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What changed in TherapeuticsMD, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of TherapeuticsMD, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+253 added−305 removedSource: 10-K (2025-03-27) vs 10-K (2024-03-29)

Top changes in TherapeuticsMD, Inc.'s 2024 10-K

253 paragraphs added · 305 removed · 208 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

61 edited+4 added−28 removed68 unchanged
Biggest changeThe divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when we changed our business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for the years ended December 31, 2023 and 2022. 3 Going concern On the Closing Date of the Mayne Transaction, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.
Biggest changeGoing concern On the Closing Date of the Mayne Transaction, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.
The healthcare laws and regulations that may affect our licensees’ ability to operate and our ability to receive licensing revenues include: ● the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of, or the arranging for, any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal physician sunshine requirements under the ACA, which require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare or Medicaid to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.
The healthcare laws and regulations that may affect our licensees’ ability to operate and our ability to receive licensing revenues include: ● the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of, or the arranging for, any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; 9 ● the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the federal physician sunshine requirements under the ACA, which require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare or Medicaid to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members.
In addition, Section 6004 of the ACA requires annual reporting of information about drug samples that manufacturers and authorized distributors provide to healthcare providers; ● federal and state laws requiring pricing transparency or limiting price increases, which are in existence today or are anticipated to be in existence in the near future, may limit the ability to raise prices, require disclosure of price increases or require disclosure of the wholesale acquisition cost of pharmaceutical products to governmental agencies and consumers; and 9 ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers or even self-pay; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; state laws requiring a license, registration or permit to engage in manufacturing and distribution of prescription products or to engage in the practice of pharmacy; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
In addition, Section 6004 of the ACA requires annual reporting of information about drug samples that manufacturers and authorized distributors provide to healthcare providers; ● federal and state laws requiring pricing transparency or limiting price increases, which are in existence today or are anticipated to be in existence in the near future, may limit the ability to raise prices, require disclosure of price increases or require disclosure of the wholesale acquisition cost of pharmaceutical products to governmental agencies and consumers; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers or even self-pay; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures; state laws requiring a license, registration or permit to engage in manufacturing and distribution of prescription products or to engage in the practice of pharmacy; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
On December 30, 2022 (the “Closing Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA® (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith.
On December 30, 2022 (the “Closing Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company (“Mayne Pharma Group”), in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA® (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith.
We do not undertake to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information or future events or developments. 1 Our company 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.
We do not undertake to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information or future events or developments. Our company 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.
TherapeuticsMD owns or has rights to trademarks, service marks, or trade names that were previously used in connection with the operation of its business, or are now licensed by another party, including TherapeuticsMD®, vitaMedMD®, BocaGreenMD®, vitaCareTM, BIJUVA®, and IMVEXXY®, which are protected under applicable intellectual property laws and are the property of the Company.
TherapeuticsMD owns or has rights to trademarks, service marks, or trade names that were previously used in connection with the operation of its business, or are now licensed by another party, including TherapeuticsMD®, vitaMedMD®, BocaGreenMD®, BIJUVA®, and IMVEXXY®, which are protected under applicable intellectual property laws and are the property of the Company.
See “– Pharmaceutical Regulation – Regulatory Exclusivity” below for information regarding our intellectual property and challenges to that intellectual property. 6 While we seek broad coverage under our patent applications, there is always a risk that an alteration to the process may provide sufficient basis for a competitor to avoid infringement claims.
See “– Pharmaceutical Regulation – Regulatory Exclusivity” below for information regarding our intellectual property and challenges to that intellectual property. While we seek broad coverage under our patent applications, there is always a risk that an alteration to the process may provide sufficient basis for a competitor to avoid infringement claims.
Pharmaceutical regulation The process required by the FDA before a new drug product may be marketed in the U.S. generally involves the following: ● completion of or reference to extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; ● submission to the FDA of an investigational new drug (“IND”) application under which the holder may begin conducting human clinical trials, provided that the FDA does not object; the IND must be updated annually; ● performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for each proposed indication; and ● submission to the FDA of an NDA after completion of all pivotal clinical trials.
Pharmaceutical regulation The process required by the FDA before a new drug product may be marketed in the U.S. generally involves the following: ● completion of or reference to extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; ● submission to the FDA of an investigational new drug (“IND”) application under which the holder may begin conducting human clinical trials, provided that the FDA does not object; the IND must be updated annually; ● performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for each proposed indication; and ● submission to the FDA of a new drug application (“NDA”) after completion of all pivotal clinical trials.
In addition, patents expire, and we cannot provide any assurance that any patents will be issued from our pending application or that any potentially issued patents will adequately protect our intellectual property. Mayne Pharma licensed US patents and trademarks for our commercial products.
In addition, patents expire, and we cannot provide any assurance that any patents will be issued from our pending application or that any potentially issued patents will adequately protect our intellectual property. 6 Mayne Pharma licensed US patents and trademarks for our commercial products.
Item 1. Business Overview Throughout this Annual Report on Form 10-K (“2023 10-K Report”), the terms “we,” “us,” “our,” “TherapeuticsMD,” “the Company,” or “our company” refer to TherapeuticsMD, Inc., a Nevada corporation, and unless specified otherwise, include our wholly owned subsidiaries vitaMedMD, LLC, a Delaware limited liability company (“vitaMed”), and BocaGreenMD, Inc., a Nevada corporation (“BocaGreen”).
Item 1. Business Overview Throughout this Annual Report on Form 10-K (“2024 10-K Report”), the terms “we,” “us,” “our,” “TherapeuticsMD,” “the Company,” or “our Company” refer to TherapeuticsMD, Inc., a Nevada corporation, and unless specified otherwise, include our wholly owned subsidiaries vitaMedMD, LLC, a Delaware limited liability company (“vitaMed”), and BocaGreenMD, Inc., a Nevada corporation (“BocaGreen”).
Solely for convenience, trademarks, trade names and service marks referred to in this 2023 10-K Report may appear without the ®, ™ 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.
Solely for convenience, trademarks, trade names and service marks referred to in this 2024 10-K Report may appear without the ®, ™ 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 believe that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to us on the date of this 2023 10-K Report, but we cannot assure you that these assumptions and expectations will prove to have been correct or that we will take any action that we may presently be planning.
We believe that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to us on the date of this 2024 10-K Report, but we cannot assure you that these assumptions and expectations will prove to have been correct or that we will take any action that we may presently be planning.
In addition, this 2023 10-K Report includes market and industry data that we obtained from periodic industry publications, third-party studies and surveys, government-agency sources, filings of public companies in our industry, and internal-company surveys. Industry publications and surveys generally state that their information has been obtained from sources believed to be reliable.
In addition, this 2024 10-K Report includes market and industry data that we obtained from periodic industry publications, third-party studies and surveys, government-agency sources, filings of public companies in our industry, and internal-company surveys. Industry publications and surveys generally state that their information has been obtained from sources believed to be reliable.
Although we believe that the industry and market data below is reliable as of the date of this 2023 10-K Report, this information could prove to be inaccurate as a result of a variety of matters. Forward-looking statements This 2023 10-K Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Although we believe that the industry and market data below is reliable as of the date of this 2024 10-K Report, this information could prove to be inaccurate as a result of a variety of matters. Forward-looking statements This 2024 10-K Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
As of December 31, 2023, we have many domestic and foreign patents that cover our licensed products, including many for each of BIJUVA and IMVEXXY that are Orange Book listed for the licensed products. We hold multiple U.S. trademark registrations and have numerous pending trademark applications.
As of December 31, 2024, we have many domestic and foreign patents that cover our licensed products, including many for each of BIJUVA and IMVEXXY that are Orange Book listed for the licensed products. We hold multiple U.S. trademark registrations and have numerous pending trademark applications.
An Abbreviated New Drug Application (“ANDA”) or 505(b)(2) application for a drug containing the protected active ingredient of the NCE product generally cannot be submitted to FDA until the end of the five-year exclusivity period, except that such applications can be submitted at year four if the product is covered by an Orange Book listed patent and the ANDA or 505(b)(2) NDA includes a Paragraph IV Certification challenging such patent.
An ANDA or 505(b)(2) application for a drug containing the protected active ingredient of the NCE product generally cannot be submitted to FDA until the end of the five-year exclusivity period, except that such applications can be submitted at year four if the product is covered by an Orange Book listed patent and the ANDA or 505(b)(2) NDA includes a Paragraph IV Certification challenging such patent.
The information contained on our website or that can be accessed through our website is not incorporated by reference into this 2023 10-K Report or in any other report or document we file with the SEC. 10
The information contained on our website or that can be accessed through our website is not incorporated by reference into this 2024 10-K Report or in any other report or document we file with the SEC.
These statements may be found in the items of this 2023 10-K Report entitled “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as in this 2023 10-K Report generally.
These statements may be found in the items of this 2024 10-K Report entitled “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as in this 2024 10-K Report generally.
See Note 2 - Discontinued Operations to the consolidated financial statements included in this Annual Report on Form 10-K for further details. 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.
See “Note 2 - Discontinued Operations” to the consolidated financial statements included in this Annual Report on Form 10-K for further details. 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.
This 2023 10-K Report also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners.
This 2024 10-K Report also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners.
In 2022, the Sunshine Act has been extended to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners (with reporting requirements going into effect in 2022 for payments made in 2021).
In 2022, the Sunshine Act was extended to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners (with reporting requirements going into effect in 2022 for payments made in 2021).
In addition, Section 505(j) of the FDCA provides for a significantly shortened regulatory pathway for approval of a “generic” version of a new drug, by way of an Abbreviated New Drug Application or ANDA.
In addition, Section 505(j) of the FDCA provides for a significantly shortened regulatory pathway for approval of a “generic” version of a new drug, by way of an Abbreviated New Drug Application (“ANDA”).
The total consideration from Mayne Pharma to TherapeuticsMD for the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement was (i) a cash payment of $140.0 million at closing, (ii) a cash payment of approximately $12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
The total consideration from Mayne Pharma to TherapeuticsMD for the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement was (i) a cash payment of $140.0 million at closing, (ii) a cash payment of approximately $12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended. 2 On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment No. 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”).
In February 2024, the Company received Mayne Pharma’s calculation of allowance for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement which differed significantly from the Company’s estimate of the allowances.
In February 2024, the Company received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed significantly from the Company’s estimate of the allowances.
On November 15, 2023 Rubric drew down an additional 877,192 shares of Common Stock at a price per share equal to $2.2761. We received gross proceeds of $2.0 million from the drawdown, before expenses.
On November 15, 2023, Rubric drew down an additional 877,192 shares of Common Stock at a price per share equal to $2.2761. We received gross proceeds of $2.0 million from the drawdown, before expenses. There were no draw downs in 2024.
Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business, and damage our reputation.
In addition, these laws and their interpretations are subject to change. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business, and damage our reputation.
As part of the transformation that included the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in our consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our consolidated balance sheets.
As part of the transformation that included the Mayne License Agreement, all results associated with former commercial operations have been reflected as discontinued operations in our consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our consolidated balance sheets.
The potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
The potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of the financial statements included in this Annual Report on Form 10-K.
If Mayne Pharma’s sales of Licensed Products grow more slowly than expected or decline, if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are unsuccessful with future financings or the supply chains related to the third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements.
(“Cosette”), if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are unsuccessful with future financings or the supply chains related to the third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements.
We and Mayne Pharma settled the $1.5 million of consideration due to Mayne Pharma for the assumed obligations under a long-term services agreement (see the section entitled “vitaCare divestiture” below for a discussion of the long-term services agreement), including our minimum payment obligations thereunder.
We and Mayne Pharma settled the $1.5 million of consideration due to Mayne Pharma for the assumed obligations under a long-term services agreement, including our minimum payment obligations thereunder.
Should this occur, the FDA would be precluded from granting final approval to any ANDA or 505(b)(2) application for the same condition of use or change to the marketed product that was granted exclusivity until after that three-year exclusivity period has run.
Should this occur, the FDA would be precluded from granting final approval to any ANDA or 505(b)(2) application for the same condition of use or change to the marketed product that was granted exclusivity until after that three-year exclusivity period has run. 8 Additionally, any ANDA or 505(b)(2) NDA that references the 505(b) product must include one of several types of patent certifications.
Historically, our product development programs were concentrated in advanced hormone therapy pharmaceutical products. Intellectual property Patents and trademarks Our success depends, in part, on our ability to obtain patents, maintain trade-secret protection, and operate without infringing the proprietary rights of others. Our intellectual property portfolio is one way we attempt to protect our competitive position.
Intellectual property Patents and trademarks Our success depends, in part, on our ability to obtain patents, maintain trade-secret protection, and operate without infringing the proprietary rights of others. Our intellectual property portfolio is one way we attempt to protect our competitive position.
On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment No. 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”). Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay us approximately $1.0 million in prepaid royalties on the Closing Date.
Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay us approximately $1.0 million in prepaid royalties on the Closing Date.
(“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.
Knight obtained regulatory approval for IMVEXXY and BIJUVA and began commercialization efforts in 2024. ● 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.
