CapsoVision（CV）2026年第2四半期決算説明会：売上高10%増、AIローンチが進展

主な要約

• CapsoCam Plusカプセルの出荷数が13%増の8,845個に伸びたことが要因となり、2026年第2四半期の売上高は前年同期比10%増の360万ドルとなりました。
• 粗利益率は、競合による価格圧力や輸入関税・関税費用の増加を反映し、前年同期の55%から51%に低下しました。平均販売価格は約3%下落しました。
• 2026年6月30日時点で、世界中で17万6,000人以上の患者がCapsoCam Plusによる撮影を受けており、前年同期の14万3,000人超から23%増加しました。
• CapsoVisionは欧州連合（EU）およびその他の国際市場で「AI Highlights」の提供を開始しました。経営陣は2026年第3四半期末までにFDA（米食品医薬品局）の承認を取得し、その後まもなく米国での商業展開を開始すると見込んでいますが、承認が保証されているわけではないと注記しています。
• 経営陣は、2026年下半期の売上高が上半期を上回ると予想しています。また、第4四半期は通常、季節性の恩恵を受ける同社にとって最も好調な四半期であると述べています。
• CapsoVisionが臨床試験、製品開発、および上場企業としてのインフラへの投資を増やしたことにより、営業費用は950万ドルに増加しました。

主要財務データ

CapsoVisionはまた、第1四半期に第三者割当増資を通じて1,400万ドルの総手取金を調達しました。その後、資金調達の柔軟性をさらに高めるため、最大1億ドルのアット・ザ・マーケット（ATM）株式売り出しプログラムを設定しました。

事業および業績ハイライト

大規模な消化器科ネットワークや病院システムにおいて、CapsoCam Plusの導入が継続しました。同社は、ミネソタ大学医療センター、ヘンリー・フォード・メディカル・センター、コロラド大学医療センター、およびプロビデンス・スウェーディッシュ・メディカル・センターとの顧客関係を更新しました。

AI Highlightsの国際的なローンチは、第2四半期における主要なマイルストーンとなりました。このソフトウェアは、病変が疑われるフレームを自動的に特定し、構造化されたレビューワークフロー内に整理します。CapsoViewおよびクラウドベースのCapsoCloudプラットフォームと統合されています。

経営陣によると、初期の顧客からのフィードバックは好調です。同社は、AI支援による読影が医師の読影時間を短縮し、より多くの検査実施を後押しするとともに、自社の幅広いカプセル内視鏡プラットフォームの差別化につながると考えています。

CapsoVisionは、当四半期末時点で85件の取得済み米国特許を保有していました。米国の商業部門は、7人の地域セールスマネージャーとトレーナーに支えられた26人の営業担当者で構成されています。経営陣は、CapsoCam Colonを含む将来の製品に対しても同じ顧客関係を活用しつつ、営業組織を厳選して拡大する予定です。

同社はまた、膵臓がん検知を目的としたCapsoCam UGI臨床研究への患者登録を継続しました。経営陣はこのプログラムを初期段階と説明しつつも、患者の登録は計画通り進んでいると述べています。

業績予想（ガイダンス）

経営陣は、2026年下半期の売上高が上半期の売上高を上回ると見込んでいます。この見通しは、CapsoCam Plusのさらなる普及、病院および消化器科ネットワークとの連携、AI Highlightsの海外での利用可能化、ならびにFDA承認後の全米ローンチの可能性によって裏付けられています。

同社は、2026年第3四半期末までにAI HighlightsのFDA承認を取得し、その後まもなく商業展開を開始することを見込んでいます。ただし、経営陣はFDA承認が保証されるものではないことを明確に注意喚起しています。

CapsoVisionは現在、2026年第4四半期中に第2世代の大腸用カプセルおよびAIモジュールのFDA審査申請を行う計画です。FDAとの協議の結果、重大な病変を持つ追加の被験者が必要となったため、スケジュールが1四半期繰り延べられました。

リスクおよび注視事項

• 粗利益率は、競合関係、平均販売価格の約3%の下落、および輸入関税費用の増加による圧迫を受けました。
• FDAはAI Highlightsの臨床データセットにおける人口統計学的表現（被験者構成）に関する追加情報を要求しており、規制承認の時期に不確実性が生じています。
• 大腸プログラムのFDA申請は、研究において重大な病変を持つ陽性被験者がさらに必要となったため、1四半期後送りされました。
• 同社がピボタル（主要）臨床試験やその他の治験、一時的な開発費用（NRE費用）、株式報酬、上場企業関連コストに資金を充てたため、営業費用が大幅に増加しました。
• アット・ザ・マーケット（ATM）プログラムは資金調達の柔軟性を提供するものの、利用された場合には追加の新株発行につながる可能性があります。

アナリストQ&Aの要点

経営陣は、第2四半期の価格設定の圧力を1社の主要競合との競争に起因するものと説明しました。また、関税の影響は販売ではなく輸入コストによるものであると述べています。CEOのジョニー・ウォン（Johnny Wong）氏は、全米でのAI Highlightsの投入により同社の提供価値が高まり、価格設定および利益率の維持に貢献する可能性があると付け加えました。

売上推移について、経営陣は季節性の影響で第4四半期が第3四半期よりも全般的に好調であることを確認しました。そのため、下半期は上半期よりも大幅に伸びると予想しています。

最高商業責任者（CCO）のダグラス・アトキンソン（Douglas Atkinson）氏は、AI Highlightsの国際的なローンチが、計画している全米展開に先立ってリアルワールドでの実践経験をもたらすと述べました。同氏はまた、既存の営業組織は小腸用製品と将来の大腸用製品の両方を同じ顧客層に販売することができ、必要に応じて対象地域を追加できると述べました。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.

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