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What changed in TherapeuticsMD, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of TherapeuticsMD, Inc.'s 2024 and 2025 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 2025 report.

+231 added−191 removedSource: 10-K (2026-03-30) vs 10-K (2025-03-27)

Top changes in TherapeuticsMD, Inc.'s 2025 10-K

231 paragraphs added · 191 removed · 164 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

39 edited+11 added−3 removed91 unchanged
Biggest changeIn 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.
Biggest changeAs of December 31, 2025, we also believed no additional accrual was required for amounts that may be owed for the allowance for returns under the Transaction Agreement. We have not recorded any contingent gains or receivables for any such allowances.
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.
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, 2025, we employed one full-time employee primarily engaged in an executive position.
The first approved Section 505(b) NDA applicant for a drug containing an active ingredient that has not previously been approved in any other 505(b) NDA (a “new chemical entity,” or NCE), is eligible for a five-year NCE exclusivity period starting on the date of the NDA approval.
The first approved Section 505(b) NDA applicant for a drug containing an active ingredient that has not previously been approved in any other 505(b) NDA (a “new chemical entity,” or “NCE”), is eligible for a five-year NCE exclusivity period starting on the date of the NDA approval.
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.
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 Patient Protection and Affordable Care Act (“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.
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”).
Item 1. Business Overview Throughout this Annual Report on Form 10-K (“2025 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”).
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.
This discussion should be read in conjunction with the consolidated financial statements and notes thereto included in this 2025 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 2025 10-K Report in the section entitled “Risk Factors” that you should review carefully.
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.
Solely for convenience, trademarks, trade names and service marks referred to in this 2025 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 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.
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 2025 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 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.
In addition, this 2025 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 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.
Although we believe that the industry and market data below is reliable as of the date of this 2025 10-K Report, this information could prove to be inaccurate as a result of a variety of matters. Forward-looking statements This 2025 10-K Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
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.
Please consider our forward-looking statements in light of those risks as you read this 2025 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.
Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
Further, Mayne Pharma agreed to pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
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.
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 2025 10-K Report for additional information.
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.
As of December 31, 2025, 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.
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.
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 2025 10-K Report.
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 “Minimum Annual Royalty”).
Mayne Pharma agreed to 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 “Minimum Annual Royalty”).
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.
The information contained on our website or that can be accessed through our website is not incorporated by reference into this 2025 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 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.
These statements may be found in the items of this 2025 10-K Report entitled “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as in this 2025 10-K Report generally.
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 agreed to 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.
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.
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. See “Note 2.
This 2024 10-K Report also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners.
This 2025 10-K Report also contains trademarks, trade names and service marks of other companies, which are the property of their respective owners.
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.
TherapeuticsMD is a pharmaceutical royalty company that 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.
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.
For information on the concentration of licenses of our products, see “Note 9. Revenue” to the consolidated financial statements included in this 2025 10-K Report. Currently, the Company collects license revenue from three licensees. Seasonality The pharmaceutical markets in which we license our products are not subject to seasonal sales fluctuations.
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.
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 2025 10-K Report.
If our past operations, including activities conducted by our sales team or agents, are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal, and administrative penalties, damages, fines, exclusion from third-party payer programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.
Although we no longer engage in commercial promotional activities, if our past operations, including activities conducted by our sales team or agents, are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal, and administrative penalties, damages, fines, exclusion from third-party payer programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.
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.
The accompanying consolidated financial statements included in this 2025 10-K Report do not include any adjustments that might be necessary if we are unable to continue as a going concern.
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.
As a result, we cannot reasonably estimate a range of loss, and accordingly, we have not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as we believe the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.
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.
Discontinued Operations” to the consolidated financial statements included in this 2025 10-K Report 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 also Item 1A. Risk Factors – “Risks related to our business” for a discussion, among other things, of the extensive and costly governmental regulation we are subject to.
See also “Item 1A. Risk Factors – Risks related to our business” for a discussion, among other things, of the extensive and costly governmental regulation we are subject to.
These forward-looking statements involve substantial risks and uncertainties. For example, statements regarding our operations, financial position, business strategy, and other plans and objectives for future operations, and assumptions and predictions about future demand, marketing, expenses and sales are all forward-looking statements.
These forward-looking statements involve substantial risks and uncertainties. For example, statements regarding our operations, financial position, business strategy, exploration of potential strategic alternatives, and other plans and objectives for future operations, and assumptions and predictions about future demand, marketing, expenses and sales are all forward-looking statements.
On June 29, 2023, we issued and sold 312,525 shares of Common Stock at a price per share equal to $3.6797 pursuant to the Subscription Agreement. We received gross proceeds of $1.15 million from the draw down, before expenses.
On June 29, 2023, we issued and sold 312,525 shares of Common Stock at a price per share equal to $3.6797 pursuant to the Subscription Agreement. We received gross proceeds of $1.15 million from the draw-down, before expenses. On November 15, 2023, Rubric drew an additional 877,192 shares of Common Stock at a price per share equal to $2.2761.
These products are also subject to other federal, state, and local statutes and regulations, including federal and state consumer protection laws, laws regarding pricing transparency, laws requiring the implementation of compliance programs, laws requiring the reporting of payments or other transfers of value to HCPs or other healthcare professionals, laws governing the financial relationships between manufacturers and HCPs or other referral sources and industry stakeholders, laws protecting the privacy of health-related information, laws restricting items and services of value provided to patients, and laws prohibiting unfair and deceptive acts and trade practices.
Although we are not currently engaged in research, development, manufacturing, or commercial distribution activities, the products from which we derive royalties are also subject to other federal, state, and local statutes and regulations, including federal and state consumer protection laws, laws regarding pricing transparency, laws requiring the implementation of compliance programs, laws requiring the reporting of payments or other transfers of value to HCPs or other healthcare professionals, laws governing the financial relationships between manufacturers and HCPs or other referral sources and industry stakeholders, laws protecting the privacy of health-related information, laws restricting items and services of value provided to patients, and laws prohibiting unfair and deceptive acts and trade practices.
