IRVINE, Calif.--(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2016, along with a general business update.
Aerie Highlights and Outlook
Rhopressa™ (netarsudil ophthalmic solution) 0.02% NDA (new drug application) filing was resubmitted on February, 28, 2017, with a standard one-year FDA review expected from the date of resubmission.
Topline six-month efficacy and safety data from Rocket 4, the Rhopressa™ Phase 3 clinical trial designed to provide adequate safety data for European regulatory filings, are expected in the second quarter of 2017.
Topline 90-day efficacy and safety data from the second Phase 3 clinical trial for Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, named Mercury 2, are also expected in the second quarter of 2017. If both Mercury 1 and Mercury 2 are successful, the Roclatan™ NDA is expected to be filed in late 2017 or early 2018.
As of December 31, 2016, Aerie had $233.7 million in cash, cash equivalents, and investments. For the full year ended December 31, 2016, cash burn totaled $84.9 million, in line with our previous guidance of $85 million.
Cash burn for 2017 is expected to approximate $100 million and includes the previously announced $16 million in Ireland manufacturing plant capital build-out costs. Projected operating expenses for 2017 are similar to 2016, with increased commercialization and scale-up expenses offset by reductions in clinical spend.
