What changed in this filing

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Item 1. Financial Statements

2025-05-13 compared with 2024-11-12 · 270 added, 294 removed, 420 unchanged (57% of the section changed)

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(in thousands, except per share data)

September 30,

Current assets:

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Prepaid and other current assets

Current assets of discontinued operations

Total current assets

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Common stock, par value $ 0.001 ;

32,000 shares authorized, 11,532 issued and outstanding as of September 30, 2024 and December 31, 2023

32,000 shares authorized, 11,574 and 11,532 issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

Additional paid-in capital

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Three Months Ended

September 30,

Nine Months Ended

September 30,

Revenue, net:

License and service revenue

License revenue

Operating expenses:

Selling, general and administrative

Impairment of long-lived assets (Note 4)

Write-off of patents and trademarks

Depreciation & amortization

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Loss from continuing operations before income taxes

Provision for income taxes

Income tax benefit

Loss from continuing operations, net of income taxes

Loss from discontinued operations, net of income taxes

(Loss) income from discontinued operations, net of income taxes

Loss per common share, basic and diluted:

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(Unaudited - in thousands)

Three and Nine Months Ended September 30, 2024

Additional Paid in

Three Months Ended March 31, 2025

Balance, January 1, 2025

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$ ( 952,475 )

Share-based compensation

Balance, June 30, 2024

$ ( 951,465 )

Share-based compensation

Balance, September 30, 2024

$ ( 952,074 )

Three and Nine Months Ended September 30, 2023

Additional Paid in

Three Months Ended March 31, 2024

Balance, January 1, 2024

$ ( 949,641 )

Shares issued for vested restricted stock units

Share-based compensation

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$ ( 950,375 )

Shares issued for vested restricted stock units

Shares issued for sale of common stock related to private placement sale

Share-based compensation

Shares issued for exercise of warrants

Balance, June 30, 2023

$ ( 945,380 )

Share-based compensation

Balance, September 30, 2023

$ ( 948,758 )

The accompanying notes are an integral part of

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(Unaudited - in thousands)

Nine Months Ended

September 30,

Three Months Ended

Cash flows from operating activities:

Loss from discontinued

operations, net of income taxes

(loss) income from discontinued operations, net of income taxes

Net loss from continuing operations

Adjustments to reconcile net loss to net cash provided by (used in) continuing operating activities:

Adjustments to reconcile net loss to net cash provided by (used in) continuing operating

Depreciation and amortization

Impairment of long-lived assets (Note 4)

Write-off of patents and trademarks

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Net cash provided by (used in) continuing operating activities

Cash flows from financing activities:

Proceeds from sale of common stock, net of costs

Net cash provided by continuing financing activities

Discontinued operations:

Net cash used in operating activities

Net cash used in discontinued operations

Net increase (decrease) in cash

Net cash (used in) provided by operating activities

Net cash (used in) provided by discontinued operations

Net increase in cash

Cash and cash equivalents - continuing operations, beginning of period

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in the United States and its possessions and territories.

Under the Mayne License Agreement, Mayne Pharma will pay us milestone

payments of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 100.0 million,

(ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million and (iii) $ 15.0

million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million.

Further, Mayne Pharma

will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80.0 million in annual

net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years following the Closing

The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation

of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.

Mayne Pharma will pay us

minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further

adjustments, including as described below.

Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the

Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.

Under the Mayne License Agreement, Mayne Pharma will pay us

milestone payments of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year

reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach

$ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach

$ 300.0 million.

Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty rate of

8.0 % on the first $ 80.0 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain

adjustments, for a period of 20 years following the Closing Date.

The royalty rate will decrease to 2.0 % on a Product-by-Product

basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version

of a Product launching in the United States.

Mayne Pharma will pay us minimum annual royalties of $ 3.0 million per year for 12

years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below.

the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully

paid-up and royalty free license for the Licensed Products.

Under the Transaction Agreement, dated December 4, 2022, between TherapeuticsMD

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The total consideration from Mayne Pharma to TherapeuticsMD for the

purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0

million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined

in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at

closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive

the contingent consideration set forth in the Mayne License Agreement, as amended.

The acquisition of net working capital was determined

in accordance with the Transaction Agreement and included significant estimates which could change materially for a period of up to two

years following the Closing Date.

purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement was

(i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of

net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment

of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below)

and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.

