Summary of Artivion Conference Call Company Overview - **Company**: Artivion - **Industry**: Medical Devices, specifically focusing on aortic technologies Key Points and Arguments Strategic Focus and Vision - Artivion has shifted its focus to cardiac and vascular surgeons treating the aorta, divesting non-aortic products to concentrate on unmet clinical needs in this area [2][3][5] - The company has made several strategic acquisitions over the past five years, including On-X, Jotec, and Ascyrus, to enhance its product offerings and address significant clinical challenges [3][5][6] Product Pipeline and Growth - Artivion has a robust pipeline with seven PMAs (Premarket Approvals) in progress, indicating a strong future growth trajectory without the immediate need for further acquisitions [9][10] - The company anticipates double-digit revenue growth and EBITDA growth at twice the rate of revenue for many years, with recent quarters showing even higher growth rates [15][17][40] AMDS Technology - The AMDS (Aortic Malperfusion Device System) is expected to expand the market for treating acute type A aortic dissections, potentially reducing mortality rates significantly [18][20] - AMDS is positioned to be used in a wider range of centers, which could lead to increased adoption and market expansion [18][20][21] Competitive Landscape - AMDS competes with existing technologies like the Frozen Elephant Trunk and hemianchor repair, but its ease of use and effectiveness may lead to broader adoption among surgeons [21][23] - The company aims to maintain a comprehensive aortic strategy by offering multiple treatment options, ensuring they meet diverse patient needs [23][24] Financial Performance and Projections - The mechanical heart valve business, particularly On-X, has seen significant growth, with recent quarters showing over 20% growth, driven by new clinical data demonstrating advantages over bioprosthetic valves [28][30][31] - The company expects gross margins to improve, with a target of reaching 70% in the long term, driven by the introduction of high-margin products [42][45] Operational and Financial Management - Artivion is focused on maintaining operational scalability to support growth, ensuring that infrastructure keeps pace with increasing demand for high-margin products [49][50] - The company has a solid cash flow management strategy, with priorities including funding for potential acquisitions and debt repayment [57] Market Dynamics and Reimbursement - The introduction of a new DRG (Diagnosis-Related Group) for complex aortic arch procedures is expected to facilitate AMDS adoption by improving reimbursement rates [27] - The company has successfully navigated previous reimbursement challenges, and the new DRG is seen as a positive development for market entry [27] Future Outlook - Artivion is optimistic about its growth prospects, with plans to train surgeons on AMDS and leverage new clinical data to drive market share [33][36] - The company is committed to a long-term growth strategy, focusing on innovation and customer needs in the aortic space [60][61] Additional Important Insights - The company has experienced a significant shift in its market positioning and is now seen as a leader in aortic technologies, with a clear focus on addressing critical clinical needs [1][2][60] - Artivion's management emphasizes the importance of aligning all teams towards a common goal of delivering innovative aortic solutions to improve patient outcomes [60][61]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $113.4 million, representing a 16% increase compared to Q3 2024 [15] - Adjusted EBITDA increased approximately 39% from $17.7 million to $24.6 million in Q3 2025 [15] - Adjusted EBITDA margin improved to 21.7%, a 320 basis point increase year-over-year [16] - Gross margins were 65.6% in Q3 2025, up from 63.7% in Q3 2024, reflecting a 200 basis point increase [17] Business Line Data and Key Metrics Changes - Stent Graft revenues grew 31% on a constant currency basis in Q3 2025 [16] - ON-X revenues increased by 23% year-over-year on a constant currency basis [16] - Tissue processing revenue rose 5% year-over-year on a constant currency basis [11] - BioGlue revenues grew 1% in Q3 compared to the same period last year [11] Market Data and Key Metrics Changes - Revenues in North America increased by 19% [16] - Asia-Pacific revenues grew by 18% [16] - EMEA revenues increased by 12% [16] - Latin America revenues rose by 10% [16] Company Strategy and Development Direction - The company aims to replicate its successful Stent Graft strategy in the U.S. and