What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-13 compared with 2024-11-12 · 149 added, 230 removed, 279 unchanged (58% of the section changed)

Management’s discussion and analysis of

financial condition and results of operations

Management’s discussion and analysis of financial

condition and results of operations

The following discussion should be read in conjunction with our 2024

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and supplemented by Part II, Item 1A of this 10-Q Report.

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.

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, 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.

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.

Pursuant to a License Agreement, dated December 4, 2022, between TherapeuticsMD

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original $1.5 million payable.

This action represented a shift in our business and therefore, the

related assets and liabilities associated with commercial operations are classified as discontinued operations on our condensed consolidated

balance sheets and the results of operations have been presented as discontinued operations within our condensed consolidated statements

of operations for all periods presented.

See Note 2 – Discontinued Operations to the condensed consolidated financial statements

included in this Quarterly Report on Form 10-Q for further details.

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

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.

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.

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 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 the first quarter of 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 December 31, 2023 and September 30,

2024, we employed one full-time employee primarily engaged in an executive position.

We have engaged external consultants, including certain

former members of our management team, who support our relationship with current partners and assist with certain financial, legal and

regulatory matters and the continued wind-down of our historical business operations.

In December 2024, we transferred the right to commercialize IMVEXXY and BIJUVA in Israel from Knight to Theramex.

Going concern

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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.

from time to time during the term of the Subscription Agreement in separate drawdowns at our election.

On June 29, 2023, we issued and

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of net working capital.

In February 2024, the Company received Mayne Pharma’s calculation of allowance for payer rebates and wholesale

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

The Company intends

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

The Company believes its estimated allowances

for payer rebates and wholesale distributor fees are reasonable.

The timing and outcome of this matter is uncertain at this point.

a result, the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability

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

In addition, the Company has received information from Mayne

Pharma pertaining to the allowance for returns that differs from the Company’s estimate of the allowance.

As of September 30,

2024, the Company believes no additional accrual is required for amounts that may be owed for the allowance for returns under the

Transaction Agreement, as the Company cannot reasonably estimate a range of loss.

The Company has not recorded any contingent gains

or receivables for any such allowances.

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

changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

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.

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, 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.

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.

Products grow more slowly than expected or decline, including as a result of Mayne Pharma Group’s pending sale to Cosette Pharmaceuticals,

(“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

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We entered into the Theramex License Agreement with

Theramex HQ UK Limited (“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.

As of September 30, 2024, no IMVEXXY sales had been made through the Theramex

licensing agreement.

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

BIJUVA (estradiol and progesterone) capsules, 1 mg/100 mg

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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 to Mayne Pharma.

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).

ANNOVERA is commercially sold in the U.S.

pursuant to the terms of the Population Council License Agreement.

ANNOVERA in the United States and its possessions and territories to Mayne Pharma.

Prenatal vitamin products

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As part of the transformation that included the Mayne License Agreement,

historical results of 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.

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.

Three months ended September 30, 2024 compared with three months

ended September 30, 2023

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

September 30,

License and service revenue

License revenue

Operating expenses:

Selling, general and administrative

Impairment of long-lived assets (Note 4)

Write-off of patents and trademarks

Depreciation and amortization

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Loss from continuing operations before income taxes

Provision for income taxes

Net loss from continuing operations

Loss from discontinued operations, net of income taxes

Income tax benefit

Loss from continuing operations, net of income taxes

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

As part of our transformation and the Mayne License

Agreement, historical results of commercial operations have been reflected as discontinued operations in the condensed consolidated financial

statements for all periods presented.

We recorded $547 thousand in license revenue for the third quarter of

2024, primarily from the Mayne License Agreement, an increase of $600 thousand, compared to $(53) thousand in license revenue for

the third quarter of 2023.

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.

Reported negative license

revenue of ($53) thousand in the third quarter of 2023 was due to product sales adjustments reported by our licensees.

Operating expenses .

Total operating expenses for the third quarter

of 2024 were $1,406 thousand, a decrease of $314 thousand, or 18.3%, compared to the third quarter of 2023.

This decrease was due to the

further optimization of our business through the reduction of costs following our transition to a royalty-based business.

Selling, general and administrative.

Selling, general and administrative

expenses were $1,310 thousand for the third quarter of 2024, a decrease of $280 thousand, or 17.6%, compared to the third quarter of 2023.

