Oyster Point Pharma, Inc.

Good evening, and welcome to Oyster Point Farmer's first quarter 2022 earnings conference call. My name is Shannon, and I will be your operator today. After the company's formal remarks, there will be a question and answer session. At this time, I would like to turn the call over to Mr. Artie Ahmed, Oyster Point Farmer's VP, Investor Relations. Please go ahead.

Thank you, and good evening, everyone, and welcome to Oyster Point Farmer's first quarter 2022 earnings conference call. This evening, we issued a press release containing our financial results and recent business highlights for the first quarter ended March 31st, 2022. In addition, our earnings press release and Form 10Q, which were filed with the SEC after the close of market today, are available on our website under the Investors in Media section at www.oysterpointrx.com. Joining us on our call today are Dr. Jeffrey Now, President and Chief Executive Officer of OysterPoint Pharma, Dan Lochner, our Chief Financial Officer, and John Smicerenko, our Chief Commercial Officer. Following our prepared remarks, we will open up the line for questions. Please note that during the call today, we will be making forward-looking statements regarding potential future events, including statements on Oyster Point Pharma's potential future financial status and results of operations, and our plans and potential for success relating to commercializing Trevia nasal spray. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results to differ materially from any future results, performance, or achievements expressed or implied by such statements. For a description of these factors, please see our quarterly report on Form 10-Q for the quarter ended March 31st, 2022, filed with the SEC after the close of market today. I will now turn the call over to Dr. Jeffrey Nao, our President and Chief Executive Officer.

Thank you, Arti. Good evening, everyone, and thank you for joining us on the call today. 2022 continues to be very exciting for Oyster Point. We've had a great first quarter, and I'm pleased to report strong quarterly results related to the sales of TIRVIA. In November 2021, we launched TIRVIA, the first and only FDA-approved nasal spray for the treatment of signs and symptoms of dry eye disease. Today, I will provide you with an update on the commercial progress during our first full quarter in the marketplace, and perspectives on the significant opportunity ahead for us with TIRVIA nasal spray. I will then review additional business highlights and our pipeline progress. Dry eye disease and ocular surface disease in general have historically been addressed by topical eye drop therapy. Topical dry eye disease drops can sting and burn when administered to an already irritated ocular surface, often resulting in poor patient compliance. Compounding the problem of patient compliance and persistence is the fact that these products often take such a long time to work for most patients. TIRVIA nasal spray is an effective treatment option with a new, innovative pathway to treating the signs and symptoms of dry eye disease for the estimated 38 million people impacted by dry eye disease in the United States. Over the past few months, I have spent a considerable amount of time in the field throughout the United States meeting with eye care professionals and listening to their feedback. I continue to see high levels of interest and enthusiasm for TIRVIA among the eye care community. Ophthalmologists and optometrists consistently tell me they are excited to finally have an effective, well-tolerated treatment option with a new mechanism of action, leveraging the biologically active natural tear film to treat dry eye patients. Most importantly, though, we are hearing significant positive feedback from dry eye disease patients on their satisfaction with Tearvia and continue to be encouraged by the stories from patients using Tearvia as their first prescription dry eye therapy, as well as for those who have tried and failed many of the other existing prescription dry eye therapies. In addition, I want to take a moment to congratulate the OysterPoint team for the amazing work that they're doing to significantly advance patient care in ophthalmology and optometry. In my estimation, we truly have the best team in the eye care space. In the first quarter of 2022, approximately 19,000 CureVaya prescriptions were filled, and these were written by over 4,500 unique prescribers. The company recognized $2.7 million of net product revenue related to sales of Tier Vaya during the quarter. Since our last earning call, OysterPoint's market access team has made significant progress in establishing formulary coverage for Tier Vaya with top payer organizations. According to a third-party syndicated source, Tier Vaya now has commercial coverage for up to approximately 95 million lives or 52% of all U.S. commercial lives. Additionally, we have continued to support patients in getting access to TIRVIA through our unique patient assistance program, Team TIRVIA. John Snizerenko will shortly provide details regarding the commercial performance of TIRVIA during the quarter. Beyond the United States, we continue to engage with international partners with a goal of leveraging our product portfolio, evaluating additional strategic opportunities, and providing our shareholders with long-term value. During 2021, the company entered into an exclusive licensing agreement with Jijing Pharmaceuticals to develop and commercialize OCO-1 and OCO-2 nasal sprays in China, where over 200 million people are impacted by dry eye disease. On March 21, 2022, Jijing announced regulatory clearance to conduct a Phase III clinical trial of OCO-1 nasal spray for the treatment of the signs and symptoms of dry eye disease in China. This progress demonstrates the potential for OCO-1 nasal spray to be a disruptive therapy for dry eye disease in China. We are excited to continue to partner with Jijing in their efforts to initiate this Phase III clinical trial as we add to the clinical evidence supporting TIRVIA's safety and effectiveness in the large population of patients of Asian descent. Moving on to our pipeline, while we remain focused on continuing the successful execution of our commercial plan for TIRVIA, our R&D team is committed to developing breakthrough therapies that address clinical unmet needs in eye care. We are excited about the potential for OCO-1 to play a role in treating stage 1 neurotrophic keratopathy, which may represent as much as 15% of the 38 million dry eye disease patients in the United States and can overlap with other comorbidities, such as late-stage diabetes. We believe that activating the natural tear film via the trigeminal nerve is an innovative approach to treating NK, as currently available dry eye therapies such as anti-inflammatories and immunomodulators do not address the underlying disease process. We continue to enroll patients in our Olympia Phase II study of OCL1 nasal spray aimed at treating Stage 1 NK. We remain on track to expect results of this trial in the second half of this year. Additionally, the lead asset from our enriched tear film gene therapy platform, OC101, An AAV vector encoding human nerve growth factor for the treatment of stage 2 and 3 NK has been progressing in preclinical animal studies to support an IND filing. Much like the promise of mRNA technology harnessing the body's cellular machinery to address infectious diseases and cancer, we believe that injecting AAV into the lacrimal gland could change the way we think about therapeutic delivery of proteins, peptides, and enzymes to treat diseases of the ocular surface. Key milestones in these studies included the safety of the intralacrimal gland injection procedure as well as the production and secretion of nerve growth factor into the tear film. We have now observed positive results across multiple animal studies with nerve growth factor secreted into the tear film as early as seven days post injection and continuing through our last assessment of 42 days. Importantly, The intralacrimal gland injection has been safe and well-tolerated in all studies, even in a safety study where we administered repeated injections. Topical nerve growth factor has already been shown to heal the corneal epithelium and improve corneal sensitivity in humans. However, current treatments are expensive and laborious, involving topical drops applied as many as eight times per day over 56 days and needing to be constantly refrigerated. Our platform aims to harness the body's own machinery, in turn reducing cost, increasing patient compliance, and raising the quality of life for stage 2 and 3 NK patients. We plan to meet with the FDA in the second half of this year to progress this exciting therapy. In summary, I'm very pleased with the company's performance in the first quarter of this year. I'm encouraged by the strong commercial performance of TIRVIA in its first full quarter of sales post-approval. as well as the progress we are making on our exciting pipeline. At OysterPoint, we strive to deliver innovative and transformative therapies for ophthalmic diseases with unmet needs. This vision guides our work every day and is reflected in the company's achievements so far in 2022. I will now turn the call over to John Stizarenko, OysterPoint's Chief Commercial Officer, to discuss our commercial activities related to Tear Viya.