Full Press Release Details
TherapeuticsMD, Inc. 8-K
| Contacts: | Investor Relations: |
| Dan Cartwright | Lisa M. Wilson |
| Chief Financial Officer | In-Site Communications |
| Tel: (561) 961-1930 | Tel: (917) 543-9932 |
| Dan.Cartwright@TherapeuticsMD.com | lwilson@insitecony.com |
reports FOURTH quarter AND FULL-YEAR 2013 results
Management to Host Conference Call at
Boca Raton, FL, March 3, 2014
- TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women's healthcare company, ("TherapeuticsMD" or the "Company")
today announced results for the three-month period and full-year ended December 31, 2013.
Fourth Quarter 2013 Highlights:
| Net revenue increased to $2.9 million compared with $1.2 million for the fourth quarter of 2012; | ||
| Net loss increased to $8.4 million compared with a net loss of $5.7 million for the fourth quarter of 2012; | ||
| Received approval ahead of schedule to screen and enroll subjects at the 50 th site in the REPLENISH Trial, a phase 3 clinical trial designed to measure the safety and efficacy of TX-12-001HR, our combination 17 estradiol and natural progesterone drug candidate for the treatment of vasomotor symptoms in post-menopausal women; | ||
| Initiated the SPRY Trial, a phase 3 clinical trial designed to evaluate safety and efficacy of TX-12-002HR, our oral progesterone drug candidate for the treatment of secondary amenorrhea; | ||
| Announced positive results from two PK studies of TX-12-004HR, our estradiol VagiCap drug candidate, data from which suggests that VagiCap may be a similar but more effective product with less systemic exposure than Vagifem ; | ||
| Received patents for our platform technology (Symboda) and lead drug candidate, TX-12-001HR; | ||
| Filed 11 additional patent applications, covering various aspects of our technology and drug candidates, to ensure patent exclusivity through 2032; | ||
| Strengthened senior management team with appointments of Sebastian Mirkin, M.D., as Chief Medical Officer; Joel S. Krasnow, M.D., M.B.A., as Chief Scientific Officer and head of our regulatory department; and Randall S. Stanicky, CFA, to our Board of Directors; and, | ||
| Closed out 2013 with $54.2 million in cash and cash equivalents, and no debt. |
Robert G. Finizio, Co-Founder and Chief
Executive Officer, stated, "This has been an exciting year for the Company, highlighted by advancements in clinical trials
for our three principal hormone therapy drug candidates. The Drug Quality and Security Act was passed into law in November 2013,
and the quick action of the FDA to implement and enforce the new law means that compounding pharmacies are now clearly governed
by it. This law is a catalyst, and presents an opportunity to move the market from compounded bio-identical hormone replacement
therapies, or BHRT, to an FDA-approved bioidentical drug market. We believe that we with our phase 3 REPLENISH Trial to evaluate
our combination product well underway, we are well-positioned to capitalize on this new opportunity.
| THERAPEUTICSMD REPORTS FOURTH QUARTER AND FULL-YEAR 2013 FINANCIAL RESULTS | |
| March 3, 2014 | Page 2 of 7 |
"We have strengthened our Board and
management team, which will support and guide us as we continue our evolution as a publicly traded company. Our robust pipeline
and strong cash position also contribute to a positive outlook for the Company, and we look forward to our ongoing progress,"
Fourth Quarter Results
Net revenue for the fourth quarter of 2013
totaled $2.9 million compared with net revenue of $1.2 million for the year ago quarter. The increase of approximately $1.7 million,
or approximately 130%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal
products, the increased productivity of our sales force, an increase in the average net sales price of our product, and new prescription
products introduced in March, April, May, and November 2012. Cost of goods sold increased by $134,000, or 40.4%, for the three
months ended December 31, 2013 compared with the prior year quarter. Research and development expenses increased to $5.8 million
for the fourth quarter of 2013 compared with $1.4 million for the fourth quarter of 2012, because of costs incurred in the development
of our new hormone replacement therapy and prescription prenatal products. Sales, general, and administrative expenses decreased
to $4.6 million for the fourth quarter of 2013 compared with $4.9 million for the fourth quarter of 2012. As a result, our operating
loss was $8.0 million for the fourth quarter of 2013 compared with $5.4 million for the fourth quarter of 2012.
