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.

Thank you, Jeff, and good evening, everyone. We are very excited about the progress we've made during the quarter. I'm happy to report continued strong uptake of Tervaya nasal spray six months post-launch. Our vision for Tervaya has always been to transform and improve the lives of the estimated 38 million people in the U.S. alone who experience dry eye. As Jeff highlighted previously, we are very pleased with the first quarter net product revenue of $2.7 million. Salesforce has been meeting with and educating eye care professionals, or ECPs, including both optometrists and ophthalmologists. In the first quarter of 2022, approximately 19,000 prescriptions have been filled and were written by over 4,500 unique ECPs. This reflects the enthusiasm for Turvaya from ECPs and patients alike. Tervaya's market position continued to strengthen as it increasingly considered an exciting and effective new treatment for the signs and symptoms of dry eye disease. Additionally, our market access team has had continued success in securing coverage for Tervaya with top payer organizations. As mentioned during our last earnings call, effective February 19, 2022, Tervaya was placed on Express Script's national preferred, basic, and high-performance formularies. which collectively make up around 26 million lives. Since then, we have successfully obtained coverage with additional payers. According to a third-party syndicated source, Tervaya now has commercial coverage for up to approximately 95 million lives, which represents 52% of all U.S. commercial lives. As we continue to gain commercial coverage, we expect an increase in the propensity of physicians to write prescriptions for Tervaya. We are pleased with the progress in commercial coverage of Tervaya since launch and anticipate receiving coverage determinations for all major commercial payers in the US by mid-2022. In addition to commercial coverage, we expect Medicare coverage determinations in time for 2023. During the first quarter, we continue to offer a patient support program known as Team Tervaya. By leveraging technology and experience, This program has helped patients get access to Tervaya with multiple benefits, including assistance in ensuring home delivery and support in the insurance process. For more information on Team Tervaya, please visit the website www.tervaya-pro.com. In addition, we continue to observe strong refill rates for Tervaya. Since launch, approximately 65% of prescriptions have been refilled within 60 days, which is an indicator of a positive response for patients and confidence from ECPs. As expected, a few months post-launch, there are ebbs and flows in the progression of new and total prescriptions written. Given TIRVIA's novel mechanism and route of action, many prescribers want to see the patients back four to eight weeks after starting treatment to evaluate response to TIRVIA. Despite strong progress in establishing commercial coverage and offering a best-in-class patient support program, we're consistently optimizing our approach to drive growth in prescriptions. For example, we're continually refining our sales rep direction and incentive comp to drive new prescribers and depth of prescriptions per prescriber. Additionally, we're continuing to explore ways to maximize fill rates across our distribution network. Also, to further promote Turbaya, we just launched peer-to-peer speaker programs in April. So with six months of launch learnings, we continue to fine-tune our tactics and optimize our approach to drive TRX and NRX. Our multifaceted marketing approach continues to be led by education and promotional efforts directed towards eye care professionals and patients. This is supported by direct-to-patient digital campaigns that emphasize Terbiah's unique benefits, including the simpler nasal spray administration and unique mechanism of action. Direct marketing efforts have been bolstered by leveraging the latest technology, including virtual detailing, digital and social media activities and partnerships, as well as best-in-class analytics. Additionally, our use of digital pharmacy system has made the process of procuring Terbiah even simpler for patients. We intend to continue using the latest technologies and most effective strategies to drive adoption and market share of Tier Bio. I remain very proud of our commercial team's continued efforts and success during the quarter. I will now turn the call over to Dan Lochner, Oyster Point's Chief Financial Officer, to discuss our first quarter financial results.

