TherapeuticsMD Announces Fourth Quarter and Full-Year 2016 Financial Results

– Pipeline of two late-stage product candidates advancing towards
commercialization, with launch of TX-004HR expected in fourth quarter
2017 pending regulatory approval –

– Management to host conference call today at 8:00 a.m. EST –

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare
company, today announced its fourth quarter and full-year financial
results for 2016.

2016 and Recent Developments

• Net revenue for the company’s prescription prenatal vitamin business
  was approximately $19.4 million in 2016 compared with approximately
  $20.1 million for the prior year.
• Net loss was approximately $89.9 million in 2016, compared with
  approximately $85.1 million for the prior year, reflecting investment
  in clinical development for the company’s two phase 3 hormone therapy
  drug candidates.
• Ended the year with approximately $131.5 million in cash and no debt.
• Reported positive topline data from the Replenish Trial, a
  phase 3 clinical trial of TX-001HR, the company’s bio-identical
  hormone therapy combination of estradiol and progesterone in a single,
  oral softgel, for the treatment of moderate-to-severe vasomotor
  symptoms due to menopause. Topline results from the trial in 1,835
  post-menopausal women demonstrated that multiple doses of TX-001HR
  resulted in a statistically significant reduction from baseline
  in both the frequency and severity of hot flashes compared to placebo.
  In addition, endometrial safety was established with an incidence rate
  of endometrial hyperplasia or malignancy of 0% across all doses. The
  company plans to submit a New Drug Application (NDA) for TX-001HR to
  the U.S. Food and Drug Administration (FDA) in the third quarter of
  2017.
• Submitted an NDA for TX-004HR, the company’s applicator-free estradiol
  vaginal softgel capsule drug candidate for the treatment of
  moderate-to-severe vaginal pain during sexual intercourse
  (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to
  menopause. The NDA is supported by the complete TX-004HR clinical
  program, including positive results from all three doses of TX-004HR
  (4 mcg, 10 mcg and 25 mcg) that were evaluated in the phase 3 Rejoice
  Trial. The FDA’s Prescription Drug User Fee Act (PDUFA) target action
  date for the NDA is May 7, 2017.
• Published three manuscripts with detailed results of the TX-004HR
  phase 3 Rejoice Trial in the peer-reviewed journal Menopause.
  The manuscripts review the positive results of TX-004HR across
  pre-specified co-primary and secondary endpoints in the Rejoice Trial,
  data from a pharmacokinetic (PK) substudy demonstrating the low
  systemic absorption of TX-004HR, as well as data from a patient
  acceptability and satisfaction survey demonstrating a high level of
  product acceptability, ease of use, and patient satisfaction with
  TX-004HR.
• The company’s intellectual property portfolio grew to a current total
  of 144 patent filings, including 74 international filings, with one
  allowed and 17 issued U.S. patents.
• Strengthened relationships with key medical, pharmacy, patient and
  industry organizations worldwide. This includes the recent launch of
  the company’s BIO-IGNITE™ program, an outreach program to quantify the
  number of compounded bio-identical estradiol and progesterone
  prescriptions currently dispensed by the 3,000-3,500 high-volume
  compounding pharmacies and qualify their interests in distributing the
  company’s bio-identical hormone product candidates, if approved.

“During 2016, we made significant advancements with our two late-stage
pipeline candidates while we pursued our goal to bring new healthcare
solutions to women to help manage their menopause symptoms,” said
TherapeuticsMD CEO Robert G. Finizio. “As we look forward to 2017, we
are planning the launch of TX-004HR, pending regulatory approval, as a
highly differentiated new treatment for moderate-to-severe dyspareunia,
a symptom of VVA due to menopause. We also intend to file an NDA for
TX-001HR, which, if approved, would be the first and only FDA-approved
bio-identical combination of estradiol and progesterone for the
treatment of moderate-to-severe vasomotor symptoms due to menopause.”

Summary of 2016 Financial Results

For the year ended December 31, 2016, net revenue was approximately
$19.4 million compared with approximately $20.1 million for the prior
year. Net revenue for the fourth quarter of 2016 was approximately $4.5
million compared with net revenue of approximately $5.6 million for the
prior year’s quarter. These changes were primarily due to a decrease in
the average net sales price of our products, partially offset by an
increase in the number of units sold.

Total operating expenses for the fourth quarter and full-year 2016
included research and development (R&D) expenses and sales, general and
administrative expenses (SG&A). R&D expenses for the full-year 2016 were
approximately $53.9 million compared with approximately $72.0 million
for the prior year. R&D expenses for the fourth quarter of 2016 were
approximately $10.3 million compared to approximately $13.3 million
during the prior year’s quarter. The decreases in R&D were primarily due
to lower clinical trial costs as the company completed its phase 3
clinical trials for TX-001HR and TX-004HR. SG&A expenses for the
full-year 2016 were approximately $51.3 million compared with
approximately $28.7 million for the prior year. SG&A expenses for the
fourth quarter of 2016 were approximately $16.3 million compared with
approximately $8.6 million for the prior year’s quarter. The increases
in SG&A were primarily due to higher sales, marketing, regulatory
expenditures, and personnel costs to support future commercialization.

Net loss for the full-year 2016 was approximately $89.9 million, or
$0.46 per basic and diluted share, compared with approximately $85.1
million, or $0.49 per basic and diluted share, for the full-year 2015.
Net loss in the fourth quarter of 2016 was approximately $22.8 million,
or $0.12 per basic and diluted share, compared with approximately $17.5
million, or $0.10 per basic and diluted share, for the fourth quarter of
2015.

At December 31, 2016, cash on hand was approximately $131.5 million,
compared with approximately $64.7 million at December 31, 2015.

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:

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com,
on the Home Page or under the “Investors & Media” section. A
digital recording of the conference call will be available for replay
beginning two hours after the call’s completion and for at least 30 days
with the dial-in 855-859-2056 or international 404-537-3406 and
Conference ID: 68412683.

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 late stage clinical pipeline includes two phase 3 product
candidates: TX-001HR for treatment of moderate-to-severe vasomotor
symptoms (VMS) due to menopause and TX-004HR for treatment of
moderate-to-severe vaginal pain during sexual intercourse (dyspareunia),
a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The
company also manufactures and distributes branded and generic
prescription prenatal vitamins as well as over-the-counter prenatal
vitamins under the vitaMedMD^® and BocaGreenMD^®
brands.

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 its hormone therapy drug candidates and obtain additional
financing necessary therefor; whether the company will be able to
prepare a new drug application for its TX-001HR product candidate and,
if prepared, whether the FDA will accept and approve the application;
whether the FDA will approve the company’s new drug application for its
TX-004HR product candidate and whether any such approval will occur by
the PDUFA date; 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.
Investor Contact
David
DeLucia, 561-961-1900
Director, Investor Relations
David.DeLucia@TherapeuticsMD.com
or
Media
Contact
SparkBioComm
Ami Knoefler, 650-739-9952
Ami@SparkBioComm.com