CapsoVision Q1 2026 Earnings Call Transcript

Quartr
Provided by Quartr
May 14, 2026

Key Takeaways

  • Positive Sentiment: CapsoVision said underlying utilization remains strong, with deeper engagement in existing accounts and continued growth in end-user consumption of CapsoCam Plus across its installed base.
  • Positive Sentiment: The company expects a meaningful near-term catalyst from AI Highlights, its AI-assisted reading feature for CapsoCam Plus, with FDA clearance anticipated around mid-year and a commercial launch shortly after.
  • Positive Sentiment: Management highlighted progress across the pipeline, including CapsoCam Colon Gen Two remaining on track for submission in the third quarter of 2026 and enrollment beginning in the pancreatic cancer clinical study.
  • Neutral Sentiment: First-quarter revenue was $2.8 million, flat year over year, while gross margin declined to 48% from 54% due mainly to tariffs affecting cost of goods sold.
  • Neutral Sentiment: Operating expenses rose to $8.4 million as the company increased investment in R&D and clinical trials, but CapsoVision ended the quarter with $17.9 million in cash after a $14 million private placement in March.
AI Generated. May Contain Errors.
Earnings Conference Call
CapsoVision Q1 2026
00:00 / 00:00

Transcript Sections

Skip to Participants
Operator

Hello, and thank you so much for standing by. Ladies and gentlemen, welcome to CapsoVision Q1 2026 earnings conference call. Please note that this call is being recorded. At this time, all participants are in listen-mode only. There will be some opening remarks followed by question and answer session. If you wish to ask a question please press star one on your telephone keypad. Thank you.

Leigh Salvo
Leigh Salvo
Investor Relations Contact at CapsoVision

Thank you, operator. Good afternoon, everyone, and thank you for joining us for CapsoVision's first 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, including 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.

Leigh Salvo
Leigh Salvo
Investor Relations Contact at CapsoVision

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. David will walk through a commercial update and recent financial results. After our prepared remarks, we'll open the call for Johnny, David, and Doug to take your questions. With that, I'll turn the call over to Johnny Wang. Johnny?

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Thank you, Leigh, and good afternoon, everyone. CapsoVision remains focused on advancing earlier, more accurate, and more accessible detection of gastrointestinal disease for patients worldwide. We are working toward a unified ingestible capsule platform capable of screening for multiple cancers, including esophageal, gastric, pancreatic, liver, and colorectal through a single non-invasive procedure enabled by advanced imaging and AI. With that as our foundation, we continued to see consistent solid underlying performance in the first quarter. While revenue and the new account additions remained stable year-over-year, we saw further expansion of CapsoCam used to detect a widening range of small bowel diseases. In the first quarter, underlying procedural volume reflecting end user consumption continued to expand, demonstrating deeper engagement with existing accounts and increasing reliance on CapsoCam Plus in routine clinical practice.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

We believe this trend reinforces the strength of our installed base and highlights the growing role our platform is playing in supporting physician workflow and patient care. During the quarter, we also secured key renewals for large GI networks, including Indiana University Health, Providence Health & Services, and Gastro Health, which we believe reinforces the value of our platform and the strength of our long-term customer relationships. Turning to our technology platform, we are entering an important phase in our AI strategy. As you know, we previously submitted our 510(k) application for our AI-assisted reading capability for CapsoCam Plus. We continue to expect the clearance around mid-year, and we are preparing for a commercial launch shortly thereafter. We have been actively demonstrating this capability, which we have branded AI Highlights, at the recent industry meetings, and the feedback from gastroenterologists has been very encouraging.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Physicians are particularly focused on the potential to streamline review time while maintaining clinical rigor, which we believe will be an important driver of adoption. AI Highlights is designed to identify frames with suspected pathology and present them within a structured review workflow, fully integrated within our cloud-native CapsoCloud platform. We believe this capability has the potential to reduce the physician reading time while enhancing workflow efficiency and represents a meaningful step forward in advancing a fully integrated AI-enabled diagnostic system. Building on that momentum, we continue to make steady progress across our pipeline. For CapsoCam Colon, our development program remains on track with submission of our second-generation capsule and its AI module expected in the third quarter of 2026.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

We continue to believe that our decision to prioritize gen two positions us to enter the market with a more competitive and clinically differentiated product. Turning to our CapsoCam UGI Program and the pancreatic cancer initiative. We are pleased to report that enrollment began this week in our clinical study. This represents an important milestone as we work to establish diagnostic criteria and build the clinical foundation for what we believe could be a first of its kind, non-invasive screening approach for pancreatic disease. While this remains a longer-term opportunity, we continue to believe the potential impact in this area is significant given the lack of effective early detection tools today. Overall, we believe the business is progressing as expected. We are seeing continued strength in utilization, advancing key pipeline programs, and are moving closer to what we expect will be an important inflection point with the introduction of AI-enabled capabilities.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

More broadly, we remain focused on redefining how gastrointestinal diseases are detected, leveraging our platform to make diagnosis earlier, more accessible, and more efficient for both patients and providers. With that, I will turn the call over to Dave to walk through our commercial and financial results.

