TXMD US Equity☆

Item 1A. Risk factors 11

Item 1B. Unresolved staff comments 37

Item 1C. Cybersecurity 37

Item 2. Properties 38

Item 3. Legal proceedings 39

Item 4. Mine safety disclosures 39

Part II

Item 6. Reserved 40

Item 7A. Quantitative and qualitative disclosures about market risk 49

Item 8. Financial statements and supplementary data 49

Item 9A. Controls and procedures 50

Item 9B. Other information 50

Item 9C. Disclosure regarding foreign jurisdictions that prevent inspections 50

Part III

Item 10. Directors, executive officers and corporate governance 51

Item 11. Executive compensation 51

Item 14. Principal accountant fees and services 51

Part IV

Item 15. Exhibits and financial statement schedules 52

i

Part

I

Item

1. Business

Overview

Throughout

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

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

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

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

TherapeuticsMD

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

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

which are protected under applicable intellectual property laws and are the property of the Company. This 2024 10-K Report also contains

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

trademarks, trade names and service marks referred to in this 2024 10-K Report may appear without the ®, TM 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 2024 10-K Report includes market and industry data that we obtained from periodic industry publications, third-party studies and

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

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

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

a result of a variety of matters.

Forward-looking

statements

This 2024

10-K Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking

statements involve substantial risks and uncertainties. For example, statements regarding our operations, financial position, business

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

and sales are all forward-looking statements. These statements may be found in the items of this 2024 10-K Report entitled “Business”

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

10-K Report generally. These statements are generally accompanied by words such as “intend,” “anticipate,” “believe,”

“estimate,” “potential(ly),” “continue,” “forecast,” “predict,” “plan,”

“may,” “will,” “could,” “would,” “should,” “expect,” or the negative

of such terms or other comparable terminology.

We have based

these forward-looking statements on our current expectations and projections about future events. We believe that the assumptions and

expectations reflected in such forward-looking statements are reasonable, based on information available to us on the date of this 2024

10-K Report, but we cannot assure you that these assumptions and expectations will prove to have been correct or that we will take any

action that we may presently be planning. These forward-looking statements are inherently subject to known and unknown risks and uncertainties.

Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. 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 2024 10-K Report. This discussion should be read in conjunction with

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

1

We have identified

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

10-K Report in the section entitled “Risk Factors” that you should review carefully. Please consider our forward-looking

statements in light of those risks as you read this 2024 10-K Report. If one or more of these or other risks or uncertainties materialize,

or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we project. We do not undertake

to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information

or future events or developments.

Our company

TherapeuticsMD

was previously a women’s healthcare company with a mission of creating and commercializing innovative products to support the

lifespan of women from pregnancy prevention through menopause. In December 2022, we changed our business to become a pharmaceutical

royalty company, currently receiving royalties on products licensed to pharmaceutical organizations that possess commercial

capabilities in the relevant territories. On December 30, 2022 (the “Closing Date”), we completed a transaction (the

“Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and

subsidiary of Mayne Pharma Group Limited, an Australian public company (“Mayne Pharma Group”), in which we and our subsidiaries (i) granted Mayne Pharma

an exclusive license to commercialize 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.

2

On the Closing

Date, TherapeuticsMD and Mayne Pharma entered into Amendment No. 1 to the Mayne License Agreement (the “Mayne License Agreement

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

royalties on the Closing Date. The prepaid royalties reduced the first four quarterly payments that would have otherwise been payable

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

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

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

minimum payment obligations thereunder. As the parties agreed, Mayne Pharma reduced the second quarterly royalty payment otherwise payable

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

As part of

the transformation that included the Mayne License Agreement, all results associated with former commercial operations have been reflected

as discontinued operations in our consolidated financial statements. Assets and liabilities associated with the commercial business are

classified as assets and liabilities of discontinued operations in our consolidated balance sheets.

See “Note 2 - Discontinued Operations” to the 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.

Employees

As of December 31, 2024, we employed

one full-time employee primarily engaged in an executive position. We have engaged external consultants who support our relationship

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

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

Ziegler serves as our Principal Financial and Accounting Officer.