Thank you, John. I will now provide a brief overview of Oyster Point Pharma's first quarter financial results. Additional details about our first quarter can be found in our Form 10-Q that was filed with the SEC this evening. For the first quarter of 2022, Oyster Point Pharma reported a net loss of $47.9 million compared to a net loss of $18.9 million for the same period in 2021. As of March 31, 2022, cash and cash equivalents were $143.4 million compared to $193.4 million As of December 31 2021 net product revenues for the first quarter of 2022 were approximately 2.7 million following the commercial launch of tier by in the US in November 2021 the company did not generate any revenues during the three months ended march 31 2021. Cost of product revenue for the three months ended March 31, 2022 was $0.3 million and consisted of product royalty expenses, third-party manufacturing costs, reserves for inventory obsolescence, and material costs of $0.7 million. This was partially offset by a $0.4 million supplier credit recognized during the three months ended March 31, 2022. Inventory manufactured prior to the FDA approval of TIR via nasal spray was charged to R&D expense, and as a result, the company expects the unit cost of product revenue will be lower until the company fully utilizes the product that was manufactured pre-FDA approval. The company started expensing pre-approval inventory in 2020. The company's sales and marketing expenses increased by $22.4 million during the three months ended March 31, 2022, compared to the same period in 2021. The increase was primarily due to higher payroll-related expenses of $11.6 million, inclusive of an increase in stock-based compensation of $0.7 million, as well as sales commission expense, which was driven by onboarding a commercial field force in the second half of 2021. The company also incurred higher marketing expenses of $8.5 million in connection with advertising, sample expense, trade shows, and other marketing efforts related to the U.S. commercial launch of Tier 5. The company's general and administrative expenses increased by $4.4 million during the three months ended March 31, 2022, compared to the same period in 2021. The increase was primarily driven by increased payroll-related expenses of $2.6 million due to an increase in headcount to support the company's business operations inclusive of an increase in stock-based compensation of $0.7 million. The company also incurred $1.3 million of other general administrative expenses related to accounting, legal, and other professional services and insurance. The increase in these other general and administrative expenses was driven by the company's transition from a clinical stage to a commercial stage company. The company's research and development expenses decreased by $1.1 million during the three months ended March 31, 2022, compared to the same period in 2021. The decrease was primarily due to lower expenses after FDA approval of Tier V in October 2021. The company incurred interest expense of $3.1 million during the three months ended March 31, 2022, related to the credit agreement with OrbiMed. Interest expense included contractual interest of $2.1 million, as well as non-cash expense of $1 million related to the amortization of loan commitment fees and accretion of other long-term debt-related costs. The company had no interest expense during the three months ended March 31, 2021. With that overview of our financials, I will now turn the call back over to the operator to open up the line for questions.

Thank you. To ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Ken Cacciatore with Cowan & Company. Your line is open.

Hey, team. A lot of good metrics here. I just want to tick through a few of them. On the pricing, it seems like you're actually driving that a little faster than we would have thought. So the gross to net here about 75%. I'm seeing like a per prescription value of about $140. Just wondering, can you talk about the pacing through the balance of the year? And then maybe that would dovetail to the consensus is around 30 million. It looks as kind of we peak at our model and some of these metrics, you're nicely on track, but wondering if you would speak to that. And then also, John gave some nice data points around the refill rate. Can you just talk about that in comparison to Restasis and Zydra, so we have a little bit of a feel for where that compares. Thanks so much.

Yeah, thanks, Ken. I'll jump in. As we progress through Q1, we clearly have a little bit more clarity on various gross net items related to, you know, folks on bridge or on commercially paid product. So we're happy where we came in in Q1. We would expect, you know, Q2 to be more or less around where Q1 is, and then an improvement in the second half versus the first half. And then, you know, related to, you know, the revenue outlook for 2022, while we haven't at this point provided that guidance, you know, of course, assuming continual growth and prescriptions and TRX, which John will get a little bit more into, we're comfortable with wherever consensus is at.

Hi, Ken. Thanks for your question on refill rates. Yes, we are quite pleased with the initial refill rates, and we're seeing kind of aggregate around 65% refills over 60 days. The interesting stuff is that we've seen actually patients that were put on Tervia in the early parts of launch, November, December, that are still on drug, getting their sixth refill now at six months in. So In comparison to zydurastasis, I mean, we haven't quite done the math to see what persistence will be, but with these refill rates, we do feel that we're really performing a little bit above expectations on, you know, terbias persistence rates. So we'll get that number for you as the year progresses, but overall the leading indicators are quite positive on the acceptance of terbias by both patients as well as our prescriber base.

Okay, and then, John, maybe I'll sneak one more in. In terms of the prescribers, can you talk about repeat prescribers, kind of what percent you're seeing? Obviously, you're nicely expanding the clinician base, but if you have that data point.

Yes. In terms of unique writers, we mentioned for Q1 we were close to 4,500. You know, if I'm looking launch to date, we're now at 5,500. and a good proportion of them do repeat and write. We're currently running around 75% of those. One thing we have fine-tuned in our launch is when we initially went out with trying to get breadth of prescriptions, we're now also doing a lot of follow-up calls to make sure that the physicians that have already written a prescription actually continue to follow up with their patients and continue to write. So that's been a bit of a fine-tuning in our approach, and we're seeing kind of higher and higher repeat prescriptions based on that.

Okay, thanks so much. Appreciate it and keep up the good work. Thanks, Ken.

Our next question comes from Chris with JPMorgan. Your line is open.

