What changed in this filing

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Item 1. Business

2024-03-29 compared with 2023-04-07 · 640 added, 418 removed, 29 unchanged (97% of the section changed)

Throughout this Annual Report on Form 10-K (“2022 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 ® , vitaCare TM , BIJUVA ® , and IMVEXXY ® , which are protected under applicable intellectual property laws and are the property of the Company.

This 2022 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 2022 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 2022 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 2022 10-K Report, this information could prove to be inaccurate as a result of a variety of matters.

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 2022 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 2022 10-K Report entitled “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as in this 2022 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 2022 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.

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 2022 10-K Report.

This discussion should be read in conjunction with the consolidated financial statements and notes thereto included in t his 2022 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 2022 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 2022 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, primarily collecting royalties from our licensees.

Our Company is no longer engaging in research and development or commercial operations and is transforming to a virtual company with limited infrastructure.

On December 30, 2022 (the “Closing Date”), the Company 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 the Company and its subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize the Company’s 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 the Company’s 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 the Company and Mayne Pharma (the “Mayne License Agreement”), the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.

Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time, milestone payments to the Company of each of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and (iii) $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million.

Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of 8.0% on the first $80 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.

The royalty rate will decrease to 2.0% on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.

Mayne Pharma will pay to the Company minimum annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments, including as described below (the “Minimum Annual Royalty”).

Upon the expiry of the 20-year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.

Pursuant to a Transaction Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Transaction Agreement”), the Company sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including the Company’s exclusive license from the Population Council to commercialize ANNOVERA (the “Transferred Assets”).

The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the Mayne License Agreement was (i) a cash payment of $140.0 million at closing, (ii) a cash payment of approximately $12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.

On the Closing Date, the Company and Mayne Pharma entered into Amendment No.

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,

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

The royalty rate will decrease to 2.0% on a

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

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

Mayne Pharma will pay us minimum annual royalties of $3.0

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

described below (the “Minimum Annual Royalty”).

Upon the expiry of the 20-year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement

will become a fully paid-up and royalty free license for the Licensed Products.

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 the Company approximately $1.0 million in prepaid royalties on the Closing Date.

The prepaid royalties will reduce the first four quarterly payments that would have otherwise be received pursuant to the Mayne License Agreement by an amount equal to $257,250 per quarterly royalty payment plus interest calculated at 19% per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.

In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement, including the Company’s minimum payment obligations thereunder.

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 consolidated balance sheets and the results of operations have been presented as discontinued operations within our consolidated statements of operations and comprehensive income (loss) for all periods presented.

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.

(“Knight”) 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.

In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.

In connection with the Company’s 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 will be paid in accordance with their employment agreements and separation agreements as previously disclosed.

As of December 31, 2022, 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.

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.

As of December 31, 2023, 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 vitaCare Prescription Services, Inc.

(“vitaCare”) with the sale of all vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”).

We received net proceeds of $142.6 million, net of 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 is recorded as restricted cash in the consolidated balance sheets.

The restricted cash was held by an escrow agent and was released to us in March 2023.

Additionally, 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 will record the contingent consideration at the settlement amount when the consideration is realized or realizable.

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

In addition, under the Mayne License Agreement Amendment, Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to us by $1.5 million in consideration of Mayne Pharma assuming our obligations under the long-term services agreement related to vitaCare.

The pre-divesture operations of vitaCare were reclassified to discontinued operations in December 2022 when the Company transitioned to becoming a royalty company and licensing its products to Mayne Pharma.

The impact of COVID-19 on our business

With multiple variant strains of the SARS-Cov-2 virus and the COVID-19 disease that it causes (collectively, “COVID-19”) still circulating, we continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic.

The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict.

As of the date of the filing of this Annual Report, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain and difficult to predict.

Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future.

Our business model

We changed our business in 2022, by out-licensing our products and collecting royalties, after granting an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD® and vitaMedMD® brands in the United States and its possessions and territories and assigning the Company’s exclusive license to commercialize ANNOVERA in the United States and its possessions and territories to Mayne Pharma.

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 the Knight License Agreement pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.

In June 2019, we entered into the Theramex License Agreement 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.

Currently, we collect royalties on sales of ANNOVERA, IMVEXXY, and BIJUVA under the TherapeuticsMD brand, prescription prenatal vitamins under our vitaMedMD brand name, and authorized generic formulations of our prescription prenatal vitamin products under BocaGreenMD brand name.

We expect that the primarily source of our future revenue will be based on payments we may receive for milestones and royalties related to these products.

The Company no longer has research and development, commercial, manufacturing and finance infrastructure and operates as a virtual corporation with no material capital investment in fixed assets.

Industry and market

Women’s healthcare market

According to BBC Research’s September 2020 report, “Pharmaceuticals for Women’s Health:

Global Markets,” post-menopausal osteoporosis, pregnancy disorders and management, menopause, endometriosis, and polycystic ovary syndrome (PCOS) are the largest segments within the global market for women’s health therapeutics.

Women’s health therapeutics established a very strong presence in the global pharmaceutical market over the last few decades.

The market is expected to grow moderately, mainly due to patent expirations of blockbuster drugs such as Evista, the Premarin family, Forteo, Mirena, Boniva, Actonel, Gonal-F and several other.

However, the launch of new drugs in the market, and novel drugs under R&D in the late-stage pipeline, has the strong potential to drive the market during the forecast period.

The global market for women’s health therapeutics is projected to grow from $31.5 billion in 2019 to $41.2 billion by 2025, at a compound annual growth rate (CAGR) of 4.7% for the period of 2019-2025.

The menopause market is projected to grow from $5.7 billion in 2019 to $7.7 billion by 2025 at a CAGR of 5.4% through 2025.

Reproductive market

Contraception can be defined as the deliberate prevention of pregnancy by interfering with normal process of ovulation, fertilization, and implantation through the use of barriers, drugs, medical devices, or surgical techniques.

The contraceptive market includes non-hormonal methods, such as the non-hormonal intrauterine device, or IUD, contraceptive sponge, diaphragm, cervical cap or shield and condoms, and hormonal methods such as oral contraceptives, injections, implants, hormonal IUDs and vaginal ring and transdermal contraceptive products.

Hormonal contraceptives can be composed of synthetic estrogens and progestins.

Contraceptives containing both estrogen and a progestin are referred to as combination hormonal contraceptives, CHCs, and contraceptives containing only progestin are referred to as progestin-only, or P-only.

The most common synthetic estrogen approved in the U.S.

for use in contraceptive products is ethinyl estradiol (EE).