Other non-operating expenses increased
by approximately $36,000 for the fourth quarter of 2013 compared with the comparable quarter in 2012. This increase was primarily
a result of non-cash financing costs incurred during the current period totaling approximately $396,000, partially offset by a
decrease in interest expense of approximately $520,000 and loss on extinguishment of debt of approximately $197,000.
As a result, net loss for the fourth quarter
of 2013 was $8.4 million, or $0.06 per basic and diluted share, compared with a net loss of $5.7 million, or $0.06 per basic and
diluted share, for the fourth quarter of 2012.
Net revenue for the year ended
December 31, 2013 totaled $8.8 million compared with net revenue of approximately $3.8 million for the year ended December
31, 2012. The increase of approximately $5.0 million, or approximately 130%, was directly attributable to an increase in the
number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, an
increase in the average net sales price of our product, and new prescription products introduced in March, April, May and
November 2012. Cost of goods sold increased by approximately $611,000, or 45%, for the full year ended December 31, 2013
compared with the prior year period. Research and development expenses increased to $13.5 million for 2013, compared with
$4.5 million for 2012 because of costs incurred in the development of our new hormone therapy drug candidates. Sales,
general, and administrative expenses increased to $19.0 million for 2013 compared with $14.1 million for the prior year. As a
result, our operating loss was $25.8 million for the year ended December 31, 2013 compared with $16.1 million for the year
ended December 31, 2012.
Other non-operating expenses decreased
by $16.4 million for the year ended December 31, 2013 compared with the prior year. This decrease resulted primarily from a reduction
in financing related costs.
As a result, net loss for the full year
ended December 31, 2013 was $28.4 million, or $0.22 per basic and diluted share, compared with a net loss of $35.1 million, or
$0.38 per basic and diluted share, for the year ended December 31, 2012.
Cash and cash equivalents were $54.2 million
at December 31, 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:
| THERAPEUTICSMD REPORTS FOURTH QUARTER AND FULL-YEAR 2013 FINANCIAL RESULTS | |
| March 3, 2014 | Page 3 of 7 |
| Date | March 3, 2014 |
| Time | 4:30 p.m. (Eastern Standard Time) |
| Telephone access | 800-709-0218 (U.S. and Canada) |
| 212-231-2900 (International) | |
| Access code | 21708486 |
| Live webcast | www.therapeuticsmd.com , under the Investor tab |
An audio replay will be available on-demand
shortly after the completion of the call until March 24, 2014 at 11:59 p.m. EST at www.therapeuticsmd.com, and will also be
available by dialing 800-633-8284 in the U.S. and Canada, or 402-977-9140 for international callers. The access code for all callers
About 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
healthcare 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,
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 Company's performance; the progress of the phase 3 clinical trials for TX 12-001HR and 12-002HR;
the results of the PK studies of TX 12-004HR and the Company's belief that such results suggest that TX 12 004HR
will be a similar but more effective product with less systemic exposure than Vagifem; the Company's belief in the impact
on the Company of the recent appointments of Drs. Mirkin and Krasnow to the Company's senior management team and the appointment
of Mr. Stanicky to the Company's Board of Directors; the Company's belief that the potential of its three principal
drug candidates has been validated by external parties, namely the size of the market to which these products would be introduced
and the passage of the Drug Quality and Security Act; the effect of the Drug Quality and Security Act on compounding pharmacies;
the Company's belief that its robust pipeline and strong cash position contribute 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, and new prescription
products introduced in 2012; 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