What changed in this filing

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Item 1. Business

2025-03-27 compared with 2024-03-29 · 528 added, 652 removed, 17 unchanged (99% of the section changed)

Throughout this Annual Report on Form 10-K (“2023

10-K Report”), the terms “we,” “us,” “our,” “TherapeuticsMD,” “the Company,”

or “our company” refer to TherapeuticsMD, Inc., a Nevada corporation, and unless specified otherwise, include our wholly

owned subsidiaries vitaMedMD, LLC, a Delaware limited liability company (“vitaMed”), and BocaGreenMD, Inc., a Nevada corporation

(“BocaGreen”).

TherapeuticsMD owns or has rights to trademarks,

service marks, or trade names that were previously used in connection with the operation of its business, or are now licensed by another

party, including TherapeuticsMD®, vitaMedMD®, BocaGreenMD®, vitaCareTM, BIJUVA®, and IMVEXXY®, which are protected

under applicable intellectual property laws and are the property of the Company.

This 2023 10-K Report also contains trademarks, trade

names and service marks of other companies, which are the property of their respective owners.

Solely for convenience, trademarks, trade

names and service marks referred to in this 2023 10-K Report may appear without the ®, ™ or SM symbols, but such references

are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right

of the applicable licensor to these trademarks, trade names, and service marks.

We do not intend our use or display of other parties’

trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement

or sponsorship of us by, these other parties.

In addition, this 2023 10-K Report includes

market and industry data that we obtained from periodic industry publications, third-party studies and surveys, government-agency sources,

filings of public companies in our industry, and internal-company surveys.

Industry publications and surveys generally state that their

information has been obtained from sources believed to be reliable.

Although we believe that the industry and market data below is reliable

as of the date of this 2023 10-K Report, this information could prove to be inaccurate as a result of a variety of matters.

Forward-looking statements

This 2023 10-K 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, business strategy, and other plans and

objectives for future operations, and assumptions and predictions about future demand, marketing, expenses and sales are all forward-looking

These statements may be found in the items of this 2023 10-K Report entitled “Business” and “Management’s

Discussion and Analysis of Financial Condition and Results of Operations,” as well as in this 2023 10-K Report generally.

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 2023 10-K Report, but 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.

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.

Factors that could cause or contribute to such differences

include, but are not limited to, competition from other businesses, market and general economic factors, and the other risks discussed

in Item 1A of this 2023 10-K Report.

This discussion should be read in conjunction with the consolidated financial statements and notes

thereto included in this 2023 10-K Report.

We have identified some of the important factors

that could cause future events to differ from our current expectations and they are described in this 2023 10-K Report in the section

entitled “Risk Factors” that you should review carefully.

Please consider our forward-looking statements in light of those

risks as you read this 2023 10-K Report.

If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions

prove to be incorrect, actual results may vary materially from what we project.

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.

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.

30, 2022 (the “Closing Date”), we completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a

Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company,

in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription

prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands (collectively, the “Licensed Products”) in the

United States and its possessions and territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA®

(together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories,

and (iii) sold certain other assets to Mayne Pharma in connection therewith.

In a License Agreement, dated December 4, 2022,

between TherapeuticsMD and Mayne Pharma (the “Mayne License Agreement”), we granted Mayne Pharma, on the Closing Date, (i)

an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell,

use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable,

perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States

for commercialization in the United States and its possessions and territories.

Under the Mayne License Agreement, Mayne

Pharma will pay us 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 $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million,

this Annual Report on Form 10-K (“2024 10-K Report”), the terms “we,” “us,” “our,” “TherapeuticsMD,”

“the Company,” or “our Company” refer to TherapeuticsMD, Inc., a Nevada corporation, and unless specified otherwise,

include our wholly owned subsidiaries vitaMedMD, LLC, a Delaware limited liability company (“vitaMed”), and BocaGreenMD,

Inc., a Nevada corporation (“BocaGreen”).

TherapeuticsMD

owns or has rights to trademarks, service marks, or trade names that were previously used in connection with the operation of its business,

or are now licensed by another party, including TherapeuticsMD®, vitaMedMD®, BocaGreenMD®, BIJUVA®, and IMVEXXY®,

which are protected under applicable intellectual property laws and are the property of the Company.

