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 2024 10-K Report. Based on that evaluation, our Principal Executive Officer
and Principal Financial and Accounting Officer concluded that, as of December 31, 2024, 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 and Accounting 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, 2024. 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, 2024.
This 2024
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 2024 10-K Report.
Item
9B. Other information
None .
Item
9C. Disclosure regarding foreign jurisdictions that prevent inspections
None.
50
PART
III
Item
10. Directors, executive officers, and corporate governance
This information
will be contained in our definitive proxy statement for our 2025 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 2025 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 2025 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 2025 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 2025 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.
51
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 2024 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)
52
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)
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*†
Amendment, dated December 17, 2024, to the Employment Agreement, dated as of December 18, 2018, as extended effective February 21, 2023, by and between TherapeuticsMD, Inc. and Marlan Walker
10.37*
General
Consulting and Services Agreement by and between TherapeuticsMD, Inc. and MCD Consulting Management Services, LLC, dated February
21, 2023 (34)
10.38
Subscription
Agreement, dated May 1, 2023, between TherapeuticsMD, Inc. and Rubric Capital Management LP (35)
10.39*
Master
Services Agreement, dated August 15, 2023, between TherapeuticsMD, Inc. and JZ Advisory Group (36)
53
19†
Insider Trading Policy
21.1†
Subsidiaries of the Company
23.1†
Consent of Berkowitz Pollack Brant
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 (37)
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).
(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).
54
(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).
(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).
55
(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).
(37)
Filed as an exhibit to Form 10-K for the year ended December 31, 2023
filed with the Commission on March 29, 2024 and incorporated herein by reference (SEC File No. 001-00100).
Item
16. Form 10-K summary
None.
56
Signatures
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this 2024 10-K Report
to be signed on its behalf by the undersigned, thereunto duly authorized, on March 27, 2025.
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 2024 10-K Report
to be signed on its behalf by the undersigned, thereunto duly authorized, on March 27, 2025.
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
57
INDEX
TO FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID Number 52 ) F-2
Consolidated Balance Sheets F-4
Consolidated Statements of Operations F-5
Consolidated Statements of Stockholders’ Equity F-6
Consolidated Statements of Cash Flows F-7
Notes to Consolidated Financial Statements F-8
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 sheets of TherapeuticsMD,
Inc. and Subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations,
stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2024, 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, 2024 and 2023, and the results of its
operations and its cash flows for each of the years in the two-year period ended December 31, 2024, 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 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 audits 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 audits, we are required to obtain an understanding of internal
control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material
misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those
risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated 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 consolidated financial statements. We believe that our audits 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, 2024. 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 performed 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 27,
2025
F- 3
TherapeuticsMD,
Inc. and Subsidiaries
Consolidated
Balance Sheets
(In
thousands, except per share amounts)
As
of December 31,
2024
2023
Assets:
Current assets:
Cash
and cash equivalents
$ 5,059
$ 4,327
Royalty
receivable, current portion
3,562
3,090
Prepaid
and other current assets
3,638
4,035
Current
assets of discontinued operations
—
344
Total
current assets
12,259
11,796
License
rights and other intangible assets, net
4,321
6,098
Right
of use assets, net
6,102
6,873
Royalty
receivable, long term
16,010
18,484
Other
non-current assets
130
58
Total
assets
$ 38,822
$ 43,309
Liabilities
and stockholders’ equity:
