It has been about a month since the last earnings report for Aerie Pharmaceuticals, Inc. . Shares have lost about 12.9% in that time frame, underperforming the market.
Will the recent negative trend continue leading up to the stock’s next earnings release, or is it due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts.
Aerie Q4 Loss Widens, Rhopressa NDA Resubmitted
Aerie posted fourth-quarter 2016 loss of $0.87 per share (including stock-based compensation), wider than both the Zacks Consensus Estimate of a loss of $0.65 and the year-ago loss of $0.76.
Being a development-stage company, Aerie has not generated any revenues from product sales yet.
Quarter in Detail
In the reported quarter, research and development expenses were up 14.5% to $14.1 million. Adjusted general and administrative expenses escalated 91.7% to $14.7 million.
The higher operating expenses in the reported quarter were due to expansion of the employee base to support clinical activities and preparatory activities associated with commercialization efforts.
Pipeline Update
The company resubmitted its NDA for lead candidate Rhopressa 0.02% on Feb 28 and expects a review period of 12 months. We note that Aerie withdrew its Rhopressa NDA (new drug application) that was filed in September as a third party manufacturing facility in Tampa, FL was not ready for pre-approval inspection by the FDA.
The company expects topline six-month efficacy and safety data from the phase III trial, Rocket 4, on Rhopressa in second-quarter 2017. The trial is being conducted to provide adequate safety data for European regulatory filings.
Apart from Rhopressa, Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Xalatan. The company expects topline 90-day efficacy and safety data from the second phase III clinical trial, Mercury 2, for Roclatan 0.02%/0.005%, in second-quarter 2017. Data from Mercury 1 is expected in third-quarter 2017. If Mercury 1 and Mercury 2 are successful, the NDA for Roclatan is expected to be filed in late 2017 or early 2018.
The company also expects to commence a trial, Mercury 3, in Europe to support filings there. The trial will be a non-inferiority trial comparing Roclatan to prescribed fixed dose combination that is Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan in Europe.
In September, Aerie reported the successful 90-day primary efficacy results of its phase III Mercury 1 clinical trial for its fixed-dose combination product candidate, Roclatan which is being developed for IOP in patients with glaucoma or ocular hypertension.
How Have Estimates Been Moving Since Then?
Analysts were quiet during the last one month period as none of them issued any earnings estimate revisions.
VGM Scores
Currently, Aerie's stock has a subpar Growth Score of 'D', though it is lagging a bit on the momentum front with an 'F'. Charting a somewhat similar path, the stock was allocated a grade of 'D' on the value side, putting it in the bottom 40% for this investment strategy.
Overall, the stock has an aggregate VGM Score of 'F'. If you aren't focused on one strategy, this score is the one you should be interested in.
Our style scores indicate investors will probably be better served looking elsewhere.
Outlook
The stock has a Zacks Rank #3 (Hold). We are expecting an inline return from the stock in the next few months.
Image: Bigstock
Aerie (AERI) Down 12.9% Since Earnings Report: Can It Rebound?
It has been about a month since the last earnings report for Aerie Pharmaceuticals, Inc. . Shares have lost about 12.9% in that time frame, underperforming the market.
Will the recent negative trend continue leading up to the stock’s next earnings release, or is it due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts.
Aerie Q4 Loss Widens, Rhopressa NDA Resubmitted
Aerie posted fourth-quarter 2016 loss of $0.87 per share (including stock-based compensation), wider than both the Zacks Consensus Estimate of a loss of $0.65 and the year-ago loss of $0.76.
Being a development-stage company, Aerie has not generated any revenues from product sales yet.
Quarter in Detail
In the reported quarter, research and development expenses were up 14.5% to $14.1 million. Adjusted general and administrative expenses escalated 91.7% to $14.7 million.
The higher operating expenses in the reported quarter were due to expansion of the employee base to support clinical activities and preparatory activities associated with commercialization efforts.
Pipeline Update
The company resubmitted its NDA for lead candidate Rhopressa 0.02% on Feb 28 and expects a review period of 12 months. We note that Aerie withdrew its Rhopressa NDA (new drug application) that was filed in September as a third party manufacturing facility in Tampa, FL was not ready for pre-approval inspection by the FDA.
The company expects topline six-month efficacy and safety data from the phase III trial, Rocket 4, on Rhopressa in second-quarter 2017. The trial is being conducted to provide adequate safety data for European regulatory filings.
Apart from Rhopressa, Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Xalatan. The company expects topline 90-day efficacy and safety data from the second phase III clinical trial, Mercury 2, for Roclatan 0.02%/0.005%, in second-quarter 2017. Data from Mercury 1 is expected in third-quarter 2017. If Mercury 1 and Mercury 2 are successful, the NDA for Roclatan is expected to be filed in late 2017 or early 2018.
The company also expects to commence a trial, Mercury 3, in Europe to support filings there. The trial will be a non-inferiority trial comparing Roclatan to prescribed fixed dose combination that is Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan in Europe.
In September, Aerie reported the successful 90-day primary efficacy results of its phase III Mercury 1 clinical trial for its fixed-dose combination product candidate, Roclatan which is being developed for IOP in patients with glaucoma or ocular hypertension.
How Have Estimates Been Moving Since Then?
Analysts were quiet during the last one month period as none of them issued any earnings estimate revisions.
Aerie Pharmaceuticals, Inc. Price and Consensus
Aerie Pharmaceuticals, Inc. Price and Consensus | Aerie Pharmaceuticals, Inc. Quote
VGM Scores
Currently, Aerie's stock has a subpar Growth Score of 'D', though it is lagging a bit on the momentum front with an 'F'. Charting a somewhat similar path, the stock was allocated a grade of 'D' on the value side, putting it in the bottom 40% for this investment strategy.
Overall, the stock has an aggregate VGM Score of 'F'. If you aren't focused on one strategy, this score is the one you should be interested in.
Our style scores indicate investors will probably be better served looking elsewhere.
Outlook
The stock has a Zacks Rank #3 (Hold). We are expecting an inline return from the stock in the next few months.