There are 10 different progestins that have been used in contraceptives sold in the U.S.

The progestin component provides most of the contraceptive effect, while the estrogen component primarily provides cycle control, for example, minimizing bleeding or spotting between cycles.

The progestin exerts its contraceptive effect by inhibiting ovulation, or release of an egg from the ovary, and by thickening cervical mucus.

Thickening cervical mucus helps to prevent sperm entry into the upper genital tract.

The estrogen component, in addition to providing cycle control, makes a small contribution to contraception by decreasing the maturation of the egg in the ovary.

As per the National Center for Health Statistics (“NCHS’) Data Brief No.

388 from the Centers for Disease Control and Prevention (“CDC”), the latest data, for 2017 to 2019, indicate that 65.3% of women aged 15 to 49 were using some type of contraceptive method with approximately half of these women in this age group using reversable prescription contraception.

Most women who were not using contraception had reasons for not doing so, such as seeking pregnancy, being pregnant or postpartum, or not being sexually active.

contraceptive market size is expected to reach $9.9 billion by 2027, expanding at a CAGR of 4.3% from 2020 to 2027 according to Grand View Research, Inc.

Increasing awareness about long-acting reversible contraceptives (“LARCs”) is expected to augment the product demand, thereby driving the market over the next few years.

According to the NCHS, the use of LARCs in the U.S.

was 10.4% in 2017-2019 among women aged 15 to 49.

We believe that the increasing awareness about LARCs will grow incremental product demand, thereby driving market growth over the coming years.

This is currently led by IUDs.

The remainder of the market is dominated by oral contraceptives, which is represented by one major brand, Lo Loestrin ® Fe by AbbVie and a variety of generics.

Menopause market

Menopause is the spontaneous and permanent cessation of menstruation, which naturally occurs in most women.

T he average age of menopause in the U.S.

The range for women is usually between 45 and 58.

Per the National Institutes of Health, i n the U.S., approximately 1.3 million women become menopausal each year, typically beginning between the ages of 51 and 52.

However, about 5.0% of women experience early menopause between the ages of 40 and 45.

Additionally, 1.0% of women experience premature menopause before the age of 40, due to permanent ovarian failure that may be associated with sex chromosome abnormalities.

Classic symptoms of menopause are vasomotor symptoms (“VMS”) (including hot flashes and night sweats), vulvovaginal symptoms (including dyspareunia and vaginal dryness) and sleep disturbances.

These symptoms are caused by the reduced levels of circulating estrogen as ovarian production shuts down.

Common treatments for menopausal VMS and vulvovaginal symptoms of menopause range from prescription medications, including hormone therapy and non-hormonal options, to over-the-counter supplements and lubrication options.

Hormone therapy is the most effective treatment in the U.S.

and Canada for relief of menopausal symptoms according to the North American Menopause Society (“NAMS”).

Approved FDA prescriptions for menopausal hormone therapy in the U.S.

dropped significantly following the Women’s Health Initiative (“WHI”) study results published in 2002, which found that subjects using conjugated equine estrogens plus the synthetic progestin medroxyprogesterone acetate had, among other things, a greater incidence of coronary heart disease, breast cancer, stroke, and pulmonary embolism.

This study caused a significant change in hormone therapy prescribing habits.

Since 2002, many women and HCPs have chosen compounded hormone therapy, a bio-identical solution for treating VMS, and the use of local vaginal therapy increased during this time.

The FDA recommends that women with moderate-to-severe menopausal symptoms who want to try menopausal hormone therapy for relief use it for the shortest time needed and at the lowest effective dose.

Prenatal vitamin market

According to the CDC, there are approximately four million births per year in the U.S.

Most HCPs encourage taking a prenatal vitamin as the recommended standard of care.

Prenatal vitamins are dietary supplements intended to be taken before and during pregnancy and during postnatal lactation that provide nutrients recognized by various health organizations as helpful for a healthy pregnancy outcome.

The prenatal vitamin market is highly fragmented, with dozens of companies selling hundreds of competitive products.

Prenatal vitamin products are marketed as either nonprescription products or prescription products, with many companies marketing their products through both channels.

Our Licensed Menopause portfolio

On December 30, 2022, we granted an exclusive license to commercialize the Company’s IMVEXXY in the United States and its possessions and territories to Mayne Pharma.

IMVEXXY is a small, digitally inserted, softgel vaginal insert that dissolves when inserted into the vagina.

It is administered mess-free, without the need for an applicator, and can be used any time of day.

IMVEXXY provides a mechanism of action and dosing that is comfortable for patients, with no patient education required for dose application or applicators.

Additionally, the dose packaging for IMVEXXY is designed to optimize compliance and convenience for users.

IMVEXXY demonstrated efficacy as early as two weeks (secondary endpoint) and maintained efficacy through week 12 in clinical studies, with no increase in systemic hormone levels beyond the normal postmenopausal range (the clinical relevance of systemic absorption rates for vaginal estrogen therapies is not known).

We previously granted licenses to commercialize the Company’s IMVEXXY product outside of the United States to Theramex and Knight.

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 License Agreement.

On December 30, 2022, we granted an exclusive license commercialize the Company’s BIJUVA in the United States and its possessions and territories to Mayne Pharma.

BIJUVA offers the convenience of a single-capsule combination of two hormones (estradiol and progesterone), which may improve a user’s compliance.

The estradiol and progesterone in BIJUVA are plant-based, not animal-sourced, and do not contain peanut oil unlike other FDA-approved progesterone products.

BIJUVA provides a sustained steady state of estradiol

which reduced the frequency and severity of hot flashes in clinical studies with no demonstrated impact on a patient’s weight or blood pressure.

Additionally, through clinical trials, BIJUVA has demonstrated endometrial safety and greater than 90% amenorrhea rates, while providing no clinically meaningful changes in mammograms, or in coagulation or lipid parameters, and while providing clinically meaningful improvements in quality of life and sleep disturbance.

In December 2021, the FDA approved the supplemental NDA for the 0.5 mg/100 mg dose of BIJUVA .

We previously granted licenses to commercialize the Company’s BIJUVA product outside of the United States to Theramex and Knight.

Estrogen (with or without a progestin) is most commonly used to treat VMS due to menopause that is a direct result of the decline in estrogen levels associated with ovarian shutdown at menopause.

Estrogen is a generic term for any substance, natural or synthetic, that exerts biological effects characteristic of estrogenic hormones, such as estradiol, a natural ovarian produced estrogen.

According to NAMS, the most effective treatment for VMS due to menopause is estrogen therapy.