Current
liabilities:
Accounts
payable
$ 258
$ 27
Accrued
expenses and other current liabilities
2,127
3,133
Current
liabilities of discontinued operations
2,781
3,694
Total
current liabilities
5,166
6,854
Operating
lease liabilities
5,542
6,532
Other
non-current liabilities
744
636
Total
liabilities
11,452
14,022
Commitments
and contingencies (Note 7)
Stockholders’
equity:
Common stock, par value $ 0.001 ; 32,000 and 12,000 shares authorized, 11,532 and 11,532 issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
11
11
Additional
paid-in capital
979,181
978,917
Accumulated
deficit
( 951,822 )
( 949,641 )
Total
stockholders’ equity
27,370
29,287
Total
liabilities and stockholders’ equity
$ 38,822
$ 43,309
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
TherapeuticsMD,
Inc. and Subsidiaries
Consolidated
Statements of Operations
(In
thousands, except per share amounts)
Years
ended December 31,
2024
2023
Revenue, net:
License
and service revenue
$ 1,761
$ 1,302
Operating
expenses:
Selling,
general and administrative
4,744
8,903
Impairment
of long-lived assets (Note 4)
1,268
—
Depreciation
& amortization
509
922
Total
operating expenses
6,521
9,825
Loss
from operations
( 4,760 )
( 8,523 )
Other
income (expense):
Miscellaneous
income
2,417
781
Total
other income
2,417
781
Loss
from continuing operations before income taxes
( 2,343 )
( 7,742 )
Benefit
for income taxes
31
43
Net
loss from continuing operations
( 2,312 )
( 7,699 )
Income
(loss) from discontinued operations, net of income taxes
131
( 2,579 )
Net
loss
$ ( 2,181 )
$ ( 10,278 )
Loss per common share,
basic:
Continuing
operations
( 0.20 )
( 0.74 )
Discontinued
operations, net
0.01
( 0.25 )
Net
loss per common share, basic
$ ( 0.19 )
$ ( 0.99 )
Loss per common share,
diluted:
Continuing
operations
( 0.20 )
( 0.74 )
Discontinued
operations, net
0.01
( 0.25 )
Net
loss per common share, diluted
$ ( 0.19 )
$ ( 0.99 )
Weighted average common
shares, basic
11,532
10,441
Weighted average common
shares, diluted
11,532
10,441
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
TherapeuticsMD,
Inc. and Subsidiaries
Consolidated
Statements of Stockholders’ Equity
(In
thousands)
Common
Stock
Additional
Paid in
Accumulated
Shares
Amount
Capital
Deficit
Total
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
Share-based
compensation
—
—
264
—
264
Net
loss
—
—
—
( 2,181 )
( 2,181 )
Balance,
December 31, 2024
11,532
$ 11
$ 979,181
$ ( 951,822 )
$ 27,370
The
accompanying notes are an integral part of these consolidated financial statements.
F- 6
TherapeuticsMD,
Inc. and Subsidiaries
Consolidated
Statements of Cash Flows
(In
thousands)
Years
ended December 31,
2024
2023
Cash flows from operating activities:
Net loss
$ ( 2,181 )
$ ( 10,278 )
Less:
Income (loss) from discontinued operations, net of tax
131
( 2,579 )
Net loss from continuing operations
( 2,312 )
( 7,699 )
Adjustments to reconcile net loss to net cash
used in continuing operating activities:
Depreciation and amortization
509
922
Impairment of long-lived
assets (Note 4)
1,268
—
Share-based payment compensation
costs
264
1,271
Other
( 219 )
( 129 )
Changes in operating assets and liabilities:
Prepaid and other current
assets
397
1,999
Other assets
1,930
( 1,126 )
Accounts payable
231
( 2,135 )
Accrued expenses and other
current liabilities
( 1,006 )
( 15,713 )
Other
non-current liabilities
108
( 471 )
Total adjustments
3,482
( 15,382 )
Net cash provided by
(used in) continuing operating activities
1,170
( 23,081 )
Cash flows from continuing financing activities:
Proceeds
from sale of common stock, net of costs
—
3,151
Net cash provided by
continuing financing activities
—
3,151
Discontinued operations:
Net
cash used in operating activities
( 438 )
( 25,060 )
Net cash used in discontinued
operations
( 438 )
( 25,060 )
Net increase (decrease) in cash
732
( 44,990 )
Cash and restricted
cash - continuing operations, beginning of period
4,327
49,317
Total cash and restricted
cash, end of period
$ 5,059
$ 4,327
The
accompanying notes are an integral part of these consolidated financial statements.
F- 7
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 (“10-K Report”) as “TherapeuticsMD,” “we,” “our” and “us.”
This 10-K Report includes trademarks, trade names and service marks, such as TherapeuticsMD®, vitaMedMD®, BocaGreenMD® ,
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 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 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.
F- 8
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.
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 Pharma for the assumed obligations under a long-term services agreement, including our
minimum payment obligations thereunder. As the parties agreed, during the second quarter of 2023 Mayne Pharma 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, all results associated with former commercial operations 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 of our consolidated financial statements.
