CapsoVision, Inc. ($CV)

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the CapsoVision Fourth Quarter 2025 Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to Leigh Salvo, Investor Relations. You may begin.

Thank you, operator. Good afternoon, everyone, and thank you for joining us for CapsoVision's Fourth Quarter and Full year 2025 Earnings Call. Joining me today are Johnny Wang, President and Chief Executive Officer; and David Garcia, Senior Vice President of Finance; as well as Doug Atkinson, Senior Vice President of Sales, who will be joining us for the Q&A session. 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 Form 10-K filed today 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 statement 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'll open the call up for Johnny, Dave and Doug to take your questions. With that, I'd like to turn the call over to Johnny.

Thank you, Leigh, and good afternoon, everyone. CapsoVision's mission remains clear to make early accurate and accessible GI disease detection available to patients everywhere. Our long-term vision is to deliver an ingestible capsule capable of screening for multiple cancers, including esophageal, gastric, pancreatic, liver and colorectal in a single noninvasive procedure powered by advanced imaging and AI. With that as our foundation we closed 2025 with increased commercial momentum for CapsoCam Plus, mobile capsule endoscopy solutions. For the full year, we delivered approximately 15% year-over-year revenue growth and 21% in new account generation, reflecting continued adoption of CapsoCam Plus across both new and existing customers. As of December 31, 2025, more than 161,000 patients have been imaged with CapsoCam Plus. We believe this growing installed base, combined with strong physician engagement reinforces the value of our differentiated platform. A wire-free capsule with unparalleled features, including 360-degree panoramic imaging on both storage and a fully cloud-based workflow that eliminates the need for external hardware worn on patient's body or on-site computing infrastructure. Importantly, cloud-based architecture is not just a workflow advantage. It also serves as the foundation of our AI strategy. Our spending image repository of the cloud storage continues to strengthen our ability to develop and deploy AI models that improve diagnostic accuracy, reducing reading time and enhanced clinical efficiency on the pipeline development front, we have continued to make exciting advances that I'd like to share. Starting with CapsoCam Plus, we are advancing our AI-enabled road map at the end of last year, we submitted our 510(k) application for our AI-assisted reading module which is designed to enhance lesion detection and streamline physician review. We believe this represents an important step in further differentiating our core platform and expanding its clinical and economic value. Building on that momentum, we continue to advance our CapsoCam Colon program Following constructive engagement with the FDA, we have refined our development strategy to prioritize our second-generation capsule. The Gen 1 submission and the subsequent FDA interactions provided valuable insights into both the regulatory pathway and the evolving product expectations. Based on that feedback we see a clear opportunity to advance directly to a more capable system that incorporates improved imaging performance, expanded field of view and enhanced AI functionality. As a result, we are focusing our resources on accelerating the development of CapsoCam Colon Gen 2 which we believe will deliver a more competitive and clinically differentiated solution at the launch. We view this as the disciplined and value-driven approach enabling us to bring a stronger product to market from the outset rather than iterating post clearance. We have already enrolled over 400 patients in our pivotal study and outstanding enrollment across the U.S. sites. We now expect to submit our 510(k) application for CapsoCam Colon Gen 2 and its AI module in the third quarter of 2026. Turning next to our CapsoCam UGI program and the pancreatic cancer initiative. We continue to see significant long-term potential for a noninvasive screening approach in one of the most challenging areas in Nevada. We believe we are pioneering a novel visual assessment method for the detection of pancreatic cancer building on our platform's ability to evaluate abnormalities of the duodenal wall and to clearly identify key anatomical landmarks such as the papilla or Vater. This approach is grounded in both our prior clinical work and established scientific literature and represents a potential paradigm shift in how pancreatic disease could be detected at an earlier more treatable stage. Following our initial Breakthrough Device Designation submission, we engaged with the FDA and received constructive feedback which confirms the system's ability to visualize the papilla and associated abnormalities. The feedback also outlined the need to further define diagnostic criteria which we view as the natural next step in developing the first of its kind screening modality. To address this, we are initiating a clinical study expected to begin in the second quarter of 2026. This study will enroll approximately 60-90 patients and is decided to establish diagnostic criteria for malignancy using the CapsoCam UGI system. We are conducting this work in collaboration with clinical experts, key opinion leaders, including leadership of the top professional societies in the pancreato biliary field. We believe this study will be an important step in generating the data needed to support both regulatory advancement and future Breakthrough Designation risk submission, while continuing to build the clinical foundation for a noninvasive approach to early pancreatic cancer detection. Importantly, our regulatory pathway for CapsoCam UGI is independent of the Breakthrough program, and we remain on track in advancing these initiatives. Finally, and supporting all these efforts, we recently strengthened our balance sheet with the completion of a $14 million private placement with participation from both new and existing investors. We believe this reflects continued confidence in our strategy and provides additional flexibility to invest in product innovation, clinical development and commercial expansion. Overall, we believe we are well positioned heading into 2026 with a growing commercial base differentiated AI-enabled platform and a disciplined approach to advancing our pipeline. We remain focused on executing our strategy and delivering long-term value for patients, physicians and shareholders. I will now turn the call to Dave to cover current commercial and operational highlights as well as our financial results for the fourth quarter, Dave?

