TherapeuticsMD, Inc.

Previous wording

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Factors that could cause or contribute to such differences include, but are not limited to, our liquidity requirements, supply chain issues, management transitions, risks related to our licensing agreements, market and general economic factors, and the other risks discussed in Part I, Item 1A of our 2024 10-K Report, as updated and supplemented by Part II, Item 1A of this 10-Q Report.

Current wording

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Factors that could cause or contribute to such differences include, but are not limited to, our liquidity requirements, supply chain issues, management transitions, risks related to our licensing agreements, risks related to the pursuit of strategic alternatives, market and general economic factors, and the other risks discussed in Part I, Item 1A of our 2024 10-K Report, as updated and supplemented by Part II, Item 1A of this 10-Q Report.

Previous wording

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 condensed 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 – Discontinued Operations to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for further details.

Current wording

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 condensed consolidated financial statements. Liabilities associated with the commercial business are classified as liabilities of discontinued operations in our consolidated balance sheets. See Note 2 – Discontinued Operations to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for further details.

Previous wording

In February 2024, the Company received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed significantly from the Company’s estimate of the allowances. The Company continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable. In August 2024 and in February 2025, the Company also 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.

Current wording

Our estimate of the allowance for payer rebates and wholesale distributor fees was determined in accordance with the Transaction Agreement which establishes the process for the determination of net working capital. In February 2024, 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. 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.

Previous wording

On April 8, 2025, the Company 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. On June 20, 2025, the Company filed an amended complaint against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit.

Current wording

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. 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.

Previous wording

On May 30, 2025, Mayne Pharma filed a lawsuit against the Company 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. On July 28, 2025, the Company filed a motion to dismiss the Mayne Countersuit. As of June 30, 2025, the Company believed no additional accrual was required for such claims, as the Company could not reasonably estimate a range of loss.

Current wording

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. On July 28, 2025, we filed a motion to dismiss the Mayne Countersuit. As of September 30, 2025, we believed no additional accrual was required for such claims, as we could not reasonably estimate a range of loss.

Previous wording

The outcome of this matter is uncertain at this point. As a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company believes the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.

Current wording

The outcome of this matter is uncertain at this point. 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.

Previous wording

As of June 30, 2025, the Company also believes no additional accrual is required for amounts that may be owed for the allowance for returns under the Transaction Agreement. The Company has not recorded any contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

Current wording

As of September 30, 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. 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.

Previous wording

Mayne Pharma has also made certain indemnification demands under the Transaction Agreement, which the Company disputes. As of June 30, 2025, the Company believed no additional accrual was required for such claims, as the Company could not reasonably estimate a range of loss.

Current wording

Mayne Pharma has also made certain indemnification demands under the Transaction Agreement, which we dispute. As of September 30, 2025, we believed no additional accrual was required for such claims, as we could not reasonably estimate a range of loss.

Previous wording

If Mayne Pharma’s sales of Licensed Products grow more slowly than expected or decline, including as a result of Mayne Pharma Group’s potential sale to Cosette Pharmaceuticals, Inc., if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if 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. The potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements.

Current wording

If Mayne Pharma’s sales of Licensed Products grow more slowly than expected or decline, including as a result of Mayne Pharma Group’s potential sale to Cosette Pharmaceuticals, Inc., if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if 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. The potential impact of these factors in conjunction with the uncertainty of the capital markets raise substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements.

Previous wording

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 condensed consolidated financial statements for all periods prior to the Closing Date. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2 to the condensed consolidated financial statements included in this Quarterly Report.

Current wording

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 condensed consolidated financial statements for all periods prior to the Closing Date. Liabilities associated with the commercial business are classified as liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2 to the condensed consolidated financial statements included in this Quarterly Report.

Previous wording

*Revenue.*We recorded $952 thousand in license revenue for the second quarter of 2025, primarily from the Mayne License Agreement, an increase of $718 thousand, compared to $234 thousand in license revenue for the second quarter of 2024. The increase is primarily attributable to changes in sales of licensed products.

Current wording

*Revenue.*We recorded $784 thousand in license revenue for the third quarter of 2025, primarily from the Mayne License Agreement, an increase of $237 thousand, compared to $547 thousand in license revenue for the third quarter of 2024. The increase is attributable to changes in sales of licensed products.

Previous wording

*Selling, general and administrative.*Selling, general and administrative expenses were $1,551 thousand for the second quarter of 2025, a decrease of $31 thousand, reflecting minimal change from the second quarter of 2024.

Current wording

*General and administrative.*General and administrative expenses were $1,518 thousand for the third quarter of 2025, a decrease of $67 thousand, reflecting minimal change from the third quarter of 2024.

Previous wording

*Depreciation & amortization.*Depreciation and amortization expense was $96 thousand for the second quarter of 2025, a decrease of $84 thousand, or 46.7%, compared to the second quarter of 2024. This balance is entirely comprised of amortization of license rights and intangible assets.

