캡소비전(CV) 2026년 2분기 실적 발표회: 매출 10% 증가, AI 출시 진전

핵심 요약

• 2026년 2분기 매출은 캡소캠 플러스(CapsoCam Plus) 캡슐 출하량이 8,845개로 13% 증가함에 힘입어 전년 동기 대비 10% 증가한 360만 달러를 기록했다.
• 총마진은 경쟁적인 가격 인하 압박과 수입 관세 및 관세 비용 증가를 반영해 55%에서 51%로 하락했다. 평균 판매 가격(ASP)은 약 3% 감소했다.
• 6월 30일 기준 전 세계적으로 17만 6,000명 이상의 환자가 캡소캠 플러스로 촬영을 진행했으며, 이는 1년 전의 14만 3,000명 이상에서 23% 증가한 수치다.
• 캡소비전(CapsoVision)은 유럽연합(EU) 및 기타 글로벌 시장에서 AI 하이라이트(AI Highlights)를 출시했다. 경영진은 2026년 3분기 말까지 FDA 승인을 획득한 후 조만간 미국 상업 출시가 이어질 것으로 예상하지만, 승인이 보장되는 것은 아니라고 언급했다.
• 경영진은 2026년 하반기 매출이 상반기 매출을 상회할 것으로 전망했다. 또한 4분기가 일반적으로 계절성 수혜를 입는 회사의 가장 강력한 분기라고 덧붙였다.
• 캡소비전이 임상 시험, 제품 개발 및 상장사 인프라에 대한 투자를 늘림에 따라 영업 비용은 950만 달러로 증가했다.

주요 재무 데이터

캡소비전은 또한 1분기 사모 펀딩을 통해 1,400만 달러의 총 공모 금액을 조달했다. 이후 추가적인 자금 조달 유연성을 확보하기 위해 최대 1억 달러 규모의 장내 주식 발행(ATM) 프로그램을 마련했다.

사업 및 영업 실적

대형 소화기내과 네트워크 및 병원 시스템 전반에서 캡소캠 플러스의 도입이 지속되었다. 회사는 미네소타 대학교 메디컬 센터, 헨리 포드 메디컬 센터, 콜로라도 대학교 메디컬 센터, 프로비던스 스웨디시 메디컬 센터와의 고객 관계를 갱신했다.

AI 하이라이트의 글로벌 출시는 2분기의 주요 성과였다. 이 소프트웨어는 병변이 의심되는 프레임을 자동으로 식별하고 체계적인 검토 워크플로 내에서 이를 정리한다. 또한 캡소뷰(CapsoView) 및 클라우드 기반의 캡소클라우드(CapsoCloud) 플랫폼과 연동된다.

경영진은 초기 고객 피드백이 긍정적이라고 전했다. 회사는 AI 보조 검토가 의사의 판독 시간을 줄이고, 더 많은 시술을 지원하며, 전체 캡슐 내시경 플랫폼을 차별화할 수 있을 것으로 믿고 있다.

캡소비전은 분기 말 기준 85개의 미국 등록 특허를 보유했다. 미국의 상업 조직은 7명의 지역 영업 관리자 및 트레이너의 지원을 받는 26명의 영업 담당자로 구성되어 있다. 경영진은 캡소캠 콜론(CapsoCam Colon)을 포함한 향후 제품에 동일한 고객 관계를 활용하면서 영업 인력을 선별적으로 확장할 계획이다.

회사는 또한 췌장암 진단을 위한 캡소캠 UGI(CapsoCam UGI) 임상 연구의 환자 등록을 계속 진행했다. 경영진은 해당 프로그램이 초기 단계라고 설명했지만, 환자 모집은 계획대로 진행되고 있다고 밝혔다.

경영진 가이던스

경영진은 2026년 하반기 매출이 상반기 매출보다 높을 것으로 예상하고 있다. 이러한 전망은 캡소캠 플러스의 추가 도입, 병원 및 소화기내과 네트워크와의 협력, AI 하이라이트의 글로벌 출시, FDA 승인 후 미국 내 출시 가능성에 힘입은 것이다.

회사는 2026년 3분기 말까지 AI 하이라이트에 대한 FDA 승인을 기대하고 있으며, 그 직후 상업적 출시를 예상하고 있다. 다만 경영진은 FDA 승인이 보장될 수는 없다고 명확히 경고했다.

캡소비전은 이제 2026년 4분기 중 차세대 대장 캡슐 및 AI 모듈에 대한 FDA 심사를 신청할 계획이다. FDA와의 논의 이후 유의미한 병변을 가진 추가 피험자가 필요함에 따라 일정이 한 분기 연기되었다.

