UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2026
or
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission File Number: 001-00100
TherapeuticsMD, Inc.
(Exact name of Registrant as specified in its
Charter)
Nevada 87-0233535
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
951 Yamato Road, Suite 220 , Boca Raton , Florida 33431
(Address of principal executive offices) (Zip Code)
561 - 961-1900
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b)
of the Act:
Title of Each Class Trading symbol Name of each exchange on which registered
Common Stock, par value $0.001 per share TXMD The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large Accelerated Filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the Registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 11, 2026, there were 11,574,362
shares of the registrant’s common stock, par value $0.001 per share, outstanding.
Table of Contents
Page
Part I - Financial Information
1
Item
1.
Financial statements (unaudited)
1
Condensed Consolidated Balance Sheets
1
Condensed Consolidated Statements of Operations
2
Condensed Consolidated Statements of Stockholders’ Equity
3
Condensed Consolidated Statements of Cash Flows
4
Notes to Unaudited Condensed Consolidated Financial Statements
5
Item
2.
Management’s discussion and analysis of financial condition and results of operations
19
Item
3.
Quantitative and qualitative disclosures about market risk
28
Item
4.
Controls and procedures
28
Part II - Other Information
29
Item
1.
Legal proceedings
29
Item 1A.
Risk factors
29
Item
2.
Unregistered sales of equity securities and use of proceeds
29
Item
3.
Defaults upon senior securities
29
Item
4.
Mine safety disclosures
29
Item
5.
Other information
30
Item
6.
Exhibits
30
Signatures
31
i
Part I - Financial Information
Item 1. Financial statements
TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
March 31,
2026
December 31,
2025
(Unaudited)
Assets:
Current assets:
Cash and cash equivalents
$ 8,419
$ 7,483
Royalty receivable, current portion
3,211
3,525
Prepaid and other current assets
3,633
3,437
Total current assets
15,263
14,445
License rights and other intangible assets, net
3,667
3,761
Right of use assets, net
5,062
5,293
Royalty receivable, long term
13,170
13,713
Other non-current assets
419
444
Total assets
$ 37,581
$ 37,656
Liabilities and stockholders’ equity:
Current liabilities:
Accounts payable
$ 15
$ 377
Accrued expenses and other current liabilities
2,229
1,741
Current liabilities of discontinued operations
2,667
2,667
Total current liabilities
4,911
4,785
Operating lease liabilities
4,824
5,122
Other non-current liabilities
873
873
Total liabilities
10,608
10,780
Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock, par value $ 0.001 ; 640,000 and 32,000 shares authorized, 11,574 and 11,574 issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
11
11
Additional paid-in capital
979,258
979,256
Accumulated deficit
( 952,296 )
( 952,391 )
Total stockholders’ equity
26,973
26,876
Total liabilities and stockholders’ equity
$ 37,581
$ 37,656
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,
2026
2025
Revenue, net:
License revenue
$ 724
$ 393
Operating expenses:
General and administrative
1,353
1,491
Write-off of patents
—
88
Depreciation & amortization
94
95
Total operating expenses
1,447
1,674
Loss from operations
( 723 )
( 1,281 )
Other income:
Interest income, net
41
29
Sublease income
517
410
Miscellaneous income
268
174
Total other income, net
826
613
Income (loss) from continuing operations before income taxes
103
( 668 )
Income tax benefit
—
32
Income (loss) from continuing operations, net of income taxes
103
( 636 )
Loss from discontinued operations, net of income taxes
( 8 )
( 17 )
Net income (loss)
$ 95
$ ( 653 )
Income (loss) per common share, basic and diluted:
Continuing operations
$ 0.01
$ ( 0.06 )
Discontinued operations, net
0.00
0.00
Net income (loss) per common share, basic and diluted
$ 0.01
$ ( 0.06 )
Weighted average common shares, basic
11,574
11,552
Weighted average common shares, diluted
11,640
11,552
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)
Common Stock
Additional
Paid in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance, January 1, 2026
11,574
$ 11
$ 979,256
$ ( 952,391 )
$ 26,876
Share-based compensation
—
—
2
—
2
Net income
—
—
—
95
95
Balance, March 31, 2026
11,574
$ 11
$ 979,258
$ ( 952,296 )
$ 26,973
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
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,
2026
2025
Cash flows from operating activities:
Net income (loss)
$ 95
$ ( 653 )
Less: Loss from discontinued operations, net of taxes
( 8 )
( 17 )
Net income (loss) from continuing operations
103
( 636 )
Adjustments to reconcile net income (loss) to net cash provided by continuing operating activities:
Depreciation and amortization
94
95
Write-off patents
—
88
Share-based compensation costs
2
23
Amortization of right of use assets
231
154
Changes in operating assets and liabilities:
Other assets
881
502
Prepaid and other current assets
( 196 )
433
Accounts payable
( 340 )
( 82 )
Accrued expenses and other current liabilities
434
274
Lease liabilities
( 266 )
( 203 )
Other non-current liabilities
1
51
Total adjustments
841
1,335
Net cash provided by continuing operating activities
944
699
Discontinued operations:
Net cash used in operating activities
( 8 )
( 13 )
Net cash used in discontinued operations
( 8 )
( 13 )
Net increase in cash
936
686
Cash and cash equivalents - continuing operations, beginning of period
7,483
5,059
Total cash and cash equivalents, end of period
$ 8,419
$ 5,745
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., a Nevada corporation, and its 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 agreed to pay us one-time
milestone payments of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach
$ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million
and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million. Further,
Mayne Pharma agreed to pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80.0
million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years
following the Closing Date. 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.
In connection with our transformation into a pharmaceutical royalty
company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief
Executive Officer) and all other employees was completed by December 31, 2022. Severance obligations for all employees other than executive
officers were paid in full in January 2023 and severance obligations for terminated executive officers have been paid in accordance with
their employment agreements and separation agreements as previously disclosed. As of March 31, 2026 and 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. On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph
Ziegler serves as our Principal Financial and Accounting Officer.