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. Knight obtained regulatory approval
for IMVEXXY and BIJUVA and began commercialization efforts in 2024.
●
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
December 2024, we transferred the right to commercialize IMVEXXY and BIJUVA in Israel from Knight to Theramex.
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 have been paid in accordance with their employment agreements and separation agreements as previously disclosed. As
of December 31, 2023 and 2024, we employed one full-time employee primarily engaged in an executive position.
F- 9
We have engaged external consultants who support our relationship with
current partners and assist with certain financial, IT, 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 serves
as our Principal Financial and Accounting Officer.
Going
concern
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 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. There were no draw downs in 2024.
In February
2024, the Company received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale distributor
fees pursuant to the Transaction Agreement, which differed significantly from the Company’s estimate of the allowances. The Company
continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve
this matter through the processes permitted in the Transaction Agreement. 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, particularly as the Company
believes the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.
In August
2024, the Company received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly
from the Company’s estimate of the allowance. As of December 31, 2024, the Company believed no additional accrual was 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 may be material.
If Mayne Pharma’s sales of Licensed Products grow more slowly
than expected or decline, including as a result of Mayne Pharma Group’s pending sale to Cosette Pharmaceuticals, Inc., 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 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- 10
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 United 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 Mayne Transaction, all results associated with former commercial operations 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
As of December
2024, we have adopted Financial Accounting Standards Board (“FASB”) Update 2023-07, “Segment Reporting (Topic 280):
Improvements to Reportable Segment Disclosures” (“Update 2023-07”). Accounting Standards Update 2023-07 applies to
all public entities that are required to report segment information in accordance with Topic 280. The amendments in Update 2023-07 revise
reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The amendments
in Update 2023-07 do not change how a public entity identifies its operating segments, aggregates those operating segments, or applies
the quantitative thresholds to determine its reportable segments.
In November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-03, “Income Statement - Reporting Comprehensive
Income (Topic 220): Disaggregation of Income Statement Expenses.” The ASU requires additional disclosures by disaggregating the
costs and expense line items that are presented on the face of the income statement. The disaggregation includes: (i) amounts of purchased
inventory, employee compensation, depreciation, amortization, and other related costs and expenses; (ii) an explanation of costs and expenses
that are not disaggregated on a quantitative basis; and (iii) the definition and total amount of selling expenses. ASU 2024-03 is effective
for our Annual Report on Form 10-K beginning in 2027 and subsequent interim reports. Early adoption is permitted. The ASU should be applied
prospectively. Retrospective application is permitted for all prior periods presented in the financial statements. The Company is evaluating
the impact of ASU 2024-03 on our financial reporting disclosures.
In December
2023, the 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
Standards Codification (“ASC”) Topic 205, Presentation of Financial Statements. In 2022, we started classifying commercial
activities as discontinued operations due to the cessation of these operations. No amounts for shared general and administrative operating
support expense were allocated to discontinued operations. As required by the terms of 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 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 sheets as of December 31, 2024 and 2023. For additional information, see Note 2 - Discontinued
Operations.
F- 11
D. Estimates
and assumptions
The preparation
of consolidated financial statements in conformity with 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 $ 250 thousand per bank. We have never experienced any losses related to these funds.
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. 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.
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 successfully 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.
F- 12
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 semi-annually during the second and 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.
H. 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, who is our Chief Operating Decision Maker (“CODM”). 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.
I. 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, all results associated with former 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.
F- 13
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.
Our royalty
revenue in 2024 and 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, 2023 and 2024, and is further subject to
offset by Mayne Pharma (see J. 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 2024,
we recorded BIJUVA license sales of $ 443 thousand made through the Theramex License Agreement, BIJUVA and IMVEXXY license sales of $ 195
thousand through the Knight License Agreement and $ 1,123 thousand pertaining to our licensed products with Mayne Pharma, which was recognized
as license revenue. Additionally, we recognized $ 1,083 thousand in other income pertaining to royalty sales of ANNOVERA.
In 2023,
we recorded BIJUVA license sales of $ 268 thousand made through the Theramex License Agreement and $ 1,003 thousand pertaining to our licensed
products with Mayne Pharma, which was recognized as license revenue. Additionally, we recognized $ 490 thousand in other income pertaining
to royalty sales of ANNOVERA.
