Item 9A. Controls and Procedures
Item 9A. Controls and procedures
Evaluation of disclosure controls and procedures
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 2023 10-K Report. Based on that evaluation, our Principal Executive Officer and Principal Financial Officer
concluded that, as of December 31, 2023, 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.
Changes in internal control over financial
reporting
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.
Inherent limitations on effectiveness of
controls
Our management does not expect that our disclosure
controls and procedures or our internal controls will prevent all error and all fraud. 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. 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. 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. Further, internal controls may become inadequate because of changes in conditions, or through the deterioration of the degree
of compliance with policies or procedures.
Management’s report on internal control
over financial reporting
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). 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. GAAP. Internal control over financial
reporting includes those policies and procedures that:
● pertain to the maintenance of records that in reasonable
detail accurately and fairly reflect the transactions and dispositions of our assets;
● 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; and
● 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.
Our management assessed the effectiveness
of our internal control over financial reporting as of December 31, 2023. 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). 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. Based on
management’s assessment, we believe that our internal controls over financial reporting were effective as of December 31,
2023.
This 2023 10-K Report does not include an attestation
report of the Company’s registered public accounting firm regarding internal control over financial reporting. 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 2023 10-K Report.
Item 9B. Other information
Effective March 22, 2024, Tommy G. Thompson resigned as the Company’s
Executive Chairman of the Board and was reappointed as the Company’s Chairman of the Board.
Item 9C. Disclosure regarding foreign jurisdictions
that prevent inspections
None.
43
PART III
Item 10. Directors, executive officers, and
corporate governance
This information will be contained in our definitive proxy statement 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 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 later
than the end of such 120 day period.
Item 11. Executive compensation
This information will be contained in our definitive proxy statement 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 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 later
than the end of such 120 day period.
Item 12. Security ownership of certain beneficial
owners and management and related stockholder matters
This information will be contained in our definitive proxy statement 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 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 later
than the end of such 120 day period.
Item 13. Certain relationships and related
transactions, and director independence
This information will be contained in our definitive proxy statement 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 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 later
than the end of such 120 day period.
Item 14. Principal accountant fees and services
This information will be contained in our definitive proxy statement
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
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
later than the end of such 120 day period.
44
PART IV
Item 15. Exhibits and financial statement
schedules
(a) Financial statements and financial statements schedules
(1) Financial Statements are listed in the Index to Financial Statements
on page F-1 of this 2023 10-K Report.
(2) 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.
(b) Exhibits
Exhibit No.
Description
2.1
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)
2.2
Agreement and Plan of Reorganization, dated June 11, 2010, among AMHN, Inc., SHN Acquisition Corp., Spectrum Health Network, Inc., and the Sole Shareholder of Spectrum Health Network, Inc.(2)
2.3
Croff Enterprises, Inc. Plan of Corporate Division and Reorganization, dated October 25, 2007 (3)
2.4
Agreement and Plan of Merger, dated July 18, 2011, among vitaMedMD, LLC, AMHN, Inc., and vitaMed Acquisition, LLC(4)
2.5***+
Stock Purchase Agreement, dated March 6, 2022, by and between TherapeuticsMD, Inc. and GoodRx, Inc. (5)
3.1
Articles of Conversion of AMHN, Inc. filed in the State of Nevada, dated July 20, 2010 (6)
3.2
Articles of Incorporation of AMHN, Inc. filed in the State of Nevada, dated July 20, 2010 (6)
3.3
Composite Amended and Restated Articles of Incorporation of the Company, as amended (7)
3.4
Bylaws of the AMHN, Inc. (8)
3.5
First Amendment to Bylaws of the Company, dated December 17, 2015 (9)
3.6
Second Amendment to Bylaws of the Company, adopted May 27, 2022 (10)
3.7
Third Amendment to Bylaws of the Company, dated July 29, 2022 (11)
3.8
Certificate of Change to Articles of Incorporation of the Company (12)
3.9
Certificate of Designation, Preferences and Rights of Series A Preferred Stock (11)
3.10
Fourth Amendment to Bylaws of the Company, dated June 29, 2023 (13)
4.1
Form of Certificate of Common Stock (14)
4.2
Description of Securities of the Company (15)
10.1
Form of Common Stock Purchase Warrant (16)
10.2*
Form of Non-Qualified Stock Option Agreement (16)
10.3*
TherapeuticsMD, Inc. 2019 Stock Incentive Plan (17)
10.4*
First Amendment to the TherapeuticsMD, Inc. 2019 Stock Incentive Plan (18)
10.5*
Amended and Restated 2012 Stock Incentive Plan (19)
10.6*
2009 Long Term Incentive Compensation Plan, as amended (20)
10.7*
TherapeuticsMD, Inc. 2020 Employee Stock Purchase Plan (21)
10.8
Form of Common Stock Purchase Warrant, dated February 24, 2012 (22)
10.9
Common Stock Purchase Warrant, issued to Plato & Associates, LLC, dated January 31, 2013 (23)
10.10
Form of Warrant to Purchase Common Stock, dated August 5, 2020 (24)
10.11
Amendment to Company Warrant issued by the Company to the Subscribers party to that certain Subscription Agreement, dated as of August 5, 2020, dated November 8, 2020 (25)
10.12
Second Amendment to Company Warrant issued by the Company to the Subscribers party to that certain Subscription Agreement, dated as of August 5, 2020 (26)
10.13
Warrant issued by the Company to Robert Finizio (26)
10.14
Amendment to Warrant issued by the Company to Robert Finizio (26)
10.15*
Warrant issued by the Company to John C.K. Milligan, IV (26)
10.16*
Amendment to Warrant issued by the Company to John C.K. Milligan, IV (26)
10.17
Subscription Agreement, dated August 5, 2020, by and among TherapeuticsMD, Inc. and the Subscribers identified on the Schedule of Subscribers attached thereto (24)
10.18***
License Agreement, dated July 30, 2018, by and between TherapeuticsMD, Inc. and The Population Council, Inc. (27)
10.19***
Lease, dated October 5, 2018, by and between 951 Yamato Acquisition Company, LLC and TherapeuticsMD, Inc. (28)
10.20***
License and Supply Agreement, dated June 6, 2019, by and between TherapeuticsMD, Inc. and Theramex HQ UK Limited (29)
10.21*
Form of Indemnification Agreement between TherapeuticsMD, Inc. and each of its executive officers and directors (25)
10.22*
2022 Executive Retention and Performance Bonus Plan. (ERB-Plan) (30)
10.23
Subscription Agreement between TherapeuticsMD, Inc. and Rubric Capital Management LP, dated July 29, 2022 (11)
10.24
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)
10.25
Subscription Agreement between TherapeuticsMD, Inc. and Rubric Capital Management LP, dated September 30, 2022 (31)
10.26
Subscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TAO Talents, LLC, dated September 30, 2022 (31)
45
10.27
Subscription Agreement between TherapeuticsMD, Inc. and Rubric Capital Management LP, dated October 28, 2022 (32)
10.28
Subscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TAO Talents, LLC, dated October 28, 2022 (32)
10.29***+
License Agreement by and between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated December 4, 2022 (33)
10.30***+
Transaction Agreement by and between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated December 4, 2022 (33)
10.31**
Amendment No. 1 to the License Agreement between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated as of December 30, 2022 (15)
10.32
Amendment No. 1 to the Transaction Agreement between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated as of December 30, 2022 (15)
10.33*
Amended and Restated Employment Agreement, dated as of December 18, 2018, by and between TherapeuticsMD, Inc. and Marlan Walker (15)
10.34*
Amendment, effective October 15, 2021, to the Employment Agreement, dated as of December 18, 2018, by and between TherapeuticsMD, Inc. and Marlan Walker (15)
10.35*
Amendment, dated February 21, 2023, to the Employment Agreement, dated as of December 18, 2018, as extended effective October 15, 2021, by and between TherapeuticsMD, Inc. and Marlan Walker (34)
10.36*
General Consulting and Services Agreement by and between TherapeuticsMD, Inc. and MCD Consulting Management Services, LLC, dated February 21, 2023 (34)
10.37
Subscription Agreement, dated May 1, 2023, between TherapeuticsMD, Inc. and Rubric Capital Management LP (35)
10.38*
Master Services Agreement, dated August 15, 2023, between TherapeuticsMD, Inc. and JZ Advisory Group (36)
21.1†
Subsidiaries of the Company
23.1†
Consent of Berkowitz Pollack Brant
23.2†
Consent of Grant Thornton LLP
31.1†
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a)
31.2†
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a)
32.1††
Section 1350 Certification of Chief Executive Officer
32.2††
Section 1350 Certification of Chief Financial Officer
97.1†
TherapeuticsMD, Inc. Policy on Recoupment of Incentive Compensation
101†
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
104†
Inline XBRL for the cover page of this Annual Report on Form 10-K, included in the Exhibit 101 Inline XBRL Document Set
* Indicates a contract with management or compensatory plan or arrangement.