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.

3

To the extent

that we raise additional capital through the sale of such securities, the ownership interests of our existing stockholders will be diluted,

and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders.

If we are not successful in obtaining additional financing, we could be forced to discontinue or curtail our business operations, sell

assets at unfavorable prices, or merge, consolidate, or combine with a company with greater financial resources in a transaction that

might be unfavorable to us.

On May 1,

2023, we entered into a Subscription Agreement (the “Subscription Agreement”) with Rubric Capital Management LP (“Rubric”),

pursuant to which we agreed to sell to Rubric, or one or more of its affiliates, up to an aggregate of 5,000,000 shares of our common

stock, par value $0.001 per share (our “Common Stock”), from time to time during the term of the Subscription Agreement 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 to $2.2761.

We received gross proceeds of $2.0 million from the drawdown, before expenses. There were no draw downs in 2024.

In February

2024, the Company received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale distributor

fees pursuant to the Transaction Agreement, which differed significantly from the Company’s estimate of the allowances. The Company

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

this matter through the processes permitted in the Transaction Agreement. The outcome of this matter is uncertain at this point. As a

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

associated with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company

believes the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.

In August

2024, the Company received information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly

from the Company’s estimate of the allowance. As of December 31, 2024, the Company believed no additional accrual was required

for amounts that may be owed for the allowance for returns under the Transaction Agreement. The Company has not recorded any contingent

gains or receivables for any such allowances. Management continues to monitor the unresolved and pending net working capital items as

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

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

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

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

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

our existing cash reserves may be insufficient to satisfy our liquidity requirements. The potential impact of these factors in conjunction

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

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

The

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

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

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.

4

IMVEXXY

(estradiol vaginal inserts), 4-μg and 10-μg

This pharmaceutical

product is for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and

vaginal atrophy due to menopause. As part of the FDA’s approval of IMVEXXY, we committed to conduct a post-approval observational

study to evaluate the risk of endometrial cancer in post-menopausal women with a uterus who use a low-dose vaginal estrogen unopposed

by a progestogen.

On December

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

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

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

and Israel. We entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex an exclusive license to

commercialize IMVEXXY for human use outside of the U.S., except for Canada and Israel. In December 2024, we transferred the right to

commercialize IMVEXXY in Israel from Knight to Theramex.

The FDA has

also asked the sponsors of other vaginal estrogen products to participate in the observational study. In connection with the observational

study, we would have been required to provide progress reports to the FDA on an annual basis. The obligation to conduct this study was

transferred to Mayne Pharma as part of the Mayne License Agreement.

BIJUVA

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

This pharmaceutical

product is the first and only FDA approved bioidentical hormone therapy combination of estradiol and progesterone in a single, oral capsule

for the treatment of moderate-to-severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with

a uterus.

On December

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

We also have entered into the Knight License Agreement with Knight pursuant to which we granted Knight an exclusive license to commercialize

BIJUVA in Canada and Israel. We have entered into the Theramex License Agreement with Theramex pursuant to which we granted Theramex

an exclusive license to commercialize BIJUVA for human use outside of the U.S., except for Canada and Israel. In December 2024, we transferred

the right to commercialize BIJUVA in Israel from Knight to Theramex.

ANNOVERA

(segesterone acetate (“SA”) and ethinyl estradiol (“EE”) vaginal system)

This pharmaceutical

product is a one-year ring-shaped contraceptive vaginal system (“CVS”) and the first and only patient-controlled, procedure-free,

reversible prescription contraceptive that can prevent pregnancy for up to a total of 13 cycles (one year).

On

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

to Mayne Pharma.

Prenatal

vitamin products

On December

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

prenatal vitamin product lines under our vitaMedMD brand name and authorized generic formulations of some of our prescription prenatal

vitamin products under our BocaGreenMD prenatal name to Mayne Pharma.

5

Sales

concentration

Our business

model is dependent on third parties achieving specified milestones and product sales. For information on the concentration of licenses

of our products, see “Note 9. Revenue” to the consolidated financial statements included in this 2024 10-K Report. Currently,

the Company collects license revenue from two licensees.

