8/8/2022

speaker
Michelle
Conference Call Operator

Good morning, and thank you for your participation. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. As a reminder, this conference call will be recorded. I would now like to turn the call over to Lee Roth of Burns McClellan. Mr. Roth, please go ahead.

speaker
Lee Roth
Investor Relations, Burns McClellan

Thanks, Michelle. Good morning, and once again, welcome to the Lenzar second quarter 2022 financial results conference call. Earlier this morning, we issued a press release providing an overview of Lenzar's financial results for the quarter ended June 30th, 2022. This release is available in the investor related section of the company's website at www.lenzar.com. Joining me on the call today is Nick Curtis, Chief Executive Officer of Lenzar, who will review the company's recent business and operational progress. Following his remarks, Tom Staub, CFO of Lenzar, will provide an overview of the company's financial highlights before we turn the call back over to the operator for the Q&A session. Before we begin, I'd like to remind you that today's conference call will contain forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information, as well as information about the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance, or achievements to be materially different from any future results or performance expressed or implied in this presentation. You should not rely on these forward-looking statements. For additional information, including a detailed discussion of the company's risk factors, please refer to our documents filed with the Securities and Exchange Commission, which can be accessed on our website. In addition, this call contains time-sensitive information accurate only as of the date of this live broadcast, August 8th, 2022. LENZAR undertakes no obligation to revise or otherwise update any forward-looking statements to reflect events or circumstances after the date of this live call. With that said, it's now my pleasure to turn the call over to LENZAR's Chief Executive Officer, Nick Curtis.

speaker
Nick Curtis
Chief Executive Officer, Lenzar

Nick? Thank you, Lee, and good morning to everyone listening. Thank you for joining us on our second quarter 2022 conference call. Lensar has continued to make significant progress since we reported our Q1 results, and we had a very exciting second quarter. We successfully grew our business and our market share in the United States, despite a challenging macroeconomic and industry landscape. More importantly, we completed an important step that positions Lensar for sustainable long-term growth and success. In June, we reached a pivotal milestone and received FDA clearance of our Ally adaptive cataract treatment system. As we shared before, interest in Ally has been high since we initiated our pre-clearance marketing initiatives, and it's continued to grow ever since. Over the last several months, members of our team and I have attended multiple industry conferences, and the level of enthusiasm toward Ally from members of the ophthalmic community has been gratifying. Now that we have clearance, our targeted mostly digital marketing will include various campaigns to initially include higher volume believers in femtosecond laser cataract surgery and other early adopters with aging competitive technologies, as well as to provide exposure and information to all cataract physicians on the many benefits of Ally. In addition, we plan extensive use of social media and peer-to-peer interaction with the initial Lensar Ally users to share their early experience. Our clinical plans include time and optimization studies in efficiency and patient flow, as well as allied cataract density imaging and customization of fragmentation and energy settings that will complement their current choices in phacoemulsification technique, as well as their phaco devices. To date, we have demoed the technology over 200 times to interested parties, including existing LensR system users, users of competitive devices, and various private equity groups acquiring ophthalmic ASCs in surgeon practices. The femtosecond laser assisted cataract surgery market is at an important inflection point as demand for premium procedures and better outcomes is continuing to grow, while surgeons efficiency and capacity is limited by the aging systems currently in the market. In addition, lower reimbursement for standard cataract surgery, private equity investment, and the growth of in-office surgical suites creates an environment in which we believe we can set a new standard of performance. With Ally, our goal is to lead the next step in the evolution of the industry, driving tangible improvements for both surgeons and patients and a new phase of growth for the market. Given the incredible excitement around Ally's advanced femtosecond laser capabilities, we're doing everything possible to get the technology into the hands of surgeon partners, sharing this vision as expeditiously as possible. As discussed, we are effectively navigating the supply chain challenges currently facing the entire industry and are on track to place the first commercial system this quarter with approximately 10 systems expected to be placed in the U.S. by year end. In terms of our rest of world strategy, for Allied, we plan to file for the CE mark in Europe very soon, as well as pursue regulatory clearances in other key markets in the near future. Ally clearance in the U.S. is just the beginning of a series of commercial filings that will ultimately bring these significant advancements in refractive laser cataract surgery to physicians and their patients in key global markets that account for approximately 90% of premium procedures worldwide. Looking at our business performance for the quarter, we achieved 15% growth in the U.S. procedure volumes in Q2 over the second quarter of 2021. The strength in our key end market was partially offset by softness in the rest of the world as physician reimbursement discussions, global economies, and system availability limited our growth near term in markets outside the United States. In addition, our product capital system sale revenues declined year over year as we shifted our manufacturing operations to focus exclusively on the production of ally systems. Despite the challenging environment, We persevered and remained on our planned filing and clearance timing for Ally. We're excited to get the first Ally systems in surgeons' hands as part of our controlled launch and make the Ally system more broadly available to all ophthalmic surgeons in 2023. The continued growth and progress in the U.S. market is important because the market represents overall the second highest number of cataract surgeries performed globally, but the highest number of premium refractive cataract surgeries performed annually. The US provides us a solid foundation to launch Ally and will be our primary focus in the next 12 months with our direct sales and marketing presence. We hope to continue to expand market share through the acceptance of Ally in the US and use this positive acceptance to bring the Ally system to global markets thereafter. Looking back at the first half of the year, I'm incredibly proud of what our team has accomplished. But I'm even more excited about the future, as I believe Ally is a generational advancement in refractive cataract surgery with the potential to fundamentally change the way cataract surgery is performed and looked at in our industry. FDA clearance was just the latest step in the Lensar journey, and I look forward to continuing down this exciting path. Now let me turn the call over to Tom to cover our financial highlights for the quarter. Tom?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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