3/5/2025

speaker
Operator
Conference Operator

Hello, and welcome to the Site Sciences fourth quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce Tripp Taylor, Investor Relations.

speaker
Tripp Taylor
Investor Relations

Thank you for participating in today's call. Presenting today are SightScience's co-founder and chief executive officer, Paul Bedali, and chief financial officer, Allie Ballerline. Also in attendance is SightScience's chief commercial officer, Matt Link. Earlier today, Site Sciences released financial results for the fourth quarter and full year ended December 31, 2024, and initiated revenue and adjusted operating expense guidance for full year 2025. A copy of the press release is available on the company's website at investors.sitesciences.com. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements within the meaning of the federal securities laws. These forward-looking statements include statements related to the company's anticipated financial performance, operating results, liquidity position, and ability to achieve cash flow break-even, 2025 revenue and adjusted operating expense guidance, and tariff impacts to gross margin, and the primary factors impacting our ability to achieve our guidance, ability to achieve current and long-term strategic objectives and value drivers, market opportunity, and ability to enter new markets and capture market share, the continued adoption of the company's products by surgeons, pricing strategy, product reimbursement coverage and strategy, including the company's ability to achieve positive reimbursement coverage policies for tear care, expectations regarding commercial momentum, account utilization and engagement, the company's pipeline of interventional glaucoma and dry eye technologies, the timing of the release of new product under development, clinical trial strategy and results, and the disposition of ongoing patent litigation. Forward-looking statements are based on estimates and assumptions as of today, are neither promises nor guarantees, and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements. A description of some of these risks and uncertainties can be found in the company's public filings with the Securities and Exchange Commission, including in the Risk Factors section of its annual report on Form 10-K and quarterly reports on Form 10-Q. The company undertakes no obligation to publicly update or revise any forward-looking statements except as required by law. On this call, management refers to certain financial measures that were not prepared in accordance with generally accepted accounting principles in the United States, including adjusted operating expenses. The company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are unrelated to and may not be indicative of its core operating results. See the company's earnings release for a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures, as well as additional information about the company's reliance on non-GAAP financial measures. I will now turn the call over to Paul. Thanks, Tripp.

