8/7/2025

speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to the Site Sciences second quarter 2025 earnings results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 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, Tripp Taylor, Investor Relations. Please go ahead.

speaker
Tripp Taylor
Investor Relations

Thank you for participating in today's call. Presenting today are Site Sciences co-founder and chief executive officer, Paul Bedawi, and chief financial officer, Allie Bauerlein. Also in attendance is Site Sciences Chief Commercial Officer Matt Link. Earlier today, Site Sciences released financial results for the second quarter ended June 30, 2025, and raised its revenue guidance and reaffirmed 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'd like to remind everyone that comments made today 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 preliminary factors impacting our ability to achieve our guidance, the impact of tariffs costs on our costs of goods sold, our plans to expand our manufacturing lines to additional manufacturing locations, and the expected timelines and related costs. 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 and or payment decisions for TierCare, expectations regarding commercial momentum, account utilization and customer engagement, our pipeline of interventional glaucoma and dry eye technologies, our clinical trial strategy and results, our investments in market development and market research and development projects, and expectations regarding the relief that we may ultimately be awarded and the potential impact of recently requested ex parte reexaminations on such relief in connection with our patent infringement case against Alcon. 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 our public filings with the Securities and Exchange Commission, including in the risk factors section of our annual report on Form 10-K and quarterly reports on Form 10-Q. We undertake 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. We believe these non-GAAP financial measures are important indicators of a company's operating performance because they exclude certain 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 Bedawi
Co-founder and Chief Executive Officer