Progestins are used in combination with estrogen in menopausal women with a uterus to avoid an increase in the incidence of endometrial hyperplasia, which is a condition caused by chronic use of estrogen alone by a woman with a uterus and is associated with an increased incidence of uterine, or endometrial, cancer.

Progestins include the naturally occurring hormone progesterone and several synthetic progestin compounds that have pregestational activity.

These agents are used for a variety of indications and conditions.

Progestins alone are also used to treat women with secondary amenorrhea to create withdrawal bleeding in these women who have not had regular menses.

Progestins are also used to treat dysfunctional uterine bleeding and endometriosis.

With the approval of BIJUVA, the FDA required a post-approval commitment to further develop and validate our in-vitro dissolution method to show how BIJUVA is released from the capsule in an in-vitro setting for quality control assessments.

The development of this method and validation were completed and submitted to the FDA as required in our approval.

Our hormone therapy pharmaceutical products are characterized by safety and efficacy profiles that can be consistently manufactured to target specifications.

This provides an alternative to the non-FDA approved compounded bio-identical market.

We believe that our FDA-approved pharmaceutical products offer advantages in terms of demonstrated safety and efficacy, consistency in the hormone dose, lower patient cost due to the increased likelihood of insurance coverage, and improved access as a result of availability from major retail pharmacy chains rather than custom order or formulation by individual compounders.

Our licensed 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 Prena1 name to Mayne Pharma.

License agreements

Mayne license agreement

Pursuant to the Mayne License Agreement, on the Closing Date the Company granted Mayne Pharma (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.

Upon the expiry of the 20-year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.

Pursuant to the Transaction Agreement, the Company sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including the Company’s exclusive license from the Population Council to commercialize ANNOVERA.

The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the 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 and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.

On the Closing Date, the Company and Mayne Pharma entered into the Mayne License Agreement Amendment.

Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay the Company approximately $1.0 million in prepaid royalties on the Closing Date.

The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $257,250 per quarterly royalty payment plus interest calculated at 19% per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.

Knight license agreement

Pursuant to the terms of the Knight License Agreement, Knight paid us $2.0 million in milestone fees upon the first regulatory approval in Canada for IMVEXXY and BIJUVA in 2020 and is required to pay us sales milestone fees based upon certain aggregate annual sales in Canada and Israel of each of IMVEXXY and BIJUVA and royalties based on aggregate annual sales of each of IMVEXXY and BIJUVA in Canada and Israel.

We may terminate the Knight License Agreement if Knight does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize IMVEXXY and BIJUVA in Canada within certain specified time periods.

We also may terminate the Knight License Agreement if Knight challenges our patents.

Either party may terminate the Knight License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.

As part of the Knight License Agreement, Knight is prohibited from exporting IMVEXXY and BIJUVA to the U.S.

Theramex license agreement

Under the terms of the Theramex License Agreement, Theramex paid us EUR 14 million, or $15.5 million, in cash as an upfront fee in August 2019.

Within thirty days of signing the Theramex License Agreement, we provided Theramex the regulatory materials and clinical data that were necessary for Theramex to obtain marketing authorizations and other applicable regulatory approvals for commercializing BIJUVA and IMVEXXY.

In 2019, at a point in time when Theramex was able to use and benefit from the license which was when the knowledge transfer of regulatory documents occurred, we recognized the revenue related to the upfront fee, which was a non-refundable payment.

In 2021, we received additional milestone payments comprised of an aggregate of EUR 1.0 million, or $1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets.

Additionally, in December 2021, we received EUR 0.5 million, or $0.6 million, in additional upfront payments for the license grants of IMVEXXY in Brazil and Mexico.

The additional upfront payment for the license grants of IMVEXXY in Brazil and Mexico may be returned to Theramex under certain conditions if IMVEXXY fails to obtain marketing authorization in one of Brazil or Mexico within a prespecified period.

We are eligible to receive additional sales milestone payments up to an aggregate of EUR 27.5 million in sales milestone payments to be paid in escalating tranches based on Theramex first attaining certain aggregate annual net sales milestones of BIJUVA and IMVEXXY outside of the U.S., excluding Canada and Israel (collectively the “Theramex Territory”), ranging from EUR 25 million to EUR 100 million.

We are also entitled to receive quarterly royalty payments at a rate of 5% on net sales of BIJUVA and IMVEXXY in the Theramex Territory.

Theramex is responsible for all regulatory and commercial activities for BIJUVA and IMVEXXY in the Theramex Territory.

Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Theramex Territory, except for certain specified markets.

We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods.

We also may terminate the Theramex License Agreement if Theramex challenges our patents.

Either party may terminate the Theramex License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.

On December 30, 2022, we assigned the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma.

The segesterone acetate component of ANNOVERA was classified by the FDA as a “new chemical entity,” or NCE, and thus ANNOVERA has five years of regulatory exclusivity under the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Act.

ANNOVERA is a one-year (13 cycles) ring-shaped contraceptive vaginal system, or CVS.

ANNOVERA, which is made with a silicone elastomer, contains segesterone acetate, a 19-nor progesterone derivative also known as Nestorone ® , or SA, and ethinyl estradiol, or EE.

EE is an approved active ingredient in many marketed hormonal contraceptive products.

Segesterone acetate, an NCE, is a potent progestin that, based on pharmacological studies in animals and in vitro , does not bind to the androgen or estrogen receptors and has no glucocorticoid activity at contraceptive doses.

SA has been evaluated in 51 clinical studies across these delivery systems with more than 26,794 cycles of exposure.

ANNOVERA can be inserted and removed by the woman herself without the aid of a healthcare provider and, unlike oral contraceptives, ANNOVERA does not require daily administration to obtain the contraceptive effect.

After 21 days of use, the woman removes ANNOVERA for seven days, thereby providing a regular bleeding pattern (i.e., withdrawal/scheduled bleeding).

The same CVS is then re-inserted for additional 21/7-days in/out, for up to a total of 13 cycles (one year).

ANNOVERA releases daily vaginal doses of both active ingredients (SA and EE).

The claimed release rate of 150 μg/day SA and 13 μg/day EE is supported by the calculated average release rate from an ex vivo analysis of ANNOVERA used for 13 cycles and is also supported by data from 13 cycles of in vitro release.

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.

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.

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

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

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.

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.

With the FDA approval of the supplemental NDA, we expect the third-party contract manufacturer will be able to supply sufficient ANNOVERA to better meet customer demand.

Our obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement.

We believe that ANNOVERA competes across all the contraception options for women, especially for those women seeking a long-lasting option without a procedure.

