TherapeuticsMD Reports Second Quarter 2013 Financial Results

TherapeuticsMD Reports Second 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 and six-month periods ended June 30, 2013.

Second Quarter Highlights:

• Net revenue for the quarter ended June 30, 2013 was $2.1 million compared with $819 thousand in the second quarter of 2012;

• Net loss improved to $6.0 million for the quarter ended June 30, 2013 compared with a net loss of $11.9 million in the second quarter of 2012;

• On June 10, 2013, the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for TX 12-004HR, a vulvar and vaginal atrophy product; and

• TXMD was added to the Russell 2000^® on June 28, 2013.

Robert G. Finizio, Co-Founder and Chief Executive Officer, stated, "With the FDA's acceptance of the IND application for TX 12-004HR, we are now positioned to move three product candidates into late-stage clinical trials. We remain on track to initiate pivotal Phase III clinical trials for our bioidentical, 17β estradiol/progesterone combination and lower-dose oral progesterone product candidates in the second half of this year. We are presently conducting pharmacokinetic studies with TX 12-004HR and expect to initiate a Phase III clinical trial early next year."

Second Quarter Results

Net revenue for the second quarter of 2013 totaled $2.1 million compared with net revenue of $819 thousand for the year ago quarter. The increase of $1.3 million, or 154%, was directly attributable to an increase in sales territories, sales people and new prescription products. Cost of goods sold increased by $92 thousand, or 25%, for the three months ended June 30, 2013 compared with the prior year quarter. Research and development expense increased to $1.7 million during the second quarter of 2013 compared with $833 thousand in the second quarter of 2012, due to costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $5.5 million during the second quarter of 2013 compared with $3.6 million in the second quarter of 2012. As a result, our operating loss was $5.6 million in the second quarter of 2013 compared with $4.0 million in the second quarter of 2012.

Other non-operating expense decreased by $7.5 million for the second quarter of 2013 compared with the comparable quarter in 2012. This decrease resulted primarily from the beneficial conversion of debt and interest expense incurred during 2012, partially offset by an increase in amortization of financing costs of $396 thousand.

As a result, net loss for the second quarter of 2013 was $6.0 million, or $0.05 per basic and diluted share, compared with a net loss of $11.9 million, or $0.14 per basic and diluted share, in the second quarter of 2012.

Six Months Results

Net revenue for the first half of 2013 totaled $3.6 million, compared with revenue of $1.5 million for the year ago period. The increase of $2.1 million, or 135%, was directly attributable to an increase in sales territories, sales people and new prescription products. Cost of goods sold increased by $135 thousand, or 20%, for the six months ended June 30, 2013 compared with the prior year period. Research and development expenses increased to $3.3 million during the first half of 2013 compared with $1.2 million in the first half of 2012, due to costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general and administrative expenses increased to $10.0 million during the first half of 2013 compared with $6.4 million in the first half of 2012. As a result, our operating loss was $10.6 million in the first half of 2013 compared with $6.8 million in the first half of 2012.

Other non-operating expense decreased by $16.5 million for the first half of 2013 compared with the comparable period in 2012. This decrease resulted primarily from a loss on extinguishment of debt, the beneficial conversion of debt and interest expense incurred during 2012, partially offset by an increase in amortization of financing costs of $660 thousand.

As a result, net loss for the first half of 2013 was $12.4 million, or $0.11 per basic and diluted share, compared with a net loss of $25.1 million, or $0.29 per basic and diluted share, in the first half of 2012.

Cash and cash equivalents increased to $34.4 million at June 30, 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 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 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 now positioned to move three product candidates into late-stage clinical trials, the Company's expectations with respect to the timing of its clinical trials, and the status of the pharmacokinetic studies with TX 12-004HR 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 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 the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.