EDAP TMS S.A. American Depositary Shares 2026 Q2 Earnings Call

Thank you for joining us for the FocalTherics second quarter 2026 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, and Ken Mobeck, Chief Financial Officer. Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and involve risks and uncertainties that could cause actual results to differ materially from those anticipated. We direct you to the Risk Factors section of our most recently filed annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission, as well as our other filings with the SEC for a description of factors that may cause such differences.

These statements speak only as of today's date, and we undertake no obligation to update or revise them except as required by law. Additionally, this call is being recorded and constitutes a public disclosure for purposes of Regulation FD. I would now like to turn the call over to Chief Executive Officer Ryan Rhodes.

Thanks, Louisa, and thank you all for joining us on our call today. Before I turn to our second quarter results, I want to take a moment to frame up today's call. We view this as a transformative moment in the evolution of our company's history, including the transition of our name from EDAP to FocalTherics, debuting as a pure-play, high-growth, market-leading focal therapy company. In the first half of this year, we have completed the steps necessary to become a U.S. domestic filer, and we are now reporting our business in U.S. dollars. Additionally, this quarter, we moved our ESWL and distribution businesses to discontinued operations to further establish clarity in our financial reporting in alignment with our strategic priorities.

Now with recently announced equity offering, we believe we are fully capitalized to drive meaningful growth while penetrating our large addressable markets and thus becoming a breakout success story within the healthcare landscape. Our team is encouraged by the notable progress we have made to date, and we are even more excited by the large global opportunity that lies ahead for FocalTherics. I am more confident than ever that we are positioned to emerge as the market leader in the growing category of focal therapy, along with our ability to create durable shareholder value. Now turning to our results. We delivered another strong quarter with $13.2 million in HIFU revenue, representing 39% year-over-year growth. We recorded 13 Focal One capital system sales in the second quarter, a 44% increase, making this our best second quarter ever for HIFU capital system sales globally.

Our total worldwide install base now stands at 184 systems, with 96 in the U.S. and 88 internationally, reflecting the continued broadening of our global commercial footprint across hospitals in both academic and community settings. In the U.S., we recorded eight capital system sales, including two conversions from existing operating leases at Vanderbilt University Medical Center and the University of Michigan, both of which are NCCN member institutions, NCI-designated comprehensive cancer centers, and SUO-approved fellowship programs. Adoption at leading academic institutions such as these allows the next generation of urologists to gain hands-on training and exposure with Focal One through their accredited fellowship programs, which we believe helps build broader clinical awareness and scale as those surgeons move into clinical practice. We now have 15 U.S. hospital networks that have invested in two or more Focal One systems.

During the quarter, there were four hospital networks that invested in an additional Focal One system, including another placement within Cleveland Clinic, which marks our fourth in the U.S. and sixth within their worldwide healthcare network. We also added a second system within Kaiser Permanente, expanding into their San Diego market following the strong performance of their first program in Los Angeles. This expanding footprint across many of the country's most respected healthcare systems continues to validate Focal One's position as the platform of choice for hospitals building a comprehensive focal therapy program, and we believe it reflects growing confidence amongst some of the most influential thought leaders in the field of urology. Internationally, we delivered five capital system sales in the second quarter across Europe, India, and Latin America. This reflects the strength and continued expansion of our global commercial infrastructure.

Of note, Imperial College London in the U.K., one of the pioneering and most highly published focal therapy programs in the world, has converted their HIFU activity from a competitive HIFU technology to Focal One. Reinforcing the growing preference of our technology platform amongst some of Europe's most established focal therapy programs. In France, we completed a new capital sale following the recent announcement of the universal coverage for use of HIFU by the French National Health System. This reimbursement coverage outcome was the result of a landmark large prospective multi-center HiFi study published in December of 2024. We also continue to expand our footprint in several important developing markets outside of Western Europe, including India, where we completed two additional capital system sales as we build our presence in one of the largest and most under-penetrated prostate cancer markets globally. Turning our attention to utilization.

U.S. Focal One procedure volumes increased 47% year-over-year, demonstrating strong usage by existing programs, as well as the impact of new Focal One programs launched during the quarter. This sustained growth demonstrates the durable recurring revenue streams created by each new Focal One system placement. As our install base has grown over the past several years, we continue to see procedure volumes scale, and this quarter's results are a continuation of this positive trend. Turning to our clinical and regulatory programs. In July, we submitted a 510(k) application to the FDA for Focal Connect, our proprietary remote connectivity technology. Focal Connect enables remote maintenance, remote proctoring, peer-to-peer collaboration, and unlocks the opportunity to accelerate surgeon training and broaden patient access to expert care.

For example, an experienced Focal One surgeon can remotely support a physician in real time, whether that connection spans across a single large hospital campus or across a broader regional network. Last year, we demonstrated the scope of this capability with the world's first transcontinental Focal One telecollaboration, where two surgeons within the Cleveland Clinic network in Ohio and Abu Dhabi collaborated to perform a Focal One patient treatment while more than 7,000 miles apart. On the positive reimbursement front, CMS has proposed an increase in HIFU facility payment of approximately 12% for 2027 compared to the current rate for 2026. If confirmed in the final rule, this would represent the fifth consecutive annual increase by CMS in the facility payment for use of Focal One robotic HIFU.

We believe this proposed increase continues to provide hospitals and physicians with a clear and predictable Medicare reimbursement pathway, which supports and justifies an investment in Focal One as the core foundation of a world-class focal therapy program. We will continue to monitor the CMS payment rule as it moves forward toward finalization, which we expect in late fall. We also continue to make progress expanding from prostate cancer into new indications with our BPH clinical program. Through a natural orifice approach and direct access to the prostate without an incision or blood loss, the Focal One platform is ideally suited to treat BPH, or benign prostatic hyperplasia, and its related symptoms.

Leveraging our growing install base and existing community of urologists specialized in prostate care and trained on Focal One, we believe that upon regulatory approval, we are positioned to capture a meaningful share of the large and highly fragmented BPH market. Our ongoing study in Latin America continues to progress with 14 patients treated to date. As a reminder, this initial clinical work is led by U.S. physicians who have received IRB approval to expand their research at the Icahn School of Medicine at Mount Sinai in New York. The first BPH patients in the U.S. are planned for treatment with Focal One later this year in New York. As for indication expansion with endometriosis, we recently announced that Toulouse University Hospital in France became the site of our first commercial endometriosis program in Europe and has since treated several additional patients since the initial program launch.

More than 10 additional hospitals across Europe, the U.K., and Latin America are now moving through our clinical training pathway. With a dedicated CE marking for this clinical application, we continue to view the treatment of deep infiltrating endometriosis as a large and growing market opportunity, offering a treatment option to women suffering from this highly debilitating condition while avoiding major pelvic surgery and its associated complications and morbidity. Together, BPH and endometriosis represent two significant opportunities to expand utilization for use of Focal One. We estimate that across prostate cancer and our expanded indications into BPH and endometriosis, this represents a total addressable market of more than 4.3 million procedures and over $10 billion in potential revenue. With an updated company name, a fortified balance sheet, and a refined reporting structure, FocalTherics is now fully aligned to capture the high-growth opportunity in front of us.

Going forward, we will remain focused on the disciplined execution of our strategic growth plan as reflected in our near and long-term financial targets. With that, I will now turn it over to Ken to review the financials in more detail.