** Certain confidential material contained in the document has been omitted
and filed separately with the Securities and Exchange Commission. Confidential treatment
has been granted with respect to this omitted information.
*** Portions of this exhibit have been redacted in compliance with Regulation
S-K Item 601(b)(2). The omitted information is not material and would likely cause competitive
harm to the Company if publicly disclosed.
+ Certain of the exhibits and
schedules to this exhibit have been omitted in accordance with Item 601(a)(5) of Regulation
S-K. The Company agrees to furnish a copy of all omitted exhibits and schedules to the SEC
upon its request.
† Filed herewith.
†† Furnished herewith.
(1) Filed as an exhibit to Form 8-K filed with the Commission on July
10, 2009 and incorporated herein by reference (SEC File No. 000-16731).
(2) Filed as an exhibit to Form 8-K filed with
the Commission on June 14, 2010 and incorporated herein by reference (SEC File No. 000-16731).
(3) 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. 000-16731).
(4) Filed as an exhibit to Form 8-K filed with the Commission on July
21, 2011 and incorporated herein by reference (SEC File No. 000-16731).
(5)
Filed as an exhibit to Form
8-K filed with the Commission on March 10, 2022 and incorporated herein by reference (SEC File No. 001-00100).
(6) 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. 000-16731).
(7) Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2023
filed with the Commission on August 14, 2023 and incorporated herein by reference (SEC File
No. 001-00100).
(8) 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. 000-16731).
46
(9) Filed as an exhibit to Form 8-K filed with the Commission on December
22, 2015 and incorporated herein by reference (SEC File No. 001-00100).
(10) Filed as an exhibit to Form 8-K filed with the Commission on June 3,
2022 and incorporated herein by reference (SEC File No. 001-00100).
(11) Filed as an exhibit to Form 8-K filed with the Commission on August
1, 2022 and incorporated herein by reference (SEC File No. 001-00100).
(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.
001-00100).
(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.
001-00100).
(14) Filed as an exhibit to Form S-3 filed
with the Commission on January 25, 2013 and incorporated hereby by reference (SEC File No.
333-186189).
(15)
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. 001-00100).
(16)
Filed as an exhibit to Form 8-K filed with the Commission on October 11, 2011 and incorporated herein by reference (SEC File No. 000-16731).
(17)
Filed as an exhibit to Form S-8 filed with the Commission on June 21, 2019 and incorporated herein by reference (SEC File No. 333-232268).
(18) Filed as an appendix to the Definitive Proxy Statement filed with the Commission on April 14, 2021 and incorporated herein by
reference (SEC File No. 001-00100).
(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. 001-00100).
(20) 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. 333-191730).
(21) 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. 001-00100).
47
(22)
Filed as an exhibit to Form 8-K filed with the Commission on February 24, 2012 and incorporated herein by reference (SEC File No. 000-16731).
(23)
Filed as an exhibit to Form 8-K filed with the Commission on February 6, 2013 and incorporated herein by reference (SEC File No. 000-16731).
(24)
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. 001-00100).
(25)
Filed as an exhibit to Form 10-Q filed with the Commission on November 9, 2020 and incorporated herein by reference (SEC File No. 001-00100).
(26)
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. 001-00100).
(27)
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. 001-00100).
(28)
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. 001-00100).
(29)
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. 001-00100).
(30)
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 (SEC
File No. 001-00100).
(31)
Filed as an exhibit to Form 8-K filed with the Commission on October
3, 2022 and incorporated herein by reference (SEC File No. 001-00100).
(32)
Filed as an exhibit to Form 8-K filed with the Commission on October
31, 2022 and incorporated herein by reference (SEC File No. 001-00100).
(33)
Filed as an exhibit to Form 8-K filed with the Commission on December
5, 2022 and incorporated herein by reference (SEC File No. 001-00100).
(34)
Filed as an exhibit to Form 8-K filed with the Commission on February
27, 2023 and incorporated herein by reference (SEC SEC File No. 001-00100).
(35)
Filed as an appendix to the Definitive Proxy Statement filed with
the Commission on May 17, 2023 and incorporated herein by reference (SEC File No. 001-00100).
(36)
Filed as an exhibit to Form 10-Q for the quarter ended September
30, 2023, filed with the Commission on November 14, 2023 and incorporated herein by reference (SEC File No. 001-00100).
Item 16. Form 10-K summary
None.
48
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities
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
authorized, on March 29, 2024.
THERAPEUTICSMD, INC.
/s/ Marlan D. Walker
Marlan D. Walker
Chief Executive Officer
Pursuant to the requirements of Section 13 or 15(d) of the Securities
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
authorized, on March 29, 2024.
Signature
Title
/s/ Marlan D. Walker
Chief Executive Officer
Marlan D. Walker
(Principal Executive Officer)
/s/ Joseph Ziegler
Principal Financial and Accounting Officer
Joseph Ziegler
/s/ Tommy G. Thompson
Chairman
Tommy G. Thompson
/s/ Cooper C. Collins
Director
Cooper C. Collins
/s/ Gail K. Naughton, Ph.D.
Director
Gail K. Naughton, Ph.D.
/s/ Justin Roberts
Director
Justin Roberts
49
INDEX TO FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID Number 52) F-2
Report of Independent Registered Public Accounting Firm (PCAOB ID Number
248 ) F-4
Consolidated Balance Sheets F-5
Consolidated Statements of Operations F-6
Consolidated Statements of Stockholders’ Equity (Deficit) F-7
Consolidated Statements of Cash Flows F-8
Notes to Consolidated Financial Statements F-9
F- 1
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Stockholders of TherapeuticsMD, Inc. and Subsidiaries
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheet of TherapeuticsMD, Inc. and Subsidiaries (the “Company”) as of December 31, 2023, and the related consolidated
statement of operations, stockholders’ equity, and cash flows for the year then ended, and the related notes (collectively referred
to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows
for the year then ended, in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s
Ability to Continue as a Going Concern
The accompanying consolidated financial statements
have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements,
the recent change in operations and negative cash flow position along with other conditions as set forth in Note 1, raise substantial
doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described
in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial
statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides
a reasonable basis for our opinion.
F- 2
Critical Audit Matters
The critical audit matters communicated below
are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated
to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and
(2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter
in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit
matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Acquisition of Net Working Capital
As described further in Note 1 to the consolidated
financial statements, the Company determined the acquisition of net working capital by Mayne Pharma, LLC in accordance with the Transaction
Agreement. The Transaction Agreement included significant estimates, which are subject to change for a period of up to two years. The
Company received financial claims from Mayne Pharma, LLC related to this agreement for amounts owed under the provisions of the Transaction
Agreement related to distributor fees, rebates and returns of licensed products. The Company does not believe these claims are substantiated
and thus, did not record an amount due to the licensee as of December 31, 2023. We identified the acquisition of net working capital as
a critical audit matter. The principal consideration for our determination that the acquisition of net working capital pursuant to the
provisions of the Transaction Agreement as a critical audit matter is due to the significant estimates and judgements required by management
when determining the inputs and assumptions utilized in the development of the initial net working capital calculation included in the
Transaction Agreement. The subjectivity of the estimates increases the level of estimation uncertainty, auditor judgement and level of
effort required to evaluate management’s evidence supporting the projected final net working capital acquisition amount as it relates
to the allowance for returns, rebates and distributor fees, including assumptions that no further liability will be incurred.
