TherapeuticsMD and Theramex Enter into Exclusive License and Supply Agreement to Commercialize BIJUVA™ and IMVEXXY® Outside the United States

-Agreement leverages Theramex’s extensive women’s health capabilities
and infrastructure to the benefit of menopausal women outside of U.S.-

-TherapeuticsMD to receive EUR 14 million as an upfront fee and is
eligible to receive up to EUR 29.5 million in regulatory and sales
milestone payments, as well as a royalty on net sales-

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s
healthcare company, today announced that it has entered into an
exclusive license and supply agreement with Theramex, a leading, global
specialty pharmaceutical company dedicated to women’s health, to
commercialize BIJUVA (estradiol and progesterone capsules) and IMVEXXY
(estradiol vaginal inserts) outside of the United States. Theramex is a
portfolio company of CVC Capital Partners.

Theramex will have exclusive commercialization rights for BIJUVA and
IMVEXXY outside the U.S., excluding Canada and Israel, for which
TherapeuticsMD has licensed BIJUVA and IMVEXXY to Knight Therapeutics.
Theramex will be responsible for conducting all regulatory and
commercial activities in connection with BIJUVA and IMVEXXY in the
licensed territories.

Under the terms of the license and supply agreement, Theramex will pay
TherapeuticsMD EUR 14 million in cash as an upfront fee. TherapeuticsMD
is eligible to receive up to an additional EUR 29.5 million in cash
milestone payments, comprised of (i) an aggregate of EUR 2 million in
regulatory milestone payments based on regulatory approvals for each of
BIJUVA and IMVEXXY in certain specified markets and (ii) an aggregate of
EUR 27.5 million in sales milestone payments to be paid in escalating
tranches based on first attaining certain aggregate annual net sales
milestones in the licensed territories ranging from EUR 25 million to
EUR 100 million. TherapeuticsMD is also entitled to receive royalty
payments on net sales of BIJUVA and IMVEXXY in the licensed territories.

“We are very pleased to announce our partnership with Theramex to bring
BIJUVA and IMVEXXY to women outside of the United States,” said Robert
G. Finizio, CEO of TherapeuticsMD. “We believe this agreement provides
our company with important non-dilutive upfront capital to help fund our
product launches in the United States as well as an incremental royalty
stream to support future growth.”

Anish Mehta, CEO of Theramex, said, “This partnership with
TherapeuticsMD marks another exciting milestone in the execution of our
women’s health growth strategy. By leveraging our best in class
commercial capabilities and global footprint, we intend to rapidly
commercialize these novel and innovative medicines for women around the
world.”

“BIJUVA and IMVEXXY strengthens Theramex’s already exciting range of
women’s health treatment options for doctors and their patients,” said
Fred Hassan, Chairman of Theramex.

Additional information concerning the license and supply agreement is
contained in the Form 8-K filed by TherapeuticsMD today with U.S.
Securities and Exchange Commission.

Copies of the U.S. Full Prescribing Information, including Boxed
Warnings, for BIJUVA and IMVEXXY are available at https://www.bijuva.com/pi.pdf
and www.imvexxy.com/pi.pdf,
respectively.

About Theramex

Theramex is a leading, global specialty pharmaceutical company dedicated
to women and their health. With a broad portfolio of innovative and
established brands covering contraception, fertility, menopause and
osteoporosis, Theramex supports women at every stage of their lives.
Theramex’s commitment is to understand its patients, serve their needs,
and offer healthcare solutions to help improve their lives. Theramex’s
vision is to be a lifetime partner for women and the healthcare
professionals who treat them by providing innovative, effective
solutions that care for and support women as they advance through each
stage of their lives. To learn more about Theramex, please visit www.theramex.com.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative, leading healthcare company,
focused on developing and commercializing novel products exclusively for
women. Our products are designed to address the unique changes and
challenges women experience through the various stages of their lives
with a therapeutic focus in family planning, reproductive health, and
menopause management. The company is committed to advancing the health
of women and championing awareness of their healthcare issues. To learn
more about TherapeuticsMD, please visit www.therapeuticsmd.com
or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking
statements. Forward-looking statements may include, but are not limited
to, statements relating to TherapeuticsMD’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 press
release are made as of the date of this press release, 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
company’s ability to maintain or increase sales of its products; the
company’s ability to develop and commercialize IMVEXXY^®,
ANNOVERA^™, BIJUVA^™ and its hormone therapy drug
candidates and obtain additional financing necessary therefor; whether
the company will be able to comply with the covenants and conditions
under its term loan facility; 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; 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 volatility
of the trading price of the company’s common stock and the concentration
of power in its stock ownership. PDF copies of the company’s historical
press releases and financial tables can be viewed and downloaded at its
website: www.therapeuticsmd.com/pressreleases.aspx.

Contacts

Investor Contact
Nichol Ochsner
Vice
President, Investor Relations
561-961-1900, ext. 2088
[email protected]