Oyster Point Pharma, Inc.

Good day, and thank you for standing by. Welcome to the Oster Point Farmer Second Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the questions during the session, you will need to press star 1 1 on your telephone. I would now like to hand the conference over to your speaker for today, Artie Ahmed. Vice President, and investor relations. You may begin.

Good evening, everyone, and welcome to Oyster Point Farmer's second quarter 2022 earnings conference call. This evening, we issued a press release containing our financial results and recent business highlights for the second quarter ended June 30th, 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.VoysterPointRx.com. Joining us on our call today are Dr. Jeffrey Now, the President and Chief Executive Officer of VoysterPoint Pharma, Dan Lochner, our Chief Financial Officer and Chief Business Officer, and Michael Campbell, our Senior Vice President and Head of Commercial. 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 Farmers' potential future financial status and results of operations, and our plans and potential for success relating to commercializing Turviya 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 June 30th, 2022, filed with the SEC after the closing market today. I will now turn the call over to Dr. Jeffrey Nau, our President and Chief Executive Officer.

Thank you, Arti. Good evening, everyone, and thank you for joining us on our call today. I am pleased to report a strong second quarter for Oyster Point, which included continued robust growth and positive sales momentum for TIRVIA nasal spray for the treatment of the signs and symptoms of dry eye disease. Our continued growth in this quarter highlights the value that our differentiated product brings to patients and physicians. We're excelling at our goal to continue to expand access to TIRVIA to more eligible patients and progressing the development of our exciting pipeline assets. Today, I will provide an update on our commercial progress with TIRVIA and discuss additional business and development highlights. We are excited by the impact that Tear Viya has had on the dry eye landscape. Dry eye disease is a condition affecting an estimated 38 million people in the U.S. alone. Patients and eye care professionals, or ECPs, have traditionally struggled to find suitable long-term treatments that are efficacious, practically administered, and fast-acting. Tear Viya is easily administered to patients, even those with poor dexterity, and provides natural tear foam production for most within minutes after administration. Tervaya's differentiated clinical profile, which rapidly bioactivates tear film production to help the body create more natural tears, continues to garner high levels of interest and enthusiasm with both patients and ECPs alike. We remain confident that this is the beginning of a paradigm shift in the way that ECPs think about dry eye treatment by harnessing the body's own natural tear-producing machinery to delivery therapy with Tervaya. We believe TierVaya's brand perception has been increasing on a quarterly basis since launch, with this enthusiasm illustrated by our refill rates and persistence data. Our 60-day refill rate is 65%, representing a blended average between our mail order and traditional retail pharmacy outlets, as is the last data available from June 3rd. Based on data from IQVIA from the November 2021 Dry Eye cohort, TIRVIA has the highest persistence rate of all prescription dry eye medications in the first six months after initiation of therapy. In addition, from that same data set and time period, TIRVIA has the highest percentage of restarts after any interruption in therapy. This data highlights the leading patient adherence and restart profile for TIRVIA, characteristic not common with other branded dry eye therapeutics, which can often take a long time to work. We believe that this data illustrates how TIRVIA has quickly become an important part of the current treatment paradigm for ECPs and how patients suffering from dry eye disease are positively responding to TIRVIA. In the second quarter of 2022, TIRVIA generated $4.7 million in net revenue. Approximately 30,000 prescriptions were filled during the quarter, and were written by over 5,700 unique eye care professionals, reflecting strong quarter-on-quarter growth. Our commercialization strategy continues to focus on engagement with both ophthalmology and optometry. Since launch, approximately 7,700 unique eye care professionals have written a prescription for TIRVIA as of July 22, 2022, which represents over a third of the total number of ECPs being targeted by our field-based sales resources. Prescriber numbers continue to show consistent growth month over month. We expect that we will continue to build commercial insurance coverage and attain coverage by Medicare Part D plans and that adoption will continue to increase as a result. We remain focused on growing Kervia into a leading dry eye disease brand underpinned by our belief that TIRVIA is a transformative solution. Simply put, there is no substitute for a patient's own natural TIR film, and this is a message that is resonating with both ECPs and patients alike. In our mission to make TIRVIA widely available to all patients suffering from dry eye disease, I'm also pleased to share that formulary access to TIRVIA has grown meaningfully. As of July 2022, TIRVIA is now covered by commercial prescription drug plans managed by the nation's top three pharmacy