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 2024
Annual Report on Form 10-K (“2024 10-K 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 2024
10-K 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, market and general economic factors, and the other risks discussed in Part I, Item 1A of our 2024 10-K 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, primarily collecting
royalties from our licensees. We are no longer engaged in research and development or commercial operations. 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”), pursuant to which we (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.
18
Pursuant to 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. Pursuant to the Mayne License Agreement, Mayne Pharma will 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 will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80 million
in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following
the Closing Date. The royalty rate will decrease to 2.0% on a Product-by-Product basis upon the earlier to occur of (i) the expiration
or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States. Mayne Pharma
will pay us minimum annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to
certain further adjustments, including as described below (the “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.
Pursuant to a 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 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 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 Parma 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 consolidated financial
statements. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations
in our consolidated balance sheets. See Note 2 – Discontinued Operations to the condensed consolidated financial statements included
in this Quarterly Report on Form 10-Q for further details.
19
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.
Going concern
Following the transaction with Mayne Pharma, our primary source of
revenue is from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
We may need to raise additional capital to provide additional liquidity to fund our operations until we become cash flow positive. To
address our capital needs, we may pursue various equity and debt financing and other alternatives. The equity financing alternatives may
include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders,
or other institutional counterparties or an underwritten public equity or equity-linked securities offering. Our ability to sell equity
securities may be limited by market conditions, including the market price of our common stock, and our available authorized shares.
To the extent that we raise additional capital through the sale of
such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include
liquidation or other preferences that adversely affect the rights of our existing stockholders. If we are not successful in obtaining
additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge,
consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us.
On May 1, 2023, we entered into a Subscription Agreement (the “Subscription
Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or more
of its affiliates, up to an aggregate of 5,000,000 shares of our common stock, par value $0.001 per share (our “Common Stock”),
from time to time during the term of the Subscription Agreement in separate drawdowns at our election. On June 29, 2023, we issued and
sold 312,525 shares of Common Stock at a price per share equal to $3.6797 pursuant to the Subscription Agreement. We received gross proceeds
of $1.15 million from the draw down, 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.
20
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.
The Company’s estimate of the allowance for payer rebates and
wholesale distributor fees was determined in accordance with the Transaction Agreement which establishes the process for the determination
of net working capital.
In February 2024, the Company received Mayne Pharma’s calculation
of the net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed
significantly from the Company’s estimate of the allowances. The Company continues to believe its estimated allowances for payer
rebates and wholesale distributor fees are reasonable. In August 2024 and in February 2025, the Company also received information from
Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly from the Company’s estimate
of the allowance.
On April 8, 2025, the Company filed a lawsuit against Mayne Pharma
in the United States District Court for the District of Delaware (the “Mayne Lawsuit”) seeking damages for breach of contract,
breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s
actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and
certain actions or inactions by Mayne Pharma relating thereto.
The outcome of this matter is uncertain at this point. As a result,
the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated
with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company believes
the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.
As of March 31, 2025, the Company also believes no additional accrual
is required for amounts that may be owed for the allowance for returns under the Transaction Agreement. The Company has not recorded any
contingent gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital
items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.
Mayne Pharma has also made certain indemnification demands under the
Transaction Agreement, which the Company disputes. As of March 31, 2025, the Company believed no additional accrual was required for such
claims, as the Company could not reasonably estimate a range of loss.
If Mayne Pharma’s sales of Licensed
Products grow more slowly than expected or decline, including as a result of Mayne Pharma Group’s pending sale to Cosette Pharmaceuticals,
Inc. (“Cosette”), if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than
our current estimates, if we are unsuccessful with future financings or the supply chains related to the third-party contract manufacturers
are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements. The potential impact
of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability to continue as
a going concern for the next twelve months from the issuance of these financial statements.
The accompanying consolidated financial statements
do not include any adjustments that might be necessary if we are unable to continue as a going concern.
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.
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.
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.
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.
21
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.
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. 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 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.