(“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.
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 the outcome of the Mayne Lawsuits is worse than we anticipate, 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 rely primarily on a combination of know-how, trade secrets, patents, trademarks, and contractual restrictions to protect our products and to maintain our competitive position. We are diligently seeking ways to protect our intellectual property through various legal mechanisms in relevant jurisdictions. Where permitted, patents for our hormone therapy drug products have been submitted to the Orange Book.
We rely primarily on a combination of know-how, trade secrets, patents, trademarks, and contractual restrictions to protect our products and to maintain our competitive position. We are diligently seeking ways to protect our intellectual property through various legal mechanisms in relevant jurisdictions.
An IND application is a request for authorization from the FDA to administer an investigational drug product to humans. Post-Approval Regulation Mayne Pharma is required to comply with several post-approval requirements for our currently approved drug products. We no longer have responsibility for any post-approval requirements.
An IND application is a request for authorization from the FDA to administer an investigational drug product to humans. Post-Approval Regulation Mayne Pharma, as the holder of the approved NDAs for our licensed products, is required to comply with several post-approval requirements for our currently approved drug products.
To address our capital needs, we may pursue various equity and debt financing and other alternatives. The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering.
The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering.
Following the transaction with Mayne Pharma, our primary source of revenue is from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories. We may need to raise additional capital to provide additional liquidity to fund our operations until we become cash flow positive.
Following the transaction with Mayne Pharma, our primary source of revenue is from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories. We may need to raise capital to provide additional liquidity to fund our operations. To address our capital needs, we may pursue various equity and debt financing and other alternatives.
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.
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.
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.
We received gross proceeds of $2.0 million from the draw-down before expenses. There were no drawdowns in 2025 and 2024. In February 2024, we 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 our estimate of the allowances.
Removed
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.
Added
We continue to believe our estimated allowances for payer rebates and wholesale distributor fees are reasonable. In August 2024 and in February 2025, we also received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly from our estimate of the allowance.
Removed
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.
Added
On April 8, 2025, we filed a lawsuit against Mayne Pharma in the United States District Court for the District of Delaware (the “Mayne Lawsuit”) seeking damages for breach of contract, breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and certain actions or inactions by Mayne Pharma relating thereto.
Removed
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.
Added
On June 20, 2025, we filed an amended complaint against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit. On March 23, 2026, a magistrate judge recommended that the court grant-in-part and deny-in-part Mayne Pharma’s motion to dismiss.
Added
The magistrate judge recommended granting Mayne’s motion to dismiss our claims for breach of the covenant of good faith and fair dealing, certain of our breach of contract claims and our claim for fraudulent inducement, but recommended the court grant us leave to amend the fraudulent inducement claim. The magistrate judge recommended denying Mayne’s motion to dismiss our other claims.
Added
The magistrate judge further recommended the court stay the Mayne Lawsuit while the parties submit the net working capital claims to a dispute resolution process. The parties have 14 days to object to these recommendations.
Added
On May 30, 2025, Mayne Pharma filed a lawsuit against us in the United States District Court for the District of Delaware (the “Mayne Countersuit” and, together with the Mayne Lawsuit, the “Mayne Lawsuits”) seeking damages for breach of contract and fraudulent inducement related to the Transaction Agreement.
Added
As part of the Mayne Countersuit, Mayne Pharma also made certain indemnification demands under the Transaction Agreement, which we dispute. On July 28, 2025, we filed a motion to dismiss the fraudulent inducement claim in the Mayne Countersuit.
Added
On March 23, 2026, a magistrate judge recommended that the court grant our motion to dismiss Mayne Pharma’s claim for fraudulent inducement, but recommended the court deny our motion to dismiss Mayne Pharma’s other claims. The parties have 14 days to object to this recommendation.
Added
As of December 31, 2025, we believed no additional accrual was required for such claims, as we could not reasonably estimate a range of loss. The outcome of this matter is uncertain at this point.
Added
Where permitted, patents for our hormone therapy drug products have been submitted to the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book).
Added
We no longer have responsibility for any post-approval requirements, although regulatory actions affecting these products could materially affect our royalty revenues.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

70 edited+33 added−16 removed250 unchanged
Biggest changeIf 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.
Biggest changeAn adverse outcome in the Mayne Lawsuits could result in significant damages, indemnification obligations, offsets against future royalty payments, or other relief that could materially reduce our available cash and expected future cash flows. 13 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.
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.
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.
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.
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.
In addition to other risks described herein, the ability of our licensees to maintain or increase existing product sales is subject to several risks and uncertainties, including the following: ● the presence of new or existing competing products, including non-authorized generic copies of our products; ● supply or distribution problems arising with any of their manufacturing and distribution partners; ● changed or increased regulatory restrictions or regulatory actions by the FDA; ● changes in healthcare laws and policy, including changes in requirements for drug pricing, rebates, reimbursement, and coverage by federal healthcare programs and commercial payers; ● the impact or efficacy of any price increases our licensees may implement in the future; ● changes to the licensed products’ labels and labeling, including new safety warnings or changes to boxed warnings, that further restrict how our licensees market and sell our products; and ● acceptance of our products as safe and effective by physicians and patients.
In addition to other risks described herein, the ability of our licensees to maintain or increase existing product sales is subject to several risks and uncertainties, including the following: ● the presence of new or existing competing products, including non-authorized generic copies of our products; ● supply or distribution problems arising with any of their manufacturing and distribution partners; ● changed or increased regulatory restrictions or regulatory actions by the FDA; ● changes in healthcare laws and policy, including changes in requirements for drug pricing, rebates, reimbursement, and coverage by federal healthcare programs and commercial payers; ● the impact or efficacy of any price increases our licensees may implement in the future; ● changes to the licensed products’ labels and labeling, including new safety warnings or changes to boxed warnings, that further restrict how our licensees’ market and sell our products; and ● acceptance of our products as safe and effective by physicians and patients.
