Item 1. Financial Statements
Item 1. Financial statements
TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
March 31,
2025
December 31,
2024
(Unaudited)
Assets:
Current assets:
Cash and cash equivalents
$ 5,745
$ 5,059
Royalty receivable, current portion
2,996
3,562
Prepaid and other current assets
3,771
3,638
Total current assets
12,512
12,259
License rights and other intangible assets, net
4,138
4,321
Right of use assets
5,948
6,102
Royalty receivable, long term
15,427
16,010
Other non-current assets
211
130
Total assets
$ 38,236
$ 38,822
Liabilities and stockholders’ equity:
Current liabilities:
Accounts payable
$ 176
$ 258
Accrued expenses and other current liabilities
1,780
2,127
Current liabilities of discontinued operations
2,785
2,781
Total current liabilities
4,741
5,166
Operating lease liabilities
5,960
5,542
Other non-current liabilities
795
744
Total liabilities
11,496
11,452
Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock, par value $ 0.001 ; 32,000 shares authorized, 11,574 and 11,532 issued and outstanding as of March 31, 2025 and December 31, 2024, respectively
11
11
Additional paid-in capital
979,204
979,181
Accumulated deficit
( 952,475 )
( 951,822 )
Total stockholders’ equity
26,740
27,370
Total liabilities and stockholders’ equity
$ 38,236
$ 38,822
The accompanying notes are an integral part of
these condensed consolidated financial statements.
1
TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited - in thousands, except per share data)
Three Months Ended
March 31,
2025
2024
Revenue, net:
License revenue
$ 393
$ 313
Operating expenses:
Selling, general and administrative
1,081
1,322
Write-off of patents and trademarks
88
—
Depreciation & amortization
95
133
Total operating expenses
1,264
1,455
Loss from operations
( 871 )
( 1,142 )
Other income (expense):
Interest expense and other financing costs
( 2 )
—
Miscellaneous income
205
333
Total other income, net
203
333
Loss from continuing operations before income taxes
( 668 )
( 809 )
Income tax benefit
32
—
Loss from continuing operations, net of income taxes
( 636 )
( 809 )
(Loss) income from discontinued operations, net of income taxes
( 17 )
75
Net loss
$ ( 653 )
$ ( 734 )
Loss per common share, basic and diluted:
Continuing operations
$ ( 0.06 )
$ ( 0.07 )
Discontinued operations, net
( 0.00 )
0.01
Net loss per common share, basic and diluted
$ ( 0.06 )
$ ( 0.06 )
Weighted average common shares, basic
11,552
11,532
Weighted average common shares, diluted
11,552
11,532
The accompanying notes are an integral part of
these condensed consolidated financial statements.
2
TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’
Equity
(Unaudited - in thousands)
Three Months Ended March 31, 2025
Common Stock
Additional
Paid in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance, January 1, 2025
11,532
$ 11
$ 979,181
$ ( 951,822 )
$ 27,370
Share-based compensation
42
—
23
—
23
Net loss
—
—
—
( 653 )
( 653 )
Balance, March 31, 2025
11,574
$ 11
$ 979,204
$ ( 952,475 )
$ 26,740
Three Months Ended March 31, 2024
Common Stock
Additional
Paid in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance, January 1, 2024
11,532
$ 11
$ 978,917
$ ( 949,641 )
$ 29,287
Share-based compensation
—
—
111
—
111
Net loss
—
—
—
( 734 )
( 734 )
Balance, March 31, 2024
11,532
$ 11
$ 979,028
$ ( 950,375 )
$ 28,664
The accompanying notes are an integral part of
these condensed consolidated financial statements.
3
TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited - in thousands)
Three Months Ended
March 31,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 653 )
$ ( 734 )
Less: (loss) income from discontinued operations, net of income taxes
( 17 )
75
Net loss from continuing operations
( 636 )
( 809 )
Adjustments to reconcile net loss to net cash provided by (used in) continuing operating
activities:
Depreciation and amortization
95
133
Write-off of patents and trademarks
88
—
Share-based compensation
23
111
Other
154
186
Changes in operating assets and liabilities:
Other assets
502
629
Prepaid and other current assets
433
34
Accounts payable
( 82 )
112
Accrued expenses and other current liabilities
274
( 413 )
Lease liabilities
( 203 )
( 213 )
Other non-current liabilities
51
1
Total adjustments
1,335
580
Net cash provided by (used in) continuing operating activities
699
( 229 )
Discontinued operations:
Net cash (used in) provided by operating activities
( 13 )
240
Net cash (used in) provided by discontinued operations
( 13 )
240
Net increase in cash
686
11
Cash and cash equivalents - continuing operations, beginning of period
5,059
4,327
Total cash and cash equivalents, end of period
$ 5,745
$ 4,338
The accompanying notes are an integral part of
these condensed consolidated financial statements.