22
Three months ended March 31, 2025 compared with three months ended
March 31, 2024
The following table sets forth the results of our operations (in thousands):
Three Months Ended
March 31,
2025
2024
Revenue:
License revenue
$ 393
$ 313
Operating expenses:
Selling, general and administrative
1,081
1,322
Write-off of patents and trademarks
88
—
Depreciation and amortization
95
133
Total operating expenses
1,264
1,455
Loss from operations
(871 )
(1,142 )
Other income (expense):
Interest expense and other financing costs
(2 )
—
Miscellaneous income
205
333
Total other income, net
203
333
Loss from continuing operations before income taxes
(668 )
(809 )
Income tax benefit
32
—
Loss from continuing operations, net of income taxes
(636 )
(809 )
(Loss) income from discontinued operations, net of income taxes
(17 )
75
Net loss
$ (653 )
$ (734 )
Revenue. As part of our transformation and the Mayne License
Agreement, all results associated with former commercial operations have been reflected as discontinued operations in the condensed consolidated
financial statements for all periods presented.
We recorded $393 thousand in license revenue for the first quarter
of 2025, primarily from the Mayne License Agreement, an increase of $80 thousand, compared to $313 thousand in license revenue for the
first quarter of 2024. The increase is primarily attributable to changes in sales of licensed products.
Selling, general and administrative. Selling, general and administrative
expenses were $1,081 thousand for the first quarter of 2025, a decrease of $241 thousand, or 18.2%, compared to the first quarter of 2024.
The change is due to the increased efficiencies realized as a royalty-based business.
Depreciation & amortization. Depreciation and amortization
expense was $95 thousand for the first quarter of 2025, a decrease of $38 thousand, or 28.6%, compared to the first quarter of 2024. This
balance is entirely comprised of amortization of license rights and intangible assets.
Operating expenses . Total operating expenses for the first quarter
of 2025 were $1,264 thousand, a decrease of $191 thousand, or 13.1%, compared to the first quarter of 2024. The change is due to the increased
efficiencies realized as a royalty-based business.
Loss from operations. In the first quarter of 2025, we had a
loss from operations of $871 thousand, as compared to a loss from operations of $1,142 thousand for the first quarter of 2024. This change
reflects the increase in sales of licensed products and the increased efficiencies realized as a royalty-based business.
23
Other income, net. During the first quarter of 2025, we had
other income of $203 thousand compared to other income of $333 thousand in the first quarter of 2024. The decrease was primarily attributable
to a decrease in royalty revenue from the licensing of Annovera to Mayne Pharma.
Income tax benefit . During the first quarter of 2025, we recorded
income tax benefit of $32 thousand for continuing operations, which is a result of refunds received from certain state tax filings. During
the first quarter of 2024, we recorded no benefit for income taxes for continuing operations.
Net loss from continuing operations . For the first quarter of
2025, we had a net loss of $636 thousand, or $0.06 per basic and diluted common share, compared to a net loss of $809 thousand, or $0.07
per basic and diluted common share, for the first quarter of 2024.
Discontinued Operations – Net loss from discontinued operations
was $17 thousand for the first quarter of 2025, compared to net income from discontinued operations of $75 thousand for the first quarter
of 2024.
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 public offerings of our common stock and private placements of equity and debt securities, and
the transactions with Mayne Pharma. As of March 31, 2025, we had cash and cash equivalents totaling $5,745 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.
24
Pursuant to the Mayne License Agreement, Mayne Pharma will 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 will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80 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.
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 2025 and
2024.
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,
2025
2024
Net cash provided by (used in) continuing operating activities
$ 699
$ (229 )
Net cash (used in) provided by discontinued operations
(13 )
240
Net increase in cash
$ 686
$ 11
Operating Activities from continuing operations . For the first three months of 2025, net cash provided by operating
activities was $699 thousand, compared to net cash used in operating activities of $229 thousand for the first three months of 2024. This
change reflects the increased efficiencies realized as a royalty-based business.
25
Net cash (used in) provided by discontinued operations. Net
cash used in operating activities from discontinued operations for the first three months of 2025 was $13 thousand as compared to net
cash provided by operating activities from discontinued operations of $240 thousand for the first three months of 2024. 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.
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, 2025, we had a royalty receivable of $2,777 thousand relating to the short-term portion of receivable from Mayne Pharma and
$15,427 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 2024 10-K 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 or omitted by
us. The maximum potential amount of future payments we could be required to make under these indemnification provisions is sometimes unlimited.
We have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. 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, 2025 and December 31, 2024.
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 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 2024 10-K Report.
26
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.