speaker
Paul Bedali
Co-founder and Chief Executive Officer

Earlier today, we reported our financial results for the fourth quarter of 2024. In the quarter, we generated total revenue of $19.1 million, a 2% increase compared to the same period in the prior year. Our results reflect the continued commitment and hard work of our team as we remain steadfast in our mission to be a leader in the development of transformative, interventional technologies that allow eye care providers to procedurally elevate the standards of care empowering people to keep seeing. Our current products address significant unmet needs in glaucoma and dry eye, two of the biggest markets in eye care. Effectively serving the physicians and patients in both of these markets with our innovative interventional technologies is our top priority. As we closed out 2024, we were pleased to see progress on multiple fronts during the fourth quarter. We experienced an increase in surgical glaucoma ordering accounts, and revenue both sequentially and compared to the fourth quarter of 2023, as well as account re-engagement momentum. We also made advancements towards our goal of achieving equitable market access for our tier care technology with an increased number of claims reimbursed under commercial plans. The clinical highlights for our technologies included the publication of three-year standalone clinical data, which demonstrated the long-term effectiveness of Omni in managing primary open angle glaucoma and the publication of the Tier Care Budget Impact Analysis, which showed a direct relationship between increased utilization of Tier Care in place of prescription medications and total cost savings from a U.S. payer perspective. And finally, throughout 2024, we were disciplined in managing our expenses and improving working capital, which contributed to a 62% reduction in net cash used for the year. As we enter 2025, we are focused on our key strategic initiatives, which include building commercial momentum in MIGS through our continued commitment to customer education and engagement, establishing equitable reimbursement for tier care, publishing new clinical and cost data supporting the adoption and use of our portfolio of interventional technologies, and progressing our robust pipeline, including an upcoming next-generation Omni release. We believe that 2025 will be a transformational year for site sciences as we expect to achieve initial positive coverage and or payment decisions for care care, which would be the first of its kind for interventional MGD treatments. We have started the year strong with our national sales meeting and the American Glaucoma Society meeting last week. We had enthusiastic engagement and buy-in from our team and our clinician partners with respect to our strategic initiatives and how to drive the interventional mindset across eye care providers in both glaucoma and dry eye disease. We believe with the focus and execution of our internal teams, combined with a growing number of partnerships with KOLs across the industry, site sciences will continue to enable the paradigm shift in procedural interventional care. Diving into our surgical glaucoma segment. Although the MIGS market has been in flux for the last 18 months, We now have improved visibility into the new market environment, and we believe the comprehensive procedure performed with OMNI will continue to be a market-leading choice for surgeons. Glaucoma is a very serious disease and remains the world's leading cause of irreversible blindness, with an estimated 83 million diagnosed primary open-angle glaucoma patients worldwide. We believe MIGS will continue to play a critical role in controlling the disease in terms of both intraocular pressure and medication reductions. and Omni remains a clear leader in the MIGS category. In the fourth quarter of 2024, we generated 9% growth in surgical glaucoma revenue compared to the same period in the prior year, and up 1% sequentially from the third quarter of 2024. In the face of the LCD-related headwinds in MIGS procedures, our team worked with our surgeon partners who were adapting their treatment algorithms to align with the final Medicare LCDs. As a reminder, These LCDs included the elimination of Medicare coverage in most states for multiple MIGS procedures that are completed at the same time as cataract surgery. With these restrictions, a surgeon must now choose one MIGS procedure at a time for these patients. Despite this dynamic environment, our hard work still resulted in important progress in several areas, including a sequential increase in ordering accounts and positive momentum with account re-engagement and utilization. After operating in this new MIGS environment during the last six weeks of the fourth quarter of 2024, we realized the headwinds were larger than initially anticipated. We estimate that the multiple MIGS claims billed was roughly a mid-teens percent of total MIGS claims billed, but we believe that Omni has had a higher utilization than the overall market in these stacked procedures. This dynamic is factored into our 2025 revenue guidance. While in the short term, we do anticipate an industry-wide decline in total utilization of MIGS devices, we are confident that we have identified a pathway from which we can generate positive momentum to maintain our leadership position, keeping in mind that patient demand and need for glaucoma treatment will continue to grow in 2025 and beyond. We are focused on surgeon education on the clinical benefits of earlier interventions with the comprehensive OMNI procedure, re-engagement efforts with accounts highlighting reimbursement clarity, enhanced competitive counter-selling, investments in targeted commercial resources, optimized pseudophakic standalone omni-market development strategy through refined patient targeting and selection, and an upcoming new product launch. Additionally, there remains opportunity in continuing to train new surgeons and expand utilization, as we believe we have trained less than half of the mixed-trained surgeons in the United States And many surgeons still have not fully adopted MIGS as a standard of care for glaucoma patients. As a reminder, the pseudophagic standalone segment consists of patients three or more years out from prior cataract surgery who may or may not have had a MIGS procedure at the time of cataract surgery, but whose IOP is not well controlled on two or more medications. These later stage patients are at risk of disease progression, and most are likely on their way to an invasive and complicated procedure. like a trabeculectomy or a tube shunt. We believe