Japan, expanding its total addressable market [5] - The establishment of a new MS-DRG code for complex aortic procedures is expected to enhance the economic value proposition of AMDS [7] - The company is focused on advancing a robust pipeline of high-margin innovations, estimating a $1 billion incremental market opportunity over the next five-plus years [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth while growing adjusted EBITDA at twice the rate of revenue growth [15] - The company anticipates continued growth driven by AMDS, On-X heart valves, and the Nexus PMA [24] - Management highlighted the importance of new clinical data and reimbursement dynamics as tailwinds for growth [24] Other Important Information - The company expects to be slightly cash flow negative for the full year 2025 due to a one-time cash payment related to facility purchases [18] - As of September 30, 2025, the company had approximately $73.4 million in cash and $214.9 million in debt [19] Q&A Session Summary Question: What is the expected annualized cost for the Arcevo trial? - Management indicated that R&D funding is expected to be 7%-8% of sales annually, with a full year of trial costs anticipated in 2026 [27] Question: What is driving the growth of ON-X? - Management noted that growth is attributed to market share gains and new clinical data showing benefits of mechanical valves over bioprosthetic valves [29] Question: Can you elaborate on the new DRG and its economic implications? - Management explained that the new DRG reflects the high cost and complexity of advanced aortic arch procedures, which should alleviate previous economic challenges [31] Question: What is the expected market size for Arcevo? - The estimated market size for the frozen elephant trunk in the U.S. is about $80 million [38] Question: How is AMDS performing in terms of sell-through versus sell-in? - Management stated that revenue is currently weighted towards initial stocking, with increasing implantations expected [35] Question: What are the expectations for AMDS in international markets? - The company plans to pursue PMA approval in the U.S. before moving towards approvals in Japan and China [42]

Medical device company Artivion (NYSE:AORT) beat Wall Street’s revenue expectations in Q3 CY2025, with sales up 18.4% year on year to $113.4 million. The company’s full-year revenue guidance of $442 million at the midpoint came in 0.9% above analysts’ estimates. Its non-GAAP profit of $0.16 per share was in line with analysts’ consensus estimates. Is now the time to buy Artivion? Find out in our full research report. Artivion (AORT) Q3 CY2025 Highlights: Revenue: $113.4 million vs analyst estimates of $ ...

Investment Activity - Oppenheimer Asset Management Inc. purchased 21,513 shares of Artivion, Inc. valued at approximately $669,000, representing about 0.05% ownership at the end of the last quarter [2] - MCF Advisors LLC increased its holdings by 109.3%, now owning 1,176 shares worth $29,000 after buying an additional 614 shares [2] - Other institutional investors, including EntryPoint Capital LLC, Natixis Advisors LLC, and Zurcher Kantonalbank Zurich Cantonalbank, also increased their stakes in Artivion during the first quarter [2] Analyst Ratings - Citigroup maintained an "outperform" rating for Artivion [3] - Needham & Company raised the price target from $45.00 to $50.00 and assigned a "buy" rating [3] - The average rating for Artivion is "Moderate Buy" with a consensus target price of $43.97 [3] Stock Performance - Artivion's stock opened at $45.41, with a 52-week low of $21.97 and a high of $46.19 [4] - The company has a market capitalization of $2.14 billion and a PE ratio of -108.12 [4] Financial Results - Artivion reported $0.24 EPS for the last quarter, exceeding estimates of $0.11 by $0.13 [5] - Revenue for the quarter was $112.97 million, up 15.3% year-over-year, surpassing estimates of $107.96 million [5] - The company has set its FY 2025 guidance at EPS, with analysts forecasting $0.37 for the current fiscal year [5] Insider Transactions - SVP Jean F. Holloway sold 23,356 shares at an average price of $43.01, totaling approximately $1,004,541.56, reducing ownership by 11.95% [6] - SVP Marshall S. Stanton sold 18,200 shares at an average price of $44.02, totaling approximately $801,164.00, representing a 22.09% decrease in position [6] - Insiders have sold a total of 74,858 shares worth $3,250,129 over the last three months, with insiders owning 7.60% of the stock [6] Company Overview - Artivion, Inc. manufactures and distributes medical devices and implantable human tissues, including BioGlue and aortic arch stent grafts [8]

