CapsoVision, Inc. Common Stock 2026 Q2 Earnings Call

Good afternoon, everyone, and thank you for joining us for CapsoVision's second quarter 2026 earnings call. Joining me today are Johnny Wang, President and Chief Executive Officer, and Senior Vice President of Finance, David Garcia, as well as Doug Atkinson, Senior Vice President of Sales. Before we begin, please remember that today's remarks include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual events or results could differ materially due to a number of risks and uncertainties, including those mentioned in the most recent Form 10-Q filed by us with the SEC.

These forward-looking statements speak only as of the date of this call, and we expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions, or circumstances on which any such statement is based. Our call today will cover the following agenda. Johnny will begin with an update on CapsoVision's business, target markets, and recent highlights from our pipeline development. Then Dave will walk through a commercial update and recent financial results. After our prepared remarks, we will open the call for Johnny, David, and Doug to take your questions. With that, I would like to turn the call over to Johnny Wang, CEO.

Johnny? Thank you, Leigh, and good afternoon, everyone.

The second quarter represented another period of steady progress for CapsoVision as we continued executing our commercial strategy while advancing several important initiatives across our product portfolio. Commercially, we delivered 10% year-over-year revenue growth, continued expanding adoption across larger hospital systems and gastroenterology networks, renewed key customer relationships, and added new customers who recognize the value of our panoramic Capso platform. More importantly, we continue to see encouraging underlying utilization trends across our installed base, reinforcing the growing role that CapsoCam Plus is playing in routine clinical practice. As of June 30, more than 176,000 patients worldwide have now been imaged using CapsoCam Plus, reflecting growth of 23% a year ago and highlighting the continued adoption of our technology by physicians around the world.

Our commercial team also continues to build momentum across both existing and new customer accounts, providing us with confidence as we look forward the second half of the year. One of the most significant accomplishments during the quarter was the commercial launch of AI Highlights in the European Union and other international markets. This launch represents an important milestone in the evolution of our AI-enabled platform and follows the inclusion of our CapsoView software with AI analysis tools and CapsoCloud within the scope of our EU quality management system certificate under the European Medical Device Regulation. Both are classified as Class IIa medical devices in Europe, providing the regulatory foundation for us to bring our integrated AI-enabled workflow to physicians across these markets. AI Highlights is designed to streamline physician review by automatically identifying frames containing suspected pathology and presenting them within a structured workflow.

Importantly, this capability is integrated across our broader software ecosystem, including CapsoView and our cloud-based CapsoCloud platform, which enables physicians to manage procedures and review and analyze CapsoCam Plus studies through a flexible cloud-based environment. We believe bringing together panoramic capsule imaging, AI-assisted analysis, and a cloud-based workflow represents an important competitive differentiator for CapsoVision. Rather than offering AI as a standalone feature, our goal is to provide physicians with an integrated platform that can make capsule endoscopy more efficient and accessible while maintaining the clinical rigor they expect. Early customer feedback has been encouraging, and we believe the international launch provides an important opportunity to demonstrate the value of AI Highlights in real-world clinical practice as we prepare for commercial introduction in the U.S.

Many of our customers have also expressed a strong interest in the U.S. launch of AI Highlights, and I would like to provide some additional perspective on the timing of our FDA review. As many of you know, we submitted our 510(k) application for AI Highlights in December of last year. During its review, the FDA requested additional information regarding demographic representation within the clinical data set supporting the submission. We have been working closely with the agency to address those requests and expect to obtain FDA clearance by the end of the third quarter, with commercial launch expected shortly thereafter. We are confident that AI Highlights will represent an important catalyst for our commercial business as we continue expanding adoption of the CapsoCam Plus platform. Turning to our broader development pipeline. We continue to make meaningful progress across multiple programs.

For CapsoCam Colon, development continues to advance well, and we now expect to submit our second-generation capsule and AI module for FDA review during the fourth quarter of this year. While the submission timing has shifted by a quarter due to the need for more positive subjects with significant polyps based on discussions with FDA, our strategy remains unchanged. We believe taking the time to deliver highly differentiated second-generation platform, incorporating our latest imaging technology and AI capabilities, positions us for greater long-term commercial success. We also continue to make encouraging progress in our CapsoCam UGI clinical study evaluating pancreatic cancer detection. Enrollment continues as planned, and we remain very encouraged by the progress of the study. While this program is still in the early stages of clinical development, we believe it represents one of the most exciting long-term opportunities for our technology platform.

Pancreatic cancer remains one of the most challenging diseases to detect early, and we believe capsule endoscopy has the potential to become a valuable non-invasive diagnostic tool in this area. More broadly, what continues to excite us is the versatility of our platform. Our strategy has always extended well beyond the small bowel imaging. We are building an integrated CapsoCam platform capable of addressing multiple gastrointestinal diseases through advanced imaging, cloud-based workflow, and artificial intelligence. Each milestone we achieve, whether expanding our commercial footprint, launching new software capabilities, or advancing pipeline programs, moves us closer to realizing that vision. Overall, we believe the business is progressing as expected. We continue to execute commercially, advance our innovation pipeline, and strengthen the foundation for long-term growth.

As we enter the second half of 2026, we remain focused on delivering additional commercial momentum while bringing new capabilities to physicians and patients around the world. With that, I will turn the call over to Dave to provide additional detail on our commercial performance and financial results.

Thank you, Johnny. Turning to our commercial performance, we are pleased with the continued momentum in the business during the second quarter. As Johnny noted, more than 176,000 patients worldwide have now been imaged with CapsoCam Plus, compared with more than 143,000 at the end of Q2 2025. During the second quarter, we shipped 8,845 CapsoCam Plus capsules compared with 7,856 in the prior year period, representing a year-over-year increase of approximately 13%. We continue to see encouraging engagement across large GI networks and hospital systems while also adding new customers to the platform. Importantly, this growth comes from a combination of continued utilization within our existing customer base and traction with new accounts.

During the quarter, we also continued to secure important customer renewals, including M Health Fairview University of Minnesota Medical Center, Henry Ford Hospital, the University of Colorado Anschutz Medical Campus, and Providence Swedish, making CapsoCam the number one capsule used in hospitals in the state of Washington. This highlights the value of the platform and the strength of our long-term customer relationships. Moreover, we believe the international launch of AI Highlights further strengthens our commercial offering. As Johnny discussed, we are also seeing meaningful interest from the U.S. customers awaiting the availability of AI Highlights, and we believe its anticipated U.S. launch represents an important opportunity to support further adoption of CapsoCam Plus in the U.S. Our technology continues to be supported by strong intellectual property portfolio with 85 issued U.S. patents as of quarter end.

From a commercial infrastructure standpoint, our U.S. direct sales organization has remained consistent with 26 representatives, supported by seven regional sales managers and trainers at quarter end. Internationally, we continue to expand our presence through a combination of direct sales and distributor relationships, including our dedicated commercial organization in Germany. As we've discussed previously, one of the advantages of our commercial model is the ability to leverage this existing infrastructure as we introduce additional products and indications over time. The gastroenterologists and health systems we serve with CapsoCam Plus today represent the same customer base we expect to address with future products, including CapsoCam Colon. Turning to our financial results, second quarter revenue was $3.6 million, an increase of approximately 10% from $3.3 million in the second quarter of 2025.