J. Contract
Assets and Liabilities
Contract
assets totaling $ 19,572 thousand and $ 21,574 thousand as of December 31, 2024 and 2023, respectively, include royalties recognized from
the Minimum Annual Royalty (see I. Revenue Recognition above).
K. 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.
F- 14
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.
L. 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.
F- 15
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.
M. 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.
N. 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.
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.
O. 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 7 for more information.
F- 16
P. Restructuring
charges
There were
no restructuring costs incurred during the years ended December 31, 2024 and 2023.
At
December 31, 2023, $ 2,459 thousand of restructuring costs were included in current liabilities of discontinued operations in the
accompanying consolidated balance sheet.
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 not allocated any amounts for shared general and administrative operating
support expense to discontinued operations.
Additionally,
the related assets and liabilities have been reported as assets and liabilities of discontinued operations in our consolidated balance
sheets as of December 31, 2024 and 2023.
As described
in Note 1, the acquisition of net working capital by Mayne Pharma 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. 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. Refer to Note 7 for a further discussion of net working capital contingencies.
F- 17
The
following table presents results of discontinued operations (in thousands):
Years
ended December 31,
2024
2023
Product
revenue, net
$ —
$ ( 833 )
General
and administrative
64
481
Total
operating expenses
64
481
Operating
loss from discontinued operations
( 64 )
( 1,314 )
Loss
on disposal of assets
—
( 1,150 )
Other
Income (expense), net
195
( 115 )
Total
other income (expense), net
195
( 1,265 )
Net
income (loss) from discontinued operations
$ 131
$ ( 2,579 )
The following
table presents the carrying amounts of the classes of assets and liabilities of discontinued operations (in thousands):
As
of December 31,
2024
2023
Assets:
Accounts
receivable
$ —
$ 344
Liabilities:
Accrued
expenses and other current liabilities
$ 2,781
$ 3,694
3. Prepaid
and other current assets
Our prepaid
and other current assets consisted of the following (in thousands):
December
31,
2024
2023
Insurance
$ 70
$ 253
Capitalized
legal
2,334
2,334
Other
1,234
1,448
Prepaid
and other current assets
$ 3,638
$ 4,035
F- 18
4. 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, 2024
As
of December 31, 2023
Gross
Gross
Carrying
Accumulated
Carrying
Accumulated
Amount
Amortization
Net
Amount
Amortization
Net
Intangible
assets subject to amortization:
Hormone
therapy drug patents
$ 5,766
$ 2,058
$ 3,708
$ 6,818
$ 1,871
$ 4,947
Hormone
therapy drug patents applied and pending approval
304
—
304
842
—
842
Intangible
assets subject to amortization
6,070
2,058
4,012
7,660
1,871
5,789
Intangible
assets not subject to amortization:
Trademarks/trade
name rights
309
—
309
309
—
309
Intangible
assets, net
$ 6,379
$ 2,058
$ 4,321
$ 7,969
$ 1,871
$ 6,098
We recorded,
in continuing operations, amortization expense related to patents of $ 509.1 thousand for 2024 and $ 844.2 thousand for 2023, of which
$ 483.5 thousand is accelerated amortization as a result of a review of our intangible assets.
The Company conducts regular reviews of the individual patents and
portfolios. As a result of this review and also based on input from its licensing partners, in the three months ended June 30, 2024 the
Company determined it had an indicator of impairment, as it had abandoned the legal right and title to a portion of its granted patent
portfolio and had ceased pursuit of a portion of its pending patents based on input from its licensing partners. The Company recognized
an impairment loss of $ 1,268 thousand related to those abandoned patents and applications, which is classified as an impairment of
long-lived assets on the Company’s consolidated statements of operations for the twelve months ended December 31, 2024. In
the year ending December 31, 2023, we did not impair any of our hormone therapy drug patent assets.
