Glaukos Corporation

Welcome to Glockus Corporation's 3rd 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.glockus.com. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. 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.glacus.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 Glaucos 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 only one question. 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 investor section of our website at www.globcoast.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 reconciliation of these measures to the 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. Today, Glockos reported record third quarter consolidated net sales of $211 million, up 58% versus the year-ago quarter. As a result of our third quarter outperformance, we are raising our full year 2026 net sales guidance to $775 to $785 million, an increase of $90 million at the midpoint over our prior guidance of $680 to $700 million. We are also introducing highly preliminary 2027 revenue guidance of $1 billion. This preliminary outlook factors in our expectations as it relates to the continued commercial rollout for Epioxa and IDOS-TR, the surgical mix landscape in our international glaucoma franchise. We expect to refine this guidance range and provide additional commentary as appropriate in the future. Our record third quarter results reflect strong performance across our global commercial and development priorities, underscoring the successful execution of our teams. The strength of our differentiated technology platforms and our continued evolution as an increasingly diversified leader in ophthalmology. Looking ahead, we believe we're well positioned to sustain this momentum driven by two transformational growth drivers, including the further advancement of the interventional glaucoma treatment paradigm with iDose-TR and the launch of Epioxa, establishing a new standard in interventional keratoconus and rare diseases. Together, these compelling and durable market Thank you. Thank you. Thank you. Thank you. more than 50 million in cash generation, 28.5 million in non-GAAP net income, and non-GAAP earnings per share of 47 cents. While we believe our business is increasingly well-positioned to deliver sustained cash generation and profitability as we scale, we remind investors that our primary focus remains on maximizing near and long-term revenue growth and capitalizing on the significant opportunities in front of us. Accordingly, we remain committed to investing strategically across our industry-leading pipeline, commercial infrastructure and market development initiatives to advance our innovative platforms, expand our addressable markets and drive sustained top-line growth. We will continue to manage the business thoughtfully, balancing these strategic investments with disciplined expense management Capital Allocation, and a focus on operational efficiency. Ultimately, we believe this approach best positions us to bring transformational therapies to patients, strengthen our financial profile, and drive sustainable, substantial long-term growth in shareholder value. Now let's discuss our third quarter results in more detail. Starting with our Corneal Health franchise, We delivered record third-quarter net sales of $59 million on robust year-over-year growth of 154%, driven by Epioxa next sales of approximately $53 million. We remain very encouraged by the early progress of our commercial launch of Epioxa as the first and only FDA-approved epithelium-on-cordial cross-linking therapy for keratoconus. Epioxa has generated strong interest from surgeons in the broader ophthalmic community reinforcing our confidence in its potential to redefine the treatment paradigm for this rare, sight-threatening disease, which we believe remains significantly underdiagnosed and undertreated. Our launch priorities remain centered on expanding patient access, building awareness, optimizing referral networks, and driving earlier diagnosis. We continue to make meaningful progress across each of these areas, supported by the ongoing expansion of our site of care network growing market access, continued development of our specialty pharmacy and patient support infrastructure. First, 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 90% of the US population. With a pipeline progressing through various approval processes that we expect will expand our treatment center reach to more than 95%. Next, we continue to make considerable progress with payers to secure access pathways and policy coverage for Apioxa with access pathways now established for approximately 90% of commercial lives in the United States, including through the five largest payers and more than 80% of Medicaid lives, reflecting encouraging receptivity of Epioxys Clinical Value. We remain committed to securing access pathways with the remaining smaller and regional plans as we increasingly focus on pathway optimization and improving the time to treatment for patients. Following the July 1st effective date of Epioxys product-specific J-code, J2789, we made encouraging progress during the third quarter in optimizing the operational processes, support supporting reporting and reimbursement. We remain focused on working with providers and our specialty pharmacy partner to further refine these workflows and facilitate a more efficient and predictable reimbursement process for epioxin. Clinically, we continue to be encouraged by physician feedback and the outcomes they are seeing with epioxin practice. These real world clinical observations are consistent with the positive results from our recently announced three-year phase three extension study, which demonstrated sustained improvements in corneal shape, meaningful visual acuity gains, and a favorable long-term safety profile following a single epioxide treatment. Together, these findings further reinforce epioxide's potential to provide durable clinical benefits for patients living with keratoconus and meaningfully advance the treatment paradigm. During the third quarter, we took another important step in our efforts to expand the Keratoconus market with the launch of our Could It Be KC disease awareness campaign in partnership with NBA champion Stephen Curry. Stephen's personal experience living with Keratoconus combined with his