Our audit procedures perform ed
to address the critical matter included, among others:
● Review
the letter sent to the licensee in response to financial claims.
● Review
original Transaction Agreement and subsequent amendments.
● Review
the rebates and returns analysis performed by the Company, assess method utilized, calculation,
and conclusion reached for reasonableness.
/s/ Berkowitz Pollack Brant, Advisors + CPAs
We have served as the Company’s auditor since 2023.
West Palm Beach, FL
March 29, 2024
F- 3
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders
TherapeuticsMD, Inc.
Opinion
on the financial statements
We have audited
the accompanying consolidated balance sheet of TherapeuticsMD, Inc. (a Nevada corporation) and subsidiaries (the “Company”)
as of December 31, 2022, the related consolidated statements of operations, stockholders’ (deficit) equity, and cash flows for
the year then ended, and the related notes collectively referred to as the “financial statements”). In our opinion, the financial
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022, and the results of
its operations and its cash flows for the year ended December 31, 2022, in conformity with accounting principles generally accepted in
the United States of America.
Going
concern
The accompanying
consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 1 to
the financial statements, the Company has recently changed its business strategy to become a royalty company. 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. 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. Management’s plans in regard to these matters are also described in Note 1. The financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for opinion
These financial
statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted
our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not
required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we
are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit
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. Such procedures included examining, on a test basis, evidence regarding the amounts
and disclosures in the financial statements. 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. We believe that our audit provides a
reasonable basis for our opinion.
/S/ GRANT
THORNTON LLP
We served
as the Company’s auditor from 2015 to 2023.
Miami, Florida
April 7, 2023
F- 4
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except per share amounts)
As of December 31,
2023
2022
Assets:
Current assets:
Cash and cash equivalents
$ 4,327
$ 38,067
Restricted cash
—
11,250
Royalty receivable, current portion
3,090
—
Prepaid and other current assets
4,035
6,034
Current assets of discontinued operations
344
—
Total current assets
11,796
55,351
Fixed assets, net
—
78
License rights and other intangible assets, net
6,098
6,943
Royalty receivable, long term
18,484
20,253
Other non-current assets
58
253
Right of use assets
6,873
7,580
Total assets
$ 43,309
$ 90,458
Liabilities and stockholders’ equity:
Current liabilities:
Accounts payable
$ 27
$ 2,162
Accrued expenses and other current liabilities
3,133
18,846
Current liabilities of discontinued operations
3,694
25,831
Total current liabilities
6,854
46,839
Operating lease liabilities, non-current
6,532
7,369
Other non-current liabilities
636
1,107
Total liabilities
14,022
55,315
Commitments and contingencies (Note 8)
Stockholders’ equity (deficit):
Common stock, par value $ 0.001 ; 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
11
9
Additional paid-in capital
978,917
974,497
Accumulated deficit
( 949,641 )
( 939,363 )
Total stockholders’ equity
29,287
35,143
Total liabilities and stockholders’ equity
$ 43,309
$ 90,458
The accompanying notes are an integral part of
these consolidated financial statements.
F- 5
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(In thousands, except per share amounts)
Years ended December 31,
2023
2022
Revenue, net:
License and service revenue
$ 1,302
$ 69,963
Total revenue, net
1,302
69,963
Cost of revenue
—
1,397
Gross profit
1,302
68,566
Operating expenses:
Selling, general and administrative
8,903
56,710
Depreciation & amortization
922
1,193
Restructuring
—
9,472
Total operating expenses
9,825
67,375
Income (loss) from operations
( 8,523 )
1,191
Other income (expense):
Miscellaneous income (expense)
781
( 117 )
Total other income (loss), net
781
( 117 )
Income (loss) from continuing operations before income taxes
( 7,742 )
1,074
Benefit (provision) for income taxes
43
—
Net income (loss) from continuing operations
( 7,699 )
1,074
Income (loss) from discontinued operations, net of income taxes
( 2,579 )
110,923
Net income (loss)
$ ( 10,278 )
$ 111,997
Income (loss) per common share, basic:
Continuing operations
( 0.74 )
0. 12
Discontinued operations, net
( 0.25 )
12.29
Net income (loss) per common share, basic
$ ( 0.98 )
$ 12.41
Income (loss) per common share, diluted:
Continuing operations
( 0.74 )
0.11
Discontinued operations, net
( 0.25 )
11.84
Net income (loss) per common share, diluted
$ ( 0.98 )
$ 11.96
Weighted average common shares, basic
10,441
9,028
Weighted average common shares, diluted
10,441
9,366
Net income (loss)
$ ( 10,278 )
$ 111,997
Other comprehensive income
—
—
Comprehensive income (loss):
$ ( 10,278 )
$ 111,997
The accompanying notes are an integral part of
these consolidated financial statements.
F- 6
TherapeuticsMD, Inc.
and Subsidiaries
Consolidated Statements of Stockholders’ (Deficit)
Equity
(In thousands)
Common Stock
Additional
Paid in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance, December 31, 2021
8,597
$ 9
$ 957,730
$ ( 1,051,360 )
$ ( 93,621 )
Shares issued for sale of common stock, net of cost
565
—
2,454
—
2,454
Lender warrants
—
—
2,727
—
2,727
Rounding for fractional shares in connection with the reverse stock split
142
—
—
—
—
Shares issued for vested restricted and performance stock units
189
—
—
—
—
Shares issued for sale of common stock related to employee stock purchase plan
5
—
14
—
14
Share-based payment award compensation costs
—
—
11,572
—
11,572
Net income
—
—
—
111,997
111,997
Balance, December 31, 2022
9,498
9
974,497
( 939,363 )
35,143
Shares issued for vested restricted stock units
844
1
—
—
1
Share-based compensation
—
—
1,271
—
1,271
Shares issued for sale of common stock related to private placement sale
1,190
1
3,149
—
3,150
Net loss
—
—
—
( 10,278 )
( 10,278 )
Balance, December 31, 2023
11,532
$ 11
$ 978,917
$ ( 949,641 )
$ 29,287
The accompanying notes are an integral part of
these consolidated financial statements.
F- 7
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
Years ended December 31,
2023
2022
Cash flows from operating activities:
Net income (loss)
$ ( 10,278 )
$ 111,997
Less: Income (loss) from discontinued operations, net of tax
( 2,579 )
110,923
Net income (loss) from continuing operations
( 7,699 )
1,074
Adjustments to reconcile net income (loss) to net cash provided by (used in) continuing operating
activities:
Depreciation and amortization
922
1,193
Share-based payment compensation costs
1,271
11,572
Make-whole payment accretion
—
( 354 )
Other
( 129 )
( 40 )
Changes in operating assets and liabilities:
Prepaid and other current assets
1,999
620
Other assets
( 1,126 )
( 7,636 )
Accounts payable
( 2,135 )
( 1,211 )
Accrued expenses and other current liabilities
( 15,713 )
4,262
Other non-current liabilities
( 471 )
( 121 )
Total adjustments
( 15,382 )
8,285
Net cash provided by (used in) continuing operating activities
( 23,081 )
9,359
Cash flows from continuing investing activities:
Receipts (payment) for patents
—
( 355 )
Net cash used in continuing investing activities
—
( 355 )
Cash flows from continuing financing activities:
Proceeds from sale of common stock, net of costs
3,151
2,454
Proceeds from sale of common stock related to employee stock purchase plan
—
14
Repayments of debt
—
( 219,432 )
Proceeds from Series A Preferred Stock, net of transaction costs
—
21,684
Repurchase of Preferred Stock at liquidation preference
—
( 38,657 )
Proceeds from make-whole derivative
—
3,322
Repayment of make-whole derivative
—
( 2,969 )
Payment of debt financing fees
—
( 1,622 )
Net cash provided by (used in) continuing financing activities
3,151
( 235,206 )
Discontinued operations:
Net cash used in operating activities
( 25,060 )
( 13,437 )
Net cash provided by investing activities
—
223,834
Net cash provided by financing activities
—
—
Net cash provided by (used in) discontinued operations
( 25,060 )
210,397
Net decrease in cash
( 44,990 )
( 15,805 )
Cash and restricted cash - continuing operations, beginning of period
49,317
64,907
Cash and restricted cash - discontinued operations, beginning of period
—
215
Total cash and restricted cash, end of period
$ 4,327
$ 49,317
Supplemental disclosure of cash flow information:
Interest paid
$ —
$ 13,545
Supplemental disclosure of noncash financing activities:
Warrants issued in relation to debt financing agreement
$ —
$ 2,727
The accompanying notes are an integral part of
these consolidated financial statements.
