Anteris Technologies (NasdaqGM:AVR) FY Conference March 10, 2026 01:30 PM ET Company ParticipantsWayne Paterson - CEOConference Call ParticipantsMatt Miksic - Medical Supplies and Devices Research AnalystMatt MiksicWell, good afternoon, everybody. Thanks for joining us. Very pleased to have with us Anteris Technologies, Wayne Paterson, CEO and founder, and there's a number of other roles and adjectives that I put behind that. Advocates, you know, of what's become, you know, the one of the promising TAVR val ...

Anteris Technologies (NasdaqGM:AVR) FY Conference March 02, 2026 03:10 PM ET Company ParticipantsWayne Paterson - CEOConference Call ParticipantsJosh Jennings - Managing Director and Senior Research AnalystJosh JenningsGood afternoon. I'm Josh Jennings from the TD Cowen Medical Devices research team. We are excited to have the CEO of Anteris, Wayne Paterson, here in Boston live, for a fireside chat. Wayne, great to see you in person. Thank you for making the trip and participating in our conference.Wayne Pa ...

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Financial Data and Key Metrics Changes - The company reported a strong fourth quarter growth of 11.6% and a full year growth of 10.7% for 2025, driven by a differentiated strategy focused on structural heart solutions [4][5] - Total sales for Q4 reached $1.57 billion, with adjusted earnings per share (EPS) of $0.58, although this was lower than expected due to increased spending on patient access initiatives and a higher tax rate [18][19] - The adjusted gross profit margin for Q4 was 78.3%, slightly down from 79.0% year-over-year, attributed to higher manufacturing expenses related to new therapies [19][20] Business Line Data and Key Metrics Changes - TAVR global sales in Q4 were $1.16 billion, increasing by 10.6% year-over-year, reflecting strong procedural growth and stable pricing [8][9] - TMTT sales grew over 40% to $156 million in Q4, with full year sales exceeding $1 billion, driven by the adoption of PASCAL and EVOQUE therapies [13][14] - Surgical product group sales for Q4 were $254 million, a 2% increase year-over-year, with full year sales surpassing $1 billion [15][16] Market Data and Key Metrics Changes - The U.S. market saw a significant increase in TAVR procedures, driven by a shift towards proactive disease management and the introduction of new clinical guidelines [10][11] - In Europe, TAVR procedure growth was healthy, supported by updated guidelines that emphasize proactive management of severe aortic stenosis [11][12] - The company noted modest year-over-year share improvement in several key countries, strengthening its leadership position following a competitor's exit [12] Company Strategy and Development Direction - The company is focused on pioneering new therapies and expanding indications to address unmet patient needs, with a long-term sales growth expectation of 10% annually [7][8] - The strategy emphasizes the importance of generating world-class clinical evidence to differentiate its valve technologies and maintain clinician preference [7] - The company plans to invest in the development of safe and effective valve therapies, with a commitment to addressing structural heart diseases [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting 2026 sales growth guidance of 8%-10% and EPS guidance of $2.90-$3.05, citing strong momentum entering the new year [23][25] - The management highlighted the importance of the Early TAVR trial and long-term data in reinforcing confidence among physicians and patients [5][10] - The company anticipates a potential tailwind from an updated national coverage determination for TAVR later in the year, which could enhance patient access [10][46] Other Important Information - The company has approximately $3 billion in cash and cash equivalents and $2 billion remaining under its share repurchase authorization [22][66] - Increased SG&A spending in Q4 was intentional to support strategic investments in patient access and education initiatives [20][36] Q&A Session Summary Question: Insights on TAVR growth and market share - Management noted that TAVR growth of 10.6% was supported by compelling clinical evidence and a renewed focus on proactive treatment, with share gains attributed to the exit of a competitor [28][30][31] Question: Increased spending on market access - The increase in SG&A spending was planned to support strategic initiatives, with expectations for moderated growth in 2026 [34][36] Question: TAVR NCD and its impact - Management indicated that the reopening of the NCD process is crucial for improving patient access, with potential impacts expected more significantly in 2027 and beyond [46][47] Question: LAA market opportunity - The company sees significant unmet needs in the LAA market and plans to enter this space with differentiated technology [49][51] Question: M3 uptake and European guidelines - The SAPIEN M3 launch is progressing as expected, with positive outcomes reported, while European guidelines are shifting towards proactive management of mitral and tricuspid diseases [70][73]

