Glaukos Corporation

Welcome to Glass Coast Corporation's second quarter 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.glasscoast.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 would like to ask a question during this time, simply press the star key followed by the number one on your telephone keypad. If you would like 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.Glockhost.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 Glockhost Chairman and CEO Tom Burns, President and COO, Joe Gilliam, and CFO, Alex Thurman. Similar to last quarter, 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 has been and will continue to be provided alongside the company's earnings press release, and it's 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 quickly transition into the question and answer session. It is our goal that this recently adopted format will make our quarterly earnings process more efficient and impactful for the investment community going forward. 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, 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 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.glowcoast.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 our 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 a 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.

Thank you, Chris. Good afternoon, and thanks to everyone for joining us today. Today, Glaucos reported second quarter net sales of approximately $72.7 million, down 5% year over year on a constant currency basis, but up 9% sequentially, versus the first quarter on a constant currency basis. As a reminder, the second quarter represents a challenging year-over-year comparable for many in the MedTech industry, but in particular for Glaucos. We are raising our 2022 net sales guidance range to $275 million to $280 million versus $270 million to $275 million previously. Given our solid execution globally, better-than-expected second quarter results and latest forward outlook. From a commercial perspective, we continue to be pleased with the execution of our strategies and the resiliency of our U.S. combo cataract franchise in the face of the reimbursement headwinds thus far in 2022, with our glaucoma, U.S. glaucoma franchise delivering strong sequential growth of 13%. During the latter part of the first quarter, we launched our Eye Access device, a novel instrument with features that allow customers to perform goniotomy procedures. Surgeon adoption and utilization of iAccess continues to grow, and market feedback remains positive. During the latter part of the second quarter, we also commenced initial commercial launch activities for iPrime, our innovative new viscoelastic delivery device. While we remain in the very early stages of iPrime's controlled launch, This platform adds to our expanding portfolio of unique solutions designed to grow and improve treatment options for our surgeons, customers, and patients. Our international glaucoma franchise once again delivered quarterly record sales despite significant foreign exchange headwinds as we execute our strategies to drive deeper penetration and broader adoption of MIGs around the globe. And within our corneal health franchise, we continue to focus on access for keratoconus patients suffering from this rare disease. We're investing in additional commercial payer market access coverage in response to sporadic issues that have emerged in 2022. On the development front, we continue to advance our pipeline. Following the recent clearances and commercial launches of iAccess and iPrime, we're delighted to announce today that we have received FDA 510K clearance for iStent Infinite, our novel three stent injectable system designed to provide foundational 24-7 IOP control for glaucoma patients. This FDA clearance represents a significant milestone for Glaucoast and the MIGS market as the first ever microinvasive implantable device indicated for use as a standalone glaucoma treatment. Supported by strong pivotal data highlighting favorable safety and effectiveness We believe iStat Infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open angle glaucoma uncontrolled by prior surgical and medical therapy. We're preparing to commence initial commercial launch activities for this promising technology later this year. Our clinical and regulatory teams also remain hard at work advancing pre-submission activities for iDoseTR and Epioxa, respectively. and we expect to be in a position to announce top line phase three data for IDOS-TR later this year. In terms of our earlier stage pipeline, we are happy to announce we completed patient enrollment in our ILLUSION phase two clinical trial for tri-eye disease during the second quarter. We also expect to complete patient enrollment for our ILLUSION phase two clinical trial for presbyopia during this third quarter and we anticipate initial data readouts for each of these trials by early 2023. We are now in the midst of several new product launches and are planning for a robust cadence of new droplets platform and product introductions over the coming years that have the potential to fundamentally transform glucose over time and meaningfully advance the standard of care and improve outcomes for patients suffering from site-threatening diseases. As such, we are continuing to invest in Glaucos to scale our team and to advance our mission to transform vision. We are excited about our prospects and confident in our ability to execute our plans in the years to come. So with that, I'll open the call to questions. Operator.