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 2022 10-K Report. Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that, as of December 31, 2022, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms, and (ii) is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
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.
53
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, 2022. 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, 2022.
This 2022 10-K Report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to the rules of the SEC that permit the Company to provide only management’s report in this 2022 10-K Report.
Item 9B. Other information
None.
Item 9C. Disclosure regarding foreign jurisdictions that prevent inspections
None.
54
PART III
Item 10. Directors, executive officers, and corporate governance
The information required by this Item relating to our directors and corporate governance is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
Item 11. Executive compensation
The information required by this Item is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
Item 12. Security ownership of certain beneficial owners and management and related stockholder matters
The information required by this Item is incorporated herein by reference to the definitive Proxy Statement to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
Item 13. Certain relationships and related transactions, and director independence
The information required by this Item is incorporated herein by reference to the definitive Proxy Statements to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
Item 14. Principal accountant fees and services
The information required by this Item is incorporated herein by reference to the definitive Proxy Statements to be filed pursuant to Regulation 14A of the Exchange Act for our 2023 Annual Meeting of Stockholders.
55
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 2022 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. ( 3 3 )
3.1
Articles of Conversion of AMHN, Inc. filed in the State of Nevada, dated July 20, 2010 (5)
3.2
Articles of Incorporation of AMHN, Inc. filed in the State of Nevada, dated July 20, 2010 (5)
3.3
Composite Amended and Restated Articles of Incorporation of the Company, as amended ( 35 )
3.4
Bylaws of the AMHN, Inc. ( 7)
3.5
First Amendment to Bylaws of the Company, dated December 17, 2015 (8)
3.6
Second Amendment to Bylaws of the Company, adopted May 27, 2022 (36)
3.7
Third Amendment to Bylaws of the Company, dated July 29, 2022 (37)
3.8
Certificate of Change to Articles of Incorporation of the Company ( 38)
3.8
Certificate of Designation, Preferences and Rights of Series A Preferred Stock (37)
4.1
Form of Certificate of Common Stock ( 9)
4.2†
Description of Securities of the Company
10.1
Form of Common Stock Purchase Warrant ( 11)
10.2*
Form of Non-Qualified Stock Option Agreement ( 11)
10.3*
TherapeuticsMD, Inc. 2019 Stock Incentive Plan ( 12)
10.4*
First Amendment to the TherapeuticsMD, Inc. 2019 Stock Incentive Plan ( 27 )
10.5*
Amended and Restated 2012 Stock Incentive Plan ( 13)
10.6*
2009 Long Term Incentive Compensation Plan, as amended ( 14)
10.7*
TherapeuticsMD, Inc. 2020 Employee Stock Purchase Plan ( 15)
10.8
Form of Common Stock Purchase Warrant, dated February 24, 2012 (17)
10.9
Common Stock Purchase Warrant, issued to Plato & Associates, LLC, dated January 31, 2013 (18)
10.10
Form of Warrant to Purchase Common Stock, dated August 5, 2020 (6)
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 (19)
56
10.1 2
Second Amendment to Company Warrant issued by the Company to the Subscribers party to that certain Subscription Agreement, dated as of August 5, 2020 (20)
10.13
Warrant issued by the Company to Robert Finizio ( 20)
10.14
Amendment to Warrant issued by the Company to Robert Finizio ( 20)
10.15*
Warrant issued by the Company to John C.K. Milligan, IV ( 20)
10.16*
Amendment to Warrant issued by the Company to John C.K. Milligan, IV ( 20)
10.17
Subscription Agreement, dated August 5, 2020, by and among TherapeuticsMD, Inc. and the Subscribers identified on the Schedule of Subscribers attached thereto ( 6)
10.18***
License Agreement, dated July 30, 2018, by and between TherapeuticsMD, Inc. and The Population Council, Inc. ( 2 2 )
10.19***
Lease, dated October 5, 2018, by and between 951 Yamato Acquisition Company, LLC and TherapeuticsMD, Inc. ( 2 3 )
10.20*
Executive Employment Agreement, dated as of August 3, 2021, by and between TherapeuticsMD, Inc. and Hugh O’Dowd ( 28 )
10.21*
TherapeuticsMD, Inc. Inducement Grant Restricted Stock Unit Agreement, dated as of August 31, 2021, by and between TherapeuticsMD, Inc. and Hugh O’Dowd ( 29 )
10.22*
Employment Agreement, dated June 1, 2020, between the Company and James C. D’Arecca ( 6)
10.23*
Amendment to Employment Agreement, dated October 15, 2021, between TherapeuticsMD, Inc. and James C. D’Arecca ( 3 0 )
10.24*
Executive Employment Agreement, dated October 15, 2021, by and between TherapeuticsMD, Inc. and Mark Glickman ( 3 1 )
10.25*
TherapeuticsMD, Inc. Inducement Grant Restricted Stock Unit Agreement, dated October 15, 2021, by and between TherapeuticsMD, Inc. and Mark Glickman ( 3 2 )
10.26*
Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and Michael Donegan ( 2 4 )
10.27*
Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and Robert G. Finizio ( 2 4 )
10.28*
Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and John C.K. Milligan, IV ( 2 4 )
10.29*
Amendment, dated April 8, 2021, to the Amended and Restated Employment Agreement, dated as of November 24, 2020, by and between TherapeuticsMD, Inc. and John C.K. Milligan, IV ( 26 )
10.30*
Employment Agreement, October 30, 2019, between the Company and Edward J. Borkowski ( 20)
10.31*
Amendment to Employment Agreement between the Company and Edward J. Borkowski ( 20)
10.32***
License and Supply Agreement, dated June 6, 2019, by and between TherapeuticsMD, Inc. and Theramex HQ UK Limited ( 21)
10.33*
Form of Indemnification Agreement between TherapeuticsMD, Inc. and each of its executive officers and directors ( 19)
10.34
Controlled Equity Offering SM Sales Agreement, dated November 27, 2020, by and between TherapeuticsMD, Inc. and Cantor Fitzgerald & Co. ( 2 4 )
10.35
Controlled Equity OfferingSM Sales Agreement, dated March 3, 2021, by and between TherapeuticsMD, Inc. and Cantor Fitzgerald & Co. ( 2 5 )
10.36*
2022 Executive Retention and Performance Bonus Plan. (ERB-Plan) ( 34)
10.37
Subscription Agreement between TherapeuticsMD, Inc. and Rubric Capital Management LP, dated July 29, 2022 (37)
10.38
S u bscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TOA Talents, LLC, dated July 29, 2022 (37)
10.39
Subscription Agreement between TherapeuticsMD, Inc. and Rubric Capital Management LP, dated September 30, 2022 (39)
10.40
Subscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TAO Talents, LLC, dated September 30, 2022 (39)
57
10 . 41
Subscription Agreement between TherapeuticsMD, Inc. and Rubric Capital Management LP, dated October 28, 2022 (40)
10.42
Subscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TAO Talents, LLC, dated October 28, 2022 (40)
10.43***+
License Agreement by and between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated December 4, 2022 (41)
10.44***+
Transaction Agreement by and between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated December 4, 2022 (41)
10.45**†
Amendment No. 1 to the License Agreement between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated as of December 30, 2022
10.46†
Amendment No. 1 to the Transaction Agreement between TherapeuticsMD, Inc. and Mayne Pharma LLC, dated as of December 30, 2022
10.47*†
Amended and Restated Employment Agreement, dated as of December 18, 2018, by and between TherapeuticsMD, Inc. and Marlan Walker
10.48*†
Amendment, effective October 15, 2021, to the Employment Agreement, dated as of December 18, 2018, by and between TherapeuticsMD, Inc. and Marlan Walker
10.49*
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 ( 16)
10.50*
General Consulting and Services Agreement by and between TherapeuticsMD, Inc. and MCD Consulting Management Services, LLC, dated February 21, 2023 (16)
21.1†
Subsidiaries of the Company
23.1†
Consent of Grant Thornton LLP
31.1†
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a)
31.2†
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a)
32.1††
Section 1350 Certification of Chief Executive Officer
32.2††
Section 1350 Certification of Chief Financial Officer
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).
58
(5)
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).
(6)
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).
(7)
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).
(8)
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).
(9)
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).
(10)
Filed as an exhibit to Form 10-K for the year ended December 31, 2019 filed with the Commission on February 24, 2020 and incorporated herein by reference (SEC File No. 001-00100).
(11)
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).
(12)
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).
(13)
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).
(14)
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).
(15)
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).
(16)
Filed as an exhibit to Form 8-K filed with the Commission on February 27, 2023 and incorporated herein by reference (SEC File No. 001-00100).
(17)
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).
(18)
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).
(19)
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).
(20)
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).
(21)
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).
(22)
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).
(23)
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).
(24)
Filed as an exhibit to Form 8-K filed with the Commission on November 27, 2020 and incorporated herein by reference (SEC File No. 001-00100).
(25)
Filed as an exhibit to Registration Statement on Form S-3 filed with the Commission on March 4, 2021 and incorporated herein by reference (SEC File No. 333-253851).
(26)
Filed as an exhibit to Form 8-K filed with the Commission on April 12, 2021 and incorporated herein by reference (File No. 001-00100).
(27)
Filed as an appendix to the Definitive Proxy Statement filed with the Commission on April 14, 2021 and incorporated herein by reference (File No. 001-00100).
(28)
Filed as an exhibit to Form 8-K filed with the Commission on August 9, 2021 and incorporated herein by reference (File No. 001-00100).
59
(29)
Filed as exhibit to Form S-8 filed with the Commission on August 31, 2021 and incorporated herein by reference (File No. 333-259221)
(30)
Filed as an exhibit to Form 10-Q for the quarterly period ended September 30, 2021 filed with the Commission on November 11, 2021 and incorporated herein by reference (SEC File No. 001-00100).
(31)
Filed as an exhibit to Form S-8 filed with the Commission on October 15, 2021 and incorporated herein by reference (File No. 333-260295).
(32)
Filed as an exhibit to Form S-8 filed with the Commission on October 15, 2021 and incorporated herein by reference (File No. 333-260295).
(33)
Filed as an exhibit to Form 8-K filed with the Commission on March 10, 2022 and incorporated herein by reference (File No. 001-00100).
(34)
Filed as an exhibit to Form 10-K for the year ended December 31, 2021, filed with the Commission on March 23, 2022 and incorporated herein by reference (File No. 001-00100).
(35)
Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2022, filed with the Commission on May 16, 2022 and incorporated herein by reference (File No. 001-00100).
(36)
Filed as an exhibit to Form 8-K filed with the Commission on June 3, 2022 and incorporated herein by reference (File No. 001-00100).
(37)
Filed as an exhibit to Form 8-K filed with the Commission on August 1, 2022 and incorporated herein by reference (File No. 001-00100).
(38)
Filed as an exhibit to Form 8-K filed with the Commission on May 9, 2022 and incorporated herein by reference (File No. 001-00100).
(39)
Filed as an exhibit to Form 8-K filed with the Commission on October 3, 2022 and incorporated herein by reference (File No. 001-00100).
(40)
Filed as an exhibit to Form 8-K filed with the Commission on October 31, 2022 and incorporated herein by reference (File No. 001-00100).
(41)
Filed as an exhibit to Form 8-K filed with the Commission on December 5, 2022 and incorporated herein by reference (File No. 001-00100).
Item 16. Form 10-K summary
None.
60
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this 2022 10-K Report to be signed on its behalf by the undersigned, thereunto duly authorized, on April 7, 2023
THERAPEUTICSMD, INC.
/s/ Marlan D. Walker
Marlan D. Walker
Chief Executive Officer
/s/ Michael C. Donegan
Michael C. Donegan
Principal Financial and Accounting Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this 2022 10-K Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated on April 7, 2023.
Signature
Title
/s/ Marlan D. Walker
Chief Executive Officer
Marlan D. Walker
(Principal Executive Officer)
/s/ Michael C. Donegan
Principal Financial and Accounting Officer
Michael C. Donegan
/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
61
INDEX TO FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID Number 248 )
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations
F-4
Consolidated Statements of Stockholders’ E quity ( Deficit)
F-5
Consolidated Statements of Cash Flows
F-6
Notes to Consolidated Financial Statements
F-7
F-1
Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
TherapeuticsMD, Inc.