Seasonality

The pharmaceutical

markets in which we license our products are not subject to seasonal sales fluctuations. However, our license revenues for the first

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

Manufacturing

of our licensed products

As of December

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

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

Research

and development

As of December

30, 2022, we no longer conduct any research and development activities. Historically, our product development programs were concentrated

in advanced hormone therapy pharmaceutical products.

Intellectual

property

Patents

and trademarks

Our success

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

rights of others. Our intellectual property portfolio is one way we attempt to protect our competitive position. We rely primarily on

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

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

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

As of December

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

are Orange Book listed for the licensed products.

We hold multiple

U.S. trademark registrations and have numerous pending trademark applications. Issuance of a federally registered trademark creates a

rebuttable presumption of ownership of the mark; however, it is subject to challenge by others claiming first use in the mark in some

or all the areas in which it is used. Federally registered trademarks have a perpetual life so long as they are maintained and renewed

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

claim priority or confusion of usage. We believe our patents and trademarks are valuable and provide us certain benefits in marketing

our products.

We intend

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

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

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

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

property rights can be expensive and time consuming, even if the outcome is favorable to us. It is possible that the patents issued or

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

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

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

property and challenges to that intellectual property.

While we

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

for a competitor to avoid infringement claims. In addition, patents expire, and we cannot provide any assurance that any patents will

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

6

Mayne Pharma

licensed US patents and trademarks for our commercial products. Under the terms of the Mayne License Agreement, Mayne Pharma exclusively

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

Government

regulation

In the U.S.,

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

Act (“FDCA”) and its implementing regulations. These products are also subject to other federal, state, and local statutes

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

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

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

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

and deceptive acts and trade practices. 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.

Pharmaceutical

regulation

The process

required by the FDA before a new drug product may be marketed in the U.S. generally involves the following:

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. 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.

7

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.

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 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 (“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 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.

8

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. (“Teva”). See

“Legal Proceedings” in Item 3 of this 2024 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.

Other

U.S. 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:

9

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.

10

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 change prescription drug costs at the federal

and state level. 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.

Available

information

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. The information contained on our website or that

can be accessed through our website is not incorporated by reference into this 2024 10-K Report or in any other report or document we

file with the SEC.

Item

1A. Risk factors

Investing

in our common stock involves a high degree of risk. You should carefully consider the following risk factors, together with all of the

information included in this 2024 10-K Report and our other filings with the SEC, before you decide to purchase shares of our common

stock. We believe the risks and uncertainties described below are the most significant we face. Additional risks and uncertainties of

which we are unaware, or that we currently deem immaterial, also may become important factors that affect us. If any of the following

risks occur, our business, financial condition, or results of operations could be materially and adversely affected. In that case, the

trading price of our common stock could decline, and you may lose all or part of your investment.

Our

business is subject to a number of risks and uncertainties. The following is a summary of the principal risk factors described in this

section:

● There is substantial doubt about our ability to continue as a going concern.

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● We could be affected by transitions in our senior management team.

● Our products and our licensees are subject to extensive government regulation.

● Our success is tied to the distribution channels of our licensees.

12

Risks

related to our business

We

currently derive all revenue from royalties related to sales of our licensed women’s healthcare products, and the failure of our

licensees to maintain or increase sales of these products could have an adverse effect on our business, financial condition, results

of operations, and growth prospects.

Following

the Mayne Transaction, we derive all revenue from royalties related to sales of our women’s healthcare products, including patient-controlled,

long-acting contraceptive, hormone therapy pharmaceutical products, prenatal and women’s multi-vitamins, and iron supplements.

We cannot assure you that our licensees will be able to sustain such sales or that such sales will grow. In addition to other risks described

herein, the ability of our licensees to maintain or increase existing product sales is subject to several risks and uncertainties, including

the following:

● changed or increased regulatory restrictions or regulatory actions by the FDA;

● acceptance of our products as safe and effective by physicians and patients.