Current wording

*Depreciation and amortization.*Depreciation and amortization expense was $96 thousand for the third quarter of 2025, consistent to the third quarter of 2024. This balance is entirely comprised of amortization of license rights and intangible assets.

Previous wording

Loss from operations. In the second quarter of 2025, we had a loss from operations of $695 thousand, as compared to a loss from operations of $2,789 thousand for the second quarter of 2024. This change reflects the increase in license revenues and the impairment recognized in 2024.

Current wording

Loss from operations. In the third quarter of 2025, we had a loss from operations of $862 thousand, as compared to a loss from operations of $1,134 thousand for the third quarter of 2024. This change reflects the increase in license revenues in 2025.

Previous wording

Other income, net. During the second quarter of 2025, we had other income of $1,240 thousand compared to other income of $1,739 thousand in the second quarter of 2024. This change is primarily due to the gain on an early termination of a sublease we recognized in 2024 partially offset by higher other income pertaining to Mayne’s royalty sales of ANNOVERA and amounts received pursuant to a settlement pertaining to trademark infringement by a third party of certain trademarks owned by us. Pursuant to the settlement, we received a payment of $413 thousand in May 2025.

Current wording

Other income, net. During the third quarter of 2025, we had other income of $912 thousand compared to other income of $567 thousand in the third quarter of 2024, reflecting an increase in sublease income and higher other income pertaining to Mayne’s royalty sales of ANNOVERA in the third quarter of 2025.

Previous wording

Net income (loss) from continuing operations. For the second quarter of 2025, we had net income of $551 thousand, or $0.05 per basic and diluted common share, compared to a net loss of $1,050 thousand, or $0.09 per basic and diluted common share, for the second quarter of 2024.

Current wording

Income (loss) from continuing operations. For the third quarter of 2025, we had net income of $50 thousand, compared to a net loss of $567 thousand for the third quarter of 2024.

Previous wording

Discontinued Operations – Net income from discontinued operations was $6 thousand for the second quarter of 2025, compared to net loss from discontinued operations of $40 thousand for the second quarter of 2024.

Current wording

Discontinued Operations – Income from discontinued operations was $102 thousand for the third quarter of 2025, compared to a loss from discontinued operations of $42 thousand for the third quarter of 2024.

Previous wording

Six months ended June 30, 2025 compared with six months ended June 30, 2024

Current wording

Nine months ended September 30, 2025 compared with nine months ended September 30, 2024

Previous wording

*Revenue.*We recorded $1,345 thousand in license revenue for the first six months of 2025, primarily from the Mayne License Agreement, an increase of $798 thousand, compared to $547 thousand in license revenue for the first six months of 2024. The increase is primarily attributable to changes in sales of licensed products.

Current wording

*Revenue.*We recorded $2,129 thousand in license revenue for the first nine months of 2025, primarily from the Mayne License Agreement, an increase of $1,035 thousand, compared to $1,094 thousand in license revenue for the first nine months of 2024. The increase is attributable to changes in sales of licensed products.

Previous wording

*Selling, general and administrative.*Selling, general and administrative expenses were $3,042 thousand for the first six months of 2025, a decrease of $257 thousand, or 7.8%, compared to the first six months of 2024. The change is primarily due to the final vesting of outstanding restricted stock units under our share-based compensation plans.

Current wording

General and administrative. General and administrative expenses were $4,560 thousand for the first nine months of 2025, a decrease of $324 thousand. The change is primarily due to the final vesting of outstanding restricted stock units under our share-based compensation plans.

Previous wording

*Depreciation & amortization.*Depreciation and amortization expense was $191 thousand for the first six months of 2025, a decrease of $122 thousand, or 39.0%, compared to the first six months of 2024. This balance is entirely comprised of amortization of license rights and intangible assets.

Current wording

*Depreciation and amortization.*Depreciation and amortization expense was $287 thousand for the first nine months of 2025, a decrease of $122 thousand. This balance is entirely comprised of amortization of license rights and intangible assets.

Previous wording

Operating expenses. Total operating expenses for the first six months of 2025 were $3,321 thousand, a decrease of $1,552 thousand, or 31.8%, compared to the first six months of 2024. The change is primarily due to the impairment recognized in 2024 and the final vesting of outstanding restricted stock units under our share-based compensation plans.

Current wording

Operating expenses. Total operating expenses for the first nine months of 2025 were $4,967 thousand, a decrease of $1,587 thousand. The change is primarily due to the impairment recognized in 2024 and the final vesting of outstanding restricted stock units under our share-based compensation plans.

Previous wording

Loss from operations. In the first six months of 2025, we had a loss from operations of $1,976 thousand, as compared to a loss from operations of $4,326 thousand for the first six months of 2024. This change reflects the increase in license revenues in 2025 and the impairment recognized in 2024.

