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Aerie Pharmaceuticals Reports Third Quarter 2015 Financial Results And Provides Business Update

The following excerpt is from the company's SEC filing.

- Based on FDA Meetings, Company Expects to File Rhopressa

NDA in 3Q 2016 -

Conference Call and Webcast Today, November 3, at 5:00 p.m. ET

IRVINE, California - (

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 third quarter ended September 30, 2015, along with a general business update.

Aerie Highlights

Based on multiple discussions with the FDA, including a recently concluded Type 2 Pre-NDA meeting, Aerie expects to file its NDA for once-daily Rhopressa

in the third quarter of 2016 utilizing the successful Rocket 2 Phase 3 clinical trial results as pivotal, with the Rocket 1 Phase 3 trial results representing supportive data.

Rocket 4, the fourth Rhopressa

Phase 3 clinical trial, is underway and is designed to provide adequate six-month safety data for regulatory filing in the EU, and also provide additional clinical data on this product candidate. The NDA filing in the U.S. is not contingent upon receipt of any Rocket 4 results, including the 90-day efficacy results which are expected in approximately one year.

Mercury 1, the first Phase 3 registration trial for Roclatan

, is also underway. Roclatan

has shown in Phase 2b results to have the potential to be the most efficacious therapy in lowering intraocular pressure.

Research collaborations are in full execution mode with GrayBug, Inc., focused on drug delivery technology, and with Ramot at Tel Aviv University, focused on their preclinical small molecule anti-beta amyloid product candidate for neuroprotection and dry age-related macular degeneration.

As of September 30, 2015, Aerie continues to be well-financed, with $163 million in cash, cash equivalents and investments on the balance sheet.

We are very pleased with the progress of our ongoing discussions with the FDA, and are now actively preparing for what promises to be a very important step in Aeries advancement, the filing of our NDA for once-daily Rhopressa

in the third quarter of next year. Additionally, we are experiencing a high degree of physician interest in our Mercury 1 and Rocket 4 trials, and expect 90-day efficacy results for each trial approximately a year from now, said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. Additionally, our recently announced research collaborations with GrayBug for drug delivery technology and Ramot for their preclinical anti-beta amyloid small molecule product candidate are progressing very well.

Dr. Anido continued, We look forward to our investor and media event at noon Pacific Time on November 13, 2015, during the American Academy of Ophthalmology meeting in Las Vegas. At the meeting, we plan to cover further details on our Phase 3 clinical trial results for Rhopressa

, including a deeper dive into Rocket 2 results and regulatory considerations, along with updates on Roclatan

and our preclinical research programs.

Third Quarter 2015 Financial Results

As of September 30, 2015, Aerie had cash, cash equivalents and investments of $162.9 million, consistent with the prior quarters as the result of sales made under our at-the-market program, a component of the shelf registration statement filed in November of 2014. For the third quarter ended September 30, 2015, Aerie reported a net loss attributable to common stockholders, as measured in accordance with U.S. generally accepted accounting principles (GAAP), of $18.0 million, or $0.69 per share, compared to $13.1 million and $0.54 per share for the third quarter 2014. The weighted average number of shares of common stock outstanding utilized in the calculation of net loss per common share was 26,061,993 and 24,325,166 for the third quarters of 2015 and 2014, respectively.

The $18.0 million net loss attributable to common stockholders for the third quarter of 2015 includes $17.4 million in operating expenses, reflecting $9.9 million in research and development expenses and $7.5 million in general and administrative expenses. Excluding $3.3 million of non-cash stock-based compensation expense, adjusted operating expenses for the third quarter of 2015 were $14.1 million, with adjusted research and development expenses of $9.3 million and adjusted general and administrative expenses of $4.7 million. Total adjusted net loss for the third quarter of 2015 was $14.6 million and adjusted net loss per share was $0.56.

The $13.1 million net loss attributable to common stockholders for the third quarter of 2014 reflects research and development expenses of $8.2 million and general and administrative expenses of $4.9 million. Excluding $2.4 million of non-cash stock-based compensation expense, adjusted operating expenses for the third quarter of 2014 were approximately $10.8 million, reflecting adjusted research and development expenses of $8.0 million and adjusted general and administrative expenses of $2.8 million. Total adjusted net loss for the third quarter of 2014 was $10.8 million and adjusted net loss per share was $0.44.

The higher operating expenses in the third quarter of 2015 as compared to the third quarter 2014...


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