The acquisition of net

working capital was determined in accordance with the Transaction Agreement and included significant estimates which could change materially

for a period of up to two years following the Closing Date.

On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment

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As part of the transformation that included the Mayne License Agreement,

historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in

our condensed consolidated financial statements.

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 of our condensed consolidated financial statements.

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 condensed consolidated balance sheets.

Additional disclosures regarding discontinued operations are provided in Note

2 of our condensed consolidated financial statements.

We also have license agreements with strategic partners to commercialize

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Knight obtained regulatory approval for IMVEXXY and BIJUVA and began commercialization efforts in 2024.

September 2019, we entered into an exclusive license and supply agreement (the “Theramex License Agreement”) with Theramex

HQ UK Limited (“Theramex”) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.

Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.

In connection with our transformation into a pharmaceutical royalty

company, the termination of our executive management team (except for Mr.

Marlan Walker, our former General Counsel and current Chief

Executive Officer) and all other employees was completed by December 31, 2022.

Severance obligations for all employees other than executive

officers were paid in full in January 2023 and severance obligations for terminated executive officers have been paid in accordance with

their employment agreements and separation agreements as previously disclosed.

As of December 31, 2023 and September 30, 2024, we employed

one full-time employee primarily engaged in an executive position.

We have engaged external consultants who support our relationship with

current partners and assist with certain financial, legal, and regulatory matters and the continued wind-down of our historical business

On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would

serve as our Principal Financial Officer.

On August 17, 2023 Michael C.

Donegan notified us of his decision to resign from the positions

of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023.

Ziegler succeeded Mr.

Donegan as Principal

Financial and Accounting Officer as of the date of Mr.

Donegan’s resignation.

In September 2019, we entered into an exclusive license and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.

In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.

In December 2024, we transferred the right to commercialize IMVEXXY and BIJUVA in Israel from Knight to Theramex.

Going concern

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of its affiliates, up to an aggregate of 5,000,000 shares of our common stock, par value $ 0.001 per share (our “Common Stock”),

from time to time during the term of the Subscription Agreement in separate draw-downs at our election.

from time to time during the term of the Subscription Agreement in separate drawdowns at our election.

On June 29, 2023, we issued and

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We received gross proceeds

of $ 1.15 million from the draw down, before expenses.

of $ 1.15 million from the drawdown, before expenses.

On November 15, 2023, Rubric drew down an additional 877,192 shares of Common Stock

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We received gross proceeds of $ 2.0 million from the drawdown, before expenses.

In February 2024, the Company received Mayne

Pharma’s calculation of allowance for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement which differed

There were no drawdowns

in the first quarter of 2025 and 2024.

In February 2024, the Company received Mayne Pharma’s calculation

of the net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed

significantly from the Company’s estimate of the allowances.

The Company intends to resolve this matter through

the dispute resolution process outlined in the Transaction Agreement.

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.

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.

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.

In addition, the Company has received

information from Mayne Pharma pertaining to the allowance for returns that differs from the Company’s estimate of the

As of September 30, 2024, the Company believes no additional accrual is required for amounts that may be owed for the

allowance for returns under the Transaction Agreement, as the Company cannot reasonably estimate a range of loss.

The Company has

not recorded any contingent gains or receivables for any such allowances.

Management continues to monitor the unresolved and pending

net working capital items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

If Mayne Pharma’s sales of Licensed

Products grow more slowly than expected or decline, 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.

potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability

to continue as a going concern for the next twelve months from the issuance of these financial statements.

the 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 of March 31, 2025, the Company also believed no additional accrual

was required for amounts that may be owed for the allowance for returns under the Transaction Agreement.

The Company has not recorded

any contingent gains or receivables for any such allowances.

Management continues to monitor the unresolved and pending net working capital

items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

Mayne Pharma has also made certain indemnification demands under the

Transaction Agreement, which the Company disputes.

As of March 31, 2025, the Company believed no additional accrual was required for such

claims, as the Company could not reasonably estimate a range of loss.

If Mayne Pharma’s sales of Licensed Products grow more slowly

than expected or decline, including as a result of Mayne Pharma Group’s pending sale to Cosette Pharmaceuticals, Inc., if the net

working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are unsuccessful

with future financings or the supply chains related to the third-party contract manufacturers are worse than we anticipate, our existing

cash reserves may be insufficient to satisfy our liquidity requirements.

