Financial Data and Key Metrics Changes - In 2025, the company achieved total revenue of $534 million, reflecting a 15% growth over 2024, with adjusted EBITDA of nearly $62 million and cash generated of $45 million [5][29] - For Q4 2025, worldwide revenue reached $140.5 million, representing a growth of 13.1% on a reported basis and 12.1% on a constant currency basis compared to Q4 2024 [20][21] - Gross margin for Q4 2025 was 75%, an increase of 45 basis points from 2024, driven primarily by a favorable product mix [22][27] Business Line Data and Key Metrics Changes - The pain management franchise grew 24% in Q4 2025, driven by the adoption of the cryoSPHERE MAX device, with full-year growth of 33% [12][13] - Appendage management saw Q4 growth of 15% globally, with full-year growth of 19%, primarily driven by the AtriClip FLEX MINI and AtriClip PRO MINI devices [14][15] - Open ablation growth was over 17% for both Q4 and full year 2025, with the Encompass clamp being the primary contributor [16] Market Data and Key Metrics Changes - U.S. revenue grew 12.6% to $114.3 million in Q4 2025, supported by contributions from newer product launches [20] - International revenue totaled $26.2 million in Q4 2025, up 15.3% on a reported basis, although impacted by a decline in the UK due to funding uncertainties [21][22] - U.S. open ablation sales increased to $143.8 million, a 16.3% growth over 2024, driven by Encompass Clamp sales [25] Company Strategy and Development Direction - The company aims for sustained double-digit revenue growth, expanding profitability, and meaningful cash generation, reaffirming guidance for 2026 revenue growth of 12%-14% [6][30] - Strategic initiatives include advancing clinical trials like LEAPS and BOX X NoAF, which are expected to unlock significant market opportunities [8][12] - The company is focused on innovation, with plans to continue developing products that enhance surgical procedures and improve patient outcomes [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the competitive landscape, noting that new entrants validate the market and have previously led to increased revenue growth [39][40] - The company remains cautiously optimistic about the minimally invasive ablation and MIS appendage management markets, expecting a moderated decline in 2026 [30][32] - Management highlighted the importance of ongoing clinical trials and product innovation to maintain a leadership position in the market [42][73] Other Important Information - The company ended 2025 with $167.4 million in cash and investments, reflecting efficient capital management [29] - Adjusted EBITDA for the full year 2025 was $61.8 million, compared to $31.1 million in 2024, indicating significant improvement [29] - The company anticipates a net cash burn in Q1 2026, followed by positive cash generation for the remainder of the year [33] Q&A Session Summary Question: Impact of competitor entering the market - Management acknowledged the competitive entry as a validation of the market, noting it has previously led to increased revenue growth [39][40] Question: Update on LEAPS trial data - Management confirmed that the trial is ongoing and received positive feedback from the Data Safety Monitoring Board, but specific data release timelines were not provided [42][43] Question: Guidance considerations with new competition - Management indicated that the guidance for 2026 had already factored in potential competitive pressures, maintaining confidence in achieving 12%-14% growth [47][48] Question: Softness in U.S. minimally invasive clip business - Management noted a 6% decline in the minimally invasive clip segment, attributing it to variability in procedure growth and ongoing competitive pressures [49][50] Question: Revenue contribution from LEAPS trial - Management confirmed that they receive payment for devices used in the trial, but the overall impact on revenue during enrollment was minimal [53][55] Question: Future enhancements for Encompass - Management stated there are no immediate new product iterations planned for Encompass, focusing instead on market penetration and ongoing clinical trials [57][58] Question: Size of U.S. appendage management business in competition - Management provided insights into the market size and competitive dynamics, emphasizing their strong position in the valvular market [62][63]

Financial Data and Key Metrics Changes - In 2025, the company achieved total revenue of $534 million, reflecting a 15% growth over 2024, with adjusted EBITDA of nearly $62 million and cash generated of $45 million [4][23][27] - For Q4 2025, worldwide revenue reached $140.5 million, representing a growth of 13.1% on a reported basis and 12.1% on a constant currency basis compared to Q4 2024 [19][20] - Gross margin for the year ended at 75%, an increase of 29 basis points from 2024, driven by a favorable product mix and production efficiencies [25][26] Business Line Data and Key Metrics Changes - The pain management franchise grew 33% in 2025, with Q4 growth of 24%, driven by the adoption of the cryoSPHERE MAX device [12][11] - Appendage management saw a 19% growth for the year, with Q4 growth of 15%, primarily due to the AtriClip FLEX MINI and AtriClip PRO MINI devices [12][13] - Open ablation revenue increased by 16.3% to $143.8 million, largely attributed to the Encompass clamp [23][24] Market Data and Key Metrics Changes - U.S. revenue grew 13.7% to $435.4 million, while international sales increased by 20.2% on a reported basis to $99.2 million [23][25] - The UK market faced challenges due to funding and reimbursement uncertainties, impacting sales significantly in Q4 2025 [20][76] Company Strategy and Development Direction - The company aims for 12%-14% revenue growth in 2026, focusing on pain management, open appendage management, and open ablation as key growth drivers [5][28] - Strategic initiatives include the LEAPS and BOX X NoAF clinical trials, which are expected to unlock significant market opportunities [6][11] - The company is committed to continuous product innovation and has plans for new product launches, including the CryoXT device for pain management [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to maintain growth despite competitive pressures, highlighting the positive impact of new entrants in the market [37][39] - The company remains focused on operational excellence and is optimistic about achieving long-term financial targets, including a goal of $1 billion in revenue by 2030 [32][70] Other Important Information - The company ended 2025 with $167.4 million in cash and investments, reflecting efficient capital management [27] - Adjusted EBITDA for the full year was $61.8 million, compared to $31.1 million in 2024, indicating significant improvement [27] Q&A Session Summary Question: Comments on competitor entering the market - Management views the entry of competitors positively, as it validates the market and has historically led to increased revenue growth [37][39] Question: Update on LEAPS trial data - Management confirmed that the trial is ongoing and received positive feedback from the Data Safety Monitoring Board, but specific data release timelines were not provided [42][43] Question: Guidance for 2026 amidst competitive entry - The company has factored in competitive pressures into its guidance and remains confident in achieving 12%-14% growth [45][46] Question: Impact of LEAPS trial on AtriClip business - The company receives payment for devices used in the trial, but the overall impact on revenue during enrollment was minimal [51][52] Question: Future product iterations for Encompass - No new product iterations are planned for Encompass in the near term, but the company will continue to market and train surgeons on its benefits [54][56] Question: Impact of UK budget issues on international sales - The UK market faced significant impacts on pain management and minimally invasive ablation due to reimbursement changes, leading to a drop in sales [75][76]