Our intangible
assets subject to amortization are expected to be amortized as follows (in thousands):
Year ending December 31,
2025
$ 384
2026
384
2027
384
2028
385
2029
384
Thereafter
1,787
Total
$ 3,708
5. Accrued
expenses and other current liabilities
Other accrued
expenses and other current liabilities consisted of the following (in thousands):
As of December 31,
2024 2023
Payroll and related costs $ 118 $ 762
Professional fees 288 489
Operating lease liabilities 1,633 1,473
Other accrued expenses and current liabilities 88 409
Accrued expenses and other current liabilities $ 2,127 $ 3,133
We incurred
no advertising costs in 2024 and 2023.
F- 19
6. Debt
Interest
and financing costs
Included
in miscellaneous income in 2024 is $ 144.9 thousand of interest income and $ 9.5 thousand of interest expense.
Included
in miscellaneous income in 2023 is $ 297.9 thousand of interest income and $ 166.6 thousand of interest expense.
7. 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 2024.
For 2024
and 2023, operating lease expense (including all variable costs) related to our real estate leases was $ 2,271 thousand and $ 2,259 thousand,
respectively. In 2024 and 2023, our rental income on sublease of our three suites which were subleased was $ 1,361 thousand and $ 1,292
thousand, respectively.
As of December
31, 2024, our remaining lease payments were as follows (in thousands):
Year ending
December 31,
2025
$ 1,513
2026
1,551
2027
1,590
2028
1,630
2029
1,671
Thereafter
993
Total undiscounted lease payments
8,948
Less: imputed interest
1,773
Present value of lease
payments
$ 7,175
F- 20
The following
table sets forth supplemental balance sheet information related to leases (in thousands):
As of December 31,
2024 2023
Assets:
Operating lease right-of-use assets $ 6,102 $ 6,873
Liabilities:
Operating lease liabilities current (included in accrued expenses and other current liabilities) $ 1,633 $ 1,473
Operating lease liabilities, non-current 5,542 6,532
Total operating lease liabilities $ 7,175 $ 8,005
The following
table presents other information related to leases:
As of December 31,
2024 2023
Weighted average remaining term (years) - operating leases 5.7 6.7
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) $ 1,477 $ 1,443
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 increased certain accrual estimates including increasing our working capital adjustment accrual by $ 2.0 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. Of the $ 5.5 million, $ 2.0 million increased the allowance
for net working capital allowances remaining to be trued up.
F- 21
The Company’s
estimate of the allowance for payer rebates and wholesale distributor fees was determined in accordance with the Transaction Agreement
which establishes the process for the determination of net working capital. In February 2024, the Company received Mayne Pharma’s
calculation of the net working capital allowances for payer rebates and wholesale distributor fees which differed significantly from
the Company’s estimate of the allowances. The Company and Mayne Pharma intend to resolve this matter through the dispute resolution
process outlined in the Transaction Agreement. 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, particularly as the Company believes the outcome of this matter to be intertwined with
the resolution of the net working capital allowance for returns.
In August
2024, the Company received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly
from the Company’s estimate of the allowance. As of December 31, 2024, the Company believed no additional accrual was 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 may be material.
Mayne
Pharma has also made certain indemnification demands under the Transaction Agreement, which the Company disputes. As of December 31,
2024, the Company believed no additional accrual was required for such claims, as the Company could not reasonably estimate a range of
loss.
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. In November 2024, the court lifted the stay. We have
incurred and recorded legal costs amounting to $ 2,334 thousand in prepaid expenses and other current assets as of December 31, 2024,
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 Mayne Pharma is 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.
In June
2024, Mayne Pharma received a Paragraph IV certification notice letter (the “Sun Notice Letter”) regarding an ANDA
submitted to the FDA by Sun Pharma Inc. (“Sun Pharma”). 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 Sun Notice Letter, Sun Pharma alleges
that the IMVEXXY Patents are invalid, unenforceable, and/or will not be infringed by Sun Pharma’s commercial manufacture, use,
or sale of its proposed generic drug product. The IMVEXXY Patents identified in the Sun Notice Letter expire in 2032 or 2033. In
July 2024, we and Mayne Pharma filed a complaint for patent infringement against Sun Pharma in the United States District Court for
the District of New Jersey arising from Sun Pharma’s ANDA filing with the FDA. We are seeking, among other relief, an order
that the effective date of any FDA approval of Sun Pharma’s ANDA would be a date no earlier than the expiration of the IMVEXXY
Patents and equitable relief enjoining Sun Pharma from infringing the IMVEXXY Patents.