Opinion on the financial statements
We have audited the accompanying consolidated balance sheets of TherapeuticsMD, Inc. (a Nevada corporation) and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the two years in the period ended December 31, 2022, and the related notes collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Going concern
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has recently changed its business strategy to become a royalty company. The Company has limited experience operating as a royalty company and may need to raise additional capital to fund its operations until the Company becomes cash flow positive. These conditions, along with other matters as set forth in Note 1, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our 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 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 financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical audit matter
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ GRANT THORNTON LLP
We have served as the Company’s auditor since 2015.
Miami, Florida
April 7, 2023
F-2
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except per share amounts)
As of December 31,
2022
2021
Assets:
Current assets:
Cash
$
38,067
$
64,907
Restricted cash
11,250
—
Prepaid and other current assets
6,034
5,859
Current assets of discontinued operations
—
48,702
Total current assets
55,351
119,468
Fixed assets, net
78
823
License rights and other intangible assets, net
6,943
7,144
Right of use assets
7,580
8,234
Royalty receivable, long term
20,253
—
Other non-current assets
253
253
Non-current assets of discontinued operations
—
33,550
Total assets
$
90,458
$
169,472
Liabilities and stockholders' equity (deficit):
Current liabilities:
Current maturities of long-term debt
$
—
$
188,269
Accounts payable
2,162
3,373
Accrued expenses and other current liabilities
18,846
13,338
Current liabilities of discontinued operations
25,831
47,911
Total current liabilities
46,839
252,891
Operating lease liabilities, non-current
7,369
8,063
Other non-current liabilities
1,107
2,139
Total liabilities
55,315
263,093
Commitments and contingencies (Note 8)
Stockholders' equity (deficit):
Preferred stock, par value $ 0.001 ; 10,000 shares authorized
—
—
Common stock, par value $ 0.001 ; 12,000 shares authorized, 9,498 and 8,598
(adjusted for the 50-for-1 reverse stock split ) issued and outstanding as of December 31, 2022 and 2021, respectively
9
9
Additional paid-in capital
974,497
957,730
Accumulated deficit
( 939,363
)
( 1,051,360
)
Total stockholders' equity (deficit)
35,143
( 93,621
)
Total liabilities and stockholders' equity (deficit)
$
90,458
$
169,472
The accompanying notes are an integral part of these consolidated financial statements.
F-3
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(In thousands, except per share amounts)
Year ended December 31,
2022
2021
Revenue:
Product revenue, net
$
—
$
—
License revenue
69,963
2,573
Total revenue, net
69,963
2,573
Cost of revenue
1,397
1,402
Gross profit
68,566
1,171
Operating expenses:
Selling and marketing
—
—
General and administrative
57,903
80,748
Research and development
—
—
Restructuring expense
9,472
—
Total operating expenses
67,375
80,748
Income (loss) from operations
1,191
( 79,577
)
Other (expense) income:
Other (expense) income, net
( 117
)
272
Total other (expense) income, net
( 117
)
272
Income (loss) from continuing operations before income taxes
1,074
( 79,305
)
Provision for income taxes
—
—
Net income (loss) from continuing operations
1,074
( 79,305
)
Income (loss) from discontinued operations, net of income taxes
110,923
( 93,110
)
Net income (loss)
$
111,997
$
( 172,415
)
Income (loss) per common share, basic:
Continuing operations
$
0.12
$
( 9.96
)
Discontinued operations, net
12.29
( 11.70
)
Net income (loss)
$
12.41
$
( 21.66
)
Income (loss) per common share, diluted:
Continuing operations
$
0.11
$
( 9.96
)
Discontinued operations, net
11.84
( 11.70
)
Net income (loss)
$
11.96
$
( 21.66
)
Weighted average common shares, basic
9,028
7,960
Weighted average common shares, diluted
9,366
7,960
Comprehensive income (loss):
Net income (loss)
$
111,997
$
( 172,415
)
Other comprehensive income
—
—
Comprehensive income (loss)
$
111,997
$
( 172,415
)
The accompanying notes are an integral part of these consolidated financial statements.
F-4
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Stockholders' (Deficit) Equity
(In thousands)
Common Stock
Additional
Paid in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance, December 31, 2020
5,995
$
6
$
754,938
$
( 878,945
)
$
( 124,001
)
Shares issued for sale of common stock, net of cost
2,435
3
184,112
—
184,115
Shares issued for exercise of warrants, net of cashless
exercises
22
—
278
—
278
Shares issued for exercise of options
2
—
44
—
44
Shares issued for vested restricted and performance stock units
136
—
—
—
-
Shares issued for sale of common stock related to employee stock purchase plan
7
—
233
—
233
Share-based payment award compensation costs
—
—
18,125
—
18,125
Net loss
—
—
—
( 172,415
)
( 172,415
)
Balance, December 31, 2021
8,597
9
957,730
( 1,051,360
)
( 93,621
)
Shares issued for sale of common stock, net of cost
565
—
2,454
—
2,454
Lender warrants
—
—
2,727
—
2,727
Rounding for fractional shares in connection with the reverse stock split
142
—
—
—
—
Shares issued for vested restricted and performance stock units
189
—
—
—
—
Shares issued for sale of common stock related to
employee stock purchase plan
5
—
14
—
14
Share-based payment award compensation costs
—
—
11,572
—
11,572
Net income
—
—
—
111,997
111,997
Balance, December 31, 2022
9,498
$
9
$
974,497
$
( 939,363
)
$
35,143
The accompanying notes are an integral part of these consolidated financial statements.
F-5
TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
Year ended December 31,
2022
2021
Cash flows from operating activities:
Net income (loss)
$
111,997
$
( 172,415
)
Less: Loss from discontinued operations, net of tax
110,923
( 93,110
)
Net income (loss) from continuing operations
1,074
( 79,305
)
Adjustments to reconcile net income (loss) to net cash used in continuing operating activities:
Depreciation and amortization
1,193
736
Share-based payment compensation costs
11,572
18,125
Make-whole payment accretion
( 354
)
—
Other
( 40
)
720
Changes in operating assets and liabilities:
Prepaid and other current assets
620
( 1,125
)
Other assets
( 7,636
)
—
Accounts payable
( 1,211
)
( 1,062
)
Accrued expenses and other current liabilities
4,262
4,639
Other non-current liabilities
( 121
)
2,139
Total adjustments
8,285
24,172
Net cash used in continuing operating activities
9,359
( 55,133
)
Cash flows from continuing investing activities:
Payment for patent related costs
( 355
)
( 2,189
)
Purchase of fixed assets
—
( 34
)
Net cash provided by (used in) continuing investing activities
( 355
)
( 2,223
)
Cash flows from continuing financing activities:
Proceeds from sale of common stock, net of costs
2,454
184,115
Proceeds from exercise of options and warrants
—
322
Proceeds from sale of common stock related to employee stock
purchase plan
14
233
Repayments of debt
( 219,432
)
( 50,000
)
Proceeds from Series A Preferred Stock, net of transaction costs
21,684
—
Repurchase of Preferred Stock at liquidation preference
( 38,657
)
—
Proceeds from make-whole derivative
3,322
—
Repayment of make-whole derivative
( 2,969
)
—
Payment of debt financing fees
( 1,622
)
( 5,118
)
Net cash (used in) provided by continuing financing activities
( 235,206
)
129,552
Discontinued operations:
Net cash used in operating activities
( 13,437
)
( 87,560
)
Net cash provided by investing activities
223,834
—
Net cash provided by financing activities
—
—
Net cash provided by (used in) discontinued operations
210,397
( 87,560
)
Net decrease in cash
( 15,805
)
( 15,364
)
Cash and restricted cash - continuing operations, beginning of period
64,907
79,019
Cash and restricted cash - discontinued operations, beginning of period
215
1,467
Total cash and restricted cash, end of period
$
49,317
$
65,122
Supplemental disclosure of cash flow information:
Interest paid
$
13,545
$
25,068
Supplemental disclosure of noncash financing activities:
Warrants issued in relation to debt financing agreement
$
2,727
$
-
The accompanying notes are an integral part of these consolidated financial statements.
F-6
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 (“2022 10-K Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 2022 10-K Report includes our trademarks, trade names and service marks, such as TherapeuticsMD ® , vitaMedMD ® , BocaGreenMD ® , vitaCare TM , IMVEXXY ® , BIJUVA ® and ANNOVERA ® , which are protected under applicable intellectual property laws and are the property of, or licensed to, the Company. Solely for convenience, trademarks, trade names and service marks referred to in this 2022 10-K Report may appear without the ® , TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. 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”), the Company completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, pursuant to which the Company and its subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD® and vitaMedMD® brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma the Company’s exclusive license to commercialize ANNOVERA (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith.
Pursuant to a License Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Mayne License Agreement”), the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.
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 minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below. 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.
Pursuant to a Transaction Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Transaction Agreement”), the Company sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including, with the Populations Council’s consent, the Company’s exclusive license from the Population Council to commercialize ANNOVERA (the “Transferred Assets”).
The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the
F-7
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, the Company 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 the Company approximately $ 1.0 million in prepaid royalties on the Closing Date. The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company. In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement (see vitaCare divestiture below), including the Company’s minimum payment obligations thereunder.
As part of the transformation that included Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2.
The Company also has license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S.
•
In July 2018, we entered into a license and supply agreement (the “Knight License Agreement”) with Knight Therapeutics Inc. (“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
•
In June 2019, we entered into an exclusive license and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel. In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.
In connection with the Company’s 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 will be paid in accordance with their employment agreements and separation agreements as previously disclosed. As of December 31, 2022, we employed 1 full-time employee primarily engaged in an executive position. We have also entered into consulting agreements with certain former members of our management team who support our relationship with current partners and assist with certain financial, legal and regulatory matters and the continued wind-down of our historical business operations.
vitaCare Divestiture
On April 14, 2022, we completed the divestiture of vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”). We received net proceeds of $ 142.6 million, net of transaction costs of $ 7.2 million, and we recognized a gain on sale of business of $ 143.4 million. Included in the net proceeds amount was $ 11.3 million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”), which is recorded as restricted cash in the consolidated balance sheets. The restricted cash was held by an escrow agent and was be released to us in March 2023. Additionally, we may receive up to an additional $ 7.0 million in earn-out consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement. We will record the contingent consideration at the settlement amount when the consideration is realized or realizable.
The Purchase Agreement contains customary representations and warranties, covenants, and indemnities of the parties thereto. The commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction. In addition, under the Mayne License Agreement Amendment, Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to us by $ 1.5 million in consideration of Mayne Pharma assuming our obligations under the long-term services agreement related to vitaCare.
The divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when the Company changed its business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for 2022 and 2021.
F-8
COVID-19
With multiple variant strains of the SARS-Cov-2 virus and the COVID-19 disease that it causes (collectively, “COVID-19”) still circulating, we continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict.
As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain and difficult to predict. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future.
Going Concern
On December 4, 2022, we entered into agreements with Mayne Pharma pursuant to which we granted Mayne Pharma an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products (in the United States and its possessions and territories), (ii) assign to Mayne Pharma the Company’s exclusive license to commercialize ANNOVERA in the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma.
The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the License Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the License Agreement, as amended.
On the Closing Date, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of the Company’s subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.
Following the transaction with Mayne Pharma, our primary source of revenue will be from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories. 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.
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.
If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA are delayed, if the net working capital settlement with Mayne Pharma under the Transaction Agreement, or if we are unsuccessful with future financings and or the continued impact of the COVID-19 pandemic or the supply chains related to the third-party contract manufacturers is worse than we anticipate, our existing cash reserves would be insufficient to satisfy our liquidity. The presence of these projected factors in conjunction with the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
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.
F-9
GAAP”). Our fiscal year-end is as of and for the year ended December 31 st for each year presented. All intercompany transactions among our businesses have been eliminated.
As part of the transformation as a result of Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2.
Certain amounts in the n otes to the consolidated financial statements may not add due to rounding, and all percentages have been calculated using unrounded amounts.
B.
New accounting standards
Adoption of new accounting standards
New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on the Company’s consolidated financial statements or processes.
Accounting standards issued but not yet adopted
Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting and Scope. These ASUs provide optional guidance for a limited period of time to ease potential accounting impacts associated with transitioning away from reference rates that are expected to be discontinued, such as London Interbank Offered Rate (LIBOR). These ASUs include practical expedients for contract modifications due to reference rate reform. Generally, contract modifications related to reference rate reform may be considered an event that does not require remeasurement or reassessment of a previous accounting determination at the modification date. These ASUs were effective upon issuance and may be applied prospectively to contract modifications made or evaluated on or before December 31, 2022. We paid off our debt as of December 30, 2022, and as a result the adoption of this guidance will not have an impact on our financial statements and, to the extent we enter into new debt agreements, we will apply such guidance to those contracts.
Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on the Company’s consolidated financial statements or processes.
C.
Discontinued Operations
Discontinued operations comprise activities that were disposed of at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes and represent a business shift having a major effect on the Company’s operations and financial results according to Accounting Standard Codification (“ASC”) Topic 205, Presentation of Financial Statements. An adjustment has been made to the consolidated statements of operations for the twelve months ended December 31, 2022 and 2021 to reclassify commercial activities and vitaCare activities to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results. No amounts for shared general and administrative operating support expense were allocated to discontinued operations. As required by the terms of our Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings. As a result, interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax. Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2022 and 2021. For additional information, see Note 2 - Discontinued Operations.
D .
Estimates and assumptions
The preparation of consolidated financial statements in conformity to U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. We evaluate our estimated assumptions based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions.
F-10
E .
Cash and Restricted Cash
We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $ 0.25 million per bank. We have never experienced any losses related to these funds.
Restricted cash is comprised of escrowed funds deposited with a bank relating to the vitaCare Divestiture. All restrictions were lifted in March 2023 and it is no longer restricted, see Note 15.
F .
Accounts receivable and allowance for doubtful accounts
Accounts receivable are customer obligations due under normal trade terms and are measured at amortized cost. We historically extended credit on an unsecured basis to most of our customers based on an evaluation of a customer’s financial condition, and collateral was not required. Our accounts receivable concentration of credit risk is primarily limited to customers who are drug wholesalers and retail pharmacy distributors.
We review accounts receivable for uncollectible and delinquent accounts and credit card chargebacks, and we provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, reasonable supportable forecasts, and existing economic conditions, and we record an allowance that presents the net amount expected to be collected. We write off uncollectible and delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts, adjustments to these reserves may be required. Our exposure to credit losses may increase if our customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current COVID-19 pandemic, or other customer-specific factors. Although we have historically not experienced significant credit losses, it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade receivables in the future. On December 30, 2022, Mayne Pharma acquired our accounts receivable balance of approximately $ 29.3 million which is subject to certain working capital adjustments.
G .
Inventories
Inventories are valued at the lower of cost or net realizable value. Our pharmaceutical products are valued using first in first out method and our vitamins are valued using the average-cost method. We review inventories for excess and obsolescence, and we write-down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Obsolescence may occur due to product expiring, product improvements rendering previous versions obsolete, or decreases in demand for our products. On December 30, 2022, Mayne Pharma acquired our inventory balance of approximately $ 8.4 million , which is subject to certain net working capital adjustments.
H .
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.
F-11
I .
Fixed assets
Fixed assets are carried at cost less accumulated depreciation and amortization. We charge maintenance costs, which do not significantly extend the useful lives of the respective assets, and repair costs to operating expenses as incurred. We compute depreciation using the straight-line method over the estimated useful lives of the related assets, which range from three to seven years . Leasehold improvements are depreciated over the shorter of their useful life or the term of the lease. Long-lived assets held and used by us, including fixed assets, are assessed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
We capitalize software and software development costs incurred to create and acquire computer software for internal use, principally related to software coding and application development. We begin to capitalize software development costs when both the preliminary project stage is completed, and it is probable that the software will be used as intended. Capitalized software costs include only external direct costs and services utilized in developing or obtaining computer software. Capitalized software costs are amortized on a straight-line basis when placed into service over the estimated useful life, generally five to seven years .
J .
License rights and other intangibles assets
We record license rights and other intangible assets at cost, which includes external costs, consisting primary of legal costs, incurred in securing our patents and trademarks.
License rights cost related to ANNOVERA were amortized until December 30, 2022 over the useful life over which the license rights would contribute directly or indirectly to our cash flows. The cost was amortized using the straight-line method as the pattern of economic benefit could not be reliably determined. On December 30, 2022, we assigned our ANNOVERA license to Mayne Pharma and included the remaining ANNOVERA license cost of $ 30.2 million in our calculation of the gain on sale of assets. In addition, amortization of license rights of $ 3.0 million for years 2022 and 2021 was reclassified to discontinued operations.
Intangible assets subject to amortization, such as patents, are amortized over the useful life of the patent using the straight-line method. If the patent is not granted, we write off any capitalized patent costs at that time. Intangible assets not subject to amortization, such as trademarks, are perpetual and have indefinite lives.
We review license rights and other intangible assets subject to amortization on a periodic basis to determine whether events and circumstances would indicate impairment or warrant a revision to their remaining useful lives. We assess other intangible assets not subject to amortization for potential impairment at least annually during the fourth quarter of each year, or more frequently if events occur or circumstances change that would more likely than not reduce the fair value of the intangible assets below their carrying value.
K .
Segment reporting
We manage and operate as one business, which prior to December 2022 was focused on creating and commercializing products targeted exclusively for women and after we signed Mayne License Agreement, is focused on collecting royalties from licensing our products. Our business is led by our chief executive officer. We do not operate separate lines of business with respect to any of our products, and we do not prepare discrete financial information with respect to separate products. Accordingly, we view our business as one reportable operating segment.
L .
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.
Essentially all of our revenue is generated through contracts with our customers. 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
F-12
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.
Prescription products
On December 30, 2022, we granted an exclusive license to commercialize our prescription products and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, which resulted in a business shift that had a major effect on our operations and financial results. As part of the transformation that included the Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date. As of December 31, 2022, we are no longer directly engaged in the sale of prescription products.
Prior to the business shift in December 2022, prescription products were sold at fixed wholesale acquisition cost, or WAC, determined based on our list price. However, the total transaction price was variable as it was calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees. These estimates were based on the amounts earned or to be claimed on the related sales and were classified as reductions of accounts receivable (if the amount was payable to the customer) or a current liability (if the amount was payable to a party other than a customer). To determine the transaction price, we estimated the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration. The estimated amount of variable consideration was included in the transaction price only to the extent that it was probable that a significant reversal in the amount of cumulative product revenue recognized would not occur when the uncertainty associated with the variable consideration was subsequently resolved. In determining amounts of variable consideration to include in a contract’s transaction price, we relied on our historical experience and other evidence that supported our qualitative assessment of whether product revenue would be subject to a significant reversal. We considered all the facts and circumstances associated with both the risk of a product revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur. Actual amounts of consideration ultimately received could differ from our estimates. If actual results in the future varied from our original estimates, we would adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.
We accepted returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration. ANNOVERA can not be returned before the expiration date and expired ANNOVERA can be returned up to 12 months past the expiration date. Our prescription vitamins, IMVEXXY and BIJUVA have a shelf life of 24 months from the date of manufacture and ANNOVERA currently has a shelf life of 18 months from the date of manufacture. We did not allow product returns for prescription products that have been dispensed to a patient. We estimated the amount of our product sales that could be returned by our customers and recorded this estimate as a reduction of product revenue in the period the related product revenue was recognized. Where historical rates of return existed, we used history as a basis to establish a returns reserve for products shipped to wholesalers. For newly launched products, for which the right of return existed but for which we did not have history of product returns, we estimated returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel. At the end of each reporting period, sometimes we constrained product revenue, if necessary, for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products being shipped, price changes of competitive products and any introductions of generic products. We recognized the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since our returns primarily consisted of expired and short dated products that would not be resold, we did not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of product revenue is deferred due to the anticipated return).
We offered various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty. We estimated the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which was reviewed and adjusted, if necessary, on a quarterly basis. We recorded distributor fees based on amounts stated in contracts. We estimated chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience. We provided discounts to our customers for prompt payment. Consumer rebates and coupons costs, distribution fees, chargebacks and discounts were deducted from gross product revenue at the time the product revenue was recognized.
For our prescription products, we offered a co-pay assistance program for eligible enrolled patients whose out of pocket costs were reduced to a more affordable price. This allowed patients to access the product at a reasonable cost and was in line with our responsible pricing approach. We reimbursed pharmacies for this discount through third-party vendors. The variable consideration was estimated based on contract prices, the estimated percentage of patients that would utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance. Payers could change coverage levels for our prescription products positively or negatively, at any time up to the time that we have formally
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contracted coverage with the payer. As such, the net transaction price of our prescription products was susceptible to such changes in coverage levels, which was outside the influence of the Company. As a result, we constrain ed variable consideration for our prescription products to an amount that would not result in a significant product revenue reversal in future periods. Our ability to estimate the net transaction price for our prescription products was constrained by our estimates of the amount to be paid for the co-pay assistance program which was directly related to the level of prescriptions paid for by insurance. As such, we record ed an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses. We re-evaluate d variable consideration each reporting period.
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 and closed the Mayne Transaction pursuant to which we sold to Mayne Pharma the exclusive license rights in our product ANNOVERA and granted an exclusive license in other products, including IMVEXXY and BIJUVA (together, the three products being the “Licensed Products” - see Note 1). 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 2022 related to royalties provided for under the Mayne License Agreement based on Mayne Pharma’s sales of the licensed products subject to that agreement. Under the Mayne License Agreement, the Company is entitled to earn royalties on net sales of all of the Licensed Products at a royalty rate of (i) 8 % on the first $ 80 million of net sales of the Licensed Products and (ii) 7.5 % on net sales of all of the Licensed Products after the first $ 80 million of net sales. The royalty rate is subject to a 2 % reduction upon the earlier to occur of (i) the expiration or revocation of the last valid claim covering a Licensed Product, and (ii) a generic product launch (a “LOE”). We are entitled to minimum annual royalties beginning with the year ending December 31, 2023 ($ 3 million annual minimum) and continuing with 3 % annual increases through the year ending December 31, 2034 (the “Minimum Annual Royalty”). The total Minimum Annual Royalty we are entitled to is $ 42.6 million, and this total amount was allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products. The portion allocated to consideration for the sale of ANNOVERA was attributed towards the gain on disposal of that asset. For the remaining portion allocated to the license grants for the other products, we determined that the minimum guarantee underlying the Minimum Annual Royalty should be treated as fixed consideration and recognized under ASC 606 at the point in time when the license was transferred. Since the Minimum Annual Royalty will be received in annual installments through 2034, we determined the transaction price allocated under ASC 606 contained a significant financing component, and we therefore determined the initial royalty revenue and corresponding receivable based on the present value of the allocated Minimum Annual Royalty. The present value was calculated using a discount rate of 10.45 %, based on the credit characteristics of Mayne Pharma and the timing of future payments, and the value will be accreted to full value through the earlier of January 1, 2034 or a LOE. This royalty receivable is a contract asset as of December 31, 2022, and is further subject to offset by Mayne Pharma (see N. 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 2021, we received milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets. In 2022 and 2021, we recorded BIJUVA sales of $ 1.4 million made through the Theramex License Agreement which was recorded as license revenue.
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M .
Cost of revenue
Cost of revenue includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs and product shipping and handling costs. Costs related to the Population Council License Agreement, which were based on our net sales of ANNOVERA, and amortization of license rights were reclassified to discontinued operations for 2022 and 2021 as a result of the transaction with Mayne Pharma.
N.
Contract Assets and Liabilities
Contract assets as of December 31, 2022, include royalties recognized from the Minimum Annual Royalty (see L. Revenue Recognition above). Pursuant to the Mayne License Agreement, this asset was reduced in December 2022 by $ 1.5 million in consideration for Mayne Pharma assuming an obligation payable to vitaCare, and will be further reduced, other than from future payments on receivables from Mayne Pharma, for $ 1.0 million in prepaid royalties that we received from Mayne Pharma on the closing date. The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable to us under the Minimum Annual Royalty by an amount equal to $ 257,250 per quarter plus interest calculated at 19 % per annum.
O .
Research and development
Research and development expenses included internal R&D activities, costs of services of third-party contract research organizations (“CROs”) and usage of their clinical research sites, manufacturing, scale-up and validation costs, and other activities. Internal R&D activity expenses included laboratory supplies, salaries, benefits, and share-based payment award compensation costs. CRO activity expenses included preclinical laboratory experiments and clinical trial studies. Other activity expenses included regulatory consulting and other costs. These consulting expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs which were reclassified to discontinued operations for 2022 and 2021 as a result of the transaction with Mayne Pharma. As of December 31, 2022, we do no t have any ongoing research and development activities.
P .
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.
Q .
