5/8/2025

speaker
Conference Operator
Call Moderator

Good day, and thank you for standing by. Welcome to the Site Sciences first quarter 2025 earning results conference call. At this time, our participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Hannah Jeffries, Investor Relations. Please go ahead.

speaker
Hannah Jeffries
Investor Relations

Thank you for participating in today's call. Presenting today are SightScience's co-founder and chief executive officer, Paul Badawi, and chief financial officer, Aoi Bowerly. Also in attendance is SightScience's chief commercial officer, Matt Link. Earlier today, Site Sciences released financial results for the first quarter ended March 31, 2025, and reaffirmed its revenue and reduced its adjusted operating expense guidance for full year 2025. A copy of the press release is available on our 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 federal securities laws. These forward-looking statements include statements related to our 2025 revenue and adjusted operating expense guidance and the primary factors impacting our ability to achieve our guidance. The impact of tariff costs on our cost of goods sold, our plans to expand our manufacturing lines to additional manufacturing locations and the expected timelines and related costs, our ability to offset costs associated with tariffs and manufacturing expansion with adjustments to our cost structure, Our ability to achieve our current and long-term strategic objectives and value drivers. Our market opportunity and ability to compete and capture market share. The continued adoption of our products by surgeons. Our product reimbursement coverage and strategy, including our ability to achieve positive reimbursement coverage decisions for tear care. Expectations regarding commercial momentum, account utilization, and customer engagement. Our pipeline of interventional glaucoma and dry eye technologies. our clinical trial strategies and results, and our investments in market development and research and development projects. 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 in these statements. A description of some of these risks and uncertainties can be found in our public filings with the Securities and Exchange Commissions. including the risk factor section of its annual report on Form 10-K and quarterly report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statements except 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. We believe 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 our 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 our reliance on non-GAAP financial measures. I will now turn the call over to Paul.