The potential impact of these factors in conjunction with the

uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve months

from the issuance of these financial statements.

The accompanying consolidated financial statements

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As part of the transformation as a result of the Mayne Transaction,

historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in

the condensed consolidated financial statements.

Assets and liabilities associated with the commercial business are classified as assets

and liabilities of discontinued operations in the condensed consolidated balance sheets.

Additional disclosures regarding discontinued

operations are provided in Note 2 of the condensed consolidated financial statements.

all results associated with former commercial operations have been reflected as discontinued operations in the condensed consolidated

financial statements.

Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued

operations in the condensed consolidated balance sheets.

Additional disclosures regarding discontinued operations are provided in Note

2 of the condensed consolidated financial statements.

Revenues, expenses, assets, liabilities, and equities can vary during

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Adoption of new accounting standards

In November 2023, the Financial Accounting Standards Board (“FASB”)

issued Update 2023-07, “Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures” (“Update 2023-07”).

Update 2023-07 applies to all public entities that are required to report segment information in accordance with Topic 280.

The amendments

in Update 2023-07 revise reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment

The amendments in Update 2023-07 do not change how a public entity identifies its operating segments, aggregates those operating

segments, or applies the quantitative thresholds to determine its reportable segments.

Update 2023-07 is effective for fiscal years beginning

after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024.

As of December 2024, we have adopted Financial Accounting Standards

Board (“FASB”) Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280):

to Reportable Segment Disclosures” (“Update 2023-07”).

ASU 2023-07 applies to all public entities that are required

to report segment information in accordance with Topic 280.

The amendments in ASU 2023-07 revise reportable segment disclosure requirements,

primarily through enhanced disclosures about significant segment expenses.

The amendments in ASU 2023-07 do not change how a public entity

identifies its operating segments, aggregates those operating segments, or applies the quantitative thresholds to determine its reportable

In November 2024, the FASB issued ASU 2024-03, “Income Statement

- Reporting Comprehensive Income (Topic 220):

Disaggregation of Income Statement Expenses.” The ASU requires additional disclosures

by disaggregating the costs and expense line items that are presented on the face of the income statement.

The disaggregation includes:

(i) amounts of purchased inventory, employee compensation, depreciation, amortization, and other related costs and expenses;

(ii) an explanation

of costs and expenses that are not disaggregated on a quantitative basis;

and (iii) the definition and total amount of selling expenses.

ASU 2024-03 is effective for our Annual Report on Form 10-K beginning in 2027 and subsequent interim reports.

Early adoption is permitted.

2023-07 should be applied retrospectively to all prior periods presented in the financial statements.

The Company is currently evaluating

the impact of adopting Update 2023-07.

In December 2023, the Financial Accounting Standards Board (“FASB”)

issued ASU 2023-09, “Income Taxes (Topic 740) - Improvements to Income Tax Disclosures” (“ASU 2023-09”).

enhances the transparency and decision usefulness of income tax disclosures by requiring consistent categories and greater disaggregation

of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction.

ASU 2023-09 will be effective for the Company

in its income tax disclosure included in its 2025 Annual Report on Form 10-K and will be applied on a prospective basis.

However, retrospective

application is permitted.

The ASU should be applied prospectively.

Retrospective application is permitted for all prior periods presented in the financial statements.

The Company is evaluating the impact of ASU 2024-03 on our financial reporting disclosures.

In December 2023, the FASB issued ASU 2023-09, “Income

Taxes (Topic 740) - Improvements to Income Tax Disclosures.” ASU 2023-09 enhances the transparency and decision usefulness of

income tax disclosures by requiring consistent categories and greater disaggregation of information in the rate reconciliation and

income taxes paid disaggregated by jurisdiction.

ASU 2023-09 will be effective for the Company in its income tax disclosure included

in its 2025 Annual Report on Form 10-K and will be applied on a prospective basis.

However, retrospective application is permitted.

Early adoption is also permitted.

The Company is evaluating the impact of ASU 2023-09 on the Company’s

income tax disclosures and on its consolidated financial statements.

The Company is evaluating the impact of ASU 2023-09 on the Company’s income tax disclosures

and on its consolidated financial statements.