Common stock reverse stock split
On May 6, 2022, we completed a reverse stock split of our Common Stock. As a result, outstanding shares of our Common Stock were split at a ratio of 50- for-1 (the “Reverse Stock Split”) with any fractional shares resulting from the Reserve Stock Split rounded up to the next whole share of Common Stock. The number of authorized shares of Common Stock was also correspondingly reduced from 600.0 million shares to 12.0 million shares to give effect to the Reverse Stock Split. Additionally, all rights to receive shares of Common Stock under outstanding warrants, options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) were adjusted to give effect of the Reverse Stock Split. Furthermore, remaining shares of Common Stock available for future issuance under share-based payment award plans and our employee stock purchase plan were adjusted to give effect of the Reverse Stock Split. Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders was not required for our Board of Directors (the “Board”) to effectuate the Reverse Stock Split.
All historical number of shares of Common Stock and per share data have been adjusted to give effect to the Reverse Stock Split. Additionally, since the Common Stock par value was unchanged, historical amounts for Common Stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split.
R .
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
F-15
taxable temporary differences, taxable income in carryback years, and available tax planning strategies. Sources of negative evidence include current and cumulative losses in recent years, losses expected in early future years, any history of operating losses or tax credit carryforwards expiring unused, and unsettled circumstances that, if unfavorably resolved, would adversely affect future profit levels.
The remaining carrying value of our deferred tax assets, after recording the valuation allowance on our deferred tax assets, is based on our present belief that it is more likely than not that we will be able to generate sufficient future taxable income to utilize such deferred tax assets. The amount of the remaining deferred tax assets considered recoverable could be adjusted if our estimates of future taxable income during the carryforward period change favorably or unfavorably. To the extent we believe that it is more likely than not that some or all the remaining deferred tax assets will not be realized, we must establish a valuation allowance against those deferred tax assets, resulting in additional income tax expense in the period such determination is made. To the extent a valuation allowance currently exists, we will continue to monitor all positive and negative evidence until we believe it is more likely than not that it is no longer necessary, resulting in an income tax benefit in the period such determination is made.
Our policy is to recognize both interest and penalties related to uncertain tax positions as part of the income tax provision. Significant judgment is required in evaluating our tax positions, and in determining our provisions for income taxes, our deferred tax assets and liabilities and any valuation allowance recorded against our net deferred tax assets. We establish reserves when, despite our belief that the income tax return positions are fully supportable, certain positions are likely to be challenged and we may ultimately not prevail in defending those positions.
S .
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.
T .
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 asset in an operating or finance lease at the asset group level (because these assets are long-lived nonfinancial assets and should be accounted for the same way as other long-lived nonfinancial assets) whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
U .
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.
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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 .
V.
Restructuring charges
During the year ended December 31, 2022, the Company initiated and completed a restructuring plan that resulted in a reduction of its workforce to one employee. One-time termination benefits include severance, continuation of health insurance coverage, and other benefits for a specified period of time, as well as contract terminations and fixed assets write-downs, which resulted in $ 15.7 million of restructuring costs for the year ended December 31, 2022. These costs have been recognized in the accompanying consolidated statement of operations as follows (in thousands):
Year ended
December 31,
2022
Executive termination benefits
$
3,897
Consulting and legal expenses
3,060
Other contract termination costs
2,515
Total restructuring expenses - general and administrative expenses
$
9,472
Employee termination benefits
$
4,813
Other contract termination costs
1,367
Total restructuring expenses - discontinued operations
$
6,180
At December 31, 2022, $ 9.3 million related to restructuring costs was included in accrued expenses and other current liabilities and $ 6.2 million was included in current liabilities of discontinued operations in the accompanying consolidated balance sheets.
W .
Reclassification of prior year presentation
Certain prior year amounts have been reclassified for consistency with the current year presentation. An adjustment has been made to the consolidated statements of operations for 2022 and 2021 to reclassify commercial operations and vitaCare operations to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results.
2 .
Discontinued Operations
We changed our business in 2022, by out-licensing our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma.
This plan represented a strategic shift having a major effect on the Company's operations and financial results. Upon the completion of the Company’s restructuring and ultimate conversion from a commercial pharmaceutical company to a licensing only company with the consummation of the Mayne Transaction, the Company classified all direct revenues, costs and expenses related to commercial operations, within income (loss) from discontinued operations, net of tax, in the consolidated statements of operations for all periods presented. No amounts for shared general and administrative operating support expense were allocated to discontinued operations. As required by the terms of our Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings, and as a result interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax (as disclosed below).
Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2022 and 2021.
The total consideration from Mayne Pharma was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of $ 12.1 million for the acquisition of net working capital subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million for prepaid royalties in connection with the License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the License Agreement, as amended.
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The Company’s es timate of net working capital at closing was determined in accordance with the Transaction Agreement which establishes the process for the determination of final net working capital. The determination of net working capital include s significant estimates which could change materially for a period of up to two years following the Closing Date . On March 29, 2023, the Company received Mayne Pharma’s closing net working capital calculation which differed significantly from the Company’s estimate of closing net working capital. The Company believes that its estimate of net working capital is reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of Mayne Pharma’s calculation and the nature of the estimates involved , the outcome of this matter is uncertain at this point. As a result , the Company cannot reasonably estimate a range of loss, and accordingly , the Company has not accrued any additional liability ass ociated with Mayne Pharma’s calculation.
The proceeds at closing were allocated separately to the sale of ANNOVERA and the license grant related to the other products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal. We recognized $ 70.0 million in revenue from transaction with Mayne Pharma, which represented license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products as well as present value of future minimum royalty payments (as discussed in Note 1).
The Company classified the $ 143.4 million gain on the sale of the vitaCare business and $ 62.0 gain on sale of ANNOVERA, net of transaction costs in discontinued operations.
The Company recorded a restructuring expense of $ 15.7 million, for the year ended December 31, 2022 for contract terminations, severance, and fixed asset write-downs, of which $ 6.2 million was recorded in discontinued operations.
The following table presents results of discontinued operations (in thousands):
Year ended December 31,
2022
2021
Product revenue, net
$
80,749
$
84,378
Cost of goods sold
15,640
17,436
Gross profit
65,109
66,942
Operating expenses:
Selling and marketing
75,208
108,195
General and administrative
11,301
11,854
Research and development
4,942
7,086
Restructuring charges
6,180
—
Total operating expenses
97,631
127,135
Loss from discontinued operations
( 32,522
)
( 60,193
)
Other (expense) income:
Gain on sale of vitaCare
143,384
—
Gain on ANNOVERA sale
62,031
—
Loss on the extinguishment of debt
( 8,380
)
—
Interest expense and other financing costs
( 36,065
)
( 32,917
)
Expense for accretion of Series A Preferred Stock
( 16,973
)
—
Other income, net
—
—
Total other income (expense), net
143,997
( 32,917
)
Loss before from income taxes
111,475
( 93,110
)
Provision for income taxes
( 552
)
—
Net income (loss) from discontinued operations
$
110,923
$
( 93,110
)
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The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations as of December 31, 2022 and December 31, 2021 (in thousands):
As of December 31,
2022
2021
Assets:
Current assets:
Cash
$
—
$
215
Accounts receivable
—
36,176
Inventory
—
7,622
Prepaid and other current assets
—
4,689
Total current assets
—
48,702
Fixed assets, net
—
376
License rights and other intangible assets, net
—
33,174
Total assets
$
—
$
82,252
Liabilities:
Current liabilities:
Accounts payable
$
12,243
$
16,945
Accrued expenses and other current liabilities
13,588
30,966
Total current liabilities
$
25,831
$
47,911
3 .
Prepaid and other current assets
Our prepaid and other current assets consisted of the following (in thousands):
As of December 31,
2022
2021
Insurance
$
1,167
$
2,731
Paragraph IV legal proceeding costs
2,334
2,304
Other
2,533
824
Prepaid and other current assets
$
6,034
$
5,859
4 .
Fixed assets
Our fixed assets, net consisted of the following (in thousands):
As of December 31,
2022
2021
Furniture and fixtures
$
931
$
891
Computer and office equipment
1,168
1,448
Computer software
375
375
Leasehold improvements
49
80
Fixed assets
2,523
2,794
Less: accumulated depreciation and amortization
2,445
1,971
Fixed assets, net
$
78
$
823
We recorded depreciation expense of $ 0.6 million for 2022 and $ 0.4 million for 2021.
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5 .
Licensed rights and other intangible assets
The following provides information about our license rights and other intangible assets, net (in thousands):
As of December 31, 2022
As of December 31, 2021
Gross
Gross
Carrying
Accumulated
Carrying
Accumulated
Amount
Amortization
Net
Amount
Amortization
Net
Intangible assets
subject to amortization:
Hormone therapy drug patents
$
6,225
$
1,598
$
4,627
$
5,834
$
1,042
$
4,792
Hormone therapy drug patents applied
and pending approval
1,995
—
1,995
2,020
—
2,020
Intangible assets
subject to amortization
8,220
1,598
6,622
7,854
1,042
6,812
Intangible assets not subject to amortization:
Trademarks/trade name rights
321
—
321
332
—
332
Intangible assets, net
$
8,541
$
1,598
$
6,943
$
8,186
$
1,042
$
7,144
We recorded, in continuing operations, amortization expense related to patents of $ 0.6 million for 2022 and $ 0.3 million for 2021.We recorded amortization expense related to the exclusive license rights agreement with Population Council of $ 3.0 million for 2022 and 2021, which was reclassified to discontinued operations after we completed transaction with Mayne Pharma in December 2022, which are excluded from the table above.
Our intangible assets subject to amortization are expected to be amortized as follows (in thousands):
Year ending December 31,
2023
$
337
2024
439
2025
438
2026
438
2027
438
Thereafter
2,537
Total
$
4,627
We use a combination of qualitative and quantitative factors to assess licensed rights and intangible assets for impairment. As a result of performing these assessments, we determined that no impairment existed as of December 31, 2022 or 2021, therefore, no write downs were recorded to our licensed rights and other intangible assets.
6 .
Accrued expenses and other current liabilities
Other accrued expenses and other current liabilities consisted of the following (in thousands):
As of December 31,
2022
2021
Payroll and related costs
$
8,748
$
6,549
Accrued contract termination costs
4,700
-
Research and development expenses
978
-
Professional fees
415
2,571
Operating lease liabilities
1,390
1,361
Prepaid royalty
1,011
-
Other
1,604
2,857
Accrued expenses and other current liabilities
$
18,846
$
13,338
We expense advertising costs when incurred, which amounted to $ 13.2 million and $ 39.7 million for 2022 and 2021, respectively, which was reclassified to discontinued operations as a result of business shift following transaction with Mayne Pharma.
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7 .
Debt
Our debt consisted of the following (in thousands):
As of December 31,
2022
2021
Financing Agreement
$
-
$
200,000
Less: deferred financing fees
-
11,731
Debt, net
-
188,269
Current maturities of long-term debt
-
188,269
Long-term debt
$
-
$
-
Financing agreement
We were party to a Financing Agreement with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent”), various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors. On December 30, 2022, we repaid all obligations under the Financing Agreement and the Financing Agreement was terminated.
The Financing Agreement was entered into in April 2019, and it provided us with up to a $ 300.0 million first lien secured term loan credit facility. The credit facility provided for availability to us in three tranches: (i) $ 200.0 million was drawn upon entering into the Financing Agreement; (ii) $ 50.0 million was drawn in February 2020 and (iii) $ 50.0 million was previously available to us in the Administrative Agent’s sole and absolute discretion either contemporaneously with the delivery of our financial statements for the quarterly period ended June 30, 2020 or at such earlier date as the Administrative Agent may have consented to. In the third quarter of 2020, the Administrative Agent terminated the undrawn $ 50.0 million tranche under the Financing Agreement, therefore, such amount was no longer available to us to borrow.
In connection with the initial borrowing under the Financing Agreement, we paid, for the benefit of the lenders, a facility fee equal to 2.5 % of the initial amount borrowed and were required to pay such a facility fee in connection with subsequent borrowings under the Financing Agreement. Borrowings under the Financing Agreement accrued interest at either (i) 3-month LIBOR plus 7.75 %, subject to a LIBOR floor of 2.70 % or (ii) the prime rate plus 6.75 %, subject to a prime rate floor of 5.2 % as selected by us. As of December 30, 2022, our interest rate was 10.45 %. Interest on amounts borrowed under the Financing Agreement was due and payable quarterly in arrears. In addition, we were required to pay an annual administrative fee, and other fees and expenses.
