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    Earnings call· Jun 2026(Q2 FY26)

    CapsoVision Q2 FY26 earnings call CV

    Aug 13, 2026 Source

    Executive summary

    CapsoVision Q2 FY26 — Strong CapsoCam Plus Adoption and AI Highlights International Launch

    CapsoVision reported solid Q2 FY26 results, marked by robust adoption of its CapsoCam Plus platform and the international launch of AI Highlights. The company is navigating competitive pricing and increased operating expenses while advancing its pipeline, with key regulatory milestones for AI Highlights in the US and CapsoCam Colon anticipated in the coming quarters. Management expects stronger revenue in the second half of the fiscal year.

    Highlights

    5

    • Delivered 10% year-over-year revenue growth to $3.6 million.

    • CapsoCam Plus patient imaging grew 23% year-over-year to over 176,000 patients worldwide.

    • Successfully launched AI Highlights commercially in the European Union and other international markets.

    • CapsoCam Plus capsule shipments increased 13% year-over-year to 8,845 units.

    • Secured key customer renewals and added new accounts, strengthening market presence.

    Concerns

    5

    • Gross margin declined to 51% from 55% in Q2 FY25 due to pricing pressure and higher customs/tariff expenses.

    • Operating expenses increased significantly to $9.5 million from $6.5 million in Q2 FY25, driven by R&D and public company costs.

    • FDA clearance for AI Highlights in the US is delayed to end of Q3 FY26 due to requests for additional demographic data.

    • CapsoCam Colon FDA submission shifted by a quarter to Q4 FY26, requiring more positive subjects with significant polyps.

    • Experienced approximately 3% decrease in average selling price due to competitive market pressure.

    Guidance & targets

    5
    CategoryTargetConfidence
    AI Highlights FDA clearance
    By end of Q3 FY26
    high materiality
    High
    AI Highlights US commercial launch
    Shortly after Q3 FY26 FDA clearance
    high materiality
    High
    CapsoCam Colon FDA submission
    During Q4 FY26
    high materiality
    Medium
    H2 FY26 Revenue
    Higher than H1 FY26
    high materiality
    Medium
    Q4 FY26 Revenue vs Q3 FY26
    Stronger than Q3 FY26
    medium materiality
    Medium

    Operational metrics

    11
    Revenue growth
    10%YoY
    Q2 FY26

    Increase from $3.3 million in Q2 FY25.

    CapsoCam Plus patients imaged
    176,000Up 23% YoY
    as of June 30

    Compared with more than 143,000 at the end of Q2 2025.

    CapsoCam Plus capsules shipped
    8,845Up 13% YoY
    Q2 FY26

    Compared with 7,856 in the prior year period.

    Average selling price change
    -3%YoY
    Q2 FY26

    Partially offset revenue growth, due to pricing pressure in a competitive market.

    Gross margin
    51%Down from 55% in Q2 FY25
    Q2 FY26

    The change primarily reflected pricing pressure in a competitive market as well as higher customs and tariff expenses.

    Operating expenses
    $9.5MUp from $6.5M in Q2 FY25
    Q2 FY26

    Reflects continued investment in product and clinical development and costs associated with operating as a public company.

    Cash and cash equivalents
    $9.1MN/A
    Q2 FY26

    As of quarter end.

    Capital raised (private placement)
    $14MN/A
    Q1 FY26

    Gross proceeds raised through a private placement with new and existing investors.

    ATM equity offering program
    $100MN/A
    N/A

    Established with Cantor Fitzgerald, providing additional financial flexibility.

    Issued U.S. patents
    85N/A
    Q2 FY26

    As of quarter end, supporting the intellectual property portfolio.

    U.S. direct sales representatives
    26Consistent
    Q2 FY26

    Supported by 7 regional sales managers and trainers.

    Industry KPIs

    8
    MetricValueDetails
    Tariff impactImpacted gross margin
    System utilization—
    Pricing realized price-3%%
    New product launch rampAI Highlights
    Procedure volume growth23%%
    Sales force commercial capacity build26representatives
    Indicated addressable patient population—
    Pivotal trial clinical evidence milestonesCapsoCam Colon FDA submission

    Product announcements

    1
    ProductTypeDetails
    AI Highlightslaunch

    Risks & headwinds

    4
    Pricing pressure in a competitive marketQ2 FY26

    Approximately 3% decrease in average selling price; contributed to gross margin decline from 55% to 51%.