Our licensees rely, and expect to continue to rely, on third parties to produce commercial quantities of our licensed drugs. Future FDA and state inspections may identify compliance issues at the facilities of the manufacturers of our licensed products that may disrupt production or distribution or require substantial resources to correct.
Future FDA and state inspections may identify compliance issues at the facilities of the manufacturers of our licensed products that may disrupt production or distribution or require substantial resources to correct.
As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees.
As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company believes the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.
Factors that could cause or contribute to such differences include, but are not limited to, competition from other businesses, market and general economic factors, and the other risks discussed in Item 1A of this 2023 10-K Report. This discussion should be read in conjunction with the consolidated financial statements and notes thereto included in this 2023 10-K Report.
Factors that could cause or contribute to such differences include, but are not limited to, competition from other businesses, market and general economic factors, and the other risks discussed in Item 1A of this 2024 10-K Report.
Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.
The Company has not recorded any contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.
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.
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. 3 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.
This pharmaceutical product is a one-year ring-shaped contraceptive vaginal system (“CVS”) and the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent pregnancy for up to a total of 13 cycles (one year). ANNOVERA is commercially sold in the U.S. pursuant to the terms of the Population Council License Agreement.
ANNOVERA (segesterone acetate (“SA”) and ethinyl estradiol (“EE”) vaginal system) This pharmaceutical product is a one-year ring-shaped contraceptive vaginal system (“CVS”) and the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent pregnancy for up to a total of 13 cycles (one year).
As of December 31, 2023, no IMVEXXY sales had been made through the Theramex and Knight licensing agreements. The FDA has also asked the sponsors of other vaginal estrogen products to participate in the observational study. In connection with the observational study, we would have been required to provide progress reports to the FDA on an annual basis.
In December 2024, we transferred the right to commercialize IMVEXXY in Israel from Knight to Theramex. The FDA has also asked the sponsors of other vaginal estrogen products to participate in the observational study. In connection with the observational study, we would have been required to provide progress reports to the FDA on an annual basis.
We have identified some of the important factors that could cause future events to differ from our current expectations and they are described in this 2023 10-K Report in the section entitled “Risk Factors” that you should review carefully. Please consider our forward-looking statements in light of those risks as you read this 2023 10-K Report.
This discussion should be read in conjunction with the consolidated financial statements and notes thereto included in this 2024 10-K Report. 1 We have identified some of the important factors that could cause future events to differ from our current expectations and they are described in this 2024 10-K Report in the section entitled “Risk Factors” that you should review carefully.
Manufacturing of our licensed products As of December 30, 2022, we were no longer responsible for any manufacturing and have no manufacturing contracts. All manufacturing responsibility of our licensed products has been transferred to our licensees. Research and development As of December 30, 2022, we no longer conduct any research and development activities.
All manufacturing responsibility of our licensed and assigned products has been transferred to our licensees. Research and development As of December 30, 2022, we no longer conduct any research and development activities. Historically, our product development programs were concentrated in advanced hormone therapy pharmaceutical products.
Our obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement. 5 Prenatal vitamin products On December 30, 2022, we granted an exclusive license to commercialize, in the United States and its possessions and territories, our prescription prenatal vitamin product lines under our vitaMedMD brand name and authorized generic formulations of some of our prescription prenatal vitamin products under our BocaGreenMD prenatal name to Mayne Pharma.
Prenatal vitamin products On December 30, 2022, we granted an exclusive license to commercialize, in the United States and its possessions and territories, our prescription prenatal vitamin product lines under our vitaMedMD brand name and authorized generic formulations of some of our prescription prenatal vitamin products under our BocaGreenMD prenatal name to Mayne Pharma. 5 Sales concentration Our business model is dependent on third parties achieving specified milestones and product sales.
The Company believes its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this point.
The Company continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the processes permitted in the Transaction Agreement. The outcome of this matter is uncertain at this point.
If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we project.
Please consider our forward-looking statements in light of those risks as you read this 2024 10-K Report. If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we project.
The accompanying consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern. 4 Portfolio of our royalty-bearing products On December 30, 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.
Portfolio of our royalty-bearing products On December 30, 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.
(“Teva”). See Legal Proceedings in Item 3 of this 2023 10-K Report for additional information. 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 U.S.
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 U.S. District Court for the District of New Jersey arising from Amneal’s ANDA filing with FDA.
If any of the HCPs, providers, or entities with whom we do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including exclusion from government funded healthcare programs.
If any of the HCPs, providers, or entities with whom we do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including exclusion from government funded healthcare programs. 10 Many aspects of these laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations that increases the risk of potential violations.
Also, quality control and manufacturing procedures must continue to conform to cGMPs to ensure and preserve the long-term stability of the drug product. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.
Although physicians may prescribe legally available products for off-label use if they deem such use to be appropriate in their professional medical judgment, manufacturers may not market or promote such off-label uses. 7 Also, quality control and manufacturing procedures must continue to conform to cGMPs to ensure and preserve the long-term stability of the drug product. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.
We have entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA for human use outside of the U.S., except for Canada and Israel. ANNOVERA (segesterone acetate (“SA”) and ethinyl estradiol (“EE”) vaginal system) On December 30, 2022, we assigned our exclusive license to commercialize ANNOVERA to Mayne Pharma.
We have entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA for human use outside of the U.S., except for Canada and Israel. In December 2024, we transferred the right to commercialize BIJUVA in Israel from Knight to Theramex.
In addition to the fraud and abuse laws, we continue to monitor the potential impact of proposals to lower prescription drug costs at the federal and state level. For example, in November 2021, the Biden Administration announced several prescription drug pricing proposals as part of the Build Back Better legislation.
In addition to the fraud and abuse laws, we continue to monitor the potential impact of proposals to change prescription drug costs at the federal and state level.
Sales concentration Our business model is dependent on third parties achieving specified milestones and product sales. For information on the concentration of licenses of our products, see “Note 10. Revenue” to the consolidated financial statements included in this 2023 10-K Report. Currently, the Company collects license revenue from two licensees.
For information on the concentration of licenses of our products, see “Note 9. Revenue” to the consolidated financial statements included in this 2024 10-K Report. Currently, the Company collects license revenue from two licensees. Seasonality The pharmaceutical markets in which we license our products are not subject to seasonal sales fluctuations.
IMVEXXY (estradiol vaginal inserts), 4-μg and 10-μg This pharmaceutical product is for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy due to menopause.
On December 30, 2022, we granted an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands and assigned our exclusive license to commercialize ANNOVERA to Mayne Pharma. 4 IMVEXXY (estradiol vaginal inserts), 4-μg and 10-μg This pharmaceutical product is for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy due to menopause.
A 30-month stay can be terminated early, and the Paragraph IV application can be immediately approved, if the district court rules in favor of the Paragraph IV applicant that the patent is invalid, unenforceable, or would not be infringed. 8 In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an ANDA submitted to FDA by Teva Pharmaceuticals USA, Inc.
Generally, no more than one 30-month stay may be applied against any specific Paragraph IV ANDA or 505(b)(2) NDA. A 30-month stay can be terminated early, and the Paragraph IV application can be immediately approved, if the district court rules in favor of the Paragraph IV applicant that the patent is invalid, unenforceable, or would not be infringed.
Seasonality The pharmaceutical markets in which we license our products are not subject to seasonal sales fluctuations. However, our license revenues for the first quarter of each year can be negatively affected by the annual reset of high-deductible commercial insurance plans.
However, our license revenues for the first quarter of each year can be negatively affected by the annual reset of high-deductible commercial insurance plans. Manufacturing of our licensed products As of December 30, 2022, we were no longer responsible for any manufacturing and have no manufacturing contracts.
On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would serve as our Principal Financial and Accounting Officer. On August 17, 2023 Michael C.
We have engaged external consultants who support our relationship with current partners and assist with certain financial, IT, legal, and regulatory matters and the continued wind-down of our historical business operations. On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler serves as our Principal Financial and Accounting Officer.
On December 30, 2022, we granted an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands and assigned our exclusive license to commercialize ANNOVERA to Mayne Pharma.
On December 30, 2022, we assigned our exclusive license to commercialize ANNOVERA in the United States and its possessions and territories to Mayne Pharma.
Accordingly, manufacturers must continue to expend time, money and effort in production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance. 7 The FDA periodically inspects manufacturing facilities to assess compliance with cGMP, which imposes extensive procedural, substantive, and record keeping requirements.
Accordingly, manufacturers must continue to expend time, money and effort in production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance. Our licensees rely, and expect to continue to rely, on third parties to produce commercial quantities of our licensed drugs.
As of December 31, 2023, the Company believes no additional accrual is required for amounts that may be owed for the allowance for returns under the Transaction Agreement. The Company has not recorded any contingent gains or receivables for any such allowances.
In August 2024, the Company received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly from the Company’s estimate of the allowance. As of December 31, 2024, the Company believed no additional accrual was required for amounts that may be owed for the allowance for returns under the Transaction Agreement.
In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries. Employees In connection with our transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr.
In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries. ● In December 2024, we transferred the right to commercialize IMVEXXY and BIJUVA in Israel from Knight to Theramex. Employees As of December 31, 2024, we employed one full-time employee primarily engaged in an executive position.
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Mayne Pharma paid us approximately $12.1 million at closing on the Closing Date for the acquisition of net working capital, subject to certain adjustments as determined in accordance with the Transaction Agreement.
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(“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
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While the Transaction Agreement calls for much of the net working capital to be trued-up shortly after the Closing Date in 2023, for a period of one year following the Closing Date in the case of payer rebates and wholesale distributor fees and two years following the Closing Date in the case for allowance for returns, net working capital amounts will be adjusted to arrive at final net working capital under the Transaction Agreement.
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If Mayne Pharma’s sales of Licensed Products grow more slowly than expected or decline, including as a result of Mayne Pharma Group’s pending sale to Cosette Pharmaceuticals, Inc.
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In September 2023, we revised certain accrual estimates including increasing our working capital adjustment accrual from $3.5 million to $5.5 million for amounts anticipated to be owed under the Transaction Agreement.
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The accompanying consolidated financial statements included in this Annual Report on Form 10-K do not include any adjustments that might be necessary if we are unable to continue as a going concern.
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In December 2023, we made a $5.5 million payment to Mayne Pharma to settle certain working capital amounts that were required to be trued-up shortly after the Closing Date, excluding the allowance for returns, allowance for payer rebates, and allowance for wholesale distributor fees. 2 In February 2024, the Company received Mayne Pharma’s calculation of allowance for payer rebates and wholesale distributor fees which differed significantly from the Company’s estimate of the allowances.
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In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an ANDA submitted to FDA by Teva Pharmaceuticals USA, Inc. (“Teva”). See “Legal Proceedings” in Item 3 of this 2024 10-K Report for additional information.
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Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma that may be material.
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Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 31, 2022. Severance obligations for all employees other than executive officers were paid in full in January 2023 and severance obligations for terminated executive officers were paid in accordance with their employment agreements and separation agreements as previously disclosed.
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As of December 31, 2023, we employed one full-time employee primarily engaged in an executive position. We have engaged external consultants who support our relationship with current partners and assist with certain financial, legal, and regulatory matters and the continued wind-down of our historical business operations.
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Donegan notified us of his decision to resign from the positions of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023. Mr. Ziegler succeeded Mr. Donegan as Principal Financial and Accounting Officer as of the date of Mr.
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Donegan’s resignation. vitaCare divestiture On April 14, 2022, we completed the divestiture of our former subsidiary vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”).
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We received net proceeds of $142.6 million, after deducting transaction costs of $7.2 million, and we recognized a gain on sale of business of $143.4 million. Included in the net proceeds amount was $11.3 million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”) which we received in 2023.
Removed
Additionally, the Purchase Agreement provides that we may receive up to an additional $7.0 million in earn-out consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement; however, we do not believe this earnout will be realized.
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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.
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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.
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The Company believes its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this point.
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As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe following is a summary of the principal risk factors described in this section: ● We currently derive all of our revenues from royalties related to sales of our products, and the failure of our licensees to maintain or increase sales of these products could have an adverse effect on our business, financial condition, results of operations, and growth prospects. ● We have incurred net losses in the past and there are no assurances we will be able to maintain or increase profitability in the future. ● There is substantial doubt about our ability to continue as a going concern. ● We could be affected by transitions in our senior management team. ● The dependence upon third parties for the manufacture and supply of our women’s healthcare products may cause delays in, or prevent our licensees from, successfully commercializing and marketing our products. ● The commercial success of our products will depend upon gaining and retaining significant market acceptance of these products among physicians and payers. ● Coverage and reimbursement may not be available for our products, which could make it difficult for our licensees to sell our products profitably. ● Time and costs associated with winding down our general and administrative, commercial, and research and development activities may be significant. ● Licensing of intellectual property involves complex legal, business and scientific issues, and disputes could jeopardize our rights under such agreements. ● Our products and our licensees are subject to extensive government regulation. ● We must rely on Mayne Pharma to prosecute, file lawsuits, or take other actions to protect or enforce our intellectual property and there can be no assurance they will take such actions or be successful. ● If efforts to protect the proprietary nature of the intellectual property covering our hormone therapy pharmaceutical products and other products are not adequate, our licensees may not be able to compete effectively in the market, which would adversely affect our royalties. ● Our products face significant competition from branded and generic products, and our operating results will suffer if our products fail to compete effectively. ● Our success is tied to the distribution channels of our licensees. ● Any failure of our licensees to adequately maintain a sales force or effectively implement sales strategies will impede our growth. ● Our future success depends on our ability to attract and retain qualified personnel. ● Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock. 11 Risks related to our business We currently derive all revenue from royalties related to sales of our licensed women’s healthcare products, and the failure of our licensees to maintain or increase sales of these products could have an adverse effect on our business, financial condition, results of operations, and growth prospects.