Thank you, Johnny. Turning to our commercial performance. As Johnny highlighted earlier, adoption of CapsoCam Plus continues to expand across both U.S. and international markets. As of December 31, 2025, more than 161,000 patients have been imaged using our system for small bowel screening. In the fourth quarter alone, approximately 9,400 patients utilized CapsoCam Plus compared to approximately 8,374 in the prior year period. representing year-over-year growth of 12%. This continued growth reflects increasing physician awareness, strong clinical utility and the ease of integration into existing practice workflows. Our platform is supported by a robust intellectual property portfolio currently with 83 issued U.S. patents, reinforcing our position as a leader in capsule endoscopy innovation. In addition, reimbursement continues to support adoption across a broad range of care settings, including both private practices and hospital systems. From a commercial strategy perspective, One of our key advantages is the ability to leverage our existing sales infrastructure as we expand into new indications. We expect that same physician call point driving adoption of CapsoCam Plus today will serve as a natural entry point for CapsoCam Colon when it is FDA-approved, creating a meaningful cross-selling opportunity without the need for significant incremental investment. As of year-end, our U.S. direct sales organization consisted of 26 representatives, supported by 7 regional sales managers and trainers. Internationally, we are continuing to build momentum including a dedicated team of 4 representatives in Germany, while also expanding our global footprint through distributor partnerships in high potential markets. New account growth remains solid in the fourth quarter, increasing 16% year-over-year, reflecting continued physician adoption of CapsoCam Plus for a small bowel screening. This momentum has been further supported by recent approvals, including use in pediatric patients over the age of 2 and the ability for remote capsule ingestion, both of which expand access and align well with the growing adoption of telemedicine. We are also encouraged by continued expansion within larger gastroenterology networks. During the quarter, we saw increased penetration in GI clinics and mega GI groups compared to the prior year period. In addition, while our historical focus has been on private gastroenterology practices, we are now seeing meaningful traction within hospital systems and group purchasing organizations. As existing contracts come up for renewal, we are increasingly being evaluated alongside incumbent solutions and in many cases, selected as a preferred alternative. This is reflected in our hospital channel performance, where the number of hospital system customers increased 87% in the fourth quarter compared to the same period last year. Turning to our financial performance. For the fourth quarter of 2025, total revenue was $3.9 million, reflecting 13% growth compared to the fourth quarter of 2024. This was driven by an increase in the number of CapsoCam Plus capsules sold. Gross profit was $2 million, an increase of $200,000 or 13% compared to the fourth quarter of 2024. Gross margin was 50% for the quarter, consistent with our expectations as we scale. Operating expenses were $9.4 million, a $3.1 million increase from the fourth quarter of 2024, driven primarily by an increase in expenses associated with the development of the new CMOS image sensors under the agreement with Canon, continued investment in the Colon clinical study and an increase in public company expenses as we now operate as a public company. We ended the year with $10.1 million in cash and equivalents. Subsequent to year-end, we strengthened our balance sheet with the closing of a $14 million private placement of equity with participation from both new and existing investors. The financing was completed at a price of $4.88 per share which represents a 5% discount to our March 16 closing price as per the terms of the agreement. This equity investment reflects continued investor confidence in our strategy and long-term growth opportunity. We intend to use the net proceeds to support our key priorities across the business, including commercial expansion, continued investment in R&D and the advancement of our pipeline programs, particularly CapsoCam Colon and our AI-enabled platform. Now I'd like to turn the call back to Johnny for some closing remarks.

Thanks, David. As we look ahead, we believe we are entering a highly compelling phase of execution for CapsoVision. We are building from a position of strength with continued commercial momentum in CapsoCam Plus, expanding adoption across both existing and new customer segments and increasing traction in larger GI networks and hospital systems. At the same time, we are advancing a focused and disciplined pipeline strategy. Our recent 510(k) submission for the AI-assisted reading module represents an important step in enhancing the clinical and economic value of our core platform. In parallel, we are progressing CapsoCam Colon with a clear path toward the next-generation product designed to meet the physician expectations at the launch. And in our pancreatic cancer initiative, we are continuing to advance what we believe could become the first of this kind noninvasive screening approach, supported by growing body of clinical work and ongoing engagement with the FDA. Underlying all of this is our differentiated platform combined wire-free capsule technology, a scalable cloud-based infrastructure and in-house AI capabilities, which we believe positions us uniquely to expand across the GI tract and address some of the most significant unmet needs in gastrointestinal care. Finally, with the additional capital raised during the quarter, we are well positioned to continue investing in innovation while maintaining a disciplined approach to execution. Taken together, we believe CapsoVision is well positioned to drive sustained growth, deliver meaningful innovation and create long-term value for patients, physicians and shareholders. I want to thank our employees for their dedication and creativity. Our clinical partners for their collaboration and our investors for their continued support. Together, we are redefining what's possible in GI screening, making early accurate and patient-friendly diagnosis a reality. We look forward to updating you on our continued progress next quarter. At this time, Dave, Doug and I would be happy to take your questions. Operator, can you please open the line?

