2021 and June 30, 2021 were reduced, and we paid amendment financing fees of $5.0 million, which was recorded as deferred financing fees since Amendment No 7 was accounted for as debt modification.
−Removed: Additionally, in connection with entering into Amendment No.
−Removed: 7, the warrants issued to the Administrative Agent and the lenders under the Financing Agreement in August 2020 were further amended to provide for an additional adjustment to the exercise price if we conducted certain dilutive issuances prior to March 31, 2021.
−Removed: No adjustments were made to the exercise price of these warrants prior to the expiration of such period.
−Removed: In March 2021, we entered into Amendment No.
−Removed: 8 to the Financing Agreement (“Amendment No.
−Removed: 8”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA were revised, the amortization and prepayment terms of the borrowings under the Financing Agreement were revised, and the Administrative Agent consented to a framework for our potential disposition of our vitaCare business.
−Removed: In connection with Amendment No.
−Removed: 8, we (i) repaid $ 50.0 million in principal under the Financing Agreement during the three months ended March 31, 2021, plus a 5.0 % prepayment fee and (ii) agreed to make additional quarterly principal repayments plus the prepayment fees as follows:
−Removed: (a) $ 5.0 million due in March 2022, June 2022 and September 2022;
−Removed: (b) $ 10.0 million due in December 2022 and March 2023;
−Removed: and (c) $ 41.25 million due in June 2023, September 2023, December 2023 and March 2024.
−Removed: Additionally, the prepayment fees on principal amounts being prepaid under the Financing Agreement were revised as follows:
−Removed: (i) 30.0 % of the principal amount being repaid through March 31, 2022 (excluding the scheduled $ 5.0 million principal repayment on such date, which is subject to a 5.0 % prepayment fee);
−Removed: (ii) 5.0 % of the principal amount being repaid from April 2022 through March 2023;
−Removed: (iii) 3.0 % of the principal amount being repaid from April 2023 through March 2024;
−Removed: and (iv) thereafter, none, in each case subject to certain limited exceptions, including with respect to a repayment in full of the obligations under the Financing Agreement.
−Removed: In March 2022, we entered into Amendment No.
−Removed: 9 to the Financing Agreement (“Amendment No.
−Removed: 9”) pursuant to which, among other amendments, (i) the lenders waived various Company breaches of the Financing Agreement, including breaches of the $ 60.0 million minimum cash covenant and the minimum net revenue covenants for the fourth quarter of 2021;
−Removed: (ii) the Company and the lenders agreed to a reduced minimum cash covenant and to the removal of the minimum net revenue covenant for the first quarter of 2022;
−Removed: (iii) the lenders waived the existing $ 60.0 million prepayment penalty under the Financing Agreement and the Company agreed to pay a paid in kind (“PIK”) amendment financing fee of $ 30.0 million, which fee was added to the principal amount of the loans under the Financing Agreement, $ 16.0 million of which fee was waivable in certain conditions;
−Removed: (iv) the maturity date of the Financing Agreement was amended to June 1, 2022;
−Removed: and (v) the Company agreed to pay to the Lenders as a prepayment of the loans under the Financing Agreement the first $ 120.0 million of net proceeds from the vitaCare Divestiture and all net proceeds of the vitaCare Divestiture in excess of $ 135.0 million.
−Removed: Amendment No.
−Removed: 9 was accounted for as an extinguishment of debt modification in accordance with U.S.
−Removed: Accordingly, in March 2022, we recorded an $ 8.4 million loss on extinguishment of debt, which represented the unamortized deferred financing fees, net of previously accrued prepayment fees.
−Removed: Additionally, Amendment No.
−Removed: 9 PIK financing fee was recorded as deferred financing fees and was amortized over the remaining term of the Financing Agreement.
−Removed: In April 2022, we utilized $ 120.0 million of net proceeds from the vitaCare Divestiture to make a prepayment of the loans under the Financing Agreement under the terms of Amendment No.
−Removed: Additionally, with the prepayment on the debt, $ 16.0 million of the PIK financing fee was waived in accordance with Amendment No.
−Removed: In May 2022, we entered into Amendment No.
−Removed: 10 to the Financing Agreement (“Amendment No.
−Removed: 10”) pursuant to which, among other amendments, (i) interest payments under the Financing Agreement were paused, such that interest on each term loan was payable in cash and in arrears (a) upon any prepayment of that term loan, whether voluntary or mandatory, to the extent accrued on the amount being prepaid and (b) on the maturity date, (ii) the minimum cash covenant was set at $ 10.0 million, (iii) the maturity date of the Financing Agreement was amended to July 13, 2022 , (iv) the termination of the Company’s merger agreement with an affiliate of EW Healthcare Partners was added as an event of default, and (v) we agreed to a PIK financing fee of $ 1.8 million, which fee was added to the principal amount of the loans under the Financing Agreement.
−Removed: Amendment No.
−Removed: 10 was accounted for as a debt amendment in accordance with U.S.
−Removed: Accordingly, in May 2022, Amendment No.
−Removed: 10 PIK financing fee was recorded as deferred financing fees and was amortized over the remaining term of the Financing Agreement.
−Removed: Also in May 2022, we entered into Amendment No.
−Removed: 11 (“Amendment No.
−Removed: 11”) to the Financing Agreement.
−Removed: Amendment No.
−Removed: 11 contains amendments to the Financing Agreement that would have gone into effect upon the satisfaction of certain conditions on or before July 13, 2022 (the “Amendment Effective Date”), including (i) the consummation of the merger with an affiliate of EW Healthcare Partners (the “Merger”), (ii) the payment in cash of (a) all accrued and unpaid interest under the Financing Agreement through and including the Amendment Effective Date and (b) all fees, costs, expenses and taxes then payable pursuant to Section 2.7 or 10.2 of the Financing Agreement, and (iii) the delivery to the administrative agent of certain customary documents with respect to the pledge of 100 % of the capital stock of the Company.
−Removed: Since the consummation of the Merger did not occur, Amendment No.
−Removed: 11 never became effective.
−Removed: On July 13, 2022, we entered into Amendment No.
−Removed: 12 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 24, 2022 , and we agreed to pay the Lenders a PIK amendment fee in the amount of $ 1.2 million.
−Removed: On July 24, 2022, we entered into Amendment No.
−Removed: 13 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 27, 2022 , we agreed to pay the Lenders a payment of accrued and unpaid interest of $ 2.9 million, and we agreed to retain Jeffrey Varsalone from G2 Capital Advisors as our chief restructuring officer.
−Removed: On July 27, 2022, we entered into Amendment No.
−Removed: 14 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 28, 2022 .
−Removed: On July 28, 2022, we entered into Amendment No.
−Removed: 15 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 29, 2022 .
−Removed: On July 29, 2022, we entered into Amendment No.
−Removed: 16 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to September 30, 2022, with the option for us to further extend the maturity date to October 31, 2022, and November 30, 2022, in each case if we receive not less than $ 7.0 million in cash proceeds from an equity issuance, which, if preferred equity, is on substantially the same terms as the Preferred Stock.
−Removed: In lieu of a cash amendment fee, to induce the Lenders to enter into Amendment No.
−Removed: 16, on July 29, 2022, we issued Lender Warrants to purchase an aggregate of 185,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders (the “July Lender Subscription Agreement”).
−Removed: The Lender Warrants to purchase 185,000 shares of our Common Stock issued pursuant to the July Lender Subscription Agreement have an exercise price of $ 0.01 per warrant, subject to certain adjustment as provided therein, and an expiration date of July 29, 2032, and may be exercised via cashless exercise pursuant to the terms thereof.
−Removed: These Lender Warrants were initially valued at $ 1.2 million based on the market price of our Common Stock on July 29, 2022 and entirely expensed as financing costs.
−Removed: In connection with the closing of a private placement offering with Rubric Capital Management LP (“the Preferred Stock Investor”) on September 30, 2022, and in accordance with Amendment No.
−Removed: 16 to the Financing Agreement, on September 30, 2022, we issued Lender Warrants to purchase an aggregate of 125,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders (the “September Lender Subscription Agreement”), and the maturity date of the Financing Agreement was extended to October 31, 2022.
−Removed: These Lender Warrants have an exercise price of $ 0.01 per share of Common Stock, subject to certain adjustment as provided therein, and an expiration date of September 30, 2032 and may be exercised via cashless exercise pursuant to the terms thereof.
−Removed: These Lender Warrants were initially valued at $ 0.8 million based on the market price of our Common Stock on September 30, 2022 and recorded as deferred financing fees, which were expensed with maturity of the Financing Agreement on October 31, 2022.
−Removed: Additionally, in September 2022, we and the Lenders agreed to PIK interest of $ 2.5 million related to the outstanding debt balance.