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. 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.
6
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 draw-down, before expenses. On November 15, 2023, Rubric drew an additional 877,192 shares of Common Stock
at a price per share equal to $ 2.2761 . We received gross proceeds of $ 2.0 million from the draw-down, before expenses. There were no
drawdowns in the first three months of 2026 and 2025.
In February 2024, we received Mayne Pharma’s calculation of
the net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed
significantly from our estimate of the allowances. We continue to believe our estimated allowances for payer rebates and wholesale distributor
fees are reasonable. In August 2024 and in February 2025, we also received information from Mayne Pharma pertaining to the net working
capital allowance for returns that differs significantly from our estimate of the allowance.
On April 8, 2025, we filed a lawsuit against Mayne Pharma in
the United States District Court for the District of Delaware (the “Mayne Lawsuit”) seeking damages for breach of contract,
breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s
actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and
certain actions or inactions by Mayne Pharma relating thereto. On June 20, 2025, we filed an amended complaint against Mayne Pharma
and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit.
On March 23, 2026, a magistrate judge recommended that the court grant-in-part
and deny-in-part Mayne Pharma’s motion to dismiss. The magistrate judge recommended granting Mayne’s motion to dismiss our
claims for breach of the covenant of good faith and fair dealing, certain of our breach of contract claims and our claim for fraudulent
inducement, but recommended the court grant us leave to amend the fraudulent inducement claim. The magistrate judge recommended denying
Mayne’s motion to dismiss our other claims. The magistrate judge further recommended the court stay the Mayne Lawsuit while the
parties submit the net working capital claims to a dispute resolution process. On April 6, 2026, we filed objections to certain of the
magistrate judge’s recommendations.
On May 30, 2025, Mayne Pharma filed a lawsuit against us in the United
States District Court for the District of Delaware (the “Mayne Countersuit” and, together with the Mayne Lawsuit, the “Mayne
Lawsuits”) seeking damages for breach of contract and fraudulent inducement related to the Transaction Agreement. As part of the
Mayne Countersuit, Mayne Pharma also made certain indemnification demands under the Transaction Agreement, which we dispute. On July 28,
2025, we filed a motion to dismiss the fraudulent inducement claim in the Mayne Countersuit. On March 23, 2026, a magistrate judge recommended
that the court grant our motion to dismiss Mayne Pharma’s claim for fraudulent inducement, but recommended the court deny our motion
to dismiss Mayne Pharma’s other claims. As of March 31, 2026, we believed no additional accrual was required for such claims, as
we could not reasonably estimate a range of loss.
The outcome of this matter is uncertain at this point. As a result,
we cannot reasonably estimate a range of loss, and accordingly, we have not accrued any additional liability associated with Mayne Pharma’s
allowance calculation for payer rebates and wholesale distributor fees, particularly as we believe the outcome of this matter to be intertwined
with the resolution of the net working capital allowance for returns.
As of March 31, 2026, we also believed no additional accrual was required
for amounts that may be owed for the allowance for returns under the Transaction Agreement. We have not recorded any contingent gains
or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes
to estimated amounts owed or amounts due from Mayne Pharma may be material.
Mayne Pharma has also made certain indemnification demands under the
Transaction Agreement, which we dispute. As of March 31, 2026, we believed no additional accrual was required for such claims, as we
could not reasonably estimate a range of loss.
7
If Mayne Pharma’s sales of Licensed Products grow more slowly
than expected or decline, including as a result of Mayne Pharma Group’s potential sale to Cosette Pharmaceuticals, Inc., if the
net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if the outcome
of the Mayne Lawsuits is worse than we anticipate, if we are unsuccessful with future financings or the supply chains related to the
third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity
requirements. The potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt
about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
The accompanying condensed consolidated financial
statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
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 2025 Annual Report
on Form 10-K/A, filed with the SEC on April 1, 2026 (the “2025 10-K/A 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 2025 10-K/A Report.
Certain amounts in the condensed 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 revised and reclassified to conform
to current-period presentation and are not material to the consolidated financial statements. These revisions and reclassifications primarily relate to the presentation of sublease income and
the separate presentation of interest income and interest expense. These reclassifications had no effect on previously reported net
loss or per share amounts.
New accounting standards
Recently Issued Accounting Standard – Adopted During the Fiscal
Year
As of March 31, 2026, we have adopted the Financial Accounting Standards
Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2025-05, “Financial Instruments-Credit
Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets.” In connection with the
adoption of ASU 2025-05, we elected the practical expedient which allows entities to assume that the current conditions applied in determining
credit loss allowances remain unchanged for the remaining life of those assets. We applied this guidance prospectively, and the adoption
did not have a material impact on our condensed consolidated financial statements.
Recently Issued Accounting Standards – Not Yet Adopted
In November 2024, the FASB issued ASU No. 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 No. 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. We are evaluating the impact of ASU No. 2024-03 on our financial reporting disclosures.
In December 2025, the FASB issued ASU No. 2025-11, “Interim Reporting
(Topic 270): Narrow-Scope Improvements.” ASU No. 2025-11 has three primary objectives: to specify the form and content choices for
interim financial statements and accompanying notes; to incorporate a comprehensive list of required interim disclosures; and to introduce
a disclosure principle requiring entities to disclose events since the end of the previous annual reporting period that have a material
impact on the entity. The amendments are not intended to change the fundamental nature of interim reporting or expand or reduce current
interim disclosure requirements. The requirements of ASU No. 2025-11 are effective for public business entities for interim reporting
periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied
either prospectively or retrospectively. For us, the requirements of ASU No. 2025-11 will be effective beginning in the first quarter
of 2028. We do not expect a material change as a result of ASU No. 2025-11.