This 2024 10-K Report also contains

trademarks, trade names and service marks of other companies, which are the property of their respective owners.

Solely for convenience,

trademarks, trade names and service marks referred to in this 2024 10-K Report may appear without the ®, ™ or SM symbols, but

such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights

or the right of the applicable licensor to these trademarks, trade names, and service marks.

We do not intend our use or display of other

parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship

with, or endorsement or sponsorship of us by, these other parties.

this 2024 10-K Report includes market and industry data that we obtained from periodic industry publications, third-party studies and

surveys, government-agency sources, filings of public companies in our industry, and internal-company surveys.

Industry publications

and surveys generally state that their information has been obtained from sources believed to be reliable.

Although we believe that the

industry and market data below is reliable as of the date of this 2024 10-K Report, this information could prove to be inaccurate as

a result of a variety of matters.

Forward-looking

10-K 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, business

strategy, and other plans and objectives for future operations, and assumptions and predictions about future demand, marketing, expenses

and sales are all forward-looking statements.

These statements may be found in the items of this 2024 10-K Report entitled “Business”

and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as in this 2024

10-K Report generally.

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 2024

10-K Report, but 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.

could cause or contribute to such differences include, but are not limited to, competition from other businesses, market and general

economic factors, and the other risks discussed in Item 1A of this 2024 10-K Report.

This discussion should be read in conjunction with

the consolidated financial statements and notes thereto included in this 2024 10-K Report.

We have identified

some of the important factors that could cause future events to differ from our current expectations and they are described in this 2024

10-K Report in the section entitled “Risk Factors” that you should review carefully.

Please consider our forward-looking

statements in light of those risks as you read this 2024 10-K Report.

If one or more of these or other risks or uncertainties materialize,

or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we project.

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.

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 our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD and

vitaMedMD brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii)

assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA® (together with the Licensed Products, collectively,

the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne

Pharma in connection therewith.

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.

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 $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million,

subject to certain adjustments, for a period of 20 years following the Closing Date.

The royalty rate will decrease to 2.0% on a

Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and

(ii) a generic version of a Product launching in the United States.

Mayne Pharma will pay us minimum annual royalties of $3.0

million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments, including as

described below (the “Minimum Annual Royalty”).

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.

Under the Transaction Agreement, dated December

4, 2022, between TherapeuticsMD and Mayne Pharma (the “Transaction Agreement”), we sold to Mayne Pharma, at closing, certain

assets for Mayne Pharma to commercialize the Products in the United States, including, with the Population Council’s consent, our

exclusive license from the Population Council to commercialize ANNOVERA (the “Transferred Assets”).

The total consideration from Mayne Pharma

to TherapeuticsMD for the purchase of the Transferred Assets under the Transaction Agreement and the grant of the licenses under the

Mayne License Agreement was (i) a cash payment of $140.0 million at closing, (ii) a cash payment of approximately $12.1 million

at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to

certain adjustments, (iii) a cash payment of approximately $1.0 million at closing for prepaid royalties in connection with the

Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the

Mayne License Agreement, as amended.

On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment

1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”).

Pursuant to the Mayne License Agreement Amendment,

Mayne Pharma agreed to pay us approximately $1.0 million in prepaid royalties on the Closing Date.

The prepaid royalties reduced the first

four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $257 thousand

per quarterly royalty payment plus interest calculated at 19% per annum accruing from the Closing Date until the date such quarterly royalty

payment was paid to us.

We and Mayne Pharma settled the $1.5 million of consideration due to Mayne Pharma for the assumed obligations

under a long-term services agreement (see the section entitled “vitaCare divestiture” below for a discussion of the long-term

services agreement), including our minimum payment obligations thereunder.

As the parties agreed, Mayne Pharma reduced the second quarterly

royalty payment otherwise payable to us by an additional $0.6 million, and in August 2023 we remitted the remaining consideration of

$0.9 million.