Biggest changeThe following is a summary of the principal risk factors described in this section: ● We currently derive all of our revenues from royalties related to sales of our products, and the failure of our licensees to maintain or increase sales of these products could have an adverse effect on our business, financial condition, results of operations, and growth prospects. ● We have incurred net losses in the past and there are no assurances we will be able to maintain or increase profitability in the future. ● There is substantial doubt about our ability to continue as a going concern. ● The dependence upon third parties for the manufacture and supply of our women’s healthcare products may cause delays in, or prevent our licensees from, successfully commercializing and marketing our products. ● The commercial success of our products will depend upon gaining and retaining significant market acceptance of these products among physicians and payers. ● Coverage and reimbursement may not be available for our products, which could make it difficult for our licensees to sell our products profitably. 11 ● Our revenue, results of operations and financial position could be affected by our ongoing disputes with Mayne Pharma. ● Time and costs associated with winding down our general and administrative, commercial, and research and development activities may be significant. ● We could be affected by transitions in our senior management team. ● We sublease our properties, which could expose us to possible liabilities and losses. ● Licensing of intellectual property involves complex legal, business and scientific issues, and disputes could jeopardize our rights under such agreements. ● Our products and our licensees are subject to extensive government regulation. ● We must rely on Mayne Pharma to prosecute, file lawsuits, or take other actions to protect or enforce our intellectual property and there can be no assurance they will take such actions or be successful. ● If efforts to protect the proprietary nature of the intellectual property covering our hormone therapy pharmaceutical products and other products are not adequate, our licensees may not be able to compete effectively in the market, which would adversely affect our royalties. ● Our products face significant competition from branded and generic products, and our operating results will suffer if our products fail to compete effectively. ● Our success is tied to the distribution channels of our licensees. ● Any failure of our licensees to adequately maintain a sales force or effectively implement sales strategies will impede our growth. ● The announcement and pendency of Mayne Pharma Group’s agreement to be acquired by Cosette Pharmaceuticals, Inc. could have an adverse effect on our business, operations, and financial condition. ● Our future success depends on our ability to attract and retain qualified personnel. ● Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock. 12 Risks related to our business We currently derive all revenue from royalties related to sales of our licensed women’s healthcare products, and the failure of our licensees to maintain or increase sales of these products could have an adverse effect on our business, financial condition, results of operations, and growth prospects.
These provisions in our articles of incorporation and bylaws include the following: ● authorizing the issuance of “blank check” preferred stock that could be issued by our board of directors (the “Board”) to increase the number of outstanding shares and thwart a takeover attempt; ● prohibiting cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates; and ● advance notice provisions in connection with stockholder proposals that may prevent or hinder any attempt by our stockholders to bring business to be considered by our stockholders at a meeting or replace our board of directors.
These provisions in our articles of incorporation and bylaws include the following: ● authorizing the issuance of “blank check” preferred stock that could be issued by our board of directors (the “Board”) to increase the number of outstanding shares and thwart a takeover attempt; ● prohibiting cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates; and ● advance notice provisions in connection with stockholder proposals that may prevent or hinder any attempt by our stockholders to bring business to be considered by our stockholders at a meeting or replace our Board.
Market acceptance of our products, including our hormone therapy pharmaceutical products and patient-controlled, long-acting contraceptive, by physicians, patients, and payers, will depend on a number of factors, many of which are beyond our control, including the following: ● the clinical indications for which our hormone therapy pharmaceutical products and patient-controlled, long-acting contraceptive are approved; ● acceptance by physicians and payers of each product as a safe and effective treatment; ● the cost of treatment in relation to alternative treatments, including numerous generic pharmaceutical products; ● the relative convenience and ease of administration of our products in the treatment of the symptoms for which they are intended; ● the availability and efficacy of competitive drugs and devices; ● the effectiveness of our licensee’s sales force and marketing efforts; ● the extent to which the product is approved for inclusion on formularies of hospitals and managed care organizations, including any access barriers such as prior authorizations and step-edits; ● the availability of coverage and adequate reimbursement by third parties, such as insurance companies and other healthcare payers, or by government healthcare programs, including Medicare and Medicaid; ● limitations or warnings contained in a product’s FDA-approved labeling; and ● prevalence and severity of adverse side effects.
Market acceptance of our products, including our hormone therapy pharmaceutical products and patient-controlled, long-acting contraceptive, by physicians, patients, and payers, will depend on a number of factors, many of which are beyond our control, including the following: ● the clinical indications for which our hormone therapy pharmaceutical products and patient-controlled, long-acting contraceptive are approved; ● acceptance by physicians and payers of each product as a safe and effective treatment; 15 ● the cost of treatment in relation to alternative treatments, including numerous generic pharmaceutical products; ● the relative convenience and ease of administration of our products in the treatment of the symptoms for which they are intended; ● the availability and efficacy of competitive drugs and devices; ● the effectiveness of our licensee’s sales force and marketing efforts; ● the extent to which the product is approved for inclusion on formularies of hospitals and managed care organizations, including any access barriers such as prior authorizations and step-edits; ● the availability of coverage and adequate reimbursement by third parties, such as insurance companies and other healthcare payers, or by government healthcare programs, including Medicare and Medicaid; ● limitations or warnings contained in a product’s FDA-approved labeling; and ● prevalence and severity of adverse side effects.
If a third-party asserts that we infringe its patents or other proprietary rights, we could face many risks that could adversely affect our business, financial condition, results of operations, and prospects, including the following: ● infringement and other intellectual property claims, which would be costly and time-consuming to defend, whether or not we are ultimately successful, which in turn could delay the regulatory approval process, consume our capital, and divert management’s attention from our business; ● substantial damages for past infringement, which we may have to pay if a court determines that our products or technologies infringe a competitor’s patent or other proprietary rights; ● a court prohibiting us from selling or licensing our technologies or future products unless the third-party licenses its patents or other proprietary rights to us on commercially reasonable terms, which it is not required to do; ● if a license is available from a third-party, we may have to pay substantial royalties or lump sum payments or grant cross licenses to our patents or other proprietary rights to obtain that license; or ● redesigning our products so they do not infringe, which may not be possible or may require substantial monetary expenditures and time.
If a third-party asserts that we infringe its patents or other proprietary rights, we could face many risks that could adversely affect our business, financial condition, results of operations, and prospects, including the following: ● infringement and other intellectual property claims, which would be costly and time-consuming to defend, whether or not we are ultimately successful, which in turn could delay the regulatory approval process, consume our capital, and divert management’s attention from our business; ● substantial damages for past infringement, which we may have to pay if a court determines that our products or technologies infringe a competitor’s patent or other proprietary rights; ● a court prohibiting us from selling or licensing our technologies or future products unless the third-party licenses its patents or other proprietary rights to us on commercially reasonable terms, which it is not required to do; 34 ● if a license is available from a third-party, we may have to pay substantial royalties or lump sum payments or grant cross licenses to our patents or other proprietary rights to obtain that license; or ● redesigning our products so they do not infringe, which may not be possible or may require substantial monetary expenditures and time.
Our stock price could be subject to wide fluctuations in response to a variety of factors, which include the following: ● changes in laws or regulations applicable to our products; ● unanticipated serious safety concerns related to the use of our products; ● the inability for our licensees to obtain adequate supply for our products or the inability to do so at acceptable prices; ● adverse regulatory decisions; ● the introduction of new products or technologies offered by our competitors; ● the effectiveness of our licensees’ commercialization efforts; 29 ● the perception of the pharmaceutical industry by the public, legislatures, regulators, and the investment community; ● disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; ● actual or anticipated variations in quarterly operating results; ● the failure to meet or exceed the estimates and projections of the investment community; ● the overall performance of the U.S. equity markets and general political and economic conditions; ● announcements of significant acquisitions, strategic partnerships, joint ventures, or capital commitments by us or our competitors; ● additions or departures of key management personnel; ● adverse market reaction to any indebtedness we may incur or securities we may issue in the future; ● sales of our common stock by us or our stockholders in the future; ● significant lawsuits, including patent or stockholder litigation; ● changes in the market valuations of similar companies; ● the trading volume of our common stock; ● increases in our common stock available for sale upon expiration of lock-up agreements; ● effects of natural or man-made catastrophic events or other business interruptions; and ● other events or factors, many of which are beyond our control.
Our stock price could be subject to wide fluctuations in response to a variety of factors, which include the following: ● changes in laws or regulations applicable to our products; ● unanticipated serious safety concerns related to the use of our products; ● the inability for our licensees to obtain adequate supply for our products or the inability to do so at acceptable prices; ● adverse regulatory decisions; ● the introduction of new products or technologies offered by our competitors; ● the effectiveness of our licensees’ commercialization efforts; 35 ● the perception of the pharmaceutical industry by the public, legislatures, regulators, and the investment community; ● disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies; ● actual or anticipated variations in quarterly operating results; ● the failure to meet or exceed the estimates and projections of the investment community; ● the overall performance of the U.S. equity markets and general political and economic conditions; ● announcements of significant acquisitions, strategic partnerships, joint ventures, or capital commitments by us or our competitors; ● additions or departures of key management personnel; ● adverse market reaction to any indebtedness we may incur or securities we may issue in the future; ● sales of our common stock by us or our stockholders in the future; ● significant lawsuits, including patent or stockholder litigation; ● changes in the market valuations of similar companies; ● the trading volume of our common stock; ● increases in our common stock available for sale upon expiration of lock-up agreements; ● effects of natural or man-made catastrophic events or other business interruptions; and ● other events or factors, many of which are beyond our control.
The release of such information or misappropriation of assets could have an adverse effect on our business, financial condition, and results of operations. Employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading. We are exposed to the risk of employee fraud or other misconduct.
The release of such information or misappropriation of assets could have an adverse effect on our business, financial condition, and results of operations. 33 Employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading. We are exposed to the risk of employee fraud or other misconduct.
There can be no assurances that we will be able to obtain a license to such patent on favorable terms or at all. Failure to obtain such license may have an adverse effect on our business. 28 There is a substantial amount of litigation involving intellectual property in the pharmaceutical industry generally.
There can be no assurances that we will be able to obtain a license to such patent on favorable terms or at all. Failure to obtain such license may have an adverse effect on our business. There is a substantial amount of litigation involving intellectual property in the pharmaceutical industry generally.
Such guidelines or recommendations may lead to lower sales of our products. 18 Manufacturers of pharmaceutical products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with the FDA’s cGMP regulations and other regulatory requirements, such as adverse event reporting.
Such guidelines or recommendations may lead to lower sales of our products. Manufacturers of pharmaceutical products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with the FDA’s cGMP regulations and other regulatory requirements, such as adverse event reporting.
Any of these disruptions or breaches of security could have an adverse effect on our business, financial condition, and results of operations. Our failure to comply with foreign data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
Any of these disruptions or breaches of security could have an adverse effect on our business, financial condition, and results of operations. 32 Our failure to comply with foreign data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
If any of our are shown to be harmful or generate negative publicity from perceived harmful effects, our business, financial condition, results of operations, and prospects could be harmed significantly. Our products face significant competition from branded and generic products, and our operating results will suffer if we fail to compete effectively.
If any of our products are shown to be harmful or generate negative publicity from perceived harmful effects, our business, financial condition, results of operations, and prospects could be harmed significantly. 23 Our products face significant competition from branded and generic products, and our operating results will suffer if we fail to compete effectively.
The foregoing could harm our business and we cannot anticipate all the ways in which unfavorable economic conditions and financial market conditions could harm our business. 15 Licensing of intellectual property involves complex legal, business, and scientific issues, and disputes could jeopardize our rights under such agreements.
The foregoing could harm our business and we cannot anticipate all the ways in which unfavorable economic conditions and financial market conditions could harm our business. Licensing of intellectual property involves complex legal, business, and scientific issues, and disputes could jeopardize our rights under such agreements.
The sales force of our licensees may continue to use a hybrid model of office visits when necessary and digital engagement tools and tactics and virtual detailing, which may be less effective than their ordinary course sales and marketing programs.
Accordingly, the sales force of our licensees may continue to use a hybrid model of office visits when necessary and digital engagement tools and tactics and virtual detailing, which may be less effective than their ordinary course sales and marketing programs.
We have also entered into licensing and supply agreements with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel and with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA, and IMVEXXY outside of the U.S., except for Canada and Israel.
We have also entered into licensing and supply agreements with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA, and IMVEXXY outside of the U.S., except for Canada.