8
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 2025 10-K/A Report.
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 liabilities have been reported as liabilities
of discontinued operations in our condensed consolidated balance sheets as of March 31, 2026 and December 31, 2025.
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,
2026
2025
General and administrative expenses
$ 8
$ 17
Total operating expenses
8
17
Operating loss from discontinued operations
( 8 )
( 17 )
Other income, net
—
—
Total other income, net
—
—
Loss from discontinued operations, net of income taxes
$ ( 8 )
$ ( 17 )
9
The following table presents the carrying amounts of the classes of
liabilities of discontinued operations as of March 31, 2026 and December 31, 2025 (in thousands):
March 31,
2026
December 31,
2025
Current liabilities of discontinued operations:
Accrued expenses and other current liabilities
$ 2,667
$ 2,667
3. Prepaid and other current assets
Our prepaid and other current assets consisted of the following as
of March 31, 2026 and December 31, 2025 (in thousands):
March 31,
2026
December 31,
2025
Insurance
$ 225
$ 89
Capitalized legal
2,334
2,334
Rent receivable
659
672
Other
415
342
Prepaid and other current assets
$ 3,633
$ 3,437
4. Licensed rights and other intangible assets
The following provides information about our license rights and other
intangible assets, net as of March 31, 2026 and December 31, 2025 (in thousands):
March 31, 2026
December 31, 2025
Gross Carrying
Amount
Accumulated
Amortization
Net
Gross Carrying
Amount
Accumulated
Amortization
Net
Intangible assets subject to amortization:
Hormone therapy drug patents
$ 5,695
$ 2,517
$ 3,178
$ 5,695
$ 2,423
$ 3,272
Hormone therapy drug patents applied and pending
approval
180
—
180
180
—
180
Intangible assets subject to amortization
5,875
2,517
3,358
5,875
2,423
3,452
Intangible assets not subject to amortization:
Trademarks/trade name rights
309
—
309
309
—
309
License rights and other intangible assets, net
$ 6,184
$ 2,517
$ 3,667
$ 6,184
$ 2,423
$ 3,761
We recorded in continuing operations amortization expenses related
to patents of $ 94 thousand and $ 95 thousand for the three months ended March 31, 2026 and 2025, respectively.
We conduct regular reviews of our individual patents and patent portfolios.
No indicators of impairment were identified, and accordingly, no write-offs were recognized for the three months ended March 31, 2026.
In comparison, we recorded write-offs of $ 88 thousand related to patents pending approval during the three months ended March 31, 2025.
10
Our intangible assets subject to amortization are expected to be amortized
as follows (in thousands):
Year ending December 31,
2026
$ 286
2027
380
2028
381
2029
380
2030
380
Thereafter
1,371
Total
$ 3,178
5. Accrued expenses and other current liabilities
Other accrued expenses and other current liabilities consisted of
the following (in thousands):
March 31,
2026
December 31,
2025
Payroll and related costs
$ 379
$ 310
Professional fees
459
265
Operating lease liabilities
1,007
975
Other accrued expenses and current liabilities
384
191
Accrued expenses and other current liabilities
$ 2,229
$ 1,741
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.
11
Our estimate of the allowance for payer rebates and wholesale distributor
fees was determined in accordance with the Transaction Agreement which establishes the process for the determination of net working capital.
In February 2024, we received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale
distributor fees pursuant to the Transaction Agreement, which differed significantly from our estimate of the allowances. We continue
to believe our estimated allowances for payer rebates and wholesale distributor fees are reasonable. In August 2024 and in February 2025,
we also received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly
from our estimate of the allowance.
On April 8, 2025, we filed the Mayne Lawsuit seeking damages for
breach of contract, breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related
to Mayne Pharma’s actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working
capital allowances and certain actions or inactions by Mayne Pharma relating thereto. On June 20, 2025, we filed an amended complaint
against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit. On March 23, 2026, a magistrate judge
recommended that the court grant-in-part and deny-in-part Mayne Pharma’s motion to dismiss. The magistrate judge recommended granting
Mayne’s motion to dismiss our claims for breach of the covenant of good faith and fair dealing, certain of our breach of contract
claims and our claim for fraudulent inducement, but recommended the court grant us leave to amend the fraudulent inducement claim. The
magistrate judge recommended denying Mayne’s motion to dismiss our other claims. The magistrate judge further recommended the court
stay the Mayne Lawsuit while the parties submit the net working capital claims to a dispute resolution process. On April 6, 2026, we filed
objections to certain of the magistrate judge’s recommendations.
On May 30, 2025, Mayne Pharma filed the Mayne Countersuit seeking damages
for breach of contract and fraudulent inducement related to the Transaction Agreement. On July 28, 2025, we filed a motion to dismiss
the Mayne Countersuit. On March 23, 2026, a magistrate judge recommended that the court grant our motion to dismiss Mayne Pharma’s
claim for fraudulent inducement, but recommended the court deny our motion to dismiss Mayne Pharma’s other claims. As of March 31,
2026, we believed no additional accrual was required for such claims, as we could not reasonably estimate a range of loss.
The outcome of this matter is uncertain at this point. As a result,
we cannot reasonably estimate a range of loss, and accordingly, we have not accrued any additional liability associated with Mayne Pharma’s
allowance calculation for payer rebates and wholesale distributor fees, particularly as we believe the outcome of this matter to be intertwined
with the resolution of the net working capital allowance for returns.
As of March 31, 2026, we also believed no additional accrual was required
for amounts that may be owed for the allowance for returns under the Transaction Agreement. We have not recorded any contingent gains
or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes
to estimated amounts owed or amounts due from Mayne Pharma may be material.
Mayne Pharma has also made certain indemnification demands under the
Transaction Agreement, which we dispute. As of March 31, 2026, we believed no additional accrual was required for such claims, as we
could not 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. (“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, 2026, 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.