Mayne Pharma paid us approximately $12.1 million at closing on the Closing Date for the acquisition of net working capital, subject to certain adjustments as determined in accordance with the Transaction

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

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 believes its estimated allowances for payer rebates and wholesale distributor fees are

reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement.

Given the recent receipt of

Mayne Pharma’s allowance calculation and the nature of the estimates involved, the outcome of this matter is uncertain at this

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

As of December 31, 2023, the Company 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 that may be material.

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

historical results of commercial operations for all periods prior to the Closing Date 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

consolidated financial statements included in this Annual Report on Form 10-K for further details.

The Company also has 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.

pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA

in Canada and Israel.

● In June 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.

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 January 2023 and severance obligations for terminated executive officers were paid

in accordance with their employment agreements and separation agreements as previously disclosed.

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

consideration from Mayne Pharma to TherapeuticsMD for the purchase of the Transferred Assets under the Transaction Agreement and the

grant of the licenses under the Mayne License Agreement was (i) a cash payment of $140.0 million at closing, (ii) a cash payment of approximately

$12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject

to certain adjustments, (iii) a cash payment of approximately $1.0 million at closing for prepaid royalties in connection with the Mayne

License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the Mayne License

Agreement, as amended.

On the Closing

Date, TherapeuticsMD and Mayne Pharma entered into Amendment No.

1 to the Mayne License Agreement (the “Mayne License Agreement

Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay us approximately $1.0 million in prepaid

royalties on the Closing Date.

The prepaid royalties reduced the first four quarterly payments that would have otherwise been payable

pursuant to the Mayne License Agreement by an amount equal to $257 thousand per quarterly royalty payment plus interest calculated at

19% per annum accruing from the Closing Date until the date such quarterly royalty payment was paid to us.

We and Mayne Pharma settled

the $1.5 million of consideration due to Mayne Pharma for the assumed obligations under a long-term services agreement, including our

minimum payment obligations thereunder.

As the parties agreed, Mayne Pharma reduced the second quarterly royalty payment otherwise payable

to us by an additional $0.6 million, and in August 2023 we remitted the remaining consideration of $0.9 million.

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 consolidated

financial statements included in this Annual Report on Form 10-K for further details.

also has license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S.

In July 2018, we entered into a license and supply

agreement (the “Knight License Agreement”) with Knight Therapeutics Inc.

(“Knight”) pursuant to which we

granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.

Knight obtained regulatory approval for IMVEXXY and BIJUVA and began commercialization efforts in 2024.

In June 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.

As of December 31, 2024, we employed

one full-time employee primarily engaged in an executive position.

We have engaged external consultants who support our relationship with

current partners and assist with certain financial, legal, and regulatory matters and the continued wind-down of our historical business

On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would

serve as our Principal Financial and Accounting Officer.

On August 17, 2023 Michael C.

Donegan notified us of his decision to resign from

the positions of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023.

Ziegler succeeded Mr.

Donegan as Principal Financial and Accounting Officer as of the date of Mr.

Donegan’s resignation.

vitaCare divestiture

On April 14, 2022, we completed the divestiture

of our former subsidiary vitaCare Prescription Services, Inc.

(“vitaCare”) with the sale of all of vitaCare’s issued

and outstanding capital stock (the “vitaCare Divestiture”).

We received net proceeds of $142.6 million, after deducting transaction

costs of $7.2 million, and we recognized a gain on sale of business of $143.4 million.

Included in the net proceeds amount was $11.3

million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”) which we received in

Additionally, the Purchase Agreement provides that we may receive up to an additional $7.0 million in earn-out consideration, contingent

upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement;

we do not believe this earnout will be realized.

The Purchase Agreement contains customary representations

and warranties, covenants, and indemnities of the parties thereto.

The commitments under a long-term services agreement related to vitaCare

were transferred to Mayne Pharma as part of the Mayne Transaction.

The divestiture of vitaCare was determined to

be a component of discontinued operations in December 2022, when we changed our business by becoming a royalty company and as a result

vitaCare activities were reclassified to discontinued operations for the years ended December 31, 2023 and 2022.

Going concern

On the Closing Date of the

Mayne Transaction, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street

Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of our subsidiaries

party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.