Adverse publicity in the form of published scientific research, statements by regulatory authorities or otherwise, whether or not accurate, that associates use of our products or any other similar products with illness or other adverse effects, or that questions the benefits of our products or similar products, or that claims that such products do not have the effect intended, or that question the marketing of our products, could have an adverse effect on our business, reputation, financial condition, or results of operations. 25 Our licensees may initiate product recalls or withdrawals or may be subject to regulatory enforcement actions that could negatively affect our business.
Adverse publicity in the form of published scientific research, statements by regulatory authorities or otherwise, whether or not accurate, that associates use of our products or any other similar products with illness or other adverse effects, or that questions the benefits of our products or similar products, or that claims that such products do not have the effect intended, or that question the marketing of our products, could have an adverse effect on our business, reputation, financial condition, or results of operations. 30 Our licensees may initiate product recalls or withdrawals or may be subject to regulatory enforcement actions that could negatively affect our business.
Obtaining and maintaining favorable reimbursement can be a time-consuming and expensive process, and our licensees may not be able to negotiate or continue to negotiate reimbursement or pricing terms for our products with payers at levels that are profitable to them, or at all. 14 In both the U.S. and some foreign jurisdictions, there have been several legislative and regulatory proposals to change the healthcare system in ways that could affect our licensees’ ability to sell our products profitably.
Obtaining and maintaining favorable reimbursement can be a time-consuming and expensive process, and our licensees may not be able to negotiate or continue to negotiate reimbursement or pricing terms for our products with payers at levels that are profitable to them, or at all. 16 In both the U.S. and some foreign jurisdictions, there have been several legislative and regulatory proposals to change the healthcare system in ways that could affect our licensees’ ability to sell our products profitably.
Any material loss that we may experience in the future could have a material adverse effect on our financial condition and could materially impact our ability to pay our operational expenses or make other payments. 16 Our products and our licensees are subject to extensive and costly government regulation.
Any material loss that we may experience in the future could have a material adverse effect on our financial condition and could materially impact our ability to pay our operational expenses or make other payments. 19 Our products and our licensees are subject to extensive and costly government regulation.
Item 1A. Risk factors Investing in our common stock involves a high degree of risk. You should carefully consider the following risk factors, together with all of the information included in this 2023 10-K Report and our other filings with the SEC, before you decide to purchase shares of our common stock.
Item 1A. Risk factors Investing in our common stock involves a high degree of risk. You should carefully consider the following risk factors, together with all of the information included in this 2024 10-K Report and our other filings with the SEC, before you decide to purchase shares of our common stock.
If we are unable to improve our liquidity position, we may not be able to continue as a going concern. 12 We have experienced significant turnover in our top executives, and our business could be adversely affected by these and other transitions in our senior management team.
If we are unable to improve our liquidity position, we may not be able to continue as a going concern. 13 We have experienced significant turnover in our top executives, and our business could be adversely affected by these and other transitions in our senior management team.
We maintain our cash at financial institutions, often in balances that exceed federally insured limits. The majority of our cash is held in accounts at U.S. banking institutions that we believe are of high quality. Cash held in depository accounts may exceed the $250,000 Federal Deposit Insurance Corporation (“FDIC”) insurance limits.
We maintain our cash at financial institutions, often in balances that exceed federally insured limits. The majority of our cash is held in accounts at U.S. banking institutions that we believe are of high quality. Cash held in depository accounts may exceed the $250 thousand Federal Deposit Insurance Corporation (“FDIC”) insurance limits.
Our current liquidity position raises substantial doubt about our ability to continue as a going concern and Berkowitz Pollack Brant, Advisors + CPAs, our independent registered public accounting firm for the fiscal year ended December 31, 2023, has included an explanatory paragraph in their opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2023, indicating such.
Our current liquidity position raises substantial doubt about our ability to continue as a going concern and Berkowitz Pollack Brant, Advisors + CPAs, LLP, our independent registered public accounting firm for the fiscal year ended December 31, 2024, has included an explanatory paragraph in their opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2024, indicating such.
We may incur substantial additional losses over the next few years because of costs associated with the winddown of our historical business as well as the ongoing costs of being a public company. As a result, we may not maintain or increase profitability.
We may incur substantial additional losses over the next few years because of costs associated with the wind down of our historical business as well as the ongoing costs of being a public company. As a result, we may not maintain or increase profitability.
If Mayne Pharma, with respect to the ANNOVERA license agreement that we have assigned to Mayne Pharma, fails to meet obligations under that license agreement in a material respect, the Population Council could have the right to terminate the agreement and upon the effective date of such termination, have the right to re-obtain the related technology as well as, potentially, aspects of any intellectual property controlled by Mayne Pharma and developed during the period the agreement was in force that relate to the applicable technology.
The Company’s license under the Population Council License Agreement was sold to Mayne Pharma as part of the Mayne Transaction. 18 If Mayne Pharma, with respect to the ANNOVERA license agreement that we have assigned to Mayne Pharma, fails to meet obligations under that license agreement in a material respect, the Population Council could have the right to terminate the agreement and upon the effective date of such termination, have the right to re-obtain the related technology as well as, potentially, aspects of any intellectual property controlled by Mayne Pharma and developed during the period the agreement was in force that relate to the applicable technology.
The order provides that the statutory stay that prevents FDA from granting final approval of the ANDA for 30 months from the date of the Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place.
The order provides that the statutory stay that prevents FDA from granting final approval of the ANDA for 30 months from the date of the Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place. In November 2024, the court lifted the stay.
These risks include the possibility of the following: ● the patent applications that we or our licenses have filed may fail to result in issued patents in the U.S. or in foreign jurisdictions; ● patents issued or licensed to us, or our partners, may be challenged or discovered to have been issued on the basis of insufficient, incomplete, or incorrect information, and thus held to be invalid or unenforceable; ● the scope of any patent protection may be too narrow to exclude competitors from developing or designing around these patents; ● we, the Population Council, or our licensees were not the first to make the inventions covered by each of our issued patents and pending patent applications, or may have created bars under U.S. or foreign laws that would preclude the issuance of patents; 22 ● we, the Population Council, or our licensees may not have been the first inventors to invent or file patent applications for these technologies in the U.S. or were not the first to file patent applications directed to these technologies abroad; ● we may fail to comply with procedural, documentary, fee payment, and other similar provisions during the patent application process, which can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights; ● future pharmaceutical product candidates may not be patentable; ● others may claim rights or ownership regarding patents and other proprietary rights that we hold or license; ● delays in development, testing, clinical trials, and regulatory review may reduce the period during which we could market our pharmaceutical products under patent protection; and ● we or our licensees may fail to timely apply for patents on our technologies or products.
We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies are covered by valid and enforceable patents or are effectively maintained as trade secrets. 26 These risks include the possibility of the following: ● the patent applications that we or our licenses have filed may fail to result in issued patents in the U.S. or in foreign jurisdictions; ● patents issued or licensed to us, or our partners, may be challenged or discovered to have been issued on the basis of insufficient, incomplete, or incorrect information, and thus held to be invalid or unenforceable; ● the scope of any patent protection may be too narrow to exclude competitors from developing or designing around these patents; ● we, the Population Council, or our licensees were not the first to make the inventions covered by each of our issued patents and pending patent applications, or may have created bars under U.S. or foreign laws that would preclude the issuance of patents; ● we, the Population Council, or our licensees may not have been the first inventors to invent or file patent applications for these technologies in the U.S. or were not the first to file patent applications directed to these technologies abroad; ● we may fail to comply with procedural, documentary, fee payment, and other similar provisions during the patent application process, which can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights; ● future pharmaceutical product candidates may not be patentable; ● others may claim rights or ownership regarding patents and other proprietary rights that we hold or license; ● delays in development, testing, clinical trials, and regulatory review may reduce the period during which we could market our pharmaceutical products under patent protection; and ● we or our licensees may fail to timely apply for patents on our technologies or products.
If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA grow more slowly than expected or decline, if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are unsuccessful with future financings or if the supply chains related to the third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements.
If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA grow more slowly than expected or decline, including as a result of Mayne Pharma Group’s pending sale to Cosette , if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are unsuccessful with future financings or if the supply chains related to the third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements.
We expect that our licensees will experience pricing pressures in connection with the sale of our products generally due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, the scrutiny of pharmaceutical pricing, the ongoing debates on reducing government spending and additional legislative proposals.
The pharmaceutical industry and our licensees may experience pricing pressures in connection with the sale of our products generally due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, the scrutiny of pharmaceutical pricing, the ongoing debates on reducing government spending and additional legislative proposals.
If any of the third-party CMOs of our products or any suppliers of raw materials or API experience further difficulties, do not comply with the terms of their agreements, or do not devote sufficient time, energy, and care to providing our manufacturing needs, or if any manufacturing specification modifications that we or Mayne Pharma have requested are not approved by the FDA, we could experience additional interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations, and financial position. 13 Our licensees also do not have long-term contracts for the supply of all the API used in BIJUVA, and ANNOVERA.
If any of the third-party CMOs of our products or any suppliers of raw materials or API experience further difficulties, do not comply with the terms of their agreements, or do not devote sufficient time, energy, and care to providing our manufacturing needs, or if any manufacturing specification modifications that we or Mayne Pharma have requested are not approved by the FDA, we could experience additional interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations, and financial position.
We have also experienced a greater than expected amount of raw materials for ANNOVERA being out of specification.
We have also in the past experienced a greater than expected amount of raw materials for ANNOVERA being out of specification.
If we are unable to maintain effective internal control over financial reporting or our independent auditors are unwilling or unable to provide us with an attestation report on the effectiveness of internal control over financial reporting for future periods as required by, or voluntarily followed under, Section 404 of the Sarbanes-Oxley Act, we may not be able to produce accurate financial statements, and investors may therefore lose confidence in our operating results, our stock price could decline and we may be subject to litigation or regulatory enforcement actions.
If we are unable to maintain effective internal control over financial reporting or our independent auditors are unwilling or unable to provide us with an attestation report on the effectiveness of internal control over financial reporting for future periods as required by, or voluntarily followed under, Section 404 of the Sarbanes-Oxley Act, we may not be able to produce accurate financial statements, and investors may therefore lose confidence in our operating results, our stock price could decline and we may be subject to litigation or regulatory enforcement actions. 29 We do not currently intend to pay dividends on our common stock so any returns may be limited to the value of our stock.
We currently anticipate that we will retain any future earnings for the operation of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the terms of any future debt agreements may also preclude us from paying dividends.
We have never declared or paid any cash dividends on our common stock. We currently anticipate that we will retain any future earnings for the operation of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the terms of any future debt agreements may also preclude us from paying dividends.
Competitors may infringe our patents or the patents of the ANNOVERA licensor. Following the Mayne Transaction, we no longer have the express right to enforce our intellectual property. To counter infringement or unauthorized use, we must rely on Mayne Pharma to file infringement claims, including with respect to Teva’s IMVEXXY Notice Letter.
Following the Mayne Transaction, we no longer have the express right to enforce our intellectual property. To counter infringement or unauthorized use, we must rely on Mayne Pharma to file infringement claims, including with respect to Teva’s IMVEXXY Notice Letter.
The FDA’s exercise of its authority could result in delays or increased costs during product development, clinical trials and regulatory review, increased costs to comply with additional post-approval regulatory requirements, and potential restrictions on sales of approved products. Foreign regulatory agencies often have similar authority and may impose comparable requirements.
The FDA’s exercise of its authority could result in delays or increased costs during product development, clinical trials and regulatory review, increased costs to comply with additional post-approval regulatory requirements, and potential restrictions on sales of approved products.
Following the closing of the vitaCare Divestiture, we may still be required to indemnify the buyer of vitaCare in the event any enforcement related to activities prior to the vitaCare Divestiture.
Following the closing of the vitaCare divestiture, we may still be required to indemnify the buyer of vitaCare in the event any enforcement related to activities prior to the vitaCare divestiture. Similar regulations apply in foreign jurisdictions.
Further, we cannot guarantee that we will not face similar turnover in the future. Although we generally enter into employment agreements with our executives, our executive officers may terminate their employment relationship with us at any time, and we cannot ensure that we will be able to retain the services of any of them.
Although we generally enter into employment agreements with our executives, our executive officers may terminate their employment relationship with us at any time, and we cannot ensure that we will be able to retain the services of any of them.
Our stockholders may experience dilution upon future equity issuances, including convertible debt or equity securities we may issue in the future, the exercise of stock options to purchase common stock granted to our employees, consultants and directors, including options to purchase common stock granted under our stock option and equity incentive plans or the issuance of common stock in settlement of previously issued awards under our stock option and equity incentive plans that may vest in the future. 30 We expect that additional capital will be needed in the future to continue our planned operations.
Our stockholders may experience dilution upon future equity issuances, including convertible debt or equity securities we may issue in the future, the exercise of stock options to purchase common stock granted to our employees, consultants and directors, including options to purchase common stock granted under our stock option and equity incentive plans or the issuance of common stock in settlement of previously issued awards under our stock option and equity incentive plans that may vest in the future.