Current wording

Loss from operations. In the first nine months of 2025, we had a loss from operations of $2,838 thousand, as compared to a loss from operations of $5,460 thousand for the first nine months of 2024. This change reflects the increase in license revenues in 2025 and the absence of the impairment recognized in 2024.

Previous wording

Other income, net. During the first six months of 2025, we had other income of $1,853 thousand compared to other income of $2,467 thousand in the first six months of 2024. This change is primarily due to the gain on an early termination of a sublease we recognized in 2024 partially offset by higher other income pertaining to Mayne’s royalty sales of ANNOVERA, and amounts received pursuant to a settlement pertaining to trademark infringement by a third party of certain trademarks owned by us.

Current wording

Other income, net. During the first nine months of 2025, we had other income of $2,765 thousand compared to other income of $3,034 thousand in the first nine months of 2024. This change is primarily due to higher other income pertaining to Mayne’s royalty sales of ANNOVERA in 2024.

Previous wording

Income tax benefit. During the first six months of 2025, we recorded income tax benefit of $32 thousand for continuing operations, which is a result of refunds received from certain state tax filings. During the first six months of 2024, we recorded no benefit for income taxes for continuing operations.

Current wording

Income tax benefit. During the first nine months of 2025, we recorded income tax benefit of $32 thousand for continuing operations, which is a result of refunds received from certain state tax filings. During the first nine months of 2024, we recorded no benefit for income taxes for continuing operations.

Previous wording

Discontinued Operations – Net loss from discontinued operations was $11 thousand for the first six months of 2025, compared to net income from discontinued operations of $35 thousand for the first six months of 2024.

Current wording

Discontinued Operations –Income from discontinued operations was $91 thousand for the first nine months of 2025, compared to a loss from discontinued operations of $7 thousand for the first nine months of 2024.

Previous wording

Our primary use of cash is to fund our continued operations. We have funded our operations primarily through public offerings of our common stock and private placements of equity and debt securities, and the transactions with Mayne Pharma. As of June 30, 2025, we had cash and cash equivalents totaling $6,069 thousand. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation insured limits of $250 thousand per bank. We have never experienced any losses related to these funds.

Current wording

Our primary use of cash is to fund our continued operations. We have funded our operations primarily through public offerings of our common stock and private placements of equity and debt securities, and the transactions with Mayne Pharma. As of September 30, 2025, we had cash and cash equivalents totaling $7,115 thousand. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation insured limits of $250 thousand per bank. We have never experienced any losses related to these funds.

Previous wording

The initial drawdown 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 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 drawdowns in the first six months of 2025 and 2024.

Current wording

The initial drawdown 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 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 drawdowns in the first nine months of 2025 and 2024.

Previous wording

Operating Activities from continuing operations. For the first six months of 2025, net cash provided by operating activities was $1,080 thousand, compared to net cash provided by operating activities of $1,224 thousand for the first six months of 2024. The decrease was primarily driven by lower non-cash adjustments, notably the absence of impairment charges on long-lived assets and reduced depreciation, amortization, and share-based compensation expense in 2025, which is partially offset by the improvement in net loss from continuing operations.

Current wording

Operating Activities from continuing operations. For the first nine months of 2025, net cash provided by operating activities was $2,079 thousand, compared to net cash provided by operating activities of $1,153 thousand for the first nine months of 2024. The 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 as decreased amortization and the absence of long-lived asset impairment charges in 2025.

Previous wording

Net cash used in discontinued operations. Net cash used in operating activities from discontinued operations for the first six months of 2025 was $70 thousand as compared to net cash used in operating activities from discontinued operations of $319 thousand for the first six months of 2024. This change relates primarily to a decreased level of activities associated with our discontinued operations.

Current wording

Net cash used in discontinued operations. Net cash used in discontinued operations for the first nine months of 2025 was $23 thousand as compared to net cash used in operating activities from discontinued operations of $433 thousand for the first nine months of 2024. This change relates primarily to a decreased level of activities associated with our discontinued operations.

Previous wording

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. As of June 30, 2025, we had a royalty receivable of $3,433 thousand relating to the short-term portion of receivable from Mayne Pharma and $14,840 thousand relating to the long-term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty. 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 our 2024 10-K Report.

Current wording

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. As of September 30, 2025, we had a royalty receivable of $3,164 thousand relating to the short-term portion of royalty receivable from Mayne Pharma and $14,269 thousand relating to the long-term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty. 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 our 2024 10-K Report.

Previous wording

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 or omitted by us. The maximum potential amount of future payments we could be required to make under these indemnification provisions is sometimes unlimited. We have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. 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 June 30, 2025 and December 31, 2024.

Current wording

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. 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 September 30, 2025 and December 31, 2024.

Previous wording

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. 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. GAAP”), an estimate is made of the loss and the appropriate accounting entries are reflected in our condensed consolidated financial statements.

Current wording

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. If, in our opinion, we have incurred a probable loss and the amount of the loss can be reasonably estimated, 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 condensed consolidated financial statements.