TherapeuticsMD Announces Second Quarter 2017 Financial Results

BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its financial results for the quarter ended June 30, 2017.

Second Quarter and Recent Developments

• Net revenue for the company’s prescription prenatal vitamin business was approximately $4.3 million for the second quarter of 2017 compared with approximately $4.4 million for the second quarter of 2016.
• Net loss was approximately $19.7 million for the second quarter of 2017, compared with approximately $21.1 million for the second quarter of 2016.
• Ended the quarter with approximately $96.5 million in cash and no debt.
• Participated in a Type A Post-Action Meeting on June 14, 2017 with the Division of Bone, Reproductive, and Urologic Products (DBRUP) of the FDA to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The Company has formally submitted additional information for consideration related to the NDA for TX-004HR and has been informed by the FDA that it will be receiving an Advice Letter within the next week outlining the FDA’s timing of its review of the submitted additional data.
• Pre-NDA meeting for TX-001HR, the company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause, scheduled with the FDA at the end of August 2017. The company anticipates that it will submit the NDA for TX-001HR in the fourth quarter of 2017.
• Dismissal without prejudice of the primary federal securities class action lawsuit recently filed against the company.
• Grew the company’s intellectual property portfolio to a current total of 158 patent filings, including 82 international filings, with one allowed and 17 issued U.S. patents.

“We continue to focus on advancing our pipeline of novel hormone therapies and, if approved, bringing new, differentiated treatment options to women suffering from symptoms of menopause,” said TherapeuticsMD CEO Robert G. Finizio.

Summary of Second Quarter 2017 Financial Results

Net revenue from the company’s prescription prenatal vitamin business was approximately $4.3 million for the second quarter of 2017 compared with net revenue of approximately $4.4 million for the prior year’s quarter. These changes were primarily due to a decrease in the number of units sold.

Cost of goods sold was approximately $0.7 million for the second quarter of 2017, compared with approximately $1.1 million for the prior year’s quarter.

Total operating expenses for the second quarter of 2017 included research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses for the second quarter of 2017 were approximately $8.7 million compared with approximately $13.8 million for the prior year’s quarter. The decrease in R&D expenses was a direct result of the completion of the REPLENISH Trial for TX-001HR. SG&A expenses for the second quarter of 2017 were approximately $14.6 million compared with approximately $10.6 million for the prior year’s quarter, primarily due to higher sales, marketing, regulatory expenditures, and personnel costs to support future commercialization.

Net loss for the second quarter of 2017 was approximately $19.7 million, or $0.10 per basic and diluted share, compared with approximately $21.1 million, or $0.11 per basic and diluted share, for the second quarter of 2016.

At June 30, 2017, cash on hand was approximately $96.5 million, compared with approximately $131.5 million at December 31, 2016.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, 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 late stage clinical pipeline includes two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD^® and BocaGreenMD^® brands.