−Removed: In connection with the closing of the private placement offering with the Preferred Stock Investor on October 28, 2022, and in accordance with Amendment No.
−Removed: 16 to the Financing Agreement, on October 28, 2022, we issued Lender Warrants to purchase an aggregate of 125,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders, and the maturity date of the Financing Agreement was extended to November 30, 2022.
−Removed: These Lender Warrants have an exercise price of $ 0.01 per share of Common Stock, subject to certain adjustment as provided therein, and an expiration date of October 28, 2032 and may be exercised via cashless exercise pursuant to the terms thereof.
−Removed: These Lender Warrants were initially valued at $ 0.7 million based on the market price of our Common Stock on October 28, 2022 and recorded as financing costs.
−Removed: The fair value of the Lender Warrants was based on the date of grant using our Common Stock’s closing price at measurement date and was recorded to “Additional paid-in-capital” in the consolidated balance sheets.
−Removed: See Note 9, Mandatory Redeemable Preferred Stock and Stockholders’ Equity (Deficit) for additional information regarding the equity financing with the Preferred Stock Investor.
−Removed: On November 30, 2022, we entered into Amendment No.
−Removed: 17 (“Amendment No.
−Removed: 17”) to the Financing Agreement.
−Removed: Pursuant to Amendment No.
−Removed: 17, among other things, (i) the maturity date of the Financing Agreement was extended to December 31, 2022 , subject to the achievement of certain milestones by the Company, (ii) the minimum cash covenant was set at $ 7.5 million, (iii) the Company agreed to pay the Lenders an amendment fee in the amount of $ 750,000 and (iv) the Company paid the Lenders all accrued and unpaid interest under the Financing Agreement as of the Amendment Date, in the amount of approximately $ 4.2 million.
−Removed: On December 30, 2022, we repaid remaining obligations under the Financing Agreement of $ 75.0 million, PIK financing fees of $ 17.0 million and the remaining accrued interest, and the Financing Agreement was terminated.
+Added: We were party to the Financing Agreement with Sixth Street
+Added: Specialty Lending, Inc., as administrative agent, various lenders from time-to-time party thereto, and certain of our subsidiaries
+Added: party thereto from time to time as guarantors.
+Added: On December 30, 2022, we repaid all obligations under the Financing Agreement and the
+Added: Financing Agreement was terminated.
Interest and financing costs
−Removed: Interest expense and other financing costs consisted of the following (in thousands):
−Removed: Interest expense
−Removed: Prepayment fees
−Removed: Financing fees amortization
+Added: Included in miscellaneous income in 2023 is $ 0.3 million of interest
+Added: income and $ 0.2 million of interest expense.
+Added: In 2022 and recorded in discontinued operations, we recognized $ 13.5 million of debt-related
+Added: interest expense and $ 22.5 million of financing fees amortization.
Commitments and contingencies
−Removed: Substantially all of our leases are for rental of office space used to conduct our business.
−Removed: In October 2018, we entered into a lease for e xecutive, administrative, operations and sales offices in Boca Raton, Florida.
−Removed: The lease includes 56,212 rentable square feet, or the full premises, of which the lease on 7,561 square feet commenced in 2018 and the lease on the remaining 48,651 square feet commenced in August 2019, or the full premises commencement date.
−Removed: The lease will expire 11 years after the full premises commencement date, unless
−Removed: terminated earlier in accordance with the terms of the lease.
+Added: In October 2018, we entered into a lease for executive, administrative,
+Added: operations and sales offices in Boca Raton, Florida.
+Added: The lease includes 62,748 rentable square feet, or the full premises, of which the
+Added: lease on 7,561 square feet commenced in 2018 and the lease on 48,651 square feet commenced in August 2019, or the full premises
+Added: commencement date.
+Added: In June 2019, we entered into an agreement with the same lessors to
+Added: lease additional 6,536 square feet of administrative office space in the same location, pursuant to an addendum to such lease, which commenced
+Added: The lease will expire 11 years after the full premises commencement date, unless terminated earlier in accordance with
+Added: the terms of the lease.
We have the option to extend the term of the lease for two additional consecutive periods of five years .
−Removed: The extension option is not included in the determination of the lease term as it is not reasonably certain to be exercised.
−Removed: The term of the lease includes escalating rent and free rent periods.
−Removed: We are also responsible for certain other operating costs under the lease, including electricity and utility expenses.
−Removed: In June 2019, we entered into an agreement with the same lessors to lease additional 6,536 square feet of administrative office space in the same location, pursuant to an addendum to such lease, which commenced in May 2020.
−Removed: We are in the process of subleasing our headquarters as a result of shifting our business to become a license company and terminating our employees.
−Removed: We anticipate that sublease income will approximate the amounts due under our existing leases, therefore no impairment of the right of use asset was recorded in 2022.
−Removed: For 2022, operating lease expense related to our real estate leases was $ 1.4 million and variable lease expense was $ 0.7 million.
−Removed: For 2021, operating lease expense related to our real estate leases was $ 2.1 million and variable lease expense was $ 0.7 million.
−Removed: In 2022, our rental income was $ 0.4 million on sublease of our two suites which were subleased following vitaCare transaction.
−Removed: As of December 31, 2022, our remaining lease payments were as follows (in thousands):
+Added: The extension
+Added: option is not included in the determination of the lease term as it is not reasonably certain to be exercised.
+Added: The term of the lease includes
+Added: escalating rent and free rent periods.
+Added: We are also responsible for certain other operating costs under the lease, including electricity
+Added: and utility expenses.
+Added: As a result of shifting our business
+Added: to become a license company and terminating our employees, we have sublet the majority of our headquarters and are in the process of subleasing
+Added: the remainder.
+Added: We anticipate that sublease income will approximate the amounts due under our existing leases, therefore no impairment
+Added: of the right of use asset was recorded in 2023.
+Added: For 2023 and 2022, operating lease expense (including all variable
+Added: costs) related to our real estate leases was $ 2.3 and $ 2.1 million, respectively.
+Added: In 2023 and 2022, our rental income on sublease of our
+Added: three suites which were subleased following the vitaCare transaction was $ 1.3 million and $ 0.0 million, respectively.
+Added: As of December 31, 2023, our remaining lease payments were as follows
+Added: (in thousands):
Year ending December 31,
2 unchanged sentences
Present value of lease payments
−Removed: The following table sets forth supplemental balance sheet information related to leases (in thousands):
+Added: The following table sets forth supplemental balance sheet information
+Added: related to leases (in thousands):
As of December 31,
Operating lease right-of-use assets
−Removed: Operating lease liabilities current (included in accrued
−Removed: expenses and other current liabilities)
+Added: Operating lease liabilities current (included in accrued expenses and other current liabilities)
Operating lease liabilities, non-current
1 unchanged sentence
The following table presents other information related to leases:
+Added: As of December 31,
Weighted average remaining term (years) - operating leases
Weighted average discount rate - operating leases
−Removed: Cash paid for amounts included in the measurement of
−Removed: lease liabilities from operating lease (in thousands)
−Removed: Right-of-use assets obtained in exchange for new operating
−Removed: lease obligations (non-cash in thousands)
+Added: Cash paid for amounts included in the measurement of lease liabilities from operating lease (in thousands)
+Added: Right-of-use assets obtained in exchange for new operating lease obligations (non-cash in thousands)
Mayne Pharma Agreement
−Removed: Mayne Pharma paid us approximately $ 12.1 million at closing for the acquisition of net working capital, as determined in accordance with the Transaction Agreement, and is subject to certain adjustments for a period of up to two years following the Closing Date.
−Removed: Pursuant to the Mayne License Agreement Amendment, Mayne Pharma also paid the Company approximately $ 1.0 million in prepaid royalties on the Closing Date.
−Removed: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.
−Removed: Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement, including the Company’s minimum payment obligations thereunder.
+Added: Mayne Pharma paid us approximately $ 12.1 million at closing on December
+Added: 30, 2022, for the acquisition of net working capital, subject to certain adjustments as determined in accordance with the Transaction
+Added: While the Transaction Agreement calls for much of the net working capital to be trued-up shortly after the Closing Date in
+Added: 2023, for a period of one year following the Closing Date in the case of payer rebates and wholesale distributor fees and two years
+Added: following the Closing Date in the case for allowance for returns, net working capital amounts will be adjusted to arrive at final net
+Added: working capital under the Transaction Agreement.
+Added: In September 2023, we revised certain accrual estimates including increasing our working capital adjustment accrual from $ 3.5 million to $ 5.5 million for amounts anticipated to be owed under the Transaction Agreement.
+Added: In December 2023, we made a $ 5.5 million payment to Mayne Pharma to settle certain working capital amounts that were required to be trued-up shortly after the Closing Date, excluding the allowance for returns, allowance for payer rebates, and allowance for wholesale distributor fees.