benefit manager group purchasing organizations. In addition to our unique patient assistance program, Team TIRVIA, we've introduced new programs to expand access to TIRVIA for eligible patients. Michael Campbell, our Senior Vice President, Head of Commercial, will shortly provide further details on these programs, as well as TIRVIA's commercial performance during the quarter. Outside of the United States, Jijing Pharmaceuticals, our licensing partner in Greater China, announced in July that the first patients were enrolled in the single phase three clinical trial to support a new drug application for regulatory approval of OCO-1 nasal spray for the treatment of signs and symptoms of dry eye disease in China. We are pleased with the progress being made and how the global footprint of TIRVIA continues to grow. We remain excited about the prospect of helping patients suffering from dry eye disease in China, where an estimated 200 million people suffer from the disease. The differentiated profile of OCO-1 is drawing positive interest from partners in numerous ex-U.S. geographies. We continue to engage with potential partners to explore opportunities to provide patient access to tirbaya in international markets beyond greater China and to improve the health of patients worldwide and create long-term value for our shareholders. Moving on to provide the quarter's update on our pipeline assets, we have made important strides to progress our Phase II Olympia clinical trial of OCO-1 nasal spray for the treatment of Stage I neurotrophic keratopathy, or NK, and our preclinical studies of OysterPoint's enriched tear film, or ETF, gene therapy program for the treatment of Stage II and III neurotrophic keratopathy. Given our unique and differentiated expertise of working in harmony with the body's natural processes, we believe that OCO-1 nasal spray will become a truly differentiated treatment option for stage one NK, which is estimated to affect as much as 15% of the 38 million dry eye disease patients in the United States. In our phase two Olympia study of OCO-1 nasal spray, we have continued to enroll patients throughout the quarter and remain on track to deliver results in the fourth quarter of 2022. Within the discovery engine of OysterPoint Labs, our enriched tear film gene therapy platform has progressed. And much like recent advances in mRNA vaccines, the goal is to turn the lacrimal gland into a protein-producing factory that naturally secretes a multitude of potential therapeutic targets into the tear film. This preclinical platform is robust, and we believe it will fuel the development of new and innovative therapies for patients with high unmet needs. We have now completed our second preclinical study of OC101, an adenoviral vector encoding the gene for human nerve growth factor delivered as a single intralacrimal gland injection. After injection, we observed significant amounts of nerve growth factor present in the natural tear film as early as day seven, and for up to 42 days after transduction. In addition, cholinergic activation of our OCO-1 nasal spray produce a further significant increase in NGF levels in the tear film within minutes after administration. These results support the future potential for our enriched tear film gene therapy program to leverage the lacrimal gland as a natural biofactory that can deliver therapy to the ocular surface. Based on this groundbreaking data, We have submitted a pre-IND meeting request to the FDA for the treatment of stages two and three neurotrophic keratopathy. We're excited about the potential to change the treatment paradigm for stage two and three neurotrophic keratopathy, which currently requires the reapplication of refrigerated drops six times a day over a two-month treatment course. We're also pleased to announce the second asset in our enriched tear film gene therapy program, OC-103, an adenoviral vector encoding for the gene for diamine oxidase, a naturally occurring human enzyme responsible for the cleavage of histamine. Once injected into the lacrimal gland, the promise of this approach is to secrete this naturally present enzyme in increased amounts as part of the natural tear film, with the potential to create antihistamine tear film. The development plan will initially target patients suffering from vernal or atopic keratoconjunctivitis to severe sight-threatening conditions of the ocular surface. In summary, I'm very pleased with our performance in the second quarter and the value to your bias delivering to patients and eye care professionals. Given the size of the U.S. market and the notable high levels of satisfaction among patients and clinicians, we see significant opportunity ahead. I am also very excited about our multiple pipeline opportunities aimed at delivering transformative innovation for ocular surface disease where there remains significant unmet need. I would now like to introduce Mike Campbell, OysterPoint's Senior Vice President and Head of Commercial. While this is Mike's first earning call at OysterPoint, Mike has been with OysterPoint since January of 2020, and has been instrumental in the pre-commercial planning for TIRBIA, as well as the day-to-day commercial operations since TIRBIA's commercial launch in November 2021. Mike is a known commercial leader in pharma biotech, and particularly in ophthalmology, with approximately 30 years of experience, including J&J VisionCare, Genentech, Shire, and Novartis. Mike will now discuss our recent commercial activities related to TIRBIA.