that standalone intervention performed with Omni can be effectively utilized for these patients to potentially delay or avoid the need for the riskier advanced procedures and improve patient care. Our team has been engaging with our customers on the topic of Omni as an optimal treatment for this underserved patient population, and the message has been resonating. Lastly, I want to briefly touch on our pipeline, specifically our next planned product launch in the Omni family. We are excited to introduce OmniEdge to market, which is planned for the first half of 2025. The addition of OmniEdge is intended to accommodate varying physician preferences and patient needs in today's evolving MIGS marketplace. OmniEdge, with intelligent VSCO delivery, is designed to increase the amount of VSCO elastic delivered with our patented motion-synchronized delivery system. to ensure the consistency, reproducibility, and safety surgeons have come to trust in the Omni procedure. With this product, we are reinforcing our commitment to best serving both our surgeon customers and the patients they care for. The addition of Omni Edge reflects our strong relationships with our customers, our ongoing dedication to enhancing our products, and our ability to rapidly respond to the evolving needs of the eye care community. Now I will turn to our dry eye business, where we also continue to make solid progress on our strategic initiatives. Our fourth quarter results in dry eye reflect our focus on reimbursed market access and new pricing, which went into effect October 1st, 2024. We are dedicated to achieving equitable market access for tier care as our top priority, and I am pleased with the advancements we are making toward this goal. We are continuing to engage in meaningful conversations with payers, supported by the positive results of the 12-month Sahara study, along with the recently published budget impact analysis, which we believe will help support positive coverage and or payment decisions in 2025. We estimate there are over 13 million U.S. patients diagnosed with meibomian gland disease, or MGD, the leading cause of dry eye disease. Historically, treatment options for these patients have been dominated by prescription and over-the-counter eye drops, which primarily focus on increasing tear volume in aqueous deficient patients. Because there is currently no reimbursed interventional treatment that addresses the root underlying cause of MGD, we believe there is a significant unmet need within this patient population. Our long-term strategy is to be a pioneer in the estimated $3 billion core market for patients with moderate to severe MGD who are candidates for an interventional procedure. We have been highly intentional in executing our strategy, beginning with developing best-in-class technology, followed by delivering superior long-term clinical outcomes demonstrated through randomized clinical trials, and now we are advancing an effective market access strategy to establish equitable reimbursement for TierCare. Our methodical approach has led us to the cusp of unlocking this multibillion-dollar market opportunity this year. Clinically, the effectiveness of TierCare was shown in the landmark Sahara trial, which evaluated treatment with tear care compared with the leading prescription eyedropper stasis for patients with dry eye disease. Following the successful completion and publication of phase one and phase two of the Sahara RCT in 2023 and 2024 respectively, we are pleased to announce that patient visits for the third and final phase of Sahara, which was designed to assess the durability and procedural treatment effect of tear care through 24 months, were completed in October 2024. We expect the results from this final phase of the Sahara RCT to be published in 2025. In December 2024, we announced the results of the Tier Care Budget Impact Analysis, which was published in the Expert Review of Ophthalmology Journal. The analysis, projected over a two-year period, compared the financial impact of Tier Care to commonly prescribed dry eye medications. Key findings indicated that a 20% increase in market share of Tier Care compared to prescription dry eye medications would yield an estimated annual savings of $36.87 per member per year across all plan members in a hypothetical health plan with 1 million covered lives. The study also demonstrated a direct relationship between increased utilization of tier care in place of prescription medications and total cost savings from a U.S. payer perspective. We believe the budget impact analysis results are a contributor to a manufacturer's formulary listing or reimbursement submission, and we are introducing the results of this analysis in our conversations with payers. We feel the combination of the strong clinical data from the Sahara RCT and the findings of this budget impact analysis create a compelling case for payers to establish coverage and or payment for treatments performed with TierCare at an appropriate reimbursement level. We are encouraged that a number of TierCare claims have already been paid through commercial insurance. Finally, on DryEye, our established commercial infrastructure has engaged with over 1,500 eye care facilities who have invested in TierCare hubs and performed over 65,000 TierCare procedures to date. This foundation will allow us to hit the ground running as reimbursement from TierCare comes into place. Our TierCare track record of significant eye care provider adoption along with the historic cash pay results, validate the patient demand and clinical need for our product. We believe these early indicators suggest demand will grow following any positive coverage or payment decisions. This catalyst, along with our commercial preparedness, represents an opportunity for a significant growth inflection. We have made significant progress in executing on our strategic initiatives and we remain confident in our business and in our continued ability to be a leader in addressing the unmet needs served by our innovative technologies. In surgical glaucoma, through a continued commitment to education and engagement with our customers, we remain focused on building commercial momentum in the new mixed market environment while also developing the pseudophagic standalone market for Omni. In dry eye, We plan to continue working towards making tear care the first mover in reimbursed interventional dry eye in 2025 for the millions of patients suffering from dry eye disease. I will now turn the call over to Ali to discuss our financial results and 2025 guidance.

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