Aerie Pharmaceuticals provided a business update associated with the impact of the COVID-19 pandemic on company operations.
While Aerie volumes increased in the first-quarter of 2020 compared to the fourth-quarter of 2019 for both Rhopressa (netarsudil ophthalmic solution) 0.02% and Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the pace of volumes, as seen with the entire pharmaceutical market according to IQVIA data, has declined as the COVID-19 impact became elevated in late March and into April 2020 to date. There has been a positive partial offset from increasing 90-days’ supply activity, but with many eye care professionals’ offices closed or in the process of closing, new prescription growth has slowed. The company is using various virtual tools to remain in contact with eye care professionals, and Aerie’s territory managers are experiencing successful engagement largely working from their homes.
Considering the rapidly evolving status of the COVID-19 situation and the uncertainty around its ultimate impact, Aerie is withdrawing its 2020 guidance for net revenues and net cash used in operations, which includes the net revenue guidance as a component. As would be expected, the company is currently experiencing travel and meeting expenses below original internal expectations. Guidance will be updated when there is clarity going forward.
Aerie has observed no disruptions to date in its supply chain for production of Rhopressa and Rocklatan. The company believes it has approximately 3 years of starting materials and active pharmaceutical ingredient in inventory, and adequate supply of finished product on hand to support its commercial efforts for at least the next 6 months, and production continues.
Regarding Aerie’s globalization strategy, the regulatory review in Europe of Roclanda (Rocklatan in the United States) remains on track, while the results for the Mercury 3 trial for Roclanda, which is designed to gauge commercialization prospects in Europe, are now expected in late 2020 or early 2021. Aerie expects to hold a meeting with the regulatory authorities in Japan during the second quarter of 2020 to discuss phase 3 trial designs for Rhopressa while continuing to prepare for the trials and exploring partnership opportunities. From a pipeline perspective, Aerie’s early stage retina implant trials remain on track, and Aerie hopes to commence its phase 2b clinical study for dry eye candidate AR-15512 (formerly AVX-012) by the end of 2020.
“The health and safety of our employees, patients, prescribers and community are of utmost importance during this time,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer, said in a company news release. “We are complying with all requirements and mandates from various agencies and governments, and we are operating quite effectively with most of our employees working diligently from home. While we believe we had been on track to execute our plan for 2020, including the growth we experienced in first-quarter 2020 volumes, given the uncertainties around COVID-19 and the unprecedented nature of this pandemic, we feel it is necessary to withdraw our current 2020 guidance. Despite these short-term disruptions, we remain confident in the long-term growth of our glaucoma franchise and Aerie’s future.”