“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.
First Quarter ResultsNet revenue for the first quarter of 2014 totaled $2.8 million compared with net revenue of $1.5 million for the prior year quarter. The increase of approximately $1.3 million, or 84%, was directly attributable to an increase in the number of physicians writing prescriptions for our prenatal products, the increased productivity of our sales force, and an increase in the average net sales price of our product. Cost of goods sold increased by $450,000, or 118%, for the three months ended March 31, 2014 compared with the prior year quarter. Research and development expenses increased to $5.9 million for the first quarter of 2014 compared with $1.6 million for the first quarter of 2013 because of the development of our hormone therapy drug candidates and related clinical trials.