CapsoVision Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 13, 2026

Key Takeaways

  • Positive Sentiment: Commercial momentum continued: Q2 revenue rose 10% year over year to $3.6 million, while CapsoCam Plus capsule shipments increased 13% and total patients imaged reached more than 176,000. Management also cited customer renewals and growing adoption among large hospital systems and GI networks.
  • Positive Sentiment: AI Highlights launched internationally and is expected to support physician efficiency and broader platform adoption. The company anticipates FDA clearance by the end of Q3 and a U.S. launch shortly thereafter, although management cautioned that clearance is not guaranteed.
  • Negative Sentiment: Gross margin declined to 51% from 55% a year ago because of competitive pricing pressure and higher inbound customs and tariff costs. Operating expenses also increased substantially to $9.5 million, driven by clinical and product development investments, public-company costs, and stock-based compensation.
  • Negative Sentiment: The CapsoCam Colon FDA submission was pushed back one quarter to Q4 2026 because the company needs additional positive subjects with significant polyps, increasing development and timing risk despite management’s confidence in the second-generation platform.
  • Positive Sentiment: Management expects second-half 2026 revenue to exceed first-half revenue, with Q4 typically the strongest quarter due to seasonality. The company ended Q2 with $9.1 million in cash and has access to a $100 million at-the-market equity program, providing additional funding flexibility.
AI Generated. May Contain Errors.
Earnings Conference Call
CapsoVision Q2 2026
00:00 / 00:00

Transcript Sections

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Operator

I will now hand the conference over to Leigh Salvo, Investor Relations. Please go ahead.

Leigh Salvo
Leigh Salvo
Investor Relations at CapsoVision

Thank you, operator. Good afternoon, everyone, and thank you for joining us for CapsoVision's Q2 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.

Leigh Salvo
Leigh Salvo
Investor Relations 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 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?

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Thank you, Leigh, and good afternoon, everyone. The Q2 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 30 June, 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.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

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.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

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.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

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 Q3, 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.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

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 Q4 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.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

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.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

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.

David Garcia
David Garcia
SVP of Finance at CapsoVision

Thank you, Johnny. Turning to our commercial performance, we are pleased with the continued momentum in the business during the Q2. 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 Q2, 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.

David Garcia
David Garcia
SVP of Finance at CapsoVision

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.

David Garcia
David Garcia
SVP of Finance at CapsoVision

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, Q2 revenue was $3.6 million, an increase of approximately 10% from $3.3 million in the Q2 of 2025.

David Garcia
David Garcia
SVP of Finance at CapsoVision

The increase was driven by a 13% year-over-year increase in the number of CapsoCam Plus capsules sold, partially offset by an approximately 3% decrease in the average selling price. We were pleased to deliver this growth while continuing to expand our presence across both existing and new customer accounts. Gross profit for the quarter was $1.9 million, compared with $1.8 million in the prior year period. Gross margin was 51%, compared with 55% in the Q2 of 2025. The change in gross margin primarily reflected pricing pressure in a competitive market, as well as higher customs and tariff expenses resulting from changes in U.S. trade policies earlier this year. Operating expenses were $9.5 million, compared with $6.5 million in the Q2 of 2025.

David Garcia
David Garcia
SVP of Finance at CapsoVision

The increase primarily reflects our continued investment in product and clinical development, including expenses associated with our colon pivotal study and other clinical trials, non-recurring engineering work related to our colon development program, as well as the incremental costs associated with operating as a public company and stock-based compensation expense. These investments support the programs Johnny discussed earlier and reflect our continued focus on advancing the pipeline while building the commercial foundation for long-term growth. We ended the Q2 with $9.1 million in cash and cash equivalents. As a reminder, during the Q1, we raised $14 million in gross proceeds through a private placement with new and existing investors. More recently, we established an at-the-market equity offering program of up to $100 million with Cantor Fitzgerald, providing us with additional financial flexibility as we continue investing in our commercial organization, product development, and clinical programs.

David Garcia
David Garcia
SVP of Finance at CapsoVision

Importantly, the ATM provides us with flexibility to access additional capital opportunistically based on market conditions and the needs of the business. As we look to the remainder of 2026, we continue to be encouraged by the underlying trends in the business. We expect continued commercial momentum in the second half of the year, supported by expanded adoption of CapsoCam Plus, continued engagement across larger hospital GI networks, the international availability of AI Highlights, and following anticipated FDA clearance, its commercial introduction in the United States. As such, we expect revenue in the second half of the year to be higher than in the first half. We also continue investing in the programs we believe can drive CapsoVision's longer-term growth, including CapsoCam Colon and our broader pipeline of capsule-based diagnostic applications. With that, 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. As we look ahead, we believe CapsoVision is entering an important period with growing commercial adoption, the international launch of AI Highlights, the anticipated U.S. launch following FDA clearance, and the continued progress across our broader pipeline. We remain focused on building on this momentum and advancing our vision of an integrated AI-enabled capsule platform that can address a growing range of gastrointestinal diseases. With that, Dave, Doug, and I would be happy to take your questions. Operator, please open the line.

Operator

Thank you. We will now begin the question-and-answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Your first question comes from Bruce Jackson from StoneX. Please go ahead.