F- 8
TherapeuticsMD, Inc. and Subsidiaries
Notes to the Consolidated Financial Statements
1. Business, basis of presentation, new accounting standards and summary of significant accounting policies
General
TherapeuticsMD, Inc. (the “Company”), a Nevada
corporation, and its consolidated subsidiaries are referred to collectively in this Annual Report on Form 10-K (“2023 10-K
Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 2023 10-K Report
includes trademarks, trade names and service marks, such as TherapeuticsMD ® , vitaMedMD ® ,
BocaGreenMD ® , vitaCareTM, IMVEXXY ® , and BIJUVA ® , which are protected under applicable
intellectual property laws and are the property of, or licensed by or to, us. Solely for convenience, trademarks, trade names and
service marks referred to in this 2023 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. 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.
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.
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. On December 30, 2022 (the “Closing
Date”), we 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, in which we and our subsidiaries
(i) granted Mayne Pharma an exclusive license to commercialize our 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 our 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.
In a License Agreement, dated December 4, 2022, between TherapeuticsMD
and Mayne Pharma (the “Mayne License Agreement”), we 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.
Under the Mayne License Agreement, Mayne Pharma will pay us
one-time milestone payments 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. Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty
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
adjustments, for a period of 20 years following the Closing Date. 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. Mayne Pharma will pay us minimum 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. 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.
Under the Transaction Agreement, dated December 4, 2022, between TherapeuticsMD
and Mayne Pharma (the “Transaction Agreement”), we sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize
the Products in the United States, including, with the Population Council’s consent, our exclusive license from the Population Council
to commercialize ANNOVERA (the “Transferred Assets”).
The total consideration from Mayne Pharma to TherapeuticsMD for
the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne 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 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 Mayne License Agreement, as
amended. 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.
F- 9
On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment
No. 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”). Pursuant to the Mayne License Agreement Amendment,
Mayne Pharma agreed to pay us approximately $ 1.0 million in prepaid royalties on the Closing Date. The prepaid royalties reduced the first
four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257 thousand
per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty
payment was paid to us. We and Mayne Pharma settled the $ 1.5 million of consideration due to Mayne for the assumed obligations under a
long-term services agreement (see the section entitled “vitaCare Divestiture” below for a discussion of the long-term services
agreement), including our minimum payment obligations thereunder. As the parties agreed, during the second quarter of 2023, Mayne Parma
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
payable.
As part of the transformation that included the Mayne License Agreement,
historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in
our consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities
of discontinued operations in our consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in
Note 2.
We also have license agreements with strategic partners to commercialize
IMVEXXY and BIJUVA outside of the U.S.
● In July 2018, we entered into a license and supply agreement
(the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”) pursuant to which we granted Knight
an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
● In
September 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. In 2021, Theramex secured
regulatory approval for BIJUVA in certain European countries and began commercialization
efforts in those countries.
In connection with our transformation into a pharmaceutical royalty
company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief
Executive Officer) and all other employees was completed by December 31, 2022. Severance obligations for all employees other than executive
officers were paid in full in January 2023 and severance obligations for terminated executive officers were paid in accordance with their
employment agreements and separation agreements as previously disclosed. As of December 31, 2022 and 2023, we employed one full-time employee
primarily engaged in an executive position.
We have engaged external consultants 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. On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would
serve as our Principal Financial and Accounting Officer. On August 17, 2023 Michael C. Donegan notified us of his decision to resign from
the positions of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023. Mr. Ziegler succeeded Mr.
Donegan as Principal Financial and Accounting Officer as of the date of Mr. Donegan’s resignation.
vitaCare Divestiture
On April 14, 2022, we completed the divestiture of our former subsidiary
vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital
stock (the “vitaCare Divestiture”). We received net proceeds of $ 142.6 million, after deducting transaction costs of $ 7.2
million, and we recognized a gain on sale of business of $ 143.4 million. Included in the net proceeds amount was $ 11.3 million of customary
holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”) which we received in 2023. Additionally,
the Purchase Agreement provides that 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; however, we do not believe this
earnout will be realized. We will record the contingent consideration at the settlement amount if and when the consideration is realized
or realizable.
The Purchase Agreement contains customary representations and warranties,
covenants, and indemnities of the parties thereto. The commitments under a long-term services agreement related to vitaCare were transferred
to Mayne Pharma as part of the Mayne Transaction.
The divestiture of vitaCare was determined to be a component of discontinued
operations in December 2022, when we changed our business by becoming a royalty company and as a result vitaCare activities were reclassified
to discontinued operations for 2023 and 2022.
F- 10
Going concern
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 our exclusive license to commercialize ANNOVERA in
the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma.
The total consideration from Mayne Pharma to the TherapeuticsMD for
the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement
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
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 Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne
License Agreement, as amended.
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 our subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”)
and the Financing Agreement was terminated.
Following the transaction with Mayne Pharma, our primary source of
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. To
address our capital needs, we may pursue various equity and debt financing and other alternatives. 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. 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.
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. 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.
On May 1, 2023, we entered into a Subscription Agreement (the “Subscription
Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or more
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”),
from time to time during the term of the Subscription Agreement in separate draw-downs at our election. On June 29, 2023, we issued and
sold 312,525 shares of Common Stock at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement. We received gross proceeds
of $ 1.15 million from the draw down, before expenses. On November 15,
2023 Rubric drew down an additional 1,000,000 shares of Common Stock at a price per share equal to $ 2.28 . We received gross proceeds of
$ 2.0 million from the drawdown, before expenses.
In February 2024, the Company received Mayne Pharma’s
calculation of allowance for payer rebates and wholesale distributor fees which differed significantly from the Company’s
estimate of the allowances. The Company believes its estimated allowances for payer rebates and wholesale distributor fees are
reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of
Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this
point. As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any
additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor
fees.
As of December 31, 2023, the Company believes no additional accrual
is required for amounts that may be owed for the allowance for returns under the Transaction Agreement. The Company has not recorded any
contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital
items as changes to estimated amounts owed or amounts due from Mayne Pharma that may be material.
If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA
grow more slowly than expected or decline, if the net working capital settlement with Mayne Pharma under the Transaction Agreement
is greater than our current estimates, if we are unsuccessful with future financings or if the supply chains related to the
third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our
liquidity requirements. The potential impact of these factors in conjunction with the uncertainty of the capital markets raises
substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial
statements.
The accompanying consolidated financial statements do not include any
adjustments that might be necessary if we are unable to continue as a going concern.
F- 11
A. Basis of presentation
The consolidated financial statements and related notes include our
parent company and all wholly owned subsidiaries. The consolidated financial statements are prepared in accordance with accounting principles
generally accepted in the Unites States of America (“U.S. GAAP”). Our fiscal year-end is as of and for the year ended December
31st for each year presented. All intercompany transactions among our businesses have been eliminated.