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.
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 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.
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.
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; ● an adverse ruling in the Mayne Lawsuits; ● 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.
We do not have long-term contracts for the commercial supply of our vitaMedMD and BocaGreen products. We believe that our licensees evolved these relationships based on the products they licensed from us. We continue to provide support for the third-party manufacturers and our licensees as needed. Regulatory requirements could pose barriers to the manufacture of our women’s healthcare products.
We do not have long-term contracts for the commercial supply of our vitaMedMD and BocaGreen products. We believe that our licensees evolved these relationships based on the products they licensed from us. We continue to provide support for the third-party manufacturers and our licensees as needed. 14 Regulatory requirements could pose barriers to the manufacture of our women’s healthcare products.
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.
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.
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 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. 24 Our financial condition and results of operations may be adversely affected by any future pandemics or epidemics.
Disputes may arise between us and any of these counterparties regarding intellectual property subject to and each parties’ obligations under such agreements, including: ● the scope of rights granted under the agreement and other interpretation-related issues; ● our or our licensees’ obligations to make milestone, royalty, or other payments under those agreements, or the amount of any such payments; ● our or our licensees’ obligations to prosecute existing and new patent applications; ● our or our licensees’ obligations to enforce infringement of our intellectual property; ● whether and the extent to which the ANNOVERA technology and processes infringe on intellectual property of the Population Council that is not subject to the ANNOVERA license agreement; ● the ownership of inventions and know-how arising under the agreement or resulting from the joint creation or use of intellectual property by our licensees and us and our partners; ● our right, or the right of our licensees, to transfer or assign the license; and ● the effects of termination.
Disputes have and may continue to arise between us and any of these counterparties regarding intellectual property subject to and each parties’ obligations under such agreements, including: ● the scope of rights granted under the agreement and other interpretation-related issues; ● our or our licensees’ obligations to make milestone, royalty, or other payments under those agreements, or the amount of any such payments; ● our or our licensees’ obligations to prosecute existing and new patent applications; ● our or our licensees’ obligations to enforce infringement of our intellectual property; ● whether and the extent to which the ANNOVERA technology and processes infringe on intellectual property of the Population Council that is not subject to the ANNOVERA license agreement; ● the ownership of inventions and know-how arising under the agreement or resulting from the joint creation or use of intellectual property by our licensees and us and our partners; ● our right, or the right of our licensees, to transfer or assign the license; and ● the effects of termination.
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.
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. Our products and our licensees are subject to extensive and costly government regulation.
Our revenue is dependent on our licensees’ distribution through wholesale distributors and retail pharmacy distributors. Our business would be harmed if our licensees’ customers refused to distribute our products and if our licensees were not able to replace such customers through their distribution channels. Our ability to utilize net operating loss carryforwards may be limited.
Our revenue is dependent on our licensees’ distribution through wholesale distributors and retail pharmacy distributors. Our business would be harmed if our licensees’ customers refused to distribute our products and if our licensees were not able to replace such customers through their distribution channels. 25 Our ability to utilize net operating loss carryforwards may be limited.
Despite our licensees coverage with commercial payers, there is no guarantee that our licensees will be able to retain ours or their agreements or obtain new agreements, or that they will be able to negotiate favorable reimbursement or pricing terms for our products in the future.
Despite our licensees’ coverage with commercial payers, there is no guarantee that our licensees will be able to retain ours or their agreements or obtain new agreements, or that they will be able to negotiate favorable reimbursement or pricing terms for our products in the future.
For example, Rubric may be able to largely control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.
For example, Rubric may be able to largely control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transactions. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.
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.
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 employee, 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.
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.
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 2025 10-K Report and our other filings with the SEC, before you decide to purchase shares of our common stock.
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.
We maintain our cash at financial institutions, often in balances that exceed federally insured limits. All 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.
Additionally, on March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals. See Item 1. Business – Pharmaceutical Regulation – Regulatory Exclusivity for more information on the BIJUVA Notice Letter.
In March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals. See Item 1. Business – Pharmaceutical Regulation – Regulatory Exclusivity for more information on the BIJUVA Notice Letter.
The 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.
The 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 may not be able to maintain or increase profitability in the future. ● There is substantial doubt about our ability to continue as a going concern. 11 ● 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. ● 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 Mayne Pharma may not 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. 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.
Our revenue, results of operations and financial position could be affected by our ongoing disputes with Mayne Pharma. We and Mayne Pharma are disputing the allowance calculation for payer rebates and wholesale distributor fees pursuant to the Mayne Transaction Agreement. This dispute commenced in February 2024 after Mayne Pharma provided us with calculations that significantly differed from our estimates.
Our revenue, results of operations and financial position could be affected by our ongoing disputes with Mayne Pharma. We and Mayne Pharma are disputing the allowance calculation for payer rebates and wholesale distributor fees pursuant to the Mayne Transaction Agreement. In February 2024, Mayne Pharma provided us with calculations that significantly differed from our estimates.
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.
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, 2025, Rubric Capital Management LP (“Rubric”) and its affiliates beneficially owned approximately 25.5% of our common stock. Rubric may be able to largely determine the outcome of all matters requiring stockholder approval.
Our employees and business partners may not appropriately secure and protect confidential information in their possession. Each of our employees and business partners is responsible for the security of the information in our systems or under our control and to ensure that private and financial information is kept confidential.
Our employees and business partners may not appropriately secure and protect confidential information in their possession. Our employee and business partners are responsible for the security of the information in our systems or under our control and to ensure that private and financial information is kept confidential.
Misconduct by employees could include intentional failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data accurately, or to disclose unauthorized activities to us.
Misconduct by our employee could include intentional failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data accurately, or to disclose unauthorized activities to us.
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.