Summary of Artivion (NYSE:AORT) FY Conference Call - September 10, 2025 Company Overview - Artivion is focused on aorta-related medical devices, particularly heart valves for patients under 65 years old, and products for treating aortic aneurysms and dissections [4][5] - The company has a revenue guidance midpoint of $440 million for the year, with a 20% EBITDA margin [4] - Artivion aims for double-digit growth in sales and to grow EBITDA at twice the rate of sales [4][6] Financial Performance and Guidance - The company expects an acceleration in growth in the second half of 2025, driven by the launch of AMDS and easier comparisons due to a cyber attack in the previous year [6][7] - Historical EBITDA margin expansion of 200 to 300 basis points annually, with expectations for continued leverage in sales and marketing [7][8] - Current gross margin is approximately 65%, with AMDS expected to contribute significantly higher margins [8] Product Portfolio and Growth Drivers - The On-X mechanical valve business has seen durable growth, with a 22% increase worldwide, driven by positive clinical data and cross-selling opportunities [9][12] - AMDS is a new device for treating acute type A aortic dissection, showing promising clinical trial results with a mortality rate of 9.7% compared to a historical rate of 35% [16][14] - The Arsivo product, a third-generation frozen elephant trunk device, is set to begin trials, with expectations for FDA approval and expansion into the U.S. and Japan [23][24] Market Position and Competitive Advantage - Artivion emphasizes its focus on the aorta, with a pipeline of PMA-protected products and a strong market position [38][39] - The company has a competitive advantage in its technologies, with few competitors in each segment and high barriers to entry due to PMA requirements [41][42] - The company is confident in its ability to maintain and grow its market share, particularly with differentiated products [39][40] International Strategy and Market Expansion - Currently, Artivion's revenue is split 50-50 between international and U.S. markets, with plans to maximize U.S. growth while continuing to expand internationally [50][53] - The company has invested significantly in Asia and Latin America, with expectations for continued double-digit growth in international markets [51][54] Capital Allocation and Future Outlook - Artivion plans to allocate capital towards acquiring Endospan and paying down debt, with no immediate plans for share repurchases [35][36] - The company has a robust R&D pipeline with five PMAs in development, indicating a long-term growth trajectory [56][57] Key Takeaways - Artivion is positioned as a unique player in the aorta-focused medical device market, with strong financial health and growth potential [56][57] - The company’s focus on innovation and differentiation in its product offerings is expected to sustain its competitive edge and drive future growth [38][39]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $113 million, representing a year-over-year increase of over 14% compared to 2024 [17] - Adjusted EBITDA grew approximately 33% from $18.6 million to $24.8 million in Q2 2025 [17] - Adjusted EBITDA margin improved to 21.9%, reflecting a 300 basis point increase from the prior year [18] - Gross margins were 64.7% in Q2 2025, slightly up from 64.6% in 2024 [19] Business Line Data and Key Metrics Changes - On X revenue increased by 24% year-over-year on a constant currency basis [5] - Stent graft revenues grew by 22% on a constant currency basis [6] - BioGlue revenue grew by 4% year-over-year [10] - Tissue processing revenues increased by 3% year-over-year [10] Market Data and Key Metrics Changes - Revenues in North America increased by 18%, Asia Pacific by 15%, EMEA by 10%, and Latin America by 7%, all compared to 2024 [18] Company Strategy and Development Direction - The company is focused on expanding its addressable market through ongoing product launches, particularly the AMDS following FDA approval [4][12] - The strategy includes leveraging cross-selling opportunities and enhancing the product portfolio to drive growth [6][26] - The company aims to deliver sustainable double-digit revenue growth and drive EBITDA margin expansion [15][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth and expanding EBITDA margins, driven by strong product performance and market opportunities [15][26] - The company anticipates a full-year revenue growth rate of 12% to 14% for 2025, raising the midpoint of its guidance [22][23] - Management