Glaukos Corporation

Good afternoon. My name is Julianne and I will be your conference operator today. At this time, I would like to welcome everyone to GALCOS's first quarter 2022 financial results conference call. 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 followed by the number one on your telephone keypad. If you'd like to withdraw your questions, please press star one again. Chris Lewis, Vice President of Investor Relations and Corporate Affairs. You may begin your conference.

Thank you and good afternoon. Joining me today are Cloud Coast Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurmond. Before we begin, we wanted to remind you of a change in the way we plan to handle our quarterly earnings disclosures and calls starting with this one. 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, beginning this quarter, we will make very brief prepared remarks and quickly transition into a question and answer session. It is our goal that this change 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, our 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, our 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 Glauco's 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 Glauco's chairman and CEO, Tom Burns.

All right. Thanks, Chris. Good afternoon and thank you all for joining us today. And we certainly hope everyone is safe and doing well. Today, Glockos reported first quarter net sales of approximately 68 million, flat versus the year-ago quarter and up 1% on a constant currency basis. Our first quarter performance reflects solid execution across our global glaucoma and corneal health franchises amidst continued COVID-related volatility and headwinds globally. and US combination cataract glaucoma dynamics associated in particular with the 2022 CMS final physician fee reimbursement rates that became effective on January 1st, 2022. From a commercial perspective, we've been very pleased with the execution of our strategies and the resiliency of our US combo cataract franchise in the face of the reimbursement headwinds thus far in 2022. During the latter part of this first quarter, We launched our eye access device that has both minimally invasive and tissue sparing features that will allow customers perform gonadotomy procedures. We also look forward to bringing iPrime to customers soon as well. And our international glaucoma and corneal health franchises continue to deliver strong results as we develop these important businesses. We are raising our 2022 net sales guidance range to 270 million to $275 million versus $265 to $275 million previously, given our better than expected first quarter results and latest forward outlook. On the development front, we continue to advance our pipeline. Following the recent clearances of iAccess and iPrime, the FDA 510K review of iSEN Infinite is continuing, and we remain focused on a potential mid-year clearance for this important product. iDose TR and Epioxa, or Epion, Activities remain on track for NDA submissions and targeted FDA approvals in 2023. The ILLUSION Phase II clinical trials for dry eye and presbyopia are well underway. Finally, the FDA did recently notify InFocus, a Shantan company, that its presser flow micro shunt PMA submission is non-approval. While the micro shunt is not a material potential driver of our near-term business, this outcome is disappointing. given our early positive commercial experience with this product in Canada and Australia, and encouraging surgeon feedback globally as they seek alternatives for late-stage glaucoma treatment. We intend to engage with the FDA to determine optimal clinical and regulatory next steps. Before we open it up to questions, I'd like to reiterate our conviction in our long-term strategic vision. We anticipate and are planning for a robust cadence of new dropless platform and product introductions over the coming years that have the potential to fundamentally transform Glaucus over time and meaningfully advance the standard of care and improve outcomes for patients suffering from sight-threatening diseases. We are continuing to invest in Glaucus to scale our team and to advance our mission to transform vision with disruptive, dropless, game-changing platform innovations. So we are excited about our prospects and confident in our ability to execute our plans in the years to come. And so with that, I'll open the call to questions. Operator?