For patients, ANNOVERA provides a single, long-lasting, reversible birth control product that does not require a procedure at the doctor’s office for insertion or removal, empowering women to be in complete control of their fertility and menstruation with a 21/7 regimen.

We believe that ANNOVERA is a unique alternative for women who have previously chosen other forms of birth control.

These include nulliparous women (or women who have never given birth), women who are considering an IUD but would rather not have a procedure, women who are between pregnancies but desire protection without a long-term commitment, and women who are not satisfied with oral options due to the daily usage or potential side effects.

Based on prescription data from Symphony Health Solutions, the FDA-approved prescription market in the U.S.

for contraceptive products during 2021 amounted to more than 69 million prescriptions, generating $5.4 billion in gross sales.

Population Council license agreement

Under the terms of the Population Council License Agreement, we paid the Population Council a milestone payment of $20.0 million in 2018, which was within 30 days following the approval by the FDA of the NDA for ANNOVERA, and $20.0 million in 2019 following the first commercial batch release of ANNOVERA.

The aggregate $40.0 million of milestone payments were recorded as license rights and amortized over the remaining useful life over which the license rights contributed directly or indirectly to our cash flows.

On December 30, 2022, we assigned the ANNOVERA license to Mayne Pharma.

The rights and obligations under the Population Council License Agreement have been transferred to Mayne Pharma and will revert back to us upon certain events.

For additional information, see “Note 5.

License rights and other intangible assets” to the consolidated financial statements included in this 2022 10-K Report .

The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA, and we had agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $20.0 million, half of such excess was to be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement.

In July 2021, we received a letter from FDA indicating that the post-marketing commitment study being conducted by the Population Council for ANNOVERA to characterize the in vivo release rate of

ANNOVERA was not fulfilled to FDA’s satisfaction.

In addition, the final reports for the two post-marketing requirement studies being performed by the Population Council for ANNOVERA were not submitted by the initial listed submission deadline, which deadlines have since been extended by FDA.

Our obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement.

We believe, Mayne Pharma is working with Population Council to complete the post-marketing commitment study to FDA’s satisfaction and reduce the delay in submitting the post-marketing requirement final reports.

To the extent that the Population Council does not fulfil these studies to FDA’s satisfaction, FDA may impose additional requirements and penalties against the NDA holder for ANNOVERA.

Unless earlier terminated, the Population Council License Agreement will remain in effect until the later of the expiration of the last-to-expire of the Population Council’s U.S.

patents that are licensed to Mayne Pharma, or the date following such expiration that follows a continuous period of six months during which Mayne Pharma has not made a commercial sale of ANNOVERA in the U.S.

The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by Mayne Pharma on 180 days’ prior notice to the Population Council.

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.

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.

Revenue” to the consolidated financial statements included in this 2023 10-K Report.

Currently, the Company collects license revenue from 3 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.

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 has been transferred to Mayne Pharma.

Mayne Pharma sources third-party contract manufacturing organizations (“CMOs”), for the commercial supply of the Products.

The regulations for manufacturing of approved drug products are significantly more extensive than the standards for manufacturing supplements or drug product for early-stage clinical trials.

The CMOs are responsible for the manufacture of licensed products in accordance with the product specifications and applicable regulatory requirements.

There are long-term supply agreements with Catalent Pharma Solutions, LLC (“Catalent”) for the commercial supply of our IMVEXXY and BIJUVA, and Sever Pharma Solution (formerly QPharma AB), both of which have their establishments registered with FDA, for the supply of ANNOVERA.

If Mayne Pharma is unable to obtain sufficient quantities of drugs or receive raw materials in a timely manner, it could be required to delay its manufacturing and seek alternative manufacturers, which would be costly and time-consuming.

See also Item 1A.

Risk Factors – “Risks related to our business” for a discussion, among other things, of the extensive and costly governmental regulation we are subject to.

Risk Factors – “Risks related to our business” for a discussion, among other things, of

the extensive and costly governmental regulation we are subject to.

Pharmaceutical regulation

The process required by the FDA before a new drug product may be marketed in the U.S.

The process required by the FDA before a new

drug product may be marketed in the U.S.

generally involves the following:

completion of or reference to extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;

submission to the FDA of an investigational new drug (“IND”) application under which the holder may begin conducting human clinical trials, provided that the FDA does not object;

● completion of or reference to extensive preclinical laboratory

tests and preclinical animal studies, all performed in accordance with the FDA’s Good

Laboratory Practice, or GLP, regulations;

● submission to the FDA of an investigational new drug (“IND”)

application under which the holder may begin conducting human clinical trials, provided that

the FDA does not object;

the IND must be updated annually;

performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for each proposed indication;

submission to the FDA of an NDA after completion of all pivotal clinical trials.

An IND application is a request for authorization from the FDA to administer an investigational drug product to humans.

● performance of adequate and well-controlled human clinical trials

to establish the safety and efficacy of the drug candidate for each proposed indication;

● submission to the FDA of an NDA after completion of all pivotal

clinical trials.

An IND application is a request for authorization

from the FDA to administer an investigational drug product to humans.

Post-Approval Regulation

Mayne Pharma is required to comply with several post-approval requirements for our currently approved drug products.

Mayne Pharma is required to comply with several

post-approval requirements for our currently approved drug products.

We no longer have responsibility for any post-approval requirements.

As the holder of an approved NDA, Mayne Pharma is required to report, among other things, certain adverse reactions and production problems to the FDA, to provide updated safety and efficacy information, to adhere to product sampling and distribution requirements, fulfill post-marketing study commitments, and to comply with requirements concerning advertising and promotional labeling for any of our drug products, which include, among other things, standards for direct-to-consumer advertising, restrictions that prohibit promoting products for certain uses or in patient populations that are not described in the product’s approved indications or that are not otherwise consistent with the approved, FDA-required label (known as “off-label use”), limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.

Although physicians may prescribe legally available products for off-label use if they deem such use to be appropriate in their professional medical judgment, manufacturers may not market or promote such off-label uses.

Also, quality control and manufacturing procedures must continue to conform to cGMPs to ensure and preserve the long-term stability of the drug product.

cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.

Manufacturers and

other entities involved in the manufacture and distribution of approved products are, depending on the nature and scope of their activities, subject to FDA and certain state agency requirements relating to establishing and maintaining product quality.

Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented.

FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon us and any third-party manufacturers that we may decide to use.

Accordingly, manufacturers must continue to expend time, money and effort in production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

The FDA periodically inspects manufacturing facilities to assess compliance with cGMP, which imposes extensive procedural, substantive, and record keeping requirements.