Current or future legislation or regulations may adversely affect reimbursement from government healthcare programs and third-party payers. There have been significant efforts by government officials and legislators to implement changes in healthcare systems to regulate prices or payment for pharmaceutical products, including legislation on drug importation, which could adversely affect our royalty revenues.
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.
We utilized most of the net proceeds to repay borrowings and redeem our preferred stock. As of December 31, 2025, our stockholders’ equity was $26.9 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.
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 the past, we have incurred recurring net losses, including net losses of $569 thousand and $2.2 million for 2025 and 2024, 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.
We cannot ensure that ours or our licensee’s compliance controls, policies, and procedures will be sufficient to protect against acts of ours or their employees, business partners, licenses, or vendors that may violate federal or state fraud and abuse laws or other applicable requirements.
Ours or our licensee’s compliance controls, policies, and procedures may not be sufficient to protect against acts of ours or their employees, business partners, licenses, or vendors that may violate federal or state fraud and abuse laws or other applicable requirements.
However, following the transaction with Mayne Pharma, when we changed our business to become a royalty company, we may be treated as a “public shell” company under the Nasdaq rules and the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act.
However, following the transaction with Mayne Pharma, when we changed our business to become a royalty company, we may be treated as a “public shell” company under the Nasdaq rules, the Securities Act of 1933, as amended (the “Securities Act”), or the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
The capital markets have in the past experienced, are currently experiencing, and may in the future experience, periods of upheaval that could impact the availability and cost of equity and debt financing and there can be no assurance that such financing will be available on terms commercially acceptable to the Company, or at all.
The capital markets have in the past experienced, are currently experiencing, and may in the future experience, periods of upheaval that could impact the availability and cost of equity and debt financing and such financing may not be available on terms commercially acceptable to the Company, or at all.
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.
We may not 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.
As of December 31, 2024, we had federal net operating loss (“NOL”) carryforwards of $579.0 million. 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.
As of December 31, 2025, we had federal net operating loss (“NOL”) carryforwards of $584.6 million. 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.
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 may not be able to retain the services of any of them.
If the sales information provided by our licensees is erroneous, it could have an adverse effect on our business, financial condition and results of operations. 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.
If the sales information provided by our licensees is erroneous, it could have an adverse effect on our business, financial condition and results of operations. We have incurred net losses in the past and may not be able to maintain or increase profitability in the future.
As substantial doubt about our ability to continue as a going concern exists, our ability to finance our operations through the sale and issuance of debt or equity securities or through bank or other financing could be impaired.
Our ability to continue as a going concern may depend on our ability to obtain additional capital. As substantial doubt about our ability to continue as a going concern exists, our ability to finance our operations through the sale and issuance of debt or equity securities or through bank or other financing could be impaired.
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.
If we are unable to implement such measures, we may not be able to continue as a going concern. 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.
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.
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.
If any of our products are marketed abroad, they will also be subject to extensive regulation by foreign governments, whether or not we have obtained FDA approval for a given product and its uses. Such foreign regulation may be equally or more demanding than corresponding U.S. regulation.
If any of our products are marketed abroad, they will also be subject to extensive regulation by foreign governments, whether or not we have obtained FDA approval for a given product and its uses.
If we or our partners were to face infringement claims or challenges by third parties relating to our pharmaceutical product candidates, an adverse outcome could subject us to significant liabilities to such third parties, and force us or our partners to curtail or cease the development of some or all of our pharmaceutical product candidates, which could adversely affect our business, financial condition, results of operations, and prospects.
If we or our partners were to face infringement claims or challenges by third parties relating to our pharmaceutical product candidates, an adverse outcome could subject us to significant liabilities to such third parties, and force us or our partners to curtail or cease the development of some or all of our pharmaceutical product candidates, which could adversely affect our business, financial condition, results of operations, and prospects. 34 If we are unable to protect the confidentiality of certain information, the value of our products and technology could be adversely affected.
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.
Our current liquidity position raises substantial doubt about our ability to continue as a going concern and Carr, Riggs & Ingram, L.L.C, our independent registered public accounting firm for the fiscal year ended December 31, 2025, has included an explanatory paragraph in their opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2025, indicating such.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. If our licensees are unable to economically promote or maintain our brand, our business, results of operations and financial condition could be severely harmed.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. If our licensees are unable to economically promote or maintain our brand, our business, results of operations and financial condition could be severely harmed. Loss of exclusivity may provide opportunity for competing products, particularly generics, to siphon off our consumers.
If any supplier of the API or other products used in our products experiences any significant difficulties in its respective manufacturing processes, chooses to cease supplying, or does not devote sufficient time, energy, and care to providing our manufacturing needs, we could experience significant interruptions in the supply of our products, which could impair our licensee’s ability to supply our products at the levels required for commercialization and prevent or delay their successful commercialization.
If any supplier of the API or other products used in our products experiences any significant difficulties in its respective manufacturing processes, chooses to cease supplying, or does not devote sufficient time, energy, and care to providing our manufacturing needs, we could experience significant interruptions in the supply of our products, which could impair our licensee’s ability to supply our products at the levels required for commercialization and prevent or delay their successful commercialization. 15 The commercial success of our existing products will depend upon gaining and retaining significant market acceptance of these products among physicians and payers.
There can be no assurance that Mayne Pharma will have sufficient financial or other resources to file and pursue such infringement claims in the United States, which typically last for years before they are concluded.
Mayne Pharma may not have sufficient financial or other resources to file and pursue such infringement claims in the United States, which typically last for years before they are concluded.
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.
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.
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 .
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.
Our results of operations could be harmed by general conditions in the global economy and in the global financial markets. A severe or prolonged economic downturn, including the impact of increased interest rates and inflation, could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at all.
A severe or prolonged economic downturn, including the impact of increased interest rates, the imposition of tariffs and inflation, could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at all.
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.
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.
On October 7, 2022, President Biden introduced an Executive Order to facilitate a new Trans-Atlantic Data Privacy Framework (the “DPF”), and on July 10, 2023, the European Commission adopted its Final Implementing Decision granting the U.S. adequacy (Adequacy Decision) for EU-U.S. transfers of personal information for companies that self-certify to the DPF.
