“We are excited about the great progress we have made in the past 5 months to execute our diversification plan by advancing our multiple drug candidates that address large markets as well as to find new sources of immediate revenue,” said Mitchell Steiner, MD, President and Chief Executive Officer of
“We recently announced the successful completion of the first stage of our clinical trial for our proprietary slow releasing powder, Tamsulosin Delayed Release Sachet (DRS), for men with benign prostatic hyperplasia (enlarged prostate) that have difficulty swallowing tablets or capsules. Our bioequivalence (BE) trial results demonstrated that Tamsulosin DRS could have benefits over FLOMAX and tamsulosin generics as it does not have to be administered after a meal and may be taken on an empty stomach. The 2nd stage of the BE trial is set to commence soon. We remain on track for a New Drug Application submission in early 2018 with an expected approval sometime in the second half of 2018. This product utilizes a potentially lower cost, lower risk and expedited approval pathway.”
“In addition to this clinical development milestone, our commercial team is working hard. I am pleased to report that the infrastructure for FC2 prescription business in now in place. FC2 is being distributed by many of the largest US healthcare distributors, making FC2 immediately available by prescription through retail pharmacies. Our marketing and sales team is also in place, and we expect to recognize revenue from the prescription business starting in fiscal Q3 2017. This is a new revenue opportunity for us, and we believe it has significant potential to contribute meaningful gross profit in the near-term.”
“We anticipate submitting with FDA an Investigational New Drug application for our proprietary oral drug candidate MSS-722 for the treatment of male infertility. There are no FDA approved oral therapies for male infertility. In addition, we will be meeting with the FDA in May for a pre-IND meeting for APP-944 for the treatment of hot flashes in men with advanced prostate cancer who are receiving hormonal therapies. Hot flashes are the most common and most distressing side effect reported by these men. These drug candidates can also utilize a potentially lower cost, lower risk and expedited approval pathway.”
Commenting on the Company’s financial results, Dr. Steiner said: “Our financial performance continues to be impacted by significant fluctuations in public sector orders for FC2. Net revenues were lower, largely due to the global decline in budgets for public sector healthcare products and reduced donor contributions. The financial results are further skewed when compared to last year’s second quarter, as it included the larger than usual amount of FC2 shipments to the
Significant quarter-to-quarter variations in the Company’s results have historically resulted from the timing and shipment of large orders rather than from any fundamental changes in the business or the underlying demand for female condoms. Two of the largest customers for FC2 operate in markets where the government health ministries are either still under a multi-year tender or have had a multi-year tender recently expire, and as a result significant orders from these customers during the remainder of fiscal 2017 are unlikely. The Company is also currently seeing pressure on spending for FC2 by large global agencies and donor governments in the developed world.
More information about the Company and its products can be found at www.PREBOOST.com and www.fc2femalecondom.com. For corporate and investor-related information about the Company, please visit https://veruhealthcare.com/investors.
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Contact: Kevin Gilbert: 312-366-2633
Press Release Kari Sharp