+Added: In February 2024, the Company received Mayne Pharma’s
+Added: calculation of allowance for payer rebates and wholesale distributor fees which differed significantly from the Company’s
+Added: estimate of the allowances.
+Added: The Company believes its estimated allowances for payer rebates and wholesale distributor fees are
+Added: reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement.
+Added: Given the recent receipt of
+Added: Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this
+Added: As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any
+Added: additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor
+Added: Additionally and as of December 31, 2023, the Company believes no additional
+Added: accrual is required for amounts that may be owed for the allowance for returns.
+Added: The Company has not recorded any contingent gains or receivables
+Added: for any such allowances.
+Added: Management continues to monitor the unresolved and pending net working capital items as changes to estimated
+Added: amounts owed or amounts due from Mayne Pharma that may be material.
Population Council License Agreement
−Removed: Under the terms of the Population Council License Agreement, we paid the Population Council a milestone payment of $ 20.0 million in 2018, which was within 30 days following the approval by the FDA of the NDA for ANNOVERA, and $ 20.0 million in 2019 following the first commercial batch release of ANNOVERA.
−Removed: The aggregate $ 40.0 million of milestone payments were recorded as license rights.
−Removed: The Population Council was also eligible to receive future payments upon the achievement of certain commercial sales milestones of ANNOVERA.
+Added: Under the terms of our license agreement with the Population Council,
+Added: (the “Population Council License Agreement”), we paid the Population Council a milestone payment of $ 20.0 million in
+Added: 2018, which was within 30 days following the approval by the FDA of the New Drug Application (“NDA”) for ANNOVERA, and $ 20.0
+Added: million in 2019 following the first commercial batch release of ANNOVERA.
+Added: The aggregate $ 40.0 million of milestone payments were recorded
+Added: as license rights.
+Added: The Population Council was also eligible to receive future payments upon the achievement of certain commercial sales
+Added: milestones of ANNOVERA.
On December 30, 2022, we assigned the ANNOVERA license to Mayne Pharma.
−Removed: The rights and obligations under the Population Council License Agreement have been transferred to Mayne Pharma and will revert back to us upon certain events.
−Removed: The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA, and we had agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $ 20.0 million, half of such excess was to be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement.
−Removed: In July 2021, we received a letter from FDA indicating that the post-marketing commitment study being conducted by the Population Council for ANNOVERA to characterize the in vivo release rate of ANNOVERA was not fulfilled to FDA’s satisfaction.
−Removed: In addition, the final reports for the two post-marketing requirement studies being performed by the Population Council for ANNOVERA were not submitted by the initial listed submission deadline, which deadlines have since been extended by FDA.
−Removed: Our obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement.
−Removed: We believe that Mayne Pharma is working with Population Council to complete the post-marketing commitment study to FDA’s satisfaction and reduce the delay in submitting the post-marketing requirement final reports.
−Removed: To the extent that the Population Council does not fulfil these studies to FDA’s satisfaction, FDA may impose additional requirements and penalties against the NDA holder for ANNOVERA.
−Removed: Unless earlier terminated, the Population Council License Agreement will remain in effect until the later of the expiration of the last-to-expire of the Population Council’s U.S.
−Removed: patents that are licensed to Mayne Pharma, or the date following such expiration that follows a continuous period of six months during which Mayne Pharma has not made a commercial sale of ANNOVERA in the U.S.
−Removed: The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by Mayne Pharma on 180 days’ prior notice to the Population Council.
−Removed: Purchase commitments
−Removed: We had manufacturing and supply agreements whereby we were required to purchase from Catalent, Inc.
−Removed: (“Catalent”) a minimum number of units of BIJUVA and IMVEXXY softgels during each respective annual contract year.
−Removed: The annual contract period for BIJUVA and IMVEXXY ended each April and July, respectively.
−Removed: If the minimum order quantities of BIJUVA or IMVEXXY were not met, we were required to pay a minimum commitment fee equal to 50 % or 60 %, respectively, of the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of BIJUVA or IMVEXXY during each product’s respective contract year.
−Removed: Additionally, with another third-party manufacturer, we had a manufacturing and supply agreement, renewable annually, whereby we were required to purchase a minimum number of units of ANNOVERA during a contract year.
−Removed: The annual contract period for ANNOVERA ended each August.
−Removed: If the minimum order quantities of ANNOVERA were not met, we were required to pay a minimum commitment fee equal to the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of ANNOVERA during the contract year.
−Removed: On December 30, 2022, after granting an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, the rights and obligations under the Catalent minimum manufacturing and supply agreements and other supply agreements have been transferred to Mayne Pharma.
+Added: Our rights and obligations under the Population
+Added: Council License Agreement have been transferred to Mayne Pharma and may revert back to us upon the occurrence of certain events.
Legal proceedings
−Removed: In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the FDA by Teva Pharmaceuticals USA, Inc.
−Removed: The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.
−Removed: In the IMVEXXY
−Removed: Notice Letter, Teva alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product.
−Removed: The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033.
−Removed: In April 2020, we filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA.
−Removed: We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents.
−Removed: Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed.
−Removed: In July 2021, following a proposal by Teva, the District Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal.
−Removed: In September 2021, the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information Teva contended was confidential.
−Removed: The order provides that the statutory stay that prevents the FDA from granting final approval of the ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place.
+Added: In February 2020, we received a Paragraph IV certification notice letter
+Added: (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the FDA by Teva
+Added: Pharmaceuticals USA, Inc.
+Added: The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic
+Added: version of the 4 mcg and 10 mcg doses of IMVEXXY.
+Added: In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in the
+Added: FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable,
+Added: and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product.
+Added: The IMVEXXY Patents
+Added: identified in the IMVEXXY Notice Letter expire in 2032 or 2033.
+Added: In April 2020, we filed a complaint for patent infringement against Teva
+Added: in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA.
+Added: We are seeking,
+Added: among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration
+Added: of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents.
+Added: Teva has filed its answer and counterclaim
+Added: to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed.
+Added: In July 2021, following a proposal by Teva, the District
+Added: Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal.
+Added: In September 2021,
+Added: the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information
+Added: Teva contended was confidential.
+Added: The order provides that the statutory stay that prevents the FDA from granting final approval of the
+Added: ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation
The length of the stay of the IMVEXXY litigation is dependent on further action by Teva.
−Removed: As of December 31 , 2022, for the IMVEXXY Paragraph IV legal proceeding, we have incurred and recorded legal costs amounting to $ 2.3 million in prepaid expenses and other current assets since we believe that we will successfully prevail in this legal proceeding.
−Removed: Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents.
−Removed: If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.
−Removed: In March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (“Amneal”).
−Removed: In April 2020, we filed a complaint for patent infringement against Amneal in the United States District Court for the District of New Jersey arising from Amneal’s ANDA filing with FDA.
−Removed: In December 2021, we entered into a settlement agreement (the “Settlement Agreement”) with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York LLC (collectively “Amneal”) to resolve the litigation over our patents listed in FDA’s Orange Book that claim compositions and methods of BIJUVA (the “BIJUVA Patents”).
−Removed: Under the terms of the Settlement Agreement, the parties filed a consent judgment with the U.S.
−Removed: District Court for the District of New Jersey that enjoins Amneal from marketing a generic version of BIJUVA (1 mg estradiol and 100 mg progesterone) before the expiration of the patents-in-suit, except as provided in the Settlement Agreement, and the Company granted Amneal a non-exclusive, non-transferable, royalty-free license to commercialize Amneal’s generic formulation of BIJUVA in the U.S.
−Removed: commencing in May 2032 (180 days before the current expiration date in November 2032 for the last to expire of our BIJUVA Patents), or earlier under certain circumstances customary for settlement agreements of this nature.
−Removed: As of December 30, 2022 and per the license agreement, Mayne Pharma is responsible for all enforcement of our patents, including this litigation with Teva.
−Removed: From time to time, we are involved in other litigations and proceedings in the ordinary course of business.
−Removed: We are currently not involved in any other litigations and proceedings that we believe would have a material effect on our consolidated financial condition, results of operations, or cash flows.
−Removed: Compliance with Nasdaq’s continued listing requirements
−Removed: In January 2023, we received a deficiency letter (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that we were not in compliance with the rules for continued listing as set forth in Nasdaq Listing Rule 5620(a) (the “Annual Meeting Rule”) due to our failure to hold an annual meeting of stockholders within 12 months after our fiscal year ended December 31, 2021.
−Removed: The Notice had no immediate effect on the listing of our Common Stock.
−Removed: We did not hold an annual meeting of stockholders during 2022 due to our then ongoing strategic processes.