12
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. As of March 31, 2026,
the litigation remains ongoing and has progressed to claim construction, which the courts determine the meaning and scope of the asserted
patent claims that will govern subsequent infringement and validity analysis.
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 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. 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. On June 20, 2025, we filed an amended complaint against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion
to dismiss the Mayne Lawsuit. On March 23, 2026, a magistrate judge recommended that the court grant-in-part and deny-in-part Mayne Pharma’s
motion to dismiss. The magistrate judge recommended granting Mayne’s motion to dismiss our claims for breach of the covenant of
good faith and fair dealing, certain of our breach of contract claims and our claim for fraudulent inducement, but recommended the court
grant us leave to amend the fraudulent inducement claim. The magistrate judge recommended denying Mayne’s motion to dismiss our
other claims. The magistrate judge further recommended the court stay the Mayne Lawsuit while the parties submit the net working capital
claims to a dispute resolution process. On April 6, 2026, we filed objections to certain of the magistrate judge’s recommendations.
On May 30, 2025, Mayne Pharma filed the Mayne Countersuit seeking damages
for breach of contract and fraudulent inducement related to the Transaction Agreement. On July 28, 2025, we filed a motion to dismiss
the Mayne Countersuit. On March 23, 2026, a magistrate judge recommended that the court grant our motion to dismiss Mayne Pharma’s
claim for fraudulent inducement, but recommended the court deny our motion to dismiss Mayne Pharma’s other claims. As of March 31,
2026, we believed no additional accrual was required for such claims, as we could not reasonably estimate a range of loss.
From time to time, we are involved in other litigations and proceedings
in the ordinary course of business. 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.
13
Off-balance sheet arrangements
As of March 31, 2026 and December 31, 2025 there were no off-balance
sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that we consider material.
Employment agreements
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, 2026, 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, 2026, the following table summarizes the status of
our outstanding and exercisable warrants and related transactions since December 31, 2025 (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)
Balance, as of December 31, 2025 98 $ 63.33 $ —
4.6
Balance, as of March 31, 2026 98 $ 63.33 $ —
4.3
Share-based compensation payment plans
As of March 31, 2026, 105,212 shares of common stock were subject to
outstanding awards under our share-based payment award plans and inducement grants. As of March 31, 2026, 429,529 shares of common stock
were available for future grants of share-based payment awards under the TherapeuticsMD, Inc. 2019 Stock Incentive Plan.
14
The following table summarizes the status of our outstanding and exercisable
options and related transactions since December 31, 2025 (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)
Balance, as of December 31, 2025 105 $ 74.05 $ —
7.3 105 $ 74.04 $ —
7.3
Balance, as of March 31, 2026 105 $ 73.18 $ —
7.1 105 $ 73.17 $ —
7.1
The following table summarizes the status of our RSUs and related
transactions since December 31, 2025 (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, 2025
26
$ 1.15
$ 41.57
Balance, as of March 31, 2026
26
$ 1.15
$ —
As of March 31, 2026 and December 31, 2025, there were no outstanding
PSUs remaining.
15
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 totaling $ 2 and $ 23 thousand for the three months ended March 31,
2026 and 2025, respectively.
The unrecognized compensation costs as of March 31, 2026 of $ 25 thousand
are expected to be recognized as share-based payment award compensation related to unvested RSUs over a weighted average period of 2.6
years. No tax benefit was realized due to a continued pattern of net losses.
8. Revenue
Pursuant to 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.
Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time,
milestone payments to us 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 us royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first
$ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20
years following the Closing Date. 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 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. 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
due to net operating loss carry forwards from prior years.
We recorded a full valuation allowance of the net operating income
and losses for the three months ended March 31, 2026 and 2025. Accordingly, there were no provisions for income taxes for the three months
ended March 31, 2026 and 2025. Additionally, as of March 31, 2026 and December 31, 2025, we maintain a full valuation allowance for all
deferred tax assets.
10. Earnings (loss) per common share
The following table sets forth the computation of basic and diluted
earnings (loss) per common share for the periods presented (in thousands, except per share amounts):
Three Months Ended
March 31,
2026
2025
Numerator:
Income (loss) from continuing operations, net of income taxes
$ 103
$ ( 636 )
Loss from discontinued operations, net of income taxes
( 8 )
( 17 )
Net income (loss)
$ 95
$ ( 653 )
Denominator:
Weighted average common shares outstanding - basic
11,574
11,552
Effect of dilutive securities
66
—
Weighted average common shares outstanding - diluted
11,640
11,552
Income (loss) per common share, continuing operations, net of income taxes
Basic
$ 0.01
$ ( 0.06 )
Diluted
$ 0.01
$ ( 0.06 )
Income (loss) per common share, discontinued operations, net of income taxes
Basic
$ 0.00
$ 0.00
Diluted
$ 0.00
$ 0.00
16
For the three months ended March 31, 2026, the remaining balance of
our warrants and a portion of the stock options were excluded from the calculation of diluted earnings (loss) per share because the weighted
exercise prices of the warrants and stock options were greater than or equal to the average price of the common shares and were therefore
anti-dilutive.
For the three months ended March 31, 2025, since we reported a net
loss from continuing operations, 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.
The following table sets forth the outstanding weighted average securities
for the periods presented which were not included in the calculation of diluted earnings (loss) per common share as of March 31 for the
respective three month periods (in thousands):
As of March 31,
2026
2025
Stock options
38
52
PSUs
-
5
Warrants
98
98
136
155
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, 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 draws in the first quarter of 2026 and 2025.
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. Liabilities associated with the commercial business are classified as liabilities
of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are
provided in Note 2.
17
For the three months ended March 31, 2026, 100 % of license revenue
related to Mayne Pharma, Theramex and Knight.