4
TherapeuticsMD, Inc. and Subsidiaries
Notes to the Condensed Consolidated Financial
Statements
(Unaudited)
1. Business, basis of presentation, new accounting standards and
summary of significant accounting policies
General
TherapeuticsMD, Inc. (the “Company”), a Nevada corporation,
and its condensed consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q Report”)
as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q Report includes trademarks, trade
names and service marks, such as TherapeuticsMD®, vitaMedMD®, BocaGreenMD®, IMVEXXY®, and BIJUVA®, which are protected
under applicable intellectual property laws and are the property of, or licensed by or to, us. Solely for convenience, trademarks, trade
names and service marks referred to in this 10-Q Report may appear without the ®, TM or SM symbols, but such references are not intended
to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable
licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade
names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship
of us by, these other parties.
TherapeuticsMD was previously a women’s healthcare company with
a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed
to pharmaceutical organizations that possess commercial capabilities in the relevant territories. On December 30, 2022 (the “Closing
Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company
(“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, in which we and our subsidiaries
(i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under
the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and
territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA® (together with the Licensed Products,
collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets
to Mayne Pharma in connection therewith.
In a License Agreement, dated December 4, 2022, between TherapeuticsMD
and Mayne Pharma (the “Mayne License Agreement”), we granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable,
perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the
Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable
license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization
in the United States and its possessions and territories.
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. 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.
5
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 total consideration from Mayne Pharma to TherapeuticsMD for the
purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the Mayne License Agreement was
(i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of
net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment
of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below)
and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended. The 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
No. 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”). Pursuant to the Mayne License Agreement Amendment,
Mayne Pharma agreed to pay us approximately $ 1.0 million in prepaid royalties on the Closing Date. 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,
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
IMVEXXY and BIJUVA outside of the U.S.
● In
July 2018, we entered into a license and supply agreement (the “Knight License Agreement”) with Knight Therapeutics Inc.
(“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
Knight obtained regulatory approval for IMVEXXY and BIJUVA and began commercialization efforts in 2024.
●
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.
6
Going concern
Following the transaction with Mayne Pharma, our primary source of
revenue is from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
We may need to raise additional capital to provide additional liquidity to fund our operations until we become cash flow positive. To
address our capital needs, we may pursue various equity and debt financing and other alternatives. The equity financing alternatives may
include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders,
or other institutional counterparties or an underwritten public equity or equity-linked securities offering. Our ability to sell equity
securities may be limited by market conditions, including the market price of our common stock, and our available authorized shares.
To the extent that we raise additional capital through the sale of
such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include
liquidation or other preferences that adversely affect the rights of our existing stockholders. If we are not successful in obtaining
additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge,
consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us.
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”),
from time to time during the term of the Subscription Agreement in separate drawdowns at our election. On June 29, 2023, we issued and
sold 312,525 shares of Common Stock at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement. We received gross proceeds
of $ 1.15 million from the drawdown, before expenses. On November 15, 2023, Rubric drew down an additional 877,192 shares of Common Stock
at a price per share equal to $ 2.2761 . We received gross proceeds of $ 2.0 million from the drawdown, before expenses. There were no drawdowns
in the first 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 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, 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
do not include any adjustments that might be necessary if we are unable to continue as a going concern.
7
Basis of presentation
We prepared the condensed consolidated financial statements included
in this 10-Q Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”)
for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting
principles generally accepted in the U.S. (“U.S. GAAP”) for complete financial statements can be condensed or omitted. However,
except as disclosed herein, there has been no material change in the information disclosed in the notes included in our 2024 Annual Report
on Form 10-K (the “2024 10-K Report”).
As part of the transformation as a result of the Mayne Transaction,
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
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 2024 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.
New accounting standards
Adoption of new accounting standards
As of December 2024, we have adopted Financial Accounting Standards
Board (“FASB”) Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements
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
segments.
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.
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.
Estimates and assumptions
The preparation of our condensed consolidated financial statements
in conformity with U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities,
disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts
of revenue and expenses during the reporting periods. We evaluate our estimates and assumptions based on historical experience and on
various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts,
from these estimates under different assumptions or conditions.
Significant accounting policies
The significant accounting policies we use for quarterly financial
reporting are disclosed in Note 1 of the notes to the consolidated financial statements included in our 2024 10-K Report.
8
2. Discontinued Operations
As discussed in Note 1, we changed our business in 2022 by licensing
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.
This plan represented a strategic shift having a major effect on our
operations and financial results. Upon our conversion from a commercial pharmaceutical company to a licensing only company with the consummation
of the Mayne Transaction, we classified all direct revenues, costs and expenses related to commercial operations, within income (loss)
from discontinued operations, net of tax, in the condensed consolidated statements of operations for all periods presented. We have not
allocated any amounts for shared general and administrative operating support expense to discontinued operations.
