NEW YORK, NY / ACCESSWIRE / November 7, 2017 / SeeThruEquity, a leading independent equity research and corporate access firm focused on small-cap and micro-cap public companies, today announced it has issued an update note on Apricus Biosciences, Inc. and maintained its target price of $4.30.
The report is available here: APRI Update Note.
Based in San Diego, CA, Apricus Biosciences, Inc. (NASDAQ: APRI) is a biopharmaceutical company developing novel therapies focused on unmet needs in urology and rheumatology. Apricus has two product candidates currently in development: 1) Vitaros™ for erectile dysfunction (ED), and 2) RayVa™ for symptoms associated with Raynaud's Phenomenon secondary to systemic sclerosis.
On November 2, 2017, Apricus reported 3Q17 results and provided a corporate update to investors. Highlights during 3Q17 include:
- Apricus completed the NDA re-submission with the FDA for its lead product Vitaros™ for erectile dysfunction (ED)
- The FDA acknowledged receipt and the PDUFA goal date is February 17, 2018
- Management stated that it has maintained a "productive dialogue" with Allergan regarding the commercial potential for Vitaros™ should the company receive approval.
- Apricus secured $3.1mn in net funding through a private placement, which is expected to provide runway through 2018.
Vitaros™ PDUFA set at February 17, 2018
The resubmission of the New Drug Application (NDA) for its lead therapeutic candidate, Vitaros™ (Alprostadil/DDAIP.HCl) for erectile dysfunction (ED) is a key milestone on the pathway towards a possible FDA approval for Vitaros™. The FDA has set a PDUFA goal date of February 17, 2018. While there is always uncertainty in the drug approval process, the PDUFA goal date is the date by which the FDA should review new drug applications.
If approved, Vitaros™ would be differentiated in the ED market as a non-PDE-5 treatment, making a new alternative available for patients who prefer an on-demand, locally acting treatment, versus an oral treatment, as well as a treatment for patients who are either non-responsive to PDE-5 treatments, or have health concerns / experience side effects from PDE-5s. We see the FDA decision for Vitaros as the key catalyst for the company in coming months. There is a significant market opportunity for ED drugs in the United States. Over 20mn men in the US have ED, according to the American Journal of Medicine, and the market size for ED drugs is estimated at $3.5 billion by IMS Database. Apricus estimated peak sales potential in the US at $350mn.
Continuing "productive" dialogue with Allergan
Apricus has the potential to benefit from an existing deal with Allergan, in which Allergan retains a one-time opt-in right upon FDA approval to assume future marketing and selling activities. Should Allergan choose to exercise this right, Apricus stated that it may receive up to $20mn in upfront license fees, $5mn in potential milestone payment, plus an ongoing double-digit royalty on sales. We believe Allergan has up to 60 days following an FDA decision to exercise this option. With a strategic partner with the scale, brand recognition, and distribution of Allergan, this deal has the potential to create value for Apricus, if the option is exercised.
Maintain price target of $4.30
Our price target for Apricus remains $4.30 as we await developments on the upcoming FDA decision on Vitaros™, expected in 1Q18. Other potential catalysts include ongoing partnership explorations for Phase 2b candidate RayVa™, and other potential partners should Allergan pass on its option to commercialize Vitaros™.
Please review important disclosures on our website at www.seethruequity.com.
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. Apricusbio.com.
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