As part of the transformation and as a result of the vitaCare divestiture
and the Mayne Transaction, historical results of commercial operations for all periods prior to the Closing Date have been reflected as
discontinued operations in the consolidated financial statements. Assets and liabilities associated with the commercial business are classified
as assets and liabilities of discontinued operations in the consolidated balance sheet. Additional disclosures regarding discontinued
operations are provided in Note 2 of these consolidated financial statements.
Certain amounts in the notes to the consolidated financial statements
may not add due to rounding. Certain prior period amounts have been reclassified to conform to current-period presentation.
B. New accounting standards
Adoption of new accounting standards
In December 2023, the Financial Accounting Standards Board (“FASB”)
issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures.” ASU 2023-09 enhances the transparency
and decision usefulness of income tax disclosures by requiring consistent categories and greater disaggregation of information in the
rate reconciliation and income taxes paid disaggregated by jurisdiction. ASU 2023-09 will be effective for the Company in its income tax
disclosure included in its 2025 Annual Report on Form 10-K and will be applied on a prospective basis. However, retrospective application
is permitted. Early adoption is also permitted. The Company is evaluating the impact of ASU 2023-09 on the Company's income tax disclosures
and on its consolidated financial statements.
C. Discontinued Operations
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. An adjustment has been made to the consolidated
statements of operations for the twelve months ended December 31, 2023 and 2022 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. No amounts for shared general and administrative operating support expense were allocated to discontinued
operations. As required by the terms of the Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding
debt borrowings. 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. 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, 2023 and 2022. For additional information, see Note 2 - Discontinued Operations.
D. Estimates and assumptions
The preparation of consolidated financial statements in conformity
to U.S. 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. 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. Actual results may differ, at times in material amounts, from these estimates under different
assumptions or conditions.
E. Cash and Restricted Cash
For the purpose of the statements of cash flows, all highly liquid
investments with an original maturity of three months or less are considered to be cash equivalents. The carrying value of these
investments approximates fair value.
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. We have never experienced any
losses related to these funds.
Restricted cash was comprised of escrowed funds deposited with a bank
relating to the vitaCare Divestiture. All restrictions were lifted in March 2023.
F- 12
F. Fair Value Measurements
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). It
represents a market-based measurement that contemplates a hypothetical transaction between market participants at the measurement date.
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. We measure fair value
using observable and unobservable inputs. 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).
We apply the following fair value hierarchy:
● Level 1 - Quoted prices (unadjusted) in active markets for
identical assets and liabilities.
● Level 2 - Quoted prices in non-active markets or in active
markets for similar assets or liabilities, observable inputs other than quoted prices; and inputs that are not directly observable but
are corroborated by observable market data.
● Level 3 - Inputs that are unobservable.
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.
G. Fixed assets
Fixed assets are carried at cost less accumulated depreciation and
amortization. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs
to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related
assets, which range from three to seven years . Leasehold improvements are depreciated over the shorter of their useful life or the term
of the lease. 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.
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. 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. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software.
Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five
to seven years .
H. License rights and other
intangibles assets
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.
License rights costs 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. The cost was amortized
using the straight-line method as the pattern of economic benefit could not be reliably determined. 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. In addition, amortization of license rights of $ 3.0 million for 2022 was reclassified to discontinued operations.
Intangible assets subject to amortization, such as patents, are amortized
over the useful life of the patent using the straight-line method. If the patent is not granted, we write off any capitalized patent costs
at that time. Intangible assets not subject to amortization, such as trademarks, are perpetual and have indefinite lives.
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. 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.
F- 13
I. Segment reporting
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. Our business is led by our chief executive officer. 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.
Accordingly, we view our business as one reportable operating segment.
J. Revenue recognition
We determine the amount of revenue to be recognized through application
of the following steps:
● Identification of the contract with a customer;
● Identification of the performance obligations in the contract;
● Determination of the transaction price;
● Allocation of the transaction price to the performance obligations in the contract; and
● Recognition of revenue when or as we satisfy the performance obligations.
A performance obligation is a promise in a contract to transfer a product
or service to a customer. 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. We generally recognize revenue at a point
in time when all of our performance obligations under the terms of a contract are satisfied. 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 for those products or services.
The collectability of consideration on the contract is reasonably assured before revenue is recognized. 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.
License revenue
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. Some of these arrangements may include multiple performance obligations. 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.
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. 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. As of December 31, 2022, we are no longer directly engaged in the sale
of prescription products.
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”). 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. The proceeds were allocated among the Licensed Products on the relative net present value of forecasted future
product sales from those products. 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.
F- 14
Our royalty revenue in 2023 primarily related to royalties provided
for under the Mayne License Agreement based on Mayne Pharma’s sales of the licensed products subject to that agreement. 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. 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”). 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”). 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. The portion allocated to consideration for the sale of ANNOVERA was attributed towards the gain on
disposal of that asset. 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. 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. 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. This royalty receivable is a contract asset as of December
31, 2022 and 2023, and is further subject to offset by Mayne Pharma (see L. Contract Assets and Liabilities below).
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: 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). 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. Therefore, royalties
on sales of products commercialized by Mayne Pharma will be recognized in the subsequent periods that the Licensed Products are sold.
In 2023, we recorded BIJUVA license sales of $ 0.3 million made through
the Theramex License Agreement and $ 1.0 million pertaining to our licensed products with Mayne Pharma, which was recognized as license
revenue. Additionally, we recognized $ 0.5 million in other income pertaining to royalty sales of ANNOVERA.
K. Cost of revenue
Cost of revenue includes the cost of inventory, manufacturing, manufacturing
overhead and supply chain costs and product shipping and handling costs. 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 as a
result of the transaction with Mayne Pharma.
L. Contract Assets and
Liabilities
Contract assets totaling $ 21.6 million as of December 31, 2023, include
royalties recognized from the Minimum Annual Royalty (see J. Revenue Recognition above).
M. Share-based payment
awards
We account for share-based payment awards on a fair value basis of
the equity instrument issued. 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. We have elected to account for forfeitures as they occur.
Common stock reverse stock split
On May 6, 2022, we completed a reverse stock split of our Common Stock.
As a result, shares of our outstanding 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. 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. 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. 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. 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.
All historical numbers of shares of Common Stock and per share data
have been adjusted to give effect to the Reverse Stock Split. 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.
F- 15
Increase of authorized shares
On June 26, 2023, at our combined 2022 and 2023 Annual Meeting, our
stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase the number of authorized shares of
Common Stock from 12 million shares to 32 million shares.
N. Income taxes
Income taxes are accounted for under the asset and liability method.
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. 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. 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.
Regular assessments are made on the likelihood that our deferred tax
assets will be recovered from our future taxable income. 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. Sources of positive evidence
include estimates of future taxable income, future reversal of existing taxable temporary differences, taxable income in carryback years,
and available tax planning strategies. 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.
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. 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.
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. 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.
Our policy is to recognize both interest and penalties related to uncertain
tax positions as part of the income tax provision. 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. 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.
O. Earnings per common
share
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. 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. 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. 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. 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.
P. Leases
We determine if an arrangement is a lease at inception. 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.
We account for our lease-related assets and liabilities based on their
classification as operating leases or finance leases, following the relevant accounting guidance. 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. 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. 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. 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.
We test right-of-use assets 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.
F- 16
We sublease our unoccupied facilities to third parties. Any impairment
to the associated right-of-use asset, leasehold improvements, or other assets as a result of the sublease is recognized in the period
when a decision to sublease is made and recorded in our consolidated statement of operations. We recognize sublease income on a straight-line
basis over the sublease term.
Q. Loss Contingencies
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. 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. 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. However, if no amount within the range is a better estimate, the minimum amount in the range should be
accrued. 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. See Note 8 for more information.