If the manufacturers of our products are unsuccessful in obtaining raw materials, if are licensees are unable to manufacture and release inventory on a timely and consistent basis, if our licensees fail to maintain an adequate level of product inventory, if inventory is destroyed or damaged, or if our licensees’ inventory reaches its expiration date, patients might not have access to our products, our reputation and brands could be harmed, and physicians may be less likely to recommend our products in the future, each of which could have an adverse effect on our business, financial condition, results of operations, and cash flows. 26 Our business may be impacted by new or changing tax laws or regulations and actions by federal, state, and/or local agencies, or how judicial authorities apply tax laws.
If the manufacturers of our products are unsuccessful in obtaining raw materials, if our licensees are unable to manufacture and release inventory on a timely and consistent basis, if our licensees fail to maintain an adequate level of product inventory, if inventory is destroyed or damaged, or if our licensees’ inventory reaches its expiration date, patients might not have access to our products, our reputation and brands could be harmed, and physicians may be less likely to recommend our products in the future, each of which could have an adverse effect on our business, financial condition, results of operations, and cash flows.
Similar regulations apply in foreign jurisdictions. 19 If our dietary supplement , hormone therapy pharmaceutical products or patient-controlled, long-acting contraceptive products do not have the effects intended or cause undesirable side effects, our business may suffer.
If our dietary supplement , hormone therapy pharmaceutical products or patient-controlled, long-acting contraceptive products do not have the effects intended or cause undesirable side effects, our business may suffer.
The length of the stay of the IMVEXXY litigation is dependent on further action by Teva. We cannot assure you that any patent infringement lawsuit that we or our licensees may file will prevent the introduction of a generic version of IMVEXXY for any particular length of time, or at all.
We cannot assure you that any patent infringement lawsuit that we or our licensees may file will prevent the introduction of a generic version of IMVEXXY for any particular length of time, or at all.
In the past, we have incurred recurring net losses, including net losses of $10.3 million and $172.4 million for 2023 and 2021, respectively. In 2022, we recognized net income of $112.0 million due to the net proceeds from the Mayne Transaction and vitaCare divestiture exceeding our costs and expenses.
In the past, we have incurred recurring net losses, including net losses of $2.2 million and $10.3 million for 2024 and 2023, respectively. In 2022, we recognized net income of $112.0 million due to the net proceeds from the Mayne Transaction and divestiture of our former subsidiary vitaCare Prescription Services, Inc. (“vitaCare”) exceeding our costs and expenses.
In addition, if securities analysts or investors perceive public announcements of the results of hearings, motions, or other interim proceedings or developments to be negative, the price of our common stock could be adversely affected. The occurrence of any of the above could adversely affect our business, financial condition, results of operations, and prospects.
In addition, if securities analysts or investors perceive public announcements of the results of hearings, motions, or other interim proceedings or developments to be negative, the price of our common stock could be adversely affected.
In addition, our inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the development and commercial production and sale of our products, which could adversely affect our business, financial condition, results of operations, and prospects.
In addition, our inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the development and commercial production and sale of our products, which could adversely affect our business, financial condition, results of operations, and prospects. 31 A failure to maintain optimal inventory levels to meet commercial demand for our products could harm our and our licensees’ reputation and subject us to financial losses.
We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.
Federal and state laws have put considerable pressure on the pricing of pharmaceutical products. We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.
As of December 31, 2023, Rubric Capital Management LP (“Rubric”) and its affiliates beneficially owned approximately 25.6% of our common stock. Rubric may be able to largely determine the outcome of all matters requiring stockholder approval.
Our principal stockholder owns a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval. As of December 31, 2024, Rubric Capital Management LP (“Rubric”) and its affiliates beneficially owned approximately 25.6% of our common stock. Rubric may be able to largely determine the outcome of all matters requiring stockholder approval.
In addition, the stock market in general, and the stock of biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
In addition, the stock market in general, and the stock of biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
If we are unable to continue to use our current consultants, or if we are unable to recruit new consultants, then our ability to operate our business will be negatively impacted and it could interfere with our ability to receive any potential royalties.
If we are unable to continue to use our current consultants, or if we are unable to recruit new consultants, then our ability to operate our business will be negatively impacted and it could interfere with our ability to receive any potential royalties. Our financial condition and results of operations may be adversely affected by any future pandemics or epidemics.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline. The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business.
The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline.
The implementation of the GDPR has increased our responsibility and liability in relation to personal data that we process, and we may in the future be required to put in place additional mechanisms to ensure compliance with the GDPR, which could divert management’s attention and increase our cost of doing business. 27 In July 2020, the Court of Justice of the European Union issued its long-awaited decision in the case Data Protection Commission v.
The implementation of the GDPR has increased our responsibility and liability in relation to personal data that we process, and we may in the future be required to put in place additional mechanisms to ensure compliance with the GDPR, which could divert management’s attention and increase our cost of doing business.
To market these products in the European Union and many other non-U.S. jurisdictions, our licensees must obtain separate regulatory approvals. We have had limited interactions with non-U.S. regulatory authorities, the approval procedures vary among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval or clearance.
We have had limited interactions with non-U.S. regulatory authorities, the approval procedures vary among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval or clearance.
As part of the FDA’s approval of IMVEXXY, we committed to conduct a post-approval observational study to evaluate the risk of endometrial cancer in post-menopausal women with a uterus who use a low-dose vaginal estrogen unopposed by a progestogen such as IMVEXXY, which study was assumed by Mayne Pharma as the holder of the new drug application (“NDA”).
Foreign regulatory agencies often have similar authority and may impose comparable requirements. 21 As part of the FDA’s approval of IMVEXXY, we committed to conduct a post-approval observational study to evaluate the risk of endometrial cancer in post-menopausal women with a uterus who use a low-dose vaginal estrogen unopposed by a progestogen such as IMVEXXY, which study was assumed by Mayne Pharma as the holder of the NDA.
In addition to the foregoing, there are certain consequences under the Securities Act of being a public shell company, including the unavailability of Rule 144 thereunder for the resale of restricted securities and the inability to utilize Form S-8 for the registration of employee benefit plan securities. 24 Our principal stockholder owns a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
In addition to the foregoing, there are certain consequences under the Securities Act of being a public shell company, including the unavailability of Rule 144 thereunder for the resale of restricted securities and the inability to utilize Form S-8 for the registration of employee benefit plan securities.
In addition, even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, and could result in related stockholder suits, any of which could also have an adverse effect on our business, financial condition and results of operations.
In addition, even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, and could result in related stockholder suits, any of which could also have an adverse effect on our business, financial condition and results of operations. 20 In addition, from time to time in the future, we or our licensees may become subject to additional laws or regulations issued by federal or state agencies, all of which are subject to influence resulting from changes in political party control.
Facebook Ireland, Schrems. The decision on this case invalidated the European Commission’s adequacy decision for the EU-U.S. Privacy Shield Framework, calling into question personal data transfers from the EU to the U.S.
In July 2020, the Court of Justice of the European Union issued its long-awaited decision in the case Data Protection Commission v. Facebook Ireland, Schrems. The decision on this case invalidated the European Commission’s adequacy decision for the EU-U.S. Privacy Shield Framework, calling into question personal data transfers from the EU to the U.S.
We may be found to have experienced an ownership change under Section 382 because of events in the past or the issuance of shares of our common stock in the future. If so, the use of our NOL carryforwards, or a portion thereof, against our future taxable income may be subject to an annual limitation under Section 382.
We may be found to have experienced an ownership change under Section 382 because of events in the past or the issuance of shares of our common stock in the future.
In addition, mechanisms exist in much of the world permitting some form of challenge by generic drug marketers to our patents before, or immediately following, the expiration of any regulatory exclusivity, and generic companies are increasingly employing aggressive strategies, such as “at risk” launches or the post-grant approval processes that exists in the U.S. and foreign jurisdictions to challenge relevant patent rights.
In such event, ours or our licensee’s ability to commercialize our pharmaceutical products may be threatened, we could lose our competitive advantage, and the competition we face could increase, all of which could adversely affect our business, financial condition, results of operations, and prospects. 27 In addition, mechanisms exist in much of the world permitting some form of challenge by generic drug marketers to our patents before, or immediately following, the expiration of any regulatory exclusivity, and generic companies are increasingly employing aggressive strategies, such as “at risk” launches or the post-grant approval processes that exists in the U.S. and foreign jurisdictions to challenge relevant patent rights.
We utilized most of the net proceeds to repay borrowings and redeem our preferred stock. As of December 31, 2023, our stockholders’ equity was $29.3 million. We have funded our operations to date primarily from public and private sales of equity and private sales of debt securities.
We utilized most of the net proceeds to repay borrowings and redeem our preferred stock. As of December 31, 2024, our stockholders’ equity was $27.4 million. We have funded our operations to date primarily through revenue from licensed royalties, public offerings of our common stock and private placements of equity and debt securities and the transactions with Mayne Pharma.
The DSCSA requirements, development of standards, and the system for product tracing have been and will continue to be phased in over a period of years. The distribution of product samples continues to be regulated under the PDMA, and some states also impose regulations on drug sample distribution.
The DSCSA requirements, development of standards, and the system for product tracing have been and will continue to be phased in over a period of years.
If the confidentiality of this intellectual property is breached, it could adversely impact our business. 23 We must rely on Mayne Pharma to file lawsuits or take other actions to protect or enforce our patents and there can be no assurance they will take such actions or be successful.
We must rely on Mayne Pharma to file lawsuits or take other actions to protect or enforce our patents and there can be no assurance they will take such actions or be successful. Competitors may infringe our patents or the patents of the ANNOVERA licensor.
Listed companies determined to be public shell companies by Nasdaq may be subject to delisting proceedings or additional and more stringent listing criteria.
Listed companies determined to be public shell companies by Nasdaq may be subject to delisting proceedings or additional and more stringent listing criteria. Additionally, we may be subject to delisting proceedings as a result of our failure to maintain compliance with additional continued listing requirements of Nasdaq.
We are uncertain of the impact or outcome of new legislation, regulation, Executive Orders, rescission of rules and policy statements, or new agency priorities, especially any relative impact on the healthcare regulatory and policy landscape, or the impact they may have on our business. 17 Such developments could, however, require reformulation of certain products to meet new standards, recalls or discontinuance of certain products not able to be reformulated, additional record-keeping requirements, increased documentation of the properties of certain products, additional or different labeling, additional scientific substantiation, additional personnel, or other new requirements.
Such developments could, however, require reformulation of certain products to meet new standards, recalls or discontinuance of certain products not able to be reformulated, additional record-keeping requirements, increased documentation of the properties of certain products, additional or different labeling, additional scientific substantiation, additional personnel, or other new requirements. Any such developments could have an adverse effect on our business.
There have been efforts by government officials and legislators to implement measures to regulate prices or payment for pharmaceutical products, including legislation on drug importation, which could adversely affect our royalty revenues. Recently enacted federal and state laws have put considerable pressure on the pricing of pharmaceutical products.
Current or future legislation or regulations may adversely affect reimbursement from government healthcare programs and third-party payers. There have been efforts by government officials and legislators to implement measures to regulate prices or payment for pharmaceutical products, including legislation on drug importation, which could adversely affect our royalty revenues.
There is no guarantee that our cash and cash equivalents on hand at any given time will be enough to cover our liabilities associated with winding down our historic operations. Unfavorable global economic conditions could harm our business, financial condition or results of operations.
There is no guarantee that our cash and cash equivalents on hand at any given time will be enough to cover our liabilities associated with winding down our historic operations. 17 We sublease our properties, which could expose us to possible liabilities and losses .
If the manufacturers of our products cannot successfully manufacture material that conforms to specifications and the strict regulatory requirements of the FDA and any applicable foreign regulatory authority, regulatory submissions related to our products may be delayed or disapproved, and our marketed products may be affected.
We believe that corrective actions to address the compliance issues identified in the referenced Forms 483 have been implemented by the CMOs and that the CMOs continue to have the right to manufacture under current regulations. 14 If the manufacturers of our products cannot successfully manufacture material that conforms to specifications and the strict regulatory requirements of the FDA and any applicable foreign regulatory authority, regulatory submissions related to our products may be delayed or disapproved, and our marketed products may be affected.
Our senior management’s knowledge of our business and industry could be difficult to replace, and management turnover could negatively affect our business, growth, financial conditions, results of operations and cash flows.
Our senior management’s knowledge of our business and industry could be difficult to replace, and management turnover could negatively affect our business, growth, financial conditions, results of operations and cash flows. We currently depend on the services of Marlan D. Walker as our Chief Executive Officer and sole employee. Should we lose Mr.
A failure to maintain optimal inventory levels to meet commercial demand for our products could harm our and our licensees’ reputation and subject us to financial losses. Our licensees’ ability to maintain optimal inventory levels to meet commercial demand depends on the performance of third-party contract manufacturers. In some instances, our products have unique ingredients used under license arrangements.
Our licensees’ ability to maintain optimal inventory levels to meet commercial demand depends on the performance of third-party contract manufacturers. In some instances, our products have unique ingredients used under license arrangements. One of our third-party contract manufacturers has in the past experienced an increase in difficulties with manufacturing of ANNOVERA, resulting in intermittent supply of ANNOVERA for commercial distribution.
