5/11/2023

speaker
Operator
Conference Call Operator

Good day and welcome to the Ascension Surgical First Quarter Financial and Operating Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Mark Klausner. Please go ahead.

speaker
Mark Klausner
Call Moderator/Investor Relations

Good afternoon, everyone, and thank you for joining us for the Ascensus Surgical First Quarter 2023 Business and Financial Update Conference Call. On the call with me today are Anthony Fernando, President and Chief Executive Officer, and Shamiz Rampertab, Chief Financial Officer. Before we begin, I would like to caution listeners that certain information discussed by management during this conference call, including any guidance provided, are forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business, including any geopolitical factors beyond our control. The company undertakes no obligation to update the information provided on this call. For discussion of risks and uncertainties associated with the Ascensus Surgical business, I encourage you to review the company's filings with the Securities and Exchange Commission, including the 2022 Form 10-K, filed in March 2023, and the Form 10-Q, expected to be filed later today, and any other filings we make with the SEC. During this call, we will also present certain non-GAAP financial information related to adjusted net loss attributable to common stockholders and the adjusted net loss per share attributable to common stockholders. Management believes that these non-GAAP financial measures taken in conjunction with U.S. GAAP financial measures provide useful information for both management and investors by excluding certain non-cash and other expenses that are not indicative of the company's core operating results. Management uses non-GAAP financial measures to compare our performance relative to forecast and strategic plans to benchmark outperformance externally against competitors and for certain compensation decisions. Reconciliations from U.S. GAAP to non-GAAP results are presented in the tables accompanying our earnings release, which can be found in the investor relations section of our website. With that, it's my pleasure to turn the call over to Ascensus Surgical's President and Chief Executive Officer, Anthony Fernando.

speaker
Anthony Fernando
President and Chief Executive Officer

Thanks, Mark, and thank you all for joining us today. I will begin by discussing our recent performance and highlights. Then Shamit will review our financial results. Following that, I will go over our priorities for the balance of 2023 before turning to Q&A. The first quarter was highly productive at Ascensus. We made significant progress across a number of our key areas of focus. including the expanded utilization of Senhance, the continued development of our clinical body of evidence, and the ongoing development of our portfolio. In addition, we had a number of very exciting announcements, in particular, the unveiling of our lunar surgical system that is in development. During the first quarter, we continued to see very positive procedure volume trends. with over 900 procedures across multiple specialties and geographies delivering 20% year-over-year growth. Procedure volume is critical as we look to expand and optimize our digital surgery capabilities. The larger our collection of surgical data, the more effective our machine learning engine becomes, which will enable us to continue to deliver more clinical intelligence to surgeons through the ISU. Another benefit of increased procedure volumes is the expansion of our clinical registry, which now includes over 2,400 patients. The primary purpose of this registry is to build a unique collection of interoperative and 12-month post-operative follow-up data, which will support an increased number of high-quality clinical publications and further bolster our market development strategy. Moving to new program initiations. Year to date, we have initiated one news enhanced program, which was in Japan. Japan continues to be one of our fastest growing regions, and we are excited to be expanding our partnerships with some of the region's leading institutions. Most recently, we initiated a program at Fukuoka Tokushikai Hospital in Kasuga City. We are delighted to see positive feedback from customers and look forward to supporting the continued adoption throughout the region moving forward. On the portfolio development front, we had multiple achievements. Early in Q1, we obtained CE mark approval for the expanded machine vision capabilities with the ISU. which continues to receive high praise across the industry. The ISU was recently honored with two prestigious awards, the first from MedTech Breakthrough, where the ISU was named the best new technology solution in the surgical category. This is a remarkable achievement as we competed against nearly 4,000 nominations from across the globe, and it reflects our commitment to pushing the boundaries of innovation in the medical technology industry. The second comes from Juniper Research's Future Digital Awards for Excellence in Digital Health Innovation, where our ISU has been honored as the best medical robotic solution and awarded the platinum winner title. These recognitions are testament to the outstanding capabilities and potential of our ISU in revolutionizing the field of surgical robotics and digital surgery. The ISU integrated with the Sennheis system is the only real-time solution on the market today that provides surgeons with a suite of tools to use during their surgical procedures, which includes eye tracking camera control, haptic feedback, digital measurement, and digital tags. Eye tracking allows surgeons to seamlessly control the camera position without pausing the procedure. There are also digital tags that enhance the communication between the surgeon at the console and the OR team bedside to further engage and support a seamless operating room experience. Digital measurement tools enabled by the ISU allow surgeons to digitally quantify distances and measure over the contour of the anatomy to support interoperative surgical planning and decision-making. In late March, we attended this year's Society of American Gastrointestinal and Endoscopic Surgeons, or SAGES, conference. We had an outstanding conference with tremendous interest in St. Hans and the ISU. To kick off Sagers, we hosted a moderated broadcast of a live Sennheis surgery performed in Germany by Dr. Vivian Domenka to a packed breakfast symposium from the conference in Montreal. This event demonstrated the capabilities of both our Sennheis system and ISU, as well as our telepresence capabilities with Sennheis Connect. Interest from this full room led to strong attendance at our booth where we also hosted multiple sessions focused on a census ability to deliver augmented intelligence in surgery through our ISU platform. Finally, with the importance of the underserved pediatric market, we had a special focus on engaging key pediatric surgeons. We hosted an event with several U.S. pediatric surgeons to better understand their needs for this unique specialty. We also attended the German Surgeons Congress 2023, or DCK, hosted in Munich, Germany. During this event, similar to Sages, we hosted a live surgery in which Senhans and the ISU drew a great deal of attention from more than 100 attendees. This led to a fully booked agenda of hands-on demonstration for surgeons to have individual dedicated time to learn more and experience the SENHAN system and the digital ISU tools. To continue the focus on the pediatric market and expand on our learnings from Sages, we hosted a group of key European pediatric surgeons to better understand their needs and how we can support further research for this specialty. We will continue this focus into next quarter at the IPEC and ESPAS International Pediatric Endoscopy Group and European Society of Pediatric Endoscopic Surgeons joined global meeting in Italy this summer. Turning to other recent developments, as we unveiled during our investor day in February, we are incredibly excited about our next generation Luna system, which is currently in development. Luna was developed over the course of nearly four years. with input from surgeons, OR teams, strategic partners, and hospital administration. We encourage you to watch the entire Investor Day webcast to learn about the unique combination of hardware and software that we believe enhances safety, reliability, performance, and scalability. In February, we disclosed we had signed a Memorandum of Understanding with Carl Stotz, a major player in the surgical device industry. The definitive agreements are progressing towards signing and will represent an important step expanding our commercial reach and development capabilities. Upon completion, it will enable Essensys to bring the benefits of the ISU to Karlsruhe's extensive global customer base. Both organizations are working diligently to finalize the agreements as quickly as possible. Before turning the call over to Shamice, I wanted to highlight our continued efforts to expand our presence in the pediatric space. As we have discussed at length on previous calls, the combination of Senhance's 3-millimeter instrumentation, haptic feedback, and the ISU's clinical intelligence make the platform uniquely effective at performing pediatric procedure. After having received a pediatric CE mark in 2020, we received FDA 510K clearance for a U.S. pediatric indication in March of this year. With this FDA clearance, we now have the ability to help surgeons deliver better outcomes globally. We have also been hard at work to develop pediatric-specific real-world data. During the first quarter, a paper was published that detailed early experience utilizing our Senhance platform in pediatric procedures in the U.S. This study conducted with IRB approval prior to 510 clearance showcases the safety and feasibility of using Senhance in pediatric cases. The surgical team successfully performed surgeries on patients ranging from four months to 16 years of age. These procedures included gallbladder removal, hernia repair, and other types of urological and GI procedures. These early results highlight the potential of our platform in the pediatric population and further validate its safety and effectiveness. We have continued to see increased interest in using SennHands and the ISU specifically for pediatrics. As we announced during the fourth quarter, we installed a system in Germany to be used exclusively with their pediatric surgery department. We believe that there is a significant opportunity to bring all of the benefits of performance-guided surgery to a largely underserved pediatric market, which will continue to be a focus of our expansion efforts to meet the increasing demand. In summary, I'm thrilled with the breadth of our accomplishments during the first quarter and how we have positioned ourselves for long-term success. With that, I will turn the call over to Shamice for a financial update.

Disclaimer

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