Thanks, Tripp. Our strong second quarter performance underscores the value of our proven interventional technologies for treating glaucoma and dry eye disease. These results also reflect the dedication and consistent efforts of our team in effectively supporting eye care providers and the patients they serve. Our second quarter revenue of $19.6 million was driven primarily by solid execution and growing momentum in our surgical glaucoma segment. Within surgical glaucoma, sequential growth in both ordering accounts and procedural utilization marked meaningful progress as we strengthened our position as the market leader in implant-free mix. We are also continuing to work towards positive reimbursement coverage and or payment decisions for care care this year. In addition, we delivered operational excellence, achieving excellent gross margins, diligent expense management, and reduced cash usage. Reflective of this execution, we are raising our full year 2025 revenue guidance to $72 to $76 million, while maintaining our full year 2025 guidance on adjusted operating expenses. Now, diving into our surgical glaucoma segment, we believe the growing demand for minimally invasive glaucoma treatments represents a significant long-term market opportunity, and we believe we are well-positioned to capitalize on the ongoing shift in surgeon behavior towards procedural interventions. As a reminder, this is only the second full quarter operating within the new MIGS environment, where Medicare coverage in most states restricts performing multiple MIGS procedures in combination with cataract surgery. We are pleased with our performance and the resilience of our surgical glaucoma segment in this environment. We continue to have conviction in our ability to drive adoption of Omni based on multiple factors, including the ongoing shift in surgeon mindset towards interventional glaucoma, our market-leading position in the mixed industry, our focus on meaningful long-term surgeon relationships and customer engagement, Omni's comprehensive procedure profile and usability, and its proven long-term safety and efficacy. In the second quarter of 2025, our surgical glaucoma revenue was 19.2 million, down 5% compared to the second quarter of 2024, and up 12% compared to the first quarter of 2025. Our stronger than anticipated second quarter performance reinforces our confidence in the Omni procedure as a leading solution in interventional glaucoma care. We remain focused on executing with agility in this evolving environment and are actively improving our commercial strategy to sustain momentum and drive growth. We are also making consistent progress across multiple strategic priorities designed to drive long-term growth and shareholder value. These efforts include enhancing our competitive positioning, investing in targeted commercial resources, expanding the pseudophagic standalone omni market, and building on the early traction with the Omni Edge, our latest MIGS innovation. I'll now walk through our recent achievements in support of these initiatives. First, I want to expand more on the commercial progress we saw in the second quarter, where we have been focused on growing ordering accounts and increasing account utilization. We reached a record high for ordering accounts in the second quarter, up 6% sequentially and 4% versus the same period in the prior year. due to both re-engagement efforts with accounts who had ordered previously but had gone dormant, and also new accounts ordering for the first time. We also saw 4% sequential increase in surgical glaucoma utilization and improvement in our average selling price, contributing to our strong quarterly performance above expectations. Next, I want to look at the early success we have seen with the recent launch of OmniEdge, the latest evolution of our Omni platforms. OmniEdge is designed to meet the diverse preferences of surgeons and the evolving needs of patients in today's MIGS landscape. Since launch, surgeons have responded positively and are achieving strong outcomes with our new technology. We believe that with this next-generation technology, we will drive further improvements in omni-utilization. Lastly, we have also been focused on educating surgeons and their clinic staff on the importance of addressing the unmet need for pseudophagic patients whose glaucoma remains uncontrolled and could benefit from a standalone OMNI procedure. While it is difficult to track specific metrics on adoption, we are helping more customers learn how to identify these patients and implement standalone procedures as part of their clinical practice. We believe addressing this population will help improve long-term clinical outcomes for primary open-angle glaucoma patients and increase adoption of OMNI for use in standalone procedures. Turning to our dry eye business, we have been intentionally executing our long-term strategy to create reimbursed market access for our interventional dry eye technology, tear care. We've developed best-in-class interventional MGD technology, delivered superior long-term clinical outcomes demonstrated through randomized controlled clinical trials, and established coding for this procedure. We've been increasing customer advocacy and advancing our market access initiatives to establish equitable reimbursement for tear care. In the second quarter of 2025, our dry eye revenue was 0.3 million, a decrease from 1.1 million in the second quarter of 2024, primarily due to fewer smart lid sales, which was a result of our focus on achieving reimbursed market access for tear care procedures. We were pleased to announce the publication of the 24-month results of the Sahara RCT, demonstrating the durability of the tear care procedure for the treatment of dry eye disease. The results show mean signs and symptoms for participants in stage three of the Sahara trial remain statistically significantly better than study baseline at all time points up to 24 months. The results further validate the durability, consistency, and strong clinical benefits of tear care as an interventional therapy for dry eye disease. As a landmark device versus drug study, This long-term data builds on the positive outcomes from the first two stages of the Sahara trial and adds to a growing body of robust clinical evidence supporting TierCare's effectiveness. We are encouraged that participants maintain clinically meaningful improvements in both signs and symptoms of dry eye disease with just one or two treatments per year, reinforcing TierCare's potential as a long-lasting and efficient treatment option. We have also recently announced the publication of a cost utility analysis assessing the cost effectiveness of tear care compared to cyclosporine for the treatment of moderate to severe MGD-associated dry eye disease. The analysis demonstrated that tear care not only improved patient outcomes, but also resulted in significant cost savings compared to cyclosporine. Both publications will further support our discussions with payers as we articulate the long-term clinical benefits of tear care and criticality of reimbursed patient access to this proven procedural intervention. There is a significant unmet need within the MGD patient population for a reimbursed interventional treatment option, and we continue to engage in meaningful conversations with both commercial and MAC payers to seek coverage and appropriate reimbursement for tier care. While formal coverage or pricing policies have not been established as soon as we would have liked, Our level of confidence in our ability to ultimately ensure reimbursed market access for care care remains high, given the compelling clinical and health economic value of care care. This includes the most recently published Sahara Stage 3 long-term two-year clinical data and the cost utility analysis. Our eye care provider partners also share our belief in the important need for care care reimbursement and are submitting claims and processing appeals to payers to demonstrate the unmet need real-world utilization, and significant value of our technology. As we are working to support coverage and payment for the TierCare procedure, we have built a foundation with an established commercial infrastructure that has trained eye care providers at over 1,500 facilities and supported over 70,000 TierCare 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 TierCare can be a catalyst to drive growth and the robust dry eye opportunity. In summary, our top priorities are strengthening our leadership position in implant-free MIGs and developing the reimbursed procedural dry eye market. And we're encouraged by the progress made through the second quarter as we execute on key strategic initiatives. As a reminder, our 2025 strategy centers on working towards securing equitable reimbursement for tier care, driving commercial momentum in MIGs through the ongoing rollout of OmniEdge and continued investment in customer education and engagement, publishing new clinical and economic data to support broader adoption of our technologies, and advancing our robust product pipeline. As we enter the second half of 2025, these developments reinforce our confidence and our ability to deliver long-term value across the ICARE landscape. I'll now turn the call over to Ali to discuss our financial results and guidance for 2025.

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