Additionally, the related assets and liabilities have been reported
as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of March 31, 2025 and December 31,
2024.
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
thousands):
Three Months Ended
March 31,
2025
2024
General and administrative expenses
$ 17
$ 55
Total operating expenses
17
55
Operating loss from discontinued operations
( 17 )
( 55 )
Other income, net
—
130
Total other income, net
—
130
(Loss) income from discontinued operations, net of income taxes
$ ( 17 )
$ 75
The following table presents the carrying amounts of the classes of
assets and liabilities of discontinued operations as of March 31, 2025 and December 31, 2024 (in thousands):
March 31,
2025
December 31,
2024
Current liabilities of discontinued operations:
Accrued expenses and other current liabilities
$ 2,785
$ 2,781
9
3. Prepaid and other current assets
Our prepaid and other current assets consisted of the following as
of March 31, 2025 and December 31, 2024 (in thousands):
March 31,
2025
December 31,
2024
Insurance
$ 231
$ 70
Capitalized legal
2,334
2,334
Other
1,206
1,234
Prepaid and other current assets
$ 3,771
$ 3,638
4. Licensed rights and other intangible assets
The following provides information about our license rights and other
intangible assets, net as of March 31, 2025 and December 31, 2024 (in thousands):
March 31, 2025
December 31, 2024
Gross
Carrying
Amount
Accumulated
Amortization
Net
Gross
Carrying
Amount
Accumulated
Amortization
Net
Intangible assets subject to amortization:
Hormone therapy drug patents
$ 5,766
$ 2,152
$ 3,614
$ 5,766
$ 2,058
$ 3,708
Hormone therapy drug patents applied and pending approval
215
—
215
304
—
304
Intangible assets subject to amortization
5,981
2,152
3,829
6,070
2,058
4,012
Intangible assets not subject to amortization:
Trademarks/trade name rights
309
—
309
309
—
309
License rights and other intangible assets, net
$ 6,290
$ 2,152
$ 4,138
$ 6,379
$ 2,058
$ 4,321
We recorded, in continuing operations, amortization expense related
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
portfolios. 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
as follows (in thousands):
Year ending December 31,
2025
$ 289
2026
384
2027
384
2028
385
2029
384
Thereafter
1,788
Total
$ 3,614
10
5. Accrued expenses and other current liabilities
Other accrued expenses and other current liabilities consisted of the
following (in thousands):
March 31,
2025 December 31,
2024
Payroll and related costs $ 129 $ 118
Professional fees 391 288
Operating lease liabilities 1,011 1,633
Other accrued expenses and current liabilities 249 88
Accrued expenses and other current liabilities $ 1,780 $ 2,127
6. Commitments and contingencies
Mayne Pharma Agreement
Mayne Pharma paid us approximately $ 12.1 million at closing on
December 30, 2022, for the acquisition of net working capital, subject to certain adjustments as determined in accordance with the Transaction
Agreement. While the Transaction Agreement calls for much of the net working capital to be trued-up shortly after the Closing Date in
2023, for a period of one year following the Closing Date in the case of payer rebates and wholesale distributor fees and two years following
the Closing Date in the case for allowance for returns, net working capital amounts will be adjusted to arrive at final net working capital
under the Transaction Agreement.
In September 2023, we increased certain accrual estimates including
increasing our working capital adjustment accrual by $ 2.0 million for amounts anticipated to be owed under the Transaction Agreement.
In December 2023, we made a $ 5.5 million payment to Mayne Pharma to settle certain working capital amounts that were required to
be trued-up shortly after the Closing Date, excluding the allowance for returns, allowance for payer rebates, and allowance for wholesale
distributor fees. 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
wholesale distributor fees was determined in accordance with the Transaction Agreement which establishes the process for the determination
of net working capital. In February 2024, 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. The
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. As a result,
the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated
with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company believes
the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.
As 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.
11
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. (“Teva”). 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
is in place. 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.
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,
Mayne Pharma is responsible for all enforcement of our patents, including the responsibility for and costs of litigation discussed above
with respect to Teva and Sun Pharma.
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
in the ordinary course of business. We are currently not involved in any other litigations and proceedings that we believe would have
a material effect on our condensed consolidated financial condition, results of operations, or cash flows.
Off-balance sheet arrangements
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.
12
Employment agreements
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 30, 2022. Severance obligations for all employees other than executive
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. We have
engaged external consultants who support our relationship with current partners and assist with certain financial, IT, legal, and regulatory
matters and the continued wind-down of our historical business operations.