−Removed: The Notice stated that, under Nasdaq Listing Rule 5810(c)(2)(G), we had 45 calendar days, or until February 20, 2023, to submit a plan to regain compliance with the Annual Meeting Rule.
−Removed: We timely submitted such plan, and Nasdaq granted us an extension until June 29, 2023, to regain compliance.
−Removed: It is our intent to hold an annual meeting of stockholders in 2023 prior to such deadline and to fully regain compliance with all applicable Nasdaq listing standards.
+Added: We have incurred and recorded legal
+Added: costs amounting to $ 2.3 million in prepaid expenses and other current assets as of December 31, 2023, for the IMVEXXY Paragraph IV legal
+Added: proceeding since we believe that we will successfully prevail in this legal proceeding.
+Added: Upon the successful conclusion of the legal proceeding,
+Added: the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying
+Added: consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents.
+Added: If we are unsuccessful in
+Added: this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that
+Added: were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.
+Added: Beginning on December 30, 2022 and per the Mayne License Agreement,
+Added: Mayne Pharma is responsible for all enforcement of our patents, including the litigation discussed above with respect to Teva.
+Added: In September 2023, one of our former contractors retained to market
+Added: ANNOVERA under Title X, filed a lawsuit that accused us of breach of contract.
+Added: We answered their complaint and filed breach of contract
+Added: counterclaims.
+Added: From time to time, we are involved in other litigations and proceedings
+Added: in the ordinary course of business.
+Added: We are not currently involved in any other litigations and proceedings that we believe would have
+Added: a material effect on our consolidated financial condition, results of operations, or cash flows.
Off-balance sheet arrangements
−Removed: As of December 31, 2022 and 2021 we had no off-balance sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
+Added: As of December 31, 2023 and 2022 we had no off-balance sheet arrangements
+Added: that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues
+Added: or expenses, results of operations, liquidity, capital expenditures or capital resources that we consider material.
Employment agreements
−Removed: In connection with the Company’s transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr.
−Removed: Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 31, 2022.
−Removed: Severance obligations for all employees other than executive officers were paid in full in the first quarter of 2023 and severance obligations for terminated executive officers will be paid in accordance with their employment agreements and separation agreements as previously disclosed.
−Removed: As of December 31, 2022, we have employed one full-time employee primarily engaged in executive position.
−Removed: We have engaged external consultants, including certain former members of our management team, who support our relationship with current partners and assist with certain financial, legal and regulatory matters and the continued wind-down of our historical business operations.
−Removed: The separation of our former Interim Co-Chief Executive Officers, former Interim Chief Financial Officer and other executives from the Company was a termination without “Good Cause,” as defined in their employment agreements.
−Removed: In the aggregate, in December 2022, we recorded severance expenses for executive termination obligations of $ 6.0 million, of which $ 1.1 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards.
−Removed: On September 6, 2022, our Board appointed interim Co-Chief Executive Officers.
−Removed: The separation of our former chief executive officer from the Company was a termination without “Good Cause,” as defined in his employment agreement.
−Removed: Accordingly, our former chief executive officer received the separation benefits provided therein, and we recorded executive officer severance expenses of $ 4.8 million, of which $ 3.2 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards for the former chief executive officer.
−Removed: In connection with our former chief executive officer’s separation from the Company, he ceased to serve as a member of our Board.
−Removed: In September 2021, our former Executive Vice President of Operations (“EVP of Operations”) and us mutually agreed that the EVP of Operations would separate from the company.
−Removed: The separation was for “Good Reason” under the employment agreement of the EVP of Operations;
−Removed: accordingly, he received the separation benefits provided therein.
−Removed: Then, i n December 2021, our Board of Directors (the “Board”) appointed a new Chief Executive Officer (“CEO”).
−Removed: Our former CEO’s separation as CEO was a termination without “Cause,” as defined in his employment agreement.
−Removed: Accordingly, our former CEO received the separation benefits provided therein.
−Removed: Additionally, in 2021, three other senior executives separated from the Company, and they received separation benefits provided by their respective employment agreements.
−Removed: In the aggregate, for 2021, we recorded executive officer severance expenses of $ 12.4 million, of which $ 8.0 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards for the former senior executives.
−Removed: Employee benefit plan
−Removed: We maintained a voluntary defined contribution 401(k) plan covering all eligible employees as defined in the plan documents.
−Removed: The plan provided for discretionary matching contribution, which is equal to up to four percent of each eligible contributing participant’s elective deferral not to exceed two thousand per year.
−Removed: Employees who elected to participate in the plan were generally fully vested in any existing matching contribution after five years of service with the Company.
−Removed: As part of termination of employees, all contributions made by the Company to each participant became 100 % vested.
−Removed: Contributions by the Company under the plan amounted to $ 0.5 million and $ 0.6 million for 2022 and 2021, respectively.
−Removed: Mandatory Redeemable Preferred Stock and Stockholders’ Equity (Deficit)
−Removed: Rubric Capital Management LP Subscription Agreements (Sale of Mandatory Redeemable Preferred Stock and Common Stock)
−Removed: On July 29, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, (i) 15,000 shares of the Company’s newly- designated Series A Preferred Stock, par value $ 0.001 per share (the “Series A Preferred Stock”) for a purchase price per share of Series A Preferred Stock equal to $ 822.21 and an aggregate purchase price of $ 12.3 million, and (ii) 565,000 shares of the Company’s Common Stock, for a purchase price per share of Common Stock equal to $ 4.72 and an aggregate purchase price of $ 2.7 million.
−Removed: This offering closed on July 29, 2022, and we received aggregate gross proceeds of $ 15.0 million, before expenses.
−Removed: On September 30, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, 7,000 shares of the Company’s Series A Preferred Stock for an aggregate offering price of $ 7.0 million.
−Removed: In addition, in lieu of issuing, selling and delivering 263,666 shares of the Company’s Common Stock to the Preferred Stock Investor, we agreed to pay the Preferred Stock Investor, on the later of (i) the Maturity Date (as defined in the Certificate of Designation, Preferences and Rights of Series A Preferred Stock, establishing the powers, designations, preferences and privileges and the
−Removed: qualifications, limitations or restrictions of the Series A Preferred Stock (the “Certificate of Designation”)) or (ii) the date our obligations under the Financing Agreement were paid in full, a make-whole payment equal to 263,666 multiplied by the closing price of our Common Stock on the principal securities exchange or securities market on which the Common Stock is then traded, on the day prior to the date of payment of the make-whole payment.
−Removed: This offering closed on September 30, 2022, and we received gross proceeds of $ 7.0 million, before expenses.
−Removed: On October 28, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, 7,000 shares of the Company’s Series A Preferred Stock for an aggregate offering price of $ 7.0 million.
−Removed: In addition, in lieu of issuing, selling and delivering 263,666 shares of the Company’s Common Stock to the Preferred Stock Investor, we agreed to pay the Preferred Stock Investor, on the later of (i) Maturity Date or (ii) the date our obligations under the Financing Agreement were paid in full, a make-whole payment equal to 263,666 multiplied by the closing price of our Common Stock on the principal securities exchange or securities market on which the Common Stock is then traded, on the day prior to the date of payment of the make-whole payment.
−Removed: This offering closed on October 28, 2022, and we received gross proceeds of $ 7.0 million, before expenses.
−Removed: The Company received gross proceeds of $ 7 million from the Offering, before expenses.
−Removed: The Series A Preferred Stock was not convertible into Common Stock and ranked senior to Common Stock, with respect to rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company.
−Removed: In the event of any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company, the Series A Preferred Stock had a liquidation preference equal to $ 1,333 per share.
−Removed: The Series A Preferred Stock did not have any voting rights other than as required by applicable law.
−Removed: The holders of Series A Preferred Stock were entitled to dividends equal to 25 % of cash dividends actually paid, if any, on shares of Common Stock, paid pro rata on the outstanding shares of Series A Preferred Stock.
−Removed: Upon the occurrence of change of control, the holders of Series A Preferred Stock could have required the Company to redeem all or part of such holder’s Series A Preferred Stock at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share of Series A Preferred Stock.
−Removed: We also had the option to redeem all the outstanding shares of Series A Preferred Stock on such terms if we consummated a change of control transaction.
−Removed: Each holder of Series A Preferred Stock also had the right to cause the Company to redeem all, but not less than all, of their shares of the Series A Preferred Stock upon the occurrence of certain events, including, without limitation, the Company’s failure to comply with any covenants under the Certificate of Designation or if the Company commenced a bankruptcy proceeding, subject to certain conditions.
−Removed: Under such circumstances, the Company was required to redeem all, but not less than all, of the holder’s outstanding shares of Series A Preferred Stock at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share.
