Aerie Pharmaceuticals Reports Third Quarter 2016 Financial Results And Provides Business Update

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 third quarter ended September 30, 2016, along with a general business update.

Aerie Highlights
  • Recent study data from Rhopressa TM (netarsudil ophthalmic solution) 0.02% and Roclatan TM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% provide confirmatory insights into how these novel product candidates, if approved, can benefit patients with glaucoma or ocular hypertension.
  • In addition to the positive Mercury 1 and Rocket 4 clinical trial results, the results of a recently completed week long 12-patient pilot study demonstrated consistent lowering of intraocular pressure (IOP) for Rhopressa TM over a 24-hour period. The study suggests Rhopressa TM has the unique potential to provide meaningfully better nocturnal IOP-lowering than currently marketed products.
  • The Company expects to resubmit Rhopressa TM New Drug Application (NDA) in January of 2017 upon notification from finished product contract manufacturer of their readiness for pre-approval inspection by the FDA.
  • Strategic plans for Rhopressa TM and Roclatan TM in Europe and Japan continue to advance, and preclinical studies of AR-13154 for wet AMD, and delivery technology for front and back of the eye are progressing.
  • As of September 30, 2016, Aerie had $255.6 million in cash, cash equivalents, and investments on the balance sheet, and 33.4 million shares outstanding. For the nine months ended September 30, 2016, cash burn totaled $62.4 million, on track with current full-year guidance of $85 million.

"We have made significant progress since we closed the second quarter, including the read-out of the successful Mercury 1 topline results for Roclatan TM, and most recently the successful Rocket 4 topline results for Rhopressa TM. During the third quarter, we also significantly added to our financial resources, with over $255 million of cash and investments at quarter-end. Further, regarding our upcoming Rhopressa TM NDA resubmission, we expect to add the positive topline results from both Mercury 1 and Rocket 4 as substantive supportive data to what will already be a robust filing," said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer.

Dr. Anido continued, "We believe the results of our recently completed week-long study to evaluate nocturnal IOP lowering for Rhopressa TM point to another potentially unique feature of the drug. In this week long 12-patient placebo-controlled study that included eight subjects on Rhopressa TM, we noted that Rhopressa TM maintained the same clinically significant IOP lowering throughout the night as it did during the day. This is meaningfully different than latanoprost, which is reported to be less effective at night compared to the day 1, 2, as well as timolol and brimonidine, which multiple studies have shown provide little if any nocturnal IOP lowering. 1, 2, 3, 4,5, 6"

1. Liu JH, et al. Am J Ophthalmol. 2004; 138:389-395.

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