TherapeuticsMD (TXMD) Reports In-Line Q1 Loss

TherapeuticsMD (AMEX: TXMD) reported Q1 EPS of ($0.06), in-line with the analyst estimate of ($0.06). Revenue for the quarter came in at $2.8 million versus the consensus estimate of $3.08 million.

Robert G. Finizio, Co-Founder and Chief Executive Officer, stated, “This has been a busy and exciting quarter for us, highlighted by advancements in clinical trials for our principal hormone therapy drug candidates. Our two largest commercial opportunities are our investigational combination estradiol and progesterone (E+P) therapy for treatment of vasomotor symptoms in menopausal women, and estradiol VagiCap for VVA. We remain on track to complete enrollment this fall in the E+P phase 3 trial, where enrollment is strong and patient retention is positive. Pending a successful trial, the U.S. Food and Drug Administration's (FDA) approval of our E+P drug candidate, we will be well positioned as a first-mover in this multi-billion dollar market to introduce and capitalize on what could be the first safe and effective bioidentical combination hormone therapy product for menopausal women.”

“We are equally excited about the opportunity in VVA. This market more than doubled over the last five years to $1.1 billion in 2013 without any generic options. Our phase 3 VVA clinical trial is designed to assess the ability of our estradiol VagiCap, which leverages our solubilized lipid-based technology to achieve new, lower effective doses that could potentially reduce or eliminate systemic exposure to estradiol. Our goal is to bring to market an innovative VVA drug candidate with a focus on a positive qualitative user experience for menopausal women, while achieving an improved therapeutic profile,” continued Mr. Finizio.

“Our progesterone-only drug candidate for the treatment of secondary amenorrhea is currently undergoing a phase 3 clinical trial, called the SPRY trial. This clinical trial has faced recruiting challenges. To remedy these challenges, we are meeting with the FDA in early June 2014 to discuss potential changes to our inclusion and exclusion criteria.”

“In summary, an increasingly receptive regulatory environment, our promising product pipeline and strong cash position all are contributing to a positive outlook for the Company and we look forward to our ongoing progress in the important field of women’s health care,” Mr. Finizio concluded.

For earnings history and earnings-related data on TherapeuticsMD (TXMD) click here.

You May Also Be Interested In

• Visa (V) stock rises as Q2 earnings, revenue come ahead of estimates
• Thermo Fisher Scientific (TMO) Tops Q1 EPS by 40c, raises guidance
• Vertiv Holdings Co. (VRT) Tops Q1 EPS by 7c ; Offers Guidance