[Operator Instructions] Our first question comes from Kyle Bauser from ROTH Capital Partners.

Maybe I'll just ask some follow-ups on the Gen 2 CapsoCam Colon efforts. Any sort of feedback you've received to date? I know you've already enrolled, I think you said over 500 patients of the up to 800. So any feedback there? And would we anticipate seeing results of this study later this year as well in conjunction with the submission or would we see those later?

Yes. Thanks, Kyle. So our Colon Gen 2 have higher resolution, higher image quality and a larger field of view for better detection. We also have better software and working with our AI module. And so far, the enrollment goes well, so far, so good. Our Clinical Director, Keri Jorgenson is a very capable person and a good manager. We are -- all this clinical study enrollment is in good hands. So we still are on track to file the submission to FDA for Gen 2 by the end of Q3. So there is no delay so far.

I appreciate that. And then my follow-up, so regarding the Breakthrough Designation application for pancreatic cancer detection. Good to know that you're kind of working with the societies and KOLs. And I believe you want to kind of understand the ideal diagnostic criteria. What sort of criteria are you contemplating? And would this 90-patient study with the results, would you be able to use those results for the actual FDA application?

In terms of this score, score system is required for diagnostic purposes because it tell you yes or no. So the score system, we rate several important features. We think in meaningful to the pancreas cancer, including the papilla abnormality. And due to some lesion, some tumor growth in the pancreas head. So they will compress the neighboring anatomy or even invaded neighboring anatomy. So you can see that on the duodenal wall next to the papilla. So for each of this abnormality, the doctor grading is yes or no. And if yes, the severity is mild or severe, then they give a grading score for that feature. And the entire score is composed of all these abnormalities or the disease probability-related variable like gender like age. So then we build the score system based on the study results. Based on the multiple various analysis. So that's how things will be implemented. And executed. So there is such a system is based on the methodical mathematic model. So we expect that this one will be very important step in developing of this noninvasive diagnostic system. So in terms of FDA, I think this one will be very important for FDA to apply, for us to apply for the Breakthrough Designation. The purpose of Breakthrough Designation is to establish priority in their -- in FDA's work because FDA has a lot of cases, and this one gives us the priority over other cases. And it can also invoke the attention of the top FDA officials to make direct decision. So for clearance, it's possible this establishing the scoring system, they need some validation. Because the population you used for validation -- for establishing the model. Establishing the model cannot be used for validation. It has to be another population. So then there might be a study following this to prove it can be used in the external population outside of the study population. But at that point, this already, we already have built a greater milestone. This is not an evolution. This is a revolution.

Okay. Excellent. That makes sense. Sounds great. Well, congrats on all the progress.

Our next question comes from Bruce Jackson from The Benchmark Company.

So the small bowel business looks like it's tracking very nicely. I think the thing I'd like to get a better handle on is the Colon cam development time line. So I apologize in advance for asking fairly detailed questions here, but how many patients were you -- had you recruited at January 1? Into how many sites? And where are we today at how many sites? And then give us a sense of like how the patient accrual is going to go from here? And how many sites do you have to add in order to like get to the target by a certain date?

Yes. For Gen 1, we enrolled more than 1,000 subjects. And in Gen 2, we target to enroll 800 patients but we will have more reading so that to create a more statistical power for the calculation of sensitivity, accuracy and specificity. And so far, in this Gen 2, we have 11 sites across covering the entire U.S. So far, we are close to 600, okay, over 500, but close to 600. So the enrollment is going well. So far, we have a capable clinical director with a very good team, effective team. So, so far, it's going so well. But I have to be honest, during summer time, doctor might take a vacation. So doctor's time, we have no control. So that is a factor. But in general, we are in good hands. So far, everything goes according to the plan.

And then my follow-up would be, once we get this 510(k) submitted, what do you anticipate that the review time would be like? And then can you perhaps give us a rough indication of when the Gen 2 Colon Cam capsule might be commercially available?

Yes. So on this one, we expect the FDA -- it takes FDA 6 months to get to clear the device. So from end of Q3, we expect Q1 2027, we'll get the clearance and launching it in the marketplace, the beginning of second half 2027.

There are no further questions at this time, and that concludes the question-and-answer session. And this concludes today's conference call. Thank you for joining. You may now disconnect.