It was a busy start to the week for TherapeuticsMD, Inc. (NASDAQ: TXMD), with the Boca Raton, Florida-based women’s healthcare company releasing results from the latest quarter and telling market participants that it is on track to re-submit the New Drug Application for TX-004HR to the U.S. Food and Drug Administration.
TX-004HR is an experimental 17β-estradiol vaginal oral drug for treating moderate-to-severe dyspareunia (vaginal pain) during sexual intercourse resulting from vulvar and vaginal atrophy in postmenopausal women. Estradiol is a hormone that, amongst other functions, is used to treat symptoms resulting from menopause of ovary removal.
In May, the FDA rejected TherapeuticsMD’s drug candidate on concerns over long-term safety data. Shares hit a more than two-year low at $3.50 on the news.
After meeting with the FDA in November, the agency said TherapeuticsMD could resubmit the NDA without conducting another pre-approval trial. Instead, the company will have to conduct an observational study following marketing approval. The application is expected to be submitted in the coming weeks with a decision anticipated from the FDA in two to six months.
On the finances front, the company posted net revenue from its prescription prenatal vitamins business of $4.4 million in the third quarter ended September 30, 2017. That was down from $5.5 million in the year prior quarter. The company blamed lower average prices for its products coupled with slightly lower sales volumes on the drop in revenue.
Net loss during the quarter contracted to $14.7 million, or seven cents per share, from about $25.0 million, or 13 cents per share, in Q3 2016. The company spent $8.3 million less on R&D in the recent quarter compared to a year earlier thanks to completing a clinical trial of TX-001HR for vasomotor symptoms related to menopause. On average, analysts expected a net loss of 9 cents per share.
The quarter ended with TherapeuticsMD having $148.3 million in cash and no debt.
Shares gapped ahead from Friday’s close at $4.36 to open Monday at $6.03. At the lunch hour, shares are holding a gain of 42.8% at $6.22.