    Mitigation: Increasing value of system by launching AI in the U.S. to help with offering.

    Higher customs and tariff expensesQ2 FY26

    Contributed to gross margin decline from 55% to 51%.

    Mitigation: N/A (inbound tariffs from changes in U.S. trade policies earlier this year).

    Delay in FDA clearance for AI Highlights in the USQ3 FY26

    Expected clearance shifted to end of Q3 FY26.

    Mitigation: Working closely with the agency to address requests regarding demographic representation within the clinical dataset.

    Delay in CapsoCam Colon FDA submissionQ4 FY26

    Submission timing shifted by a quarter to Q4 FY26.

    Mitigation: Need for more positive subjects with significant polyps based on discussions with the FDA; taking time to deliver a highly differentiated platform.

    What to watch in Q3 FY26

    5

    AI Highlights US FDA Clearance

    End of Q3 FY26
    CurrentPending FDA review, additional demographic data requested
    TargetClearance obtained

    Why it matters

    FDA clearance is a critical catalyst for commercial introduction in the US, expected to drive further adoption and counter pricing pressure.

    We have been working closely with the agency to address those requests and expect to obtain FDA clearance by the end of the third quarter, with commercial launch expected shortly thereafter.

    Q&A highlights

    4

    What is the source of pricing pressure (competition vs. hospital cost-consciousness)? Are tariffs on inbound raw materials or outbound sales?

    Pricing pressure is primarily from a specific competitor. The tariff impact is due to inbound raw material costs.

    “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.”

    asked by Bruce Jackson · answered by David Garcia

    2 min read5 chapters

    Detailed Narrative

    01

    CapsoCam Plus Adoption & Utilization

    CapsoVision continues to see strong adoption of its CapsoCam Plus platform, with over 176,000 patients imaged worldwide as of June 30, a 23% increase year-over-year from 143,000 patients in Q2 2025. This growth is driven by continued utilization within the existing customer base and traction with new accounts, including key renewals with major medical centers like University of Minnesota Medical Center and Henry Ford Medical Center. The platform is now the #1 capsule used in hospitals in Washington state, highlighting its value and strong customer relationships.

    02

    AI Highlights International Launch & US Outlook

    The company successfully launched AI Highlights in the EU and other international markets, integrating AI analysis tools with CapsoView software and the CapsoCloud platform. These are classified as Class IIa medical devices in Europe, providing a regulatory foundation. Early customer feedback is encouraging, and the international launch is expected to provide valuable real-world experience ahead of the anticipated US commercial introduction in Q4 FY26, following expected FDA clearance by the end of Q3 FY26. This AI integration is seen as a key competitive differentiator.

    03

    CapsoCam Colon Development Progress

    Development of CapsoCam Colon, a second-generation capsule with an AI module, is progressing. The FDA submission is now expected in Q4 FY26, a quarter later than initially planned, to allow for the inclusion of more positive subjects with significant polyps in the clinical dataset, based on FDA discussions. This strategic delay aims to deliver a highly differentiated platform incorporating the latest imaging technology and AI capabilities for greater long-term commercial success.

    04

    CapsoCam UGI for Pancreatic Cancer

    The CapsoCam UGI clinical study, evaluating its potential for pancreatic cancer detection, is in early stages but enrollment is proceeding as planned. Management views this as a significant long-term opportunity, given the challenges of early pancreatic cancer detection and the potential for capsule endoscopy as a non-invasive diagnostic tool. This program highlights the versatility of CapsoVision's platform beyond small bowel imaging.

    05

    Financial Flexibility & Investment Strategy

    CapsoVision ended the quarter with $9.1 million in cash and cash equivalents. The company raised $14 million in Q1 FY26 through a private placement and established an at-the-market (ATM) equity offering program of up to $100 million with Cantor Fitzgerald. These measures provide financial flexibility to continue investing in commercial organization, product development, and clinical programs, supporting long-term growth initiatives and advancing the pipeline.

    AI-generated summary of the company’s earnings call. Not investment advice.