Glaukos Corporation

Welcome to the Glaucos Corporation's fourth quarter and full year 2022 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.glaucos.com. All lines have been placed on mute to prevent any background noise. After the speaker's remarks will be a question and answer session. If you would like to ask a question during this time, you can press star one on your telephone keypad. If you'd like to remove yourself from the queue, you can press star one again. This call is being recorded, and an archived replay will be available online at 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. Please go ahead.

Thank you, and good afternoon. Joining me today are Gloukos 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 earnings call. As such, for this call, we will make brief prepared remarks and transition into a questions 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, U.S. and international commercialization, integration, and market development efforts, the efficacy of our current and future products, our competitive market position, regulatory strategies, and reimbursement for our products, financial condition and results of operations, as well as the expected impact of the COVID-19 pandemic 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.glaucos.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, thank you, Chris. Good afternoon to everyone, and thank you for joining us today. Today, Glockos reported a fourth quarter net sales of approximately $71.2 million, and full year 2022 net sales of approximately $283 million. We are also introducing a 2023 net sales guidance range of $290 million to $295 million based on the latest foreign currency exchange rates. Alex will discuss our financial results and outlook in more detail later in the call. Overall, I am proud of our performance this past year as our results exceeded our initial expectations and reflect solid execution across our glaucoma and corneal health franchises in the face of reimbursement headwinds and a challenging macroeconomic environment. I'd like to recognize the continued dedication and resiliency of our teams around the globe who remain steadfastly committed to their work. Take a minute to highlight some of the key accomplishments we achieved in 2022. One, we showcased the resiliency of our U.S. glaucoma combo cataract franchise in the face of significant reimbursement headwinds. Two, we strengthened our core franchises with the U.S. commercial introduction of several novel ophthalmic technologies, including iAccess, iPrime, and iStentInfinite. Three, we continue to grow and expand our international glaucoma and corneal health businesses. Four, we advanced our near-term pipeline, most notably with the positive high-dose TR Phase III top-line data that will be the basis for an imminent NDA submission. Five, we progressed earlier-stage R&D programs with two Phase II dilution studies and other preclinical program developments. And finally, we expanded our global operations and infrastructure to support our long-term growth goals with the build-out of our new headquarter campus in Aliso Viejo, our Cornell Innovation Center outside of Boston, and our state-of-the-art hybrid pharmaceutical manufacturing facility based in San Clemente. Our achievements in 2022 leave us excited about our prospects and well-positioned for the next phase of our pioneering journey as we sunset CMS-related combo cataract headwinds and position the portfolio for sustainable top-line growth beginning this year and the years ahead. From a commercial perspective, in 2023, we will continue to execute our strategies that fueled the resiliency of our U.S. glaucoma combo cataract franchise in 2022. Alongside our combo cataract efforts, we anticipate advancing iPrime and iScent Infinite, the latter pending the establishment of MAC coverage and payment. In parallel, we are investing in our founding mission at Glaucos, which is to transform glaucoma therapy by driving earlier treatment intervention for glaucoma disease progression, which in turn will greatly increase our standalone market opportunity over time. While we are bullish on the long-term prospects for these efforts, we have remained prudent in our initial 2023 guidance as remains early and revenue contributions in 2023 versus 2024 and beyond remain uncertain. Within our international glaucoma and corneal health franchises, we plan to continue developing these important businesses by driving deeper penetration, adoption, and access for our MIGS and iLINK technologies around the globe. While we execute upon these commercial and market development strategies for our core franchises, We also continue to successfully 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. Starting with IDOS, our clinical and regulatory teams have made great progress preparing our NDA, and we are on track for a submission this month. Earlier this year, we were delighted to announce results for the IDOS-TR exchange trial, which included a second administration of IDOS-TR and the removal of the original TR implant, with the second IDOS-TR demonstrating a favorable safety profile over a 12-month evaluation period. Additionally, no subject in the exchange trial exhibited a greater than 30% endothelial cell loss over the extended evaluation period of more than five years on average. We look forward to including this data set, which will augment the powerful phase three data results in our upcoming NDA to support the safety and tolerability of redosing I-dose patients over time. This further adds to our market leading body of clinical evidence supporting the best in class benefit to risk calculus of our microinvasive technologies over other competitive alternatives. In addition to our NDA preparation for IDOS, we are also already well underway with a team of cross-functional leaders across our commercial and market access organization in the preparation and planning of the IDOS-PR commercial launch targeted for next year. Shifting gears, we also recently announced positive clinical updates for several of our corneal health pipeline programs. First, we commence subject enrollment in the second phase three confirmatory trial for Epioxa, our next-generation corneal cross-linking therapy for the treatment of keratoconus, and are targeting enrollment completion by the end of this year. As we advance our clinical plans for Epioxa, we remain well-positioned to serve keratoconus patients with our first-generation corneal cross-linking therapy for Trexa, or Epiof, which remains the only FDA-approved treatment shown to slow and halt progression of keratoconus. Second, we announced promising initial results from the first in-human Phase II-A clinical trial for GLK301, our ILLUSION dry eye disease program. GLK301 is a sterile ophthalmic topical cream to be applied to the eyelids for the treatment of the signs and symptoms of dry eye disease. Based on these encouraging observations, we are planning to commence a Phase IIb trial for GLK301 later this year. We are also evaluating the Phase IIa data for GLK302, our Ileucine presbyopia program, while we continue to closely monitor the evolving market conditions associated with available presbyopic therapies. Finally, in addition to these pipeline developments, we also anticipate several additional pipeline milestones over the course of 2023, including a now-open IND for Iolution TravelProst, a first-in-human retinal trial, and an IDE label expansion study for Einstein Infinite. 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. So in conclusion, our mission at Glockos is to truly transform vision by pioneering novel dropless platforms that can meaningfully advance the standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases. Innovation is at the core of everything we do. Our mantra, We'll Go First, embodies our commitment and determination to take chances, to push the limits of science, and to disrupt the legacy treatment paradigms in glaucoma corneal disorders, and retinal diseases through our pursuit of game-changing technologies. I believe our foundation has never been stronger and our prospects never quite as promising. I'm confident we have the right people, strategy, infrastructure, pipeline, and balance sheet to execute our plans and deliver on our future aspirations. And so with that, I'll open the call to Alex to briefly discuss our forward outlook.