This decrease was due to the increased efficiencies realized following our transition to a royalty-based business.

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 $96 thousand for the third quarter of 2024, a decrease of $34 thousand, or 26.2%, compared to the third

quarter of 2023.

In the 2024 period, this balance is entirely comprised of amortization of license rights and intangible assets.

Loss from operations.

In the third quarter of 2024, we had a

loss from operations of $859 thousand, as compared to a loss from operations of $1,773 thousand for the third quarter of 2023.

change reflects the streamlining of our business and increased efficiencies realized as a royalty-based business.

Other income (expense), net .

During the third quarter of

2024, we had other income of $292 thousand compared to other income of $339 thousand in the third quarter of 2023.

Other income in

the 2024 period was mainly comprised of interest income, while other income in the prior year period was mainly comprised of

Provision for income taxes .

During the third quarter of 2024

and 2023, we recorded no provision for income taxes for continuing operations.

Net loss from continuing operations .

For the third quarter of

2024, we had a net loss of $567 thousand, or $0.05 per basic and diluted common share,

compared to a net loss of $1,434 thousand, or $0.13 per basic and diluted common share, for the third quarter of 2023.

Discontinued Operations – Net loss from discontinued operations

was $42 thousand for the third quarter of 2024, compared to a net loss from discontinued operations of $1,944 thousand for the third quarter

Nine months ended September 30, 2024 compared with nine months ended

September 30, 2023

The following table sets forth the results of our operations (in thousands):

Nine Months Ended

September 30,

License and service revenue

Operating expenses:

Selling, general and administrative

Impairment of long-lived assets (Note 4)

Depreciation and amortization

Total operating expenses

Loss from operations

Other income (expense):

Interest expense and other financing costs

Miscellaneous income

Total other income, net

Loss from continuing operations before income taxes

Provision for income taxes

Net loss from continuing operations

Loss from discontinued operations, net of income taxes

As part of our transformation and the Mayne License

Agreement, historical results of commercial operations have been reflected as discontinued operations in the condensed consolidated financial

statements for all periods presented.

We recorded $1,094 thousand in

license revenue for the first nine months of 2024, primarily from the Mayne License Agreement, an increase of $294

thousand, or 36.8%, compared to $800 thousand in license revenue for the first nine months of 2023.

The increase is primarily attributable

to changes in sales of licensed products.

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.

balance is entirely comprised of amortization of license rights and intangible assets.

Operating expenses .

Total operating expenses for the first nine

months of 2024 were $5,535 thousand, a decrease of $2,177 thousand, or 28.2 %, compared to the first nine months of 2023.

This decrease

was due to the further optimization of our business through the reduction of costs following our transition to a royalty-based business

and is partially off-set by the patent impairment recognized in the second quarter of 2024.

Selling, general and administrative.

Selling, general and administrative

expenses were $3,865 thousand for the first nine months of 2024, a decrease of $3,562 thousand, or 48.0%, compared to the first nine months

This decrease was due to the increased efficiencies realized following our transition to a royalty-based business.

Depreciation & amortization.

Depreciation and amortization

expense was $409 thousand for the first nine months of 2024, an increase of $124 thousand, or 43.5%, compared to the first nine months

In the 2024 period, this balance is entirely comprised of amortization of license rights and intangible assets.

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 nine months of 2024, we had

a loss from operations of $4,441 thousand, as compared to a loss from operations of $6,912 thousand for the first nine months of 2023.

This change reflects the streamlining of our business and increased efficiencies realized as a royalty-based business.

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.

reflects the increase in sales of licensed products and the increased efficiencies realized as a royalty-based business.

Other income, net.

During the first nine months of 2024, we

had other income of $2,015 thousand compared to other income of $754 thousand in the first nine months of 2023.

The difference is mainly

due to a $1,250 thousand one-time payment the Company received from its sublessee on its early termination on the sublease, which

was recognized in the second quarter of 2024.

Royalties reported as other income for intellectual

property licensed by us totaled approximately $660 thousand in the first nine months of 2024.

Provision for income taxes .

During the first nine months of

2024 and 2023, we recorded no provision for income taxes for continuing operations.

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.

the first quarter of 2024, we recorded no benefit for income taxes for continuing operations.

