Revenue: As of FY2025, the actual value is USD 13.55 M.EPS: As of FY2025, the actual value is USD -1.03.<h4>Segment Revenue</h4><ul><li>CapsoCam Plus Revenue: CapsoVision, Inc. generated approximately $13.6 million in revenue from sales of CapsoCam Plus for the year ended December 31, 2025, compared to $11.8 million for the year ended December 31, 2024, representing an increase of approximately 15% over the prior year.</li><li>International Sales Percentage: In 2025, international sales accounted for 21% of total revenue, down from 23% in 2024.</li><li>International Sales Growth: International sales increased by 8% year-over-year.</li><li>U.S. Sales Growth: U.S. sales increased by 17% year-over-year.</li><li>Revenue from Reading Services: Revenue from remote capsule endoscopy reading services provided through board-certified physicians was $295 thousand for 2025 and $232 thousand for 2024.</li></ul><h4>Operational Metrics</h4><ul><li>Net Loss: CapsoVision, Inc. incurred a net loss of -$25.3 million for the year ended December 31, 2025, compared to -$19.9 million for the year ended December 31, 2024.</li><li>Accumulated Deficit: As of December 31, 2025, the accumulated deficit was -$155.7 million.</li><li>Costs of Revenue: Costs of revenue increased by $1.0 million, or 19%, to $6.4 million for the year ended December 31, 2025, from $5.4 million for the year ended December 31, 2024.</li><li>Gross Profit: Gross profit increased by $0.8 million, or 12%, to $7.2 million for the year ended December 31, 2025, from $6.4 million for the year ended December 31, 2024.</li><li>Gross Margin: The gross margin was 53% for the year ended December 31, 2025, and 54% for the year ended December 31, 2024.</li><li>Selling and Marketing Expenses: Selling and marketing expenses increased by $0.6 million, or 8%, to $7.5 million for the year ended December 31, 2025, from $7.0 million for the year ended December 31, 2024.</li><li>Research and Development Expenses: Research and development expenses increased by $3.2 million, or 21%, to $18.3 million for the year ended December 31, 2025, from $15.1 million for the year ended December 31, 2024.</li><li>General and Administrative Expenses: General and administrative expenses increased by $2.6 million, or 63%, to $6.8 million for the year ended December 31, 2025, from $4.2 million for the year ended December 31, 2024.</li><li>Operating Loss: The operating loss was -$25.5 million for the year ended December 31, 2025, compared to -$19.9 million for the year ended December 31, 2024.</li><li>Total Non-Operating Income, Net: Total non-operating income, net, was $0.2 million for the year ended December 31, 2025, compared to $30 thousand for the year ended December 31, 2024.</li><li>Loss Before Income Taxes: Loss before income taxes was -$25.3 million for the year ended December 31, 2025, compared to -$19.9 million for the year ended December 31, 2024.</li><li>Provision for Income Taxes: Provision for income taxes was $24 thousand for the year ended December 31, 2025, compared to $11 thousand for the year ended December 31, 2024.</li></ul><h4>Cash Flow</h4><ul><li>Cash and Cash Equivalents: As of December 31, 2025, CapsoVision, Inc. had $10.1 million in cash and cash equivalents, compared to $9.3 million as of December 31, 2024.</li><li>Net Cash Used in Operating Activities: Net cash used in operating activities was -$22.9 million for the year ended December 31, 2025, and -$20.1 million for the year ended December 31, 2024.</li><li>Net Cash Used in Investing Activities: Net cash used in investing activities was -$90 thousand for the year ended December 31, 2025, and -$153 thousand for the year ended December 31, 2024.</li><li>Net Cash Provided by Financing Activities: Net cash provided by financing activities was $23.6 million for the year ended December 31, 2025, and $15.1 million for the year ended December 31, 2024.</li><li>Net Increase (Decrease) in Cash and Cash Equivalents: Net increase in cash and cash equivalents was $650 thousand for the year ended December 31, 2025, compared to a decrease of -$5.2 million for the year ended December 31, 2024.</li></ul><h4>Unique Metrics</h4><ul><li>CapsoCam Plus Patients: As of December 31, 2025, CapsoCam Plus has been used in more than 161,000 patients.</li><li>Customer Retention Rate: The customer retention rate for 2025 was approximately 90%.</li><li>Accounts Receivable: The average accounts receivable balance for 2025 was $2.0 million, with 11% aged more than 60 days. As of December 31, 2025, one customer represented more than 10% of outstanding accounts receivable, totaling approximately $0.6 million.</li><li>Sales Employees: As of December 31, 2025, the company had 28 full-time sales employees, including 4 sales directors and 23 territory managers.</li><li>Exclusive Distributors: As of December 31, 2025, CapsoVision, Inc. had entered into distribution agreements with approximately 55 exclusive distributors for non-U.S. regions.</li><li>Non-U.S. Sales Revenue by Region (2025): European Union accounted for approximately 43%, South and Central America 9%, Asia 4%, Australia 3%, the Middle East 6%, and Africa 5% of total non-U.S. sales revenue.</li><li>Top Ten Distributors (Non-U.S.): Revenue from the top ten distributors accounted for approximately 72% of total non-U.S. sales revenue in 2025.</li><li>Provider Complaint Rate: For 2025, the provider complaint rate was approximately 2.5%, mainly due to patient failure to retrieve the capsule or correctly enter serial numbers/shipping labels.</li><li>Issued Patents: As of December 31, 2025, CapsoVision, Inc. had over 140 issued patents worldwide.</li><li>Employees: As of December 31, 2025, CapsoVision, Inc. had approximately 99 full-time employees.</li></ul><h4>Outlook / Guidance</h4>CapsoVision, Inc. expects to submit the 510(k) application for its second generation CapsoCam Colon capsule to the FDA in Q3 2026 and aims for FDA clearance for updated CapsoCam Plus with AI by mid-2026. The company plans to commercialize a capsule delivery device in Q4 2026 and seeks a tentative FDA 510(k) submission for a patency capsule by the end of Q2 2026. CapsoVision, Inc. will likely need additional capital-raising activities before year-end 2026 to fund operations and planned clinical studies, as its financial statements raise substantial doubt about its ability to continue as a going concern.

CapsoVision | 10-K: FY2025 Revenue: USD 13.55 M