Glaukos Corporation

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to Gloucester's fourth quarter and full year 2025 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, Simply press star, then the number one on your telephone keypad. I would now like to turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Chris, please go ahead.

Thank you and good afternoon. Joining me today are Galacos Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurmond. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to be read by investors before the regularly scheduled quarterly conference call. To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, product approvals, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition, and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the Investors section of our website at www.cloudcoast.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaucos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables and our earnings press release available in the Investor Relations section of our website for a reconciliation of these measures to the most directly comparable GAAP financial measure. With that, I will turn the call over to Glaucos Chairman and CEO, Tom Burns.

Okay, thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glockos reported record fourth quarter consolidated net sales of 143.1 million, consistent with our pre-announcement last month, and up 36% on a reported basis and 34% on a constant currency basis versus the year-ago quarter. For the full year of 2025, consolidated record net sales of 507.4 million, who is 32% versus 2024. We are also reaffirming our full year 2026 net sales guidance range of 600 to 620 million, which implies continued strong year-over-year growth of more than 20% at the midpoint. A record fourth quarter and full year results reflect a highly successful year of global execution across our key commercial and development initiatives and underscore the dedication of our global teams strength of our differentiated technology platforms, and our evolution into a more diversified ophthalmic leader. From a corporate perspective, 2025 was a milestone year. In addition to surpassing a half a billion dollars in annual sales, we celebrated our 10th anniversary of our 2015 IPO, surpassed 1,000 employees worldwide, and broke ground on a new facility in Huntsville, Alabama. As we enter into 2026, we are well positioned to sustain our strong growth momentum, led by two transformational growth drivers, including the continued advancement of the interventional glaucoma treatment paradigm with IDOS-TR, along with the launch of Epioxa, opening up a new paradigm in interventional keratoconus and rare diseases. These two highly differentiated and durable market opportunities underpin our confidence to deliver a best-in-class, growth profile extending well into the next decade as we continue to invest in and advance a robust industry-leading pipeline while remaining disciplined in capital allocation, focusing on ROI-driven investments and cash flow. Our record fourth quarter results are a testament to the progress we continue to make in advancing our mission to transform vision therapies for the benefits of patients worldwide. Within our U.S. glaucoma franchise, we delivered record fourth quarter net sales of 86.4 million on strong year-over-year growth of 53%, driven by growing contributions from IDOS-TR, which generated sales of approximately 45 million in the fourth quarter. IDOS-TR's positive clinical outcomes continue to generate momentum with sales of approximately 136 million in 2025. reflecting strong physician adoption, reaffirming the compelling patient impact of this game-changing therapy. Operationally, our teams continue to execute well on our plans, focused on growing training surgeons and accounts, increasing utilization, broadening market access, expanding the clinical evidence, and accelerating targeted marketing investments. We believe IDOS-TR remains early in its overall adoption curve, with significant value yet to be unlocked as we expand market access and build on the progress in 2026 and beyond. Last month, we were pleased to announce that the US FDA approved our NDA labeling supplement, allowing for unlimited re-administration of IDOS-TR in patients who maintain a healthy cornea. We welcome this important labeling enhancement and believe it should help expand access for patients who may benefit from a repeat treatment and provide physicians with greater flexibility in managing their glaucoma patients over time. With IDOS-TR as the foundation, our goal to advance and improve glaucoma treatment by driving earlier intervention continues to gain steam as we educate surgeons and thought leaders globally to organically drive this broader evolution in the standard of care for the benefits of patients. While we remain in the early stages of these interventional glaucoma efforts, we are encouraged with the increasing levels of clinical interest for this paradigm-changing evolution. Moving on, our international glaucoma franchise delivered net sales of 32.8 million on year-over-year growth of 18% on a reported basis. and 13% on a constant currency basis. This strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MIGS forward as the standard of care in each region and major market in the world. As previously discussed, we continue to expect new competitive product trialing headwinds in some of our major international markets as we progress through 2026. partially offset by growing contributions from Kysted Infinite, following its EU MDR certification and associated European commercial launch late last year. And finally, our corneal health franchise delivered net sales of 24 million on year-over-year growth of 12%, including for tracts and net sales of 21.4 million. As you know, during the fourth quarter, we were delighted to announce the FDA approval of Epioxa, a novel groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare site-threatening disease that is currently far too often undiagnosed and untreated. Interest from the physician community following approval has been very encouraging and reinforces our view that with Epioxa, we are ushering in a new standard of care for keratoconus patients and practitioners with the first and only FDA-improved topical drug fair of the corneal epithelium, the outermost layer of the front of the eye. As a reminder, Epioxin utilizes a proprietary combination of an oxygen-enriched novel therapeutic that is bioactivated by UV light in an incision-free procedure. It is the result of more than a decade of research focused on slowing or halting the progression of keratoconus while significantly improving patient comfort and minimizing recovery time to provide a new way forward for patients afflicted with this