−Removed: We were required to redeem from each holder of Series A Preferred Stock all outstanding shares of Series A Preferred Stock held by such holder, at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share of Series A Preferred Stock, upon the earlier to occur of (i) the Maturity Date and (ii) the incurrence of Permitted Refinancing Indebtedness (as defined in the Certificate of Designation).
−Removed: The Company accreted the Series A Preferred Stock from its fair value on the date of issuance to its redemption value using the effective interest rate method.
−Removed: On December 30, 2022, and in accordance with the terms of the Certificate of Designation, the Company mandatorily redeemed all 29,000 outstanding shares of Series A Preferred Stock at a purchase price of $ 1,333 per share.
−Removed: The Company also paid certain affiliates of the Preferred Stock Investor approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between the Company and the Preferred Stock Investor.
−Removed: In March 2021, we entered into an at-the-market equity offering program (the “2021 ATM Program”) relating to shares of our common stock.
−Removed: The 2021 ATM Program permitted us to offer and sell shares of our common stock having an aggregate offering price of up to $ 100.0 million from time to time through or to the sales agent under the 2021 ATM Program.
−Removed: Sales of our common stock could be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act, including by means of ordinary broker’s transactions on The Nasdaq Stock Market LLC (“Nasdaq”) or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent.
−Removed: The sales agent was entitled to compensation at a fixed commission rate of 3.0 % of the aggregate gross sales price per share sold.
−Removed: The sales agent was not required to sell any specific number or dollar amounts of securities but acted as sales agent and used commercially reasonable efforts to sell on our behalf all the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed terms between us and the sales agent.
−Removed: Through December 31, 2021, we sold a total of 674,106 shares of our common stock under the 2021 ATM Program at an average sale price of $ 60.5 per share and we received estimated net proceeds of $ 39.4 million, after deducting discounts and commissions to the sales agent and estimated offering expenses.
−Removed: Subsequently, through the date of this 2022 10-K Report, we have not sold any additional shares of our common stock under the 2021 ATM Program .
−Removed: The Company does not currently have an effective shelf registration statement in place and therefore, the 2021 ATM program has been suspended.
−Removed: Future sales, if any, under the 2021 ATM Program will depend on a variety of factors, including among others, market conditions, the trading price of our common stock, determinations by us of the appropriate sources of funding, and potential uses of funding available to us.
−Removed: In February 2021, we closed on an underwritten public offering of our common stock, pursuant to which we issued 1,189,189 shares of our common stock at an offering price of $ 92.5 per share, and we received net proceeds of $ 96.6 million, after deducting the underwriting discounts and commissions and estimated offering expenses.
−Removed: As disclosed in Note 7.
−Removed: Debt, in 2022 we issued to the Administrative Agent and the lenders under the Financing Agreement Lender Warrants to purchase an aggregate of 435,000 shares of common stock in relation to Amendment No.16 to the Financing Agreement.
−Removed: In 2020, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 95,042 shares of our common stock.
−Removed: The following table summarizes the status of our outstanding and exercisable warrants and related for each of the following years (in thousands, except weighed average exercise price and weighted average remaining contractual life data):
+Added: In connection with our transformation into a pharmaceutical royalty
+Added: company, the termination of our executive management team (except for Mr.
+Added: Marlan Walker, our former General Counsel and current Chief
+Added: Executive Officer) and all other employees was completed by December 30, 2022.
+Added: Severance obligations for all employees other than executive
+Added: officers were paid in full in the first quarter of 2023.
+Added: As of December 31, 2023, we employ one full-time employee primarily engaged in
+Added: an executive position.
+Added: We have engaged external consultants who support our relationship with current partners and assist with certain
+Added: financial, legal, and regulatory matters and the continued wind-down of our historical business operations.
+Added: The separation of our former
+Added: Interim Co-Chief Executive Officers, former Interim Chief Financial Officer and other executives from TherapeuticsMD was each a termination
+Added: without “Good Cause,” as defined in their respective employment agreements.
+Added: In the aggregate, as of December 31, 2023, we
+Added: have accrued severance liabilities for executive termination obligations of $ 0.4 million.
+Added: Stockholders’ Equity
+Added: Increase of authorized shares
+Added: On June 26, 2023, at our combined 2022
+Added: and 2023 Annual Meeting, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase the
+Added: number of authorized shares of Common Stock from 12 million shares to 32 million shares.
+Added: As of December 31, 2023, the following table summarizes the status
+Added: of our outstanding and exercisable warrants and related transactions since December 31, 2021 (in thousands, except weighted average exercise
+Added: price and weighted average remaining contractual life data):
Warrants outstanding and exercisable
2 unchanged sentences
Balance, December 31, 2023
−Removed: We used the Black Scholes option pricing model to estimate the fair value of warrants issued.
−Removed: The weighted average fair value of the warrants issued in 2022 was $ 0.13 per warrant and the assumptions used to determine such fair value were as follows:
−Removed: expected term of 10 years, volatility of 69.4 %, dividend yields of 0 % and risk-free interest rates of 2.9 %.
−Removed: The fair value of the Lender Warrants was based on the date of grant using our Common Stock’s closing price at measurement date and was recorded to “Additional paid-in-capital” in the consolidated balance sheets.
−Removed: There were no warrant grants in 2021.
−Removed: Share-based payment award plans
−Removed: Plan summary and description
−Removed: In June 2019, our stockholders approved the TherapeuticsMD, Inc.
−Removed: 2019 Stock Incentive Plan, as amended (the “2019 Plan”), which replaced our previously adopted 2012 Stock Incentive Plan, as amended, and the 2009 Long-Term Incentive Compensation Plan ( referred to collectively as the “ Prior Plans”).
−Removed: Outstanding awards granted under the Prior Plans will remain subject to the terms and conditions in the Prior Plans.
−Removed: The 2019 Plan is administered by the Compensation Committee of the Board.
−Removed: The purpose of the 2019 Plan is to provide a means for us and our subsidiaries and other designated affiliates (the “Related Entities”) to attract key personnel to provide services to us and the Related Entities, as well as to provide a means by which those key persons can acquire and maintain stock ownership, resulting in a strengthening of their commitment to our welfare and the welfare of the Related Entities and promoting the mutuality of interests between participants and our stockholders.
−Removed: A further purpose of the 2019 Stock Incentive Plan is to provide participants with additional incentive and reward opportunities designed to enhance our profitable growth and the profitable growth of the Related Entities, and provide participants with annual and long-term performance incentives to expend their maximum efforts in the creation of stockholder value.
−Removed: The persons eligible to receive awards under the 2019 Plan are our employees, officers, members of the Board, and consultants who provide services to us or any subsidiary.
−Removed: The provisions of the 2019 Plan authorize the grant of (i) stock options, which can be “qualified” or “nonqualified” under the Internal Revenue Code of 1986, as amended, (ii) stock appreciation rights, (iii) restricted stock, (iv) restricted stock units (“RSUs”), (v) performance shares and performance units, such as performance stock units (“PSUs”), and (vi) other share-based awards.
−Removed: The 2019 Plan will terminate at the earliest of (i) such time as no shares remain available for issuance under the 2019 Stock Plan, (ii) termination of the 2019 by the Board, or (iii) the tenth anniversary of the effective date of the 2019 Stock Incentive Plan.
−Removed: Awards outstanding upon termination of the 2019 Plan will remain in effect until they have been exercised or terminated, or have expired.
−Removed: The term and vesting period of awards granted under the 2019 Plan are established on a per grant basis, and option expiration date is generally ten years from the date of grant.
−Removed: Under the 2019 Plan, 749,500 shares of common stock are authorized for issuance, which includes 449,500 shares from the First Amendment to the 2019 Plan, which was approved by our stockholders in May 2021 plus any unallocated shares previously available for issuance under the Prior Plans that were not then subject to outstanding awards.
−Removed: Any shares subject to outstanding share-based payment awards under the 2019 Plan and Prior Plans that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such award (other than shares tendered or withheld in connection with the exercise of an award or the satisfaction of withholding tax liabilities), the shares to which those awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to awards under the 2019 Plan.
−Removed: In August 2021, the Company hired a new President, who became our CEO in December 2021, and granted an “inducement grant” under Listing Rule 5635(c)(4) of Nasdaq of 55,000 RSUs (designated as “Time-Based Units”) and 55,000 PSUs (designated as “Performance Units”).
−Removed: In October 2021, the Company appointed a new Chief Business Officer and granted an “inducement grant” under Listing Rule 5635(c)(4) of Nasdaq of 13,200 RSUs (designated as “Time-Based Units”) and 5,200 PSUs (designated as “Performance Units”) .
−Removed: The Time-Based Units and Performance Units were granted pursuant to certain Inducement Grant Restricted Stock Unit Agreement;
−Removed: accordingly, these equity awards were not counted against the shares of common stock available for issuance under the 2019 Plan.
