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Aerie (AERI) Reports Second Quarter 2017 Financial Results And Provides Business Update



8/2/2017 8:19:03 AM

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Conference Call and Webcast Today, August 1st, at 5:00 p.m. ET

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 second quarter ended June 30, 2017, along with a general business update.

Aerie Highlights

  • Phase 3 clinical trials required for approval in the U.S. for both RhopressaTM (netarsudil ophthalmic solution) 0.02%, and RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, are now successfully completed.
  • All programs remain on track, with the goal date of February 28, 2018 set for the RhopressaTM FDA (U.S. Food and Drug Administration) PDUFA (Prescription Drug User Fee Act), and the Company’s submission of the RoclatanTM New Drug Application (NDA) anticipated in the first half of 2018.
  • Initial scientific introductory meetings on RhopressaTM have been held with many major U.S. payors.
  • Mercury 3, the RoclatanTM Phase 3 clinical trial to be conducted in Europe for European markets, is set to commence in the third quarter of 2017.
  • Recently announced collaboration with DSM is focused on the potential of sustained delivery of Aerie compounds to treat retinal diseases, unlocking a new pipeline opportunity.
  • As of June 30, 2017, Aerie had $307.9 million in cash, cash equivalents and investments. Cash burn for the first half of 2017 totaled $48.4 million. Cash burn for the year ending December 31, 2017 is expected to be in the range of $100 million to $110 million.

“This has been a highly productive period for Aerie, and we are actively engaged in all facets of commercialization preparation as we look to make our RhopressaTM launch as successful as possible, upon approval. For our RoclatanTM program, we also recently completed the Mercury 1 12-month study, and we look forward to the upcoming commencement of the Mercury 3 trial in Europe. Our recent agreement with DSM also continues our journey into treating retinal disease, and we are very excited about the potential of this early program as well,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer.

Dr. Anido continued, “We ended the second quarter with the highest cash, cash equivalents and investments balance in Aerie history, and are well-financed as we continue to build a major ophthalmic pharmaceutical company.”

Second Quarter 2017 Financial Results

As of June 30, 2017, Aerie had cash, cash equivalents and investments of $307.9 million. For the second quarter ended June 30, 2017, Aerie reported a net loss, as measured in accordance with accounting principles generally accepted in the United States (GAAP), of $28.4 million, or $0.82 per share, compared to $23.2 million and $0.87 per share for the second quarter of 2016. The weighted average number of shares of common stock outstanding utilized in the calculation of net loss per common share was 34,783,195 and 26,773,337 for the second quarters of 2017 and 2016, respectively. Total shares outstanding as of June 30, 2017, were 36,337,542.

The $28.4 million net loss for the second quarter of 2017 includes $27.8 million in total operating expenses, including $10.6 million in research and development expenses and $17.2 million in selling, general and administrative expenses. Excluding $6.7 million of non-cash stock-based compensation expense, adjusted total operating expenses for the second quarter of 2017 were $21.1 million, with adjusted research and development expenses of $9.2 million and adjusted selling, general and administrative expenses of $11.9 million. Total adjusted net loss for the second quarter of 2017 was $21.8 million, and adjusted net loss per share was $0.63.

The $23.2 million net loss for the second quarter of 2016 includes $22.7 million in total operating expenses, including $13.3 million in research and development expenses and $9.4 million in selling, general and administrative expenses. Excluding $3.9 million of non-cash stock-based compensation expense, adjusted total operating expenses for the second quarter of 2016 were approximately $18.8 million, with adjusted research and development expenses of $12.5 million and adjusted selling, general and administrative expenses of $6.3 million. Total adjusted net loss for the second quarter of 2016 was $19.3 million, and adjusted net loss per share was $0.72.

The higher operating expenses in the second quarter of 2017 as compared to the second quarter 2016 primarily reflect increased activities associated with the expansion of our employee base to support the growth of our operations, and preparatory activities associated with our commercialization efforts, including commercial manufacturing for RhopressaTM.

Conference Call / Webcast Information

Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss Aerie’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company's website at http://investors.aeriepharma.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 734-0328 (U.S.) or (678) 894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 51660946. Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 51660946. The telephone replay will be available until August 8, 2017.

About Aerie Pharmaceuticals, Inc.

Aerie is 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. Aerie's two current product candidates are once-daily intraocular pressure lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA (new drug application) for RhopressaTM (netarsudil ophthalmic solution) 0.02% was submitted to the U.S. Food and Drug Administration (FDA) in February 2017, and, in May 2017, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the RhopressaTM NDA for February 28, 2018. Aerie’s second product candidate, RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of RhopressaTM and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1. The RoclatanTM NDA submission is expected to take place in the first half of 2018. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.


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