Aerie Pharmaceuticals, Inc., reported financial results for the second quarter ended June 30, 2018, along with a general business update.
- The Rhopressa (netarsudil ophthalmic solution) 0.02% United States commercial launch commenced on April 30, 2018, and second quarter net revenues on a US GAAP (generally accepted accounting principles) basis totaled $2.4 million.
- As of August 1, 2018, Rhopressa market access has increased to approximately 80% (up from 70% as last reported) of commercial lives, including 55% in Tier 3 and 25% in preferred brand Tier 2. Medicare Part D coverage is now 12% (up from 10% as last reported) in Tier 2.
- The Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% PDUFA (Prescription Drug User Fee Act) date has been set for March 14, 2019, and there are no current expectations for an advisory committee.
- International expansion activities are progressing with the ongoing Roclatan Mercury 3 Phase 3 clinical trial in preparation for potential regulatory submission in Europe, and the expected expansion into Japan with an additional Rhopressa Phase 2 clinical trial in preparation for potential regulatory submission in Japan.
- Pre-IND (Investigational New Drug application) activities are well underway for the further advancement of Aerie’s retina program candidates, including AR-13503 (Rho kinase and Protein kinase C inhibitor implant) and AR-1105 (dexamethasone steroid implant), and the recently announced expansion of our agreement with DSM opens new opportunities for further advancement of Aerie’s ophthalmic pipeline.
- Cash burn for the first half of 2018 totaled approximately $103 million, with $286.1 million in cash, cash equivalents and investments as of June 30, 2018. Shares outstanding at quarter-end totaled 39,839,373 (or 45,208,820 after giving effect to the recently announced issuance of shares to certain entities affiliated with Deerfield Management Company L.P. in connection with the conversion of the convertible notes).
- Aerie reiterated that it expects full year 2018 Rhopressa net revenues in the range of $20 million to $30 million, on a US GAAP basis, and total 2018 cash burn in the range of $200 million to $210 million.
“The physician feedback to date from the Rhopressa launch has been quite positive, and we have seen solid uptake in prescription volumes along with substantial progress in market access. We have obtained a high degree of access to prescribing physicians, both in their offices and at educational venues, as they had been anxiously awaiting the introduction of Rhopressa, and they are now experiencing how Rhopressa performs when taken in combination with other therapies in a real-world setting. We are also delighted with the FDA’s response on the Roclatan review process, and we are in the process of refining our Roclatan launch plans,” said Vicente Anido Jr., PhD, chairman and chief executive officer. “We remain very well-financed, including the flexibility of having our $100 million undrawn credit facility, as we continue with our preclinical retina program and global expansion activities.”
Second Quarter 2018 Financial Results
As of June 30, 2018, Aerie had cash, cash equivalents, and investments of $286.1 million. For the second quarter ended June 30, 2018, Aerie reported net product revenues of $2.4 million related to sales of Rhopressa, which was launched in the United States on April 30, 2018. The company reported a GAAP net loss of $55.0 million, or $1.40 loss per share, for the second quarter of 2018, compared to a net loss of $28.4 million and $0.82 loss per share for the second quarter of 2017. The weighted average number of shares outstanding utilized in the calculation of net loss per share was 39,204,762 and 34,783,195 for the second quarters of 2018 and 2017, respectively. Total shares outstanding as of June 30, 2018 were 39,839,373.
The $55.0 million net loss for the second quarter of 2018 is primarily comprised of $58.0 million in total operating expenses, including $18.2 million in research and development expenses and $39.9 million in selling, general and administrative expenses. Excluding $10.3 million of stock-based compensation expense, adjusted total operating expenses for the second quarter of 2018 were $47.7 million, with adjusted research and development expenses of $15.6 million and adjusted selling, general and administrative expenses of $32.1 million. Total adjusted net loss for the second quarter of 2018 was $44.7 million, and adjusted net loss per share was $1.14.
The $28.4 million net loss for the second quarter of 2017 is primarily comprised of $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 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 higher operating expenses in the second quarter of 2018 as compared to the second quarter 2017 primarily reflect increased activities associated with the expansion of our employee base to support the growth of our operations, and activities associated with our Rhopressa commercialization efforts.