−Removed: As part of the termination agreement with our CEO, 55,000 Performance Units were cancelled and 55,000 RSUs vested in 2022.
−Removed: As part of the termination agreements with our Chief Business Officer, 3,900 Performance Units and 11,466 RSUs vested in 2022.
−Removed: As of December 31, 2022, 518,074 shares of common stock were subject to outstanding awards under our share-based payment award plans and inducement grants including outstanding PSUs that were vested at 100 % as a result of termination of employees.
−Removed: The following table summarizes the outstanding awards issued pursuant to our share-based payment award plans and inducement grants as of December 31, 2022 and the remaining shares of common stock available for future issuance (in thousands):
−Removed: Remaining shares of
−Removed: common stock available
−Removed: for future issuance (2)
−Removed: 2019 Plan (3)
−Removed: 2012 Plan (4)
−Removed: 2009 Plan (5)
−Removed: 2021 Inducement Grants
−Removed: The number of PSUs represents the number of PSUs that will vest.
−Removed: The number of remaining shares of common stock available for future issuance is based on the number of PSUs that will vest .
−Removed: As of December 31, 2022, outstanding options have exercise prices ranging from $ 53.5 to $ 136.5 and will expire on March 30, 2023, due to termination of employees except for awards for one employee and several consultants.
−Removed: Unvested RSUs will vest until July 2024.
−Removed: The unvested PSUs will vest until April 2025.
−Removed: As of December 31, 2022, outstanding options have exercise prices ranging from $ 221.5 to $ 446 and will expire on March 30, 2023, due to termination of employees except for awards for one employee and several consultants.
−Removed: As of December 31, 2022, outstanding options have exercise prices ranging from $ 90 to $ 446 and will expire on March 30, 2023 due to termination of employees except for awards for one employee and several consultants.
−Removed: 2021 Exchange of eligible options for RSUs
−Removed: In May 2021, our stockholders approved an Offer to Exchange Eligible Options for Restricted Stock Units (the “Exchange Offer”).
−Removed: The Exchange Offer allowed certain employee option holders, excluding the Company’s named executive officers, advisers, consultants, contractors, or present or past non-employee directors, to exchange some or all of their outstanding options to purchase shares of common stock that were granted before August 26, 2019, and had a per share exercise price equal to or greater than $ 250.5 (“Eligible Options”), for an award of RSUs of the Company (“New RSUs”), subject to specified conditions.
−Removed: In September 2021, following the expiration of the Exchange Offer, 69 eligible employees elected to exchange Eligible Options, and the Company accepted for cancellation Eligible Options to purchase an aggregate of 89,860 shares of common stock, representing approximately 91.5 % of the total shares of common stock underlying the Eligible Options.
−Removed: Also, in September 2021, promptly following the expiration of the Exchange Offer, the Company granted 14,005 New RSUs in exchange for the cancellation of the tendered Eligible Options.
−Removed: The New RSUs vest in three equal annual installments beginning in September 2022, subject to the terms and conditions of the 2019 Plan.
−Removed: The following table summarizes the status of our outstanding and exercisable options and related transactions, including the Exchange Offer, for each for the following years (in thousands, except weighed average exercise price and weighted average remaining contractual life data):
−Removed: Options awards outstanding
−Removed: Options awards exercisable
−Removed: Balance, December 31, 2020
+Added: We used the Black Scholes option pricing model to estimate the fair
+Added: value of the warrants issued.
+Added: The weighted average fair value of the warrants issued in 2022 was $ 0.13 per warrant and the assumptions
+Added: used to determine such fair value were as follows:
+Added: expected term of 10 years, volatility of 69.4 %, dividend yields of 0 % and risk-free
+Added: interest rates of 2.9 %.
+Added: Share-based compensation payment plans
+Added: As of December 31, 2023, 126,573 shares of common stock were subject
+Added: to outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may
+Added: As of December 31, 2023, 394,669 shares of common stock were available for future grants of share-based payment awards under the
+Added: TherapeuticsMD, Inc.
+Added: 2019 Stock Incentive Plan.
+Added: The following table summarizes the status of our outstanding and exercisable
+Added: options and related transactions (each adjusted to account for the Reverse Stock Split) since December 31, 2022 (in thousands, except
+Added: weighed average exercise price and weighted average remaining contractual life data):
+Added: Weighted Average Exercise
+Added: Weighted Average Remaining Contractual Life
+Added: Weighted Average Remaining Contractual Life (in Years)
+Added: As of January 1, 2022
Cancelled/Forfeited
−Removed: Balance, December 31, 2021
+Added: As of December 31, 2022
Cancelled/Forfeited
−Removed: Balance, December 31, 2022
−Removed: We used the Black Scholes option pricing model to estimate the fair value of options granted.
−Removed: There were no option grants in 2022.
−Removed: The weighted average fair value of the options granted in 2021 was $ 0.77 per option, and the assumptions used to determine such fair value were as follows:
−Removed: expected term of 6.9 years, volatility of 67.6 %, dividend yields of 0 % and risk-free interest rates of 1.1 %.
−Removed: Restricted stock units
−Removed: The following table summarizes the status of our RSUs and related transactions, including the Exchange Offer, for each for the following years (in thousands, except weighed average grant date fair value):
+Added: As of December 31, 2023
+Added: The following table summarizes the status of our RSUs and related transactions
+Added: (each adjusted to account for the Reverse Stock Split) (in thousands, except weighed average grant date fair value):
RSUs awards outstanding
−Removed: RSUs awards vested
−Removed: and not settled
−Removed: Balance, December 31, 2020
−Removed: Vested and settled
+Added: Balance, January 1, 2022
Cancelled/Forfeited
−Removed: Balance, December 31, 2021
−Removed: Vested and settled
+Added: Balance, as of December 31, 2022
Cancelled/Forfeited
+Added: Balance, as of December 31, 2023
+Added: The following table summarizes the status of our PSUs and related transactions
+Added: for each for the following years (each adjusted to account for the Reverse Stock Split) (in thousands, except weighed average grant date
Balance, December 31, 2021
−Removed: Performance stock units
−Removed: The following table summarizes the status of our PSUs and related transactions for each for the following years (in thousands, except weighed average grant date fair value):
−Removed: PSUs awards outstanding
−Removed: PSUs awards vested
−Removed: and not settled
−Removed: Balance, January 1, 2020
Vested and settled
Cancelled/Forfeited
−Removed: Balance, December 31, 2021
−Removed: Vested and settled
+Added: Unvested, as of January 1, 2023
Cancelled/Forfeited
−Removed: Balance, December 31, 2022
−Removed: The number of PSUs represents the number of PSUs that will vest.
−Removed: Employee stock purchase plan
−Removed: In June 2020, our stockholders approved the TherapeuticsMD, Inc.
−Removed: 2020 Employee Stock Purchase Plan (“ESPP”), which reserved 108,000 shares of our common stock for purchase by eligible employees.
−Removed: The ESPP permits eligible employees to purchase our common stock at a price per share which is equal to 85 % of the lesser of (i) the fair market value of the shares on the offering date of the offering period or (ii) the fair market value of the shares on the purchase date.
−Removed: In 2022, 5,229 shares were sold under the ESPP at the average price of $ 2.6 per share and we received proceeds of approximately $ 14,000 .
−Removed: In 2021, 6,721 shares were sold under the ESPP at an average sale price of $ 34.5 per share and we received proceeds of $ 0.2 million.
−Removed: In the second quarter of 2022, the ESPP Plan was suspended.
+Added: Unvested, as of December 31, 2023
Share-based payment compensation cost
−Removed: Share-based payment compensation expense for PSUs is based on 100 % vesting which was a part of termination of benefits for all employees who were terminated in 2022.
−Removed: We recorded share-based payment award compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under the ESPP totaling $ 11.6 million for 2022 and $ 18.1 million for 2021.
−Removed: As of December 31, 2022, we had $ 0.7 million of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under the ESPP, which may be adjusted for future changes in forfeitures and is included as additional paid-in capital in the accompanying consolidated balance sheets.
−Removed: No tax benefit was realized due to a continued pattern of net losses.
−Removed: The unrecognized compensation cost as of December 31, 2022, is expected to be recognized as share-based payment award compensation over a weighted average period of 1.4 years.
−Removed: Disaggregated revenue
−Removed: The following table provides information about disaggregated revenue (in thousands) recognized in continuing operations:
−Removed: License revenue:
−Removed: Total revenue, net
−Removed: License agreements
−Removed: Mayne license agreement
−Removed: Pursuant to a License Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Mayne License Agreement”), the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.
−Removed: Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time, milestone payments to the Company of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million.
−Removed: Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
−Removed: The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.
−Removed: Mayne Pharma will pay to the Company minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below.
−Removed: Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.