On July 10, 2023, the European Commission adopted its Final Implementing Decision granting the U.S. adequacy (Adequacy Decision) for EU-U.S. transfers of personal information for companies that self-certify to the Trans-Atlantic Data Privacy Framework (the “DPF”).
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.
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 the future, our access to our cash in amounts adequate to finance our operations could be significantly impaired by the financial institutions with which we have arrangements directly facing liquidity constraints or failures.
If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations. In the future, our access to our cash in amounts adequate to finance our operations could be significantly impaired by the financial institutions with which we have arrangements directly facing liquidity constraints or failures.
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.
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.
The GDPR, which is wide-ranging in scope, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of personal data.
Moreover, the collection and use of personal health data in the European Union is governed by the European Union General Data Protection Regulation the (“GDPR”), which imposes wide-ranging requirements relating to, among other things, the consent of the individuals to whom the personal data relates, the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of personal data.
In addition, these products may not have the effect intended if they are not taken in accordance with certain instructions, which include certain dietary or other labeling restrictions.
In addition, these products may not have the effect intended if they are not taken in accordance with certain instructions, which include certain dietary or other labeling restrictions. Furthermore, the products, even when used as directed, may not have the effects intended or will not have harmful side effects in an unforeseen way or on an unforeseen cohort.
We and our licensees are also subject to additional healthcare regulation and enforcement by the federal government and the states in which we conduct our business.
Such foreign regulation may be equally or more demanding than corresponding U.S. regulation. 19 We and our licensees are also subject to additional healthcare regulation and enforcement by the federal government and the states in which we conduct our business.
Our lease agreements may also expose us to liabilities, such as rent escalations, maintenance obligations, termination rights, or indemnification claims, that may negatively affect our operations and profitability. Unfavorable global economic conditions could harm our business, financial condition or results of operations.
Our lease agreements may also expose us to liabilities, such as rent escalations, maintenance obligations, termination rights, or indemnification claims, that may negatively affect our operations and profitability. Licensing of intellectual property involves complex legal, business, and scientific issues, and disputes could jeopardize our rights under such agreements.
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.
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. We must rely on Mayne Pharma to file lawsuits or take other actions to protect or enforce our patents and they may not take such actions or be successful.
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.
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.
Similarly, if state government shutdowns were to occur, state payment obligations may be delayed. If the federal or state governments fail to make payments under these programs on a timely basis, the ability of our licensees to sell our products to government payers may be limited, thereby reducing anticipated revenues and profitability.
If the federal or state governments fail to make payments under these programs on a timely basis, the ability of our licensees to sell our products to government payers may be limited, thereby reducing anticipated net sales and royalty revenues. Time and costs associated with winding down our general and administrative, commercial, and research and development activities may be significant.
If any such actions are instituted against us or our licensees, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.
If any such actions are instituted against us or our licensees, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions. 33 General risks related to our intellectual property If we are sued for infringing intellectual property rights of third parties, litigation will be costly and time consuming and could prevent or delay us from developing or commercializing our pharmaceutical product candidates.
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.
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.
In addition, loss of exclusivity may provide opportunity for competing products, particularly generics, to siphon off our consumers. In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an ANDA submitted to the FDA by Teva Pharmaceuticals USA, Inc. (“Teva”).
In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an ANDA submitted to the FDA by Teva Pharmaceuticals USA, Inc. (“Teva”) seeking approval to market a generic version of IMVEXXY.
Moreover, our trade secrets, know-how, and technological advancements may otherwise become known or be independently developed by competitors in a manner providing us with no practical recourse against the competing parties. If any such events were to occur, they could adversely affect our business, financial condition, results of operations, and prospects.
Non-U.S. courts are sometimes less willing than U.S. courts to protect this information. Moreover, our trade secrets, know-how, and technological advancements may otherwise become known or be independently developed by competitors in a manner providing us with no practical recourse against the competing parties.
Recent government enforcement has targeted pharmaceutical companies for violations of fraud, abuse and other laws.
Government authorities continue to pursue actions against pharmaceutical companies for violations of fraud, abuse and other laws.
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.
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 commercial success of our existing products will depend upon gaining and retaining significant market acceptance of these products among physicians and payers. Physicians may not prescribe our products, which would prevent us from generating revenue or becoming profitable.
Physicians may not prescribe our products, which would prevent us from generating revenue or becoming profitable.
In addition, enforcement of claims that a third-party has illegally obtained and is using trade secrets, know-how, or technological advancements is expensive, time-consuming, and uncertain. Non-U.S. courts are sometimes less willing than U.S. courts to protect this information.
We cannot, however, ensure that these protective arrangements will be honored by third parties, and we may not have adequate remedies if these arrangements are breached. In addition, enforcement of claims that a third-party has illegally obtained and is using trade secrets, know-how, or technological advancements is expensive, time-consuming, and uncertain.
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”).
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”).
We may also experience other unknown impacts from 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. 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.
If we are unable to protect the confidentiality of certain information, the value of our products and technology could be adversely affected. We rely and previously relied on trade secrets, know-how, and continuing technological advancement to develop and maintain our competitive position.
We rely and previously relied on trade secrets, know-how, and continuing technological advancement to develop and maintain our competitive position. To protect this competitive position, we regularly enter into confidentiality and proprietary information agreements with third parties, including employees, independent contractors, suppliers, and collaborators.
The Patient Protection and Affordable Care Act (“ACA”) and any further changes in the law or regulatory framework could also have an adverse effect on our business, financial condition, and results of operations. Further, if a federal government shutdown were to occur for a prolonged period, federal government payment obligations, including its obligations under Medicaid and Medicare, may be delayed.
The ACA, the IRA and any further changes in the law or regulatory framework, including additional drug pricing reform measures, could also have an adverse effect on our business, financial condition, and results of operations.