F- 22
Beginning
on December 30, 2022 and per the Mayne License Agreement, Mayne Pharma is responsible for all enforcement of our patents, including the
responsibility for and costs of litigation discussed above with respect to Teva and Sun Pharma.
From time
to time, we are involved in other litigations and proceedings in the ordinary course of business. We are currently not involved in any
other litigations and proceedings that we believe would have a material effect on our consolidated financial condition, results of operations,
or cash flows.
Off-balance
sheet arrangements
As of December
31, 2024 and 2023 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, 2024 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, IT, legal, and regulatory matters and the continued wind-down
of our historical business operations. In the aggregate, as of December 31, 2024, we have accrued severance liabilities for executive
termination obligations of $ 17 thousand.
8. 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, 2024, the following table summarizes the status of our outstanding and exercisable warrants and related transactions since December
31, 2022 (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, 2022 536 $ 13.10 2,427 9.3
Exercised ( 435 ) 0.01 ( 2,720 )
Expired ( 2 ) 0.89
Balance, December 31, 2023 99 66.61 1,793 6.5
Expired ( 1 ) 281.50 — —
Balance, December 31, 2024 98 $ 63.33 $ — 5.6
F- 23
Share-based
compensation payment plans
As of December
31, 2024, 56,530 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, 2024, 410,719 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 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 December 31, 2022 172 $ 228.28 — 3.6 170 229.43 $ — 3.6
Expired ( 100 ) 206.15 — — ( 98 ) — — —
As of December 31, 2023 72 258.55 — 3.0 72 258.46 — 3.0
Expired ( 15 ) 217 — — ( 15 ) — — —
As of December 31, 2024 57 $ 270.33 $ — 2.8 57 270.20 $ — 2.8
The following
table summarizes the status of our RSUs and related transactions (in thousands, except weighed average grant date fair value):
RSUs
awards outstanding
RSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Balance, as
of December 31, 2022
57
$ 14.57
$ 318.63
Granted
163
4.82
—
Vested
( 180 )
6.83
—
Balance, as of December
31, 2023
40
9.67
89.60
Vested
( 38 )
9.11
—
Balance,
as of December 31, 2024
2
$ 21.78
$ 1.49
The following
table summarizes the status of our PSUs and related transactions for each for the following years (in thousands, except weighed average
grant date fair value):
PSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Unvested, as
of December 31, 2022
19
$ 52.15
$ 107.55
Vested
( 7 )
56.05
( 10.72 )
Unvested, as of December
31, 2023
12
49.36
27.3
Vested
( 7 )
60.50
16.16
Balance,
as of December 31, 2024
5
$ 34.50
$ 4.47
F- 24
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 $ 264.1 thousand for 2024 and $ 1,271.2
thousand for 2023.
As of December
31, 2024, we had $ 23.9 thousand 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, 2024 of $ 23.9 thousand is expected to be recognized as share-based payment award compensation over
a weighted average period of 0.2 years.
9. 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. 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 2024,
we recorded BIJUVA license sales of $ 443 thousand made through the Theramex License Agreement, BIJUVA and IMVEXXY license sales of $ 195
thousand through the Knight License Agreement and $ 1,123 thousand pertaining to our licensed products with Mayne Pharma, which was recognized
as license revenue. Additionally, we recognized $ 1,083 thousand in other income pertaining to royalty sales of ANNOVERA.
In 2023,
we recorded BIJUVA license sales of $ 268 thousand made through the Theramex License Agreement and $ 1,003 thousand pertaining to our licensed
products with Mayne Pharma, which was recognized as license revenue. Additionally, we recognized $ 490 thousand in other income pertaining
to royalty sales of ANNOVERA.
F- 25
10. Income
taxes
Our loss
from continuing operations before income taxes is as follows (in thousands):
Year
Ending December 31,
2024
2023
United States
$ ( 2,343 )
$ ( 7,742 )
For the year
ended December 31, 2024 and 2023, there was no provision for income taxes in continuing and discontinued operations, current or deferred.
For the year ended, December 31, 2024 and 2023, we recorded a benefit of 1.3 % and 0.5 %, respectively, in continuing operations.