Failure to obtain regulatory approval outside the U.S. will prevent our licensees from marketing our hormone therapy pharmaceutical products in non-U.S. markets. We have entered into licensing and supply agreements with Knight and Theramex to commercialize IMVEXXY and BIJUVA in non-U.S. markets.
We have entered into licensing and supply agreements with Knight and Theramex to commercialize IMVEXXY and BIJUVA in non-U.S. markets. To market these products in the European Union and many other non-U.S. jurisdictions, our licensees must obtain separate regulatory approvals.
Subject to applicable limitations, our NOL may be used to offset future taxable income, to the extent we generate any taxable income, and thereby reduce our future federal income taxes otherwise payable. 21 Section 382 of the Internal Revenue Code of 1986, as amended, imposes limitations on a corporation’s ability to utilize NOL carryforwards if it experiences an ownership change as defined in Section 382.
Section 382 of the Internal Revenue Code of 1986, as amended, imposes limitations on a corporation’s ability to utilize NOL carryforwards if it experiences an ownership change as defined in Section 382.
To raise capital, we may sell equity securities, convertible securities or other securities in one or more transactions at prices and in a manner we determine from time to time. If we sell equity securities, convertible securities or other securities current investors may be materially diluted by subsequent sales.
We expect that additional capital will be needed in the future to continue our planned operations. To raise capital, we may sell equity securities, convertible securities or other securities in one or more transactions at prices and in a manner we determine from time to time.
Our activities and the activities of our licensees are also potentially subject to federal and state consumer protection and unfair competition laws.
The distribution of product samples continues to be regulated under the PDMA, and some states also impose regulations on drug sample distribution. 22 Our activities and the activities of our licensees are also potentially subject to federal and state consumer protection and unfair competition laws.
We cannot predict whether new proposals will be made or adopted, when they may be adopted, or what impact they may have on us if they are adopted. The availability of generic products at lower prices than branded products may substantially reduce the likelihood of reimbursement for branded products, such as IMVEXXY, BIJUVA, and ANNOVERA.
The availability of generic products at lower prices than branded products may substantially reduce the likelihood of reimbursement for branded products, such as IMVEXXY, BIJUVA, and ANNOVERA.
Risks related to ownership of our common stock We may be treated as a “public shell” company which could have negative consequences, including potential Nasdaq delisting of our common stock. Our common stock is currently listed on the Nasdaq Global Select Market. We have no current plans to delist our common stock from Nasdaq.
The occurrence of any of the above could adversely affect our business, financial condition, results of operations, and prospects. 28 Risks related to ownership of our common stock We may be treated as a “public shell” company which could have negative consequences, including potential Nasdaq delisting of our common stock.
Our business also may rely on unpatented proprietary technology, know-how, and trade secrets.
Our business also may rely on unpatented proprietary technology, know-how, and trade secrets. If the confidentiality of this intellectual property is breached, it could adversely impact our business.
If our licensees are unable to hire, engage, and develop enough productive sales personnel or fail to adequately promote our products, our business prospects could suffer.
If our licensees are unable to hire, engage, and develop enough productive sales personnel or fail to adequately promote our products, our business prospects could suffer. The announcement and pendency of Mayne Pharma Group’s agreement to be acquired by Cosette Pharmaceuticals, Inc. could have an adverse effect on our business, operations, and financial condition.
Accordingly, disruptions to our business as a result of COVID-19 and other pandemics or epidemics could continue to result in an adverse effect on our business, results of operations, financial condition and prospects in the near-term and beyond 2024.
Accordingly, disruptions to our business as a result of pandemics or epidemics could result in an adverse effect on our business, results of operations, financial condition and prospects. 24 Failure to obtain regulatory approval outside the U.S. will prevent our licensees from marketing our hormone therapy pharmaceutical products in non-U.S. markets.
Management transition is often difficult and inherently causes some loss of institutional knowledge, which could negatively affect the results of operations and financial condition. Our ability to execute our business strategies may be adversely affected by the uncertainty associated with these transitions and the time and attention of the board and management dedicated to management transitions could disrupt our business.
Our ability to execute our business strategies may be adversely affected by the uncertainty associated with these transitions and the time and attention of the board and management dedicated to management transitions could disrupt our business. Further, we cannot guarantee that we will not face similar turnover in the future.
In 2017, the U.S. federal government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “2017 Tax Act”).
If so, the use of our NOL carryforwards, or a portion thereof, against our future taxable income may be subject to an annual limitation under Section 382. 25 In 2017, the U.S. federal government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “2017 Tax Act”).
The severity of the impact of any pandemic on our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted. 20 During the COVID-19 pandemic, stay at home, quarantine, and social distancing orders and closures and restrictions on travel negatively affected the ability of our sales force to access healthcare providers to promote our products and the ability of patients to visit their healthcare professionals for non-emergent matters.
Our business may be impacted by any future pandemics or epidemics. The severity of the impact of any pandemic on our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted.
While policymakers globally have responded with fiscal policy actions to support the healthcare industry and economy as a whole, the magnitude and overall effectiveness of these actions remains uncertain. We may also experience other unknown impacts from COVID-19 or any future pandemics or epidemics that cannot be predicted.
We may also experience other unknown impacts from any future pandemics or epidemics that cannot be predicted.
Removed
We believe that corrective actions to address the compliance issues identified in the referenced Forms 483 have been implemented by the CMOs and that the CMOs continue to have the right to manufacture under current regulations.
Added
In August 2023, our former Principal Financial and Accounting Officer resigned and was replaced with a new Principal Financial and Accounting Officer. Management transition is often difficult and inherently causes some loss of institutional knowledge, which could negatively affect the results of operations and financial condition.
Removed
We expect that the pharmaceutical industry will experience pricing pressures due to the trend toward managed healthcare, the increasing influence of managed care organizations, and additional legislative proposals. Our results of operations could be adversely affected by current and future healthcare reforms.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe audit committee of our board of directors bears primary responsibility for the board’s oversight of our cybersecurity risk. Periodically management updates our audit committee about various risks facing the Company, of which cybersecurity may be included. 31 Our cybersecurity risk assessment and management processes are implemented and maintained by management and IT consultants.
Biggest changePeriodically management updates our audit committee about various risks facing the Company, of which cybersecurity may be included. Our cybersecurity risk assessment and management processes are implemented and maintained by management and IT consultants. The IT consultants have relevant expertise, experience, education and training as well as knowledge of our company’s critical systems and information technology policies.
Risk Factors in this 2023 10-K Report, including the risk factor captioned “We may not be able to maintain effective and efficient information systems or properly safeguard our information systems.” While to date we have not identified any breaches from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition, the sophistication of cybersecurity threats continues to increase, and the preventative actions we take to reduce the risk of cybersecurity incidents and protect our systems and information may be insufficient.
Risk Factors in this 2024 10-K Report, including the risk factor captioned “We may not be able to maintain effective and efficient information systems or properly safeguard our information systems.” While to date we have not identified any breaches from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition, the sophistication of cybersecurity threats continues to increase, and the preventative actions we take to reduce the risk of cybersecurity incidents and protect our systems and information may be insufficient.
We use third-party service providers to perform a variety of functions throughout our business, including but not limited to application providers and hosting companies. All of our critical information is hosted by a third-party service provider. We have a vendor management program to assess cybersecurity risks associated with our use of these providers.
We use third-party service providers to perform a variety of functions throughout our business, including but not limited to application providers and hosting companies. All of our critical information is hosted by a third-party service provider.
Accordingly, no matter how well our program is designed or implemented, we will not be able to anticipate all security breaches, and we may not be able to implement effective preventive measures against such security breaches in a timely manner. Cybersecurity Governance Our board of directors considers cybersecurity risk as part of its risk oversight function.
Accordingly, no matter how well our program is designed or implemented, we will not be able to anticipate all security breaches, and we may not be able to implement effective preventive measures against such security breaches in a timely manner.
Our officers, contractors and third-party IT vendors help assess, identify and manage our cybersecurity threats and risks by monitoring and evaluating our threat environment and risk profile using various methods including, for example: through the use of automated tools; conducting audits and threat assessments for internal and external threats; analyzing reports of threats and actors; conducting vulnerability assessments to identify vulnerabilities; evaluating our and our industry’s risk profile; and evaluating threats reported to us.
For example, cybersecurity risk is addressed as a component of our enterprise risk management program and has historically been included as part of compliance reports provided to our audit committee. 37 Our officers, contractors and third-party IT vendors help assess, identify and manage our cybersecurity threats and risks by monitoring and evaluating our threat environment and risk profile using various methods including, for example: through the use of automated tools; conducting audits and threat assessments for internal and external threats; analyzing reports of threats and actors; evaluating our and our industry’s risk profile; and evaluating threats reported to us.
Removed
For example, cybersecurity risk is addressed as a component of our enterprise risk management program and has historically been included as part of compliance reports provided to our audit committee.
Added
We also carry cybersecurity insurance to protect the Company in the event of a cybersecurity breach and to provide resources if a cybersecurity breach occurs. Cybersecurity Governance Our board of directors considers cybersecurity risk as part of its risk oversight function. The audit committee of our board of directors bears primary responsibility for the board’s oversight of our cybersecurity risk.
Removed
The IT consultants have relevant expertise, experience, education and training as well as knowledge of our company’s critical systems and information technology policies.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe have sublet 41,418 square feet and are in the process of subletting the remaining 21,330 square feet of our headquarters in Boca Raton as a result of shifting our business to become a pharmaceutical royalty company and terminating our employees.
Biggest changeWe have sublet 41,418 square feet and are in the process of subletting the remaining 21,330 square feet of our headquarters in Boca Raton as a result of shifting our business to become a pharmaceutical royalty company and terminating our employees. 38

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe 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 had 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.
Biggest changeWe have incurred and recorded legal costs amounting to $2,334 thousand in prepaid expenses and other current assets as of December 31, 2024, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully prevail in this legal proceeding.
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. Item 4. Mine safety disclosures Not applicable. 32 PART II
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. Item 4. Mine safety disclosures Not applicable. 39 PART II
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 order provides that the statutory stay that prevents the FDA from granting final approval of the ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place. In November 2024, the court lifted the stay.
As of December 30, 2022, and per the Mayne 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.
Beginning on December 30, 2022 and per the Mayne License Agreement, Mayne Pharma is responsible for all enforcement of our patents, including the responsibility for and costs of litigation discussed above with respect to Teva and Sun Pharma. From time to time, we are involved in other litigations and proceedings in the ordinary course of business.
Added
In June 2024, Mayne Pharma received a Paragraph IV certification notice letter (the “Sun Notice Letter”) regarding an ANDA submitted to the FDA by Sun Pharma Inc. (“Sun Pharma”). The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.
Added
In the Sun Notice Letter, Sun Pharma alleges that the IMVEXXY Patents are invalid, unenforceable, and/or will not be infringed by Sun Pharma’s commercial manufacture, use, or sale of its proposed generic drug product. The IMVEXXY Patents identified in the Sun Notice Letter expire in 2032 or 2033.
Added
In July 2024, we and Mayne Pharma filed a complaint for patent infringement against Sun Pharma in the United States District Court for the District of New Jersey arising from Sun Pharma’s ANDA filing with the FDA.
Added
We are seeking, among other relief, an order that the effective date of any FDA approval of Sun Pharma’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Sun Pharma from infringing the IMVEXXY Patents.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeAs of March 29, 2024, there were 80 stockholders of record of our common stock. Performance graph As a “smaller reporting company,” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and pursuant to Instruction 6 to Item 201(e) of Regulation S-K, we are not required to provide this information.
Biggest changeAs of March 27, 2025, there were 56 stockholders of record of our common stock. Performance graph As a “smaller reporting company,” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and pursuant to Instruction 6 to Item 201(e) of Regulation S-K, we are not required to provide this information.
Item 5. Market for registrant’s common equity, related stockholder matters, and issuer purchases of equity securities market information on common stock Since October 2017, our common stock has been listed on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “TXMD.” As of December 29, 2023, the closing price of our common stock on Nasdaq was $2.25 per share.
Item 5. Market for registrant’s common equity, related stockholder matters, and issuer purchases of equity securities market information on common stock Since October 2017, our common stock has been listed on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “TXMD.” As of December 31, 2024, the closing price of our common stock on Nasdaq was $0.86 per share.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

58 edited+14 added−51 removed34 unchanged
Biggest changeOn December 30, 2022 (the “Closing Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA® (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith.
Biggest changeOn December 30, 2022 (the “Closing Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company (“Mayne Pharma Group”), in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA® (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith. 40 In a License Agreement, dated December 4, 2022, between TherapeuticsMD and Mayne Pharma (the “Mayne License Agreement”), we granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.
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.
The royalty rate will decrease to 2.0% on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.
Mayne Pharma will pay us minimum annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments, including as described below.
Mayne Pharma will pay us minimum annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments, including as described below.
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 to the consolidated financial statements included in this 2023 10-K Report), 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 asset.
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 to the consolidated financial statements included in this 2024 10-K Report), 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 asset.
This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Statement Regarding Forward-Looking Information.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under “Risk Factors” elsewhere in this 2023 10-K Report.
This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Statement Regarding Forward-Looking Information.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under “Risk Factors” elsewhere in this 2024 10-K Report.
