Company to Focus on Vitaros® Revenue Growth, U.S. NDA Re-Submission and Additional Commercial Launches in Europe, Latin America and the Middle East
Company Announces a 30% Reduction in Staff and Cash-Based Operating Expenses
SAN DIEGO, April 06, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, updated its strategic objectives today to include its plans to prioritize the Vitaros® commercial and regulatory activities and to deprioritize all other pipeline programs. This strategic re-positioning focuses on achieving profitability through Vitaros ex-U.S. revenue growth, obtaining approval for Vitaros in the U.S. and substantially reducing operating expenses.
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).
“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,” said Richard Pascoe, Chief Executive Officer of Apricus. “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.”
Apricus expects to provide further details regarding its strategic priorities during its upcoming May conference call to discuss its Q1 2016 financial results. Apricus’ SEC filings can be found on the Company’s website at www.apricusbio.com and on the SEC’s website at www.sec.gov.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. In September 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus’ marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH, Recordati Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring Pharmaceuticals), Mylan NV and Elis Pharmaceuticals Ltd. Apricus currently has one active product candidate, RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon.
For further information on Apricus, visit http://www.apricusbio.com.
*Vitaros® is a registered trademark of NexMed International Limited. Such trademark is registered in certain countries throughout the world and pending registration in the United States.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: Apricus’ plans to grow revenues for Vitaros® outside the United States, the timing of regulatory submission and approval of Vitaros in the United States, if any; Apricus’ plans for life-cycle development programs for Vitaros; Apricus’ development and partnering plans for RayVa™; and Apricus’ plans to streamline the Company, reduce operating expenses and achieve profitability. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: the risk that the cost and other negative effects related to the reduction of Apricus’ workforce may be greater than anticipated; the risk that Apricus may not realize the benefits expected from the new strategic focus, workforce reduction and other cost control measures; Apricus’ dependence on its commercial partners to carry out the commercial launch or grow sales of Vitaros in various territories and the potential for delays in the timing of commercial launches in additional countries; competition in the erectile dysfunction market and other markets in which Apricus and its partners operate; Apricus’ ability to obtain FDA and other requisite governmental approval for Vitaros; Apricus’ ability to further develop Vitaros, such as delivery device improvements; Apricus' ability to carry out further clinical studies for Vitaros, if required, as well as the timing and success of the results of such studies; Apricus’ ability to achieve U.S. and EU Orphan Designation for RayVa; Apricus’ ability to retain and attract key personnel; Apricus’ ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus’ ability to remain in compliance with the terms and restrictions under the credit facility; Apricus’ ability to secure an ex-U.S. strategic partner for RayVa; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus’ most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC’s website at www.sec.gov or without charge from Apricus.
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