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 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. 17 We sublease our properties, which could expose us to possible liabilities and losses . We sublease our former headquarters to third parties.
Removed
Our ability to continue as a going concern may depend on our ability to obtain additional capital as well as our ability to minimize operational expenses, including any potential net working capital adjustments relating to the Mayne Transaction.
Added
As of December 31, 2025, we had $7.5 million in cash and cash equivalents.
Removed
Time and costs associated with winding down our general and administrative, commercial, and research and development activities may be significant.
Added
Our ability to fund operations over the next twelve months is dependent upon, among other things, continued receipt of royalty payments under the Mayne License Agreement, resolution of the Mayne Lawsuits on terms that do not materially adversely affect our liquidity, and our ability to minimize operating expenses.
Removed
We sublease part of our headquarters to third parties and intend to sublease the remainder to one or more third parties.
Added
If we are unable to improve our liquidity position, we may be required to significantly reduce operating expenses, seek additional equity or debt financing that may be materially dilutive, sell assets, enter into strategic transactions or pursue other alternatives, any of which may be unfavorable to our stockholders.
Removed
We intend to resolve this matter, but the outcome is uncertain and can lead to unforeseen losses. We are also disputing the allowance for returns as Mayne Pharma’s estimates significantly differ from our estimates. These ongoing disputes may adversely affect our revenue, results of operations and financial position.
Added
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.
Removed
If such banking institutions were to fail, such as Silicon Valley Bank when the FDIC took control in March 2023, we could lose all or a portion of those amounts held in excess of such insurance limitations.
Added
In August 2024 and February 2025, Mayne Pharma provided additional information relating to the net working capital allowance for returns that we believe also differs significantly from our estimates. On April 8, 2025, we filed the Mayne Lawsuit seeking damages for breach of contract, breach of implied covenant of good faith and fair dealing, fraudulent inducement and unjust enrichment.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe 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.
Biggest changeWe 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 oversight of our cybersecurity risk.
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.
Risk Factors in this 2025 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.

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. 38
Biggest changeWe have sublet all of our leased property in Boca Raton as a result of shifting our business to become a pharmaceutical royalty company and terminating our employees. 38
Item 2. Properties Our headquarters are in Boca Raton, Florida. We operate from a fully remote environment. We have a lease that includes 62,748 rentable square feet, or the full premises, of which the lease of 7,561 square feet commenced in 2018 and the lease of 55,187 square feet commenced in August of 2019, or the full premises commencement date.
Item 2. Properties We operate from a fully remote environment. We have a lease in Boca Raton, Florida that includes 62,748 rentable square feet, or the full premises, of which the lease of 7,561 square feet commenced in 2018 and the lease of 55,187 square feet commenced in August of 2019, or the full premises commencement date.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeBeginning 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.
Biggest changeBeginning 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.
If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.
If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal proceeding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.
We have incurred and recorded legal costs amounting to $2,334 thousand in prepaid expenses and other current assets as of December 31, 2024, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully prevail in this legal proceeding.
We have incurred and recorded legal costs amounting to $2,334 thousand in prepaid expenses and other current assets as of December 31, 2025, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully prevail in this legal proceeding.
In June 2024, Mayne Pharma received a Paragraph IV certification notice letter (the “Sun Notice Letter”) regarding an ANDA submitted to the FDA by Sun Pharma Inc. (“Sun Pharma”). The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.
In June 2024, Mayne Pharma received the Sun Notice Letter regarding an ANDA submitted to the FDA by 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
As of December 31, 2025, the litigation remains ongoing and has progressed to claim construction, which the courts determine the meaning and scope of the asserted patent claims that will govern subsequent infringement and validity analysis.
Added
On April 8, 2025, we filed the Mayne Lawsuit seeking damages for breach of contract, breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and certain actions or inactions by Mayne Pharma relating thereto.
Added
On June 20, 2025, we filed an amended complaint against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit. On March 23, 2026, a magistrate judge recommended that the court grant-in-part and deny-in-part Mayne Pharma’s motion to dismiss.
Added
The magistrate judge recommended granting Mayne’s motion to dismiss our claims for breach of the covenant of good faith and fair dealing, certain of our breach of contract claims and our claim for fraudulent inducement, but recommended the court grant us leave to amend the fraudulent inducement claim. The magistrate judge recommended denying Mayne’s motion to dismiss our other claims.
Added
The magistrate judge further recommended the court stay the Mayne Lawsuit while the parties submit the net working capital claims to a dispute resolution process. The parties have 14 days to object to these recommendations. On May 30, 2025, Mayne Pharma filed the Mayne Countersuit seeking damages for breach of contract and fraudulent inducement related to the Transaction Agreement.
Added
As part of the Mayne Countersuit, Mayne Pharma also made certain indemnification demands under the Transaction Agreement, which we dispute. On July 28, 2025, we filed a motion to dismiss the fraudulent inducement claim in the Mayne Countersuit.
Added
On March 23, 2026, a magistrate judge recommended that the court grant our motion to dismiss Mayne Pharma’s claim for fraudulent inducement, but recommended the court deny our motion to dismiss Mayne Pharma’s other claims. The parties have 14 days to object to this recommendation.
Added
As of December 31, 2025, we believed no additional accrual was required for such claims, as we could not reasonably estimate a range of loss. From time to time, we are involved in other litigations and proceedings in the ordinary course of business.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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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.
Biggest changeAs of March 30, 2026, there were 58 stockholders of record of our common stock. Performance graph As a “smaller reporting company,” as defined by Rule 12b-2 of 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 31, 2024, the closing price of our common stock on Nasdaq was $0.86 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, 2025, the closing price of our common stock on Nasdaq was $1.63 per share.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThese 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.
Biggest changeIf, 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. 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.
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.
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.
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, 2025, we employed one full-time employee primarily engaged in an executive position.
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.
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 2025 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 2024 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 2025 10-K Report.