Financial Data and Key Metrics Changes - The company reported total sales of $1.57 billion for Q4 2025, reflecting an 11.6% year-over-year growth, and a full-year growth of 10.7% [4][19] - Adjusted earnings per share (EPS) for Q4 was $0.58, while GAAP EPS was $0.11, impacted by one-time charges related to the GeneValve acquisition and litigation expenses [19][20] - The adjusted gross profit margin for Q4 was 78.3%, slightly down from 79.0% in the previous year, attributed to increased manufacturing expenses [20][21] Business Line Data and Key Metrics Changes - TAVR global sales reached $1.16 billion in Q4, growing 10.6% year-over-year, with procedural growth in the high single digits [9][10] - TMTT sales grew over 40% to $156 million in Q4, with full-year sales exceeding $1 billion [15] - Surgical product group sales were $254 million in Q4, a 2% increase year-over-year, with full-year sales surpassing $1 billion [17] Market Data and Key Metrics Changes - The U.S. market showed strong procedural growth for TAVR, driven by increased urgency in treating severe aortic stenosis patients [11][52] - In Europe, updated guidelines are reshaping clinical discussions and expanding the patient population eligible for TAVR [12][50] - The company noted modest year-over-year share improvement in several key countries, strengthening its leadership position [13] Company Strategy and Development Direction - The company is focused on structural heart solutions, aiming for 8%-10% sales growth in 2026 and a long-term average annual sales growth of 10% [6][9] - Plans include pioneering new therapies, launching next-generation technologies, and expanding indications to treat more patients [8][9] - The company is investing in patient access initiatives and partnerships, such as with the American Heart Association, to improve care for heart valve disease [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting 2026 sales and EPS guidance, citing strong Q4 performance and growth catalysts [25][26] - The company anticipates a potential tailwind from an updated national coverage determination for TAVR later in the year [7][36] - Management highlighted the importance of lifetime management in TAVR, emphasizing the shift towards earlier treatment of aortic stenosis [41][42] Other Important Information - The company maintains a strong balance sheet with approximately $3 billion in cash and cash equivalents [23] - There is approximately $2 billion remaining under the share repurchase authorization, with plans to continue repurchasing shares opportunistically [24][47] Q&A Session Summary Question: Insights on TAVR growth and market share - Management noted strong TAVR growth of 10.6% year-over-year, driven by compelling clinical evidence and a renewed focus on TAVR as a treatment option [28] Question: Increased spending on market access initiatives - The company increased SG&A spending by $112 million year-over-year to support strategic investments in patient access and education [30] Question: Impact of distributor inventory adjustments - The company clarified that the distributor adjustments in Q4 were specific to one country and did not significantly impact overall sales [55]

Financial Data and Key Metrics Changes - The company reported a delay in FDA approval by approximately one month due to a government shutdown, but European approval was achieved on time, and the paradigm study commenced largely as scheduled [46][47] - The cost structures are expected to reflect the scale-up into the study and the pathway to commercialization, with increased investments in R&D and manufacturing [47][48] - Access to capital has improved significantly with the company's data, transitioning from a penny dreadful to a legitimate multi-billion dollar product [48][52] Business Line Data and Key Metrics Changes - The company is focused on scaling up manufacturing and ensuring high-quality product delivery, with recent facility expansions tripling capacity [15][16] - The ADAPT process is highlighted for its unique anti-calcific response and improved patient outcomes, which is critical for clinical trials and production [12][13] Market Data and Key Metrics Changes - The company has seen a significant increase in liquidity, up 1,000%, following its listing on Nasdaq, which has improved access to capital [58] - The share price has been volatile, influenced by broader market trends, particularly in the MedTech sector, which has faced challenges [59][60] Company Strategy and Development Direction - The company aims to lead in the TAVR space by focusing on innovation and quality, with a commitment to patient outcomes and a strong corporate culture [4][5][6] - The management emphasizes the importance of quality and manufacturing processes to support the investment thesis and ensure successful commercialization [43][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting the importance of resilience and vision in navigating the complex healthcare landscape [7] - The company is positioned to lead the market, with competitors following its advancements in addressing aortic stenosis [44][45] Other Important Information - The company has expanded its distribution center significantly, preparing for increased volume in the upcoming months [33] - The leadership team includes experienced professionals from major global companies, enhancing the company's operational capabilities [43] Q&A Session Summary Question: What are the key milestones that support the investment thesis? - The integration of a team of leaders and experienced physicians has been crucial in achieving milestones, ensuring that the product meets market needs [76] Question: How does the company differentiate itself from competitors? - The company focuses on fundamentally different approaches to product development, aiming for significant improvements rather than incremental changes [70][71]

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