What changed in this filing

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Item 1. Financial Statements

2024-11-12 compared with 2024-08-12 · 291 added, 251 removed, 423 unchanged (56% of the section changed)

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(in thousands, except per share data)

September 30,

Current assets:

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Common stock, par value $ 0.001 ;

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

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

Additional paid-in capital

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Revenue, net:

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Loss from continuing operations, net of income taxes

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

Loss 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

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$ ( 951,465 )

Share-based compensation

Balance, September 30, 2024

$ ( 952,074 )

Three and Nine Months Ended September 30, 2023

Additional Paid in

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$ ( 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)

Six Months Ended

Nine Months Ended

September 30,

Cash flows from operating activities:

income (loss) from discontinued operations, net of tax

Loss 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 activities:

Depreciation and amortization

Impairment of long-lived assets (Note 4)

Write-off of patents and trademarks

Share-based compensation

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Net cash used in operating activities

Net cash provided by financing activities

Net cash used in discontinued operations

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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.

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.

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.

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 Transaction Agreement, dated December 4, 2022, between TherapeuticsMD

and Mayne Pharma (the “Transaction Agreement”), we sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize

the Products in the United States, including, with the Population Council’s consent, our exclusive license from the Population

Council to commercialize ANNOVERA (the “Transferred Assets”).

the Products in the United States, including, with the Population Council’s consent, our exclusive license from the Population Council

to commercialize ANNOVERA (the “Transferred Assets”).

The total consideration from Mayne Pharma to TherapeuticsMD for the

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years following the Closing Date.

On the Closing Date, TherapeuticsMD and Mayne Pharma entered into

Amendment No.

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

1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”).

Pursuant to the Mayne License Agreement

Amendment, Mayne Pharma agreed to pay us approximately $ 1.0 million in prepaid royalties on the Closing Date.

The prepaid royalties reduced

the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to

$ 257 thousand per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such

quarterly royalty payment was paid to us.

We and Mayne Pharma settled the $ 1.5 million of consideration due to Mayne Pharma for the assumed

obligations under a long-term services agreement, including our minimum payment obligations thereunder.

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.

Pursuant to the Mayne License Agreement Amendment,

Mayne Pharma agreed to pay us approximately $ 1.0 million in prepaid royalties on the Closing Date.

The prepaid royalties reduced the first

four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257 thousand

per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty

payment was paid to us.

We and Mayne Pharma settled the $ 1.5 million of consideration due to Mayne Pharma for the assumed obligations

under a long-term services agreement, including our minimum payment obligations thereunder.

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.

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.

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

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their employment agreements and separation agreements as previously disclosed.

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

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 operations.

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

Ziegler would serve as our Principal Financial Officer.

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.

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 as Principal

Financial and Accounting Officer as of the date of Mr.

Donegan’s resignation.

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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,

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.

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On May 1, 2023, we entered into a Subscription Agreement (the “Subscription

Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or

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

Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or more

of its affiliates, up to an aggregate of 5,000,000 shares of 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.

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In February 2024, the Company received Mayne

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

differed significantly from the Company’s estimate of the allowances.

The Company and Mayne Pharma intend 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.

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

significantly from the Company’s estimate of the allowances.

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.

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.

As of June 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.

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

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

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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.

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

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.

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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.

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

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each quarter of the year.

Therefore, the results and trends in these interim financial statements may not be representative of those

for the full year.

In our opinion, all adjustments necessary for a fair presentation of the financial statements, which are of a normal

and recurring nature, have been made for the interim periods reported.

The information included in this 10-Q Report should be read in

conjunction with the consolidated financial statements and accompanying notes included in our 2023 10-K Report.

Certain amounts in the

consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using

unrounded amounts.

Therefore, the results and trends in these interim financial statements may not be representative of those for

the full year.

In our opinion, all adjustments necessary for a fair presentation of the financial statements, which are of a normal and

recurring nature, have been made for the interim periods reported.

The information included in this 10-Q Report should be read in conjunction

with the consolidated financial statements and accompanying notes included in our 2023 10-K Report.

Certain amounts in the consolidated

financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts.

Certain prior period amounts have been reclassified to conform to current-period presentation.

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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.

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.

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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our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize our

IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and

assigning our exclusive license to commercialize ANNOVERA to Mayne Pharma.

IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and assigning

our exclusive license to commercialize ANNOVERA to Mayne Pharma.

This plan represented a strategic shift having a major effect on our

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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 June 30, 2024 and December 31,

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

Mayne Pharma 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.

Our estimate of net working capital at closing was determined in accordance

with the Transaction Agreement which establishes the process for the determination of final net working capital.