Net loss from continuing operations .

For the first nine months

of 2024, we had a net loss of $2,426 thousand , or $0.21

per basic and diluted common share, compared to a net loss of $6,158 thousand, or $0.60 per basic and diluted common share, for

the first nine months of 2023.

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 $7 thousand for the first nine months of 2024, compared to a net loss from discontinued operations of $3,237 thousand for the first

nine months of 2023.

This change reflects the continued wind-down of our legacy business.

was $17 thousand for the first quarter of 2025, compared to net income from discontinued operations of $75 thousand for the first quarter

For additional information, see Note 2 - Discontinued Operations, in

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Our primary use of cash is to fund our continued operations.

funded our operations primarily through public offerings of our common stock and private placements of equity and debt securities, the

divestiture of our former subsidiary vitaCare, and the transactions with Mayne Pharma.

As of September 30, 2024, we had cash and cash

equivalents totaling $5,047 thousand.

We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance

Corporation insured limits of $250 thousand per bank.

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.

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(collectively, the “Private Placement”).

The initial draw down occurred on June 29, 2023 consisting of a sale

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.

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We received gross proceeds of $2.0 million from the drawdown, before expenses.

Managed Client Agreement with IWG

On September 30, 2024 (the “Commencement Date”), we entered

into a Managed Client Agreement (the “Managed Client Agreement”) with RGN-MCA Florida VI, LLC (“IWG”) pursuant

to which IWG agreed to provide managed services for flexible workspaces under the “HQ” brand for 21,330 square feet of our

office spaces located at 951 Yamato Road, Boca Raton, Florida 33431 (the “Premises”).

The Managed Client Agreement is subject

to termination by us or IWG if either party does not approve the specification, plans and drawings for the fit out of the Premises on

or before the date that is 120 days after the Commencement Date.

There were no drawdowns in the first quarter of 2025 and

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.

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

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each of the periods (in thousands).

Nine Months Ended

September 30,

Three Months Ended

Net cash provided by (used in) continuing operating activities

Net cash provided by financing activities

Net cash used in discontinued operations

Net increase (decrease) in cash

Net cash (used in) provided by discontinued operations

Net increase in cash

Operating Activities from continuing operations .

For the first

nine months of 2024, net cash provided by operating activities was $1,153 thousand, compared to net cash used in operating activities

of $18,121 thousand for the first nine months of 2023.

This change of $19,274 thousand was primarily due to a $3,732 thousand decrease

in our net loss from continuing operations following our transition from a manufacturing and commercialization business to a royalty-based

business combined with the pay-down of current liabilities in the prior-year period.

Financing Activities from continuing operations.

first nine months of 2024, there was no cash received from financing activities, compared to net cash received from financing activities

of $1,149 thousand for the first nine months of 2023, reflecting the sale of common stock during the first nine months of 2023.

Net cash used in discontinued operations.

Net cash used in operating

activities from discontinued operations for the first nine months of 2024 was $433 thousand as compared to net cash used in operating

activities of $22,179 thousand for the first nine months of 2023.

This change relates primarily to a decrease in expenses incurred and

the payment of current liabilities associated with our transition from a manufacturing and commercialization business to a royalty-based

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.

change reflects the increased efficiencies realized as a royalty-based business.

Net cash (used in) provided by discontinued operations.

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

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Other liquidity measures

Receivable from Mayne .

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 September

30, 2024, we had a royalty receivable of $3,160 thousand relating to the short-term portion

of receivable from Mayne Pharma and $16,610 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 2023 10-K Report.

On December 30, 2022, Mayne Pharma acquired our inventory

balance of approximately $6.6 million, which is subject to certain net working capital adjustments.

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.

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

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Accordingly, we had no liabilities recorded for these provisions

as of September 30, 2024 and December 31, 2023.

as of March 31, 2025 and December 31, 2024.

In the normal course of business, we may be confronted with issues

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If, in our opinion, we have incurred

a probable loss as set forth by U.S.

GAAP, an estimate is made of the loss and the appropriate accounting entries are reflected in our

condensed consolidated financial statements.

a probable loss as set forth by accounting principles generally accepted in the United States of America (“U.S.

estimate is made of the loss and the appropriate accounting entries are reflected in our condensed consolidated financial statements.

Critical accounting policies and estimates

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis