The Company | The Company Aerie Pharmaceuticals, Inc. (“Aerie”), with its wholly-owned subsidiaries, Aerie Distribution, Inc., Aerie Pharmaceuticals Limited, Aerie Pharmaceuticals Ireland Limited and Avizorex Pharma S.L. (“Aerie Distribution,” “Aerie Limited,” “Aerie Ireland Limited” and “Avizorex,” respectively, together with Aerie, the “Company”), is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases. The Company has its principal executive offices in Durham, North Carolina, and operates as one business segment. U.S Commercial Products The Company has developed and commercialized two U.S. Food and Drug Administration (“FDA”) approved products, Rhopressa ® (netarsudil ophthalmic solution) 0.02% (“Rhopressa ® ”) and Rocklatan ® (netarsudil/ latanoprost ophthalmic solution) 0.02%/0.005% (“Rocklatan ® ”), which are sold in the United States and comprise its glaucoma franchise. Rhopressa ® is a once-daily eye drop designed to reduce elevated intraocular pressure (“IOP”) in patients with open-angle glaucoma or ocular hypertension. Rocklatan ® is a once-daily fixed-dose combination of Rhopressa ® and latanoprost, the most widely-prescribed drug for the treatment of patients with open-angle glaucoma. The Company is commercializing Rhopressa ® , which was launched in the United States in April 2018, and Rocklatan ® , which was launched in the United States in May 2019. Outside the United States In addition to actively promoting Rhopressa ® and Rocklatan ® in the United States, the Company’s strategy also includes developing business opportunities outside of the United States including the successful commercialization of Rhopressa ® and Rocklatan ® in Europe, Japan and other regions . At present, the Company has a development and commercialization partner for Japan and certain other Asian countries, and is evaluating potential collaborators for Europe and other regions. Rhopressa ® and Rocklatan ® will be marketed under the names Rhokiinsa ® and Roclanda ® , respectively, if ultimately commercialized in Europe. In Europe, Rhokiinsa ® and Roclanda ® were granted a Centralised Marketing Authorisation (“Centralised MA”) by the European Commission (“EC”) in November 2019 and January 2021, respectively. In April 2021, Roclanda ® received marketing authorisation from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) in Great Britain. As the EC decision was received after the end of the Brexit transition period, the Company was required to complete a further administrative step in order to obtain authorisation in Great Britain, which has now been granted. The Company reported positive interim topline 90-day efficacy data in September 2020 for the Phase 3b clinical trial for Roclanda ® , named Mercury 3, a six-month efficacy and safety trial designed to compare Roclanda ® to Ganfort ® , a fixed-dose combination product marketed in Europe of bimatoprost (a prostaglandin analog), and timolol (a beta blocker). As a result of the positive Mercury 3 results, discussions are underway with third parties, who have expressed interest in a commercialization partnership in and potentially beyond Europe, while the Company has been simultaneously preparing on its own for pricing discussions in Germany. In Japan, the Company entered into a Collaboration and License Agreement (the “Santen Agreement”) with Santen Pharmaceuticals Co., Ltd. (“Santen”) in October 2020 to advance its clinical development and ultimately commercialize Rhopressa ® and Rocklatan ® in Japan and eight other countries in Asia. See Note 3 for additional information. The Company initiated a Rhopressa ® Phase 3 clinical trial in December 2020, the first of three expected Phase 3 clinical trials in Japan. Clinical trials for Rocklatan ® in Japan have not yet begun. Glaucoma Product Manufacturing The Company has a sterile fill production facility in Athlone, Ireland, for the production of its FDA approved products and clinical supplies. The Company received FDA approval to produce Rocklatan ® and Rhopressa ® at the Athlone manufacturing plant for commercial distribution in the United States in January 2020 and September 2020, respectively. The manufacturing plant began manufacturing commercial supplies of Rocklatan ® during the first quarter of 2020 and Rhopressa ® in the third quarter of 2020 for distribution to the United States. Shipments of commercial supply of Rocklatan ® and Rhopressa ® from the Athlone manufacturing plant to the United States commenced in the third quarter of 2020 and in the fourth quarter of 2020, respectively. The Athlone manufacturing plant has also manufactured clinical supplies of Rhopressa ® for the Phase 3 clinical trials in Japan. Product Candidates and Pipeline The Company is furthering the development of its product candidates focused on dry eye and retinal diseases, particularly AR-15512, AR-1105, AR-13503 SR and AR-14034 SR, described below. The Company acquired Avizorex, a Spanish ophthalmic pharmaceutical company, developing therapeutics for the treatment of dry eye disease, in late 2019. The active ingredient in AR-15512 is a potent and selective agonist of the TRPM8 ion channel, a cold sensor and osmolarity sensor that regulates tear production and blink rate. In addition, activating the TRPM8 receptor may reduce ocular discomfort by promoting a cooling sensation. The Investigational New Drug Application (“IND”) for AR-15512 eye drop for dry eye became effective in September 2020, allowing Aerie to initiate clinical studies in the treatment of dry eye. The Company is currently testing two concentrations of AR-15512 in an ongoing 90-day Phase 2b clinical trial with 360 subjects, which could potentially be considered pivotal. The Company initiated this now fully enrolled clinical trial, named COMET-1, in October 2020 and a topline readout is expected in the third quarter of 2021. The Company is currently developing three sustained-release implants focused on retinal diseases, AR-1105, AR-13503 SR and AR-14034 SR. In July 2020, the Company completed a Phase 2 clinical trial for AR-1105, a dexamethasone steroid implant, in patients with macular edema due to retinal vein occlusion (“RVO”). Also, in July 2020, the Company reported topline results of the Phase 2 clinical trial for AR-1105 indicating sustained efficacy of up to six months, an important achievement in validating the capabilities of Aerie’s sustained release platform. The Company is in the process of meeting with regulatory agencies in order to harmonize development plans across both Europe and the United States and continues to evaluate next steps regarding clinical and regulatory pathways for Phase 3 clinical trials along with commercialization prospects in both markets. The Company is also developing AR-13503, a Rho kinase (“ROCK”) and Protein kinase C inhibitor that is the active ingredient in the AR-13503 sustained-release implant. The IND for AR-13503 SR became effective in April 2019, allowing the Company to initiate human studies in the treatment of wet age-related macular degeneration (age-related macular degeneration, “AMD”) and diabetic macular edema (“DME ”). The Company initiated a first-in-human clinical safety study for AR-13503 SR in the third quarter of 2019 . The Company expects to complete the dose escalation safety evaluation with the current implant design for AR-13503 SR in the first quarter of 2022. The preclinical stage sustained-release implant AR-14034 SR, is being designed to deliver the active ingredient axitinib, a potent small molecule pan-VEGF receptor inhibitor. AR-14034 SR has the potential to provide a duration of effect of approximately one year with a once per-year injection. It may potentially be used to treat DME, wet AMD and related diseases of the retina. IND-enabling preclinical studies are underway and the Company anticipates filing an IND for AR-14034 SR with the FDA in the second half of 2022. Liquidity The Company commenced generating product revenues related to the sales in the United States of Rhopressa ® in the second quarter of 2018 and Rocklatan ® in the second quarter of 2019. The Company’s activities prior to the commercial launch of Rhopressa ® had primarily consisted of developing product candidates, raising capital and performing research and development activities. The Company has incurred losses and experienced negative operating cash flows since inception. The Company had previously funded its operations primarily through the sale of equity securities and issuance of convertible notes prior to generating product revenues. In September 2019, the Company issued an aggregate principal amount of $316.25 million of 1.50% convertible senior notes due 2024 (the “Convertible Notes”) (Note 10). Further, in October 2020, the Company entered into the Santen Agreement, pursuant to which Santen paid an upfront payment of $50.0 million (Note 3). The Company expects to incur ongoing operating losses until such a time when Rhopressa ® or Rocklatan ® or any current or future product candidates or future product candidates, if approved, generate sufficient cash flows for the Company to achieve profitability. Accordingly, the Company may be required to obtain further funding through debt or equity offerings or other sources. Adequate additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on acceptable terms, it may be forced to delay, reduce or eliminate its research and development programs or commercialization and manufacturing efforts. |