Recent Updates
Recently added Catalysts
TXMD

THERAPEUTICSMD REPORTS FIRST QUARTER 2014 RESULTS Management to Host Conference Call at 4:30 EDT Today Boca Raton, FL

Key Takeaway: TherapeuticsMD, Inc. 8-K THERAPEUTICSMD REPORTS FIRST QUARTER Management to Host Conference Call at Boca Raton, FL, May 5, 2014 - TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women's health care company, ("TherapeuticsMD," the "Company," "we," or "our") today announced results f

Full Press Release Details

TherapeuticsMD, Inc. 8-K
THERAPEUTICSMD REPORTS FIRST QUARTER
Management to Host Conference Call at
Boca Raton, FL, May 5, 2014 -
TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women's health care company, ("TherapeuticsMD," the "Company,"
"we," or "our") today announced results for the quarter ended March 31, 2014.
First Quarter 2014 Highlights:
Net revenue increased to $2.8 million compared with $1.5 million for the quarter ended March 31, 2013;
Net loss was $9.2 million compared with a net loss of $6.4 million for the quarter ended March 31, 2013;
Launched Prena1 Pearl , the sole generic equivalent formulation of vitaPearl, the smallest complete prescription prenatal multivitamin and the first to contain FOLMAX , FePlus , and pur-DHA ;
Reported positive results of toxicity study of TX-004HR, its estradiol VagiCap drug candidate, for treatment of vulvar vaginal atrophy (VVA), that demonstrated it was "non-irritant" following a 28-day repeated application;
Filed four additional patent applications, bringing total applications filed and issued to 33; and
Ended the quarter with $45.4 million in cash and cash equivalents, and no debt.
Robert G. Finizio, Co-Founder and Chief
Executive Officer, stated, "This has been a busy and exciting quarter for us, highlighted by advancements in clinical trials
for our principal hormone therapy drug candidates. Our two largest commercial opportunities are our investigational combination
estradiol and progesterone (E+P) therapy for treatment of vasomotor symptoms in menopausal women, and estradiol VagiCap for VVA.
We remain on track to complete enrollment this fall in the E+P phase 3 trial, where enrollment is strong and patient retention
is positive. Pending a successful trial, the U.S. Food and Drug Administration's (FDA) approval of our E+P drug candidate, we will
be well positioned as a first-mover in this multi-billion dollar market to introduce and capitalize on what could be the first
safe and effective bioidentical combination hormone therapy product for menopausal women."
"We are equally excited about the
opportunity in VVA. This market more than doubled over the last five years to $1.1 billion in 2013 without any generic options.
Our phase 3 VVA clinical trial is designed to assess the ability of our estradiol VagiCap, which leverages our solubilized lipid-based
technology to achieve new, lower effective doses that could potentially reduce or eliminate systemic exposure to estradiol. Our
goal is to bring to market an innovative VVA drug candidate with a focus on a positive qualitative user experience for menopausal
women, while achieving an improved therapeutic profile." continued Mr. Finizio.
"Our progesterone-only drug candidate
for the treatment of secondary amenorrhea is currently undergoing a phase 3 clinical trial, called the SPRY trial. This clinical
trial has faced recruiting challenges. To remedy these challenges, we are meeting with the FDA in early June 2014 to discuss potential
changes to our inclusion and exclusion criteria."
"In summary, an increasingly receptive
regulatory environment, our promising product pipeline and strong cash position all are contributing to a positive outlook for
the Company and we look forward to our ongoing progress in the important field of women's health care," Mr. Finizio
First Quarter Results
Net revenue for the first quarter of 2014
totaled $2.8 million compared with net revenue of $1.5 million for the prior year quarter. The increase of approximately $1.3 million,
or 84%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the
increased productivity of our sales force, and an increase in the average net sales price of our product. Cost of goods sold increased
by $450,000, or 118%, for the three months ended March 31, 2014 compared with the prior year quarter.
Research and development expenses increased
to $5.9 million for the first quarter of 2014 compared with $1.6 million for the first quarter of 2013 because of the development
of our hormone therapy drug candidates and related clinical trials.
Sales, general, and administrative expenses
increased to $5.0 million for the first quarter of 2014 compared with $4.5 million for the first quarter of 2013. As a result,
our operating loss was $9.0 million for the first quarter of 2014 compared with $4.9 million for the first quarter of 2013.
Other non-operating expenses decreased
by approximately $1.2 million for the first quarter of 2014 compared with the comparable quarter in 2013. This decrease was primarily
a result of a decrease in interest expense.