Estimates and assumptions

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Additionally, the related assets and liabilities have been reported

as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of September 30, 2024 and December

as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of March 31, 2025 and December 31,

As described in Note 1, the acquisition of net working capital by Mayne

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Three Months Ended

September 30,

Nine Months Ended

September 30,

Product revenue, net

General and administrative expenses

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Operating loss from discontinued operations

Other income (expense), net

Total other income (expense), net

Loss from discontinued operations, net of income taxes

Other income, net

Total other income, net

(Loss) income from discontinued operations, net of income taxes

The following table presents the carrying amounts of the classes of

assets and liabilities of discontinued operations as of September 30, 2024 and December 31, 2023 (in thousands):

September 30,

Accounts receivable

assets and liabilities of discontinued operations as of March 31, 2025 and December 31, 2024 (in thousands):

Current liabilities of discontinued operations:

Accrued expenses and other current liabilities

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Our prepaid and other current assets consisted of the following as

of September 30, 2024 and December 31, 2023 (in thousands):

September 30,

of March 31, 2025 and December 31, 2024 (in thousands):

Capitalized legal

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The following provides information about our license rights and other

intangible assets, net as of September 30, 2024 and December 31, 2023 (in thousands):

September 30, 2024

intangible assets, net as of March 31, 2025 and December 31, 2024 (in thousands):

March 31, 2025

December 31, 2024

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Hormone therapy drug patents

applied and pending approval

Hormone therapy drug patents applied and pending approval

Intangible assets subject to amortization

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We recorded, in continuing operations, amortization expense related

to patents of $ 96 thousand and $ 110 thousand for the three months ended September 30, 2024 and 2023, respectively, and $ 409 thousand and

$ 227 thousand for the nine months ended September 30, 2024 and 2023, respectively.

to patents of $ 95 thousand and $ 133 thousand for the three months ended March 31, 2025 and 2024, respectively.

The Company conducts regular reviews of the individual patents and

As a result of this review, also based on input from its licensing partners in the three months ended June 30, 2024, the Company

determined it had an indicator of impairment, as it had abandoned the legal right and title to a portion of its granted patent portfolio

and had ceased pursuit of a portion of its pending patents based on input from its licensing partners.

The Company recognized an impairment

loss of $ 1,261 thousand related to those abandoned patents and applications, which is classified as an impairment of long-lived assets

on the Company’s condensed consolidated statements of operations for the nine months ended September 30, 2024.

During the three months ended March 31, 2025, we recorded $ 88 thousand in write-off of patents pending approval as a result

of our review.

Our intangible assets subject to amortization are expected to be amortized

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following (in thousands):

September 30,

2025 December 31,

Payroll and related costs $ 129 $ 118

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of net working capital.

In February 2024, the Company received Mayne Pharma’s calculation of allowance for payer rebates and wholesale

distributor fees which differed significantly from the Company’s estimate of the allowances.

The Company intends

to resolve this matter through the dispute resolution process outlined in the Transaction Agreement.

The Company believes its estimated allowances for payer rebates and

wholesale distributor fees are reasonable.

The timing and 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.

In addition, the Company has received information from Mayne

Pharma pertaining to the allowance for returns that differs from the Company’s estimate of the allowance.

As of September 30,

2024, the Company believes no additional accrual is required for amounts that may be owed for the allowance for returns, as the

Company cannot reasonably estimate a range of loss.

The Company has not recorded any contingent gains or receivables for any such

Management continues to monitor the unresolved and pending net working capital items as changes to estimated amounts

owed or amounts due from Mayne Pharma may be material.

Mayne Pharma has also made certain indemnification demands under

the Transaction Agreement, which the Company disputes.

As of September 30, 2024, the Company believes no additional accrual is

required for such claims, as the Company cannot reasonably estimate a range of loss.

In February 2024, the Company received Mayne Pharma’s calculation of the net working capital allowances

for payer rebates and wholesale distributor fees which differed significantly from the Company’s estimate of the allowances.

Company continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable.

In August 2024

and 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.

On April 8, 2025, the Company 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.

The outcome of this matter is uncertain at this point.

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 of March 31, 2025, the Company also believed no additional accrual

was required for amounts that may be owed for the allowance for returns under the Transaction Agreement.

The Company has not recorded

any contingent gains or receivables for any such allowances.

Management continues to monitor the unresolved and pending net working capital

items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

Mayne Pharma has also made certain indemnification

demands under the Transaction Agreement, which the Company disputes.

As of March 31, 2025, the Company believed no additional accrual

was required for such claims, as the Company could not reasonably estimate a range of loss.