highlighted the positive reception of the AMDS launch and the potential for significant market opportunities [10][12] Other Important Information - The company successfully reduced its net leverage ratio from 4.1 to 2.2 by retiring convertible debt [21][22] - Free cash flow for Q2 2025 was $11.7 million, with expectations to remain positive for the full year [21][86] Q&A Session Summary Question: Update on AMDS and hospital adoption - Management noted that there are about 1,000 accounts capable of performing AMDS procedures, with ongoing training sessions leading to increased cross-selling opportunities [35][36] Question: BioGlue launch in China - Management indicated that BioGlue is expected to launch in the second half of 2025, with ongoing preparations [40] Question: Guidance dynamics and currency impact - Management explained that the guidance was adjusted due to strong Q2 performance and favorable currency movements, leading to an increase in revenue expectations [42][43] Question: Physician adoption of AMDS - Management reported positive feedback from physicians, noting that the device is simple to use and has been quickly integrated into practices [47][49] Question: Future expansion of the commercial team - Management stated that while they are evaluating expansion, the focus remains on the top 600 centers for the AMDS launch [54] Question: Next steps for Arecibo trial - Management confirmed that they expect to enroll the first patient in the Arecibo trial by the end of the year, pending hospital contracts and IRB approvals [57] Question: Pricing trends - Management indicated that there has been no significant price pressure, with modest inflationary price increases continuing [79] Question: Contribution of On X growth from cross-selling - Management acknowledged a meaningful uptick from new accounts, attributing growth to both cross-selling and new data [84]

Financial Performance and Guidance - Artivion reported approximately $400 million in revenue and around $70 million in EBITDA for FY24[4] - The company projects revenue between $423 million and $435 million for 2025, representing constant currency revenue growth of 11%-14% compared to 2024[3] - Artivion anticipates Adjusted EBITDA between $84 million and $91 million in 2025, a growth of 18-28% over 2024[3] - The company expects net debt leverage to decrease to below 20x by the end of 2025[3] Market Opportunities and Growth Strategy - Artivion is focused on driving sustained double-digit revenue growth and 2x+ EBITDA growth[3, 13] - The company estimates a total addressable market of approximately $4 billion for E-vita OPEN NEO, AMDS, NEXUS, E-nside, Artivex and E-tegra, with market growth rates between mid-single and mid-teen digits[3] - Mechanical Heart Valves (On-X) hold the 2 position with 34% market share in a $250 million global market[16] - Preservation Services (CryoValve® SG) holds the 1 position with 65% market share in a $150 million global market[16] - Surgical Sealant (BioGlue) holds the 2 position with 28% market share in a $260 million global market[16] Clinical Trial Data and Product Development - AMDS PERSEVERE US IDE study data demonstrates a significant reduction in Major Adverse Events (MAEs) at 30 days compared to the hemiarch control group (269% vs 580%)[38] - Endospan NEXUS ® TRIOMPHE US IDE Trial 30-day data demonstrates a 63% reduction in major adverse event (MAE) rate compared to the reference performance goal (130% vs 350%, p<0001)[41] - On-X Aortic Heart Valve Post Approval Study (PAS) shows a 66% reduction in major events and an 87% reduction in major bleeding compared to the PROACT IDE study[19]

Summary of Artivion (AORT) Conference Call Company Overview - **Company**: Artivion (AORT) - **Industry**: Medical Devices, specifically focused on aortic treatments Key Points and Arguments Market Potential and Growth Strategy - Artivion operates in multiple Total Addressable Markets (TAMs) that, while individually smaller, collectively provide a durable growth runway [2][4] - The company is focused on the aortic segment, particularly advanced stent grafts, with a global market for stents and stent grafts estimated at $4 billion, of which $2 billion is in advanced stent grafts [5][6] - Artivion's pipeline includes several products with upcoming PMA submissions, including AMDS, NexSys, and Arecibo, which are expected to contribute to growth every 18 months [9][10] Product Pipeline and Innovations - **AMDS**: Expected PMA approval by mid-2026, with a TAM of over $500 million [12][13] - **NexSys**: A pivotal trial with 60 patients showed promising