Item 2. Management’s Discussion and Analysis
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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.