TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company, ("TherapeuticsMD" or the "Company") today announced results for the three-month period and full-year ended December 31, 2013.
Fourth Quarter 2013 Highlights:
- Net revenue increased to $2.9 million compared with $1.2 million for the fourth quarter of 2012;
- Net loss increased to $8.4 million compared with a net loss of $5.7 million for the fourth quarter of 2012;
- Received approval ahead of schedule to screen and enroll subjects at the 50 th site in the REPLENISH Trial, a phase 3 clinical trial designed to measure the safety and efficacy of TX-12-001HR, our combination 17β-estradiol and natural progesterone drug candidate for the treatment of vasomotor symptoms in post-menopausal women;
- Initiated the SPRY Trial, a phase 3 clinical trial designed to evaluate safety and efficacy of TX-12-002HR, our oral progesterone drug candidate for the treatment of secondary amenorrhea;
- Announced positive results from two PK studies of TX-12-004HR, our estradiol VagiCap drug candidate, data from which suggests that VagiCap may be a similar but more effective product with less systemic exposure than Vagifem ®;
- Received patents for our platform technology (Symboda) and lead drug candidate, TX-12-001HR;
- Filed 11 additional patent applications, covering various aspects of our technology and drug candidates, to ensure patent exclusivity through 2032;
- Strengthened senior management team with appointments of Sebastian Mirkin, M.D., as Chief Medical Officer; Joel S. Krasnow, M.D., M.B.A., as Chief Scientific Officer and head of our regulatory department; and Randall S. Stanicky, CFA, to our Board of Directors; and,
- Closed out 2013 with $54.2 million in cash and cash equivalents, and no debt.
Robert G. Finizio, Co-Founder and Chief Executive Officer, stated, “This has been an exciting year for the Company, highlighted by advancements in clinical trials for our three principal hormone therapy drug candidates. The Drug Quality and Security Act was passed into law in November 2013, and the quick action of the FDA to implement and enforce the new law means that compounding pharmacies are now clearly governed by it. This law is a catalyst, and presents an opportunity to move the market from compounded bio-identical hormone replacement therapies, or BHRT, to an FDA-approved bioidentical drug market. We believe that we with our phase 3 REPLENISH Trial to evaluate our combination product well underway, we are well-positioned to capitalize on this new opportunity.