Glaukos Corporation

If you would like to ask a question during that time, press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star followed by the number one. This call is being recorded and an archived replay will be made available online in the investor relations section of www.glycos.com. I will now turn today's call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

Thank you and good afternoon. Joining me today are Glaucus Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurman. 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 provide the investment community with a summarized and easily accessible reference document that details key facts associated with the quarters statements or guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call. As such, for this call, we will make brief prepared remarks and transition into a question and answer session. To ensure ample time and opportunity to address everyone's questions, we request that you delimit 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, the efficacy of our current and future products, dependent 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. Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor relations section of our website at www.globcos.com. Finally, please don't forget to turn today's call to 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 Cloud Coast's ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables on earnings press release available in the investor list relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Cloud Coast Chairman and CEO, Tom Burns.

Okay, thank you, Chris. Good afternoon, and thank you all for joining us. Today, Glocos reported record first quarter consolidated net sales of 106.7 million, 25% on a reported basis or 26% on a constant currency basis versus the year-ago quarter. We are also reaffirming our full year 2025 net sales guidance range of 475 to 485 million as we balance our first quarter outperformance while continuing to closely monitor the global macroeconomic environment and associated uncertainties. Our first quarter record results reflect the sustained growth acceleration in our business with strong performance driven by IDOS TR adoption and both our US and international glaucoma franchises overall. Our continued growth trajectory globally is the result of our ongoing efforts to pioneer and develop the interventional glaucoma or IG marketplace with new standalone therapies designed to slow disease progression and reduce drug burden for the benefit of physicians and patients. These efforts were on full display at the AGS conference in February, and more recently at the ASCRS annual meeting last weekend, where the interest and excitement levels for interventional glaucoma and our technologies were high. While we remain in the early stages of these IG efforts, we are encouraged with the increasing levels of clinical interest for this paradigm-changing evolution. Within our U.S. glaucoma franchise, we delivered record first quarter net sales of 59.1 million on strong year-over-year growth of 41%, driven by growing contributions from IDOS-TR, a first-of-its-kind intracameral procedural pharmaceutical, that was designed to continuously deliver glaucoma drug therapy for up to three years. Importantly, clinical outcomes and product feedback from a growing number of cases and trained surgeons continue to be very positive and reaffirms our view that with the launch of IDOS-TR, we are pioneering a brand new therapeutic category that has the potential to reshape glaucoma management as we know it today. Operationally, our teams continue to make great progress in the execution of our detailed launch plans for IDOS-TR, including first, growing the universe of trained surgeons and accounts. Second, expanding utilization of the installed active surgeon base. Third, broadening and streamlining market access among MACs, commercial and Medicare Advantage payers. Fourth, expanding the robust body of clinical evidence. And fifth, accelerating and marketing investments increase patient awareness and education. Overall, while we remain in the early 80s, I couldn't be more pleased with the strong foundation we built to bring this transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension. Shifting to our U.S. business as anticipated, the five MAC LCDs implemented in the fourth quarter of 2024 continue to cause some transient turbulence in the market during the first quarter as surgeons navigate restrictions when using two MACE surgical devices in the same procedure. We expect this MACE market headwind will continue over the course of 2025 as providers continue to navigate the impacts associated with these LCDs until an anniversary later this year. Moving on, our interventional Glaucoma franchise also delivered record net sales of $29 million on a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis. The strong growth was once again broad-based as we continued to scale our international infrastructure and execute our plans to drive makes forward as a standard of care in each region and major market in the world. We remain in the early stages of expanding our IG and product portfolio initiatives globally ahead of anticipated new product approvals and expanding market access in the years to come. As previously discussed, we expect the trialing of new competitive products in some of our major international markets may become an increasing headwind as we progress through 2025. And finally, our Corneo Health franchise delivered net sales of 18.5 million including Fortrexa then sales of $15.4 million. As discussed throughout 2024, our first quarter results reflect the continued impact of Fortrexa realized revenues as a result of our entry as a company into the Medicare Drug Rebate Program, or NDRP. Shifting gears to our corneal health pipeline, during the first quarter, we announced FDA acceptance for review of the previously submitted NDA for epioxa. our next-generation corneal cross-linking eye link therapy for the treatment of keratoconus, a rarely diagnosed sight and driving disease. This important milestone brings us one step closer in being able to provide keratoconus patients in the Epsom community with the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. We look forward to working closely with the FDA and their pending review process as we progress toward the agency's established PDUFA date of October 20, 2025. Alongside this, our teams continue to make nice progress with the preparation and planning of the EPIOXA commercial launch targeted for next year. It is worth reminding investors that an Epioxa approval also provides us with the opportunity to launch this pharmaceutical therapy supported by the right long-term pillars to optimize patient access, a persistent and at times frustrating challenge for us historically with Latrexan. We continue to believe that Epioxa, which is designed to preserve the corneal epithelium, streamline procedure times, improve patient comfort, and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus. Beyond Epioxa, we're also pleased to share we recently commenced a 510K pivotal study under FDA ID for the Pressor Flow Microshunt, an ab external system designed to help drain excess fluid from the eye and reduce intraocular pressure in refractory glaucoma patients. Our commercialization efforts of pressure flow in Canada, Australia, and several Latin American countries have reaffirmed the strong appetite within the global ophthalmic community for this technology as a more elegant, better tolerated, and external alternative to conventional filtration surgeries for late-stage glaucoma management. Additionally, we continue to advance several other important clinical trials, including one PMA pivotal trial for i7 infinite mild to moderate glaucoma patients. Two, phase two trials for our ILIG third generation therapy. Three, a first in human clinical development for GLK401, our intravitreal multi-kinase inhibitor retinal program in wet AMD patients, where we now also have an open US FDA INDE. And four, a Phase 2b3 clinical program for I-Dose T-Rex, our next generation I-Dose therapy. Finally, we remain on track to file a U.S. FDA IND to commence clinical studies for I-Lution, Devon X blood for our insulator this year. As you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create. At the same time, as we consistently discuss, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based investments in our capital position now and in the future. To that end, we ended the first quarter of 2025 in a strong capital position with cash and equivalents of more than $303 million and no debt. This has allowed us to continue to be active on the business development front with a focus on transactions that support our existing organic growth initiatives. One such example of this is our recently announced expanded collaboration with RadiusXR and TopCon Healthcare that enables us to accelerate our global efforts to bring the tools and software solutions needed to democratize the diagnosis of glaucoma and in turn create more efficient care networks for patients afflicted with this lifelong disease. Finally, given the ongoing conversations around tariff and geopolitical issues, we wanted to highlight that we manufacture and source our products primarily within the United States. And as such, we expect minimal direct exposure to the most recently implemented tariff related policies. In conclusion, I am very pleased with a record quarter and strong momentum in our business as we continue to successfully advance our mission to truly transform vision by pioneering novel, dropless platforms that can meaningfully advance standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases. So with that, I'll open the call for questions. Operator.