As of March 31, 2026, we had a royalty receivable of $ 3,211 thousand
relating to the short-term portion of receivable from Mayne Pharma, Theramex and Knight and $ 13,170 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.
13. Segment Reporting
We operate in one segment. Accordingly, our license revenue, net income
(loss), and total assets reflect the revenue, income (loss), and assets of the single segment, respectively.
Our 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 our reportable segment. The CODM
is regularly provided expense information consistent with the expense categories presented in the Condensed Consolidated Statements of
Operations
The following tables present total revenue by geographic location.
Three Months Ended
March 31,
2026
2025
License revenue
United States
$ 244
$ 174
Non-U.S.
480
219
Total
$ 724
$ 393
18
Item 2. Management’s discussion and analysis of financial
condition and results of operations
The following discussion should be read in conjunction with our 2025
Annual Report on Form 10-K/A, filed with the SEC on April 1, 2026 (“2025 10-K/A Report”), and the condensed consolidated financial
statements and related notes in Item 1, Financial Statements, appearing elsewhere in this Quarterly Report on Form 10-Q (“10-Q Report”).
The following discussion may contain forward-looking statements, and our actual results may differ materially from the results suggested
by these forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Part
I, Item 1A of our 2025 10-K/A Report under the heading “Risk Factors.” We assume no obligation to revise or update any forward-looking
statements for any reason, except as required by law.
Certain amounts in the following discussion may not add due to rounding,
and all percentages have been calculated using unrounded amounts.
Forward-looking statements
This 10-Q Report contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties.
For example, statements regarding our operations, financial position, debt position, liquidity, business strategy, and other plans and
objectives for future operations, and assumptions and predictions about future cost reduction strategies, expenses and royalties are
all forward-looking statements. These statements are generally accompanied by words such as “intend,” “anticipate,”
“believe,” “estimate,” “potential(ly),” “continue,” “forecast,” “predict,”
“plan,” “may,” “will,” “could,” “would,” “should,” “expect,”
or the negative of such terms or other comparable terminology.
We have based these forward-looking statements on our current expectations
and projections about future events. We believe that the assumptions and expectations reflected in such forward-looking statements are
reasonable, based on information available to us on the date of this 10-Q Report, and we cannot assure you that these assumptions and
expectations will prove to have been correct or that we will take any action that we may presently be planning. These forward-looking
statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from
those expected or anticipated in the forward-looking statements. We do not undertake to update any forward-looking statements or to publicly
announce the results of any revisions to any statements to reflect new information or future events or developments, except as required
by law or by the rules and regulations of the SEC.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties, many of which are outside of our control. Factors that could cause or contribute to such differences
include, but are not limited to, our liquidity requirements, supply chain issues, management transitions, risks related to our licensing
agreements, risks related to the pursuit of strategic alternatives, market and general economic factors, and the other risks discussed
in Part I, Item 1A of our 2025 10-K/A Report, as updated and supplemented by Part II, Item 1A of this 10-Q Report.
Our company
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 (“Mayne Pharma Group”),
in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize 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.
19
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 agreed to pay us one-time,
milestone payments of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach
$100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million
and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million. Further,
Mayne Pharma agreed to pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80 million
in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following
the Closing Date. 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
agreed to pay us minimum annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject
to certain further adjustments, including as described below (the “Minimum Annual Royalty”). 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 total consideration from Mayne Pharma to us 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 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. Liabilities associated with the commercial business are classified as liabilities of discontinued operations in
our consolidated balance sheets. See Note 2 – Discontinued Operations to the condensed consolidated financial statements included
in this Quarterly Report on Form 10-Q for further details.
20
We also have license agreements with strategic partners to commercialize
IMVEXXY and BIJUVA outside of the U.S.
● In
July 2018, we entered into the “Knight License Agreement” with 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.
We continue to evaluate a variety of strategic alternatives that may
include, but not be limited to, an acquisition, merger, other business combination, sale of assets, or other strategic transactions.
Although we are exploring potential strategic alternatives, there can be no assurance of a transaction, a successful outcome of these
efforts, or the form or timing of any such outcome. We have not set a timetable for completion of this exploration process and do not
intend to disclose further developments unless and until required by applicable laws or regulations or as otherwise deemed appropriate
by our Board of Directors or Chief Executive Officer.
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 draw-downs 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.
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 revised certain accrual estimates including
increasing our working capital adjustment accrual from $3.5 million to $5.5 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.
21
Our estimate of the allowance for payer rebates and wholesale distributor
fees was determined in accordance with the Transaction Agreement which establishes the process for the determination of net working capital.
In February 2024, we received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale
distributor fees pursuant to the Transaction Agreement, which differed significantly from our estimate of the allowances. We continue
to believe our estimated allowances for payer rebates and wholesale distributor fees are reasonable. In August 2024 and in February 2025,
we also received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly
from our estimate of the allowance.
On April 8, 2025, we filed a lawsuit against Mayne Pharma in the
United States District Court for the District of Delaware (the “Mayne Lawsuit”) seeking damages for breach of contract, breach
of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s actions
in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and certain
actions or inactions by Mayne Pharma relating thereto. On June 20, 2025, we filed an amended complaint against Mayne Pharma and on
July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit. On March 23, 2026, a magistrate judge recommended that the court
grant-in-part and deny-in-part Mayne Pharma’s motion to dismiss. The magistrate judge recommended granting Mayne’s motion
to dismiss our claims for breach of the covenant of good faith and fair dealing, certain of our breach of contract claims and our claim
for fraudulent inducement, but recommended the court grant us leave to amend the fraudulent inducement claim. The magistrate judge recommended
denying Mayne’s motion to dismiss our other claims. The magistrate judge further recommended the court stay the Mayne Lawsuit while
the parties submit the net working capital claims to a dispute resolution process. On April 6, 2026, we filed objections to certain of
the magistrate judge’s recommendations.