In August 2020, we entered into Amendment No. 5 to the Financing Agreement (“Amendment No. 5”) pursuant to which, among other amendments, the covenant in the Financing Agreement regarding our achievement of minimum consolidated net revenue attributable to commercial sales of our IMVEXXY, BIJUVA and ANNOVERA products were adjusted in order to reflect the impact of COVID-19 on our business. In lieu of a cash amendment fee, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 95,042 shares of our common stock with an exercise price of $ 79 per share and a ten-year term (the “Lender Warrants”). The Lender Warrants were issued pursuant to an exemption from registration under the Securities Act of 1933, as amended, and no registration rights were issued. The estimated fair value of the Lender Warrants was $ 7.4 million and was recorded as deferred financing cost since Amendment No. 5 was accounted for as a debt modification.
In November 2020, in connection with Amendment No. 6 to the Financing Agreement (“Amendment No. 6”), we amended the Lender Warrants to provide for an adjustment to the exercise price if we conduct certain dilutive issuances prior to December 31, 2020, or if the volume-weighted average price of our common stock for the fifteen trading days ending December 31, 2020 was lower than the then current exercise price. Also, in November 2020, we concluded an underwritten public offering of our common stock and received consideration of $ 59.5 per share, after deducting for underwriting discounts and commissions. This offering of our common stock automatically triggered the down round provision to the exercise price of the Lender Warrants, which lowered the exercise price from $ 79 to $ 59.5 per share. The estimated fair value of the adjustment to the exercise price of Lender Warrants was $ 0.2 million and was recorded as deferred financing cost since Amendment No. 6 was accounted for as a debt modification. No other amendment financing fees were paid.
In January 2021, we entered into Amendment No. 7 to the Financing Agreement (“Amendment No. 7”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA for the fiscal quarters ending March 31, 2021 and June 30, 2021 were reduced, and we paid amendment financing fees of $5.0 million, which was recorded as deferred financing fees since Amendment No 7 was accounted for as debt modification. Additionally, in connection with entering into Amendment No. 7, the warrants issued to the Administrative Agent and the lenders under the Financing Agreement in August 2020 were further amended to provide for an additional adjustment to the exercise price if we conducted certain dilutive issuances prior to March 31, 2021. No adjustments were made to the exercise price of these warrants prior to the expiration of such period.
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In March 2021, we entered into Amendment No. 8 to the Financing Agreement (“Amendment No. 8”) pursuant to which, among other amendments, the minimum quarterly product net revenue requirements attributable to commercial sales of IMVEXXY, BIJUVA, and ANNOVERA were revised, the amortization and prepayment terms of the borrowings under the Financing Agreement were revised, and the Administrative Agent consented to a framework for our potential disposition of our vitaCare business. In connection with Amendment No. 8, we (i) repaid $ 50.0 million in principal under the Financing Agreement during the three months ended March 31, 2021, plus a 5.0 % prepayment fee and (ii) agreed to make additional quarterly principal repayments plus the prepayment fees as follows: (a) $ 5.0 million due in March 2022, June 2022 and September 2022; (b) $ 10.0 million due in December 2022 and March 2023; and (c) $ 41.25 million due in June 2023, September 2023, December 2023 and March 2024. Additionally, the prepayment fees on principal amounts being prepaid under the Financing Agreement were revised as follows: (i) 30.0 % of the principal amount being repaid through March 31, 2022 (excluding the scheduled $ 5.0 million principal repayment on such date, which is subject to a 5.0 % prepayment fee); (ii) 5.0 % of the principal amount being repaid from April 2022 through March 2023; (iii) 3.0 % of the principal amount being repaid from April 2023 through March 2024; and (iv) thereafter, none, in each case subject to certain limited exceptions, including with respect to a repayment in full of the obligations under the Financing Agreement.
In March 2022, we entered into Amendment No. 9 to the Financing Agreement (“Amendment No. 9”) pursuant to which, among other amendments, (i) the lenders waived various Company breaches of the Financing Agreement, including breaches of the $ 60.0 million minimum cash covenant and the minimum net revenue covenants for the fourth quarter of 2021; (ii) the Company and the lenders agreed to a reduced minimum cash covenant and to the removal of the minimum net revenue covenant for the first quarter of 2022; (iii) the lenders waived the existing $ 60.0 million prepayment penalty under the Financing Agreement and the Company agreed to pay a paid in kind (“PIK”) amendment financing fee of $ 30.0 million, which fee was added to the principal amount of the loans under the Financing Agreement, $ 16.0 million of which fee was waivable in certain conditions; (iv) the maturity date of the Financing Agreement was amended to June 1, 2022; and (v) the Company agreed to pay to the Lenders as a prepayment of the loans under the Financing Agreement the first $ 120.0 million of net proceeds from the vitaCare Divestiture and all net proceeds of the vitaCare Divestiture in excess of $ 135.0 million. Amendment No. 9 was accounted for as an extinguishment of debt modification in accordance with U.S. GAAP. Accordingly, in March 2022, we recorded an $ 8.4 million loss on extinguishment of debt, which represented the unamortized deferred financing fees, net of previously accrued prepayment fees. Additionally, Amendment No. 9 PIK financing fee was recorded as deferred financing fees and was amortized over the remaining term of the Financing Agreement. In April 2022, we utilized $ 120.0 million of net proceeds from the vitaCare Divestiture to make a prepayment of the loans under the Financing Agreement under the terms of Amendment No. 9. Additionally, with the prepayment on the debt, $ 16.0 million of the PIK financing fee was waived in accordance with Amendment No. 9.
In May 2022, we entered into Amendment No. 10 to the Financing Agreement (“Amendment No. 10”) pursuant to which, among other amendments, (i) interest payments under the Financing Agreement were paused, such that interest on each term loan was payable in cash and in arrears (a) upon any prepayment of that term loan, whether voluntary or mandatory, to the extent accrued on the amount being prepaid and (b) on the maturity date, (ii) the minimum cash covenant was set at $ 10.0 million, (iii) the maturity date of the Financing Agreement was amended to July 13, 2022 , (iv) the termination of the Company’s merger agreement with an affiliate of EW Healthcare Partners was added as an event of default, and (v) we agreed to a PIK financing fee of $ 1.8 million, which fee was added to the principal amount of the loans under the Financing Agreement. Amendment No. 10 was accounted for as a debt amendment in accordance with U.S. GAAP. Accordingly, in May 2022, Amendment No. 10 PIK financing fee was recorded as deferred financing fees and was amortized over the remaining term of the Financing Agreement.
Also in May 2022, we entered into Amendment No. 11 (“Amendment No. 11”) to the Financing Agreement. Amendment No. 11 contains amendments to the Financing Agreement that would have gone into effect upon the satisfaction of certain conditions on or before July 13, 2022 (the “Amendment Effective Date”), including (i) the consummation of the merger with an affiliate of EW Healthcare Partners (the “Merger”), (ii) the payment in cash of (a) all accrued and unpaid interest under the Financing Agreement through and including the Amendment Effective Date and (b) all fees, costs, expenses and taxes then payable pursuant to Section 2.7 or 10.2 of the Financing Agreement, and (iii) the delivery to the administrative agent of certain customary documents with respect to the pledge of 100 % of the capital stock of the Company. Since the consummation of the Merger did not occur, Amendment No. 11 never became effective.
On July 13, 2022, we entered into Amendment No. 12 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 24, 2022 , and we agreed to pay the Lenders a PIK amendment fee in the amount of $ 1.2 million. On July 24, 2022, we entered into Amendment No. 13 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 27, 2022 , we agreed to pay the Lenders a payment of accrued and unpaid interest of $ 2.9 million, and we agreed to retain Jeffrey Varsalone from G2 Capital Advisors as our chief restructuring officer. On July 27, 2022, we entered into Amendment No. 14 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 28, 2022 . On July 28, 2022, we entered into Amendment No. 15 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 29, 2022 .
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On July 29, 2022, we entered into Amendment No. 16 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to September 30, 2022, with the option for us to further extend the maturity date to October 31, 2022, and November 30, 2022, in each case if we receive not less than $ 7.0 million in cash proceeds from an equity issuance, which, if preferred equity, is on substantially the same terms as the Preferred Stock. In lieu of a cash amendment fee, to induce the Lenders to enter into Amendment No. 16, on July 29, 2022, we issued Lender Warrants to purchase an aggregate of 185,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders (the “July Lender Subscription Agreement”). The Lender Warrants to purchase 185,000 shares of our Common Stock issued pursuant to the July Lender Subscription Agreement have an exercise price of $ 0.01 per warrant, subject to certain adjustment as provided therein, and an expiration date of July 29, 2032, and may be exercised via cashless exercise pursuant to the terms thereof. These Lender Warrants were initially valued at $ 1.2 million based on the market price of our Common Stock on July 29, 2022 and entirely expensed as financing costs.
In connection with the closing of a private placement offering with Rubric Capital Management LP (“the Preferred Stock Investor”) on September 30, 2022, and in accordance with Amendment No. 16 to the Financing Agreement, on September 30, 2022, we issued Lender Warrants to purchase an aggregate of 125,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders (the “September Lender Subscription Agreement”), and the maturity date of the Financing Agreement was extended to October 31, 2022. These Lender Warrants have an exercise price of $ 0.01 per share of Common Stock, subject to certain adjustment as provided therein, and an expiration date of September 30, 2032 and may be exercised via cashless exercise pursuant to the terms thereof. These Lender Warrants were initially valued at $ 0.8 million based on the market price of our Common Stock on September 30, 2022 and recorded as deferred financing fees, which were expensed with maturity of the Financing Agreement on October 31, 2022. Additionally, in September 2022, we and the Lenders agreed to PIK interest of $ 2.5 million related to the outstanding debt balance.
In connection with the closing of the private placement offering with the Preferred Stock Investor on October 28, 2022, and in accordance with Amendment No. 16 to the Financing Agreement, on October 28, 2022, we issued Lender Warrants to purchase an aggregate of 125,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders, and the maturity date of the Financing Agreement was extended to November 30, 2022. These Lender Warrants have an exercise price of $ 0.01 per share of Common Stock, subject to certain adjustment as provided therein, and an expiration date of October 28, 2032 and may be exercised via cashless exercise pursuant to the terms thereof. These Lender Warrants were initially valued at $ 0.7 million based on the market price of our Common Stock on October 28, 2022 and recorded as financing costs.
The fair value of the Lender Warrants was based on the date of grant using our Common Stock’s closing price at measurement date and was recorded to “Additional paid-in-capital” in the consolidated balance sheets. See Note 9, Mandatory Redeemable Preferred Stock and Stockholders’ Equity (Deficit) for additional information regarding the equity financing with the Preferred Stock Investor.
On November 30, 2022, we entered into Amendment No. 17 (“Amendment No. 17”) to the Financing Agreement. Pursuant to Amendment No. 17, among other things, (i) the maturity date of the Financing Agreement was extended to December 31, 2022 , subject to the achievement of certain milestones by the Company, (ii) the minimum cash covenant was set at $ 7.5 million, (iii) the Company agreed to pay the Lenders an amendment fee in the amount of $ 750,000 and (iv) the Company paid the Lenders all accrued and unpaid interest under the Financing Agreement as of the Amendment Date, in the amount of approximately $ 4.2 million. On December 30, 2022, we repaid remaining obligations under the Financing Agreement of $ 75.0 million, PIK financing fees of $ 17.0 million and the remaining accrued interest, and the Financing Agreement was terminated.
Interest and financing costs
Interest expense and other financing costs consisted of the following (in thousands):
2022
2021
Interest expense
$
13,545
$
22,568
Prepayment fees
-
4,660
Financing fees amortization
22,520
5,689
Total
$
36,065
$
32,917
8 .
Commitments and contingencies
Leases
Substantially all of our leases are for rental of office space used to conduct our business. In October 2018, we entered into a lease for e xecutive, administrative, operations and sales offices in Boca Raton, Florida. The lease includes 56,212 rentable square feet, or the full premises, of which the lease on 7,561 square feet commenced in 2018 and the lease on the remaining 48,651 square feet commenced in August 2019, or the full premises commencement date. The lease will expire 11 years after the full premises commencement date, unless
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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. 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. We are in the process of subleasing our headquarters as a result of shifting our business to become a license company and terminating our employees. We anticipate that sublease income will approximate the amounts due under our existing leases, therefore no impairment of the right of use asset was recorded in 2022.