Chris, your line is open. Great, thanks for taking the questions in. Congrats on the progress. First one's on payer coverage. Just wanted to get a bit more color on the additional covered commercial lives you added. Were these patients kind of downstream from ESI, or were there additional kind of major pairs that you brought on board? Maybe any additional call you could provide there would be helpful.

Yeah, thanks, Chris. Yeah, we did have some downstream plans from ESI that continued to be added to the original national preferred formularies. I think there's another big group, the United Health Group, that was added during the period. Kaiser, Tricare, and we're very pleased that we're now able to be providing a covered drug to the VA as well. Those are kind of the top six plans and payers that make up the majority of those 95 million lives that we currently cover.

Great. That's great progress to hear. And maybe just one kind of tangential but related point. So as we think about kind of the expansion of coverage through the remainder of the year, and you guys have had the bridge program in place. So how effective has that been really for patients who are either facing script rejections or who don't currently have coverage? How successful have you been in converting those patients over and making sure they actually do get scripts? I know there's oftentimes there is some... there could be some timing issues, and there can be some friction in getting them through the patient hub. So maybe some color there, and then also should we expect that as you expand coverage that we're going to see some flow-throughs in terms of the script trends, or should we think about that impact being more on pricing?

Yeah, let me comment first on the – our progress with commercial payer listings. So we do expect coverage determinations by mid-year this year with the other two large PBMs that control the majority of commercial lives. So while we're awaiting that coverage, we do encourage our physicians to enroll the patient into our Team Tervaia program. If they're deemed insured but not covered, they automatically get enrolled into our bridge program. And we've seen very, very good results kind of fulfillment rates through our partner. 90% of those scripts that do get processed get shipped to the patient. So very, very pleased with that partnership with our third party hub provider. And as we do get additional commercial listings on board, we expect to start to convert these patients to revenue patients over time. And we'll keep that rich program going while there's still a need for the patient. So we wanna make sure that If an appropriate patient is deemed to be prescribed Shurvaya and the physician feels that the patient is appropriate, we want to make sure that that script gets to that patient.

Great. Thanks. That's it for my end.

Thank you. As a reminder, to ask a question at this time, please press star then 1 on your touchtone telephone. Our next question comes from Patrick Dolezal with LifeSci Capital. Your line is open.

Hi, this is Corey on for Patrick. Thanks for taking our questions. Just a quick one from us. So looking forward into 2022, how do you plan on or how's your commercial strategy looking to shift over the course of the year? Do you have any granularity on, you know, when a DTC focus might emerge and when that does occur? What are some of the implications you have on cash burn and runway of that campaign?

Yeah, so I'll talk a little bit around the DTC efforts. You know, right out of the gate, we launched a lot of digital efforts targeting both patients as well as our physicians. So a lot of focus on social media, on search, on digital efforts, and very, very targeted. We don't plan to really go broad on DTC until we get good coverage, not just commercially, but in 2023, we do expect to get Medicare coverage. Only then we'll start to consider kind of a broader DTC effort. We feel that the more targeted digital efforts that we've started since launch have been working quite well for us.

Got it. And can you provide any additional guidance on where SG&A spend might net out going forward? And, you know, thinking about cash runway, you know, what are some of the near-term payouts you're anticipating from the Xing agreement? And is this included in your Guided Cash Runway?

Yeah, so at the moment, I would say that our OPX, as reported in Q1, would likely remain pretty consistent on a quarterly basis going forward. Throughout 2022, we've really built out all the internal infrastructure to effectively market to your buyer. whether it's on the SG&A side as well as everything that we need provision on the R&D side. So, you know, stopping short of providing, you know, quarterly consensus, I would say that we feel comfortable with the current OPEX run rate. And then, you know, we'll re-look at that as we enter into 2023. Of course, adding in additional buckets of capital, you know, as John alluded to on the DTC spend. To date, you know, we've been, you know, pretty adamant on taking a direct to patient perspective with digital. And we've been spending, you know, a decent amount of capital on social media that John could kind of speak a little bit closer to. But at the current, you know, cash runway, you know, we're still seeing, you know, about 12 months forward on our current budgets.

Excellent. Thanks for taking our questions.

Thank you. I will now turn the call back to Dr. Nell for closing comments.

Thank you, Operator, and thanks for all of you for joining the call today. In closing, we hope you have a clear picture of the strong trajectory of TIRVIA as a truly unique and innovative option for the treatment of dry eye disease. We're extremely excited about the potential for significant growth ahead for TIRVIA, as well as our pipeline assets. We endeavor to continue to bring transformational ophthalmic therapies to patients while delivering long-term value to shareholders. I want to thank everybody for joining the call today. Have a great evening.

This concludes today's conference call. Thank you for participating. You may now disconnect.