site-threatening rare disease. As we've discussed, the FDA approval of Epioxa has allowed us to reset and redefine our go-to-market approach to better address this site-threatening disease and truly expand patient care and access. Immediately following approval, our cross-functional teams commenced execution of our detailed methodical initial commercial launch plans ahead of epioxid drug availability expectedly in this quarter. Importantly, with this launch, we plan to substantially increase our investments in patient awareness, education, and access while addressing the long-standing challenges of underdiagnosis and undertreatment that have affected this rare disease community. Our efforts are designed to support patients and families at every stage, from awareness and diagnosis through ongoing treatment, making the entire journey as seamless, efficient, and patient-friendly as possible over time. As with all pharmaceutical launches, initial patient access will be gated by our site of care network deployment and typical payer adoption headwinds and hurdles, but we're investing in the infrastructure, teams, and processes necessary to get Epioxin to as many patients as soon as possible in 2026 and beyond. We've been encouraged by the progress we've made in short order following approval. First, I'm proud to report we are ahead of schedule in establishing our Epioxys site-secured network. Our early wave one efforts are yielding results with acquired O2N systems already actively deployed in locations covering nearly 50% of the US population and a broader pipeline of systems moving through the approval processes that would expand our treatment center reach closer to 90%. Looking ahead, we will continue evolving this network to bring treatment access closer to patients as reimbursement and drug acquisition pathways become further established and streamlined. Next, on the market access front, we have completed our initial payer communications and updated key payer databases with the details associated with the EPIAXA launch. Our payer team is already actively engaged today with insurers, representing approximately 50% of commercially covered lives in the United States, including four of the top five commercial payers. As a result, we have seen several early positive coverage determinations spanning across the Medicaid and commercial payer landscape. We successfully submitted for the permanent J code and expect it to become effective in July of 2026. based on the CMS cycle for J-Codes. Until then, we anticipate Epioxa will be commercially available under a new technology, miscellaneous J-Code, and anticipate measured adoption over this initial period until the permanent J-Code is in place. In addition, we've also rolled out various new patient services and support programs led by our patient access liaison teams designed to streamline care coordination demystify the insurance approval process, and advance covered decisions where possible. Our teams are also deploying new marketing and DTC campaigns designed to significantly enhance awareness, education, and detection, driven by increased engagement with the optometric community, the development of a handheld KC screening device, and expanded advocacy partnerships alongside new patient education efforts to identify and reach patients earlier. Finally, as we've discussed with the launch of Epioxa, a critical focus of ours is to improve patient access to the site-saving keratoconus treatment. On that front, we have successfully deployed a new financial copay assistance program for eligible patients and operationalized a comprehensive specialty pharma option available for our customers As you can see, we are very excited by the significant potential Epioxa offers to patients living with keratoconus and believe it will deliver an exceptional value to patients, providers, and the healthcare system. This enthusiasm was on full display during our recent national sales meeting where anticipation for Epioxa's availability later this quarter was palpable. We're proud to lead the way once again in forging a new path to drive expanded patient access and enhanced treatment standards. Beyond that epioxin, we continue to advance a broad and differentiated clinical pipeline across our five novel therapeutic platforms with several notable milestones. Within our iStent surgical glaucoma prep platform, we completed patient enrollment in a PMA pivotal trial for iStent Infinite in mild to moderate glaucoma patients during the fourth quarter and continue to advance a 510K Pivotal Study for the Pressor Flow Microshub. Within our iDOS platform, patient enrollment is well underway in the Phase 2b3 clinical program for iDOS T-REX, our next generation iDOS therapy, with initial results of our Phase 2a clinical trial demonstrating substantial ILP reductions of 8.6 to 10.8 millimeters of mercury through three months. In addition, we recently commenced a phase 3B study for high-dose TRIO and continue to advance several phase 4 studies. Within our iLink platform, we plan to bring a KC screening tool to market later this year and initiate a phase 3 program for our third-gen iLink therapy next year. Within our Iolution platform, we commenced the Phase II study for Iolution demodex blepharitis in the fourth quarter. And finally, within our retinal platform, we recently completed enrollment in a first in human clinical development program for GLK401, our intravitreal multikinase inhibitor retinal program in patients with wet AMD. Despite being a relatively young company, LogCoast has invested over $1 billion in R&D since inception to develop a robust pipeline focused on chronic and rare ophthalmic diseases. Our continued investment in R&D remains best in class, underscoring our commitment to going first and advancing the standard of care for ophthalmic patients worldwide into the future. In conclusion, at Glaucos, we're in the business of pioneering entirely new marketplaces within ophthalmology. Innovation is at the core of everything we do as we advance our mission to transform vision therapies that can meaningfully advance the standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases. Our mantra of We'll Go First embodies our commitment and determination to take chances push the limits of science and disrupt the legacy of treatment paradigms in glaucoma, rare disease, and retinal diseases through our pursuit of game-changing innovation. Our record fourth quarter and full year 2025 highlights the strength of our strategy and execution as we continue evolving into a diversified ophthalmic leader with multiple transformational growth drivers in IDOS-TR and Epioxa and advance our mission to transform vision therapies for the benefit of patients worldwide. So with that, I'll open the call for questions. Operator.