Legal proceedings

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ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation

The length of the stay of the IMVEXXY litigation is dependent on further action by Teva.

We have incurred and recorded legal

costs amounting to $ 2,334 thousand in prepaid expenses and other current assets as of September 30, 2024, for the IMVEXXY Paragraph IV

legal proceeding since we believe that we will successfully prevail in this legal proceeding.

Upon the successful conclusion of the legal

proceeding, the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in

the accompanying condensed consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents.

If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized

IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful

legal proceeding.

In June 2024, Mayne received a Paragraph IV certification notice letter

(the “Sun Notice Letter”) regarding an ANDA submitted to the FDA by Sun Pharma Inc.

In November 2024, the court lifted the stay.

We have incurred and recorded legal costs amounting to $ 2,334 thousand in prepaid

expenses and other current assets as of March 31, 2025, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully

prevail in this legal proceeding.

Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be

reclassified to patents, in license rights and other intangible assets, net, in the accompanying condensed consolidated balance sheets,

and such costs will be amortized over the remaining useful life of the patents.

If Mayne Pharma is unsuccessful in this legal proceeding,

then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized

will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.

In June 2024, Mayne Pharma received a Paragraph IV certification notice

letter (the “Sun Notice Letter”) regarding an ANDA submitted to the FDA by Sun Pharma Inc.

(“Sun Pharma”).

The ANDA seeks

approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.

Notice Letter, Sun Pharma alleges that the IMVEXXY Patents are invalid, unenforceable, and/or will not be infringed by Sun Pharma’s

commercial manufacture, use, or sale of its proposed generic drug product.

The IMVEXXY Patents identified in the Sun Notice Letter expire

in 2032 or 2033.

In July 2024, we and Mayne Pharma filed a complaint for patent infringement against Sun Pharma in the United States District

Court for the District of New Jersey arising from Sun Pharma’s ANDA filing with the FDA.

We are seeking, among other relief, an

order that the effective date of any FDA approval of Sun Pharma’s ANDA would be a date no earlier than the expiration of the IMVEXXY

Patents and equitable relief enjoining Sun Pharma from infringing the IMVEXXY Patents.

ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.

In the Sun Notice Letter, Sun Pharma alleges that the IMVEXXY Patents are invalid, unenforceable, and/or will not be infringed by Sun

Pharma’s commercial manufacture, use, or sale of its proposed generic drug product.

The IMVEXXY Patents identified in the Sun Notice

Letter expire in 2032 or 2033.

In July 2024, we and Mayne Pharma filed a complaint for patent infringement against Sun Pharma in the United

States District Court for the District of New Jersey arising from Sun Pharma’s ANDA filing with the FDA.

We are seeking, among other

relief, an order that the effective date of any FDA approval of Sun Pharma’s ANDA would be a date no earlier than the expiration

of the IMVEXXY Patents and equitable relief enjoining Sun Pharma from infringing the IMVEXXY Patents.

Beginning on December 30, 2022 and per the Mayne License Agreement,

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with respect to Teva and Sun Pharma.

On April 8, 2025, we filed a lawsuit against Mayne Pharma in

the United States District Court for the District of Delaware 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.

We are seeking, among other relief, money damages for all of Mayne Pharma’s profits arising from

their unlawful conduct and for any injury sustained by us as a result of Mayne Pharma’s unlawful conduct.

From time to time, we are involved in other litigations and proceedings

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Off-balance sheet arrangements

As of September 30, 2024 and December 31, 2023 there were no off-balance

sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial

condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that we consider material.

As of March 31, 2025 and December 31, 2024 there were no

off-balance sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition,

changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources

that we consider material.

Employment agreements

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Severance obligations for all employees other than executive

officers were paid in full in the first quarter of 2023.

As of September 30, 2024, we employed one full-time employee primarily engaged

in an executive position.

We have engaged external consultants who support our relationship with current partners and assist with certain

financial, legal, and regulatory matters and the continued wind-down of our historical business operations.

In the aggregate, as of September

30, 2024, we have accrued severance liabilities for executive termination obligations of $ 56 thousand.

officers were paid in full in the first quarter of 2023, and severance obligations for executive officers were paid out by the end of

the first quarter of 2025.

As of March 31, 2025, we employed one full-time employee primarily engaged in an executive position.

engaged external consultants who support our relationship with current partners and assist with certain financial, IT, legal, and regulatory

matters and the continued wind-down of our historical business operations.

