TherapeuticsMD Announces Third Quarter 2015 Financial Results

Topline phase 3 data anticipated in fourth quarter for TX-004HR to
treat symptoms of VVA

Completed enrollment in phase 3 Replenish Trial for first potential
FDA-approved bio-identical oral combination hormone therapy

Management to host conference call today at 4:30 p.m. EST

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced its third quarter financial results for the
period ended September 30, 2015.

Recent and Third Quarter Developments

• Revenues, net for the company’s prescription prenatal vitamin business
  increased to approximately $5.2 million for the third quarter of 2015
  compared with approximately $4.2 million for the third quarter of 2014.
• Net loss was approximately $19.5 million for the third quarter of
  2015, compared with approximately $17.8 million for the third quarter
  of 2014, reflecting the costs of two phase 3 clinical trials for the
  company’s novel hormone therapy drug candidates.
• Completed last patient visit in the Rejoice Trial, a phase 3 clinical
  trial of TX-004HR, an applicator-free vaginal estradiol softgel drug
  candidate for the treatment of moderate to severe pain during sexual
  intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy
  (VVA) due to menopause.
• Completed patient enrollment in the Replenish Trial, a phase 3
  clinical trial of TX-001HR, a combination estradiol and progesterone
  drug candidate, for the treatment of moderate to severe vasomotor
  symptoms due to menopause.
• Ended the quarter with approximately $81.1 million in cash and no debt.
• Grew the company’s intellectual property portfolio to a current total
  of 111 patent filings, including 61 international filings, with two
  allowed and 13 issued U.S. patents.
• Supported scientific abstracts and presentations at the annual meeting
  of the North American Menopause Society.
• Continued to develop relationships with key medical, pharmacy, patient
  and industry organizations.

“As we pursue our mission to address women’s health needs, we believe
that there is a unique confluence of factors evolving on the scientific,
regulatory, legislative and commercial fronts that will help us to make
significant progress toward delivering on our vision and strategy,” said
TherapeuticsMD CEO Robert G. Finizio. “We continue to execute
both commercially and in R&D, including completion of enrollment in our
Replenish Trial of TX-001HR, our combination estradiol and progesterone
drug candidate for treatment of moderate to severe vasomotor symptoms
due to menopause. We also expect topline data from our Rejoice Trial of
TX-004HR for dyspareunia associated with VVA by the end of this year.
The market need for our products is large and growing, and we are
building key alliances with healthcare providers, women’s health
advocates and industry organizations.”

Third Quarter Financial Results Summary

Revenues, net for the third quarter of 2015 increased by 24 percent to
approximately $5.2 million compared with revenues, net of approximately
$4.2 million for the prior year’s quarter. Revenue growth during the
third quarter was primarily driven by increased number of units sold,
product mix, and average net sales price of the company’s prenatal
vitamin products.

Cost of goods sold increased to approximately $1.2 million for the three
months ended September 30, 2015, compared with approximately $1.1
million in the prior year’s quarter.

Total operating expenses for the third quarter of 2015 included research
and development (R&D) expenses and sales, general and administration
(SG&A). R&D expenses for the third quarter of 2015 were approximately
$16.4 million compared with approximately $14.9 million for the prior
year’s quarter. The increase in R&D expense was primarily due to an
increase in scale-up and manufacturing activities for the company’s
phase 3 drugs in development, which was partially offset by lower
clinical trial costs. SG&A expenses for the third quarter of 2015 were
approximately $7.0 million compared with approximately $6.0 million for
the third quarter of 2014, primarily as a result of increases in human
resources costs and professional fees, which were partially offset by a
decrease in marketing costs.

Non-operating income remained insignificant for the third quarter of
2015 and 2014 and included miscellaneous and interest income for both
periods.

Net loss for the third quarter of 2015 was approximately $19.5 million,
or $0.11 per basic and diluted share, compared with approximately $17.8
million, or $0.12 per basic and diluted share, for the third quarter of
2014.

At September 30, 2015, TherapeuticsMD had cash on hand of approximately
$81.1 million, compared with approximately $51.4 million at December 31,
2014.

Conference Call Today

As previously announced, TherapeuticsMD will host a conference call
today to discuss these financial results and provide a business update.
Details for the call are:

Date: Wednesday, November 4, 2015
Time: 4:30 p.m. EST
Telephone
Access (US): 866-665-9531
Telephone Access (International):
724-987-6977
Access Code for All Callers: 61714687

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com,
on the “Home Page” or under the “Investor” section.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on
developing and commercializing products exclusively for women. With its
SYMBODA™ technology, TherapeuticsMD is developing advanced hormone
therapy pharmaceutical products to enable delivery of bio-identical
hormones through a variety of dosage forms and administration routes.
The company’s clinical development pipeline includes two phase 3
products. The company also manufactures and distributes branded and
generic prescription prenatal vitamins as well as over-the-counter
vitamins under the vitaMedMD^® and BocaGreenMD^®
brands. More information is available at the following websites: www.therapeuticsmd.com,
www.vitamedmd.com,
www.vitamedmdrx.com
and www.bocagreenmd.com.

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 its hormone therapy drug candidates and obtain additional
financing necessary therefor; the length, cost and uncertain results of
the company’s clinical trials; the potential of adverse side effects or
other safety risks that could preclude the approval of the company’s
hormone therapy drug candidates; the company’s reliance on third parties
to conduct its clinical trials, research and development and
manufacturing; 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

TherapeuticsMD, Inc.
Investors:
Dan Cartwright, 561-961-1900
Chief
Financial Officer
Dan.Cartwright@TherapeuticsMD.com