For 2022, operating lease expense related to our real estate leases was $ 1.4 million and variable lease expense was $ 0.7 million. For 2021, operating lease expense related to our real estate leases was $ 2.1 million and variable lease expense was $ 0.7 million. In 2022, our rental income was $ 0.4 million on sublease of our two suites which were subleased following vitaCare transaction.
As of December 31, 2022, our remaining lease payments were as follows (in thousands):
Year ending December 31,
2023
$
1,443
2024
1,477
2025
1,513
2026
1,551
2027
1,590
Thereafter
4,294
Total undiscounted lease payments
11,868
Less: imputed interest
3,109
Present value of lease payments
$
8,759
The following table sets forth supplemental balance sheet information related to leases (in thousands):
As of December 31,
2022
2021
Assets:
Operating lease right-of-use assets
$
7,580
$
8,234
Liabilities:
Operating lease liabilities current (included in accrued
expenses and other current liabilities)
$
1,390
$
1,361
Operating lease liabilities, non-current
7,369
8,063
Total operating lease liabilities
$
8,759
$
9,424
The following table presents other information related to leases:
2022
2021
Weighted average remaining term (years) - operating leases
7.7
8.7
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)
$
1,413
$
2,335
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 for the acquisition of net working capital, as determined in accordance with the Transaction Agreement, and is subject to certain adjustments for a period of up to two years following the Closing Date.
Pursuant to the Mayne License Agreement Amendment, Mayne Pharma also paid the Company approximately $ 1.0 million in prepaid royalties on the Closing Date. The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company. In addition,
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Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement, including the Company’s minimum payment obligations thereunder.
Population Council license agreement
Under the terms of the Population Council License Agreement, we paid the Population Council a milestone payment of $ 20.0 million in 2018, which was within 30 days following the approval by the FDA of the NDA for ANNOVERA, and $ 20.0 million in 2019 following the first commercial batch release of ANNOVERA. The aggregate $ 40.0 million of milestone payments were recorded as license rights. The Population Council was also eligible to receive future payments upon the achievement of certain commercial sales milestones of ANNOVERA. On December 30, 3022, we assigned the ANNOVERA license to Mayne Pharma. The rights and obligations under the Population Council License Agreement have been transferred to Mayne Pharma and will revert back to us upon certain events.
The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA, and we had agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $ 20.0 million, half of such excess was to be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement. In July 2021, we received a letter from FDA indicating that the post-marketing commitment study being conducted by the Population Council for ANNOVERA to characterize the in vivo release rate of ANNOVERA was not fulfilled to FDA’s satisfaction. In addition, the final reports for the two post-marketing requirement studies being performed by the Population Council for ANNOVERA were not submitted by the initial listed submission deadline, which deadlines have since been extended by FDA. Our obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement. We believe that Mayne Pharma is working with Population Council to complete the post-marketing commitment study to FDA’s satisfaction and reduce the delay in submitting the post-marketing requirement final reports. To the extent that the Population Council does not fulfil these studies to FDA’s satisfaction, FDA may impose additional requirements and penalties against the NDA holder for ANNOVERA.
Unless earlier terminated, the Population Council License Agreement will remain in effect until the later of the expiration of the last-to-expire of the Population Council’s U.S. patents that are licensed to Mayne Pharma, or the date following such expiration that follows a continuous period of six months during which Mayne Pharma has not made a commercial sale of ANNOVERA in the U.S. The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by Mayne Pharma on 180 days’ prior notice to the Population Council.
Purchase commitments
We had manufacturing and supply agreements whereby we were required to purchase from Catalent, Inc. (“Catalent”) a minimum number of units of BIJUVA and IMVEXXY softgels during each respective annual contract year. The annual contract period for BIJUVA and IMVEXXY ended each April and July, respectively. If the minimum order quantities of BIJUVA or IMVEXXY were not met, we were required to pay a minimum commitment fee equal to 50 % or 60 %, respectively, of the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of BIJUVA or IMVEXXY during each product’s respective contract year.
Additionally, with another third-party manufacturer, we had a manufacturing and supply agreement, renewable annually, whereby we were required to purchase a minimum number of units of ANNOVERA during a contract year. The annual contract period for ANNOVERA ended each August. If the minimum order quantities of ANNOVERA were not met, we were required to pay a minimum commitment fee equal to the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of ANNOVERA during the contract year.
On December 30, 2022, after granting an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, the rights and obligations under the Catalent minimum manufacturing and supply agreements and other supply agreements have been transferred to Mayne Pharma.
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
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Notice Letter, Teva alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product. The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033. In April 2020, we filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents. Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed. In July 2021, following a proposal by Teva, the District Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal. In September 2021, the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information Teva contended was confidential. The order provides that the statutory stay that prevents the FDA from granting final approval of the ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place. The length of the stay of the IMVEXXY litigation is dependent on further action by Teva. As of December 31 , 2022, for the IMVEXXY Paragraph IV legal proceeding, we have incurred and recorded legal costs amounting to $ 2.3 million in prepaid expenses and other current assets since we believe that we will successfully prevail in this legal proceeding. Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents. If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.
In March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (“Amneal”). In April 2020, we filed a complaint for patent infringement against Amneal in the United States District Court for the District of New Jersey arising from Amneal’s ANDA filing with FDA. In December 2021, we entered into a settlement agreement (the “Settlement Agreement”) with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York LLC (collectively “Amneal”) to resolve the litigation over our patents listed in FDA’s Orange Book that claim compositions and methods of BIJUVA (the “BIJUVA Patents”). Under the terms of the Settlement Agreement, the parties filed a consent judgment with the U.S. District Court for the District of New Jersey that enjoins Amneal from marketing a generic version of BIJUVA (1 mg estradiol and 100 mg progesterone) before the expiration of the patents-in-suit, except as provided in the Settlement Agreement, and the Company granted Amneal a non-exclusive, non-transferable, royalty-free license to commercialize Amneal’s generic formulation of BIJUVA in the U.S. commencing in May 2032 (180 days before the current expiration date in November 2032 for the last to expire of our BIJUVA Patents), or earlier under certain circumstances customary for settlement agreements of this nature. As of December 30, 2022 and per the license agreement, Mayne Pharma is responsible for all enforcement of our patents, including this litigation with Teva.
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.
Compliance with Nasdaq’s continued listing requirements
In January 2023, we received a deficiency letter (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that we were not in compliance with the rules for continued listing as set forth in Nasdaq Listing Rule 5620(a) (the “Annual Meeting Rule”) due to our failure to hold an annual meeting of stockholders within 12 months after our fiscal year ended December 31, 2021. The Notice had no immediate effect on the listing of our Common Stock. We did not hold an annual meeting of stockholders during 2022 due to our then ongoing strategic processes.
The Notice stated that, under Nasdaq Listing Rule 5810(c)(2)(G), we had 45 calendar days, or until February 20, 2023, to submit a plan to regain compliance with the Annual Meeting Rule. We timely submitted such plan, and Nasdaq granted us an extension until June 29, 2023, to regain compliance. It is our intent to hold an annual meeting of stockholders in 2023 prior to such deadline and to fully regain compliance with all applicable Nasdaq listing standards.
Off-balance sheet arrangements
As of December 31, 2022 and 2021 we had no off-balance sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
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Employment agreements
In connection with the Company’s 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 the first quarter of 2023 and severance obligations for terminated executive officers will be paid in accordance with their employment agreements and separation agreements as previously disclosed. As of December 31, 2022, we have employed one full-time employee primarily engaged in executive position. We have engaged external consultants, including certain former members of our management team, who support our relationship with current partners and assist with certain financial, legal and regulatory matters and the continued wind-down of our historical business operations. The separation of our former Interim Co-Chief Executive Officers, former Interim Chief Financial Officer and other executives from the Company was a termination without “Good Cause,” as defined in their employment agreements. In the aggregate, in December 2022, we recorded severance expenses for executive termination obligations of $ 6.0 million, of which $ 1.1 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards.
On September 6, 2022, our Board appointed interim Co-Chief Executive Officers. The separation of our former chief executive officer from the Company was a termination without “Good Cause,” as defined in his employment agreement. Accordingly, our former chief executive officer received the separation benefits provided therein, and we recorded executive officer severance expenses of $ 4.8 million, of which $ 3.2 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards for the former chief executive officer. In connection with our former chief executive officer’s separation from the Company, he ceased to serve as a member of our Board.
In September 2021, our former Executive Vice President of Operations (“EVP of Operations”) and us mutually agreed that the EVP of Operations would separate from the company. The separation was for “Good Reason” under the employment agreement of the EVP of Operations; accordingly, he received the separation benefits provided therein. Then, i n December 2021, our Board of Directors (the “Board”) appointed a new Chief Executive Officer (“CEO”). Our former CEO’s separation as CEO was a termination without “Cause,” as defined in his employment agreement. Accordingly, our former CEO received the separation benefits provided therein. Additionally, in 2021, three other senior executives separated from the Company, and they received separation benefits provided by their respective employment agreements. In the aggregate, for 2021, we recorded executive officer severance expenses of $ 12.4 million, of which $ 8.0 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards for the former senior executives.
Employee benefit plan
We maintained a voluntary defined contribution 401(k) plan covering all eligible employees as defined in the plan documents. The plan provided for discretionary matching contribution, which is equal to up to four percent of each eligible contributing participant’s elective deferral not to exceed two thousand per year. Employees who elected to participate in the plan were generally fully vested in any existing matching contribution after five years of service with the Company. As part of termination of employees, all contributions made by the Company to each participant became 100 % vested.
Contributions by the Company under the plan amounted to $ 0.5 million and $ 0.6 million for 2022 and 2021, respectively.
9 .
Mandatory Redeemable Preferred Stock and Stockholders’ Equity (Deficit)
Rubric Capital Management LP Subscription Agreements (Sale of Mandatory Redeemable Preferred Stock and Common Stock)
On July 29, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, (i) 15,000 shares of the Company’s newly- designated Series A Preferred Stock, par value $ 0.001 per share (the “Series A Preferred Stock”) for a purchase price per share of Series A Preferred Stock equal to $ 822.21 and an aggregate purchase price of $ 12.3 million, and (ii) 565,000 shares of the Company’s Common Stock, for a purchase price per share of Common Stock equal to $ 4.72 and an aggregate purchase price of $ 2.7 million. This offering closed on July 29, 2022, and we received aggregate gross proceeds of $ 15.0 million, before expenses.
On September 30, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, 7,000 shares of the Company’s Series A Preferred Stock for an aggregate offering price of $ 7.0 million. In addition, in lieu of issuing, selling and delivering 263,666 shares of the Company’s Common Stock to the Preferred Stock Investor, we agreed to pay the Preferred Stock Investor, on the later of (i) the Maturity Date (as defined in the Certificate of Designation, Preferences and Rights of Series A Preferred Stock, establishing the powers, designations, preferences and privileges and the
F-27
qualifications, limitations or restrictions of the Series A Preferred Stock (the “Certificate of Designation”)) or (ii) the date our obligations under the Financing Agreement were paid in full, a make-whole payment equal to 263,666 multiplied by the closing price of our Common Stock on the principal securities exchange or securities market on which the Common Stock is then traded, on the day prior to the date of payment of the make-whole payment. This offering closed on September 30, 2022, and we received gross proceeds of $ 7.0 million, before expenses.
On October 28, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, 7,000 shares of the Company’s Series A Preferred Stock for an aggregate offering price of $ 7.0 million. In addition, in lieu of issuing, selling and delivering 263,666 shares of the Company’s Common Stock to the Preferred Stock Investor, we agreed to pay the Preferred Stock Investor, on the later of (i) Maturity Date or (ii) the date our obligations under the Financing Agreement were paid in full, a make-whole payment equal to 263,666 multiplied by the closing price of our Common Stock on the principal securities exchange or securities market on which the Common Stock is then traded, on the day prior to the date of payment of the make-whole payment. This offering closed on October 28, 2022, and we received gross proceeds of $ 7.0 million, before expenses. The Company received gross proceeds of $ 7 million from the Offering, before expenses.