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.

We have engaged external consultants who support our relationship

with current partners and assist with certain financial, IT, legal, and regulatory matters and the continued wind-down of our historical

business operations.

On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph

Ziegler serves as our Principal Financial and Accounting Officer.

On the Closing

Date of the Mayne Transaction, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with

Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of our

subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.

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

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 at a

purchase price of the five-day volume-weighted average price of the Common Stock at the time of the sale of such shares of Common

Stock, at an aggregate purchase price of up to $5,000,000.

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

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.

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 at

a purchase price of the five-day volume-weighted average price of the Common Stock at the time of the sale of such shares of Common Stock,

at an aggregate purchase price of up to $5,000,000.

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

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.

In February 2024, the Company received Mayne Pharma’s

calculation of allowance 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 believes its estimated allowances for payer rebates

and wholesale distributor fees are reasonable and intends to resolve this matter through the process outlined in the Transaction

Given the recent receipt of Mayne Pharma’s allowance calculation and the nature of the estimates involved, 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.

As of December 31, 2023, the Company 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.

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.

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

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

On December 30, 2022, we changed our

business to become a pharmaceutical royalty company, currently receiving royalties on products licensed to pharmaceutical

There were no draw downs in 2024.

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.

continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable and intends to resolve

this matter through the processes permitted in the Transaction Agreement.

The outcome of this matter is uncertain at this point.

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.

2024, the Company 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.

As of December 31, 2024, the Company believed no additional accrual was required

for amounts that may be owed for the allowance for returns under the Transaction Agreement.

The Company has not recorded any contingent

gains or receivables for any such allowances.

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

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

If Mayne Pharma’s sales of Licensed Products grow more slowly

than expected or decline, including as a result of Mayne Pharma Group’s pending sale to Cosette Pharmaceuticals, Inc.

if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are

unsuccessful with future financings or the supply chains related to the third-party contract manufacturers are worse than we anticipate,

our existing cash reserves may be insufficient to satisfy our liquidity requirements.

The potential impact of these factors in conjunction

with the uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve

months from the issuance of the financial statements included in this Annual Report on Form 10-K.

accompanying consolidated financial statements included in this Annual Report on Form 10-K do not include any adjustments that might

be necessary if we are unable to continue as a going concern.

of our royalty-bearing products

30, 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 assigned our exclusive license to commercialize ANNOVERA to Mayne Pharma.

IMVEXXY (estradiol vaginal inserts), 4-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.

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 assigned

our exclusive license to commercialize ANNOVERA to Mayne Pharma.

(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.

30, 2022, we granted an exclusive license to commercialize IMVEXXY in the United States and its possessions and territories to Mayne

We also have entered into licensing agreements with third parties to market and sell IMVEXXY outside of the U.S.

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.

As of December 31, 2023, no IMVEXXY

sales had been made through the Theramex and Knight licensing agreements.

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,

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.

ANNOVERA (segesterone acetate (“SA”)

and ethinyl estradiol (“EE”) vaginal system)

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.

As part of the approval of ANNOVERA, the FDA has required a post-approval observational study be performed

to measure the risk of venous thromboembolism.

We agreed to perform and pay the costs and expenses associated with this post-approval

study, provided that if the costs and expenses associated with such post-approval study exceed $20.0 million, half of such excess will

offset against royalties or other payments owed by us under the Population Council License Agreement.

In August 2021, we filed a supplemental

New Drug Application (“NDA”) with the FDA to modify the testing specifications for ANNOVERA to allow increased consistency

of supply of ANNOVERA.

In May 2022, the FDA approved the supplemental NDA for ANNOVERA.

Our obligations to perform the post-approval

study have been transferred to Mayne Pharma as part of the Mayne License Agreement.

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.

Sales concentration

Our business model is dependent on third parties

achieving specified milestones and product sales.

For information on the concentration of licenses of our products, see “Note 10.

the Knight License Agreement, with Knight pursuant to which, we granted Knight an exclusive license to commercialize IMVEXXY in Canada

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.

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.

(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

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.

(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).

