Item 8.01Other Events.
On December 28, 2021, TherapeuticsMD, Inc., a Nevada corporation (the
"Company"), received approval from the U.S. Food and Drug Administration (the
"FDA") on the supplemental New Drug Application for the 0.5 mg/100 mg dose of
the Company's BIJUVA® product. The Company is currently evaluating plans for
commercialization of the low dosage BIJUVA® product.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements.
Forward-looking statements may include, but are not limited to, statements
relating to the Company's objectives, plans and strategies as well as
statements, other than historical facts, that address activities, events or
developments that the company intends, expects, projects, believes or
anticipates will or may occur in the future. These statements are often
characterized by terminology such as "believes," "hopes," "may," "anticipates,"
"should," "intends," "plans," "will," "expects," "estimates," "projects,"
"positioned," "strategy" and similar expressions and are based on assumptions
and assessments made in light of management's experience and perception of
historical trends, current conditions, expected future developments and other
factors believed to be appropriate. Forward-looking statements in this Current
Report on Form 8-K are made as of the date of this Current Report on Form 8-K,
and the Company undertakes no duty to update or revise any such statements,
whether as a result of new information, future events or otherwise.
Forward-looking statements are not guarantees of future performance and are
subject to risks and uncertainties, many of which are outside of the Company's
control. Important factors that could cause actual results, developments and
business decisions to differ materially from forward-looking statements are
described in the sections titled "Risk Factors" in the Company's filings with
the Securities and Exchange Commission, including its most recent Annual Report
on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K,
and include the following: the effects of the COVID-19 pandemic; the Company's
ability to maintain or increase sales of its products; the Company's ability to
develop and commercialize IMVEXXY®, ANNOVERA, and BIJUVA®, including the low
dose of BIJUVA, and obtain additional financing necessary therefor; whether the
Company will be able to comply with the revenue, minimum cash, and other
covenants and conditions under its term loan facility; whether the Company will
be able to successfully divest, or obtain an investment in, its vitaCare
business and how the proceeds that may be generated by any such divestiture or
investment will be utilized; the effects of supply chain issues on the supply of
the Company's products; the potential of adverse side effects or other safety
risks that could adversely affect the commercialization of the Company's current
or future approved products or preclude the approval of the Company's future
drug candidates; whether the FDA will approve the manufacturing testing limit
revisions for ANNOVERA; the Company's ability to protect its intellectual
property, including with respect to the Paragraph IV notice letters the company
received regarding IMVEXXY and BIJUVA and the corresponding settlement regarding
BIJUVA; the length, cost and uncertain results of future clinical trials; the
Company's reliance on third parties to conduct its manufacturing, research and
development and clinical trials; the ability of the Company's licensees to
commercialize and distribute the company's products; the availability of
reimbursement from government authorities and health insurance companies for the
Company's products; the impact of product liability lawsuits; the influence of
extensive and costly government regulation; the impact of leadership
transitions; the volatility of the trading price of the Company's common stock
and the concentration of power in its stock ownership.
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THERAPEUTICSMD, INC. 