David Garcia
David Garcia
SVP of Finance at CapsoVision

Thank you, Johnny. Turning to our commercial performance. As of March 31st, 2026, more than 167,000 patients have been imaged with CapsoCam Plus for small bowel screening across the U.S. and international markets. During the first quarter, we shipped 6,229 CapsoCam Plus capsules compared to 6,447 in the prior year period, representing a year-over-year decrease of 3%, reflecting the timing of shipments that have now been placed in the second quarter. Our technology continues to be supported by a strong intellectual property portfolio, currently with 85 issued U.S. patents, reinforcing our position in capsule endoscopy innovation. In addition, reimbursement under CPT Code 91110 continues to support adoption across a broad range of care settings, including both private practices and hospital systems.

David Garcia
David Garcia
SVP of Finance at CapsoVision

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 the same physician call point driving adoption of CapsoCam Plus today will serve as a natural entry point for CapsoCam Colon following regulatory clearance, creating a meaningful cross-selling opportunity without requiring significant incremental headcount. We continue to see encouraging engagement across larger gastroenterology networks, including GI clinics and multi-site group practices, where we are expanding our presence within existing accounts and continuing to deepen utilization across larger networks. We are seeing ongoing traction within hospital systems and group purchasing organizations, particularly as contracts come up for renewal and providers evaluate alternative solutions.

David Garcia
David Garcia
SVP of Finance at CapsoVision

As Johnny noted, we are also pleased to secure renewals with several large GI networks during the quarter, including Indiana University Health, Providence Health & Services, and Gastro Health, supporting continued engagement across our installed base. As of quarter end, our U.S. direct sales organization remained consistent at 26 representatives, supported by seven regional sales managers and trainers. Internationally, we continue to build momentum, including a dedicated team of four representatives in Germany, while expanding our global footprint through distributor partnerships in high-potential markets. Turning to our financial performance. For the first quarter of 2026, total revenue was $2.8 million, consistent with prior year period. While the number of capsules sold was modestly lower year-over-year, this was offset by a slight increase in ASP.

David Garcia
David Garcia
SVP of Finance at CapsoVision

As Johnny noted earlier, we continue to see strong underlying patient volume and utilization expansion trends across our installed base. Gross profit for the quarter was $1.3 million with a gross margin of 48%, compared to 54% in the first quarter of 2025. The change in gross margin was primarily due to tariffs impacting our cost of goods sold. Operating expenses were $8.4 million, an increase of $1.5 million compared to the prior year period. This increase was driven primarily by continued investment in our pipeline, including development work related to the next-generation imaging sensor under our agreement with Canon, as well as clinical trial activities supporting the CapsoCam Colon Gen Two program. We ended the quarter with $17.9 million in cash and cash equivalents.

David Garcia
David Garcia
SVP of Finance at CapsoVision

As a reminder, in March, we strengthened our balance sheet with the closing of a $14 million private placement with participation from both new and existing investors. We believe this financing reflects continued confidence in our strategy and provides additional flexibility to support our key priorities, including product innovation, clinical development, and commercial expansion. Overall, we remain focused on disciplined investment to support long-term growth. Before I turn the call back to Johnny, I'd like to provide some perspective on how we're thinking about the remainder of the year.

David Garcia
David Garcia
SVP of Finance at CapsoVision

We expect second quarter revenue to be higher than the first quarter, and we also expect revenue in the second half of the year to be higher than in the first half as we continue to build on the momentum we're seeing in our pipeline and customer engagement, as well as the anticipated launch of the AI module for CapsoCam Plus. Now, I'd like to turn the call back to Johnny for some closing remarks.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Thanks, Dave. To close, we believe the business is progressing as expected. We are seeing continued strength in utilization across our installed base, reinforcing the growing role CapsoCam Plus is playing in routine clinical practice. At the same time, we are approaching an important inflection point with the anticipated introduction of our AI-assisted capabilities, which we believe will further enhance workflow efficiency and strengthen the value of our platform for physicians. Across the pipeline, we continue to execute with discipline with CapsoCam Colon on track and early progress underway in our pancreatic cancer program following the initiation of our clinical study. More broadly, we remain focused on advancing a differentiated AI-enabled platform designed to improve how gastrointestinal diseases are detected through panoramic imaging, cloud-native workflow capabilities, and AI-assisted diagnostics that make review more accessible and efficient for physicians.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Our platform enables physicians to securely review cases anytime and anywhere without the need for on-site servers or a dedicated IT infrastructure. We're also creating a growing cloud-based data depository that we believe will serve as an important foundation for continued AI development and training over time. At this time, Dave, Doug, and I would be happy to take your questions. Operator, can you please open the line?

Operator

Thank you. We will now begin the question-and-answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Kyle Bauser with Titan Partners. Please go ahead.