As of December
31, 2024, we had a federal net operating loss (“NOL”) carryforward of $ 579.0 million, which is available to offset future
taxable income. Approximately $ 22.7 million of the federal NOLs can be carried forward for 20 years and will begin to expire in 2035.
The remaining $ 557 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 in 2022. As a result, our NOLs carryforward as of December 31, 2022 is limited.
A reconciliation
between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows:
2024
2023
Federal statutory tax rate
$ ( 492 )
21.0 %
21.0 %
State tax rate, net of federal tax benefit
( 8,745 )
373.3 %
0.0 %
Adjustment in valuation allowances
9,772
( 417.1 )%
286.4 %
Excess stock benefits
566
( 24.2 )%
( 31.8 )%
Interest expense accretion
-
0.0 %
( 0.5 )%
Permanent and other
differences
( 1,132 )
48.3 %
( 274.6 )%
Benefit
for income taxes
$ ( 31 )
1.3 %
0.5 %
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 income tax asset as of December 31, 2024 and 2023 are as follows (in thousands):
December
31,
2024
2023
Deferred income tax assets:
Net operating loss
$ 167,366
$ 158,040
Share-based payment compensation
2,222
3,339
Interest expense limitation
20,901
19,547
Gain on sale of ANNOVERA
( 3,637 )
( 3,401 )
Accrual for sales returns and coupons
670
288
R&D credit
186
186
Other, net
319
256
Deferred income tax asset
188,027
178,255
Valuation allowance
( 188,027 )
( 178,255 )
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 a portion of tax benefits related
to the deferred tax assets and as such, a valuation allowance has been established against a portion of the deferred tax assets as of
both December 31, 2024 and 2023.
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, 2024 and 2023, we had no tax positions relating to open tax returns that were considered to be uncertain, and we had no unrecognized
tax benefits.
F- 26
11. Loss
per common share
The following
table sets forth the computation of basic and diluted loss per common share for the periods presented (in thousands, except per share
amounts):
Years
Ending December 31,
2024
2023
Numerator:
Net
loss from continuing operations
$ ( 2,312 )
$ ( 7,699 )
Net
income (loss) from discontinued operations
131
( 2,579 )
Net
loss
$ ( 2,181 )
$ ( 10,278 )
Denominator:
Weighted average common
shares for basic income (loss) per common share
11,532
10,441
Effect
of dilutive securities
—
—
Weighted
average common shares for diluted income (loss) per common share
11,532
10,441
Income
(loss) per common share, continuing operations
Basic
$ ( 0.20 )
$ ( 0.74 )
Diluted
$ ( 0.20 )
$ ( 0.74 )
Income
(loss) per common share, discontinued operations
Basic
$ 0.01
$ ( 0.25 )
Diluted
$ 0.01
$ ( 0.25 )
Since we
reported a net loss from continuing operations for 2024, 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 2024.
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 2024 and 2023 (in thousands):
December
31,
2024
2023
Stock
options
57
72
RSUs
2
40
PSUs
5
14
Warrants
98
99
162
225
12. 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. There were no draw downs in 2024.
F- 27
13. 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, all results associated with former commercial operations
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, 2024, 100 % of license revenue is related to Mayne Pharma, Theramex and Knight.
As of December
31, 2024, we had a royalty receivable of $ 3.6 million relating to the short-term portion of receivable from Mayne Pharma, Theramex and
Knight and $ 16.0 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.
14. Segment
Reporting
The Company
operates in one segment. Accordingly, the Company’s License and service revenue, Net loss, and Total assets reflect the revenue,
loss, and assets of the Company’s single segment, respectively.
The Company’s
Chief Executive Officer is the chief operating decision maker (“CODM”). The CODM uses Net loss in assessing the performance
and in determining the allocation of resources of the Company’s reportable segment. The CODM is regularly provided expense information
consistent with the expense categories presented in the Company’s Consolidated Statements of Operations
The following
tables present total revenue of the Company by geographic location.
As
of December 31,
2024
2023
License and service revenue
United States
$ 1,123
$ 1,003
Non-U.S.
638
299
Total
$ 1,761
$ 1,302
15. Subsequent
Events
None.
F-28