As a result, net loss for the first quarter
of 2014 was $9.2 million, or $0.06 per basic and diluted share, compared with a net loss of $6.4 million, or $0.06 per basic and
diluted share, for the first quarter of 2013.
As previously announced, today Robert G.
Finizio, Co-Founder and Chief Executive Officer, and Dan Cartwright,
Chief Financial Officer, will host a conference
call, which may include forward-looking statements, to review the financial results as follows:
Date Monday, May 5, 2014
Time 4:30pm EDT
Telephone access: U.S. and Canada 800-753-0594
Telephone access: International 212-231-2911
Access code for all callers 21714227
Live audio webcast www.therapeuticsmd.com See Events and Presentations under the Investors tab
An audio replay will be available on-demand
shortly after the completion of the call until May 26, 2014 at 11:59 p.m. EDT at www.therapeuticsmd.com and by dialing
800-633-8284 in the U.S. and Canada, or 402-977-9140 for international callers. The access code for all callers is 21714227.
About Hormone Therapy
Hormone therapy (HT) is the
administration of hormones to supplement a lack of naturally occurring hormones. HT options include natural,
bioidentical, and non-bioidentical (conjugated) hormones. HT is projected to be the largest growth segment in the overall
women's health market. The potential market for pharmacy-compounded, bioidentical HT products is estimated to be
approximately $1.5 billion per year.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a
women's health care company focused on developing and commercializing products targeted exclusively for women. We
manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and
cosmetics, under our vitaMedMD and BocaGreenMD brands. We are currently developing advanced hormone therapy
pharmaceutical drug candidates designed to alleviate the symptoms of and reduce the health risks resulting from
menopause-related hormone deficiencies. We are also evaluating various other potential indications for
our hormone therapy technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian
failure. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com,
vitaMedMD , TherapeuticsMD ,
and BocaGreenMD are registered trademarks of TherapeuticsMD, Inc.
Except for the historical information
contained herein, the matters set forth in this press release, including statements relating to future events or performance, including
statements regarding the results of TX-004HR clinical trial; the Company's performance; the progress of the Company's
principal hormone therapy drug candidates; the Company's belief that its combination 17 -estradiol and progesterone
(E+P) and estradiol VagiCap are the Company's two largest commercial opportunities; the progress of enrollment in the Company's
E+P Phase 3 trial; the Company's belief that it will be well positioned as a first-mover in the [$1.5 billion] market
to introduce and capitalize on what could be the first safe and effective bioidentical combination hormone therapy drug product
for menopausal women; the Company's assessment of its opportunity in the VVA market and the increase in the size of the VVA
market; the design of the Company's Phase 3 VVA clinical trial; the attributes and potential benefits of VagiCap; the Company's
goal of bringing to market an innovative VVA drug candidate with a focus on a positive qualitative user experience for menopausal
women, while achieving an improved therapeutic profile; the status of enrollment in the Company's progesterone-only clinical
trial and the challenges facing this clinical trial; the results of the meeting with the FDA and any subsequent changes to the
inclusion and exclusion criteria in the SPRY Trial; the Company's belief that an increasingly receptive regulatory environment,
its promising pipeline and strong cash position are contributing to a positive outlook for the Company; the impact of the number
of physicians writing prescriptions for the Company's prenatal products, the increased productivity of the Company's
sales force, an increase in the average net sales price of the Company's products; projected growth and the size of the potential
market for pharmacy-compounded, bioidentical HT products; and the Company's current product pipeline and hormone technology
that the Company is evaluating are forward-looking statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that
may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies
and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic
and market conditions; risks and uncertainties associated with the Company's business and finances in general; and other
risks detailed in the Company's filings with the U.S. Securities and Exchange Commission including its annual report on Form
10-K filed on March 5, 2014, reports on Form 10-Q and Form 8 K, and other such filings. These forward-looking statements are
based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary
statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances
Last updated: May 5, 2014