On May 30, 2025, Mayne Pharma filed the Mayne Countersuit seeking damages
for breach of contract and fraudulent inducement related to the Transaction Agreement. As part of the Mayne Countersuit, Mayne Pharma
also made certain indemnification demands under the Transaction Agreement, which we dispute. On July 28, 2025, we filed a motion to dismiss
the fraudulent inducement claim in the Mayne Countersuit. On March 23, 2026, a magistrate judge recommended that the court grant our motion
to dismiss Mayne Pharma’s claim for fraudulent inducement, but recommended the court deny our motion to dismiss Mayne Pharma’s
other claims. As of March 31, 2026, we believed no additional accrual was required for such claims, as we could not reasonably estimate
a range of loss.
The outcome of this matter is uncertain at this point. As a result,
we cannot reasonably estimate a range of loss, and accordingly, we have not accrued any additional liability associated with Mayne Pharma’s
allowance calculation for payer rebates and wholesale distributor fees, particularly as we believe the outcome of this matter to be intertwined
with the resolution of the net working capital allowance for returns.
As of March 31, 2026, we also believed no additional accrual was required
for amounts that may be owed for the allowance for returns under the Transaction Agreement. We have not recorded any contingent gains
or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as changes
to estimated amounts owed or amounts due from Mayne Pharma may be material.
Mayne Pharma has also made certain indemnification demands under the
Transaction Agreement, which we dispute. As of March 31, 2026, we believed no additional accrual was required for such claims, as we
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 potential sale to Cosette Pharmaceuticals,
Inc., if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates,
if the outcome of the Mayne Lawsuits is worse than we anticipate, if we are unsuccessful with future financings or the supply chains
related to the third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy
our liquidity requirements. The potential impact of these factors in conjunction with the uncertainty of the capital markets raise substantial
doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
The accompanying condensed consolidated financial
statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
22
Portfolio of our royalty-bearing products
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, we granted an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription
prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands and assigning our exclusive license to commercialize ANNOVERA
to Mayne Pharma.
IMVEXXY (estradiol vaginal inserts), 4-µg and 10-µg
This pharmaceutical product is for the treatment of moderate-to-severe
dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy due to menopause. As part of the FDA’s
approval of IMVEXXY, we committed to conduct a post-approval observational study to evaluate the risk of endometrial cancer in post-menopausal
women with a uterus who use a low-dose vaginal estrogen unopposed by a progestogen.
On December 30, 2022, we granted an exclusive license to commercialize
IMVEXXY in the United States and its possessions and territories to Mayne Pharma. We also have entered into licensing agreements with
third parties to market and sell IMVEXXY outside of the U.S. We entered into the Knight License Agreement, with Knight pursuant to which,
we granted Knight an exclusive license to commercialize IMVEXXY in Canada and Israel. We entered into the Theramex License Agreement
with Theramex pursuant to which we granted Theramex an exclusive license to commercialize IMVEXXY for human use outside of the U.S.,
except for Canada and Israel. In December 2024, we transferred the right to commercialize IMVEXXY in Israel from Knight to Theramex.
The FDA has also asked the sponsors of other vaginal estrogen products
to participate in the observational study. In connection with the observational study, we would have been required to provide progress
reports to the FDA on an annual basis. The obligation to conduct this study was transferred to Mayne Pharma as part of the Mayne License
Agreement.
BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg
This pharmaceutical product is the first and only FDA approved bioidentical
hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate-to-severe vasomotor
symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.
On December 30, 2022, we granted an exclusive license to commercialize
BIJUVA in the United States and its possessions and territories to Mayne Pharma. We also have entered into the Knight License Agreement
with Knight pursuant to which we granted Knight an exclusive license to commercialize BIJUVA in Canada and Israel. We have entered into
the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to commercialize BIJUVA for human
use outside of the U.S., except for Canada and Israel. In December 2024, we transferred the right to commercialize BIJUVA in Israel from
Knight to Theramex.
ANNOVERA (segesterone acetate (“SA”) and ethinyl estradiol
(“EE”) vaginal system)
This pharmaceutical product is a one-year ring-shaped contraceptive
vaginal system (“CVS”) and the first and only patient-controlled, procedure-free, reversible prescription contraceptive that
can prevent pregnancy for up to a total of 13 cycles (one year).
On December 30, 2022, we assigned our exclusive license to commercialize
ANNOVERA in the United States and its possessions and territories to Mayne Pharma.
Prenatal vitamin products
On December 30, 2022, we granted an exclusive license to commercialize,
in the United States and its possessions and territories, our prescription prenatal vitamin product lines under our vitaMedMD brand name
and authorized generic formulations of some of our prescription prenatal vitamin products under our BocaGreenMD Prenatal name to Mayne
Pharma.
23
Results of operations
As part of the transformation that included the Mayne License Agreement,
all results associated with former commercial operations have been reflected as discontinued operations in our condensed consolidated
financial statements for all periods prior to the Closing Date. Liabilities associated with the commercial business are classified as
liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations
are provided in Note 2 to the condensed consolidated financial statements included in this Quarterly Report.
The discussion below, and the revenues and expenses discussed below,
are based on, and relate to, our continuing operations.
Three months ended March 31, 2026 compared with three months ended
March 31, 2025
The following table sets forth the results of our operations (in thousands):
Three Months Ended
March 31,
2026
2025
Revenue:
License revenue
$ 724
$ 393
Operating expenses:
General and administrative
1,353
1,491
Write-off of patents
—
88
Depreciation and amortization
94
95
Total operating expenses
1,447
1,674
Loss from operations
(723 )
(1,281 )
Other income:
Interest income, net
41
29
Sublease income
517
410
Miscellaneous income
268
174
Total other income, net
826
613
Income (loss) from continuing operations before income taxes
103
(668 )
Income tax benefit
—
32
Income (loss) from continuing operations, net of income taxes
103
(636 )
Loss from discontinued operations, net of income taxes
(8 )
(17 )
Net income (loss)
$ 95
$ (653 )
Revenue. We recorded $724 thousand in license revenue for the first quarter
of 2026, an increase of $331 thousand, compared to $393 thousand in license revenue for the first quarter of 2025. The increase is attributable
to changes in sales of licensed products.