Bruce Jackson
Analyst at StoneX

Hi. Good afternoon, and congratulations on all of the progress you've made during the quarter. Two-part question. You mentioned that there was some pricing pressure and some tariff pressure. Can you tell us a little bit more about the source of the pricing pressure? Did it come from competitive types of influences, or are hospitals just becoming more cost-conscious? With regard to the tariffs, is this with the inbound raw material costs or is it with the outbound sales that you're feeling the tariff pressure?

David Garcia
David Garcia
SVP of Finance at CapsoVision

Thank you, Bruce. This is Dave. I'll take that. In terms of the first part of your question, the competitive pressure, yeah. We do have one particular competitor that we go up against, and we just see that pressure, and that impacted us a little bit in the quarter. The second part of your question about the tariffs, that's inbound. We saw a little bit of that impact as well in Q2.

Bruce Jackson
Analyst at StoneX

Okay. For my follow-up, given those conditions and looking at the second half cadence between the Q3 and the Q4, would we expect that the Q4 would be a little bit stronger than Q3?

David Garcia
David Garcia
SVP of Finance at CapsoVision

Yeah, that is correct. There is some seasonality that we see in this business. The Q4 tends to be the strongest quarter. When you look at the whole year, the second half ends up being much stronger than the first half.

Bruce Jackson
Analyst at StoneX

Okay, great.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Yeah. Bruce, this is Johnny. To complement what David mentioned, in order to keep this price, keep the margin, I think one of the things we need to do is to increase the value of our system, right? By launching the AI in the U.S., this should help with increase the value of our offering. Okay. Thank you.

Bruce Jackson
Analyst at StoneX

Thank you.

Operator

Our next question comes from Kyle Bauser from Titan Partners. Please go ahead.

Kyle Bauser
Analyst at Titan Partners

Great. Thanks. Hi, Johnny, Dave, and Doug. Thanks for all the updates. Maybe just on launching AI Highlights in the EU and international markets. Great to see this for the small bowel indication. It sounds like this is going to be pretty helpful for your launch in the U.S. to streamline physician review. But any initial feedback on this? It might be a little bit early, but would love to hear any thoughts that you've been able to capture since launching to international markets and the feedback.

Doug Atkinson
Doug Atkinson
SVP of Global Sales at CapsoVision

Kyle, that's a great question, and we're so excited at CapsoVision on the launch of AI Highlights internationally. Primarily looking at the EU. Looking at AI as a whole, it's a primary and important driver of adoption of capsule endoscopy. Why? Because it's going to make the physicians more efficient with reading. They'll be able to decrease the time it takes to read a capsule endoscopy study, thus being able to perform more studies. It's something that's being asked by our customers. How we are positioning the international launch is it's going to give us the opportunity to build real-world experience in using this exciting new platform that's been added to CapsoCloud and CapsoView.

Doug Atkinson
Doug Atkinson
SVP of Global Sales at CapsoVision

Over time, we believe the AI can help drive that broader platform of adoption, not only with customers that we currently have, but more so opening up additional doors that the competition may be in, but they do not have the AI platform that is going to really benefit us tremendously going into Q3, Q4, and then into 2027.

Kyle Bauser
Analyst at Titan Partners

Got it.

Doug Atkinson
Doug Atkinson
SVP of Global Sales at CapsoVision

The real key is going to be and how we are going to position the AI here in the U.S. come Q4, at the end of Q3, Q4 with marketing.

Kyle Bauser
Analyst at Titan Partners

Sure. Got it. I appreciate that. Then for my follow-up, maybe a two-part. On CapsoCam Colon for submission by Q4, can you talk about any sort of outstanding items that you are working on or need to be addressed before submitting? Just on housekeeping, I think you said 26 reps, seven regional managers, and of course your international commercial operations as well. How do we feel about these numbers going forward, or is it pretty good number for the foreseeable future? Thank you.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Yeah. This is Johnny Wang. I will take the question on the AI FDA clearance. The demographic analysis is something we are aware of. We feel that is the key thing we need to address based on the interaction with FDA. However, I have to say, no one can guarantee FDA approval, clearance. This one is beyond our control. Thank you. Yeah, Doug Atkinson.

Doug Atkinson
Doug Atkinson
SVP of Global Sales at CapsoVision

Then Kyle Bauser, also with regards to the sales force, we will continue to grow our sales force and add additional territories where I will be working with David Garcia on that. At this time, the luxury of having CapsoVision capsule endoscopy and selling multiple products for colon in the colon area as well as the small bowel diagnostic space, is that we have one sales force with one call point selling both products. So, we will expand where it makes sense. We see that our sales force growing over time. But at this time, we can utilize what we have, the feet on the street that we have and the management team in place.

Kyle Bauser
Analyst at Titan Partners

Makes sense. Okay, excellent. Thanks for all the updates, guys, and for taking my questions.

Doug Atkinson
Doug Atkinson
SVP of Global Sales at CapsoVision

Thank you.

Johnny Wang
Johnny Wang
President and CEO at CapsoVision

Thank you.

Executives
    • Leigh Salvo
      Leigh Salvo
      Investor Relations
    • Johnny Wang
      Johnny Wang
      President and CEO
    • David Garcia
      David Garcia
      SVP of Finance
    • Doug Atkinson
      Doug Atkinson
      SVP of Global Sales
Analysts
    • Bruce Jackson
      Analyst at StoneX
    • Kyle Bauser
      Analyst at Titan Partners
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