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. For additional discussion on revenue, see “J.
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. For additional discussion on revenue, see “I.
For additional details, see the consolidated statements of cash flows included in our consolidated financial statements in this 2023 10-K Report. Other liquidity measure Receivable from Mayne. On December 30, 2022, Mayne Pharma acquired our accounts receivable balance of approximately $29.3 million which is subject to certain working capital adjustments.
For additional details, see the consolidated statements of cash flows included in our consolidated financial statements in this 2024 10-K Report. Other liquidity measure Receivable from Mayne Pharma. On December 30, 2022, Mayne Pharma acquired our accounts receivable balance of approximately $29.3 million which is subject to certain working capital adjustments.
The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, including those related to unbilled revenue, identifiable intangible assets, certain accrued liabilities, and income taxes.
The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, including those related to identifiable intangible assets, certain accrued liabilities, and income taxes.
Item 7. Management’s discussion and analysis of financial condition and results of operations You should read the following discussion and analysis in conjunction with the information set forth under our consolidated financial statements and the notes to those financial statements included elsewhere in this 2023 10-K Report.
Item 7. Management’s discussion and analysis of financial condition and results of operations You should read the following discussion and analysis in conjunction with the information set forth under our consolidated financial statements and the notes to those financial statements included elsewhere in this 2024 10-K Report.
We have engaged external consultants who support our relationship with current partners and assist with certain financial, legal, and regulatory matters and the continued wind-down of our historical business operations. On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would serve as our Principal Financial and Accounting Officer.
We have engaged external consultants who support our relationship with current partners and assist with certain financial, IT, legal, and regulatory matters and the continued wind-down of our historical business operations. On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler serves as our Principal Financial and Accounting Officer.
For additional information on any of the following and other obligations and arrangements, see “Note 8. Commitments and Contingencies” to the consolidated financial statements included in this 2023 10-K Report. In the normal course of business, we may be confronted with issues or events that may result in contingent liability.
For additional information on any of the following and other obligations and arrangements, see “Note 7. Commitments and Contingencies” to the consolidated financial statements included in this 2024 10-K Report. In the normal course of business, we may be confronted with issues or events that may result in contingent liability.
Commitments and contingencies” to the consolidated financial statements included in this 2023 10-K Report. Critical accounting policies and estimates Management’s discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements included elsewhere in this 2023 10-K Report, which has been prepared in accordance with U.S. GAAP (“U.S. GAAP”).
Commitments and contingencies” to the consolidated financial statements included in this 2024 10-K Report. Critical accounting policies and estimates Management’s discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements included elsewhere in this 2024 10-K Report, which has been prepared in accordance with U.S. GAAP.
This royalty receivable is a contract asset as of December 31, 2023, and is further subject to offset by Mayne Pharma.
This royalty receivable is a contract asset as of December 31, 2024, and is further subject to offset by Mayne Pharma.
In February 2024, the Company received Mayne Pharma’s calculation of allowance for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement which differed significantly from the Company’s estimate of the allowances.
In February 2024, the Company received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed significantly from the Company’s estimate of the allowances.
See Note 1 Business, basis of presentation, new accounting standards and summary of significant accounting policies (Revenue Recognition) to the consolidated financial statements included in this 2023 10-K Report. Contractual obligations, off-balance sheet arrangements, purchase commitments and employment agreements Our contractual obligations and off-balance sheet arrangements are discussed below.
See “Note 1 Business, basis of presentation, new accounting standards and summary of significant accounting policies (Revenue Recognition)” to the consolidated financial statements included in this 2024 10-K Report. 46 Contractual obligations, off-balance sheet arrangements, purchase commitments and employment agreements Our contractual obligations and off-balance sheet arrangements are discussed below.
As part of our transformation and 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 presented.
As part of our transformation and the Mayne License Agreement, all results associated with former commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods presented.
For additional information, see Note 2 – Discontinued Operations, in the notes to the consolidated financial statements appearing elsewhere in this Report. Loss contingencies – Mayne Pharma 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.
For additional information, see “Note 2 – Discontinued Operations”, in the notes to the consolidated financial statements appearing elsewhere in this 2024 10-K Report. 47 Loss contingencies – Mayne Pharma 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.
GAAP, an estimate is made of the loss and the appropriate accounting entries are reflected in our consolidated financial statements. Commitments Information regarding commitments is in “Note 8. Commitments and contingencies” to the consolidated financial statements included in this 2023 10-K Report. Employment agreements Information regarding employment agreements is in “Note 8.
GAAP”), an estimate is made of the loss and the appropriate accounting entries are reflected in our consolidated financial statements. Commitments Information regarding commitments is in “Note 7. Commitments and contingencies” to the consolidated financial statements included in this 2024 10-K Report. Employment agreements Information regarding employment agreements is in “Note 7.
On November 15, 2023 Rubric drew down an additional 877,192 shares of Common Stock at a price per share equal to $2.2761. We received gross proceeds of $2.0 million from the drawdown, before expenses.
On November 15, 2023, Rubric drew down an additional 877,192 shares of Common Stock at a price per share equal to $2.2761. We received gross proceeds of $2.0 million from the drawdown, before expenses. There were no draw downs in 2024.
These generally relate to lawsuits, claims, environmental actions, or the actions of various regulatory agencies. We consult with counsel and other appropriate experts to assess the claim. If, in our opinion, we have incurred a probable loss as set forth by U.S.
These generally relate to lawsuits, claims, environmental actions, or the actions of various regulatory agencies. We consult with counsel and other appropriate experts to assess the claim. If, in our opinion, we have incurred a probable loss as set forth by accounting principles generally accepted in the United States of America (“U.S.
BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg This pharmaceutical product is the first and only FDA approved bioidentical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate-to-severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.
The obligation to conduct this study was transferred to Mayne Pharma as part of the Mayne License Agreement. 42 BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg This pharmaceutical product is the first and only FDA approved bioidentical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate-to-severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.
As part of the transformation that included the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in our consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our consolidated balance sheets.
As part of the transformation that included the Mayne License Agreement, all results associated with former commercial operations have been reflected as discontinued operations in our consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our consolidated balance sheets.
We and Mayne Pharma settled the $1.5 million of consideration due to Mayne for the assumed obligations under a long-term services agreement (see the section entitled “vitaCare divestiture” below for a discussion of the long-term services agreement), including our minimum payment obligations thereunder.
We and Mayne Pharma settled the $1.5 million of consideration due to Mayne for the assumed obligations under a long-term services agreement, including our minimum payment obligations thereunder.
The Company has not recorded any contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma that may be material.
The Company has not recorded any contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material. Mayne Pharma has also made certain indemnification demands under the Transaction Agreement, which the Company disputes.
Our obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement. 35 Prenatal vitamin products On December 30, 2022, we granted an exclusive license to commercialize, in the United States and its possessions and territories, our prescription prenatal vitamin product lines under our vitaMedMD brand name and authorized generic formulations of some of our prescription prenatal vitamin products under our BocaGreenMD Prenatal name to Mayne Pharma.
Prenatal vitamin products On December 30, 2022, we granted an exclusive license to commercialize, in the United States and its possessions and territories, our prescription prenatal vitamin product lines under our vitaMedMD brand name and authorized generic formulations of some of our prescription prenatal vitamin products under our BocaGreenMD Prenatal name to Mayne Pharma.
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. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
Results of operations As part of the transformation that included the Mayne License Agreement, all results associated with former commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
Basis of presentation, new accounting standards and summary of significant accounting policies” to the consolidated financial statements included in this 2023 10-K Report. 40 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.
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.
As of December 31, 2023, we had a royalty receivable of $3.1 million relating to the short-term portion of receivable from Mayne Pharma and $18.5 million relating to the long-term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty.
As of December 31, 2024, and 2023, we had a royalty receivable of $3,562 thousand and $3,090 thousand, respectively, relating to the short-term portion of receivable from Mayne Pharma and $16,010 thousand and $18,484 thousand, respectively, relating to the long-term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty.
As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees.
As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company believes the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.
Recent accounting pronouncements Information regarding accounting standards issued or effective in 2023 is included in “Note 1. Basis of Presentation, New Accounting Standards and Significant Accounting Policies” to the consolidated financial statements.
Revenue recognition” in Note 1. Basis of presentation, new accounting standards and summary of significant accounting policies to the consolidated financial statements included in this 2024 10-K Report. Recent accounting pronouncements Information regarding accounting standards issued or effective in 2024 is included in “Note 1. Basis of Presentation, New Accounting Standards and Significant Accounting Policies” to the consolidated financial statements.
Subscription Agreement with Rubric Capital Management LP On May 1, 2023, we entered into the Subscription Agreement with Rubric, pursuant to which we agreed to sell to Rubric, or one or more of its affiliates, up to an aggregate of 5,000,000 shares of Common Stock, from time to time during the term of the Subscription Agreement in separate draw downs at our election, at a purchase price of the five-day volume-weighted average price of our common stock at the time of the sale of such shares, at an aggregate purchase price of up to $5,000,000 (collectively, the “Private Placement”).
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. 45 Subscription Agreement with Rubric Capital Management LP On May 1, 2023, we entered into the Subscription Agreement with Rubric, pursuant to which we agreed to sell to Rubric, or one or more of its affiliates, up to an aggregate of 5,000,000 shares of Common Stock, from time to time during the term of the Subscription Agreement in separate drawdowns at our election, at a purchase price of the five-day volume-weighted average price of our common stock at the time of the sale of such shares, at an aggregate purchase price of up to $5,000,000 (collectively, the “Private Placement”).
We entered into the Knight License Agreement, with Knight pursuant to which, we granted Knight an exclusive license to commercialize IMVEXXY in Canada and Israel.
We entered into the Knight License Agreement, with Knight pursuant to which, we granted Knight an exclusive license to commercialize IMVEXXY in Canada and Israel. We entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to commercialize IMVEXXY for human use outside of the U.S., except for Canada and Israel.
This pharmaceutical product is a one-year ring-shaped contraceptive vaginal system (“CVS”) and the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent pregnancy for up to a total of 13 cycles (one year). ANNOVERA is commercially sold in the U.S. pursuant to the terms of the Population Council License Agreement.
ANNOVERA (segesterone acetate (“SA”) and ethinyl estradiol (“EE”) vaginal system) This pharmaceutical product is a one-year ring-shaped contraceptive vaginal system (“CVS”) and the first and only patient-controlled, procedure-free, reversible prescription contraceptive that can prevent pregnancy for up to a total of 13 cycles (one year).
The total consideration from Mayne Pharma to us under the Mayne License Agreement consisted of (i) a cash payment of $140.0 million at closing, (ii) a cash payment of approximately $12.1 million at closing for the acquisition of net working capital 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. 37 Pursuant to the Mayne License Agreement, Mayne Pharma will pay us one-time, milestone payments of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million.
The total consideration from Mayne Pharma to us under the Mayne License Agreement consisted of (i) a cash payment of $140.0 million at closing, (ii) a cash payment of approximately $12.1 million at closing for the acquisition of net working capital 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.
Liquidity and capital resources Our primary use of cash is to fund our continuing operations. We have funded our operations primarily through public offerings of our common stock and private placements of equity and debt securities, the divestiture of our former subsidiary vitaCare, and the transactions with Mayne Pharma.
Liquidity and capital resources Our primary use of cash is to fund our continuing operations. We have funded our operations primarily through revenue from licensed royalties, public offerings of our common stock and private placements of equity and debt securities, and the transactions with Mayne Pharma. As of December 31, 2024, we had cash and cash equivalents totaling $5,059 thousand.
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 the “Knight License Agreement” with 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 the “Theramex License Agreement” with Theramex to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.
Additional disclosures regarding discontinued operations are provided in Note 2 of our consolidated financial statements. 41 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 the “Knight License Agreement” with Knight pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
The Company believes its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement. Given the recent receipt of Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this point.
The Company continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve this matter through the processes permitted in the Transaction Agreement. The outcome of this matter is uncertain at this point.
Years ended December 31, Cash flow from continuing operations 2023 2022 Net cash provided by (used in) operating activities $ (23,081 ) $ 9,359 Net cash (used in) investing activities — (355 ) Net cash provided by (used in) financing activities 3,151 (235,206 ) Net cash provided by (used in) discontinued operations (25,060 ) 210,397 Net decrease in cash $ (44,990 ) $ (15,805 ) Operating Activities from continuing operations.
Years ended December 31, Cash flow from continuing operations 2024 2023 Net cash provided by (used in) operating activities $ 1,170 $ (23,081 ) Net cash provided by financing activities — 3,151 Net cash used in discontinued operations (438 ) (25,060 ) Net increase (decrease) in cash $ 732 $ (44,990 ) Operating Activities from continuing operations.
The FDA has also asked the sponsors of other vaginal estrogen products to participate in the observational study. In connection with the observational study, we would have been required to provide progress reports to the FDA on an annual basis. The obligation to conduct this study was transferred to Mayne Pharma as part of the Mayne License Agreement.
In December 2024, we transferred the right to commercialize IMVEXXY in Israel from Knight to Theramex. The FDA has also asked the sponsors of other vaginal estrogen products to participate in the observational study. In connection with the observational study, we would have been required to provide progress reports to the FDA on an annual basis.