리스크 및 주요 점검 사항

• 총마진은 경쟁 심화, 평균 판매 가격의 약 3% 하락, 수입 관세 비용 증가로 인해 압박을 받았다.
• FDA가 AI 하이라이트의 임상 데이터 세트에 포함된 인구통계학적 대표성에 관한 추가 정보를 요청하면서 규제 관련 일정의 불확실성이 발생했다.
• 연구에서 유의미한 병변을 가진 양성 피험자가 더 필요했기 때문에 대장 프로그램의 FDA 제출 일정이 한 분기 연기되었다.
• 회사가 중대 임상 및 기타 임상 시험, 비반복적 엔지니어링(NRE) 작업, 주식 기반 보상, 상장사 관련 비용을 집행함에 따라 영업 비용이 크게 증가했다.
• 장내 주식 발행(ATM) 프로그램은 자금 조달의 유연성을 제공하지만, 활용될 경우 추가적인 신주 발행으로 이어질 수 있다.

애널리스트 Q&A 하이라이트

경영진은 2분기 가격 압박의 원인을 주요 경쟁사 1곳과의 경쟁 때문으로 돌렸다. 또한 관세 영향은 수출 매출이 아닌 수입 비용에서 발생했다고 밝혔다. 조니 웡(Johnny Wong) CEO는 미국 내 AI 하이라이트 출시가 제품군 가치를 높이고 가격 및 마진 방어에 도움이 될 수 있다고 덧붙였다.

매출 추세와 관련해 경영진은 계절성으로 인해 일반적으로 4분기가 3분기보다 호조를 보인다는 점을 확인했다. 이에 따라 하반기가 상반기보다 실질적으로 더 호조를 보일 것으로 예상하고 있다.

더글러스 애트킨슨(Douglas Atkinson) 최고상업책임자(CCO)는 글로벌 AI 하이라이트 출시를 통해 예정된 미국 출시에 앞서 실제 임상 경험을 축적할 수 있을 것이라고 말했다. 또한 기존 영업 조직이 동일한 고객층을 대상으로 소장용 제품 및 향후 대장용 제품 모두를 마케팅할 수 있으며, 적절한 경우 새로운 지역을 추가할 것이라고 설명했다.

실적 발표 전화회의 전체 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Hello everyone. Thank you for joining us and welcome to CAPS Ambition's second quarter 2026 earnings conference call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. I will now hand the conference over to Lee Salvo, Investor Relations. Please go ahead.

Unknown Speaker

you, Operator. Good afternoon, everyone, and thank you for joining us for Capital Vision's second quarter of 2026 earnings call. Joining me today are Johnny Wong, 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, I'd like to thank all of 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 to 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 Taxo Vision'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 for Johnny, David, and Doug to take the questions. With that, I'd like to turn the call over to Johnny Wong, CEO. Johnny?.

Unknown Speaker

Thank you, Lee, and good afternoon, everyone. The second quarter represented another period of steady progress for capital bridging. 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 extending adoption across larger hospital systems. the digital enteralogy networks, renew the key customer relationships, and the added new customers who recognize the value of our panoramic capsule platform. More importantly, we continue to see encouraging underlying utilization trends. close our installed base reinforcing the growing role of the capital 10 plus is playing in routine clinical practice. As of June 30, more than 176,000 patients worldwide have now been imaged using Capsule Can Plus. reflecting growth of 23% a year ago, and highlighting the continued adoption of our technology. 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 AR Highlights in the European Union and other international markets.

This launch represents an important milestone in the evolution of our AI-enabled platform. and the photos including of our capsule view software with AI analysis tools. and the types of cloud within the scope of our EU Quality Management System Certificate under the European Medical Device Regulation. both 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. AR Highlights is designed to streamline physician review by automatically identifying frames containing suspected pathology and presenting them within a structured workflow.

Unknown Speaker

Importantly, this capability is integrated across our broader software ecosystem. including CapsuleView and our cloud-based CapsuleCloud platform. which enables physicians to manage procedures and review and analyze test-tube chemplot studies through a flexible cloud-based environment. We believe bringing together panoramic capsule imaging, AI-assisted analysis, and And the cloud-based workflow represents an important competitive differentiator for capital vision. Rather than offering AI as a standalone feature, our goal is to provide physicians with an integrated platform that can make a 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 AR highlights in real world clinical practice as we prepare for commercial introduction in the United States. Many of our customers have also expressed a strong interest in the US launch of AI highlights. I would like to provide some additional perspective on the timing of our FDA review. As many of you know, we submitted our CitingK application for AI Highlights in December of last year.

During its review, USDA requested additional information regarding demographic representation within the clinical dataset supporting the submission. We have been working closely with the agency to address those requests. expect to obtain FDA clearance by the end of the third quarter. commercial launch expected to show to be thereafter We are confident that AI highlights will represent an important catalyst for our commercial business. And as we continue spending adoption of the Capsule 10 Plus platform. Turning to our broader development pipeline, we continue to make meaningful progress across multiple programs. So kept soaking cold and the run-up movement 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 to the need for more positive subjects with significant parties 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 capsocan 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 small ball imaging. we are building an integrated capsule endoscopy 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 As we enter the second half of 2026, we remain focused on delivering additional commercial momentum. By bringing new capabilities to physicians and patients around the world. We start our technical over to Dave to provide additional detail on our commercial performance and financial results.

