Aerie Pharmaceuticals, Inc. AERI reported third-quarter 2015 loss of 69 cents per share (including stock-based compensation), much narrower than the Zacks Consensus Estimate of a loss of 81 cents, but wider the year-ago loss of 54 cents.
Being a development-stage company, Aerie did not generate any revenue from product sales yet.
In the reported quarter, research and development (R&D) expenses were $9.9 million, up 20.3% year over year. General and administrative (SG&A) expenses increased 50.9% year over year to $7.5 million. The company stated that this increase in operating expenses was primarily driven by higher investments in pipeline development and associated growth in operations.
Pipeline Update
Aerie’s efforts to develop its pipeline are encouraging. The company remains on track to file for an FDA approval of Rhopressa (once-daily) for lowering intraocular pressure (IOP) in patients suffering from glaucoma or ocular hypertension in the third quarter of 2016.
Meanwhile, Rhopressa is in a fourth phase III study (ROCKET 4), which has been designed to provide six-month safety data required for filing for Rhopressa in the EU. 90-day efficacy results from the study should be out by mid-2016 with six-month efficacy data expected by the end of 2016. However, data from this study is not necessary for filing for the candidate in the U.S.
Meanwhile, another later-stage candidate in the company’s pipeline is Roclatan, which is in a phase III study (Mercury 1) for lowering IOP in patients with glaucoma or ocular hypertension. The company expects to commence another study on Roclatan (Mercury 2) in the second quarter of 2016. Aerie said that both Rocket 4 and Mercury 1 are running ahead of the company’s expectations in terms of patient enrolment. The company expects to submit a new drug application for Roclatan in the second half or later in 2017.
Fourth-Quarter 2015 Outlook
Aerie provided its outlook for expenses in the fourth quarter of 2015. The company expects a slight rise in expenses due to higher expenditure associated with the Rocket 4 and Mercury 1 studies.
Aerie carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector are UCB S.A. UCBJF, Spectrum Pharmaceuticals, Inc. SPPI and Alcobra Ltd. ADHD. While UCB and Spectrum Pharma carry a Zack Rank #1 (Strong Buy), Alcobra holds the same Zack Rank as Aerie.
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