Kyle Bauser
Analyst at Titan Partners

Great. Thanks. Hi, Johnny, David, and Doug. I appreciate all of the updates and for taking my questions. Maybe I will just start out regarding the application for the AI-assisted reading feature. Johnny, I guess any sort of remaining items that need to be addressed with the FDA or are responses in and you're now just waiting for a response? I guess any color on the update there.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Yes. FDA and CapsoVision had a few interactions during these months. Right now, we have reacted on their request during these previous interactions. We are waiting for a meeting in the next few weeks. That's its current status. We have no showstoppers to my knowledge.

Kyle Bauser
Analyst at Titan Partners

Great. Appreciate that. Can you remind me, so for the pancreatic cancer clinical study, which you just started enrolling, which is great, can you remind me the size of this trial, how many patients and kind of the expected timeline for enrollment?

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

For this study, we plan to enroll 120 patient with high-grade dysplasia or cancer, pancreatic cancer, confirmed HGD or cancer. We account for possible dropout, patient dropout, we plan to enroll 140 to make sure we have 120 to make statistics more powerful. Also, we will have 120 subjects as a reference, healthy patients reference. This 120 patients imagery will be extracted, pulled out from our cloud storage.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

As we just mentioned, we have enormous data repository in our cloud storage due to our workflow. We can pull out this reference, healthy reference images. Total is 240. Yes. Enrollment, we cannot speculate at this time. I would see this as a much shorter study than colon. Yeah. Yeah. That's what I can say at this point without, you know, saying too much as a public company. Thank you.

Kyle Bauser
Analyst at Titan Partners

No, yep. Makes sense. That's helpful. Appreciate all that color. Then, maybe lastly, David, I guess appreciate the thoughts on the cadence of revenue, you know, on Q2 and the back half of this year. Any sort of thoughts you can call out on OpEx? Just kinda wondering how this line item should kinda trend throughout the year. Thank you.

David Garcia
David Garcia
SVP of Finance at CapsoVision

Yeah. Thanks, Kyle. I think that the next couple of quarters, you're gonna see continued investment in the colon study, as we, you know, continue to progress on that. That'll continue through Q3. Only until we get to Q4 will be the time when that'll start to trail off a bit when as we will have completed the colon study at that point in time. All the remaining items, you know, should be fairly stable, nominal growth to support the business.

Kyle Bauser
Analyst at Titan Partners

Okay, great. thanks so much for all the updates.

Operator

Thank you. Your next question comes from the line of Bruce Jackson of StoneX. Please go ahead.

Bruce Jackson
Analyst at StoneX

Hi, good afternoon. I'd like to kind of take a closer look at the first quarter revenue number. You mentioned that the ASPs were higher. I was wondering if you potentially have put in a price increase and if there was any forward buying behavior. You also said that some of the sales may have moved into the second quarter. I'm kind of curious about that. Of course, you often get deductible resets and everything like that out in the market. If you could kind of put those pieces together for us and tell us how that impacted the first quarter revenue number, that'd be very helpful.

David Garcia
David Garcia
SVP of Finance at CapsoVision

Sure. I'll take that one. Thank you. In terms of the capsule volume, it was really just the impact of timing. We saw some of the orders, some of our bigger orders actually fall into April, as opposed to March. In terms of the ASP, there was no price increase. The only thing that happened there was we just saw a little bit of a shift in our mix, to some of the higher priced regions in the world. That's really the only thing impacting ASP there and the volume. Other than that, the underlying business remains strong, and there's nothing, you know, that, you know, that would have changed that.

Bruce Jackson
Analyst at StoneX

Okay, great. Just a quick question on the research and development spending. How do you expect that level for the full year to look in comparison to 2025?

David Garcia
David Garcia
SVP of Finance at CapsoVision

Yeah. It will be pretty similar to 2025. You know, we did spend quite heavily in 2025 on the colon study, and that continues through, it continued through Q1, and it will continue through Q3, as I just mentioned. You know, when it's all said and done, the full year R&D spending will be pretty similar to 2025.

Bruce Jackson
Analyst at StoneX

All right. great. That's it for me. Thank you.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Bruce, this is Johnny. Please allow me to add. During our workflow, our capsule is shipped to the downloading center to retrieve data for the Cloud review by the doctor. We can measure the end user consumption very easily. That's another benefit of Cloud. We know what features Cloud doctor are using. We can monitor that through Cloud. During monitoring of this end user consumption, we can tell you the end user consumption growing growth is healthy. Okay. Is growing and very healthy. Yeah.

Bruce Jackson
Analyst at StoneX

Okay.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

That's my opinion. Thank you.

Bruce Jackson
Analyst at StoneX

Thank you.

Operator

Thank you. Again, if you would like to ask a question, please press star followed by the number one on your telephone keypad. There are no further questions from the analyst. That concludes our question and answer session. That concludes our today's call as well. Thank you all for joining. You may now disconnect.

Executives
    • David Garcia
      David Garcia
      SVP of Finance
    • Johnny Wang
      Johnny Wang
      President and CEO
    • Leigh Salvo
      Leigh Salvo
      Investor Relations Contact
Analysts
    • Bruce Jackson
      Analyst at StoneX
    • Kyle Bauser
      Analyst at Titan Partners
Powered by Quartr