results, with a focus on chronic dissections [32][33] - **Arecibo**: A product for total replacement of the aortic arch, with trials expected to start later this year [8] - The company has a unique patented technology for aortic dissection that significantly reduces mortality rates [15][16] Financial Performance and Projections - Artivion aims for EBITDA growth at twice the rate of top-line growth, driven by margin expansion and operational efficiencies [69][71] - The company has successfully reduced leverage and improved cash flow, with a focus on maintaining reasonable debt levels while funding growth initiatives [45][46] Sales and Market Penetration - The existing sales force is deemed adequate for launching new products, with no immediate plans for expansion [21][22] - The company is actively working with over 150 accounts to navigate hospital bureaucracy for product adoption [23][24] Risks and Challenges - The primary risk to growth acceleration is the timing of hospital bureaucracy related to product adoption [68] - The company experienced a cyber attack that impacted supply chains, but recovery is expected by the end of Q3 [63][66] Competitive Landscape - Artivion's On X mechanical valve has shown a 14% CAGR over the past eight years, with a TAM of $250 million [54] - Recent studies indicate a mortality benefit for mechanical valves, opening up additional market opportunities [58][61] Conclusion - Artivion is positioned for significant growth in the aortic medical device market, with a strong pipeline of innovative products and a focus on operational efficiency and margin expansion. The company is navigating challenges related to market entry and hospital adoption but remains optimistic about future performance.

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $99 million, representing a 4% increase compared to Q1 2024 [21] - Adjusted EBITDA increased approximately 1% from $17.3 million to $17.5 million in Q1 2025 [21] - Adjusted EBITDA margin was 17.7% in Q1 2025, relatively flat compared to Q1 2024 [22] - Gross margins decreased to 64.2% in Q1 2025 from 64.6% in Q1 2024 due to lower revenue from higher margin preservation services [23] Business Line Data and Key Metrics Changes - Strength graft revenues grew 19% on a constant currency basis in Q1 2025 compared to the same period last year [10] - On X revenue increased by 11% year over year on a constant currency basis [13] - BioGlue revenues grew 9% on a constant currency basis compared to the same period last year [14] - Tissue processing revenues declined 23% year over year on a constant currency basis due to the backlog caused by a cybersecurity incident [14] Market Data and Key Metrics Changes - Revenues in Latin America increased by 26%, EMEA increased by 14%, Asia Pacific increased by 8%, while North America declined by 6% compared to Q1 2024 [22] - Latin America and Asia Pacific delivered constant currency revenue growth of 268% respectively in Q1 2025 [15] Company Strategy and Development Direction - The company is focused on ramping up On X supply and clearing the tissue processing backlog, with expectations to fully catch up by the end of Q3 2025 [9][15] - The ongoing launch of AMDS in the U.S. is expected to penetrate a $150 million annual market opportunity [33] - The company aims to leverage positive clinical data to drive growth in the On X heart valve segment, targeting a $100 million market expansion opportunity [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth and twice that rate for EBITDA in 2025 [20][31] - The company anticipates strong revenue growth in the second half of 2025 due to ramping AMDS sales and an easier comparable in Q4 [28] - Management highlighted the positive reception from the clinical community regarding AMDS and the potential for significant market expansion [51] Other Important Information - The company incurred approximately $4.7 million in Q1 2025 associated with the cybersecurity incident, which is excluded from adjusted EBITDA [23] - The net leverage at the end of Q1 was 4.0, down from 4.5 in the prior year [26] - The company does not anticipate the need to raise additional capital to fund its debt obligations or investments in the foreseeable future [25] Q&A Session Summary Question: Contribution of AMDS to growth and onboarding of facilities - Management noted that AMDS contributed to the strong growth, but specific numbers were not disclosed. They are encouraged by the reception from the clinical community and the progress in onboarding facilities [38][40] Question: Tissue growth expectations for the year - Management expects