December 30, 2022, we assigned our exclusive license to commercialize ANNOVERA in the United States and its possessions and territories

to Mayne Pharma.

vitamin products

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.

concentration

model is dependent on third parties achieving specified milestones and product sales.

For information on the concentration of licenses

of our products, see “Note 9.

Revenue” to the consolidated financial statements included in this 2024 10-K Report.

Currently, the Company collects license revenue

from two licensees.

The pharmaceutical markets in which we license

our products are not subject to seasonal sales fluctuations.

However, our license revenues for the first quarter of each year can be

negatively affected by the annual reset of high-deductible commercial insurance plans.

Manufacturing of our licensed products

As of December 30, 2022, we were no longer responsible for any manufacturing

and have no manufacturing contracts.

All manufacturing responsibility of our licensed products has been transferred to our licensees.

Research and development

As of December 30, 2022, we no longer

conduct any research and development activities.

Historically, our product development programs were concentrated in advanced

hormone therapy pharmaceutical products.

Intellectual property

Patents and trademarks

Our success depends, in part, on our ability

to obtain patents, maintain trade-secret protection, and operate without infringing the proprietary rights of others.

Our intellectual

property portfolio is one way we attempt to protect our competitive position.

We rely primarily on a combination of know-how, trade secrets,

patents, trademarks, and contractual restrictions to protect our products and to maintain our competitive position.

We are diligently

seeking ways to protect our intellectual property through various legal mechanisms in relevant jurisdictions.

Where permitted, patents

for our hormone therapy drug products have been submitted to the Orange Book.

As of December 31, 2023, we have many domestic and foreign patents that cover our licensed products,

including many for each of BIJUVA and IMVEXXY that are Orange Book listed for the licensed products.

We hold multiple U.S.

trademark registrations

and have numerous pending trademark applications.

Issuance of a federally registered trademark creates a rebuttable presumption of ownership

however, it is subject to challenge by others claiming first use in the mark in some or all the areas in which it is used.

Federally registered trademarks have a perpetual life so long as they are maintained and renewed on a timely basis and used properly

as trademarks, subject to the rights of third parties to seek cancellation of the trademarks if they claim priority or confusion of usage.

We believe our patents and trademarks are valuable and provide us certain benefits in marketing our products.

We intend to actively protect our intellectual

property with patents, trademarks, trade secrets, or other legal avenues for the protection of intellectual property and to aggressively

prosecute, enforce, and defend our patents, trademarks, and proprietary technology, including those licensed by Mayne Pharma, Knight

and Theramex with our licensees to the extent permitted under their respective license agreements.

The loss, by expiration or otherwise,

of any one patent may have a material effect on our business.

Defense and enforcement of our intellectual property rights can be expensive

and time consuming, even if the outcome is favorable to us.

It is possible that the patents issued or licensed to us will be successfully

challenged, that a court may find that we are infringing on validly issued patents of third parties, or that we may have to alter or

discontinue the development of our products or pay licensing fees to account for patent rights of third parties.

See “– Pharmaceutical

Regulation – Regulatory Exclusivity” below for information regarding our intellectual property and challenges to that intellectual

While we seek broad coverage under our patent

applications, there is always a risk that an alteration to the process may provide sufficient basis for a competitor to avoid infringement

In addition, patents expire, and we cannot provide any assurance that any patents will be issued from our pending application

or that any potentially issued patents will adequately protect our intellectual property.

Mayne Pharma licensed US patents and trademarks

for our commercial products.

Under the terms of the Mayne License Agreement, Mayne Pharma exclusively took over prosecution of our US

patent and trademark portfolio and enforcement of our licensed patents and trademarks.

Government regulation

In the U.S., the FDA regulates pharmaceuticals,

biologics, medical devices, dietary supplements, and cosmetics under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and

its implementing regulations.

These products are also subject to other federal, state, and local statutes and regulations, including

federal and state consumer protection laws, laws regarding pricing transparency, laws requiring the implementation of compliance programs,

laws requiring the reporting of payments or other transfers of value to HCPs or other healthcare professionals, laws governing the financial

relationships between manufacturers and HCPs or other referral sources and industry stakeholders, laws protecting the privacy of health-related

information, laws restricting items and services of value provided to patients, and laws prohibiting unfair and deceptive acts and trade

the Company collects license revenue from two licensees.