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.
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 2025 and 2024 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.
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.
For additional details, see the consolidated statements of cash flows included in our consolidated financial statements in this 2025 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.
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.
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 2025 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 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).
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 2025 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).
Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
Further, Mayne Pharma agreed to pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
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.
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 2025 10-K Report.
As the parties agreed, during the second quarter of 2023, Mayne Parma held back our royalty payment of $0.6 million and we funded an additional $0.9 million in August 2023 to settle the original $1.5 million payable.
As the parties agreed, during the second quarter of 2023, Mayne Pharma held back our royalty payment of $0.6 million and we funded an additional $0.9 million in August 2023 to settle the original $1.5 million payable.
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 agreed to 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.
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.
Pursuant to the Mayne License Agreement, Mayne Pharma has agreed to pay us one-time, milestone payments of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million.
Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
Further, Mayne Pharma has agreed to pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
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 agreed to 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.
Basis of presentation, new accounting standards and summary of significant accounting policies” to the consolidated financial statements included in this 2024 10-K Report.
Basis of presentation, new accounting standards and summary of significant accounting policies” to the consolidated financial statements included in this 2025 10-K Report.
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 has agreed to 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.
This royalty receivable is a contract asset as of December 31, 2024, and is further subject to offset by Mayne Pharma.
This royalty receivable is a contract asset as of December 31, 2025, and is further subject to offset by Mayne Pharma.
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.
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 2025 10-K Report. Recent accounting pronouncements Information regarding accounting standards issued or effective in 2025 is included in “Note 1. Basis of Presentation, New Accounting Standards and Significant Accounting Policies” to the consolidated financial statements.
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.
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, 2025, we had cash and cash equivalents totaling $7,483 thousand.
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.
As a result, we cannot reasonably estimate a range of loss, and accordingly, we have not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as we believe the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.
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.
Discontinued Operations”, in the notes to the consolidated financial statements appearing elsewhere in this 2025 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.
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.
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 2025 10-K Report, which has been prepared in accordance with U.S. GAAP.
The initial draw down occurred on June 29, 2023, consisting of a sale of 312,525 shares of Common Stock at a price per share equal to $3.6797. We received gross proceeds of $1.15 million from the drawdown, before expenses.
The initial draw-down occurred on June 29, 2023, consisting of a sale of 312,525 shares of Common Stock at a price per share equal to $3.6797. We received gross proceeds of $1.15 million from the drawdown, before expenses. On November 15, 2023, Rubric drew an additional 877,192 shares of Common Stock at a price per share equal to $2.2761.
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.
We recorded $3,022 thousand in license revenue during the year ended December 31, 2025 primarily from the Mayne License Agreement, an increase of $1,261 thousand, or 71.6%, compared to $1,761 thousand in license revenue during the year ended December 31, 2024. The increase is primarily attributable to changes in sales of licensed products. General and administrative.
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.
In February 2024, we 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 our estimate of the allowances. We continue to believe our estimated allowances for payer rebates and wholesale distributor fees are reasonable.
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 of December 31, 2025, and 2024, we had a royalty receivable of $3,159 thousand and $3,327 thousand, respectively, relating to the short-term portion of royalty receivable from Mayne Pharma and $13,713 thousand and $16,010 thousand, respectively relating to the long-term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty.
In 2022, we started classifying commercial activities as discontinued operations due to the cessation of these operations.
In 2022, we started classifying commercial activities as discontinued operations due to the cessation of these operations. For additional information, see “Note 2.
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.
For 2025, we had a loss from operations of $4,390 thousand, a decrease in loss of $1,722 thousand, or 28.2%, compared to loss from operations of $6,112 thousand for 2024. This change reflects the increase in sales from licensed products and the increased efficiencies realized as a royalty-based business. Other income.
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.
For 2025, net income from discontinued operations was $84 thousand, a decrease of $47 thousand, compared to net income from discontinued operations of $131 thousand for 2024. For additional information, see “Note 2. Discontinued Operations”, in the notes to the consolidated financial statements appearing elsewhere in this 2025 10-K Report for further details.
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 2025, we had net loss from continuing operations of $653 thousand, or $0.06 per basic and diluted common share, a decrease in loss of $1,659 thousand, compared to net loss from continuing operations of $2,312 thousand, or $0.20 per basic and diluted common share, for 2024. Discontinued Operations.
See “Going Concern” above for further discussion related to our ability to generate and obtain adequate amounts of cash to meet our liquidity needs and our plans to satisfy our such needs in the short-term and in the long-term.
We received gross proceeds of $2.0 million from the draw-down, before expenses. There were no draw-downs in 2025 and 2024. See “Going Concern” above for further discussion related to our ability to generate and obtain adequate amounts of cash to meet our liquidity needs and our plans to satisfy our such needs in the short-term and in the long-term.
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.
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 2025 10-K Report.
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.
Commitments and contingencies” to the consolidated financial statements included in this 2025 10-K Report. Employment agreements Information regarding employment agreements is in “Note 7. Commitments and contingencies” to the consolidated financial statements included in this 2025 10-K Report.
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.
Years ended December 31, Cash flow from continuing operations 2025 2024 Net cash provided by operating activities $ 2,454 $ 1,170 Net cash used in discontinued operations (30 ) (438 ) Net increase in cash $ 2,424 $ 732 Operating Activities from continuing operations.
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.
Additional disclosures regarding discontinued operations are provided in Note 2 to the consolidated financial statements included in this 2025 10-K Report. 43 The following table sets forth the results of our operations (in thousands): Years ended December 31, 2025 2024 Revenue, net: License revenue $ 3,022 $ 1,761 Operating expenses: General and administrative 6,852 6,096 Write-off and impairment of patents 176 1,268 Depreciation & amortization 384 509 Total operating expenses 7,412 7,873 Loss from operations (4,390 ) (6,112 ) Other income (expense): Interest income, net 142 135 Sublease income 1,847 1,352 Miscellaneous income 1,748 2,282 Total other income 3,737 3,769 Loss from continuing operations before income taxes (653 ) (2,343 ) Income tax benefit - 31 Net loss from continuing operations (653 ) (2,312 ) Income from discontinued operations, net of income taxes 84 131 Net loss $ (569 ) $ (2,181 ) Revenue.