R. Restructuring charges
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. 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. There were no restructuring
costs incurred during the year ended December 31, 2023. Restructuring costs have been recognized in the accompanying consolidated statement
of operations as follows (in thousands):
Year ended
December 31,
2022
Executive termination benefits
$ 3,897
Consulting and legal expenses
3,060
Other contract termination costs
2,515
Total restructuring expenses - general and administrative expenses
$ 9,472
Employee termination benefits
$ 4,813
Other contract termination costs
1,367
Total restructuring expenses - discontinued operations
$ 6,180
At December 31, 2023 and 2022 respectively, $ 2.5 million and $ 6.2 million
of restructuring costs were included in current liabilities of discontinued operations in the accompanying consolidated balance sheets.
At December 31, 2022, $ 9.3 million related to restructuring costs was included in accrued expenses and other current liabilities.
S. Reclassification of prior year presentation
Certain prior year amounts have been reclassified for consistency with
the current year presentation.
2. Discontinued Operations
As discussed in Note 1, we changed our business in 2022 by
licensing our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize
our IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and
assigning our exclusive license to commercialize ANNOVERA to Mayne Pharma.
This plan represented a strategic shift having a major effect
on our operations and financial results. Upon our conversion from a commercial pharmaceutical company to a licensing only company with
the consummation of the Mayne Transaction, we 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. We have
no t allocated any amounts for shared general and administrative operating support expense to discontinued operations. As required by the
terms of the Financing Agreement, proceeds from the Mayne Transaction and the vitaCare Divestiture 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).
Additionally, the related assets and liabilities have been
reported as assets and liabilities of discontinued operations in our consolidated balance sheet as of December 31, 2023 and 2022.
F- 17
The total consideration from Mayne Pharma consisted of (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 Mayne License Agreement
Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
Our estimate 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. The determination of
final net working capital includes significant estimates which could change materially for a period of up to two years following the Closing
Date.
The following table presents results of discontinued operations
(in thousands):
Years ended December 31,
2023
2022
Product revenue, net
$ ( 833 )
$ 80,749
Cost of goods sold
—
15,640
Gross profit (loss)
( 833 )
65,109
Operating expenses:
Selling and marketing
—
75,208
General and administrative
481
11,301
Research and development
—
4,942
Restructuring charges
—
6,180
Total operating expenses
481
97,631
Loss from discontinued operations
( 1,314 )
( 32,522 )
Other income (expense):
Gain on sale of vitaCare
—
143,384
Gain on ANNOVERA sale
—
62,031
Loss on the extinguishment of debt
—
( 8,380 )
Interest expense and other financing costs
—
( 36,065 )
Expense for accretion of Series A Preferred Stock
—
( 16,973 )
Loss on disposal of assets
( 1,150 )
—
Other expense, net
( 115 )
—
Total other income (expense), net
( 1,265 )
143,997
Loss before from income taxes
( 2,579 )
111,475
Benefit (provision) for income taxes
—
( 552 )
Net income (loss) from discontinued operations
$ ( 2,579 )
$ 110,923
The following table presents the carrying amounts of the classes of
assets and liabilities of discontinued operations (in thousands):
As of December 31,
2023
2022
Assets:
Current assets:
Accounts receivable
$ 344
$ —
Total assets
344
—
Current liabilities:
Accounts payable
$ —
$ 12,243
Accrued expenses and other current liabilities
3,694
13,588
Total liabilities
$ 3,694
$ 25,831
F- 18
3. Prepaid and other current
assets
Our prepaid and other current assets consisted of the following
(in thousands):
December 31,
2023
2022
Insurance
$ 253
$ 1,167
Capitalized legal
2,334
2,334
Other
1,448
2,533
Prepaid and other current assets
$ 4,035
$ 6,034
4. Fixed assets
Our fixed assets, net consisted of the following (in thousands):
December 31,
2023
2022
Furniture and fixtures
$ 931
$ 931
Computer and office equipment
1,167
1,168
Computer software
375
375
Leasehold improvements
49
49
Fixed assets
2,522
2,523
Less: accumulated depreciation and amortization
2,522
2,445
Fixed assets, net
$ —
$ 78
We recorded in continuing operations, depreciation expense of $ 0.1
million for 2023 and $ 0.6 million for 2022.
5. Licensed rights and other intangible assets
The following provides information about our license rights and other
intangible assets, net (in thousands):
As of December 31, 2023
As of December 31, 2022
Gross
Gross
Carrying
Accumulated
Carrying
Accumulated
Amount
Amortization
Net
Amount
Amortization
Net
Intangible assets subject to amortization:
Hormone therapy drug patents
$ 6,818
$ 1,871
$ 4,947
$ 6,225
$ 1,598
$ 4,627
Hormone therapy drug patents applied and pending approval
842
—
842
1,995
—
1,995
Intangible assets subject to amortization
7,660
1,871
5,789
8,220
1,598
6,622
Intangible assets not subject to amortization:
Trademarks/trade name rights
309
—
309
321
—
321
Intangible assets, net
$ 7,969
$ 1,871
$ 6,098
$ 8,541
$ 1,598
$ 6,943
We recorded, in continuing operations, amortization expense related
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,
and $ 0.6 million for 2022. We recorded amortization expense related to the exclusive license rights agreement with Population Council
of $ 3.0 million for 2022, which was reclassified to discontinued operations after we completed transaction with Mayne Pharma in December
2022, and excluded from the table above.
Our intangible assets subject to amortization are expected to be amortized
as follows (in thousands):
Year ending December 31,
2024
533
2025
445
2026
445
2027
445
2028
445
Thereafter
5,347
Total
$ 7,660
F- 19
We use a combination of qualitative and quantitative factors to assess
licensed rights and intangible assets for impairment. In the year ending December 31, 2023, we have not impaired any of our hormone therapy
drug patent assets.
6. Accrued expenses and other current liabilities
Other accrued expenses and other current liabilities consisted of the
following (in thousands):
As of December 31,
2023
2022
Payroll and related costs
$ 762
$ 8,748
Accrued contract termination costs
—
4,700
Research and development expenses
—
978
Professional fees
489
415
Operating lease liabilities
1,473
1,390
Prepaid royalty
—
1,011
Other accrued expenses and current liabilities
409
1,604
Accrued expenses and other current liabilities
$ 3,133
$ 18,846
We expense advertising costs when incurred, which amounted to
$ 13.2 million for 2022, which was reclassified to discontinued operations as a result of our business shift following the Mayne
Transaction. We incurred no advertising costs in 2023.
7. Debt
Financing agreement
We were party to the Financing Agreement with Sixth Street
Specialty Lending, Inc., as administrative agent, various lenders from time-to-time party thereto, and certain of our subsidiaries
party thereto from time to time as guarantors. On December 30, 2022, we repaid all obligations under the Financing Agreement and the
Financing Agreement was terminated.
Interest and financing costs
Included in miscellaneous income in 2023 is $ 0.3 million of interest
income and $ 0.2 million of interest expense. In 2022 and recorded in discontinued operations, we recognized $ 13.5 million of debt-related
interest expense and $ 22.5 million of financing fees amortization.
8. Commitments and contingencies
Leases
In October 2018, we entered into a lease for executive, administrative,
operations and sales offices in Boca Raton, Florida. The lease includes 62,748 rentable square feet, or the full premises, of which the
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
commencement date. 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. The lease will expire 11 years after the full premises commencement date, unless terminated earlier in accordance with
the terms of the lease. We have the option to extend the term of the lease for two additional consecutive periods of five years . The extension
option is not included in the determination of the lease term as it is not reasonably certain to be exercised. The term of the lease includes
escalating rent and free rent periods. We are also responsible for certain other operating costs under the lease, including electricity
and utility expenses. As a result of shifting our business
to become a license company and terminating our employees, we have sublet the majority of our headquarters and are in the process of subleasing
the remainder. 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 2023.
F- 20
For 2023 and 2022, operating lease expense (including all variable
costs) related to our real estate leases was $ 2.3 and $ 2.1 million, respectively. In 2023 and 2022, our rental income on sublease of our
three suites which were subleased following the vitaCare transaction was $ 1.3 million and $ 0.0 million, respectively.