General and administrative. General and administrative expenses were $1,353 thousand for the first
quarter of 2026, a decrease of $138 thousand or 9.3%, compared to $1,491 thousand for 2025. The decrease is primarily attributable to
lower professional fees and share-based compensation costs.
Write-off of patents. We have no write-off for abandoned patents for the first quarter of
2026, compared to an $88 thousand written off for abandoned pending patents in the first quarter of 2025.
Depreciation and amortization. Depreciation and amortization
expense was $94 thousand for the first quarter of 2026, compared to $95 thousand for the first quarter of 2025. This balance is entirely
comprised of amortization of license rights and intangible assets.
Operating expenses . Total operating expenses for the first quarter
of 2026 were $1,447 thousand, a decrease of $227 thousand, or 13.6%, compared to $1,674 thousand for the first quarter of 2025. The decrease
is primarily attributable to the absence of write-off expense recognized in 2025 as well as lower professional fees and share-based compensation
costs.
24
Loss from operations. In the first quarter of 2026, we had a
loss from operations of $723 thousand, as compared to a loss from operations of $1,281 thousand for the first quarter of 2025. This change
reflects the increase in revenue from licensed product sales, the absence of write-off expense recognized, and lower professional fees.
Other income, net. During the first quarter of 2026, we had other income of $826 thousand compared
to other income of $613 thousand in the first quarter of 2025, reflecting an increase in sublease income and higher other income pertaining
to Mayne’s royalty sales of ANNOVERA in the first quarter of 2026.
Income (loss) from continuing operations . For the first quarter
of 2026, we had net income of $103 thousand, compared to a net loss of $636 thousand for the first quarter of 2025.
Discontinued Operations – Net loss from discontinued
operations was $8 thousand for the first quarter of 2026, compared to a loss from discontinued operations of $17 thousand for the first
quarter of 2025.
For additional information, see Note 2 - Discontinued Operations,
in the notes to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report.
Liquidity and capital resources
Our primary use of cash is to fund our continued operations. We have
funded our operations primarily through revenue from licensed royalties, public offerings of our common stock and private placements of
equity and debt securities, and the transactions with Mayne Pharma. As of March 31, 2026, we had cash and cash equivalents totaling $8,419
thousand. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation insured limits
of $250 thousand per bank. We have never experienced any losses related to these funds.
Mayne Pharma License Agreement
On December 30, 2022, we granted Mayne Pharma (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. The total consideration from Mayne Pharma to us under the Mayne License Agreement
consisted of (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 dated December 4, 2022, 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
and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
25
Pursuant to the Mayne License Agreement, Mayne Pharma agreed to pay
us one-time, milestone payments of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar
year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach
$200.0 million and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0
million. Further, Mayne Pharma agreed to pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0%
on the first $80 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 agreed to pay us minimum annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual
rate of 3%, subject to certain further adjustments, including as described below. 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.
Subscription Agreement with Rubric Capital Management LP
On May 1, 2023, we entered into the Subscription Agreement with 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 Common Stock,
from time to time during the term of the Subscription Agreement in separate drawdowns at our election, at a purchase price of the five-day
volume-weighted average price of our common stock at the time of the sale of such shares, at an aggregate purchase price of up to $5,000,000
(collectively, the “Private Placement”).
The initial drawdown occurred on June 29, 2023 consisting of a sale
of 312,525 shares of Common Stock at a price per share equal to $3.6797. We received gross proceeds of $1.15 million from the drawdown,
before expenses. On November 15, 2023 Rubric drew down an additional 877,192 shares of Common Stock at a price per share equal to $2.2761.
We received gross proceeds of $2.0 million from the drawdown, before expenses. There were no drawdowns in the first quarter of 2026 and
2025.
See “Going Concern” above for further discussion related
to our ability to generate and obtain adequate amounts of cash to meet our liquidity needs and our plans to satisfy our such needs in
the short-term and in the long-term. As a result, there is substantial doubt about our ability to continue as a going concern for the
next twelve months from the issuance of these financial statements.
Cash flows
The following table reflects the major categories of cash flows for
each of the periods (in thousands).
Three Months Ended
March 31,
2026
2025
Net cash provided by continuing operating activities
$ 944
$ 699
Net cash used in discontinued operations
(8 )
(13 )
Net increase in cash
$ 936
$ 686
Operating Activities from continuing operations . For the first quarter of 2026, net cash provided by operating activities
was $944 thousand, compared to net cash provided by operating activities of $699 thousand for the first quarter of 2025. The increase
was primarily driven by cash received from royalty receivable, partially offset by a larger use of cash for outstanding accounts payable,
and the absence of the prior-year write-off of abandoned patents.
Net cash used in discontinued operations . Net cash used in
discontinued operations for the first three months of 2026 was $8 thousand as compared to net cash used in operating activities from
discontinued operations of $13 thousand for the first three months of 2025. This change relates primarily to a decreased level of activities
associated with our discontinued operations.
For additional details, see the condensed consolidated statements
of cash flows in Item 1, Financial Statements, appearing elsewhere in this 10-Q Report.
26
Other liquidity measures
Receivable from Mayne Pharma . On December 30, 2022, Mayne Pharma acquired our accounts receivable
balance of approximately $29.3 million which is subject to certain working capital adjustments. As of March 31, 2026, we had a royalty
receivable of $2,731 thousand relating to the short-term portion of royalty receivable from Mayne Pharma and $13,170 thousand relating
to the long-term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty. See “Note 1
Business, basis of presentation, new accounting standards and summary of significant accounting policies (Revenue Recognition)”
to the consolidated financial statements included in our 2025 10-K/A Report.