For example, Catalent, the CMO that contracted for the commercial supply of the BIJUVA and IMVEXXY hormone therapy drug products, was issued a Form FDA 483 in 2019 with respect to its softgel manufacturing plant.

The observations and associated corrective actions related to the BIJUVA product was identified in Catalent’s response to the Form FDA 483.

The current inspection classification status of that Form FDA 483 is that the response was adequate and Voluntary Action Indicated.

Voluntary Action Indicated status indicates that objectionable conditions or practices were found but the FDA is not prepared to take or recommend any administrative or regulatory action.

Our licensees rely, and expect to continue to rely, on third parties to produce commercial quantities of our licensed drugs.

Future FDA and state inspections may identify compliance issues at the facilities of the manufacturers of our licensed products that may disrupt production or distribution or require substantial resources to correct.

In addition, discovery of previously unknown problems (for example, through adverse events observed in the post-marketing context, or in Phase 4 / post-marketing studies) with a product or the failure to comply with applicable requirements may result in restrictions on a product, manufacturer, or holder of an approved NDA, including withdrawal or recall of the product from the market or other voluntary, FDA-initiated or judicial action that could delay or prohibit further marketing.

Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and may require the implementation of other risk management measures.

Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products.

As the holder of an approved NDA, Mayne Pharma is required to report, among other things, certain adverse reactions and production problems

to the FDA, to provide updated safety and efficacy information, to adhere to product sampling and distribution requirements, fulfill

post-marketing study commitments, and to comply with requirements concerning advertising and promotional labeling for any of our drug

products, which include, among other things, standards for direct-to-consumer advertising, restrictions that prohibit promoting products

for certain uses or in patient populations that are not described in the product’s approved indications or that are not otherwise

consistent with the approved, FDA-required label (known as “off-label use”), limitations on industry-sponsored scientific

and educational activities, and requirements for promotional activities involving the internet.

Although physicians may prescribe legally

available products for off-label use if they deem such use to be appropriate in their professional medical judgment, manufacturers may

not market or promote such off-label uses.

Also, quality control and manufacturing procedures

must continue to conform to cGMPs to ensure and preserve the long-term stability of the drug product.

cGMP regulations require among

other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation

to investigate and correct any deviations from cGMP.

Manufacturers and other entities involved in the manufacture and distribution of

approved products are, depending on the nature and scope of their activities, subject to FDA and certain state agency requirements relating

to establishing and maintaining product quality.

Changes to the manufacturing process are strictly regulated, and, depending on the significance

of the change, may require prior FDA approval before being implemented.

FDA regulations also require investigation and correction of

any deviations from cGMP and impose reporting and documentation requirements upon us and any third-party manufacturers that we may decide

Accordingly, manufacturers must continue to expend time, money and effort in production and quality control to maintain compliance

with cGMP and other aspects of regulatory compliance.

The FDA periodically inspects manufacturing facilities to assess compliance

with cGMP, which imposes extensive procedural, substantive, and record keeping requirements.

For example, Catalent, the CMO that contracted

for the commercial supply of the BIJUVA and IMVEXXY hormone therapy drug products, was issued a Form FDA 483 in 2019 with respect to its

soft gel manufacturing plant.

The observations and associated corrective actions related to the BIJUVA product were identified in Catalent’s

response to the Form FDA 483.

The current inspection classification status of that Form FDA 483 is that the response was adequate and

Voluntary Action Indicated.

Voluntary Action Indicated status indicates that objectionable conditions or practices were found but the

FDA is not prepared to take or recommend any administrative or regulatory action.

Our licensees rely, and expect to continue to

rely, on third parties to produce commercial quantities of our licensed drugs.

Future FDA and state inspections may identify compliance

issues at the facilities of the manufacturers of our licensed products that may disrupt production or distribution or require substantial

resources to correct.

In addition, discovery of previously unknown problems (for example, through adverse events observed in the post-marketing

context, or in Phase 4/post-marketing studies) with a product or the failure to comply with applicable requirements may result in restrictions

on a product, manufacturer, or holder of an approved NDA, including withdrawal or recall of the product from the market or other voluntary,

FDA-initiated or judicial action that could delay or prohibit further marketing.

Newly discovered or developed safety or effectiveness

data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications, and may

require the implementation of other risk management measures.

Also, new government requirements, including those resulting from new legislation,

may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products.

Regulatory exclusivity

There are two types of NDAs available under Section 505(b) of the FDCA.

Section 505(b)(1) of the FDCA provides a marketing approval pathway that is known as the “traditional” or “full” NDA process.

Sponsors use 505(b)(1) applications to obtain marketing approval of a new drug with active ingredients that have not previously been approved by FDA.

The data package necessary for approval of this new drug requires demonstration of safety and efficacy based on adequate and well controlled human clinical trials conducted by or for the sponsor, without allowance for reference to third party data.

In contrast, Section 505(b)(2) of the FDCA provides a n alternative NDA process for approving a new drug that contains the same active ingredient as a previously approved product but allows sponsors to rely on clinical trials not conducted by or for the sponsor, as well as other clinical data or literature produced by other parties.

In addition, Section 505(j) of the FDCA provides for a significantly shortened regulatory pathway for approval of a “generic” version of a new drug, by way of an Abbreviated New Drug Application or ANDA.

Rather than demonstrating safety and effectiveness as required for an NDA, the ANDA requires proof that the generic drug is the “same” as or “bioequivalent” to the new drug under the standard of “bioequivalence,” often using pharmacokinetic, pharmacodynamic, and/or in vitro studies.

A Section 505(b) NDA applicant may be eligible for its own regulatory exclusivity period, such as a five-year or three-year exclusivity.

The first approved Section 505(b) NDA applicant for a drug containing an active ingredient that has not previously been approved in any other 505(b) NDA (a “new chemical entity,” or NCE), is eligible for a five-year NCE exclusivity period starting on the date of the NDA approval.

During this period, an Abbreviated New Drug Application (“ANDA”) or 505(b)(2) application for a drug containing the protected active ingredient of the NCE product generally cannot be submitted to FDA until the end of the five-year exclusivity period, except that such applications can be submitted at year four if the product is covered by an Orange Book listed patent and the ANDA or 505(b)(2) NDA includes a Paragraph IV Certification challenging such patent.

There are two types of NDAs available under

Section 505(b) of the FDCA.

Section 505(b)(1) of the FDCA provides a marketing approval pathway that is known as the “traditional”

or “full” NDA process.

