Glaukos Corporation

there will be a question and answer session. If you would like to ask a question, simply press star followed by the number one on your telephone keypad. To withdraw your question, press star one again. This call is being recorded and an archived replay will be available online in the investor relations section at www.glowcoast.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 Glowcoast 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 the key facts associated with the quarter, the state of the company's business objectives and strategies, and any forward 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 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, 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. 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.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 in our earnings press release available in the investor relations section of our website for reconciliation of these measures to their 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 thanks to all for joining us today. Today, Glockos reported record first quarter consolidated net sales of 85.6 million, up 16% versus the year-ago quarter. As a result of our strong start to the year, we are increasing our full-year 2024 net sales guidance range to 357 to 365 million versus 350 to 360 million previously. These record results were broad-based. with 20% year-over-year growth achieved in both our U.S. and international glaucoma franchises, where we continue to accelerate efforts to expand access to interventional glaucoma tools for the benefit of physicians and patients. Our goal to advance and improve glaucoma care by driving earlier intervention continues to build momentum as we lead and work closely with surgeons and thought leaders globally to organically drive this broader evolution in the standard of care. These efforts were on full display at the AGS conference in late February, and more recently at the ASCRS meeting last month, where the interest and excitement levels for interventional glaucoma and our technologies were palpable. Within our U.S. glaucoma franchise, we delivered first quarter sales of $42 million on strong year-over-year growth of 20%, driven by iStent Infinite and our overall iStent portfolio. Market receptivity and adoption of ISDA and INFINIT remain strong as we continue to pioneer and lead the interventional glaucoma paradigm shift. In parallel, we continue to advance key market access initiatives to support consistent and dependable professional fee payment with five of the seven MACs now including CPT code 0671T on the latest fee schedules. During the first quarter, for IDOS-TR, a revolutionary microinvasive injectable therapy designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. IDOS-TR is a first-of-its-kind intracameral procedural pharmaceutical designed to deliver glaucoma drug therapy for up to three years. I could not be more pleased with how the early stages of this launch have gone. Our initial target wave of 15 surgeons all successfully completed their initial IDOS-TR procedures during the first quarter, and the early feedback and outcomes have been very positive. As a reminder, these early access surgeons provide valuable insight to our training and field teams that helps to optimize training and skills transfer to our sales force and surgical community. supporting our expanded training and broader launch efforts over the course of 2024. In addition to training, a key element to the stage gating of our IDOS-TR commercial launch is market access, where there have been several recent positive reimbursement developments designed to support fulsome coverage and payment for the IDOS-TR procedural pharmaceutical over time. So first, CMS assigned a unique permanent J code for IDOS-TR J7355 said to become effective on July 1, 2024. This new J code, once effective, is expected to increase patient access here in the United States and should provide more streamlined, consistent, and dependable coverage and payment for IDOS-TR as we advance and ultimately accelerate our initial commercial launch activities. Second, CMS assigned the CPT codes that are designed to be used to cover the procedural component of IDOS-TR 0660T and 0661T to ambulatory payment classification, or APC, 5492, effective April 1, 2024. This translates into a national average facility fee of nearly $3,900 in the HOPED setting and more than $2,000 in the ASC setting. Third, we have participated in several initial part of our efforts to secure professional fee coverage and payment over the course of 2024. And fourth, we successfully entered into the Medicaid Drug Rebate Program, or MDRP. And finally, fifth, we have successfully commenced early initiatives to secure coverage for commercial and Medicare Advantage plans, efforts that we plan to accelerate in the second half of 2024 after the J code is effective. So in summary, The response we received from surgeons in the broader ophthalmic community since FDA approval and the more recent initial commercial launch activities has been overwhelmingly positive and reaffirms our view that with the launch of Leidos TR, we are pioneering a brand new category of procedural pharmaceuticals that has the potential to reshape glaucoma management as we know it today. We are excited to now be building the strong foundation to bring this transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension. Moving on, our international glaucoma franchise delivered record sales of $25.2 million on year-over-year growth of 20% on a reported basis and 21% 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 banks forward as the standard of care in each region and every major market in the world. We remain in the early stages of expanding our IG initiatives globally ahead of what we hope will be supported by a healthy cadence of new product approvals and expanding market access in the years to come. And finally, our corneal health franchise delivered sales of 18.4 million on 4% year-over-year growth, including Fortrexa sales of 15.1 million on a year-over-year growth of 7%. These first quarter results do include, in particular, the impact of our entry as a company into MDRP. These dynamics were anticipated and will continue to impact the Trexa realized revenues going forward. Shifting gears, we continue to prudently invest in and successfully advance our pipeline of novel, promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time. This includes Epioxa, our next generation corneal cross-linking therapy, for which we continue to progress towards trial completion in the second phase three pivotal trial and remain on track for data readout in the second half of this year, supporting our targeted NDA submission by the end of 2024. We continue to make enrollment progress in several important clinical trials, including one, a PMA pivotal trial for iStin Infinite in mild to moderate glaucoma patients. Two, a Phase IIa study for Ilusia travel frost with an initial data readout expected later this year. Three, Phase II trials for iLink third-generation therapy. And four, a first-in-human clinical development program for GLK401, our intravitreal multikinase inhibitor retinal program in wet AMD patients. We also remain on track to commence a phase three study for iDose T-Rex, our next generation iDose therapy by the end of 2024. Beyond these clinical activities, our development teams continue to pursue potential game changing early stage programs across the areas of glaucoma, retina, and rare disease. So in conclusion, I'm pleased with the strong start to the year given our team's solid execution. I'd like to thank the nearly 1,000 Glock Host employees who remain dedicated to the work and advancing our strategic plans. We look forward to continuing to sustain and build upon the growing momentum in our business over the coming quarters and years. Our foundation is strong and our teams are energized as we are ideally positioned to continue transforming vision for the benefits of patients worldwide. So with that, I'll open the call for questions. Operator?