Glaukos Corporation

Welcome to Glowcoast Corporation's first quarter 2026 financial results conference call. Copies of the company's press release and quarterly summary document, both issued after the market closed today, are available at www.glowcoast.com. 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. To ask a question, simply press star 1 on your telephone keypad. To withdraw your question, press star 1 again. This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.gloukos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Thank you, and good afternoon. Joining me today are Glocko's 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 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. you still have additional questions, you may get back into the queue. Please note that all statements, other than statements of historical factors made on this call, 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, for 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, putting 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 investor relations 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 Glockos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables and earnings press release available in the investor 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 Glockos Chairman and CEO, Tom Burns.

Okay, thank you, Chris. Good afternoon, and thank you all for joining us. Today, Glockos reported record first quarter consolidated net sales of $150.6 million, up 41% on a reported basis and 39% on a constant currency basis versus the year-ago quarter. As a result of our first quarter outperformance, we are raising our full year 2026 net sales guidance to 620 to 635 million compared to 600 to 620 million previously. Our first quarter results reflect strong execution across our global commercial and development priorities, highlighting the commitment of our teams, strength of our differentiating technology platforms, and our continued progression as an increasingly diversified leader in ophthalmology. Looking ahead, We believe we are well positioned to sustain this momentum driven by two transformational growth drivers, including the continued advancement of the interventional glaucoma treatment paradigm with iDoseTR and the launch of Epiaxa, establishing a new standard in interventional keratoconus and rare diseases. Together, these compelling and durable market opportunities reinforce our confidence in delivering a best-in-class growth profile 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 to support our near-term objectives of continued operating leverage and cash flow breakeven. Now let's discuss our first quarter results in more detail. Within our U.S. glaucoma franchise, we delivered record first quarter net sales of $93.5 million on strong year-over-year growth of 58%, driven by growing contributions from IDOS-TR, which generated sales of approximately $54 million in the first quarter. IDOS-TR continues to deliver strong clinical outcomes that meaningfully improve patients' lives, driving strong physician interest and adoption. From an execution standpoint, we remain focused on our key initiatives, including expanding our base of trained surgeons and active accounts, increasing utilization, broadening market access, scaling targeted commercial investments, and expanding body of clinical evidence. On that last point, EidosTR is supported by a robust and growing body of clinical evidence demonstrating strong efficacy, safety, and durability of effect. This now includes 22 peer-reviewed publications, complemented by a broad portfolio of active Phase IV studies across diverse real-world clinical settings, further reinforcing its consistent performance in real-world practice. Importantly, INOS-TR is serving as the foundation for a broader shift towards earlier interventional glaucoma care. Our efforts to educate surgeons and key opinion leaders globally are gaining traction and helping to drive a steady evolution in the standard of care. This momentum was evident at recent major industry meetings, including AGS and ASCRS, where engagement and enthusiasm around interventional glaucoma and our novel therapies were notably strong and growing. To support these efforts, we continue to invest in our commercial organization and infrastructure to expand disease awareness and education, while enabling our customers to effectively adopt and operationalize interventional care into their clinical practice. Moving on, our international glaucoma franchise delivered record net sales of $35.8 million on year-over-year growth of 23% on a reported basis and 16% 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 and export as a 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 ISEN Infinite following its EU MDR certification and associated European commercial launch late last year. We also expect the currency tailwinds to abate going forward based on the current rate environment. And finally, our corneal health franchise delivered net sales of 21.3 million on year-over-year growth of 15%, including for Trexa and very early Epioxa net sales of 17.7 million. At the end of the first quarter, we are delighted to announce commercial availability of Epioxa, our novel groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare site-threatening disease, that is currently far too often underdiagnosed, undiagnosed, and untreated. We believe Epioxa represents a transformative innovation in keratoconus care, offering an incision-free alternative to traditional corneal cross-linking procedures, as it does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. This novel, oxygen-enriched, topical therapeutic, bioactivated by UV light, is designed to reduce the pain associated with removal of the epithelium, streamline the procedure, and minimize recovery, all while delivering clinically meaningful outcomes and exceptional value to patients, providers, and the healthcare system. The response we've received from surgeons in the broader ophthalmic community since FDA approval and the more recent initial commercial launch activities has been very encouraging. As we've discussed, with the launch of Epioxa, we have redefined our go-to-market approach to better address this site-threatening disease and truly expand patient care and access. Importantly, with this launch, we are substantially increasing our investments in patient awareness, education, and access while addressing the longstanding challenges of underdiagnosis and undertreatment that have affected this rare disease community. As with all pharmaceutical launches, initial patient access will be gated by typical payer adoption headwinds and hurdles, but we've been encouraged by the progress we've made in short order through the early days of our launch. First, I'm proud to report that we have successfully established and continue to selectively expand a broad-reaching site of care network. Our acquired O2N systems are already actively deployed across locations serving roughly 65% of the US population. with a pipeline progressing through various approval processes that we expect will expand our treatment center reach to approximately 95%. 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, we continue to make considerable progress with payers to secure access pathways or policy coverage for Epioxa. with several plans having already updated or are in the process of updating their policies to include this novel therapy. These efforts are translating into expanded access with pathways now established for more than 100 million covered commercial lives in the United States, including with four of the five largest payers reflecting encouraging initial receptivity of Epioxus clinical value. While we expect the pace of policy adoption to build over time, we remain focused on driving broader coverage across both commercial payers and Medicaid programs to support more streamlined access pathways over time. Earlier this month, we achieved another important market access milestone as CMS assigned a product-specific J-code for Apioxa consistent with our expectations and in response to our application. The new code, J2789, is scheduled to take effect on July 1, 2026, and we believe it will help streamline the reporting and reimbursement process for Epioxa among U.S. payers over time. 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 and solidified operationally by providers in our specialty pharmacy. Beyond market access, we're proud to lead the way once again in forging a new path for interventional care to Congress by advancing targeted marketing and DTC initiatives to drive awareness, education, and earlier detection supported by greater optometric engagement and strengthened advocacy partnerships. Finally, We've launched a co-pay assistance program for eligible patients and are operationalizing a specialty pharmacy partner network in support of Epioxa patients. As you can see, we are very excited by the significant potential Epioxa offers to patients living with keratoconus. While Epioxa remains in the early stages of its launch, our teams are energized and executing with focus. and we're encouraged by the solid progress we're making against our core launch priorities. Beyond Epioxy, we continue to advance a broad and differentiated clinical pipeline across our five novel therapeutic platforms, encompassing 13 publicly disclosed programs and additional undisclosed assets supported by a robust portfolio of active clinical and phase four studies. This includes ongoing pivotal trials for iDose T-Rex, iStent Infinite in mild to moderate patients, and the Pressor Flow Microshump, an active phase two trial for Iolution Demodex Blufferitis, ongoing development for our iLink platform, including a planned market introduction of our KC screening device later this year, and our promising earlier stage rental assets. Overall, we remain on track with our clinical timelines and encouraged by the progress across our complete portfolio. In conclusion, at Glockos, we're in the business of pioneering new marketplaces within ophthalmology for the benefits of patients. Our record first quarter performance highlights the strength of our strategy and execution as we continue evolving into an increasingly diversified ophthalmic leader with moldable transformational growth drivers in IDOS-TR and Epioxa, and advance our mission to transform vision therapies for the benefits of patients worldwide. So with that, I'll open the call for questions. Operator?