7. Stockholders’ equity
Warrants
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):
Warrants outstanding and exercisable
Warrants Weighted
Average
Exercise
Price Aggregate
Intrinsic
Value Weighted
Average
Remaining
Contractual
Life
(in Years)
As of December 31, 2024 98 $ 63.33 -
5.6
As of March 31, 2025 98 $ 63.33 $ -
5.3
Share-based compensation payment plans
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
vest). As of March 31, 2025, 415,219 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD,
Inc. 2019 Stock Incentive Plan.
The following table summarizes the status of our outstanding and exercisable
options and related transactions since December 31, 2024 (in thousands, except weighted average exercise price and weighted average remaining
contractual life data):
Outstanding Exercisable
Options
Awards Weighted Average Exercise Price Aggregate
Intrinsic
Value Weighted Average Remaining Contractual Life (in Years) Options
Awards Weighted
Average
Exercise
Price Aggregate
Intrinsic
Value Weighted Average Remaining Contractual Life (in Years)
As of December 31, 2024 57 $ 270.33 $ —
2.8 57 $ 270.20 $ —
2.8
Expired ( 5 ) 296.00 —
—
( 5 ) —
—
—
As of March 31, 2025 52 $ 268.11 $ —
2.7 52 $ 267.97 $ —
2.7
13
The following table summarizes the status of our RSUs and related transactions
since December 31, 2024 (in thousands, except weighted average grant date fair value):
RSUs awards outstanding
RSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Balance, as of December 31, 2024
2
$ 21.78
$ 1.5
Vested
( 2 )
21.78
—
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):
PSUs (1)
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
Balance, as of December 31, 2024
5
$ 34.50
$ 4.47
Balance, as of March 31, 2025
5
$ 34.50
$ 4.84
(1) The number of PSUs represents the base number of PSUs that may vest.
Share-based payment compensation cost
Share-based payment compensation expense for PSUs is based on 100 %
vesting which was a part of the termination benefits for all employees who were terminated in 2022. We recorded share-based payment award
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 $ 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
for future changes in forfeitures and is included as additional paid-in capital in the accompanying condensed consolidated balance sheets.
No tax benefit was realized due to a continued pattern of net losses. The unrecognized compensation cost of $ 1 thousand is expected to
be recognized as share-based payment award compensation over a weighted average period of less than a month.
8. Revenue
Pursuant to the Mayne License Agreement, the Company granted Mayne
Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture,
have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories
and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed
Products outside the United States for commercialization in the United States and its possessions and territories.
14
Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time,
milestone payments to the Company 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 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 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.
9. Income taxes
We do not expect to pay any significant federal or state income taxes
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 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
tax assets.
10. Loss per common share
The following table sets forth the computation of basic and diluted
loss per common share for the periods presented (in thousands, except per share amounts):
Three Months Ended
March 31,
2025
2024
Numerator:
Loss from continuing operations, net of income taxes
$ ( 636 )
$ ( 809 )
(Loss) income from discontinued operations, net of income taxes
( 17 )
75
Net loss
$ ( 653 )
$ ( 734 )
Denominator:
Weighted average common shares for basic loss per common share
11,552
11,532
Effect of dilutive securities
—
—
Weighted average common shares for diluted loss per common share
11,552
11,532
Loss per common share, continuing operations, net of income taxes
Basic
$ ( 0.06 )
$ ( 0.07 )
Diluted
$ ( 0.06 )
$ ( 0.07 )
Income per common share, discontinued operations, net of income taxes
Basic
$ ( 0.00 )
$ 0.01
Diluted
$ ( 0.00 )
$ 0.01
Since we reported a net loss from continuing operations for the three
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.
15
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 months ended
March 31, 2025 and 2024 (in thousands):
As of March 31,
2025
2024
Stock options
52
80
RSUs
-
84
PSUs
5
14
Warrants
98
99
155
277
11. Related parties
On August 23, 2022, we appointed Mr. Justin Roberts as a director to
fill a newly created vacancy on our Board of Directors. Mr. Roberts was elected to serve as a director at our combined 2022 and 2023 Annual
Meeting held on June 26, 2023. Mr. 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, 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. Mr. 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. There were no drawdowns in the first quarter of 2025 and 2024.
12. Business concentrations
TherapeuticsMD was previously a women’s healthcare company with
a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed
to pharmaceutical organizations that possess commercial capabilities in the relevant territories. As part of the transformation that included
the Mayne License Agreement, all results associated with former commercial operations have been reflected as discontinued operations in
our condensed consolidated financial statements. Assets and liabilities associated with the commercial business are classified as assets
and liabilities of discontinued operations in our consolidated balance sheets. 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.
16
13. 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
location.
Three Months Ended March 31,
2025
2024
License revenue
United States
$ 174
$ 203
Non-U.S.
219
110
Total
$ 393
$ 313
14. 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. Pursuant to
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.
17
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.