-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-
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190607005196/en/
Investor ContactNichol
OchsnerVice President, Investor Relations561-961-1900, ext.
2088Nochsner@TherapeuticsMD.com
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