The pharmaceutical

markets in which we license our products are not subject to seasonal sales fluctuations.

However, our license revenues for the first

quarter of each year can be negatively affected by the annual reset of high-deductible commercial insurance plans.

Manufacturing

of our licensed products

As of December

30, 2022, we were no longer responsible for any manufacturing and have no manufacturing contracts.

All manufacturing responsibility of

our licensed and assigned products has been transferred to our licensees.

and development

As of December

30, 2022, we no longer conduct any research and development activities.

Historically, our product development programs were concentrated

in advanced hormone therapy pharmaceutical products.

and trademarks

depends, in part, on our ability to obtain patents, maintain trade-secret protection, and operate without infringing the proprietary

rights of others.

Our intellectual property portfolio is one way we attempt to protect our competitive position.

We rely primarily on

a combination of know-how, trade secrets, patents, trademarks, and contractual restrictions to protect our products and to maintain our

competitive position.

We are diligently seeking ways to protect our intellectual property through various legal mechanisms in relevant

jurisdictions.

Where permitted, patents for our hormone therapy drug products have been submitted to the Orange Book.

As of December

31, 2024, we have many domestic and foreign patents that cover our licensed products, including many for each of BIJUVA and IMVEXXY that

are Orange Book listed for the licensed products.

We hold multiple

trademark registrations and have numerous pending trademark applications.

Issuance of a federally registered trademark creates a

rebuttable presumption of ownership of the mark;

however, it is subject to challenge by others claiming first use in the mark in some

or all the areas in which it is used.

Federally registered trademarks have a perpetual life so long as they are maintained and renewed

on a timely basis and used properly as trademarks, subject to the rights of third parties to seek cancellation of the trademarks if they

claim priority or confusion of usage.

We believe our patents and trademarks are valuable and provide us certain benefits in marketing

our products.

to actively protect our intellectual property with patents, trademarks, trade secrets, or other legal avenues for the protection of intellectual

property and to aggressively prosecute, enforce, and defend our patents, trademarks, and proprietary technology, including those licensed

by Mayne Pharma, Knight and Theramex, with our licensees to the extent permitted under their respective license agreements.

by expiration or otherwise, of any one patent may have a material effect on our business.

Defense and enforcement of our intellectual

property rights can be expensive and time consuming, even if the outcome is favorable to us.

It is possible that the patents issued or

licensed to us will be successfully challenged, that a court may find that we are infringing on validly issued patents of third parties,

or that we may have to alter or discontinue the development of our products or pay licensing fees to account for patent rights of third

See “– Pharmaceutical Regulation – Regulatory Exclusivity” below for information regarding our intellectual

property and challenges to that intellectual property.

seek broad coverage under our patent applications, there is always a risk that an alteration to the process may provide sufficient basis

for a competitor to avoid infringement claims.

In addition, patents expire, and we cannot provide any assurance that any patents will

be issued from our pending application or that any potentially issued patents will adequately protect our intellectual property.

licensed US patents and trademarks for our commercial products.

Under the terms of the Mayne License Agreement, Mayne Pharma exclusively

took over prosecution of our US patent and trademark portfolio and enforcement of our licensed patents and trademarks.

the FDA regulates pharmaceuticals, biologics, medical devices, dietary supplements, and cosmetics under the Federal Food, Drug, and Cosmetic

Act (“FDCA”) and its implementing regulations.

These products are also subject to other federal, state, and local statutes

and regulations, including federal and state consumer protection laws, laws regarding pricing transparency, laws requiring the implementation

of compliance programs, laws requiring the reporting of payments or other transfers of value to HCPs or other healthcare professionals,

laws governing the financial relationships between manufacturers and HCPs or other referral sources and industry stakeholders, laws protecting

the privacy of health-related information, laws restricting items and services of value provided to patients, and laws prohibiting unfair

and deceptive acts and trade practices.

What changed 10-K

Item 1. Business