speaker
Paul Badawi
Co-founder and Chief Executive Officer

Thanks, Anna. Earlier today, we reported our financial results for the first quarter of 2025, including total revenue of $17.5 million. In a dynamic MIGS market, our solid results reflect the significance of our proven interventional technologies for our customers and patients, and the consistency and hard work of our team to effectively serve eye care providers and their patients. We remain focused on addressing the significant unmet medical needs in two of the largest markets in eye care, glaucoma and dry eye, and committed to our mission to develop transformative, interventional technologies that allow eye care providers to procedurally elevate the standards of care, empowering people to keep seeing. As we discussed on our prior call, our focus in 2025 is rooted in 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 economic data, supporting the adoption and use of our portfolio of interventional technologies, and progressing our robust product pipeline, including a recent next generation Omni release. I would also like to address our tariff exposure, considering the material tariff increases on all goods imported from China. As most of our products are manufactured and assembled in China, We expect increases to our cost of goods sold starting in the second quarter of 2025 and throughout 2025 for as long as these tariffs remain in effect. We expect to mostly offset the incremental tariff costs with reductions in our operating expenses. Allie will cover these details and their associated financial impact in her prepared remarks shortly. As part of our routine assessment of manufacturing operations, we have been evaluating additional manufacturing locations and are in the process of establishing third-party manufacturing lines outside of China, which would lower our tariff costs over time. In nine to 12 months, we expect a new manufacturing line to be available outside of China to produce our OmniEdge product. We plan to phase in additional manufacturing capacity outside of China for our other impacted product lines over the subsequent six to nine months. Diving into our surgical glaucoma segment, The first quarter of 2025 marked the first full quarter in this new MIGS environment, in which Medicare coverage in most states for multiple MIGS procedures that are performed at the same time as cataract surgery has been restricted. In these regions, Medicare limits coverage to only one MIGS procedure performed with cataract surgery. Our better than expected results in the first quarter, despite these changes, reinforce our belief that the comprehensive procedure enabled by Omni, will continue to be a market leading treatment option in the MIGS category. We believe Omni is performing well against the competition at or slightly above the levels we expected due to Omni's clinical efficacy, surgeon preference, our focus on our long-term customer relationships, and our expanding Omni technology platform. We will continue to adapt within this new MIGS environment and are actively optimizing our commercial approach. In the first quarter of 2025, surgical glaucoma revenue was 17.1 million. We are encouraged to see only a slight decline in sequential ordering accounts considering the MIGS restrictions, and our account engagement efforts are gaining traction. We are confident that patient need and demand for glaucoma treatment will continue to grow in 2025 and beyond, and we believe we are well positioned to benefit from the shift in surgeon adoption and utilization toward an interventional mindset. We are focused on advancing multiple strategic initiatives, including demonstrating the clinical benefits of earlier interventions with the comprehensive Omni procedure, engaging accounts around reimbursement clarity, enhancing competitive counter-selling, investing in targeted commercial resources, optimizing pseudophakic standalone Omni market development strategy through refined patient targeting and selection, and expanding the use of our new product, the OmniEdge. I will now highlight our recent progress made against these initiatives. We recently attended the annual meeting of the American Society of Cataract and Refractive Surgery, or ASCRIS, a large industry event. At ASCRIS, we hosted several events and spent time highlighting the pseudophagic standalone unmet need. We are excited by the growing interest in learning about earlier interventions with OMNI, and we were pleased with the strong surgeon engagement and increased focus on interventional glaucoma. We believe that standalone intervention performed with Omni can be effectively utilized for pseudophagic standalone glaucoma patients to potentially delay or avoid the need for riskier advanced future procedures. We continue to make headway as a result of our team's engagement with surgeons and other customers on the advantages of Omni for this patient population. We believe we have trained approximately half of the mixed-train surgeons in the United States, and we continue to add Omni and Scion-trained surgeons. Our robust clinical data highlighting the efficacy and benefits of our Omni technology supports our surgeon education and account engagement efforts. Lastly, I want to briefly touch on our product pipeline. We recently launched our next generation OmniEdge, which is the latest evolution of our MIGS platform that is helping glaucoma surgeons effectively treat primary open-angle glaucoma patients. Surgeons are leveraging this technology to address the diverse needs of these patients, including combination cataract and standalone patients, as well as mild, moderate, and severe patients. In March, we commenced a controlled release of our OmniEdge devices to select key opinion leaders before our formal launch at ASCRIS two weeks ago. We are pleased with the early reception from surgeons and their clinical outcomes. OmniEdge, with TruSync technology, incorporates a proprietary motion synchronized viscoelastic delivery mechanism whereby surgeon rotation of the control wheel results in predictable and reproducible viscoelastic deployment along every treated clock hour of Schlem's Canal. OmniEdge is designed to deliver significantly more visco-dilation than prior versions of the Omni system, while maintaining the consistency and safety surgeons have come to trust in the Omni platform. The addition of OmniEdge is intended to accommodate varying physician preferences and patient needs in today's evolving MIGS marketplace. With this product, we are expanding our portfolio to supply surgeons with more options to support their patients. Now I'll turn to our dry eye business, where we continue to advance our strategic initiatives. As a reminder, our long-term strategy is to be a pioneer in the estimated $3 billion core market for patients with moderate to severe meibomian gland disease, or MGD, who are candidates for an interventional procedure. We have been intentional in executing our strategy beginning with developing best-in-class technology, followed by delivering superior long-term clinical outcomes demonstrated through randomized controlled clinical trials. We are now increasing customer advocacy and advancing our market access initiatives to establish equitable reimbursement for tier care, with coverage policies and or payment decisions still expected to begin in 2025. In the first quarter of 2025, dry eye revenue was 0.4 million. Our results for the first quarter of 2025 in our dry eye segment reflect our focus on market access and our new pricing. We believe there is a significant unmet need within the MGD patient population for an interventional treatment option, and we continue to engage in meaningful conversations with payers to seek coverage and appropriate reimbursement for care care. Our customers have been very supportive and are actively submitting claims to payers to demonstrate the unmet need, real-world utilization, and significant value of our technology. We continue to develop our clinical evidence with the progression of our three-stage Sahara RCT, a landmark trial that has demonstrated the effectiveness of tear care when compared with the leading prescription eyedropper stasis in stages one and two. We expect the results from the third and final stage, which assesses the durability of tear care treatment effect through 24 months, will be published in 2025. As we have worked to support coverage and payment for the tear care procedure, we have built a foundation with an established commercial infrastructure that has trained eye care providers at over 1,500 facilities and performed over 65,000 tear care procedures to date. We are confident this meaningful and experienced customer base is capable of quickly ramping to meet demand if and when reimbursement determinations come. We believe tear care can be a catalyst to drive growth and the robust dry eye opportunity. Our continued ability to be a leader in addressing the unmet needs served by our innovative technologies is a top priority for us. And we are pleased with our achievements through the first quarter to solidify our position as we execute our strategic initiatives. In our surgical glaucoma segment, we are building commercial momentum within the evolving MIGS market through surgeon education and engagement with our customers, as well as developing the pseudophagic standalone market. In dry eye, we have created an important foundation from which we can execute and appropriately scale following coverage and or payment decisions for Tiercare. I will now turn the call over to Allie to discuss our financial results and guidance for 2025.

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