New Update: Apricus Biosciences, Inc. (NASDAQ CM: APRI)
SeeThruEquity Issues Company Update on Apricus Biosciences (NASDAQ: APRI) with Target Price of $4.30
October 3, 2017
Based in San Diego, CA, Apricus Biosciences, Inc. (Nasdaq CM: 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. We are updating our coverage of Apricus following recent accomplishments at the company, which include regaining compliance with the Nasdaq CM this spring, successful new capital raising activities, and the resubmission of the Vitaros™ New Drug Application (NDA) with the United States Food and Drug Administration (FDA).
We are updating our price target to $4.30 reflecting these initiatives, as well as results and an updated share count since the last company note. We see several near-term catalysts ahead for Apricus, most importantly the FDA decision for its Vitaros™ resubmission - Apricus has already received its PDUFA date which is February 17, 2018.
Resubmission of NDA for Vitaros™ a significant milestone
On August 31, 2017, Apricus announced that the FDA had acknowledged receipt of the company's resubmission of its New Drug Application (NDA) for its lead therapeutic candidate, Vitaros™ (Alprostadil/DDAIP.HCl) for erectile dysfunction (ED). This is a significant accomplishment by management and a key milestone on the pathway towards a possible FDA approval for Vitaros™. 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. Additionally, Vitaros™ would provide a treatment for patients who are either non-responsive to PDE-5 treatments, or have health concerns / experience side effects from PDE-5s.
If approved Vitaros™ could be commercialized in multi-billion dollar ED market by end of 2018
We note that 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 is estimating peak sales potential in the US at $350mn, and expects to receive feedback on the resubmission of its NDA for Vitaros™ from the FDA following a six-month review period, which suggests that the drug could potentially be approved by the end of 1Q18, with commercialization possible by the end of the year.
Moreover, 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 may receive up to $25mn in upfront and potential regulatory milestones, plus an ongoing double-digit royalty on sales. 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.
Updating price target to $4.30
We are updating our price target for Apricus to $4.30. The new target reflects recent events at the company, an improved balance sheet, and the upcoming FDA decision on Vitaros™ expected in 1Q18.
Please review important disclosures on the company's website at www.seethruequity.com.
Click here for the entire press release: APRI Press Release
Click here for the update note: APRI Update Note
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DISCLOSURE
See www.seethruequity.com for important disclosures.