Sponsors use 505(b)(1) applications to obtain marketing approval of a new drug with active ingredients

that have not previously been approved by FDA.

The data package necessary for approval of this new drug requires demonstration of safety

and efficacy based on adequate and well controlled human clinical trials conducted by or for the sponsor, without allowance for reference

to third party data.

In contrast, Section 505(b)(2) of the FDCA provides an alternative NDA process for approving a new drug that contains

the same active ingredient as a previously approved product but allows sponsors to rely on clinical trials not conducted by or for the

sponsor, as well as other clinical data or literature produced by other parties.

In addition, Section 505(j) of the FDCA provides for

a significantly shortened regulatory pathway for approval of a “generic” version of a new drug, by way of an Abbreviated

New Drug Application or ANDA.

Rather than demonstrating safety and effectiveness as required for an NDA, the ANDA requires proof that

the generic drug is the “same” as or “bioequivalent” to the new drug under the standard of “bioequivalence,”

often using pharmacokinetic, pharmacodynamic, and/or in vitro studies.

A Section 505(b) NDA applicant may be eligible

for its own regulatory exclusivity period, such as a five-year or three-year exclusivity.

The first approved Section 505(b) NDA applicant

for a drug containing an active ingredient that has not previously been approved in any other 505(b) NDA (a “new chemical entity,”

or NCE), is eligible for a five-year NCE exclusivity period starting on the date of the NDA approval.

An Abbreviated

New Drug Application (“ANDA”) or 505(b)(2) application for a drug containing the protected active ingredient of the NCE product

generally cannot be submitted to FDA until the end of the five-year exclusivity period, except that such applications can be submitted

at year four if the product is covered by an Orange Book listed patent and the ANDA or 505(b)(2) NDA includes a Paragraph IV Certification

challenging such patent.

Additional exclusivities may also apply.

The first approved Section 505(b) NDA applicant for a particular condition, or a supplemental NDA approval for a change to a marketed product, such as a new extended-release formulation for a previously approved product, may be eligible for a three-year Hatch-Waxman exclusivity if one or more new clinical studies, other than bioavailability or bioequivalence studies, was essential to the approval of the application and was conducted or sponsored by the applicant.

Should this occur, the FDA would be precluded from granting final approval to any ANDA or 505(b)(2) application for the same condition of use or change to the marketed product that was granted exclusivity until after that three-year exclusivity period has run.

Additionally, any ANDA or 505(b)(2) NDA that references the 505(b) product must include one of several types of patent certifications.

If the Section 505(b) NDA drug has one or more unexpired patents listed in the Orange Book, an ANDA or 505(b)(2) NDA must include either a “Paragraph III Certification” or a “Paragraph IV Certification.” A Paragraph III Certification identifies the expiration date of

the listed patent and requires FDA to withhold final approval until that patent has expired.

A “Paragraph IV Certification” states that, in the applicant’s opinion, the relevant patent is invalid, unenforceable, or would not be infringed by the commercial marketing of the proposed ANDA or 505(b)(2) NDA product.

The sponsor of a Paragraph IV ANDA or 505(b)(2) NDA must also provide the holder of the marketed product NDA, and the owner of the challenged patent, with notification of the Paragraph IV filing along with a detailed statement of the reasons the applicant believes the patent is invalid, unenforceable, or would not be infringed.

If the patent owner brings an infringement action against the Paragraph IV applicant within 45 days of the notification, a statutory stay is imposed which prevents FDA from granting final approval of the Paragraph IV application for 30 months from the date of the Paragraph IV Notification.

Generally, no more than one 30-month stay may be applied against any specific Paragraph IV ANDA or 505(b)(2) NDA.

A 30-month stay can be terminated early, and the Paragraph IV application can be immediately approved, if the district court rules in favor of the Paragraph IV applicant that the patent is invalid, unenforceable, or would not be infringed.

In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an ANDA submitted to FDA by Teva Pharmaceuticals USA, Inc.

See Legal Proceedings in Item 3 of this 2022 10-K Report for additional information.

In March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (“Amneal”).

The first approved Section 505(b) NDA applicant

for a particular condition, or a supplemental NDA approval for a change to a marketed product, such as a new extended-release formulation

for a previously approved product, may be eligible for a three-year Hatch-Waxman exclusivity if one or more new clinical studies, other

than bioavailability or bioequivalence studies, was essential to the approval of the application and was conducted or sponsored by the

Should this occur, the FDA would be precluded from granting final approval to any ANDA or 505(b)(2) application for the same

condition of use or change to the marketed product that was granted exclusivity until after that three-year exclusivity period has run.

Additionally, any ANDA or 505(b)(2) NDA that

references the 505(b) product must include one of several types of patent certifications.

If the Section 505(b) NDA drug has one or more

unexpired patents listed in the Orange Book, an ANDA or 505(b)(2) NDA must include either a “Paragraph III Certification”

or a “Paragraph IV Certification.” A Paragraph III Certification identifies the expiration date of the listed patent and

requires FDA to withhold final approval until that patent has expired.

A “Paragraph IV Certification” states that, in the

applicant’s opinion, the relevant patent is invalid, unenforceable, or would not be infringed by the commercial marketing of the

proposed ANDA or 505(b)(2) NDA product.

The sponsor of a Paragraph IV ANDA or 505(b)(2) NDA must also provide the holder of the marketed

product NDA, and the owner of the challenged patent, with notification of the Paragraph IV filing along with a detailed statement of

the reasons the applicant believes the patent is invalid, unenforceable, or would not be infringed.

If the patent owner brings an infringement

action against the Paragraph IV applicant within 45 days of the notification, a statutory stay is imposed which prevents FDA from granting

final approval of the Paragraph IV application for 30 months from the date of the Paragraph IV Notification.

Generally, no more than

one 30-month stay may be applied against any specific Paragraph IV ANDA or 505(b)(2) NDA.

A 30-month stay can be terminated early, and

the Paragraph IV application can be immediately approved, if the district court rules in favor of the Paragraph IV applicant that the

patent is invalid, unenforceable, or would not be infringed.

In February 2020, we received a Paragraph IV certification notice letter

(the “IMVEXXY Notice Letter”) regarding an ANDA submitted to FDA by Teva Pharmaceuticals USA, Inc.

Legal Proceedings in Item 3 of this 2023 10-K Report for additional information.

In March 2020, we received a Paragraph IV certification

notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (“Amneal”).

In April 2020, we filed a complaint for patent infringement against Amneal in the U.S.

District Court for the District of New Jersey arising from Amneal’s ANDA filing with FDA.

