The company announced in its results that it is preparing to launch its NATESTO in the United States in partnership with Aytu BioScience.
Acerus Pharmaceuticals (TSX:ASP, OTCQB:ASPCF) has reported its Q3 2019 financial results for the quarter ended September 30, 2019.
As quoted in the press release:
Third Quarter Highlights
- Preparing for United States launch under Amended and Restated License Agreement (“A&R Agreement) with Aytu BioScience to co-promote NATESTO® in the USA
- Reported positive clinical study results showing that NATESTO® increases serum testosterone and improves symptoms while maintaining normal semen parameters in men with low testosterone
“In anticipation of the closing of the A&R Agreement, we have begun the process of standing-up both a US market access team and specialty sales organization to co-promote NATESTO® to the United States market. This expansion of our footprint to enter the United States market confirms our men’s health strategy and truly establishes Acerus as a globally focused company headquartered in Canada, not just a company servicing the Canadian marketplace”, said Ed Gudaitis, President and Chief Executive Officer of Acerus. “We are also excited about the results of a clinical study showing that NATESTO® increases serum testosterone and improves symptoms while maintaining normal semen parameters in men with low testosterone. This positive study, presented initially by Dr. Ranjith Ramasamy, MD, Associate Professor and Director of Reproductive Urology at the University of Miami School of Medicine, at the American Society for Reproductive Medicine Conference on October 17, 2019, and subsequently at an Acerus Key Opinion Leader presentation in New York City on October 30, 2019, clearly differentiates NATESTO® from other approved testosterone therapies. We are very excited by the outcomes of this study and will look to further develop the growing evidence-base supporting NATESTO®.”
Summary of Results for the Three Months Ended September 30, 2019 (compared to the Three Months Ended September 30, 2018 unless otherwise noted)
Total revenue in the quarter was negative $0.2 million compared to $1.6 million in the third quarter of 2018. This decline is due to a $0.8 million drop in Estrace® and UrivarxTM product revenues and the net impact of $0.6 million in Q3-2019 for returns associated with the delay in returning NATESTO® to the Canadian and South Korean markets (previously it was assumed that the product would be replaced rather than returned) and reversing the Q2-2019 $0.1 million charge to revenue discounts for incentives to customers to accept replacement product.