[May 05, 2015]

TherapeuticsMD Announces First Quarter 2015 Financial Results

TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, today announced its first quarter financial results for the period ended March 31, 2015.

First quarter and recent corporate developments

• Net revenue increased to approximately $4.5 million for the quarter ended March 31, 2015, compared with approximately $2.8 million for the quarter ended March 31, 2014.
• Net loss was approximately $20.9 million for the quarter ended March 31, 2015, compared with approximately $9.2 million for the quarter ended March 31, 2014, reflecting increased costs associated with the company's continued enrollment of patients in two phase 3 clinical trials for its novel hormone therapy product candidates.
• Ended the quarter with $91.7 million in cash and no debt.
• The company's intellectual property portfolio grew to a current total of 102 patent filings, of which 57 were filed in international jurisdictions, including 11 issued U.S. patents.
• The company supported scientific abstracts and presentations at multiple medical meetings, including International Society for the Study of Women's Sexual Health (ISSWSH), Endocrine Society (ENDO) and American College of Obstetricians and Gynecologists (ACOG).

"We are very excited about the developments at our company so far in 2015, and we are enthusiastic about our future prospects," said TherapeuticsMD CEO Robert G. Finizio. "We are enrolling patients in our two phase 3 clinical trials for novel hormone therapy product candidates, we are executing well in our current women's health business, and we have compelling new science that is emerging from our earlier stage pipeline programs. We are making great progress toward our goal to build a leading women's health company."

Summary of first quarter financial results

Net revenue for the first quarter of 2015 totaled approximately $4.5 million compared with net revenue of approximately $2.8 million for the prior year's quarter, an increase of approximately 58 percent. Revenue growth during the first quarter was primarily driven by increased sales of the company's prenatal vitamin products and an increase in the average net sales price of the company's products.

Cost of goods sold increased to approximately $1.0 million for the three months ended March 31, 2015, compared with approximately $831,000 in the prior year's quarter.

Total operating expenses for the first quarter of 2015 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the first quarter of 2015 were approximately $18.2 million compared with approximately $5.9 million for the prior year's quarter, reflecting costs of the company's two ongoing phase 3 clinical trials, as well as scale-up and manufacturing activities for its novel hormone therapy products in development. SG&A expenses for the first quarter of 2015 were approximately $6.2 million compared with approximately $5.0 million for the first quarter of 2014, primarily as a result of increased personnel costs and legal and accounting expenses.

Non-operating income for the first quarter of 2015 included miscellaneous and interest income of approximately $28,000, compared with a non-operating loss of approximately $232,000 during the prior year's quarter. The non-operating loss during the first quarter of 2014 included financing costs of approximately $260,000.

Net loss for the first quarter of 2015 was approximately $20.9 million, or $0.13 per basic and diluted share, compared with approximately $9.2 million, or $0.06 per basic and diluted share, for the first quarter of 2014.

At March 31, 2015, TherapeuticsMD had cash on hand of approximately $91.7 million, compared with approximately $51.4 million at December 31, 2014. In February 2015, the company completed a public offering of shares of its common stock for net proceeds of approximately $59.1 million.

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 and webcast include:

Date: Tuesday, May 5, 2015

Time: 4:30 p.m. EDT

Telephone Access (US): 866-665-9531

Telephone Access (International): 724-987-6977

Access Code for All Callers: 28458424

Additionally, a live webcast can be accessed on the company's website, www.therapeuticsmd.com, under the "Investor" section.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its patented SYMBODA™ technology platform, 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 clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the vitaMedMD^® and BocaGreenMD^® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.

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; 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.

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