extraordinary platform and reach gives us a unique opportunity to increase awareness of this underdiagnosed disease and to drive earlier detection and diagnosis. We view this as an important long-term investment in the KC market and an important component of our commitment to addressing the significant unmet need across the Keratoconus care continuum with additional campaign activities planned for 2027. Implementing these efforts, we remain focused on deepening engagement with the optometric community, which we believe plays a critical role in identifying and referring patients with Keratoconus. We remain on schedule to launch our KC screening devices we enter 2027, which we intend to leverage to raise disease awareness, facilitate more accessible screening and diagnosis, and to enable earlier identification of patients who may benefit from treatment. Together with our broader disease awareness initiatives and strength and advocacy partnerships, we believe these efforts position us to meaningfully advance the KC care continuum and expand patient access to treatment. Finally, we continue to enhance and optimize our patient and physician support services, including our co-pay assistance program for eligible patients to help facilitate access to Apioxa and to support patients throughout their treatment journey. While we still remain in the early stages of the launch, we're encouraged by the solid progress we're making against our core launch priorities and remain very excited by the significant potential Epioxa offers to KC patients. Moving on, our U.S. Glaucoma franchise delivered record third quarter net sales of $118.6 million on strong year-over-year growth of 47% driven by growing contributions from IDOS-TR, which generated sales of approximately 76 million in the third quarter. ITOS-TR continues to deliver strong clinical outcomes that meaningfully improve patients' lives, resulting in strong physician interest in adoption, while helping to accelerate a broader treatment paradigm shift towards earlier interventional glaucoma care. 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 the robust body of clinical evidence supporting IDOS-TR. To that last point, we recently announced positive top-line results from our phase four randomized control trial evaluating IDOS-TR in combination with cataract surgery. The study achieved its primary endpoint, demonstrating statistically significant superiority and a clinically meaningful IOP reduction compared to cataract surgery alone with an 11.1 millimeter mercury mean reduction in IOP and a 3.6 millimeter mercury incrementally superior treatment effect at three months. These results further strengthen the extensive body of clinical evidence supporting iDOSIS-TR's efficacy, durability and safety while reinforcing the versatility of the therapy across different treatment settings. Additionally, we continue to monitor developments related to the proposed local coverage determinations for IDOS-TR. We have engaged in the process to ensure the therapy is appropriately understood within the Medicare coverage framework while preparing for a variety of potential outcomes. We believe the strength of IDOS-TR's clinical evidence, real-world outcomes, and broad stakeholder advocacy supports appropriate Medicare coverage that preserves physician decision-making and patient access. And finally, our international glaucoma franchise delivered net sales of $33.4 million on a year-over-year growth of 13% on a reported basis and 15% on a constant currency basis. The strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plan as a standard of care in each region and major market in the world. Shifting to our pipeline, we continue to advance a broad and differentiating clinical pipeline across our five novel therapeutic platforms, encompassing 14 publicly disclosed programs and additional undisclosed assets supported by a robust portfolio of active clinical and phase four studies. Within our iDose platform, we're advancing a Phase 2B3 clinical program for iDose T-Rex, our next generation iDose therapy, and a Phase 3B clinical program for iDose Trio. We're targeting FDA approval for iDose Trio by the end of 2027. We also continue to advance various additional Phase 4 studies. Within our iLink platform, in addition to our KC screening device, we're preparing to commence a phase three clinical program for our third generation customized tomography guided cross-linking therapy in 2027. Within our iStent surgical glaucoma platform, we have completed patient enrollment of both the PMA pivotal trial for iStent infinite patients with mild to moderate glaucoma and the 510K pivotal study for the pressor flow micro shunt and are now advancing patient follow-up in both of these studies. Within our ILLUSION platform, we completed patient enrollment in a phase two study for demodex blepharitis and expect to have top-line results by the end of this year. And finally, within our retinal platform, we recently announced an exclusive licensing agreement with RevOps Therapeutics for RO-104, which was assigned glucose development code J-O and JLK901, a first-in-class tri-specific biologic, as well as exclusive rights to the proprietary RevMod platform to discover and to develop up to four additional next-generation multi-specific biologics for retinal diseases. This agreement represents an important strategic step in the continued expansion of our retinal franchise and is highly complementary to our ongoing retinal R&D initiatives including the ongoing first in human wet AMD clinical development program for GLK401, our intravitreal multi-kinase inhibitor program. We believe each of these novel differentiated platforms have the potential to generate transformative therapies that significantly improve the existing treatment paradise for patients suffering from chronic eye diseases. In conclusion, at Glockos, we are in the business of pioneering new marketplaces within ophthalmology. Our record third quarter performance highlights the strength of our strategy and execution as we continue evolving into an increasingly diversified ophthalmic leader with multiple transformational growth drivers in IDOS-TR and epioxa as we advance our mission to transform vision therapies for the benefit of patients worldwide. So with that, I will open the call to questions.