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The earnings call summary reveals strong financial performance, product development, and market expansion, particularly with the EnCompass Clamp and AtriClip devices. The Q&A section highlights challenges like U.K. budget issues but emphasizes strategic investments and clinical trials. Despite some softer Clip sales, the company's guidance remains optimistic, and increased R&D leverage is expected. The market cap suggests a moderate reaction, leading to a positive stock price movement prediction of 2% to 8% over the next two weeks.
Total Revenue $534 million, reflecting 15% growth over 2024. The growth was driven by newer product launches, continued adoption of therapies, and operational execution.
Adjusted EBITDA $61.8 million, an improvement of $30.6 million from 2024. This was due to operational leverage and favorable product mix.
Cash Generated $45 million in 2025. This reflects efficient capital management and financial flexibility.
Gross Margin 75%, an increase of 29 basis points from 2024. This was driven by favorable product mix and production efficiencies.
U.S. Revenue $435.4 million, a 13.7% increase over 2024. Growth was supported by product launches in pain management and open appendage management, and adoption of the EnCompass Clamp.
International Revenue $99.2 million, a 20.2% increase on a reported basis and 17.5% on a constant currency basis. Growth was robust across major regions except for the U.K., which faced funding and reimbursement challenges.
Pain Management Revenue $81.9 million in the U.S., a 32.5% increase over 2024. Growth was driven by the adoption of the cryoSPHERE MAX probe.
Open Ablation Revenue $143.8 million in the U.S., a 16.3% growth over 2024. Growth was driven by the EnCompass Clamp.
Open Appendage Management Revenue $178.1 million in the U.S., a 17.5% increase over 2024. Growth was driven by the adoption of the AtriClip FLEX-Mini device.
Minimally Invasive Ablation Revenue $31.5 million in the U.S., a 31.2% decline over 2024. The decline was due to the prioritization of PFA catheters over the company's devices.
New Product Launches: Launched cryoSPHERE MAX Probe, AtriClip FLEX-Mini device, AtriClip PRO Mini, and cryoXT PRO in 2025. These products contributed to revenue growth and operational improvements.
Product Development: Advanced development of dual energy EnCompass Clamp, combining RF ablation and PFA for improved speed and flexibility. Completed first-in-human treatments in December 2025.
Market Expansion: Achieved 15% revenue growth in 2025, driven by product launches and adoption. Expanded U.S. accounts for cryoSPHERE MAX to 500 and EnCompass Clamp to 830 accounts globally.
International Growth: International revenue grew 20.2% in 2025, with strong performance in appendage management and open ablation franchises. However, U.K. sales declined due to NHS funding issues.
Operational Efficiencies: Improved gross margin to 75% in 2025 due to favorable product mix and production efficiencies. SG&A expenses grew below revenue growth, showing leverage.
Clinical Trials: Completed enrollment for LeAAPS trial with 6,500 patients and initiated BoxX-NoAF trial for reducing postoperative Afib. Progressed on site initiation and enrollment for BoxX-NoAF.
Strategic Shifts: Focused on preventative treatment of Afib and related complications through clinical trials (LeAAPS and BoxX-NoAF). Shifted towards building standards of care in cardiac surgery and pain management.
Hybrid AF Therapy: Faced challenges in minimally invasive Afib treatment due to PFA catheter adoption. Committed to stabilizing and scaling Hybrid AF therapy for advanced Afib patients.
Regulatory and reimbursement uncertainty in the U.K.: The decline in sales in the U.K. due to ongoing funding and reimbursement uncertainty with the National Health Service impacted international revenue growth in the fourth quarter of 2025.
Pressure on minimally invasive ablation and MIS appendage management: The Hybrid AF therapy faced significant headwinds due to the dominance of PFA catheters in the U.S., leading to a 31.2% decline in U.S. MIS revenue in 2025. This trend is expected to continue in 2026, albeit at a moderated rate.
Postoperative Afib complications: Up to 50% of cardiac surgery patients without preexisting Afib develop postoperative Afib, leading to worse clinical outcomes and higher healthcare costs, estimated at over $2 billion annually in the U.S.
Underpenetration of pre-op Afib treatment: Despite the EnCompass Clamp's success, the treatment of pre-op Afib patients undergoing cardiac surgery remains vastly underpenetrated, representing a missed opportunity for growth.
Dependence on clinical trial outcomes: The success of key clinical trials like LeAAPS and BoxX-NoAF is critical for market expansion and future growth. Delays or unfavorable outcomes could adversely impact strategic objectives.
Market competition in Hybrid AF therapy: The Hybrid AF therapy is under pressure from competing PFA catheter technologies, which dominate the standalone Afib treatment market, creating challenges for adoption and revenue growth.
2026 Revenue Growth: Reaffirmed guidance for 2026 revenue growth of 12% to 14%, translating to $600 million to $610 million in revenue.
Pain Management Growth: Anticipated to lead growth in 2026, driven by cryoSPHERE MAX and cryoXT devices, with cryoXT expected to contribute more meaningfully in the back half of 2026.
Open Appendage Management and Open Ablation Growth: Expected to grow in line with the overall guidance range of 12% to 14%.
Minimally Invasive Ablation and MIS Appendage Management: Expected to decline in revenue in 2026, but at a moderated rate compared to 2025.
Geographic Growth: Both U.S. and international businesses expected to deliver growth at more closely aligned rates, with ongoing uncertainty in the U.K. market.
Gross Margin Expansion: Modest gross margin expansion expected in 2026 due to product and geographic mix and cost savings initiatives.
Operating Expenses: R&D expenses projected to grow in low teens on an organic basis and mid-teens factoring in PFA milestone payments. SG&A spending expected to grow below top-line growth rates.
Adjusted EBITDA and Net Income: Reaffirmed 2026 adjusted EBITDA guidance of $80 million to $82 million and full-year net income, with adjusted earnings per share of $0.09 to $0.15.
Cash Generation: Anticipates positive cash generation for 2026, with a net cash burn in Q1 followed by positive cash generation for the remainder of the year.
Clinical Trials and Product Development: Plans to complete device and generate development for dual energy EnCompass Clamp in preparation for a clinical trial. BoxX-NoAF and LeAAPS trials to continue, with results awaited for LeAAPS.
Long-Term Financial Targets: Committed to double-digit revenue growth towards a $1 billion revenue goal by 2030, with over 20% adjusted EBITDA margin.
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The earnings call summary reveals strong financial performance, product development, and market expansion, particularly with the EnCompass Clamp and AtriClip devices. The Q&A section highlights challenges like U.K. budget issues but emphasizes strategic investments and clinical trials. Despite some softer Clip sales, the company's guidance remains optimistic, and increased R&D leverage is expected. The market cap suggests a moderate reaction, leading to a positive stock price movement prediction of 2% to 8% over the next two weeks.
The earnings call reflects strong product development, market expansion, and optimistic guidance, with new launches and international growth. Adjusted EBITDA guidance was raised, indicating financial health. The Q&A highlighted sustained growth in key segments and strategic focus on underpenetrated markets. While some uncertainties remain, the overall sentiment is positive, with a market cap indicating potential for significant stock movement.
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