−Removed: The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
−Removed: The proceeds at closing were allocated separately to the sale of ANNOVERA and the license grant related to the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal of approximately $ 62.0 million.
−Removed: We also recognized approximately $ 70.0 million in revenue from transaction with Mayne Pharma which represented license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products as well as present value of future minimum royalty payments (as discussed in Note 1).
−Removed: On the Closing Date, the Company and Mayne Pharma entered into Amendment No.
−Removed: 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”).
−Removed: Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay the Company approximately $ 1.0 million in prepaid royalties on the Closing Date.
−Removed: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.
−Removed: In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement, including the Company’s minimum payment obligations thereunder.
−Removed: Knight license agreement
−Removed: Pursuant to the terms of the Knight License Agreement, in 2020, Knight paid us $ 2.0 million in milestone fees upon the first regulatory approval in Canada for IMVEXXY and BIJUVA, and is required to pay us sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel.
−Removed: We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada within certain specified time periods.
−Removed: We also may terminate the Knight License Agreement if Knight challenges our patents.
−Removed: Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.
−Removed: As part of the Knight License Agreement, Knight is prohibited from exporting IMVEXXY and BIJUVA to the United States.
−Removed: As of December 31, 2022, no IMVEXXY or BIJUVA sales have been made through the Knight License Agreement.
−Removed: Theramex license agreement
−Removed: Under the terms of the Theramex License Agreement, Theramex paid us EUR 14 million, or $ 15.5 million, in cash as an upfront fee in August 2019.
−Removed: Within thirty days of signing the Theramex License Agreement, we provided Theramex the regulatory materials and clinical data that were necessary for Theramex to obtain marketing authorizations and other applicable regulatory approvals for commercializing BIJUVA and IMVEXXY.
−Removed: In 2019, at a point in time when Theramex was able to use and benefit from the license which was when the knowledge transfer of regulatory documents occurred, we recognized the revenue related to the upfront fee, which was a non-refundable payment.
−Removed: In 2021, we received additional milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets.
−Removed: Additionally, in December 2021, we received EUR 0.5 million, or $ 0.6 million, in additional upfront payments for the license grants of IMVEXXY in Brazil and Mexico.
−Removed: The additional upfront payment for the license grants of IMVEXXY in Brazil and Mexico may be returned to Theramex under certain conditions if IMVEXXY fails to obtain marketing authorization in one of Brazil or Mexico within a prespecified period.
−Removed: Accordingly, the additional upfront payment for the license grants of IMVEXXY in Brazil and Mexico was recorded as other non-current liabilities as of December 31, 2021 in the accompanying balance sheets.
−Removed: We are eligible to receive additional sales milestone payments up to an aggregate of EUR 27.5 million in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones of BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel (collectively the “Theramex Territory”) ranging from EUR 25 million to EUR 100 million.
−Removed: We are also entitled to receive quarterly royalty payments at a rate of 5 % on net sales of BIJUVA and IMVEXXY in the Theramex Territory.
−Removed: Theramex is responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Theramex Territory.
−Removed: Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Theramex Territory, except for certain specified markets.
−Removed: We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods.
−Removed: We also may terminate the Theramex License Agreement if Theramex challenges our patents.
−Removed: Either party may terminate the Theramex License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.
−Removed: In both 2022 and 2021, we recorded BIJUVA sales of $ 1.4 million made through the Theramex License Agreement.
−Removed: In addition, in 2021, we received milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets.
−Removed: As of December 31, 2022, no IMVEXXY sales have been made through the either of the licensing agreements.
−Removed: Our income (loss) from continuing operations before income taxes is as follows (in thousands):
+Added: Share-based payment compensation expense for PSUs is based on 100 %
+Added: vesting which was a part of the termination benefits for all employees who were terminated in 2022.
+Added: We recorded share-based payment award
+Added: compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under our employee stock
+Added: purchase plan (“ESPP”) totaling $ 1.3 million for 2023 and $ 11.6 million for 2022.
+Added: As of December 31, 2023, we had $ 0.3 million of unrecognized share-based
+Added: payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP, which may be adjusted
+Added: for future changes in forfeitures and is included as additional paid-in capital in the accompanying consolidated balance sheets.
+Added: benefit was realized due to a continued pattern of net losses.
+Added: The unrecognized compensation cost as of December 31, 2023 of $ 0.3
+Added: million is expected to be recognized as share-based payment award compensation over a weighted average period of 0.8 years.
+Added: Pursuant to the Mayne License Agreement, the Company granted Mayne
+Added: Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture,
+Added: have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories
+Added: and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed
+Added: Products outside the United States for commercialization in the United States and its possessions and territories.
+Added: Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time,
+Added: milestone payments to the Company of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar
+Added: year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach
+Added: $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0
+Added: Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of
+Added: 8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for
+Added: a period of 20 years following the Closing Date.
+Added: The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier
+Added: to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in
+Added: the United States.
+Added: Mayne Pharma will pay to the Company minimum annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation
+Added: at an annual rate of 3 %, subject to certain further adjustments, including as described below.
+Added: Upon the expiry of the 20 -year royalty
+Added: term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for
+Added: the Licensed Products.
+Added: In 2023, we recorded BIJUVA license sales of $ 0.3 million made through
+Added: the Theramex License Agreement and $ 1.0 million pertaining to our licensed products with Mayne Pharma, which was recorded as license revenue.
+Added: Additionally, we recognized $ 0.5 million in other income pertaining to royalty sales of ANNOVERA.
+Added: Our income (loss) from continuing operations before income taxes is
+Added: as follows (in thousands):
+Added: Year Ending December 31,
United States
−Removed: For the year ended December 31, 2022, there was 0 % and 0.5 % provision for income taxes in continuing and discontinued operations, respectively, current or deferred.
−Removed: For the year ended December 31, 2021, there was no provision for income taxes in continuing and discontinued operations, current or deferred.
−Removed: As of December 31, 2022, we had a federal net operating loss (“NOL”) carryforwards of $ 640.0 million, which is available to offset future taxable income.
−Removed: Approximately $ 92.8 million of the federal NOLs can be carried forward for 20 years and will begin to expire in 2031 .
+Added: For the year ended December 31, 2023, there was no provision for income
+Added: taxes in discontinued operations, current or deferred.
+Added: For the year ended, December 31, 2023, we recorded a benefit of 0.5 % in continuing
+Added: For the year ended December 31, 2022, there was 0 % and 0.5 % provision for income taxes in continuing and discontinued operations,
+Added: respectively, current or deferred.
+Added: As of December 31, 2023, we had federal net operating loss (“NOL”)
+Added: carryforwards of $ 577.0 million, which is available to offset future taxable income.
+Added: Approximately $ 19.2 million of the federal NOLs can
+Added: be carried forward for 20 years and will begin to expire in 2035.
The remaining $ 557.8 million can be carried forward indefinitely.
−Removed: In the event of future income, the NOL deduction arising from NOLs generated in taxable years beginning in 2021 will be limited to 80 % of the excess taxable income.
+Added: the event of future income, the NOL deduction arising from NOLs generated in taxable years beginning in 2021 will be limited to 80 % of
+Added: the excess taxable income.
The Company experienced an ownership change pursuant to IRC Sec.
−Removed: As a result, our NOLs carryforward as of December 31, 2022 will be limited.
−Removed: A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows:
+Added: As a result, our NOLs carryforward as
+Added: of December 31, 2023 will be limited.
+Added: A reconciliation between taxes computed at the federal statutory rate
+Added: and the consolidated effective tax rate is as follows:
Federal statutory tax rate
4 unchanged sentences
Permanent and other differences
−Removed: Provision for income taxes
−Removed: Deferred income taxes result from temporary differences between the amount of assets and liabilities recognized for financial reporting and tax purposes.
−Removed: The components of the net deferred income tax asset as of December 31, 2022 and 2021 are as follows (in thousands):
−Removed: As of December 31,
−Removed: Deferred income tax assets:
+Added: (Benefit) provision for income taxes
+Added: We do not expect to pay any significant federal or state income taxes
+Added: as a result of (i) the losses recorded during 2023, (ii) net operating losses carry forwards from prior years.
+Added: Deferred income taxes result from temporary differences between the amount
+Added: of assets and liabilities recognized for financial reporting and tax purposes.
+Added: The components of the net deferred tax assets as of December
+Added: 31, 2023 and 2022 are as follows:
+Added: Deferred income tax assets (liabilities):
Net operating loss
6 unchanged sentences
Deferred income tax assets, net
−Removed: We believe that it is more likely than not that we will not generate sufficient future taxable income to realize a portion of tax benefits related to the deferred tax assets and as such, a valuation allowance has been established against a portion of the deferred tax assets as of both December 31, 2022 and 2021.