Contractual obligations, off-balance sheet arrangements and purchase
commitments and employment agreements
Our contractual obligations and off-balance sheet arrangements are
set forth below. For additional information on any of the following and other obligations and arrangements, see “Note 6. Commitments
and Contingencies” to the condensed consolidated financial statements included in this 10-Q Report.
In the ordinary course of business, we enter into agreements with
third parties that include indemnification provisions, which, in our judgment, are normal and customary for companies in our industry
sector. Pursuant to these agreements, we agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered, for
which there may or may not be limitations on potential damages. The maximum potential amount of future payments we could be required
to make under these indemnification provisions is sometimes unlimited. As a result, the estimated fair value of liabilities relating
to these provisions is minimal. Accordingly, we had no liabilities recorded for these provisions as of March 31, 2026 and December 31,
2025.
In the normal course of business, we may be confronted with issues
or events that may result in contingent liability. These generally relate to lawsuits, claims, environmental actions, or the actions
of various regulatory agencies. We consult with counsel and other appropriate experts to assess the claim. If, in our opinion, we have
incurred a probable loss and the amount of the loss can be reasonably estimated, as set forth by accounting principles generally accepted
in the United States of America (“U.S. GAAP”), an estimate is made of the loss and the appropriate accounting entries are
reflected in our condensed consolidated financial statements.
Critical accounting policies and estimates
Management’s discussion and analysis of our financial condition
and results of operations are based upon our condensed consolidated financial statements included elsewhere in this 10-Q Report, which
has been prepared in accordance with U.S. GAAP and SEC rules and regulations related to interim financial reporting. We make estimates
and assumptions that affect the reported amounts on our condensed consolidated financial statements and accompanying notes as of the date
of the condensed consolidated financial statements. The critical accounting policies and estimates used are disclosed in Item 7 –
Management’s discussion and analysis of financial condition and results of operations – Critical accounting policies and estimates
in our 2025 10-K/A Report.
27
Item 3. Quantitative and qualitative disclosures about market
risk
As a “smaller reporting company,” as defined by Rule 12b-2
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and pursuant to Instruction 6 to Item 201(e) of
Regulation S-K, we are not required to provide this information.
Item 4. Controls and procedures
Management’s evaluation of disclosure controls and procedures
Disclosure Controls and Procedures
Disclosure controls and procedures are designed to ensure that information
required to be disclosed in the reports filed or submitted under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), is recorded, processed, summarized and reported, within the time period specified in the SEC’s rules and forms and
is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial and Accounting Officer,
as appropriate, in order to allow timely decisions regarding required disclosure.
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer evaluated the effectiveness of our disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this
10-Q Report. Based on that evaluation, our Chief Executive Officer concluded that our disclosure controls and procedures as of the end
of the period covered by this 10-Q Report were effective in providing reasonable assurance that information required to be disclosed
by us in reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods
specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our Chief Executive Officer
and Principal Financial and Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our Chief Executive Officer does not expect that our disclosure controls
and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control
issues, misstatements, errors, and instances of fraud, if any, within our company have been or will be prevented or detected. Further,
internal controls may become inadequate as a result of changes in conditions, or through the deterioration of the degree of compliance
with policies or procedures.
Changes in internal controls over financial reporting
There was no change in our internal control over financial reporting
during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
28
Part II - Other Information
Item 1. Legal proceedings
From time to time, we are involved in litigation and proceedings in
the ordinary course of our business. Other than the legal proceedings disclosed in Note 6, Commitments and contingencies in Part I, Item
1, Financial Statements, appearing elsewhere in this 10-Q Report, we are not involved in any legal proceeding that we believe would have
a material effect on our business or financial condition.
Item 1A. Risk factors
Our business, financial condition and operating results can be affected
by a number of factors, whether currently known or unknown, including but not limited to those described in Part I, Item 1A of the 2025
10-K/A Report under the heading “Risk Factors,” any one or more of which could, directly or indirectly, cause our actual financial
condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any
of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results and
stock price. There have been no material changes to our risk factors since the 2025 10-K/A Report.
Item 2. Unregistered sales of equity securities and use of proceeds
None.
Item 3. Defaults upon senior securities
None.
Item 4. Mine safety disclosures
None.
29
Item 5. Other information
Rule 10b5-1 Trading Plans
During the three months ended March 31, 2026, none of our directors
or officers adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined
in Item 408 of Regulation S-K).
Item 6. Exhibits
Exhibit No.
Description
3.1
Articles of Incorporation of AMHN, Inc. filed in the State of Nevada, dated July 20, 2010 (1)
3.2
Bylaws of AMHN, Inc. (2)
31.1†
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a)
31.2†
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a)
32.1††
Section 1350 Certification of Chief Executive Officer
32.2††
Section 1350 Certification of Principal Financial Officer
101†
Inline XBRL Document Set for the condensed consolidated financial statements and accompanying notes in Part I, Item 1, “Financial Statements” of this Quarterly Report on Form 10-Q
104†
Inline XBRL for the cover page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set
†
Filed herewith.
††
Furnished herewith.
(1)
Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2010 filed with the Commission on August 3, 2010 and incorporated herein by reference (SEC File No. 000-16731).
(2)
Filed as an exhibit to Definitive 14C Information Statement filed with the Commission on June 29, 2010 and incorporated herein by reference (SEC File No. 000-16731).
30
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: May 12, 2026
TherapeuticsMD, Inc.
/s/ Marlan
D. Walker
Marlan D. Walker
Chief Executive Officer
(Principal Executive Officer)
/s/ Joseph
Ziegler
Joseph Ziegler
Principal Financial and Accounting Officer
31
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.