Oyster Point Pharma, Inc.

Good evening and welcome to Oyster Point Farmer's fourth quarter 2021 earnings conference call. My name is Valerie and I'll be your operator today. After the company's formal remarks, there will be a question and answer session. At this time, I'd like to turn the call over to Mr. Daniel Lochner, Oyster Point Farmer's chief financial officer. Please go ahead.

Good evening, everyone, and welcome to Oyster Point Farmer's fourth quarter earnings conference call for the three months ended December 31st, 2021. This evening, we issued a press release containing our fourth quarter and full year-ended December 31, 2021 financial results and recent business highlights. In addition, our earnings press release and our Form 10-K, which were filed with the SEC after the close of market today, are available on our website under the Investor News section at www.oysterpointrx.com. Joining us on our call today are Dr. Jeffrey Now, President and Chief Executive Officer of Oyster Point Pharma, and John Snizerenko, Chief Commercial Officer. Following Dr. Now, Mr. Snizerenko, and my prepared remarks, we will open up the line for questions. During the call today, we will be making forward-looking statements regarding potential future events, including statements regarding Oyster Point Pharma's potential future financial status and results of operations, and our plans and potential for success relating to commercializing tiered bias. 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 annual report on Form 10-K for the year ended December 31, 2021, filed with the SEC after the close of market today. I will now turn the call over to Dr. Jeffrey Now, President and Chief Executive Officer of Oyster Point Farms.

Thank you, Dan. Good evening, everyone, and thank you for joining us on our call today to discuss our fourth quarter 2021 financial results and recent business highlights. This is a particularly exciting time for Oyster Point. This is our very first earnings call where we are pleased to be reporting partial revenues from the commercial launch of tear via nasal spray for the treatment of the signs and symptoms of dry eye disease in the United States marketplace. Today, you will learn more about how we are delivering these encouraging commercial results on the launch of tear via nasal spray. But first, let me provide the company's 2021 business highlights. In October of 2021, we received FDA approval of tear via nasal spray for the treatment of the signs and symptoms of dry eye disease. Dry eye disease is a chronic condition that impacts an estimated 38 million people in the U.S. and is growing in prevalence. The dry eye market is now being introduced to the first nasally delivered pharmaceutical dry eye therapy, and we believe that given the high level of patient and physician satisfaction that we are seeing in the field with Tear Viya, that significant growth remains ahead. You will be hearing more shortly from John Smezarenko, our Chief Commercial Officer, about the details of the launch of TIRVIA Nasal Spray, but I'm happy to state that we had a great partial fourth quarter commercial performance in 2021. We're happy to report that TIRVIA Nasal Spray had a net product revenue of 1.2 million in Q4 of 2021. In addition, we recognized 5.4 million from our license agreement with Jijing Pharmaceuticals. We are now entering 2022, having demonstrated the ability to achieve the successful commercialization of TIRVIA as well as drive strong execution across multiple areas of our business, including our exclusive license agreement with Jijing to develop and commercialize OCO-1 and OCO-2 in Greater China, securing non-dilutive funding, and pursuing additional treatment advancements in the clinic as well as in the R&D laboratory for patients with ophthalmic diseases. This week, we publicly announced an early commercial win with one of the largest commercial payers, Our press release from Tuesday announced that TIRVIA nasal spray is now covered by Express Scripts, effective on February 19th. This is a fantastic accomplishment for our market access team in achieving the addition of 26 million covered lives, and more importantly, this early in our first full quarter since launch. Patients are increasingly gaining access to TIRVIA in the U.S. for a disease state that up until 2021 we believe experience very little innovation for the current large unmet need in dry eye disease. Tervia is a first-in-class cholinergic agonist nasal spray that is highly differentiated from the other pharmaceutical products in the dry eye space and includes the following potential advantages. Tervia nasal spray is a differentiated mechanism of action, as it is believed to activate the trigeminal parasympathetic pathway via the nose, resulting in increased production of basal tear film as a treatment for dry eye disease. Basal tear film is responsible for lubricating, nourishing, and protecting the cornea. Tear Vita is the only ocular surface-sparing pharmaceutical therapy for dry eye patients. For those patients with a compromised ocular surface, increasing tear production without the burden of administering a topical medication may provide a welcome method to treat their disease. For the first time, dry eye disease patients have an FDA-approved pharmaceutical treatment options that is not administered as a topical eye drop to an already irritated ocular surface. Although we are focused on the critical launch of TIRVIA nasal spray and continue to execute plans for the lifecycle development of the TIRVIA franchise, our R&D team remains committed to multiple exciting pipeline projects aimed at bringing additional innovative therapies to address diseases like neurotrophic keratopathy and severe allergic or vernal keratoconjunctivitis. In 2022, we will continue to advance our enriched tear film gene therapy platform, as well as our research and development collaboration with companies like Adaptive Phase Therapeutics. We remain excited about the ongoing Olympia Phase II study of OCO-1 nasal spray in stage 1 neurotrophic keratopathy. We're expecting a readout in the second half of this year. NK is a disease that is currently underdiagnosed or misdiagnosed in many patients, with ocular surface disease. We feel that stage one neurotrophic keratopathy could represent a meaningful indication for OCO-1 nasal spread. Our vision and focus is clear. The world needs an innovative leader that can bring innovative and transformative ophthalmic disease treatments, and we aim to be that leader. We believe that we're building OysterPoint into a best-in-class eye care company. I would now like to turn the call over to John Snizerenko, Oyster Point's Chief Commercial Officer, to discuss our ongoing commercial launch of Tear Via nasal spray for the treatment of the signs and symptoms of dry eye disease.