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The earnings call reflects a positive sentiment with reaffirmed revenue growth guidance, strong adoption of cryoSPHERE MAX, and significant growth potential in pain management. Despite challenges in the U.K. and APAC, other markets show strong growth. The Q&A reveals optimism with strong clinical outcomes and product adoption, despite some uncertainties. Given the market cap, the overall sentiment and strategic plans suggest a positive stock price movement of 2% to 8% over the next two weeks.
Worldwide Revenue $141.2 million in Q1 2026, up 14.3% year-over-year (12.8% on a constant currency basis). Growth driven by adoption of new products in the U.S. and globally.
U.S. Revenue $116.2 million in Q1 2026, a 14.9% increase year-over-year. Growth fueled by adoption of EnCompass clamp and AtriClip FLEX-Mini and PRO-Mini devices.
Open Ablation Product Sales (U.S.) $39.1 million in Q1 2026, up 17.3% year-over-year. Growth driven by adoption of EnCompass clamp across new and existing accounts.
Appendage Management Product Sales (U.S.) $48.4 million in Q1 2026, up 14.9% year-over-year. Growth driven by adoption of AtriClip FLEX-Mini and PRO-Mini devices.
MIS Ablation Sales (U.S.) $6.4 million in Q1 2026, a decline of approximately 25% year-over-year. Decline attributed to headwinds in the minimally invasive ablation franchise.
Pain Management Sales (U.S.) $22.4 million in Q1 2026, up 29.5% year-over-year. Growth led by cryoSPHERE MAX probe, contributing approximately 70% of pain management sales.
International Revenue $25 million in Q1 2026, up 11.5% year-over-year (3.3% on a constant currency basis). Growth tempered by uncertainty in the U.K. and lower distributor sales in Asia, offset by growth in other geographies.
European Sales $16.1 million in Q1 2026, up 13.2% year-over-year. Growth driven by adoption across franchises.
Asia Pacific and Other International Market Sales $8.9 million in Q1 2026, up 8.4% year-over-year. Growth offset by lower distributor sales in Asia.
Gross Margin 77.4% in Q1 2026, up 246 basis points year-over-year. Increase driven by favorable product and geographic mix.
Operating Expenses $108.8 million in Q1 2026, up 10.3% year-over-year. Increase due to rapid enrollment in BoxX-NoAF clinical trial and increased headcount for product development.
Adjusted EBITDA $17.1 million in Q1 2026, up 95% year-over-year. Growth reflects balanced capital allocation and improved profitability.
Net Income Approximately $100,000 in Q1 2026, compared to a net loss of $6.7 million in Q1 2025. Improvement driven by revenue growth and operational leverage.
Earnings Per Share (EPS) $0.00 in Q1 2026, compared to a loss of $0.14 per share in Q1 2025. Reflects improved financial performance.
Cash and Investments $146 million at the end of Q1 2026. Slightly improved cash burn compared to Q1 2025, with expectations for positive cash flow for the full year.
AtriClip FLEX-Mini and PRO-Mini devices: Strong adoption in the U.S. market, contributing significantly to appendage management revenue. FLEX-Mini accounted for approximately 40% of open appendage management revenue.
cryoSPHERE MAX probe: Primary driver of pain management sales, contributing roughly 70% of the segment's revenue. Recognized for time savings and clinical effectiveness.
cryoXT probe: Gaining traction for amputation procedures with positive feedback from surgeons. Expected to contribute more meaningfully in the latter half of 2026.
International expansion: Received CE Mark under EU MDR for AtriClip FLEX-Mini and PRO-Mini devices, with plans to launch in Europe later in 2026. Growth observed in Europe and Asia-Pacific regions despite some headwinds.
Revenue growth: Worldwide revenue reached $141.2 million in Q1 2026, a 14.3% increase year-over-year. U.S. revenue grew by 14.9%, driven by new product adoption.
Clinical trials: BoxX-NoAF trial enrollment is ahead of schedule, with approximately 300 patients enrolled. Expected to complete enrollment by the end of 2026, nearly a year ahead of plan.
Profitability: Adjusted EBITDA nearly doubled year-over-year to $17.1 million. Gross margin improved to 77.4%, driven by favorable product and geographic mix.
Focus on innovation: Continued investment in product development and clinical trials, including BoxX-NoAF and LeAAPS, to address unmet clinical needs and expand market opportunities.
Operational leverage: Disciplined cost management while accelerating R&D investments, particularly in clinical trials and product innovation.
Minimally Invasive Ablation Franchise: The minimally invasive ablation franchise faced headwinds in the first quarter, indicating challenges in adoption or market acceptance of this product line.
International Revenue Growth: International revenue growth was tempered by continued uncertainty in the U.K. and lower distributor sales in Asia, which could impact overall revenue performance in these regions.
Manufacturing Costs: The expansion of manufacturing facilities in the second half of 2026 is expected to increase manufacturing cost burden, potentially moderating gross margin improvements.
MIS Ablation Sales in the U.S.: U.S. MIS ablation sales declined approximately 25% compared to the first quarter of 2025, highlighting a significant challenge in this segment.
R&D Investment for BoxX-NoAF Clinical Trial: Accelerated enrollment in the BoxX-NoAF clinical trial has led to increased R&D investment, which could strain financial resources in the short term.
Revenue Guidance for 2026: The company expects full-year revenue of $600 million to $610 million, reflecting growth of approximately 12% to 14% over full-year 2025 results.
Revenue Drivers: Performance is expected to be driven by pain management, appendage management, and open ablation franchises, partially offset by headwinds in the MIS ablation franchise and certain international markets.
Second Quarter 2026 Revenue Expectations: Anticipates mid-single-digit sequential growth due to typical seasonality.
Gross Margin Outlook: Expects modest improvement in full-year 2026 gross margin over 2025, with favorable product and geographic mix in the near term. However, expanded manufacturing facilities in the second half of 2026 will increase manufacturing costs, moderating the full-year gross margin outlook.
Adjusted EBITDA Guidance for 2026: Reiterates expectations for full-year adjusted EBITDA of $80 million to $82 million.
Net Income and Earnings Per Share Guidance: Expects full-year net income translating to earnings per share of approximately $0.00 to $0.04 and adjusted earnings per share of approximately $0.09 to $0.15.
R&D Spending Outlook: Anticipates increased R&D spending over the next three quarters due to accelerated enrollment in the BoxX-NoAF clinical trial, with slightly higher R&D spending in the second half of 2026 compared to 2025.
BoxX-NoAF Clinical Trial: Enrollment is expected to complete around the end of 2026, nearly one year ahead of schedule, with significant R&D investment planned to support this acceleration.
Product Launches and Market Expansion: Plans to launch AtriClip FLEX-Mini and PRO-Mini devices in Europe later in 2026 following CE Mark approval. New product launches in the U.S., Europe, China, and Japan are expected to drive growth in the appendage management franchise.
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The earnings call reflects a positive sentiment with reaffirmed revenue growth guidance, strong adoption of cryoSPHERE MAX, and significant growth potential in pain management. Despite challenges in the U.K. and APAC, other markets show strong growth. The Q&A reveals optimism with strong clinical outcomes and product adoption, despite some uncertainties. Given the market cap, the overall sentiment and strategic plans suggest a positive stock price movement of 2% to 8% over the next two weeks.
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.
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