Refer to Note 6 for

a further discussion of net working capital contingencies.

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

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

Pharma 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.

Our estimate of net working capital at closing was determined in accordance with

the Transaction Agreement which establishes the process for the determination of final net working capital.

Refer to Note 6 for a further

discussion of net working capital contingencies.

The following table presents results of discontinued operations (in

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Product revenue, net

General and administrative expenses

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Total other income (expense), net

(Loss) income from discontinued operations, net

Loss 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 June 30, 2024 and December 31, 2023 (in thousands):

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

September 30,

Accounts receivable

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Our prepaid and other current assets consisted of the following as

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

December 31, 2023

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

September 30,

Capitalized legal

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The following provides information about our license rights and other

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

June 30, 2024

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

September 30, 2024

December 31, 2023

Gross Carrying Amount

Accumulated Amortization

Gross Carrying Amount

Accumulated Amortization

Intangible assets subject to amortization:

Hormone therapy drug patents

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 $ 180 thousand and $ 19 thousand for the three months ended June 30, 2024 and 2023, respectively, and $ 313 thousand and $ 39

thousand for the six months ended June 30, 2024 and 2023, respectively.

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.

The Company conducts regular reviews of the individual patents and

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

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

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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 consolidated statements of operations.

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

Our intangible assets subject to amortization are expected to be amortized

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Accrued expenses and other current liabilities

Other accrued expenses and other current liabilities consisted of

the following (in thousands):

Other accrued expenses and other current liabilities consisted of the

following (in thousands):

September 30,

Payroll and related costs

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distributor fees.

Of the $ 5.5 million, $ 2.0 million increased the allowance for net working capital allowances remaining to be trued

Of the $ 5.5 million, $ 2.0 million increased the allowance for net working capital allowances remaining to be trued up.

The Company’s estimate of the allowance for payer rebates and

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

The Company and Mayne Pharma intend

The Company intends

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

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Pharma’s allowance calculation for payer rebates and wholesale distributor fees.

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

required for amounts that may be owed for the allowance for returns.

The Company has not recorded any contingent gains or receivables

for any such allowances.

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

amounts owed or amounts due from Mayne Pharma that may be material.

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.

Legal proceedings

In February 2020, we received a Paragraph IV certification notice

letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the

FDA by Teva Pharmaceuticals USA, Inc.

The ANDA seeks approval from the FDA to commercially manufacture, use, or

sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.

In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents

listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid,

unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product.

The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033.

In April 2020, we filed a complaint for patent infringement

against Teva in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA.

are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier

than the expiration of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents.

Teva has filed its

answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed.

In July 2021, following a

proposal by Teva, the District Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was

filed under seal.

In September 2021, the District Court made available a public version of the order following the parties’ agreement

to a consent motion to redact information Teva contended was confidential.

The order provides that the statutory stay that prevents the

FDA from granting final approval of the ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number

of days that the stay of the IMVEXXY litigation is in place.

The length of the stay of the IMVEXXY litigation is dependent on further

action by Teva.

We have incurred and recorded legal costs amounting to $ 2,334 thousand in prepaid expenses and other current assets as

of June 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 February 2020, we received a Paragraph IV certification notice letter

(the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the FDA by Teva

Pharmaceuticals USA, Inc.

The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic

version of the 4 mcg and 10 mcg doses of IMVEXXY.

In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in the

FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable,

and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product.

The IMVEXXY Patents

identified in the IMVEXXY Notice Letter expire in 2032 or 2033.

In April 2020, we filed a complaint for patent infringement against Teva

in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA.

We are seeking,

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

of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents.

Teva has filed its answer and counterclaim

to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed.

In July 2021, following a proposal by Teva, the District

Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal.

In September 2021,

the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information

Teva contended was confidential.

The order provides that the statutory stay that prevents the FDA from granting final approval of the

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

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

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Off-balance sheet arrangements

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

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

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

As of June 30, 2024, we employ 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 June 30, 2024,

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.

Stockholders’ equity

As of June 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 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

price and weighted average remaining contractual life data):

Warrants Outstanding and exercisable

Warrants Weighted Average

Price Aggregate

Value Weighted Average Remaining Contractual Life (in Years)

Warrants Weighted

Price Aggregate Intrinsic Value Weighted

Contractual Life

As of January 1, 2024 99 $ 66.61 $ —

Expired ( 2 ) 281.50 —

As of June 30, 2024 97 $ 63.33 $ —

As of September 30, 2024 97 $ 63.33 $ —

Share-based compensation payment plans

As of June 30, 2024, 106,799 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 June 30, 2024, 403,369 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD,

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.

