Vitaros U.S. NDA Resubmission Review Remains on Track
PDUFA Goal Date of February 17, 2018
Conference Call / Webcast Today, November 2, 2017 at 4:30 p.m. ET
SAN DIEGO, Calif., Nov. 02, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported financial results for the third quarter of 2017 and provided a corporate update on its priorities for the remainder of the year.
“In the third quarter of this year, we continued to execute on our key corporate objectives by filing the U.S. Vitaros NDA resubmission with the FDA and improving our financial outlook, resulting in a balance sheet that is expected to fund our current operating plan through the end of 2018,” stated Richard W. Pascoe, Chief Executive Officer. “Importantly, the FDA acknowledged receipt of our resubmission and our PDUFA goal date is February 17, 2018. For the remainder of 2017, we will focus on working with the FDA regarding the Vitaros NDA, maintaining a productive dialogue with Allergan regarding the commercial potential for Vitaros in the United States, securing a development partner for RayVa, and continuing to diligently manage our corporate resources.”
Apricus continues to execute on its corporate strategy as highlighted below:
- Resubmitted Vitaros NDA to the FDA, which Apricus believes addressed all issues raised by the FDA’s complete response letter to the original Vitaros NDA submission; specifically, all safety, chemistry, manufacturing and control (CMC) related issues; and
- Completed the transition of the Vitaros ex-US rights and assets to Ferring International. Apricus received the final $0.25 million payment related to transition services during the third quarter of 2017.
- Continued a partnering process to secure a global or regional RayVa partnership prior to initiating a Phase 2b clinical study.
- Closed a private placement of common stock and warrants for net proceeds of approximately $3.1 million.
Third Quarter and Year-to-Date Financial Results
Net loss for the quarter ended September 30, 2017 was $3.8 million, or loss per share of $0.29, compared to a net loss of $1.3 million, or loss per share of $0.19, for the third quarter of 2016. Net loss during the third quarter of 2017 was primarily due to the $1.5 million regulatory milestone payment made to Allergan upon the FDA’s acknowledgment of our Vitaros NDA resubmission, Vitaros commercial preparation activities, as well as other general and administrative expenses.
Net income for the nine months ended September 30, 2017 was $2.8 million, or income per share of $0.26, compared to a net loss of $7.1 million, or loss per share of $1.17, for the third quarter of 2016. Net income during the nine months ended September 30, 2017 was primarily due to the $12.3 million gain recorded for the sale of our ex-U.S. Vitaros rights and assets to Ferring.
For all periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations. As of September 30, 2017, the Company’s cash totaled $8.5 million, compared to $2.1 million as of December 31, 2016.
Conference Call Details
Apricus will host a live conference call and webcast today at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a corporate update. To participate by telephone, please dial (855) 780-7196 (Domestic) or (631) 485-4867 (International). The conference ID number is 8498419. The live and archived audio webcast can be accessed through the Investors Relations’ section of the Company’s website at www.apricusbio.com. Please log in approximately five to ten minutes before the event to ensure a timely connection. The archived webcast will be available for 30 days following the live call.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates currently in development. Vitaros is a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan). RayVa is our product candidate in Phase 2 development for the treatment of the circulatory disorder Raynaud’s phenomenon, secondary to scleroderma, for which we own worldwide rights.
For further information on Apricus, visit http://www.apricusbio.com.
Vitaros™ is Apricus’ trademark in the United States, which is pending registration and subject to the agreement with Allergan. Vitaros® is a registered trademark of Ferring International Center S.A. in certain countries outside of the United States. RayVa™ is Apricus’ trademark, which is registered in certain countries throughout the world and pending registration in the United States.
Forward Looking Statements
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: the timing of regulatory review and approval of the Vitaros NDA in the United States, if any; Apricus’ partnering plans for RayVa; discussions with Allergan regarding the commercial potential for Vitaros ; and Apricus’ management of resources and strategic objectives. 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: Apricus’ ability to obtain FDA and other requisite governmental approval for Vitaros; the FDA could require additional clinical and pre-clinical data; Apricus’ ability to have addressed any conditions for approvability raised by the FDA in the 2008 complete response letter or the FDA identifying other deficiencies in the resubmission; risks related to the possibility of an advisory committee meeting related to 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; the failure to remain in compliance with NASDAQ continued listing requirements which could result in Apricus’ common stock being delisted from the exchange; 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 secure a strategic partner for RayVa; competition in the erectile dysfunction market and other markets in which Apricus operates; 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.
(Financial Information to Follow)
The Trout Group
|Selected Financial Information|
|Condensed Consolidated Statements of Operations|
|(In thousands, except per share amounts)|
|Three Months Ended|
|Nine Months Ended|
|Research and development||$||(1,960||)||$||(170||)||$||(3,226||)||$||(5,274||)|
|General and administrative||(1,756||)||(1,550||)||(4,799||)||(5,878||)|
|Total other income (expense)||(293||)||124||(1,125||)||3,808|
|Loss from continuing operations||(4,009||)||(1,596||)||(9,150||)||(7,344||)|
|Income from discontinued operations||177||305||11,917||210|
|Net income (loss)||$||(3,832||)||$||(1,291||)||$||2,767||$||(7,134||)|
|Basic and diluted earnings (loss) per share|
|Total earnings (loss) per share||$||(0.29||)||$||(0.19||)||$||0.26||$||(1.17||)|
|Weighted average common shares outstanding for basic and diluted earnings (loss) per share||13,208||6,632||10,781||6,108|
|Condensed Consolidated Balance Sheets|
|Other current assets||216||177|
|Property and equipment, net||100||164|
|Other long term assets||35||60|
|Assets of discontinued operations||$||9||$||2,212|
|Liabilities and stockholders’ equity (deficit)|
|Current liabilities of discontinued operations||101||2,108|
|Notes payable, net||—||6,650|
|Other long term liabilities||54||76|
|Stockholders’ equity (deficit)||6,319||(7,516||)|
|Total liabilities and stockholders’ equity (deficit)||$||8,823||$||4,700|