If

revenue from royalties related to sales of our products does not increase, we may be required to seek to raise additional funds, which

could have an adverse effect on our business, financial condition, results of operations, and growth prospects. In addition, our revenue

from royalties is based on information compiled by, and received from, our licensees. If the sales information provided by our licensees

is erroneous, it could have an adverse effect on our business, financial condition and results of operations.

We

have incurred net losses in the past and there are no assurances we will be able to maintain or increase profitability in the future.

In the past, we have incurred recurring net losses, including net losses

of $2.2 million and $10.3 million for 2024 and 2023, respectively. In 2022, we recognized net income of $112.0 million due to the net

proceeds from the Mayne Transaction and divestiture of our former subsidiary vitaCare Prescription Services, Inc. (“vitaCare”)

exceeding our costs and expenses. We utilized most of the net proceeds to repay borrowings and redeem our preferred stock. As of December

31, 2024, our stockholders’ equity was $27.4 million. We have funded our operations to date primarily through revenue from licensed

royalties, public offerings of our common stock and private placements of equity and debt securities and the transactions with Mayne Pharma.

We may incur substantial additional losses over the next few years because of costs associated with the wind down of our historical business

as well as the ongoing costs of being a public company. As a result, we may not maintain or increase profitability. If we continue to

incur substantial losses, because the royalties of our products are insufficient or otherwise, and are unable to secure additional financing,

we could be forced to discontinue or curtail our business operations, merge, consolidate, or combine with a company with greater financial

resources in a transaction that might be unfavorable to us.

There is substantial doubt about our ability to continue as a

going concern.

Our current liquidity position raises substantial doubt about our ability

to continue as a going concern and Berkowitz Pollack Brant, Advisors + CPAs, LLP, our independent registered public accounting firm for

the fiscal year ended December 31, 2024, has included an explanatory paragraph in their opinion that accompanies our audited consolidated

financial statements as of and for the year ended December 31, 2024, indicating such. If Mayne Pharma’s sales of IMVEXXY, BIJUVA,

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

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

unsuccessful with future financings or if 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. Our ability to continue as a going concern may depend

on our ability to obtain additional capital as well as our ability to minimize operational expenses, including any potential net working

capital adjustments relating to the Mayne Transaction. As substantial doubt about our ability to continue as a going concern exists, our

ability to finance our operations through the sale and issuance of debt or equity securities or through bank or other financing could

be impaired. Our ability to obtain financing on reasonable terms is subject to factors beyond the Company’s control, including general

economic, political, and financial market conditions. The capital markets have in the past experienced, are currently experiencing, and

may in the future experience, periods of upheaval that could impact the availability and cost of equity and debt financing and there can

be no assurance that such financing will be available on terms commercially acceptable to the Company, or at all. If we sell equity securities,

convertible securities or other securities current investors may be materially diluted by subsequent sales. If we are unable to improve

our liquidity position, we may not be able to continue as a going concern.

13

We

have experienced significant turnover in our top executives, and our business could be adversely affected by these and other transitions

in our senior management team.

We have experienced

turnover in our top executives and the replacement of these positions with new officers. In December 2022, following the Mayne Transaction,

all our top executives, except for our former General Counsel, were terminated, and our former General Counsel was appointed as Chief

Executive Officer. In August 2023, our former Principal Financial and Accounting Officer resigned and was replaced with a new Principal

Financial and Accounting Officer.

Management

transition is often difficult and inherently causes some loss of institutional knowledge, which could negatively affect the results of

operations and financial condition. Our ability to execute our business strategies may be adversely affected by the uncertainty associated

with these transitions and the time and attention of the board and management dedicated to management transitions could disrupt our business.

Further, we cannot guarantee that we will not face similar turnover in the future. Although we generally enter into employment agreements

with our executives, our executive officers may terminate their employment relationship with us at any time, and we cannot ensure that

we will be able to retain the services of any of them. Our senior management’s knowledge of our business and industry could be

difficult to replace, and management turnover could negatively affect our business, growth, financial conditions, results of operations

and cash flows.