−Removed: Since our first year of operations in 2011, we generated net operating losses, and our U.S.
+Added: We believe that it is more likely than not that we will not generate
+Added: sufficient future taxable income to realize tax benefits related to our deferred tax assets and as such, a valuation allowance has been
+Added: established against all the deferred tax assets as of both December 31, 2023 and 2022.
+Added: Since our first year of operations in 2011, we generated net operating
+Added: losses, and our U.S.
federal and state tax returns remain open to examination.
−Removed: As of December 31, 2022 and 2021, we had no tax positions relating to open tax returns that were considered to be uncertain, and we had no unrecognized tax benefits.
+Added: As of December 31, 2023 and 2022, we had no tax positions relating
+Added: to open tax returns that were considered to be uncertain, and we had no unrecognized tax benefits.
Income (loss) per common share
−Removed: The following table sets forth the computation of basic and diluted income (loss) per common share for the periods presented (in thousands, except per share amounts):
+Added: The following table sets forth the computation of basic and diluted
+Added: income (loss) per common share (each adjusted to account for the Reverse Stock Split) for the periods presented (in thousands, except
+Added: per share amounts):
+Added: Years Ending December 31,
Net income (loss) from continuing operations
1 unchanged sentence
Net income (loss)
−Removed: Weighted average common shares for basic income (loss) per
+Added: Weighted average common shares for basic income (loss) per common share
Effect of dilutive securities
−Removed: Weighted average common shares for diluted income (loss) per
+Added: Weighted average common shares for diluted income (loss) per common share
Income (loss) per common share, continuing operations
Income (loss) per common share, discontinued operations
−Removed: Since we reported a net loss for 2021, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities.
−Removed: Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common share are the same for 2021.
−Removed: The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per common share during 2022 and 2021 (in thousands):
−Removed: As of December 31,
+Added: Since we reported a net loss from continuing operations for 2023, our potentially
+Added: dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities.
+Added: Therefore, our basic and
+Added: diluted loss per common share and our basic and diluted weighted average common shares are the same for 2023.
+Added: The following table sets forth the outstanding securities as of the
+Added: periods presented which were not included in the calculation of diluted earnings per common share during 2023 and 2022 (in thousands):
Stock options
Related parties
−Removed: A former member of our Board, J.
−Removed: Martin Carrol, who resigned in December 2021, is also a director of Catalent.
−Removed: From time to time, we have entered into agreements with Catalent and its affiliates in the normal course of business.
−Removed: From July 2015 to December 2021, agreements with Catalent have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company.
−Removed: For manufacturing activities, Catalent billed us $ 4.1 million and $ 3.0 million for 2021 and 2020, respectively.
−Removed: As of December 31, 2021, estimated amounts payable to Catalent was $ 0.9 million.
−Removed: In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 8, Commitments and contingencies to the financial statements included in this Annual Report.
−Removed: The Catalent supply agreements were assigned to Mayne as part of our transaction with Mayne Pharma.
On August 23, 2022, we appointed Mr.
−Removed: Justin Roberts as a director to fill a newly created vacancy on the Board.
−Removed: Roberts will serve until the Company’s 2022 Annual Meeting of Stockholders or until his successor is duly elected or appointed or his earlier death or resignation.
−Removed: As a director of the Company, Mr.
−Removed: Roberts is entitled to receive compensation in the same manner as our other non-employee directors, described in the section entitled “Director Compensation” in our Amendment No.
−Removed: 1 to Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission on April 29, 2022, but he has elected not to receive any
−Removed: compensation for his service as a non-employee director at this time.
−Removed: Roberts currently serves as a Partner of the Preferred Stock Investor.
−Removed: On July 29, 2022, September 30, 2022 and October 28, 2022, we entered into subscription agreements with Preferred Stock Investor .
−Removed: On December 30, 2022, and in accordance with the terms of the Certificate of Designation, the Company redeemed all 29,000 outstanding shares of Series A Preferred Stock at a purchase price of $ 1,333 per share.
−Removed: The Company also paid certain affiliates of the Preferred Stock Investor approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between the Company and Preferred Stock Investor.
−Removed: See Note 9 , Mandatory Redeemable Preferred Stock and Stockholders’ Equity ( Deficit ) for additional information.
−Removed: In April 2020, Karen L.
−Removed: Ling was appointed to our Board, who was an executive vice president and chief human resources officer of American International Group, Inc.
−Removed: (“AIG”) until May 2021.
−Removed: From time to time, we have entered into agreements with AIG in the normal course of business.
−Removed: From April 2020 to May 2021, agreements with AIG were reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company.
−Removed: For various insurance premiums, AIG billed us less than $ 0.1 million and $ 0.2 million for 2021 and 2020, respectively.
−Removed: As of December 31, 2021, we had no amounts payable to AIG.
+Added: Justin Roberts as a director to
+Added: fill a newly created vacancy on our Board of Directors.
+Added: Roberts was elected to serve as a director at our combined 2022 and 2023 Annual
+Added: Meeting held on June 26, 2023.
+Added: Roberts will serve until our next Annual Meeting of Stockholders or until his successor is duly elected
+Added: or appointed or his earlier death or resignation.
+Added: As a director of our Company, Mr.
+Added: Roberts is entitled to receive compensation in the
+Added: same manner as our other non-employee directors, described in the section entitled “Director Compensation” in our Amendment
+Added: 1 to Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission on May 1, 2023, but
+Added: he has elected not to receive any compensation for his service as a non-employee director at this time.
+Added: Roberts currently serves as
+Added: a Partner of Rubric.
+Added: On July 29, 2022, September 30, 2022, October 28, 2022, and May 1, 2023, we entered into subscription agreements
+Added: On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000 outstanding
+Added: shares of Series A Preferred Stock previously issued to affiliates of Rubric at a purchase price of $ 1,333 per share.
+Added: also paid certain
+Added: affiliates of Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into
+Added: between us and Rubric.
+Added: On June 29, 2023, we issued and sold 312,525 shares of Common Stock to Rubric at a price per share equal to $ 3.6797
+Added: pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, before expenses.
+Added: On November 15, 2023 Rubric drew
+Added: down an additional 877,192 shares of Common Stock at a price per share equal to $ 2.2761 .
+Added: We received gross proceeds of $ 2.0 million from
+Added: the drawdown, before expenses.
Business concentrations
−Removed: TherapeuticsMD was previously a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
−Removed: In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
−Removed: As part of the transformation that included License Agreement with Mayne Pharma, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
−Removed: Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
−Removed: Additional disclosures regarding discontinued operations are provided in Note 2.
−Removed: In 2022, 98 % of license revenue related to one customer - Mayne Pharma.
−Removed: In 2021, 100 % of license revenue related to one customer - Theramex.
−Removed: As of December 31, 2022, we had a royalty receivable of $ 1.5 million relating to the short-term portion of receivable from Mayne Pharma and $ 20.3 million relating to long term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty (see L.
−Removed: Revenue Recognition above).
−Removed: As of December 31, 2022, we also recorded $ 1.0 million in prepaid royalties that we received from Mayne Pharma which were recorded in accrued expenses and other current liabilities.
−Removed: As of December 31, 2022, three vendors each accounted for more than 10 % of our accounts payable related to continued operations.
−Removed: As of December 31, 2021, one vendor accounted for 54.5 % of our accounts payable balance at December 31, 2021 related to continued operations.
+Added: TherapeuticsMD was previously a women’s healthcare company with a
+Added: mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
+Added: In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed
+Added: to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
+Added: As part of the transformation that included
+Added: the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected
+Added: as discontinued operations in our consolidated financial statements.
+Added: Assets and liabilities associated with the commercial business are
+Added: classified as assets and liabilities of discontinued operations in our consolidated balance sheets.
+Added: Additional disclosures regarding discontinued
+Added: operations are provided in Note 2.
+Added: For the year ended December 31, 2023, 100 % of license revenue related to
+Added: Mayne Pharma and Theramex.
+Added: As of December 31, 2023, we had a royalty receivable of $ 3.1 million
+Added: relating to the short-term portion of receivable from Mayne Pharma and Theramex and $ 18.5 million relating to the long-term portion of
+Added: royalty receivable which includes royalties recognized from the minimum annual royalty that Mayne Pharma is obligated to pay to us under
+Added: the Mayne License Agreement.
Subsequent Events
−Removed: On March 28, 2023, we received escrowed funds of $ 11.3 million related to customary holdbacks related to the vitaCare transaction that were recorded as restricted cash in the consolidated balance sheets as of December 31, 2022.
+Added: Effective March 22, 2024, Tommy G.
+Added: Thompson resigned as the Company’s
+Added: Executive Chairman of the Board and was reappointed as the Company’s Chairman of the Board.
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.