On November 2, 2017 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, reported financial results for the third quarter of 2017 and provided a corporate update on its priorities for the remainder of the year (Press release, Apricus Biosciences, NOV 2, 2017, View Source [SID1234521509]).
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“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.”
Recent Highlights
Apricus continues to execute on its corporate strategy as highlighted below:
Vitaros (alprostadil)
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.
RayVa (alprostadil)
Continued a partnering process to secure a global or regional RayVa partnership prior to initiating a Phase 2b clinical study.
Corporate/Financial
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.