CapsoVision (CV) 2026 年第二季法說會：營收成長 10%，AI 產品發布取得進展

重點摘要

• 2026 財年第二季營收年增 10% 至 360 萬美元，主因是 CapsoCam Plus 膠囊出貨量成長 13% 至 8,845 顆。
• 毛利率自 55% 下降至 51%，反映出競爭價格壓力以及進口關稅與海關費用增加。平均售價 (ASP) 下滑約 3%。
• 截至 6 月 30 日，全球已有超過 17.6 萬名患者使用 CapsoCam Plus 進行影像檢查，較去年同期的 14.3 萬多名成長 23%。
• CapsoVision 已於歐盟及其他國際市場推出 AI Highlights。管理層預計將在 2026 年第三季末前取得 FDA 許可，並在隨後於美國商業化推出，但同時指出無法保證一定能取得許可。
• 管理層預計 2026 年下半年營收將超過上半年。公司亦表示，第四季通常受惠於季節性因素，是該公司表現最強勁的季度。
• 由於 CapsoVision 加大對臨床試驗、產品開發及上市企業基礎設施的投資，營業費用增加至 950 萬美元。

關鍵財務數據

CapsoVision 還在第一季透過私募籌集了 1,400 萬美元的總收益。該公司隨後建立了一個高達 1 億美元的市價股票發行 (ATM) 計畫，以提供額外的融資靈活性。

業務與營運表現

大型腸胃科醫療網絡與醫院系統持續採用 CapsoCam Plus。該公司續簽了與明尼蘇達大學醫療中心、亨利福特醫療中心、科羅拉多大學醫療中心及普羅維登斯瑞典醫療中心的客戶合作關係。

在國際市場推出 AI Highlights 是第二季的重要里程碑。該軟體可自動識別包含疑似病變的畫面，並將其整理於結構化的審閱工作流程中。該軟體已與 CapsoView 及雲端平台 CapsoCloud 整合。

管理層表示早期的客戶回饋令人鼓舞。公司相信，AI 輔助審閱能減少醫師判讀時間、支援更多診察程序，並使旗下更廣泛的膠囊內視鏡平台脫穎而出。

CapsoVision 在本季末擁有 85 項已獲批的美國專利。其美國商業組織包含 26 名業務代表，並由 7 名區域業務經理與培訓人員提供支援。管理層預期將選擇性地擴充業務團隊，同時利用現有客戶關係推廣包括 CapsoCam Colon 在內的未來產品。

該公司還繼續招募患者參與 CapsoCam UGI 用於胰臟癌檢測的臨床研究。管理層形容該計畫仍處於早期階段，但收案進度正按計畫進行。

管理層業績展望

管理層預計 2026 年下半年的營收將高於上半年。此展望獲得 CapsoCam Plus 的進一步採用、與醫院及腸胃科網絡的合作、AI Highlights 的國際市場發售，以及在獲得 FDA 許可後潛在的美國上市支援。

該公司預計 AI Highlights 將在 2026 年第三季末前取得 FDA 許可，並在不久後進行商業推廣。管理層明確警告，無法保證一定能取得 FDA 許可。

CapsoVision 目前計畫在 2026 年第四季將其第二代大腸膠囊和 AI 模組提交 FDA 審查。時程推遲了一個季度，主因是在與 FDA 討論後，需要增加更多具顯著病變的受試者。

風險與關注事項

• 毛利率受到競爭、平均售價下跌約 3% 以及進口關稅費用增加的壓力。
• FDA 要求提供關於 AI Highlights 臨床數據集中人口統計代表性的額外資訊，帶來監管時程的不確定性。
• 大腸膠囊計畫提交 FDA 審查的時間推遲了一個季度，因為該研究需要更多具顯著病變的陽性受試者。
• 由於公司資助關鍵性及其他臨床試驗、一次性工程 (NRE) 費用、股份基礎給付以及上市企業成本，營業費用大幅增加。
• 市價股票發行 (ATM) 計畫提供了融資靈活性，但如果使用，可能會導致額外的股權發行。

分析師問答亮點

管理層將第二季的價格壓力歸因於來自主要對手的競爭。管理層指出，關稅影響來自進口成本而非出口銷售。執行長 Johnny Wong 補充表示，在美國推出 AI Highlights 可能提升公司產品的價值，並有助於維持價格與毛利率。

在營收節奏方面，管理層確認由於季節性因素，第四季通常強於第三季。因此，預計下半年的表現將明顯強於上半年。

商業長 Douglas Atkinson 表示，AI Highlights 在國際市場的推出將在預期的美國推廣前累積真實世界經驗。他還表示，現有的銷售團隊可以向相同的客戶群推廣小腸以及未來的產品，並在適當情況下擴展額外區域。

電話會議完整逐字稿

完整財報電話會議逐字稿

管理層陳述

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.

分析師問答

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.

[Call has ended.]