As of December 31, 2023, our remaining lease payments were as follows
(in thousands):
Year ending December 31,
2024
1,477
2025
1,513
2026
1,551
2027
1,590
2028
1,630
Thereafter
2,664
Total undiscounted lease payments
10,425
Less: imputed interest
2,420
Present value of lease payments
$ 8,005
The following table sets forth supplemental balance sheet information
related to leases (in thousands):
As of December 31,
2023
2022
Assets:
Operating lease right-of-use assets
$ 6,873
$ 7,580
Liabilities:
Operating lease liabilities current (included in accrued expenses and other current liabilities)
$ 1,473
$ 1,390
Operating lease liabilities, non-current
$ 6,532
7,369
Total operating lease liabilities
$ 8,005
$ 8,759
The following table presents other information related to leases:
As of December 31,
2023
2022
Weighted average remaining term (years) - operating leases
6.7
7.7
Weighted average discount rate - operating leases
8.3 %
8.3 %
Cash paid for amounts included in the measurement of lease liabilities from operating lease (in thousands)
$ 1,443
$ 1,413
Right-of-use assets obtained in exchange for new operating lease obligations (non-cash in thousands)
$ —
$ —
Mayne Pharma Agreement
Mayne Pharma paid us approximately $ 12.1 million at closing on December
30, 2022, for the acquisition of net working capital, subject to certain adjustments as determined in accordance with the Transaction
Agreement. While the Transaction Agreement calls for much of the net working capital to be trued-up shortly after the Closing Date in
2023, for a period of one year following the Closing Date in the case of payer rebates and wholesale distributor fees and two years
following the Closing Date in the case for allowance for returns, net working capital amounts will be adjusted to arrive at final net
working capital under the Transaction Agreement.
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. 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.
In February 2024, the Company received Mayne Pharma’s
calculation of allowance for payer rebates and wholesale distributor fees which differed significantly from the Company’s
estimate of the allowances. The Company believes its estimated allowances for payer rebates and wholesale distributor fees are
reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of
Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this
point. As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any
additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor
fees.
Additionally and as of December 31, 2023, the Company believes no additional
accrual is required for amounts that may be owed for the allowance for returns. The Company has not recorded any contingent gains or receivables
for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes to estimated
amounts owed or amounts due from Mayne Pharma that may be material.
F- 21
Population Council License Agreement
Under the terms of our license agreement with the Population Council,
Inc. (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 New Drug Application (“NDA”) for ANNOVERA, and $ 20.0
million in 2019 following the first commercial batch release of ANNOVERA. The aggregate $ 40.0 million of milestone payments were recorded
as license rights. The Population Council was also eligible to receive future payments upon the achievement of certain commercial sales
milestones of ANNOVERA. On December 30, 2022, we assigned the ANNOVERA license to Mayne Pharma. Our rights and obligations under the Population
Council License Agreement have been transferred to Mayne Pharma and may revert back to us upon the occurrence of certain events.
Legal proceedings
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. (“Teva”). 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. In the IMVEXXY 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. The IMVEXXY Patents
identified in the IMVEXXY Notice Letter expire in 2032 or 2033. 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. 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. Teva has filed its answer and counterclaim
to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed. 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. 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. 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. The length of the stay of the IMVEXXY litigation is dependent on further action by Teva. We have incurred and recorded legal
costs amounting to $ 2.3 million in prepaid expenses and other current assets as of December 31, 2023, for the IMVEXXY Paragraph IV legal
proceeding since we believe that we will successfully prevail in this legal proceeding. 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. 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.
Beginning on December 30, 2022 and per the Mayne License Agreement,
Mayne Pharma is responsible for all enforcement of our patents, including the litigation discussed above with respect to Teva.
In September 2023, one of our former contractors retained to market
ANNOVERA under Title X, filed a lawsuit that accused us of breach of contract. We answered their complaint and filed breach of contract
counterclaims.
From time to time, we are involved in other litigations and proceedings
in the ordinary course of business. We are not currently 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.
Off-balance sheet arrangements
As of December 31, 2023 and 2022 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 we consider material.
Employment agreements
In connection with our transformation into a pharmaceutical royalty
company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief
Executive Officer) and all other employees was completed by December 30, 2022. Severance obligations for all employees other than executive
officers were paid in full in the first quarter of 2023. As of December 31, 2023, we employ one full-time employee primarily engaged in
an executive position. We have engaged external consultants 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. The separation of our former
Interim Co-Chief Executive Officers, former Interim Chief Financial Officer and other executives from TherapeuticsMD was each a termination
without “Good Cause,” as defined in their respective employment agreements. In the aggregate, as of December 31, 2023, we
have accrued severance liabilities for executive termination obligations of $ 0.4 million.
F- 22
9. Stockholders’ Equity
Increase of authorized shares
On June 26, 2023, at our combined 2022
and 2023 Annual Meeting, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase the
number of authorized shares of Common Stock from 12 million shares to 32 million shares.
Warrants
As of December 31, 2023, the following table summarizes the status
of our outstanding and exercisable warrants and related transactions since December 31, 2021 (in thousands, except weighted average exercise
price and weighted average remaining contractual life data):
Warrants outstanding and exercisable
Warrants
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Weighted
Average
Remaining
Contractual
Life
(in Years)
Balance, December 31, 2021
103
$ 76.19
$ —
8.3
Granted
436
0.14
Expired
( 3 )
341.5
Balance, December 31, 2022
536
13.10
2,427
9.3
Exercised
( 435 )
0.01
( 2,270 )
Expired
( 2 )
0.89
Balance, December 31, 2023
99
$ 66.61
$ 1,793
6.5
We used the Black Scholes option pricing model to estimate the fair
value of the warrants issued. 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: expected term of 10 years, volatility of 69.4 %, dividend yields of 0 % and risk-free
interest rates of 2.9 %.
Share-based compensation payment plans
As of December 31, 2023, 126,573 shares of common stock were subject
to outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may
vest). As of December 31, 2023, 394,669 shares of common stock were available for future grants of share-based payment awards under the
TherapeuticsMD, Inc. 2019 Stock Incentive Plan.
The following table summarizes the status of our outstanding and exercisable
options and related transactions (each adjusted to account for the Reverse Stock Split) since December 31, 2022 (in thousands, except
weighed average exercise price and weighted average remaining contractual life data):
Outstanding
Exercisable
Options
Awards
Weighted Average Exercise
Price
Aggregate
Intrinsic
Value
Weighted Average Remaining Contractual Life
(in Years)
Options
Awards
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Weighted Average Remaining Contractual Life (in Years)
As of January 1, 2022
353
$ 225.98
—
3.8
336
230.93
$ —
3.6
Granted
—
—
—
—
—
—
—
—
Exercised
—
—
—
—
—
—
—
—
Cancelled/Forfeited
( 4 )
94.99
—
—
—
—
—
—
Expired
( 177 )
226.56
—
—
—
—
—
—
As of December 31, 2022
172
228.28
—
3.6
170
229.43
—
3.6
Granted
—
—
—
—
—
—
—
—
Exercised
—
—
—
—
—
—
—
—
Cancelled/Forfeited
—
—
—
—
—
—
—
—
Expired
( 100 )
206.15
—
—
—
—
—
—
As of December 31, 2023
72
$ 258.55
$ —
3.0
73
258.46
$ —
3.0
F- 23
The following table summarizes the status of our RSUs and related transactions
(each adjusted to account for the Reverse Stock Split) (in thousands, except weighed average grant date fair value):
RSUs awards outstanding
RSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Balance, January 1, 2022
272
$ 58.00
$ 4,890.00
Granted
170
16.05
Vested
( 327 )
48.20
Cancelled/Forfeited
( 58 )
37
Balance, as of December 31, 2022
57
14.57
318.63
Granted
163
4.82
—
Vested
( 180 )
6.83
—
Cancelled/Forfeited
—
—
—
Balance, as of December 31, 2023
40
$ 9.67
$ 89.6
The following table summarizes the status of our PSUs and related transactions
for each for the following years (each adjusted to account for the Reverse Stock Split) (in thousands, except weighed average grant date
fair value):
PSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Balance, December 31, 2021
164
$ 51.50
$ 2,953
Granted
63
34.50
Vested and settled
( 133 )
47.12
( 2,382.98 )
Cancelled/Forfeited
( 75 )
( 44.85 )
Unvested, as of January 1, 2023
19
52.15
107.55
Granted
—
—
—
Vested
( 5 )
56.05
( 10.72 )
Cancelled/Forfeited
—
—
—
Unvested, as of December 31, 2023
14
$ 50.87
$ 33
Share-based payment compensation cost
Share-based payment compensation expense for PSUs is based on 100 %
vesting which was a part of the termination benefits for all employees who were terminated in 2022. 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 our employee stock
purchase plan (“ESPP”) totaling $ 1.3 million for 2023 and $ 11.6 million for 2022.