In December 2021, we entered into a settlement agreement (the “Settlement Agreement”) with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York LLC (collectively “Amneal”) to resolve the litigation over our patents listed in FDA’s Orange Book that claim compositions and methods of BIJUVA (the “BIJUVA Patents”).

Under the terms of the Settlement Agreement, the Company granted Amneal a non-exclusive, non-transferable, royalty-free license to commercialize Amneal’s generic formulation of BIJUVA in the U.S.

commencing in May 2032 (180 days before the current expiration date in November 2032 for the last to expire of our BIJUVA Patents), or earlier under certain circumstances customary for settlement agreements of this nature.

healthcare laws and compliance requirements

Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights, among other topics, are and will be applicable to our business.

Our licensees and the licensed products are subject to regulation by both the federal government and the states in which we or our partners conduct our business.

The healthcare laws and regulations that may affect our licensees’ ability to operate and our ability to receive licensing revenues include:

the federal Anti-Kickback Statute, which prohibits, among other things, any person or entity from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce either the referral of an individual or in return for the purchase, lease, or order of, or the arranging for, any good, facility item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as the Medicare and Medicaid programs;

federal civil and criminal false claims laws and civil monetary penalty laws, including, for example, the federal civil False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

the federal physician sunshine requirements under the ACA, which require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare or Medicaid to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value provided to physicians and teaching hospitals,

and ownership and investment interests held by physicians and their immediate family members.

In 2022, the Sunshine Act has been extended to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners (with reporting requirements going into effect in 2022 for payments made in 2021).

In addition, Section 6004 of the ACA requires annual reporting of information about drug samples that manufacturers and authorized distributors provide to healthcare providers;

federal and state laws requiring pricing transparency or limiting price increases, which are in existence today or are anticipated to be in existence in the near future, may limit the ability to raise prices, require disclosure of price increases or require disclosure of the wholesale acquisition cost of pharmaceutical products to governmental agencies and consumers;

state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers or even self-pay;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be provided to healthcare providers and other potential referral sources;

state laws that require drug manufacturers to report information related to payments and other transfers of value to healthcare providers or marketing expenditures;

state laws requiring a license, registration or permit to engage in manufacturing and distribution of prescription products or to engage in the practice of pharmacy;

and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Pharmaceutical company interactions with HCPs, patient advocacy groups, and patients, including with respect to product and patient assistance programs and other education and support initiatives, have been and continue to be, the subject of regulatory scrutiny for compliance with fraud and abuse laws.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of the business activities of the entities with whom we do business could be subject to challenge under one or more of such laws.

Efforts to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations could be costly.

If our past operations, including activities conducted by our sales team or agents, are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal, and administrative penalties, damages, fines, exclusion from third-party payer programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.

If any of the HCPs, providers, or entities with whom we do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including exclusion from government funded healthcare programs.

Many aspects of these laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations that increases the risk of potential violations.

District Court for the District of New Jersey

arising from Amneal’s ANDA filing with FDA.

In December 2021, we entered into a settlement agreement (the “Settlement Agreement”)

with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York LLC (collectively “Amneal”)

to resolve the litigation over our patents listed in FDA’s Orange Book that claim compositions and methods of BIJUVA (the “BIJUVA

Under the terms of the Settlement Agreement, the Company granted Amneal a non-exclusive, non-transferable, royalty-free

license to commercialize Amneal’s generic formulation of BIJUVA in the U.S.

commencing in May 2032 (180 days before the current

expiration date in November 2032 for the last to expire of our BIJUVA Patents), or earlier under certain circumstances customary for

settlement agreements of this nature.

healthcare laws and compliance

Certain federal and state healthcare laws and

regulations pertaining to fraud and abuse and patients’ rights, among other topics, are and will be applicable to our business.

Our licensees and the licensed products are subject to regulation by both the federal government and the states in which we or our partners

conduct our business.

The healthcare laws and regulations that may affect our licensees’ ability to operate and our ability to

receive licensing revenues include:

● the federal Anti-Kickback Statute, which prohibits, among other

things, any person or entity from knowingly and willfully offering, soliciting, receiving

or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly,

overtly or covertly, in cash or in kind, to induce either the referral of an individual or

in return for the purchase, lease, or order of, or the arranging for, any good, facility

item or service, for which payment may be made, in whole or in part, under federal healthcare

programs such as the Medicare and Medicaid programs;

● federal civil and criminal false claims laws and civil monetary

penalty laws, including, for example, the federal civil False Claims Act, which impose criminal

and civil penalties, including civil whistleblower or qui tam actions, against individuals

or entities for, among other things, knowingly presenting, or causing to be presented, to

the federal government, including the Medicare and Medicaid programs, claims for payment

that are false or fraudulent or making a false statement to avoid, decrease or conceal an

obligation to pay money to the federal government;

● the federal Health Insurance Portability and Accountability Act

of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit

knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare

benefit program or obtain, by means of false or fraudulent pretenses, representations or

promises, any of the money or property owned by, or under the custody or control of, any

healthcare benefit program, regardless of the payer (e.g., public or private), knowingly

and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing

a criminal investigation of a healthcare offense and knowingly and willfully falsifying,

concealing or covering up by any trick or device a material fact or making any materially

false statements in connection with the delivery of, or payment for, healthcare benefits,

items or services relating to healthcare matters;

● HIPAA, as amended by the Health Information Technology for Economic

and Clinical Health Act, and their implementing regulations, which impose obligations on

covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses,

as well as their respective business associates that create, receive, maintain or transmit

individually identifiable health information for or on behalf of a covered entity, with respect

to safeguarding the privacy, security and transmission of individually identifiable health

● the federal physician sunshine requirements under the ACA, which

require certain manufacturers of drugs, devices, biologics and medical supplies for which

payment is available under Medicare or Medicaid to report annually to the Centers for Medicare

& Medicaid Services information related to payments and other transfers of value provided

to physicians and teaching hospitals, and ownership and investment interests held by physicians

and their immediate family members.

