Glaukos Corporation

Welcome to Glowcoast Corporation's first quarter 2023 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. If you'd like to ask a question during this time, simply press star, then the number one on your telephone keypad. To withdraw your question, please press start 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'll 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 effects 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, our 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 CloudCoast's ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables and our earnings press release available on the Investors 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 CloudCoast's Chairman and CEO, Tom Burns.

Okay, thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glockos reported first quarter net sales of approximately 74 million, up 9% versus the year-ago quarter on a reported basis, and up 11% on a constant currency basis. Our first quarter results in return to top-line growth reflects continued strong performance across our international glaucoma and corneal health franchises, alongside the re-emerging growth in our U.S. glaucoma franchise, driven by the initial commercial launch of iSpend Infinite. I'd like to recognize the continued dedication and performance of our teams around the globe who remain committed to their work in advancing our key initiatives. Given our solid first quarter and latest forward outlook, we are raising our 2023 net sales guidance range to $295 million to $300 million, versus 290 to 295 million previously. From a commercial perspective, strong execution of key strategies within our core franchises drove an encouraging start to the year. Within our U.S. glaucoma franchise, where we delivered 4% year-over-year growth in the quarter, we are progressing our combo cataract efforts and continue to advance ICE and Infinite ahead of establishing formal MAC coverage and payment. In parallel, we are accelerating our founding mission at Glaucus, which is to advance glaucoma care by driving intervention of therapies earlier in the treatment paradigm for glaucoma disease, and in turn, pioneering a new standalone market over time. These efforts will be on full display at the ASCRS meeting this weekend in San Diego, where an extensive array of symposia highlighting the performance of our novel technologies will be presented. This includes a new subgroup analysis of the combined IDOS phase 3 trials, which demonstrated statistically significant superiority of IDOS's IOP lowering effect versus current standard of care topical prostaglandin therapy. We believe this first-of-a-kind, real-world effectiveness data further validates the game-changing potential of IDOS. Moving on. Our international glaucoma franchise delivered strong broad-based growth this quarter of 20% on a reported basis and 28% on a constant currency basis. And our corneal health franchise saw 10% growth as key strategic initiatives continue to take hold in support of this important business. In addition to our commercial efforts, we also continue to prudently invest in and advance our robust 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. During the first quarter, we achieved a significant company milestone with the successful NDA submission of iDoseTR, our novel microinvasive interocular implant designed to continuously deliver therapeutic levels of proprietary formulation of travel cross from within the eye for extended periods of time. We're also pleased to announce today we recently received communication from the FDA that our submission has been received and accepted for substantive review. We look forward to learning of our PDUFA date imminently, which we expect will be in line with our approval target by year end. Alongside this, our teams continue to make encouraging progress with the preparation and planning of the IDOS commercial launch targeted for early next year. Turning to the corneal health pipeline, we've built strong subject enrollment momentum in the second phase three confirmatory trial for Apioxa, our next generation corneal cross-linking therapy for the treatment of keratoconus. And we are now on track for targeted enrollment completion by mid-year, ahead of our prior expectations of year end. So 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, given the macroeconomic environment and associated uncertainties, as well as anticipated investment to support the potential commercial launch of IDOS, we continue to prudently review the prioritization and 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. As such, we will continue to keep you updated as we evaluate and potentially adjust development timelines associated with our earlier stage pipelines. In conclusion, I'm very pleased with the strong start to the year and excited about what is to come as we continue to advance our mission to truly transform vision with disruptive, dropless, and game-changing technologies. And so with that, I'll open the call to questions. Operator.