After reviewing the potential for our current assets with our Board of Directors and our larger shareholders following the disappointing fispemifene Phase 2b study results, we have decided to focus only on the priorities that we believe are most likely to generate strategic value, while reducing our capital needs.
Strategic Corporate Objectives:
Focus on Vitaros Growth
Re-submit U.S. NDA with the FDA in Q3 2016, with potential approval in 1H 2017;
Continue to support existing commercial partners’ efforts to increase revenue in 2016 and beyond; and
Expand Vitaros availability in Europe, Latin America and the Middle East, targeting approximately ten new country launches in 2016 and 1H 2017 through our commercialization partners.
Rationalize the Development Pipeline
Immediately discontinue all ongoing fispemifene clinical activities on secondary hypogonadism and deprioritize work for other indications;
Continue Vitaros delivery device improvements; and
Finalize the RayVa™ Phase 2b delivery device and study protocol, explore U.S. and EU Orphan Designation, and partner ex-U.S. prior to initiating any future clinical studies.
Significantly Reduce Operating Expenses
Reduce staff, including the executive team, by approximately 30%;
Reduce Board of Directors expenses by decreasing the size of the Board and reducing the Board’s cash compensation; and
Reduce operating expenses (excluding non-cash stock-based compensation expense and depreciation expense) by approximately 30% in 2016 and 60% in 2017 as compared to 2015 operating expenses (excluding non-cash stock-based compensation expense and depreciation expense).
Apricus’ development priority is now focused on Vitaros, both to accelerate commercialization outside of the U.S. and to attempt to bring this novel erectile dysfunction therapy to patients in the U.S. next year, with the goal of achieving profitability in 2017. I would like to express my sincere gratitude to the talented employees affected by the reduction in force and to our valued employees who remain committed to our long-term success.
As always, thank you for your continued support and interest in Apricus Biosciences.