For 2023, we had net loss from continuing operations of $7.7 million, or $0.74 per basic and diluted common share, a decrease of $8.8 million, compared to net income from continuing operations of $1.1 million, or $0.12 per basic and $0.11 per diluted common share, for 2022.
For 2024, we had net loss from continuing operations of $2,312 thousand, or $0.20 per basic and diluted common share, a decrease of $5,387 thousand, compared to net loss from continuing operations of $7,699 thousand, or $0.74 per basic and diluted common share, for 2023. Discontinued Operations.
For 2023, net loss from discontinued operations was $2.6 million, a decrease of $113.5 million, compared to net income from discontinued operations of $110.9 million for 2022. For additional information, see Note 2 – Discontinued Operations, in the notes to the consolidated financial statements appearing elsewhere in this 2023 10-K Report.
For 2024, net income from discontinued operations was $131 thousand, an increase of $2,710 thousand, compared to net loss from discontinued operations of $2,579 thousand for 2023. For additional information, see “Note 2 – Discontinued Operations”, in the notes to the consolidated financial statements appearing elsewhere in this 2024 10-K Report.
The year ended December 31, 2023 also includes $0.5 million in other income pertaining to royalty sales of ANNOVERA. Benefit (provision) for income taxes . In 2023, the Company recognized an immaterial benefit for income taxes from continuing operations, while no provision for income taxes was recognized in 2022 from continuing operations. Net income (loss) from continuing operations .
The year ended December 31, 2023 also includes $490 thousand in other income pertaining to royalty sales of ANNOVERA. 44 Benefit for income taxes . For 2024, we recorded $31 thousand of income tax benefits from continuing operations. In 2023, the Company recognized $43 thousand of income tax benefits from continuing operations. Net loss from continuing operations .
We have entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA for human use outside of the U.S., except for Canada and Israel. ANNOVERA (segesterone acetate (“SA”) and ethinyl estradiol (“EE”) vaginal system) On December 30, 2022, we assigned our exclusive license to commercialize ANNOVERA to Mayne Pharma.
We have entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA for human use outside of the U.S., except for Canada and Israel. In December 2024, we transferred the right to commercialize BIJUVA in Israel from Knight to Theramex.
As of December 31, 2023, we had cash and cash equivalents totaling $4.3 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation insured limits of $0.25 million per bank. We have never experienced any losses related to these funds. vitaCare Divestiture On April 14, 2022, we completed the vitaCare Divestiture.
We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation insured limits of $250 thousand per bank. We have never experienced any losses related to these funds.
Our royalty revenue recognized in 2023 primarily related to royalties provided for under the Mayne License Agreement based on Mayne Pharma’s sales of the Licensed Products subject to that agreement.
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. 48 Our royalty revenue recognized in 2024 and 2023 primarily related to royalties provided for under the Mayne License Agreement based on Mayne Pharma’s sales of the Licensed Products subject to that agreement.
In a License Agreement, dated December 4, 2022, between TherapeuticsMD and Mayne Pharma (the “Mayne License Agreement”), we granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories. 33 Under the Mayne License Agreement, Mayne Pharma will pay us one-time milestone payments of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million.
Under the Mayne License Agreement, Mayne Pharma will pay us one-time milestone payments of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million.
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.
As of December 31, 2024, the Company believed no additional accrual was required for such claims, as the Company could not reasonably estimate a range of loss. 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.
The following table sets forth the results of our operations (in thousands): Years ended December 31, 2023 2022 Revenue, net: License and service revenue $ 1,302 $ 69,963 Total revenue, net 1,302 69,963 Cost of revenue — 1,397 Gross profit 1,302 68,566 Operating expenses: Selling, general and administrative 8,903 56,710 Depreciation & amortization 922 1,193 Restructuring — 9,472 Total operating expenses 9,825 67,375 Income (loss) from operations (8,523 ) 1,191 Other income (expense): Miscellaneous income (expense) 781 (117 ) Total other income (loss), net 781 (117 ) Income (loss) from continuing operations before income taxes (7,742 ) 1,074 Benefit (provision) for income taxes 43 — Net income (loss) from continuing operations (7,699 ) 1,074 Income (loss) from discontinued operations, net of income taxes (2,579 ) 110,923 Net income (loss) $ (10,278 ) $ 111,997 Revenue.
Additional disclosures regarding discontinued operations are provided in Note 2 to the consolidated financial statements included in this 2024 10-K Report. 43 The following table sets forth the results of our operations (in thousands): Years ended December 31, 2024 2023 Revenue, net: License and service revenue $ 1,761 $ 1,302 Operating expenses: Selling, general and administrative 4,744 8,903 Impairment of long-lived assets (Note 4) 1,268 — Depreciation & amortization 509 922 Total operating expenses 6,521 9,825 Loss from operations (4,760 ) (8,523 ) Other income (expense): Miscellaneous income 2,417 781 Total other income 2,417 781 Loss from continuing operations before income taxes (2,343 ) (7,742 ) Benefit for income taxes 31 43 Net loss from continuing operations (2,312 ) (7,699 ) Income (loss) from discontinued operations, net of income taxes 131 (2,579 ) Net loss $ (2,181 ) $ (10,278 ) Revenue.
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. 41 On December 30, 2022, we closed a License Agreement with Mayne Pharma 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.
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.
Revenue recognition” in Note 1. Basis of presentation, new accounting standards and summary of significant accounting policies to the consolidated financial statements included in this 2023 10-K Report. Restructuring Costs. Our restructuring costs consist primarily of severance, employee termination costs, contract termination costs, and write off of fixed assets related to restructuring activities.
Basis of presentation, new accounting standards and summary of significant accounting policies” to the consolidated financial statements included in this 2024 10-K Report.
Net cash used in investing activities for 2023 was $0.0 million, a decrease of $0.4 million, compared to net cash used in investing activities of $0.4 million for 2022. This change was due our transition from a manufacturing and commercialization business to a royalty-based business. Financing Activities from continuing operations.
Net cash used in discontinued operations for 2024 was $438 thousand, a decrease of $24,622 thousand, as compared to net cash used in discontinued operations of $25,060 thousand for 2023. This change relates primarily to a decrease in expenses incurred and the payment of current liabilities associated with our transition from a manufacturing and commercialization business to a royalty-based business.
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.
The proceeds were allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products.
Total operating expenses for 2023 were $9.8 million, a decrease of $57.6 million, compared to the $67.4 million we had for 2022. Total operating expenses decreased primarily due to lower general and administrative expenses due to the transition of our business from a manufacturing and commercialization business to a royalty- based business with limited infrastructure. Income (loss) from operations.
Total operating expenses for 2024 were $6,521 thousand, a decrease of $3,304 thousand, or 33.6%, compared to the $9,825 thousand we had for 2023. This decrease was due to the further optimization of our business through the reduction of costs and continued transition from a commercial business to a royalty-based business. Loss from operations.
The accompanying consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern. Cash flows The following table reflects the major categories of cash flows from continuing operations for each of the periods (in thousands).
As a result, there is substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of the financial statements included in this 2024 10-K Report. Cash flows The following table reflects the major categories of cash flows from continuing operations for each of the periods (in thousands).
Results of operations In December 2022, we granted an exclusive license to commercialize our IMVEXXY, BIJUVA, and prescription prenatal vitamin products and assigned our 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.
On December 30, 2022, we closed a License Agreement with Mayne Pharma 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.
As of December 31, 2023, the Company believes no additional accrual is required for amounts that may be owed for the allowance for returns under the Transaction Agreement. The Company has not recorded any contingent gains or receivables for any such allowances.
In August 2024, the Company received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly from the Company’s estimate of the allowance. As of December 31, 2024, the Company believed no additional accrual was required for amounts that may be owed for the allowance for returns under the Transaction Agreement.
Net cash used in operating activities in 2023 was $23.1 million, a decrease of $32.4 million, compared to net cash provided by operating activities of $9.4 million for 2022. This change was due our transition from a manufacturing and commercialization business to a royalty-based business.
Net cash provided by operating activities in 2024 was $1,170 thousand, an increase of $24,251 thousand, compared to net cash used in operating activities of $23,081 thousand for 2023. This change was primarily due to a $5,387 thousand decrease in our net loss from continuing operations combined with the pay-down of current liabilities in the prior-year period.
We recorded $1.3 million in license revenue during the year ended December 31, 2023 primarily from the Mayne License Agreement, a decrease of $68.7 million, compared to $70.0 million in license revenue recorded for the allocation of the initial upfront payment and guaranteed minimum royalties from the Mayne License Agreement during the year ended December 31, 2022. 36 Gross profit.
We recorded $1,761 thousand in license revenue during the year ended December 31, 2024 primarily from the Mayne License Agreement, an increase of $459 thousand, or 35.3%, compared to $1,302 thousand in license revenue during the year ended December 31, 2023. The increase is primarily attributable to changes in sales of licensed products. Selling, general and administrative.
Removed
Additional disclosures regarding discontinued operations are provided in Note 2 of our consolidated financial statements.
Added
Knight obtained regulatory approval for IMVEXXY and BIJUVA and began commercialization efforts in 2024. ● In June 2019, we entered into the “Theramex License Agreement” with Theramex to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.
Removed
In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries. In connection with our transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 31, 2022.
Added
In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries. ● In December 2024, we transferred the right to commercialize IMVEXXY and BIJUVA in Israel from Knight to Theramex. Employees As of December 31, 2024, we employed one full-time employee primarily engaged in an executive position.
Removed
Severance obligations for all employees other than executive officers were paid in full in January 2023 and severance obligations for terminated executive officers were paid in accordance with their employment agreements and separation agreements as previously disclosed. As of December 31, 2023, we employed one full-time employee primarily engaged in an executive position.
Added
On December 30, 2022, we assigned our exclusive license to commercialize ANNOVERA in the United States and its possessions and territories to Mayne Pharma.
Removed
On August 17, 2023 Michael C. Donegan notified us of his decision to resign from the positions of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023. Mr. Ziegler succeeded Mr. Donegan as Principal Financial and Accounting Officer as of the date of Mr.
Added
Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
Removed
Donegan’s resignation. 34 vitaCare divestiture On April 14, 2022, we completed the divestiture of vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all 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.
Added
Selling, general and administrative expenses for 2024 were $4,744 thousand, a decrease of $4,159 thousand, or 46.7%, compared to the $8,903 thousand we had for 2023. This decrease was due to the increased efficiencies realized year over year and continued transition from a commercial business to a royalty-based business. Impairment of long-lived assets .
Removed
Included in the net proceeds amount was $11.3 million of customary holdbacks as provided in the stock purchase agreement between us and GoodRx, Inc. (the “Purchase Agreement”), which was recorded as restricted cash in the consolidated balance sheets until the cash was released to us.
Added
We recognized an impairment loss of $1,268 thousand related to abandoned patents and applications, which is classified as an impairment of long-lived assets on the Company’s consolidated statements of operations for the twelve months ended December 31, 2024. We did not impair any of our long-lived assets during the year ended December 31, 2023. Depreciation & amortization.
Removed
The restricted cash was held by an escrow agent and was 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, however we do not believe this earnout will be realized.
Added
Depreciation and amortization expense for 2024 was $509 thousand, a decrease of $413 thousand, or 44.8%, compared to the $922 thousand we had for 2023. In the 2024 period, this balance is entirely comprised of amortization of license rights and intangible assets. Operating expenses.
Removed
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. Our commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction.
Added
For 2024, we had a loss from operations of $4,760 thousand, a decrease of $3,763 thousand, or 44.2%, compared to loss from operations of $8,523 thousand for 2023. This change reflects the increase in sales from licensed products and the increased efficiencies realized as a royalty-based business. Other income.
Removed
In addition, under the Mayne License Agreement Amendment, we owed Mayne Pharma $1.5 million payable from one royalty payment. During the second quarter of 2023, Mayne Pharma held back our royalty payment of $0.6 million and we funded an additional $0.9 million in August 2023 to settle the original $1.5 million payable.
Added
In 2024, we had other income of $2,417 thousand, an increase of $1,636 thousand, compared to other income of $781 thousand in 2023.
Removed
The pre-divesture operations of vitaCare were reclassified to discontinued operations in December 2022 when we transitioned to becoming a royalty company and licensed our products to Mayne Pharma.
Added
The difference is mainly due to a $1,250 thousand one-time payment the Company received from its sublessee on its early termination on the sublease, which was recognized in the second quarter of 2024 and an increase in royalties reported as other income for intellectual property licensed by us totaling approximately $1,083 thousand in 2024.
Removed
We entered into the Theramex License Agreement with Theramex HQ UK Limited (“Theramex”) pursuant to which we granted Theramex an exclusive license to commercialize IMVEXXY for human use outside of the U.S., except for Canada and Israel. As of December 31, 2023, no IMVEXXY sales had been made through the Theramex and Knight licensing agreements.
Added
Pursuant to the Mayne License Agreement, Mayne Pharma will pay us one-time, milestone payments of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million.

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Other TXMD 10-K year-over-year comparisons