2019 Stock Incentive Plan.

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Expired ( 10 ) 224.58 —

As of June 30, 2024 63 $ 264.14 —

As of September 30, 2024 62 $ 264.66 $ —

2.8 62 $ 264.54 $ —

The following table summarizes the status of our RSUs and related

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

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

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

RSUs awards outstanding

As of January 1, 2024

As of June 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):

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

Cancelled/Forfeited

Unvested, as of June 30, 2024

Unvested, as of September 30, 2024

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

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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 $ 96 thousand and $ 437 thousand for the three months ended June 30, 2024 and 2023, respectively,

and $ 207 thousand and $ 919 thousand for the six months ended June 30, 2024 and 2023, respectively.

As of June 30, 2024, we had $ 81 thousand of unrecognized share-based

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

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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No tax benefit was realized due to a continued pattern of net losses.

The unrecognized compensation cost of $ 81 thousand is expected

to be recognized as share-based payment award compensation over a weighted average period of 0.7 years.

The unrecognized compensation cost of $ 48 thousand is expected to

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

Pursuant to the Mayne License Agreement, the Company granted Mayne

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have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories

and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the

Licensed Products outside the United States for commercialization in the United States and its possessions and territories.

and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed

Products outside the United States for commercialization in the United States and its possessions and territories.

Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time,

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$ 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

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

of 8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments,

for a period of 20 years following the Closing Date.

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

8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for

a period of 20 years following the Closing Date.

The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier

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

in the United States.

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

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

Upon the expiry of the 20 -year

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

for the Licensed Products.

to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in

the United States.

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

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

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 six months ended June 30, 2024 and 2023, (ii) additional losses expected

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

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.

We recorded a full valuation allowance of the net operating losses

for the three and six months ended June 30, 2024 and 2023.

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

months ended June 30, 2024 and 2023.

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

for all deferred tax assets.

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

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Loss from continuing operations, net of income taxes

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

Loss 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

Loss per common share, discontinued operations

Loss per common share, continuing

operations, net of income taxes

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

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

and six months ended June 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 six months ended June 30, 2024 and 2023.

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.

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 six

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

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,

Stock options

1 unchanged sentence

On August 23, 2022, we appointed Mr.

Justin Roberts as a director

to fill a newly created vacancy on our Board of Directors.

Roberts was elected to serve as a director at our combined 2022 and 2023

Annual Meeting held on June 26, 2023.

Roberts will serve until our next Annual Meeting of Stockholders or until his successor is

duly elected or appointed or his earlier death or resignation.

Justin Roberts as a director to

fill a newly created vacancy on our Board of Directors.

Roberts was elected to serve as a director at our combined 2022 and 2023 Annual

Meeting held on June 26, 2023.

Roberts will serve until our next Annual Meeting of Stockholders or until his successor is duly elected

or appointed or his earlier death or resignation.

As a director of our Company, Mr.

Roberts is entitled to receive compensation

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

Amendment No.

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

29, 2024, but he has elected not to receive any compensation for his service as a non-employee director at this time.

Roberts currently

serves as a Partner of Rubric.

On July 29, 2022, September 30, 2022, October 28, 2022, and May 1, 2023, we entered into subscription

agreements with Rubric.

On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000

outstanding shares of Series A Preferred Stock previously issued to affiliates of Rubric at a purchase price of $ 1,333 per share and

also paid certain affiliates of Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously

entered into between us and Rubric.

On June 29, 2023, we issued and sold 312,525 shares of Common Stock to Rubric at a price per share

equal to $ 3.6797 pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, 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.

Roberts is entitled to receive compensation in the

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

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

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

Roberts currently serves as

a Partner of Rubric.

On July 29, 2022, September 30, 2022, October 28, 2022, and May 1, 2023, we entered into subscription agreements

On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000 outstanding

shares of Series A Preferred Stock previously issued to affiliates of Rubric at a purchase price of $ 1,333 per share and also paid certain

affiliates of Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into

between us and Rubric.

On June 29, 2023, we issued and sold 312,525 shares of Common Stock to Rubric at a price per share equal to $ 3.6797

pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, 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.

Business concentrations

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to pharmaceutical organizations that possess commercial capabilities in the relevant territories.

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.

disclosures regarding discontinued operations are provided in Note 2.

For the three and six months ended June 30, 2024, 100 % of license

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.

As of June 30, 2024, we had a royalty receivable of $ 2,908 thousand

relating to the short-term portion of receivable from Mayne Pharma, Theramex and Knight and $ 17,224 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.

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.

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