We

currently depend on the services of Marlan D. Walker as our Chief Executive Officer and sole employee. Should we lose Mr. Walker due

to death, disability, retirement or otherwise, such loss could adversely affect our business, management and operations.

Marlan

Walker is presently our sole employee and we are therefore dependent upon Mr. Walker, who works for us as an at will employee. Mr. Walker

may terminate his employment with us at any time and we cannot guarantee that we would be able to hire a similarly qualified executive

if he should choose to leave. We do not currently maintain key person life insurance on Mr. Walker. Any change in Mr. Walker's involvement

with our Company may negatively affect our business, management and operations. The loss of his services could be detrimental to the

business and could force us to no longer operate. Our future success could depend in part on our ability to retain Mr. Walker.

Our

dependence upon third parties for the manufacture and supply of our existing women’s healthcare products may cause delays in or

prevent our licensees from successfully commercializing and marketing our products.

We do not

currently have, nor do we currently plan to build or acquire, the infrastructure or capability to internally manufacture our existing

women’s healthcare products, IMVEXXY, BIJUVA, and ANNOVERA. We have relied, and will continue to rely, on third parties to manufacture

these products in accordance with specifications and in compliance with applicable regulatory requirements, including the FDA’s

current Good Manufacturing Practice (“cGMPs”). We entered into long-term supply agreements with Catalent Pharma Solutions,

LLC for the commercial supply of IMVEXXY and BIJUVA which have been assigned to Mayne Pharma. We also entered into a long-term supply

contract with QPharma AB, now known as Sever Pharma Solutions, for ANNOVERA, which contract was also assigned to Mayne Pharma. We depended

on Lang, a full-service, private label and corporate brand manufacturer, to supply our vitaMedMD and BocaGreen products. We do not have

long-term contracts for the commercial supply of our vitaMedMD and BocaGreen products. We believe that our licensees evolved these relationships

based on the products they licensed from us. We continue to provide support for the third-party manufacturers and our licensees as needed.

Regulatory

requirements could pose barriers to the manufacture of our women’s healthcare products. All of our existing products are manufactured

by third-party contract manufacturing organizations (“CMOs”). These CMOs are required to manufacture our products in compliance

with the applicable regulatory requirements. The CMO that manufactures IMVEXXY and BIJUVA has previously been inspected by the FDA and

received Form 483 observations with respect to its softgel manufacturing plant that is used for the manufacture of the commercial supply

of IMVEXXY and BIJUVA. The CMO that manufactures ANNOVERA has previously been inspected by the FDA and received Form 483 observations

with respect to its facility that is used for the commercial supply of ANNOVERA. We believe that corrective actions to address the compliance

issues identified in the referenced Forms 483 have been implemented by the CMOs and that the CMOs continue to have the right to manufacture

under current regulations.

14

If

the manufacturers of our products cannot successfully manufacture material that conforms to specifications and the strict regulatory

requirements of the FDA and any applicable foreign regulatory authority, regulatory submissions related to our products may be delayed

or disapproved, and our marketed products may be affected. If these facilities are not in compliance for the manufacture of our products,

our licensees may need to find alternative manufacturing facilities, which would result in substantial disruptions of sales of our products.

In addition, manufacturers of our products will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state

and foreign agencies for compliance with cGMPs and similar regulatory requirements. Failure by any of the manufacturers of our products

to comply with applicable cGMP regulations or other applicable requirements could result in sanctions being imposed on us or our licensees,

including fines, injunctions, civil penalties, violation letters, delays, suspensions or withdrawals of approvals, operating restrictions,

interruptions in supply, recalls, withdrawals, issuance of safety alerts, and criminal prosecutions, any of which could have an adverse

impact on our business, financial condition, results of operations, and prospects. Our licensees may seek to enter into long-term agreements

with alternative manufacturers on commercially reasonable terms, and if they do enter into agreements with alternative manufacturers,

those alternative manufacturers may not be approved by the FDA or subsequently lose FDA approval to manufacture our drugs, any of which

could have an adverse impact on our business. We also could experience manufacturing delays if our CMOs give greater priority to the