The Series A Preferred Stock was not convertible into Common Stock and ranked senior to Common Stock, with respect to rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company. In the event of any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company, the Series A Preferred Stock had a liquidation preference equal to $ 1,333 per share. The Series A Preferred Stock did not have any voting rights other than as required by applicable law. The holders of Series A Preferred Stock were entitled to dividends equal to 25 % of cash dividends actually paid, if any, on shares of Common Stock, paid pro rata on the outstanding shares of Series A Preferred Stock. Upon the occurrence of change of control, the holders of Series A Preferred Stock could have required the Company to redeem all or part of such holder’s Series A Preferred Stock at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share of Series A Preferred Stock.
We also had the option to redeem all the outstanding shares of Series A Preferred Stock on such terms if we consummated a change of control transaction. Each holder of Series A Preferred Stock also had the right to cause the Company to redeem all, but not less than all, of their shares of the Series A Preferred Stock upon the occurrence of certain events, including, without limitation, the Company’s failure to comply with any covenants under the Certificate of Designation or if the Company commenced a bankruptcy proceeding, subject to certain conditions. Under such circumstances, the Company was required to redeem all, but not less than all, of the holder’s outstanding shares of Series A Preferred Stock at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share.
We were required to redeem from each holder of Series A Preferred Stock all outstanding shares of Series A Preferred Stock held by such holder, at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share of Series A Preferred Stock, upon the earlier to occur of (i) the Maturity Date and (ii) the incurrence of Permitted Refinancing Indebtedness (as defined in the Certificate of Designation). The Company accreted the Series A Preferred Stock from its fair value on the date of issuance to its redemption value using the effective interest rate method.
On December 30, 2022, and in accordance with the terms of the Certificate of Designation, the Company mandatorily redeemed all 29,000 outstanding shares of Series A Preferred Stock at a purchase price of $ 1,333 per share. The Company also paid certain affiliates of the Preferred Stock Investor approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between the Company and the Preferred Stock Investor.
F-28
Common stock
In March 2021, we entered into an at-the-market equity offering program (the “2021 ATM Program”) relating to shares of our common stock. The 2021 ATM Program permitted us to offer and sell shares of our common stock having an aggregate offering price of up to $ 100.0 million from time to time through or to the sales agent under the 2021 ATM Program. Sales of our common stock could be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act, including by means of ordinary broker’s transactions on The Nasdaq Stock Market LLC (“Nasdaq”) or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent. The sales agent was entitled to compensation at a fixed commission rate of 3.0 % of the aggregate gross sales price per share sold. The sales agent was not required to sell any specific number or dollar amounts of securities but acted as sales agent and used commercially reasonable efforts to sell on our behalf all the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed terms between us and the sales agent. Through December 31, 2021, we sold a total of 674,106 shares of our common stock under the 2021 ATM Program at an average sale price of $ 60.5 per share and we received estimated net proceeds of $ 39.4 million, after deducting discounts and commissions to the sales agent and estimated offering expenses. Subsequently, through the date of this 2022 10-K Report, we have not sold any additional shares of our common stock under the 2021 ATM Program . The Company does not currently have an effective shelf registration statement in place and therefore, the 2021 ATM program has been suspended. Future sales, if any, under the 2021 ATM Program will depend on a variety of factors, including among others, market conditions, the trading price of our common stock, determinations by us of the appropriate sources of funding, and potential uses of funding available to us.
In February 2021, we closed on an underwritten public offering of our common stock, pursuant to which we issued 1,189,189 shares of our common stock at an offering price of $ 92.5 per share, and we received net proceeds of $ 96.6 million, after deducting the underwriting discounts and commissions and estimated offering expenses.
Warrants
As disclosed in Note 7. Debt, in 2022 we issued to the Administrative Agent and the lenders under the Financing Agreement Lender Warrants to purchase an aggregate of 435,000 shares of common stock in relation to Amendment No.16 to the Financing Agreement. In 2020, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 95,042 shares of our common stock.
The following table summarizes the status of our outstanding and exercisable warrants and related for each of the following years (in thousands, except weighed average exercise price and weighted average remaining contractual life data):
Warrants outstanding and exercisable
Warrants
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Weighted
Average
Remaining
Contractual
Life
(in Years)
Balance, December 31, 2020
131
$
77.50
$
1,041
7.3
Exercised
( 23
)
$
15.50
$
1,146
Expired
( 5
)
$
395.00
Balance, December 31, 2021
103
$
76.19
$
-
8.3
Granted
436
$
0.14
Expired
( 3
)
$
341.50
Balance, December 31, 2022
536
$
13.10
$
2,427
9.3
We used the Black Scholes option pricing model to estimate the fair value of warrants issued. The weighted average fair value of the warrants issued in 2022 was $ 0.13 per warrant and the assumptions used to determine such fair value were as follows: expected term of 10 years, volatility of 69.4 %, dividend yields of 0 % and risk-free interest rates of 2.9 %. The fair value of the Lender Warrants was based on the date of grant using our Common Stock’s closing price at measurement date and was recorded to “Additional paid-in-capital” in the consolidated balance sheets. There were no warrant grants in 2021.
F-29
Share-based payment award plans
Plan summary and description
In June 2019, our stockholders approved the TherapeuticsMD, Inc. 2019 Stock Incentive Plan, as amended (the “2019 Plan”), which replaced our previously adopted 2012 Stock Incentive Plan, as amended, and the 2009 Long-Term Incentive Compensation Plan ( referred to collectively as the “ Prior Plans”). Outstanding awards granted under the Prior Plans will remain subject to the terms and conditions in the Prior Plans.
The 2019 Plan is administered by the Compensation Committee of the Board. The purpose of the 2019 Plan is to provide a means for us and our subsidiaries and other designated affiliates (the “Related Entities”) to attract key personnel to provide services to us and the Related Entities, as well as to provide a means by which those key persons can acquire and maintain stock ownership, resulting in a strengthening of their commitment to our welfare and the welfare of the Related Entities and promoting the mutuality of interests between participants and our stockholders. A further purpose of the 2019 Stock Incentive Plan is to provide participants with additional incentive and reward opportunities designed to enhance our profitable growth and the profitable growth of the Related Entities, and provide participants with annual and long-term performance incentives to expend their maximum efforts in the creation of stockholder value. The persons eligible to receive awards under the 2019 Plan are our employees, officers, members of the Board, and consultants who provide services to us or any subsidiary.
The provisions of the 2019 Plan authorize the grant of (i) stock options, which can be “qualified” or “nonqualified” under the Internal Revenue Code of 1986, as amended, (ii) stock appreciation rights, (iii) restricted stock, (iv) restricted stock units (“RSUs”), (v) performance shares and performance units, such as performance stock units (“PSUs”), and (vi) other share-based awards. The 2019 Plan will terminate at the earliest of (i) such time as no shares remain available for issuance under the 2019 Stock Plan, (ii) termination of the 2019 by the Board, or (iii) the tenth anniversary of the effective date of the 2019 Stock Incentive Plan. Awards outstanding upon termination of the 2019 Plan will remain in effect until they have been exercised or terminated, or have expired. The term and vesting period of awards granted under the 2019 Plan are established on a per grant basis, and option expiration date is generally ten years from the date of grant.
Under the 2019 Plan, 749,500 shares of common stock are authorized for issuance, which includes 449,500 shares from the First Amendment to the 2019 Plan, which was approved by our stockholders in May 2021 plus any unallocated shares previously available for issuance under the Prior Plans that were not then subject to outstanding awards. Any shares subject to outstanding share-based payment awards under the 2019 Plan and Prior Plans that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such award (other than shares tendered or withheld in connection with the exercise of an award or the satisfaction of withholding tax liabilities), the shares to which those awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to awards under the 2019 Plan.
In August 2021, the Company hired a new President, who became our CEO in December 2021, and granted an “inducement grant” under Listing Rule 5635(c)(4) of Nasdaq of 55,000 RSUs (designated as “Time-Based Units”) and 55,000 PSUs (designated as “Performance Units”). In October 2021, the Company appointed a new Chief Business Officer and granted an “inducement grant” under Listing Rule 5635(c)(4) of Nasdaq of 13,200 RSUs (designated as “Time-Based Units”) and 5,200 PSUs (designated as “Performance Units”) . The Time-Based Units and Performance Units were granted pursuant to certain Inducement Grant Restricted Stock Unit Agreement; accordingly, these equity awards were not counted against the shares of common stock available for issuance under the 2019 Plan. As part of the termination agreement with our CEO, 55,000 Performance Units were cancelled and 55,000 RSUs vested in 2022. As part of the termination agreements with our Chief Business Officer, 3,900 Performance Units and 11,466 RSUs vested in 2022.
As of December 31, 2022, 518,074 shares of common stock were subject to outstanding awards under our share-based payment award plans and inducement grants including outstanding PSUs that were vested at 100 % as a result of termination of employees.
F-30
The following table summarizes the outstanding awards issued pursuant to our share-based payment award plans and inducement grants as of December 31, 2022 and the remaining shares of common stock available for future issuance (in thousands):
Plan Name
Options
RSUs
PSUs (1)
Remaining shares of
common stock available
for future issuance (2)
2019 Plan (3)
47
198
96
352
2012 Plan (4)
11
—
—
—
2009 Plan (5)
114
—
—
—
2021 Inducement Grants
—
48
4
—
(1)
The number of PSUs represents the number of PSUs that will vest.
(2)
The number of remaining shares of common stock available for future issuance is based on the number of PSUs that will vest .
(3)
As of December 31, 2022, outstanding options have exercise prices ranging from $ 53.5 to $ 136.5 and will expire on March 30, 2023, due to termination of employees except for awards for one employee and several consultants. Unvested RSUs will vest until July 2024. The unvested PSUs will vest until April 2025.
(4)
As of December 31, 2022, outstanding options have exercise prices ranging from $ 221.5 to $ 446 and will expire on March 30, 2023, due to termination of employees except for awards for one employee and several consultants.
(5)
As of December 31, 2022, outstanding options have exercise prices ranging from $ 90 to $ 446 and will expire on March 30, 2023 due to termination of employees except for awards for one employee and several consultants.
2021 Exchange of eligible options for RSUs
In May 2021, our stockholders approved an Offer to Exchange Eligible Options for Restricted Stock Units (the “Exchange Offer”). The Exchange Offer allowed certain employee option holders, excluding the Company’s named executive officers, advisers, consultants, contractors, or present or past non-employee directors, to exchange some or all of their outstanding options to purchase shares of common stock that were granted before August 26, 2019, and had a per share exercise price equal to or greater than $ 250.5 (“Eligible Options”), for an award of RSUs of the Company (“New RSUs”), subject to specified conditions. In September 2021, following the expiration of the Exchange Offer, 69 eligible employees elected to exchange Eligible Options, and the Company accepted for cancellation Eligible Options to purchase an aggregate of 89,860 shares of common stock, representing approximately 91.5 % of the total shares of common stock underlying the Eligible Options. Also, in September 2021, promptly following the expiration of the Exchange Offer, the Company granted 14,005 New RSUs in exchange for the cancellation of the tendered Eligible Options. The New RSUs vest in three equal annual installments beginning in September 2022, subject to the terms and conditions of the 2019 Plan.
F-31
Options
The following table summarizes the status of our outstanding and exercisable options and related transactions, including the Exchange Offer, for each for the following years (in thousands, except weighed average exercise price and weighted average remaining contractual life data):
Options awards outstanding
Options awards 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)
Balance, December 31, 2020
476
$
240.00
$
152
5.2
397
$
253.00
$
117
4.6
Granted
1
$
60.50
Exercised
( 2
)
$
1.50
$
61
Cancelled/Forfeited
( 101
)
$
300.50
Expired
( 21
)
$
201.00
Balance, December 31, 2021
353
$
225.98
$
-
3.8
336
$
230.93
$
-
3.6
Granted
-
$
-
Exercised
-
$
-
$
-
Cancelled/Forfeited
( 4
)
$
94.99
Expired
( 177
)
$
226.56
Balance, December 31, 2022
172
$
228.28
$
-
3.6
170
$
229.43
$
-
3.6
We used the Black Scholes option pricing model to estimate the fair value of options granted. There were no option grants in 2022. The weighted average fair value of the options granted in 2021 was $ 0.77 per option, and the assumptions used to determine such fair value were as follows: expected term of 6.9 years, volatility of 67.6 %, dividend yields of 0 % and risk-free interest rates of 1.1 %.