In 2022, the Sunshine Act has been extended to payments

and transfers of value to physician assistants, nurse practitioners, and other mid-level

practitioners (with reporting requirements going into effect in 2022 for payments made in

In addition, Section 6004 of the ACA requires annual reporting of information about

drug samples that manufacturers and authorized distributors provide to healthcare providers;

● federal and state laws requiring pricing transparency or limiting

price increases, which are in existence today or are anticipated to be in existence in the

near future, may limit the ability to raise prices, require disclosure of price increases

or require disclosure of the wholesale acquisition cost of pharmaceutical products to governmental

agencies and consumers;

● state law equivalents of each of the above federal laws, such

as anti-kickback and false claims laws, which may apply to items or services reimbursed by

any third-party payer, including commercial insurers or even self-pay;

state laws that require

pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance

guidelines and the applicable compliance guidance promulgated by the federal government,

or otherwise restrict payments that may be provided to healthcare providers and other potential

referral sources;

state laws that require drug manufacturers to report information related

to payments and other transfers of value to healthcare providers or marketing expenditures;

state laws requiring a license, registration or permit to engage in manufacturing and distribution

of prescription products or to engage in the practice of pharmacy;

and state laws governing

the privacy and security of health information in certain circumstances, many of which differ

from each other in significant ways and may not have the same effect, thus complicating compliance

Pharmaceutical company interactions with HCPs,

patient advocacy groups, and patients, including with respect to product and patient assistance programs and other education and support

initiatives, have been and continue to be, the subject of regulatory scrutiny for compliance with fraud and abuse laws.

Because of the breadth of these laws and the

narrowness of the statutory exceptions and safe harbors available, it is possible that some of the business activities of the entities

with whom we do business could be subject to challenge under one or more of such laws.

Efforts to ensure that our business arrangements

with third parties comply with applicable healthcare laws and regulations could be costly.

If our past operations, including activities

conducted by our sales team or agents, are found to be in violation of any of these laws or any other governmental regulations that may

apply to us, we may be subject to significant civil, criminal, and administrative penalties, damages, fines, exclusion from third-party

payer programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.

If any of the HCPs, providers,

or entities with whom we do business are found to not be in compliance with applicable laws, they may be subject to criminal, civil,

or administrative sanctions, including exclusion from government funded healthcare programs.

Many aspects of these laws have not been definitively

interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations that

increases the risk of potential violations.

In addition, these laws and their interpretations are subject to change.

Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business, and damage our reputation.

In addition to the fraud and abuse laws, we continue to monitor the potential impact of proposals to lower prescription drug costs at the federal and state level.

For example, in November 2021, the Biden Administration announced several prescription drug pricing proposals as part of the Build Back Better legislation.

In particular, the plan would allow for Medicare to negotiate prices for high-cost prescription drugs, including for both Part D and Part B drugs, after the drugs have been on the market for a fixed number of years:

9 years for small molecule drugs and 12 years for biologics.

Medicare will negotiate up to 10 drugs per year during 2023, with the negotiated prices taking effect in 2025, increasing up to 20 drugs per year.

Any action against

us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert

our management’s attention from the operation of our business, and damage our reputation.

In addition to the fraud and abuse laws, we

continue to monitor the potential impact of proposals to lower prescription drug costs at the federal and state level.

For example, in

November 2021, the Biden Administration announced several prescription drug pricing proposals as part of the Build Back Better legislation.

In particular, the plan would allow for Medicare to negotiate prices for high-cost prescription drugs, including for both Part D and

Part B drugs, after the drugs have been on the market for a fixed number of years:

9 years for small molecule drugs and 12 years for

Medicare will negotiate up to 10 drugs per year during 2023, with the negotiated prices taking effect in 2025, increasing

up to 20 drugs per year.

Further, the plan imposes a tax penalty if drug manufacturers increase their prices faster than inflation.

Finally, the plan places a $2,000 per year cap on out-of-pocket drug costs under Medicare Part D.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

We are unable to predict the future course of federal or state healthcare legislation in the U.S.

the plan places a $2,000 per year cap on out-of-pocket drug costs under Medicare Part D.

At the state level, legislatures have increasingly

passed legislation and implemented regulations designed to control pharmaceutical pricing, including price or patient reimbursement constraints,

discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed

to encourage importation from other countries and bulk purchasing.

We are unable to predict the future course of federal or state healthcare

legislation in the U.S.

directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.

In addition, from time to time in the future, our licensees and the licensed products may become subject to additional laws or regulations administered by the FDA, the FTC, U.S.

Department of Health and Human Services (“HHS”), or by other federal, state, local, or foreign regulatory authorities, or the repeal of laws or regulations that we generally consider favorable, such as DSHEA, or to more stringent interpretations of current laws or regulations.

We are not able to predict the nature of such future laws, regulations, repeals, or interpretations, and we cannot predict what effect additional governmental regulation, if and when it occurs, would have on our business in the future.

Such developments could, however, require reformulation of certain products to meet new standards, recalls or discontinuance of certain products not able to be reformulated, additional record-keeping requirements, increased documentation of the

properties of certain products, additional or different labeling, additional scientific substantiation, additional personnel, or other new requirements.

Any such developments could have a material adverse effect on our business.

In connection with the Company’s 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.

As of December 31, 2022, we employed one full-time employee primarily engaged in an executive position.

None of our employees are covered by a collective bargaining agreement, and we are unaware of any union organizing efforts.

We have never experienced a major work stoppage, strike, or dispute.

We consider our relationship with our employees to be good.

In addition, from time to time in the future,

our licensees and the licensed products may become subject to additional laws or regulations administered by the FDA, the FTC, U.S.

of Health and Human Services (“HHS”), or by other federal, state, local, or foreign regulatory authorities, or the repeal

of laws or regulations that we generally consider favorable, such as DSHEA, or to more stringent interpretations of current laws or regulations.

We are not able to predict the nature of such future laws, regulations, repeals, or interpretations, and we cannot predict what effect

additional governmental regulation, if and when it occurs, would have on our business in the future.

Such developments could, however,

require reformulation of certain products to meet new standards, recalls or discontinuance of certain products not able to be reformulated,

additional record-keeping requirements, increased documentation of the properties of certain products, additional or different labeling,

additional scientific substantiation, additional personnel, or other new requirements.

Any such developments could have a material adverse

effect on our business.

Available information

We are a Nevada corporation, and we maintain our principal executive offices at 951 Yamato Road, Suite 220, Boca Raton, Florida 33431.

We are a Nevada corporation, and we maintain

our principal executive offices at 951 Yamato Road, Suite 220, Boca Raton, Florida 33431.

Our telephone number is (561) 961-1900.

We maintain a corporate website at www.therapeuticsmd.com as well as various product websites.

The information contained on our websites or that can be accessed through our websites is not incorporated by reference into this 2022 10-K Report or in any other report or document we file with the SEC.

maintain a corporate website at www.therapeuticsmd.com.

The information contained on our website or that can be accessed through our

website is not incorporated by reference into this 2023 10-K Report or in any other report or document we file with the SEC.

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-K

Item 1. Business