to return to mid-single-digit growth for tissue processing for the full year, with the backlog being cleared by Q2 and Q3 [41][43] Question: Cash flow expectations for the year - Management expects to be free cash flow positive for the year, with Q1 typically being the worst quarter for cash flow due to seasonal expenses [53][54] Question: Growth rates for On X and stent grafts - Management expects On X to continue double-digit growth and stent grafts to grow at a mid-teens rate for the full year, with AMDS expected to improve overall growth rates by 1-2 percentage points [64] Question: Timing for acquiring Endospan - The option to acquire Endospan will trigger upon FDA approval, which is expected in the second half of 2026 [75] Question: Nexus data and its implications - Management expressed optimism about the Nexus data and its potential for FDA approval, which would trigger the acquisition option [76][81]

Financial Data and Key Metrics Changes - The company reported total revenues of $99 million for Q1 2025, reflecting a 4% increase compared to Q1 2024 [21] - Adjusted EBITDA increased approximately 1% from $17.3 million to $17.5 million in Q1 2025 [21] - Adjusted EBITDA margin was 17.7% in Q1 2025, relatively flat compared to Q1 2024 [22] - Gross margins decreased to 64.2% in Q1 2025 from 64.6% in Q1 2024 due to lower revenue from higher margin preservation services [23] Business Line Data and Key Metrics Changes - Strength graft revenues grew 19% on a constant currency basis in Q1 2025 compared to the same period last year [10] - On X revenue increased by 11% year over year on a constant currency basis [13] - BioGlue revenues grew 9% on a constant currency basis compared to the same period last year [14] - Tissue processing revenues declined 23% year over year on a constant currency basis due to the backlog caused by a cybersecurity incident [14] Market Data and Key Metrics Changes - Revenues in Latin America increased by 26%, EMEA increased by 14%, Asia Pacific increased by 8%, while North America declined by 6% compared to Q1 2024 [22] - Latin America and Asia Pacific delivered constant currency revenue growth of 268% respectively in Q1 2025 [15] Company Strategy and Development Direction - The company is focused on ramping up On X supply and clearing the tissue processing backlog, with expectations to be fully caught up by the end of Q3 2025 [9][15] - The ongoing launch of AMDS in the U.S. is a key growth driver, with approximately 150 facilities actively seeking IRB and Value Analysis Committee approvals [12][13] - The company aims to capitalize on the $100 million market expansion opportunity for mechanical valves based on new clinical data [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion [20] - The company raised its full-year 2025 revenue guidance to expect constant currency growth of between 11% to 14% [26] - Management noted that the unfavorable impact of preservation services in Q1 will be fully caught up by the end of Q3, with AMDS sales expected to grow sequentially each quarter [27] Other Important Information - The company incurred approximately $4.7 million in Q1 2025 associated with the cybersecurity incident, which is excluded from adjusted EBITDA [23] - The net leverage at the end of Q1 was 4.0, down from 4.5 in the prior year [26] Q&A Session Summary Question: Contribution of AMDS to growth and onboarding of facilities - Management indicated that AMDS contributed to the growth but did not break out specific numbers, and the onboarding of facilities is progressing well with a 100% hit rate on targeted accounts [39][41] Question: Tissue growth expectations for the year - Management expects tissue growth to return to mid-single digits for the full year, with the backlog from the cybersecurity incident being cleared [43][45] Question: Cash flow expectations for the year - Management anticipates being free cash flow positive for the year, with Q1 typically being the worst quarter for cash flow due to seasonal expenses [56][58] Question: Growth rates for On X and stent grafts - Management expects On X to continue double-digit growth and stent grafts to grow at a mid-teens rate, with AMDS expected to improve overall growth rates by 1-2 percentage points [66] Question: Timing for potential acquisition of Endospan - The option to acquire Endospan will trigger upon FDA approval, with a decision required within 90 days of approval [76][78] Question: Nexus data and its implications - Management expressed optimism about the Nexus data and its potential for FDA approval, which would trigger the acquisition option [76][80]