Oyster Point Pharma, Inc.

Good evening, and welcome to Oyster Point Farmer's Second Quarter 2021 Earnings Conference Call. My name is Justin, and I will be your operator today. After the company's full remarks, there will be a question and answer session. At this time, I would 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 the Oyster Point Farmer's Second Quarter Earnings Conference Call for the three months ending June 30th, 2021. This evening, we issued a press release containing our second quarter financial results and recent business highlights. In addition, our earnings press release and our Form 10-Q that was 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 Nell, 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 our call today, we will be making forward-looking statements regarding future events and the future performance of Oyster Point Pharma. Forward-looking statements include statements regarding Oyster Point's possible or assumed future results of operations, expenses and financial position, business strategies and plans, research, development, and commercial plans or expectations, Trends, market sizing, competitive position, our belief regarding our clinical trial outcome, including secondary input analysis, predictions regarding product approvals or FDA decision-making, the impact of COVID-19, and the industry environment and potential growth opportunities, among other things. These statements are based upon the information available to the company today, and at which point it seems no obligation to update these statements as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements. Additional information concerning these factors could cause results to differ materially from our forward-looking statements or described in greater detail in the company's filings with the SEC, including our quarterly report on Form 10-Q for the quarters ended June 30, 2021, and March 31, 2021, and our annual report on Form 10-K, for the year ended December 31st, 2020. I will now turn the call over to Dr. Jeffrey Nell, President and Chief Executive Officer of Oyster Point Pharma.

Thank you, Dan. Good evening, everyone, and thank you for joining us on our call today to discuss our second quarter 2021 financial results and recent business highlights. As you know, our PDUFA target action date for OCO-1 varenicline nasal spray for the treatment of the signs and symptoms of dry eye is October 17th, 2021. We are currently preparing the organization to support the launch of OCO-1 nasal spray in the fourth quarter if approved by the FDA. As you've seen in our Q2 earnings press release, we have initiated hiring of sales representatives in July, and we are extremely pleased with the sales talent we have hired already from across the country. To date, we have received more than 6,000 applications from individuals interested in joining our sales organization, And we are excited about the culture and the team that we are building here at Oyster Point. As you may recall, we have previously communicated that we plan to hire 150 to 200 sales representatives calling on both ophthalmology and optometry. And we are on track to deliver this goal at the time of launch. Once in place, Oyster Point will have one of the leading US eye care provider focused sales teams in the industry. Oyster Point sales representatives are already in the field. communicating our Dry Eye Disease State Awareness Campaign, and we look forward to completing hiring of the sales team as we approach our PDUFA date. With regards to payer access, our medical affairs and access teams have been providing pre-approval information exchange to many of the key payers already, and we are currently building our payer engagement calendars for the remainder of 2021 and into 2022. Our goal is to focus on achieving broad payer coverage, to ensure access for eye care providers and patients. As we prepare for a potential launch, there are a number of major ophthalmology meetings that are important for Oyster Point to attend for the remainder of 2021, either virtually or live, depending upon the environment in light of the current COVID pandemic. We have accepted presentations at the Women in Ophthalmology meeting and the European Society of Cataract and Refractive Surgeons meeting in Amsterdam. The 2021 American Academy of Optometry meeting will be held in Boston, November 3rd to the 6th, and Oyster Point will have three accepted abstracts presented at this meeting. The 2021 American Academy of Ophthalmology meeting will be held in New Orleans, November 12th to the 15th, and Oyster Point has three accepted abstracts that were presented at this meeting as well. I want to commend our medical affairs team for their 100% abstract acceptance rate for these major ophthalmology and optometry meetings. for the year of 2021. In addition to our development of OCO-1 nasal spray for dry eye disease, we filed an IND in November to evaluate the potential of OCO-1 for the treatment of stage one neurotrophic keratopathy and announced that the first patient was enrolled in June 21st, 2021. We expect enrollment to continue through 2021 and into the first half of 2022. We believe that OCO1's unique mechanism of action of stimulating natural tear film via the trigeminal parasympathetic pathway, as seen in preclinical and clinical studies, may be beneficial for patients with corneal epithelial hyperplasia and or punctate keratopathy. This patient population is often underdiagnosed and or misdiagnosed based on our clinical trial experience, and we think that these patients represent a meaningful proportion of the population suffering from ocular surface disease. Looking at our earlier stage pipeline, OysterPoint is moving ahead with plans to engage with the Food and Drug Administration with pre-IND meetings for our enriched tear film gene therapy platform. The first gene therapy target that we will focus on is the adeno-associated virus vector that codes for the human nerve growth factor protein. In our preclinical studies, we have shown the ability to transduce the lacrimal gland and harness its protein-producing machinery to scrape nerve growth factor onto the ocular surface for patients with stage two and stage three neurotrophic keratopathy. We look forward to continued progress and the start of IND-enabling studies in the second half of this year. Also, this past quarter, we entered into a collaboration agreement with Adaptive Phase Therapeutics to develop what has the potential to be the first evergreen antimicrobial to enter the ophthalmic market. Our focus will be bacterial infections of the ocular surface and anterior segment, and we look forward to announcing our first disease state target in the latter half of this year or early part of 2022. Lastly, at our recent analyst day this past July, we shared preclinical data on OCO1 and OCO2 simpinacline, antiviral activity against SARS-CoV-2 and variants of concern. We have recently completed a number of in vivo studies and a non-human primate study with OCO-1 nasal spray, and it's illustrated that within 24 hours of exposure, these compounds have the potential to dramatically reduce viral entry and replication with no evidence of viral subgenomic RNA in the nasal cavity after 48 hours. We believe that a nasal spray approach could represent a meaningful pre-exposure and post-exposure prophylaxis therapy, as well as have the possibility to change the transmission dynamics and positively impact the coronavirus pandemic. In the upcoming weeks, we plan to complete a second non-human primate study investigating both OCO-1 and OCO-2 nasal spray, respectively, against the Delta variant of the SARS-CoV-2 virus. Our vision and focus on bringing innovative and transformative ophthalmic disease treatments to patients and building Oyster Point Pharma into a best-in-class ophthalmology company remains our primary goal. I would now like to turn the call over to John Snizerenko, Oyster Point's Chief Commercial Officer, to discuss our ongoing preparations for the potential commercial launch of OCO-1 nasal spray in dry eye disease in Q4 of 2021. Thank you, Jeff.