TherapeuticsMD's fourth quarter 2013 net revenue increases to $2.9 million

Mar 4 2014

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.

"We have strengthened our Board and management team, which will support and guide us as we continue our evolution as a publicly traded company. Our robust pipeline and strong cash position also contribute to a positive outlook for the Company, and we look forward to our ongoing progress," Finizio concluded.

Fourth Quarter Results

Net revenue for the fourth quarter of 2013 totaled $2.9 million compared with net revenue of $1.2 million for the year ago quarter. The increase of approximately $1.7 million, or approximately 130%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, an increase in the average net sales price of our product, and new prescription products introduced in March, April, May, and November 2012. Cost of goods sold increased by $134,000, or 40.4%, for the three months ended December 31, 2013 compared with the prior year quarter. Research and development expenses increased to $5.8 million for the fourth quarter of 2013 compared with $1.4 million for the fourth quarter of 2012, because of costs incurred in the development of our new hormone replacement therapy and prescription prenatal products. Sales, general, and administrative expenses decreased to $4.6 million for the fourth quarter of 2013 compared with $4.9 million for the fourth quarter of 2012. As a result, our operating loss was $8.0 million for the fourth quarter of 2013 compared with $5.4 million for the fourth quarter of 2012.

Other non-operating expenses increased by approximately $36,000 for the fourth quarter of 2013 compared with the comparable quarter in 2012. This increase was primarily a result of non-cash financing costs incurred during the current period totaling approximately $396,000, partially offset by a decrease in interest expense of approximately $520,000 and loss on extinguishment of debt of approximately $197,000.

As a result, net loss for the fourth quarter of 2013 was $8.4 million, or $0.06 per basic and diluted share, compared with a net loss of $5.7 million, or $0.06 per basic and diluted share, for the fourth quarter of 2012.

Full Year Results

Net revenue for the year ended December 31, 2013 totaled $8.8 million compared with net revenue of approximately $3.8 million for the year ended December 31, 2012. The increase of approximately $5.0 million, or approximately 130%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, an increase in the average net sales price of our product, and new prescription products introduced in March, April, May and November 2012. Cost of goods sold increased by approximately $611,000, or 45%, for the full year ended December 31, 2013 compared with the prior year period. Research and development expenses increased to $13.5 million for 2013, compared with $4.5 million for 2012 because of costs incurred in the development of our new hormone therapy drug candidates. Sales, general, and administrative expenses increased to $19.0 million for 2013 compared with $14.1 million for the prior year. As a result, our operating loss was $25.8 million for the year ended December 31, 2013 compared with $16.1 million for the year ended December 31, 2012.

Other non-operating expenses decreased by $16.4 million for the year ended December 31, 2013 compared with the prior year. This decrease resulted primarily from a reduction in financing related costs.

As a result, net loss for the full year ended December 31, 2013 was $28.4 million, or $0.22 per basic and diluted share, compared with a net loss of $35.1 million, or $0.38 per basic and diluted share, for the year ended December 31, 2012.

Cash and cash equivalents were $54.2 million at December 31, 2013.