As of December 31, 2023, we had $ 0.3 million of unrecognized share-based
payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP, which may be adjusted
for future changes in forfeitures and is included as additional paid-in capital in the accompanying consolidated balance sheets. No tax
benefit was realized due to a continued pattern of net losses.
The unrecognized compensation cost as of December 31, 2023 of $ 0.3
million is expected to be recognized as share-based payment award compensation over a weighted average period of 0.8 years.
F- 24
10. Revenue
Pursuant to 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.
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. 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. 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. Mayne Pharma will pay to the Company minimum 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. 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.
In 2023, we recorded BIJUVA license sales of $ 0.3 million made through
the Theramex License Agreement and $ 1.0 million pertaining to our licensed products with Mayne Pharma, which was recorded as license revenue.
Additionally, we recognized $ 0.5 million in other income pertaining to royalty sales of ANNOVERA.
11. Income
taxes
Our income (loss) from continuing operations before income taxes is
as follows (in thousands):
Year Ending December 31,
2023
2022
United States
$ ( 7,742 )
$ 1,074
For the year ended December 31, 2023, there was no provision for income
taxes in discontinued operations, current or deferred. For the year ended, December 31, 2023, we recorded a benefit of 0.5 % in continuing
operations. 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.
As of December 31, 2023, we had federal net operating loss (“NOL”)
carryforwards of $ 577.0 million, which is available to offset future taxable income. Approximately $ 19.2 million of the federal NOLs can
be carried forward for 20 years and will begin to expire in 2035. The remaining $ 557.8 million can be carried forward indefinitely. 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. The Company experienced an ownership change pursuant to IRC Sec. 382. As a result, our NOLs carryforward as
of December 31, 2023 will be limited.
A reconciliation between taxes computed at the federal statutory rate
and the consolidated effective tax rate is as follows:
2023
2022
Federal statutory tax rate
$ ( 1,626 )
21.0 %
21.0 %
State tax rate, net of federal tax benefit
—
0.0 %
3.9 %
Adjustment in valuation allowances
( 22,173 )
286.4 %
( 3,228.6 )%
Excess stock benefits
2,460
( 31.8 )%
835.2 %
Interest expense accretion
35
( 0.5 )%
0.0 %
Permanent and other differences
21,261
( 274.6 )%
2,368.5 %
(Benefit) provision for income taxes
$ ( 43 )
0.5 %
0.0 %
F- 25
We do not expect to pay any significant federal or state income taxes
as a result of (i) the losses recorded during 2023, (ii) net operating losses carry forwards from prior years.
Deferred income taxes result from temporary differences between the amount
of assets and liabilities recognized for financial reporting and tax purposes. The components of the net deferred tax assets as of December
31, 2023 and 2022 are as follows:
December 31,
2023
2022
Deferred income tax assets (liabilities):
Net operating loss
$ 158,040
$ 176,631
Share-based payment compensation
3,339
8,590
Interest expense limitation
19,547
19,707
Gain on sale of ANNOVERA
( 3,401 )
( 3,624 )
Accrual for sales returns and coupons
288
—
R&D credit
186
186
Other, net
256
( 1,062 )
Deferred income tax asset
178,255
( 200,428 )
Valuation allowance
( 178,255 )
200,428
Deferred income tax assets, net
$ —
$ —
We believe that it is more likely than not that we will not generate
sufficient future taxable income to realize tax benefits related to our deferred tax assets and as such, a valuation allowance has been
established against all the deferred tax assets as of both December 31, 2023 and 2022.
Since our first year of operations in 2011, we generated net operating
losses, and our U.S. federal and state tax returns remain open to examination.
As of December 31, 2023 and 2022, we had no tax positions relating
to open tax returns that were considered to be uncertain, and we had no unrecognized tax benefits.
12. Income (loss) per common share
The following table sets forth the computation of basic and diluted
income (loss) per common share (each adjusted to account for the Reverse Stock Split) for the periods presented (in thousands, except
per share amounts):
Years Ending December 31,
2023
2022
Numerator:
Net income (loss) from continuing operations
$ ( 7,699 )
$ 1,074
Net income (loss) from discontinued operations
( 2,579 )
110,923
Net income (loss)
$ ( 10,278 )
$ 111,997
Denominator:
Weighted average common shares for basic income (loss) per common share
10,441
9,028
Effect of dilutive securities
—
338
Weighted average common shares for diluted income (loss) per common share
10,441
9,366
Income (loss) per common share, continuing operations
Basic
$ ( 0.74 )
$ 0.12
Diluted
$ ( 0.74 )
$ 0.11
Income (loss) per common share, discontinued operations
Basic
$ ( 0.25 )
$ 12.29
Diluted
$ ( 0.25 )
$ 11.84
Since we reported a net loss from continuing operations for 2023, our potentially
dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and
diluted loss per common share and our basic and diluted weighted average common shares are the same for 2023.
F- 26
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 2023 and 2022 (in thousands):
December 31,
2023
2022
Stock options
72
172
RSUs
40
—
PSUs
14
—
Warrants
99
101
225
273
13. Related parties
On August 23, 2022, we appointed Mr. Justin Roberts as a director to
fill a newly created vacancy on our Board of Directors. Mr. Roberts was elected to serve as a director at our combined 2022 and 2023 Annual
Meeting held on June 26, 2023. Mr. Roberts will serve until our next Annual Meeting of Stockholders or until his successor is duly elected
or appointed or his earlier death or resignation. As a director of our Company, Mr. 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. 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
he has elected not to receive any compensation for his service as a non-employee director at this time. Mr. Roberts currently serves as
a Partner of Rubric. On July 29, 2022, September 30, 2022, October 28, 2022, and May 1, 2023, we entered into subscription agreements
with Rubric. On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000 outstanding
shares of Series A Preferred Stock previously issued to affiliates of Rubric at a purchase price of $ 1,333 per share. also paid certain
affiliates of Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into
between us and Rubric. 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
pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, before expenses. On November 15, 2023 Rubric drew
down an additional 877,192 shares of Common Stock at a price per share equal to $ 2.2761 . We received gross proceeds of $ 2.0 million from
the drawdown, before expenses.
14. Business concentrations
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.
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. As part of the transformation that included
the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected
as discontinued operations in our consolidated financial statements. Assets and liabilities associated with the commercial business are
classified as assets and liabilities of discontinued operations in our consolidated balance sheets. Additional disclosures regarding discontinued
operations are provided in Note 2.
For the year ended December 31, 2023, 100 % of license revenue related to
Mayne Pharma and Theramex.
As of December 31, 2023, we had a royalty receivable of $ 3.1 million
relating to the short-term portion of receivable from Mayne Pharma and Theramex and $ 18.5 million relating to the long-term portion of
royalty receivable which includes royalties recognized from the minimum annual royalty that Mayne Pharma is obligated to pay to us under
the Mayne License Agreement.
15. Subsequent Events
Effective March 22, 2024, Tommy G. Thompson resigned as the Company’s
Executive Chairman of the Board and was reappointed as the Company’s Chairman of the Board.
F- 27