Stockholders’ equity

As of September 30, 2024, the following table summarizes the status

of our outstanding and exercisable warrants and related transactions since December 31, 2023 (in thousands, except weighted average exercise

As of March 31, 2025, the following table summarizes the status of

our outstanding and exercisable warrants and related transactions since December 31, 2024 (in thousands, except weighted average exercise

price and weighted average remaining contractual life data):

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Warrants Weighted

Price Aggregate Intrinsic Value Weighted

Contractual Life

As of January 1, 2024 99 $ 66.61 $ —

Expired ( 2 ) 281.50 —

As of September 30, 2024 97 $ 63.33 $ —

Price Aggregate

Value Weighted

As of December 31, 2024 98 $ 63.33 -

As of March 31, 2025 98 $ 63.33 $ -

Share-based compensation payment plans

As of September 30, 2024, 61,530 shares of common stock were subject

to outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may

As of September 30, 2024, 405,719 shares of common stock were available for future grants of share-based payment awards under the

TherapeuticsMD, Inc.

As of March 31, 2025, 57,230 shares of common stock were subject to

outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may

As of March 31, 2025, 415,219 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD,

2019 Stock Incentive Plan.

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Outstanding Exercisable

Awards Weighted

Price Aggregate

Value Weighted

(in Years) Options

Awards Weighted Average Exercise Price Aggregate

Value Weighted Average Remaining Contractual Life (in Years) Options

Awards Weighted

Price Aggregate

Value Weighted

As of January 1, 2024 72 $ 258.55 $ —

Value Weighted Average Remaining Contractual Life (in Years)

As of December 31, 2024 57 $ 270.33 $ —

2.8 57 $ 270.20 $ —

Expired ( 5 ) 296.00 —

As of September 30, 2024 62 $ 264.66 $ —

As of March 31, 2025 52 $ 268.11 $ —

2.7 52 $ 267.97 $ —

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RSUs awards outstanding

As of January 1, 2024

As of September 30, 2024

The following table summarizes the status of our PSUs and related transactions

since December 31, 2023 (in thousands, except weighted average grant date fair value):

Unvested, as of January 1, 2024

Unvested, as of September 30, 2024

number of PSUs represents the base number of PSUs that may vest.

Balance, as of December 31, 2024

Balance, as of March 31, 2025

The following table summarizes the status of our PSUs and related

transactions since December 31, 2024 (in thousands, except weighted average grant date fair value):

Balance, as of December 31, 2024

Balance, as of March 31, 2025

(1) The number of PSUs represents the base number of PSUs that may vest.

Share-based payment compensation cost

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compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under our employee stock

purchase plan (“ESPP”) totaling $ 33 thousand and $ 234 thousand for the three months ended September 30, 2024 and 2023, respectively,

and $ 240 thousand and $ 1,155 thousand for the nine months ended September 30, 2024 and 2023, respectively.

As of September 30, 2024, we had $ 48 thousand of unrecognized share-based

purchase plan (“ESPP”) totaling $ 23 thousand and $ 111 thousand for the three months ended March 31, 2025 and 2024, respectively.

As of March 31, 2025, we had $ 1 thousand of unrecognized share-based

payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP, which may be adjusted

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The unrecognized compensation cost of $ 1 thousand is expected to

be recognized as share-based payment award compensation over a weighted average period of 0.5 years.

be recognized as share-based payment award compensation over a weighted average period of less than a month.

Pursuant to the Mayne License Agreement, the Company granted Mayne

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the United States.

Mayne Pharma will pay to the Company minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation

Mayne Pharma will pay to the Company minimum annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation

at an annual rate of 3 %, subject to certain further adjustments.

Upon the expiry of the 20 -year royalty

term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for

the Licensed Products.

Upon the expiry of the 20 -year royalty term, the licenses granted to

Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.

We do not expect to pay any significant federal or state income taxes

as a result of (i) the losses recorded during the three and nine months ended September 30, 2024 and 2023, (ii) additional losses expected

for the remainder of 2024 or losses recorded in 2023, or (iii) net operating loss carry forwards from prior years.

as a result of (i) the losses recorded during the three months ended March 31, 2025 and 2024, (ii) additional losses expected for the

remainder of 2025 or losses recorded in 2024, or (iii) net operating loss carry forwards from prior years.

We recorded a full valuation allowance of the net operating losses

for the three and nine months ended September 30, 2024 and 2023.

