TherapeuticsMD Reports First Quarter 2013 Financial Results

TherapeuticsMD Reports First Quarter 2013 Financial Results

BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NYSE MKT:TXMD), a women's healthcare company focused on developing and commercializing products targeted exclusively for women, today announced financial results for the three months ended March 31, 2013.

First Quarter and Subsequent Highlights:

• Net revenue for the quarter ended March 31, 2013 was $1.5 million compared with approximately $722,000 in the first quarter of 2012;

• Net loss improved to $6.4 million for the quarter ended March 31, 2013 compared with a net loss of $13.3 million in the first quarter of 2012;

• Cash and cash equivalents were $38.8 million at March 31, 2013, compared with $1.6 million at December 31, 2012;

• The Company generated approximately $48.5 million in net proceeds through the issuance and sale of approximately 31.4 million shares of TXMD common stock in an underwritten public offering, which includes net proceeds of approximately $3.1 million from the issuance and sale of approximately 2.0 million shares to cover over-allotments; and

• TXMD common stock commenced trading on the NYSE MKT on April 23, 2013.

"With our newly strengthened balance sheet, NYSE MKT listing, and strong portfolio of bioidentical hormone therapy product candidates, we believe TherapeuticsMD is well positioned for success as we execute our strategy to become a leader in the women's healthcare field," said Robert G. Finizio, Chief Executive Officer.

"We look forward to initiating pivotal Phase III clinical trials with two of our bioidentical hormone therapy product candidates, 17β estradiol/ progesterone combination and lower dose oral progesterone, which we believe can achieve equivalent efficacy at lower doses of active compound and lower cost to patients versus currently available products. We expect to file an IND application for an additional hormone therapy candidate, a novel estradiol suppository, later this year."

First Quarter Results

Net revenue for the first quarter of 2013 totaled $1.5 million, compared with net revenue of approximately $722,000 for the year ago quarter. The increase of approximately $815,000, or 113%, was directly attributable to an increase in sales territories, sales people and new prescription products. Cost of goods sold increased by approximately $44,000, or 13%, for the three months ended March 31, 2013 compared with the prior year quarter. Research and development expenses increased to $1.6 million during the first quarter of 2013 compared with approximately $400,000 in the first quarter of 2012, due to costs incurred for the development of our new hormone replacement therapy and prescription prenatal products. Selling, general and administrative expenses increased to $4.5 million during the first quarter of 2013 compared with $2.8 million in the first quarter of 2012. As a result, our operating loss was $4.9 million in the first quarter of 2013 compared with $2.9 million in the first quarter of 2012.

Other non-operating expenses decreased by approximately $9.0 million for the first quarter of 2013 compared with the comparable quarter in 2012. This decrease resulted primarily from a loss on extinguishment of debt incurred during 2012, partially offset by an increase in amortization of debt discount of approximately $1.0 million and amortization of financing costs of approximately $300,000.

As a result, net loss for the first quarter of 2013 was $6.4 million, or $0.06 per basic and diluted share, compared with a net loss of $13.3 million, or $0.16 per basic and diluted share, in the first quarter of 2012.

Cash and cash equivalents increased to $38.8 million at March 31, 2013.

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 hormone therapy 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 (OTC) vitamins and cosmetics, under our vitaMedMD^® and BocaGreenMD™ brands. We are currently developing advanced hormone therapy pharmaceutical products 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 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, and www.bocagreenmd.com.

vitaMedMD^® is a registered trademark and TherapeuticsMD™ and BocaGreenMD™ are trademarks of TherapeuticsMD, Inc.

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company's belief that it is well positioned for success as it executes its strategy to become a leader in the women's healthcare field, the Company's expectations with respect to the timing of the Company's planned clinical trials, the Company's belief that it can achieve equivalent efficacy at lower doses of active compound and lower cost to patients versus currently available products, and the Company's expectations with respect to the timing of filing an IND application, 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 TherapeuticsMD's business and finances in general; and other risks detailed in TherapeuticsMD's filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, 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 TherapeuticsMD undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.