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.
We recognized a $176 thousand write-off for abandoned patents and application in 2025, compared to a $1,268 thousand impairment loss in 2024. Depreciation & amortization. Depreciation and amortization expense for 2025 was $384 thousand, a decrease of $125 thousand, or 24.6%, compared to $509 thousand for 2024. This balance is entirely comprised of amortization of license rights and intangible assets.
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.
Net cash used in discontinued operations. Net cash used in discontinued operations for 2025 was $30 thousand, a decrease of $408 thousand, as compared to net cash used in discontinued operations of $438 thousand for 2024. This change relates primarily to a decreased level of activities associated with our discontinued operations.
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 August 2024 and in February 2025, we also received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly from our estimate of the allowance.
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.
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. 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 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 .
In 2024, the Company recognized $31 thousand income tax benefits from continuing operations. Net loss from continuing operations .
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.
In 2025, we had other income of $3,737 thousand, a decrease of $32 thousand, or 0.8%, compared to other income of $3,769 thousand in 2024.
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.
Net cash provided by operating activities in 2025 was $2,454 thousand, an increase of $1,284 thousand, compared to net cash provided in operating activities of $1,170 thousand for 2024.
Removed
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 .
Added
General and administrative expenses for 2025 were $6,852 thousand, an increase of $756 thousand, or 12.4%, compared to $6,096 thousand for 2024. This increase was primarily attributable to higher bonus expense and increased investor relations costs in 2025. Write-off and impairment of patents .
Removed
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.
Added
Operating expenses. Total operating expenses for 2025 were $7,412 thousand, a decrease of $461 thousand, or 5.9%, compared to $7,873 thousand for 2024. The decrease was primarily attributable to lower impairment charges recognized in 2025 compared to 2024, which was partially offset by higher bonus expense and increased costs related to investor communications. Loss from operations.
Removed
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.
Added
The decrease was primarily attributable to the absence of rental settlement gain and contract breakage settlements recognized in 2024, which was partially offset by the higher sublease income and increased royalty income from Mayne Pharma in 2025. 44 Benefit for income taxes . For 2025, no income tax benefits was recognized from continuing operations.
Removed
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.
Added
This increase was primarily driven by the significant reduction in loss from continuing operations and favorable changes in accrued expenses and other current liabilities, partially offset by lower non-cash adjustments such decreased long-lived asset impairment charges in 2025. Financing Activities from continuing operations. There was no cash received from financing activities for both 2025 and 2024.
Removed
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.
Added
In the ordinary course of business, we enter into agreements with third parties that include indemnification provisions, which, in our judgment, are normal and customary for companies in our industry sector. Pursuant to these agreements, we agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered, for which there may or may not be limitations on potential damages.
Removed
Financing Activities from continuing operations. For 2024, there was no cash received from financing activities, compared to net cash received from financing activities of $3,151 thousand for 2023, reflecting the sale of common stock during 2023. Discontinued operations.
Added
The maximum potential amount of future payments we could be required to make under these indemnification provisions is sometimes unlimited. As a result, the estimated fair value of liabilities relating to these provisions is minimal. Accordingly, we had no liabilities recorded for these provisions as of December 31, 2025.
Removed
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.
Added
In the normal course of business, we may be confronted with issues or events that may result in contingent liability. 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.
Removed
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.
Added
On April 8, 2025, we filed the Mayne Lawsuit seeking damages for breach of contract, breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and certain actions or inactions by Mayne Pharma relating thereto.
Added
On June 20, 2025, we filed an amended complaint against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit. On March 23, 2026, a magistrate judge recommended that the court grant-in-part and deny-in-part Mayne Pharma’s motion to dismiss.
Added
The magistrate judge recommended granting Mayne’s motion to dismiss our claims for breach of the covenant of good faith and fair dealing, certain of our breach of contract claims and our claim for fraudulent inducement, but recommended the court grant us leave to amend the fraudulent inducement claim. The magistrate judge recommended denying Mayne’s motion to dismiss our other claims.
Added
The magistrate judge further recommended the court stay the Mayne Lawsuit while the parties submit the net working capital claims to a dispute resolution process. The parties have 14 days to object to these recommendations. On May 30, 2025, Mayne Pharma filed the Mayne Countersuit seeking damages for breach of contract and fraudulent inducement related to the Transaction Agreement.
Added
As part of the Mayne Countersuit, Mayne Pharma also made certain indemnification demands under the Transaction Agreement, which we dispute. On July 28, 2025, we filed a motion to dismiss the fraudulent inducement claim in the Mayne Countersuit.
Added
On March 23, 2026, a magistrate judge recommended that the court grant our motion to dismiss Mayne Pharma’s claim for fraudulent inducement, but recommended the court deny our motion to dismiss Mayne Pharma’s other claims. The parties have 14 days to object to this recommendation.
Added
As of December 31, 2025, we believed no additional accrual was required for such claims, as we could not reasonably estimate a range of loss. The outcome of this matter is uncertain at this point.
Added
As of December 31, 2025, we also believed no additional accrual was required for amounts that may be owed for the allowance for returns under the Transaction Agreement. We have not recorded any contingent gains or receivables for any such allowances.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

1 edited+0 added−0 removed0 unchanged
Biggest changeItem 7A. Quantitative and qualitative disclosures about market risk 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 changeItem 7A. Quantitative and qualitative disclosures about market risk As a “smaller reporting company,” as defined by Rule 12b-2 of the Exchange Act, and pursuant to Instruction 6 to Item 201(e) of Regulation S-K, we are not required to provide this information.

Other TXMD 10-K year-over-year comparisons