David Garcia

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 CapsuleCam Plus, compared with more than 143,000 at the end of the year. of Q2 2025. During the second quarter, we shipped 8,845 CapsuCam 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 gastroenterology 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 University of Minnesota Medical Center, Henry Ford Medical Center, University of Colorado Medical Center. and Providence Swedish Medical Center, making CapsuleCam 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're also seeing meaningful interest from the US customers awaiting the availability of AI Highlights, and we believe its anticipated US launch represents an important opportunity to support further adoption of CapsuleCam 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 CapsuleCam Plus today represent the same customer base we expect to address with future products, including CapsuleCam 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. The increase was driven by a 13% year-over-year increase in the number of CapsuleCam 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 second quarter 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 second quarter of 2025.

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 canon development program, as well as the incremental costs associated with operating as a public company and stock-based companies. 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 second quarter with $9.1 million in cash and cash equivalents. As a reminder, during the first quarter, 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 Hunter Fitzgerald, providing us with additional financial flexibility as we continue investing in our commercial organization, product development, and clinical programs. 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+, continued engagement across larger hospital and GI networks, the international availability of AI highlights, and following anticipated FDA clearance, its commercial introduction to the AI. 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 CapsuleVision's longer-term growth, including CapsuleCam 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.

Unknown Speaker

Thanks, Dave. As we look ahead, we believe capsulovigin is entering an important period with growing commercial adoption. international launch of AI highlights, the anticipated US 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. 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 1 to raise your hand. To withdraw your question, press star 1 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.

질의응답

Bruce Jackson

Hi, good afternoon and congratulations on all of the progress you've made during the quarter. So, two-part question, you mentioned that there was some pricing pressure and some tariff pressure. So, can you tell us a little bit more about the source of the pricing pressure? You know, did it come from competitive type influences or are hospitals just becoming more cost conscious? And then 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

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

Bruce Jackson

well in Q2. Okay and then for my follow-up so given those conditions and looking at the second half cadence between the third quarter and the fourth quarter would we expect that the fourth quarter would be a little bit stronger than third quarter?.

David Garcia

Yes, that's correct. There is some seasonality that we see in this business. And the fourth quarter tends to be the strongest quarter. And then, so when you look at the whole year, the second half ends up being much more.

Unknown Speaker

stronger than the first half. Yes, so Bruce, this is Johnny. So, yes. To complement what Dave 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 to by launching the ai in the us this should help with the increase the value of our offering okay thank you.

Operator

Thank you. Our next question comes from Kyle Paulson from Titan Partners. Please go ahead.

Unknown Speaker

Great. Thanks. Hi, Johnny, Dave, and Doug. Thanks for all the updates. Maybe just on launching AI highlight in the EU and international markets, great to see this for the small bowel indication. So 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. you know, that you've been able to capture since launching to international markets and the feedback.

Douglas Atkinson

Yes, Kyle, that's a great question. And we're so excited at Capsule Vision on the launch of AI highlights internationally, primarily looking at the EU. Looking at AI as a whole, you know, 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. And it's something that's being asked for by our customers. How we are positioning the international launch is it's It's going to give us the opportunity to build real world experience in using this exciting new platform that's been added to Capsule Cloud and Capsule View. And 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 has. may be in, but they do not have the AI platform that's going to really benefit us tremendously going into Q3, Q4, and then into 2027.

But the real key is going to be, and how we're going to position the AI here in the United come Q4, at the end of Q3, Q4, with marketing. Sure.

Unknown Speaker

Got it, I appreciate that. And then for my follow-up, maybe a two-part. So on capital K and colon for submission by Q4, can you talk about any outstanding items that you're working on or need to be addressed before submitting, and then 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?.

Unknown Speaker

good number for the foreseeable future. Thank you. Yes, this is Johnny. I will take the question on the AI FDA clearance. So the demographic analysis is something we're aware of. We feel that is the key things we need to address. based on the interaction with FDA. However, I have to say no one can guarantee FDA approval or clearance. This one is beyond our.

Douglas Atkinson

Then, Kyle, also with regards to the sales force, so we will continue to grow our sales force and add additional territories where I'll be working with David on that at this time in the luxury of having capsule endoscopy and selling multiple products for colon in the colon area as well. as well as the small bowel diagnostic space, is that we have one sales force with one call point. selling both products. So, you know, we will expand where it makes sense. And 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 in the management team in place.

Unknown Speaker

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

Operator

Thank you. Thank you. Again, if you'd like to ask a question, please press star 1. There are no further questions at this time and this concludes today's call. Thank you for attending. You may now disconnect.

This live transcript is auto-generated without human intervention or review.

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