Restricted stock units
The following table summarizes the status of our RSUs and related transactions, including the Exchange Offer, for each for the following years (in thousands, except weighed average grant date fair value):
RSUs awards outstanding
RSUs awards vested
and not settled
RSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
RSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Balance, December 31, 2020
141
$
88.00
$
8,544
—
$
-
$
-
Granted
260
$
52.50
Vested and settled
( 103
)
$
78.50
$
4,021
Cancelled/Forfeited
( 27
)
$
73.50
Balance, December 31, 2021
272
$
58.00
$
4,890
31
$
105.00
$
566
Granted
170
$
16.05
Vested and settled
( 138
)
$
67.50
$
1,343
Cancelled/Forfeited
( 58
)
$
37.49
Balance, December 31, 2022
246
$
29.64
$
1,376
189
$
26.28
$
1,059
F-32
Performance stock units
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 awards outstanding
PSUs awards vested
and not settled
PSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
PSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Balance, January 1, 2020
48
$
54.00
$
2,909
—
$
—
$
—
Granted
152
$
52.00
Vested and settled
( 34
)
$
58.00
$
1,057
Cancelled/Forfeited
( 2
)
$
53.50
Balance, December 31, 2021
164
$
51.50
$
2,953
39
$
59.00
$
709
Granted
63
$
34.50
Vested and settled
( 52
)
$
58.26
$
108
Cancelled/Forfeited
( 75
)
$
44.85
Balance, December 31, 2022
100
(1)
$
42.30
$
558
81
$
39.95
$
450
(1)
The number of PSUs represents the number of PSUs that will vest.
Employee stock purchase plan
In June 2020, our stockholders approved the TherapeuticsMD, Inc. 2020 Employee Stock Purchase Plan (“ESPP”), which reserved 108,000 shares of our common stock for purchase by eligible employees. The ESPP permits eligible employees to purchase our common stock at a price per share which is equal to 85 % of the lesser of (i) the fair market value of the shares on the offering date of the offering period or (ii) the fair market value of the shares on the purchase date. In 2022, 5,229 shares were sold under the ESPP at the average price of $ 2.6 per share and we received proceeds of approximately $ 14,000 . In 2021, 6,721 shares were sold under the ESPP at an average sale price of $ 34.5 per share and we received proceeds of $ 0.2 million. In the second quarter of 2022, the ESPP Plan was suspended.
Share-based payment compensation cost
Share-based payment compensation expense for PSUs is based on 100 % vesting which was a part of termination of benefits for all employees who were terminated in 2022. We recorded share-based payment award compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under the ESPP totaling $ 11.6 million for 2022 and $ 18.1 million for 2021.
As of December 31, 2022, we had $ 0.7 million of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under the ESPP, which may be adjusted for future changes in forfeitures and is included as additional paid-in capital in the accompanying consolidated balance sheets. No tax benefit was realized due to a continued pattern of net losses.
The unrecognized compensation cost as of December 31, 2022, is expected to be recognized as share-based payment award compensation over a weighted average period of 1.4 years.
F-33
1 0 .
Revenue
Disaggregated revenue
The following table provides information about disaggregated revenue (in thousands) recognized in continuing operations:
2022
2021
License revenue:
Mayne Pharma
$
68,561
$
-
Theramex
1,402
2,573
Total revenue, net
$
69,963
$
2,573
License agreements
Mayne license agreement
Pursuant to a License Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Mayne License Agreement”), the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.
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 minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below. 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.
The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
The proceeds at closing were allocated separately to the sale of ANNOVERA and the license grant related to the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal of approximately $ 62.0 million. We also recognized approximately $ 70.0 million in revenue from transaction with Mayne Pharma which represented license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products as well as present value of future minimum royalty payments (as discussed in Note 1).
On the Closing Date, the Company 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 the Company approximately $ 1.0 million in prepaid royalties on the Closing Date. The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company. In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement, including the Company’s minimum payment obligations thereunder.
F-34
Knight license agreement
Pursuant to the terms of the Knight License Agreement, in 2020, Knight paid us $ 2.0 million in milestone fees upon the first regulatory approval in Canada for IMVEXXY and BIJUVA, and is required to pay us sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel.
We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada within certain specified time periods. We also may terminate the Knight License Agreement if Knight challenges our patents. Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters. As part of the Knight License Agreement, Knight is prohibited from exporting IMVEXXY and BIJUVA to the United States.
As of December 31, 2022, no IMVEXXY or BIJUVA sales have been made through the Knight License Agreement.
Theramex license agreement
Under the terms of the Theramex License Agreement, Theramex paid us EUR 14 million, or $ 15.5 million, in cash as an upfront fee in August 2019. Within thirty days of signing the Theramex License Agreement, we provided Theramex the regulatory materials and clinical data that were necessary for Theramex to obtain marketing authorizations and other applicable regulatory approvals for commercializing BIJUVA and IMVEXXY. In 2019, at a point in time when Theramex was able to use and benefit from the license which was when the knowledge transfer of regulatory documents occurred, we recognized the revenue related to the upfront fee, which was a non-refundable payment.
In 2021, we received additional milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets. Additionally, in December 2021, we received EUR 0.5 million, or $ 0.6 million, in additional upfront payments for the license grants of IMVEXXY in Brazil and Mexico. The additional upfront payment for the license grants of IMVEXXY in Brazil and Mexico may be returned to Theramex under certain conditions if IMVEXXY fails to obtain marketing authorization in one of Brazil or Mexico within a prespecified period. Accordingly, the additional upfront payment for the license grants of IMVEXXY in Brazil and Mexico was recorded as other non-current liabilities as of December 31, 2021 in the accompanying balance sheets.
We are eligible to receive additional sales milestone payments up to an aggregate of EUR 27.5 million in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones of BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel (collectively the “Theramex Territory”) ranging from EUR 25 million to EUR 100 million. We are also entitled to receive quarterly royalty payments at a rate of 5 % on net sales of BIJUVA and IMVEXXY in the Theramex Territory. Theramex is responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Theramex Territory.
Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Theramex Territory, except for certain specified markets. We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods. We also may terminate the Theramex License Agreement if Theramex challenges our patents. Either party may terminate the Theramex License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.
In both 2022 and 2021, we recorded BIJUVA sales of $ 1.4 million made through the Theramex License Agreement. In addition, in 2021, we received milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets. As of December 31, 2022, no IMVEXXY sales have been made through the either of the licensing agreements.
F-35
1 1 .
Income taxes
Our income (loss) from continuing operations before income taxes is as follows (in thousands):
2022
2021
United States
$
1,074
$
( 79,305
)
For the year ended December 31, 2022, there was 0 % and 0.5 % provision for income taxes in continuing and discontinued operations, respectively, current or deferred. For the year ended December 31, 2021, there was no provision for income taxes in continuing and discontinued operations, current or deferred.
As of December 31, 2022, we had a federal net operating loss (“NOL”) carryforwards of $ 640.0 million, which is available to offset future taxable income. Approximately $ 92.8 million of the federal NOLs can be carried forward for 20 years and will begin to expire in 2031 . The remaining $ 547.2 million can be carried forward indefinitely. In the event of future income, the NOL deduction arising from NOLs generated in taxable years beginning in 2021 will be limited to 80 % of the excess taxable income. The Company experienced an ownership change pursuant to IRC Sec. 382. As a result, our NOLs carryforward as of December 31, 2022 will be limited.
A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows:
2022
2021
Federal statutory tax rate
21.0
%
21.0
%
State tax rate, net of federal tax benefit
3.9
%
4.7
%
Adjustment in valuation allowances
( 3228.6
%)
( 17.8
%)
Excess stock benefits
835.2
%
( 3.2
%)
Interest expense accretion
0.0
%
0.0
%
Permanent and other differences
2368.5
%
( 4.6
%)
Provision for income taxes
0.0
%
0.0
%
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, 2022 and 2021 are as follows (in thousands):
As of December 31,
2022
2021
Deferred income tax assets:
Net operating loss
$
176,631
$
224,660
Share-based payment compensation
8,590
17,698
Interest expense limitation
19,707
20,391
Gain on sale of ANNOVERA
( 3,624
)
-
Accrual for sales returns and coupons
-
-
R&D credit
186
186
Other, net
( 1,062
)
( 1,250
)
Deferred income tax asset
200,428
261,685
Valuation allowance
( 200,428
)
( 261,685
)
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, 2022 and 2021.
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, 2022 and 2021, we had no tax positions relating to open tax returns that were considered to be uncertain, and we had no unrecognized tax benefits.
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1 2 .
Income (loss) per common share
The following table sets forth the computation of basic and diluted income (loss) per common share for the periods presented (in thousands, except per share amounts):
2022
2021
Numerator:
Net income (loss) from continuing operations
$
1,074
$
( 79,305
)
Net income (loss) from discontinued operations
110,923
( 93,110
)
Net income (loss)
$
111,997
$
( 172,415
)
Denominator:
Weighted average common shares for basic income (loss) per
common share
9,028
7,960
Effect of dilutive securities
338
-
Weighted average common shares for diluted income (loss) per
common share
9,366
7,960
Income (loss) per common share, continuing operations
Basic
$
0.12
$
( 9.96
)
Diluted
$
0.11
$
( 9.96
)
Income (loss) per common share, discontinued operations
Basic
$
12.29
$
( 11.70
)
Diluted
$
11.84
$
( 11.70
)
Since we reported a net loss for 2021, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common share are the same for 2021.
The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per common share during 2022 and 2021 (in thousands):
As of December 31,
2022
2021
Stock options
172
353
RSUs
-
272
PSUs
-
164
Warrants
101
103
273
892
1 3 .
Related parties
A former member of our Board, J. Martin Carrol, who resigned in December 2021, is also a director of Catalent. From time to time, we have entered into agreements with Catalent and its affiliates in the normal course of business. From July 2015 to December 2021, agreements with Catalent have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company. For manufacturing activities, Catalent billed us $ 4.1 million and $ 3.0 million for 2021 and 2020, respectively. As of December 31, 2021, estimated amounts payable to Catalent was $ 0.9 million. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 8, Commitments and contingencies to the financial statements included in this Annual Report. The Catalent supply agreements were assigned to Mayne as part of our transaction with Mayne Pharma.
On August 23, 2022, we appointed Mr. Justin Roberts as a director to fill a newly created vacancy on the Board. Mr. Roberts will serve until the Company’s 2022 Annual Meeting of Stockholders or until his successor is duly elected or appointed or his earlier death or resignation. As a director of the 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, 2021, filed with the Securities and Exchange Commission on April 29, 2022, but he has elected not to receive any
F-37
compensation for his service as a non-employee director at this time. Mr. Roberts currently serves as a Partner of the Preferred Stock Investor. On July 29, 2022, September 30, 2022 and October 28, 2022, we entered into subscription agreements with Preferred Stock Investor . On December 30, 2022, and in accordance with the terms of the Certificate of Designation, the Company redeemed all 29,000 outstanding shares of Series A Preferred Stock at a purchase price of $ 1,333 per share. The Company also paid certain affiliates of the Preferred Stock Investor approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between the Company and Preferred Stock Investor. See Note 9 , Mandatory Redeemable Preferred Stock and Stockholders’ Equity ( Deficit ) for additional information.
In April 2020, Karen L. Ling was appointed to our Board, who was an executive vice president and chief human resources officer of American International Group, Inc. (“AIG”) until May 2021. From time to time, we have entered into agreements with AIG in the normal course of business. From April 2020 to May 2021, agreements with AIG were reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company. For various insurance premiums, AIG billed us less than $ 0.1 million and $ 0.2 million for 2021 and 2020, respectively. As of December 31, 2021, we had no amounts payable to AIG.
1 4 .
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 License Agreement with Mayne Pharma, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2.
In 2022, 98 % of license revenue related to one customer - Mayne Pharma. In 2021, 100 % of license revenue related to one customer - Theramex.
As of December 31, 2022, we had a royalty receivable of $ 1.5 million relating to the short-term portion of receivable from Mayne Pharma and $ 20.3 million relating to long term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty (see L. Revenue Recognition above). As of December 31, 2022, we also recorded $ 1.0 million in prepaid royalties that we received from Mayne Pharma which were recorded in accrued expenses and other current liabilities.
As of December 31, 2022, three vendors each accounted for more than 10 % of our accounts payable related to continued operations. As of December 31, 2021, one vendor accounted for 54.5 % of our accounts payable balance at December 31, 2021 related to continued operations.
15. Subsequent events
On March 28, 2023, we received escrowed funds of $ 11.3 million related to customary holdbacks related to the vitaCare transaction that were recorded as restricted cash in the consolidated balance sheets as of December 31, 2022.
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