Accordingly, there were no provisions for income taxes for the three

and nine months ended September 30, 2024 and 2023.

Additionally, as of September 30, 2024 and December 31, 2023, we maintain a full valuation

allowance for all deferred tax assets.

Income (Loss) per common share

for the three months ended March 31, 2025 and 2024.

Accordingly, there were no provisions for income taxes for the three months ended

March 31, 2025 and 2024.

Additionally, as of March 31, 2025 and December 31, 2024, we maintain a full valuation allowance for all deferred

Loss per common share

The following table sets forth the computation of basic and diluted

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Three Months Ended

September 30,

Nine Months Ended

September 30,

Loss from continuing operations, net of income taxes

Loss from discontinued operations, net of income taxes

(Loss) income from discontinued operations, net of income taxes

Weighted average common shares for basic loss per common share

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Weighted average common shares for diluted loss per common share

Loss per common share, continuing

operations, net of income taxes

Loss per common share, discontinued operations, net of income taxes

Loss per common share, continuing operations, net of income taxes

Income per common share, discontinued operations, net of income taxes

Since we reported a net loss from continuing operations for the three

and nine months ended September 30, 2024 and 2023, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there

was no effect of dilutive securities.

Therefore, our basic and diluted loss per common share and our basic and diluted weighted average

common shares are the same for the three and nine months ended September 30, 2024 and 2023.

months ended March 31, 2025 and 2024, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect

of dilutive securities.

Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common shares

from continuing operations are the same for the three months ended March 31, 2025 and 2024.

The following table sets forth the outstanding securities as of the

periods presented which were not included in the calculation of diluted earnings per common share during the respective three and nine

months ended September 30, 2024 and 2023 (in thousands):

September 30,

periods presented which were not included in the calculation of diluted earnings per common share during the respective three months ended

March 31, 2025 and 2024 (in thousands):

As of March 31,

Stock options

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same manner as our other non-employee directors, described in the section entitled “Director Compensation” in our Amendment

1 to Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on April 29, 2024, but

1 to Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission on May 1, 2023, but

he has elected not to receive any compensation for his service as a non-employee director at this time.

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the drawdown, before expenses.

There were no drawdowns in the first quarter of 2025 and 2024.

Business concentrations

4 unchanged sentences

As part of the transformation that included

the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected

as discontinued operations in our condensed consolidated financial statements.

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.

For the three and nine months ended September 30, 2024, 100 % of license

revenue related to Mayne Pharma, Theramex and Knight.

A s of September 30, 2024, we

had a royalty receivable of $ 3,323 thousand relating to the short-term portion of receivable from Mayne Pharma, Theramex and Knight and

$ 16,610 thousand relating to the long-term portion of royalty receivable which includes royalties recognized from the minimum annual

royalty that Mayne Pharma is obligated to pay to us under the Mayne License Agreement.

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.

Additional disclosures regarding discontinued operations

are provided in Note 2.

For the three months ended March 31, 2025, 100 % of license revenue

related to Mayne Pharma, Theramex and Knight.

As of March 31, 2025 , we had

a royalty receivable of $ 2,996 thousand relating to the short-term portion of receivable from Mayne Pharma, Theramex and Knight and $ 15,427

thousand relating to the long-term portion of royalty receivable which includes royalties recognized from the minimum annual royalty that

Mayne Pharma is obligated to pay to us under the Mayne License Agreement.

Segment Reporting

The Company operates in one segment.

Accordingly, the Company’s

license revenue, net loss, and total assets reflect the revenue, loss, and assets of the Company’s single segment, respectively.

The Company’s Chief Executive Officer is the chief operating

decision maker (“CODM”).

The CODM uses Net loss in assessing the performance and in determining the allocation of resources

of the Company’s reportable segment.

The CODM is regularly provided expense information consistent with the expense categories presented

in the Company’s Condensed Consolidated Statements of Operations

The following tables present total revenue of the Company by geographic

Three Months Ended March 31,

License revenue

United States

Subsequent Events

In May 2025, the Company reached an agreement in principle with respect

to an amended settlement pertaining to trademark infringement by a third party of certain trademarks owned by the Company.

the agreement, the Company received a payment of $ 412.5 thousand in May 2025 and the agreement calls for the Company to receive an additional

$ 812.5 thousand in equal monthly installments of $ 12.5 thousand.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements