EDAP TMS S.A.

Greetings and welcome to the EDAP TMS fourth quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. John Francis of LifeSci Advisors. Thank you. You may begin.

Good morning. Thank you for joining us for the EDAP-TMS Fourth Quarter and Full Year 2023 Financial and Operating Results Conference Call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, Ken Mobik, Chief Financial Officer, and Francois Dietsch, Chief Accounting Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain forward-looking statements, which include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. I would now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Thank you, John, and good morning, everyone. We are pleased to report strong operating results for the fourth quarter capping a highly successful year in which we established Focal One Robotic Haifu as one of the fastest growing treatment options in the management of prostate cancer. EDAP reported record fourth quarter 2023 total revenue in U.S. dollars of $21.3 million, an increase of 31.4% over the fourth quarter of 2022. Many of the potential deals that had reached an advanced stage in discussion in the third quarter, eventually closed in the fourth quarter, which reflects the seasonality of the capital equipment purchasing cycle. More importantly, we believe that the final decision in selecting FOCAL 1 was based on a growing recognition amongst hospitals that the FOCAL 1 robotic technology platform represents a strategic capital investment to help maintain and attract prostate cancer patients to their facilities. For the full year 2023, EDAP reported record revenues in U.S. dollars of $65.4 million, an increase of 12.9% over 2022. Full-year HIFU revenue came in at $22.3 million, an increase of 35.6% over full-year 2022, which again reflects an increased number of Local 1 system placements and continued strong procedure volumes year over year. In the fourth quarter of 2023, we placed quarterly record of 12 focal one systems. Demand for focal one continues to grow in a very balanced manner with placements made in the U.S. and outside the U.S. and across both academic and community urologists. We also experienced some notable wins during the quarter, which included a focal one sale to New York University Landone Hospital, which is ranked number three in urology hospitals in the US News and World Report. According to the same report, focal one is now in seven of the 10 best hospitals for urology and six of the 10 best hospitals for cancer. We also sold the Focal One system to Roswell Park Comprehensive Cancer Center in Buffalo, New York. Roswell Park is included amongst the select group of prestigious national cancer institute-designated hospitals in the United States and also offers one of the few select uro-oncology fellowship programs approved by the Society of Urologic Oncology. Additional capital sales included Hartford Healthcare Hospital in Connecticut, which is the first system placement in the state of Connecticut, and Baptist Health Regional Hospital, a leading hospital located in Boca Raton, Florida. I would now like to briefly touch on the positive trends we are seeing with respect to Boca One Haifu procedure growth in the U.S., which represents one of the most important metrics for the growth of our business. The fourth quarter of 2023 marked the fifth consecutive quarter of sequential procedure growth, and on a year-over-year basis, the number of U.S. VOCA1 HIFU procedures grew an impressive 136%. We believe procedure growth is being driven by the investments that we continue to make in expanding our commercial and clinical teams, along with positive reimbursement for HIFU, and more patients seeking out effective non-invasive treatment options for the management of prostate cancer. Focal One is enabling urologists to offer select patients a non-invasive, non-surgical, and radiation-free treatment solution with excellent oncologic control. Along with physician demand, we also believe that more men who are diagnosed with prostate cancer continue to seek out treatment options that target the cancer with the potential for fewer patient side effects that negatively impact quality of life. As the number of focal one procedures continues to grow, we believe that more men are becoming aware of this new treatment option, and this is likely to accelerate ongoing patient-driven demand. We also believe that recent and ongoing investments in both cancer diagnostics and imaging technology should lead to improved patient risk stratification which in turn will help identify more patients who could benefit from focal one robotic HIFU. Demand is also being driven by reimbursement. At the APC six level reimbursement, it is economically attractive for hospitals to make the investment into a focal one program. And we think this is providing another meaningful driver for overall demand. In a moment, a more detailed update on our progress with respect to reimbursement. Finally, the strategic investments we made in our regional clinical teams are also helping to drive demand for hospital-based Focal One programs. Over time, we have carefully selected outstanding and accomplished professionals who possess the experience in both building significant relationships as well as launching successful Focal One programs. These investments are a key component to our continued growth and success. I would also like to mention the appointment of Dr. Lance Wilsey to our Board of Directors in December. Dr. Wilsey is a trained neurologist and researcher who has over 30 years of private and public board experience focused in the areas of cancer diagnostics and therapeutics. He completed his surgical and urology training at the Massachusetts General Hospital and additional postgraduate training in the Harvard University Steel Lab and the Dana-Farber Cancer Institute. Dr. Wilsey has already made significant contributions to our company, and we are very excited to have him as both an EDAP board member and a trusted advisor as we move forward. Now I would like to spend some time discussing the progress we have made with respect to reimbursement. As a reminder, the CMS final rule for the hospital outpatient prospective payment system and physician fee schedule for 2024 was released in November of 2023. The hospital payment for a FOCA-1 procedure was maintained as a urology ambulatory payment classification or APC level six procedure. This results in a national average Medicare payment of $8,777, a 2.6% increase over 2023. This new rate became effective on January 1, 2024. I would also like to note that as hospitals look to adopt focal therapy, it is clear that Focal One is a desirable option for them to invest in, as the Focal One robotic high-through platform provides a precise and efficient treatment option as compared to older, or MRI-based technologies that typically require higher staffing levels and that absorb more hospital resources. I would like to also note that we are already seeing the effects from improved reimbursement in Switzerland. In July of 2023, we announced reimbursement approval in Switzerland for the use of high-intensity focused ultrasound for the treatment of prostate cancer. With this higher reimbursement now in place, I am pleased to report that we sold a focal lens system to HOMAD Clinic, located in the city of Tum, in the fourth quarter, which was a direct result of securing reimbursement approval. Finally, in December, we announced that the French National Authority for Health, or HAS, released a favorable recommendation for the reimbursement of hypotherapy for the treatment of prostate cancers. More specifically, the favorable opinion relates to HIFU as a primary treatment for intermediate-risk localized prostate cancer as well as a salvage option after failed radiation therapy. A positive opinion from HAS is an important milestone along the pathway for securing final reimbursement in France. Based on this positive opinion, the French Social Security authorities can now use this recommendation for including HIFU procedures and its next review cycle to determine the procedure's reimbursement rate and the timing for when such reimbursement would go into effect. I will now provide an update on recent regulatory actions. In December, the Taiwan Health Authorities approved FOCAL-1 for the treatment of prostate cancer. With this positive news, the EDAP Southeast Asia local team secured the first sale of FOCAL-1 through its Taiwanese distribution partner. Taiwan represents an attractive market for FOCAL-1, and we expect this region to contribute to the ongoing growth of our international business over time. On March 4th, we announced that the FDA granted our FOCAL-1 robotic HIFU system breakthrough device designation for the treatment of deep infiltrating endometriosis. Receiving breakthrough device designation from the FDA is not only a significant milestone for our company, but also reflects the FDA's recognition that deep infiltrating endometriosis remains a significant unmet medical need in women's healthcare today with fewer treatment alternatives. The designation also reflects our continued commitment to expand the use of FOCAL-1 robotic HIFU technology to treat other medical conditions beyond prostate disease. By expanding our company's proprietary robotic HIFU technology, we aim to provide women with a safe and effective treatment option that is significantly less invasive and less morbid than conventional surgical approaches. As a reminder, our ongoing Phase III study is a comparative, randomized, double-blind clinical trial with a primary objective of evaluating acute pelvic pain levels in 60 patients. On February 1st, we announced the completion enrollment of the Phase III study. Considering the fact that the Phase III study included a sham-controlled arm, We are highly encouraged by the robust pace of enrollment, which we believe reflects a growing interest among patients and physicians to explore alternative treatment modalities beyond surgery. We expect to announce results from the Phase III study in the second half of 2024. In November, we announced that EDAP entered into a clinical research collaboration with the prestigious Icahn School of Medicine at Mount Sinai Department of Urology in New York. The purpose of this collaboration is to accelerate the understanding of the role of immunotherapy treatment in conjunction with high-intensity focused ultrasound in patients with prostate cancer. Vocal therapy using HIFU delivers precise ablative energy to a targeted prostate lesion. Existing research shows HIFU treatment increases the body's immune response. More specifically, EDAP and Mount Sinai study whether HIFU in combination with immunotherapy can generate measurable oncologic results in patients with prostate cancer. The research is being supervised by an internationally recognized leader in the field, Professor Ashutosh Tiwari, Chairman of the Department of Urology at the Icahn School of Medicine at Mount Sinai Health System. I'll now briefly touch on the performance of our distribution business. In the fourth quarter, we sold 20 ExactView systems, which is a quarterly record for system sales. The ExactView micro-ultrasound platform enables urologists to perform precise targeted biopsies of the prostate within a standard urological workflow. We believe U.S. Salesforce realignment that went into effect several months ago to support ExactView is now having a positive effect on demand, and the results in the fourth quarter reflect this progress. We also believe that the success of ExactView offering will strengthen our position in the prostate cancer market and translate into greater visibility for the FOCAL1 platform and help drive additional placement. EDAP was very active through the quarter in attending several important scientific meetings. FOCAL1 was a featured leading technology at the FOCAL 2023 meeting in Chicago. This meeting was attended by several hundred leading neurologists from across the United States who have a keen and active growing interest in advancing focal therapy for the treatment and management of prostate cancer. Of note, Dr. Ruben Olivares from the Cleveland Clinic, who has performed approximately 500 Focal-1 HIFU procedures, presented a one-hour presentation titled, Initiating a Focal HIFU Program, based on Cleveland Clinic's successful experience in building a focal therapy program centered around the FOCAL1 technology. Cleveland Clinic is recognized as one of the very top leading academic centers amongst leading urology hospitals in the United States. Additionally, FOCAL1 had a strong presence at the 24th Annual Meeting of the Society of Urologic Oncology, which was held from November 28 to December 1 in Washington, D.C. The SUO is one of the largest gatherings of urologists who focus exclusively on the treatment of urologic cancers. EDAP's presence at the meeting was noteworthy as we were busy conducting numerous physician hands-on test drives highlighting the FOCAL-1 robotic technology. The growing interest in our FOCAL-1 HIFU technology is clearly evident at these very important meetings. We are looking forward to attending the upcoming European Association of Urology meeting taking place next week in Paris, France, and the American Urology Association meeting taking place in May in San Antonio, Texas. These are the two largest urology-focused conferences in the world, and we expect to have our largest presence ever at both of these highly influential global medical meetings. With respect to advancing the development of our focal one technology for the management and treatment of endometriosis, Professor Gil deBunard presented results from a Phase II multicentric study of robotic HIFU treatment of rectal endometriosis using FOCAL-1 on October 2nd in a plenary session at the European Society for Gynecological Endoscopy Annual Congress. The data was also selected as an oral presentation at the American Association of Gynecological Laparoscopists meeting in November, which is one of the largest global meetings focused on gynecological surgery with over 3,000 attendees. As I mentioned earlier, we are very excited about the progress we are making in this area of women's healthcare, which provides EDAP with the opportunity and substantial unmet need, and we expect results from our ongoing endometriosis phase 3 study in the second half of 2024. I will now turn the call over to Ken to review our financial results for the fourth quarter.