Financial Performance - For the year ended December 31, 2025, Artivion reported annual revenues of $441.3 million, a 14% increase from the prior year, with a 13% increase when excluding foreign exchange effects[262]. - Revenue from aortic stent grafts increased by 29% to $159.4 million, contributing 36% of total revenues in 2025[270]. - On-X product revenues rose by 21% to $101.7 million, accounting for 23% of total revenues[270]. - Surgical sealants revenue increased by 4% to $76.6 million, representing 17% of total revenues[270]. - Preservation services revenue decreased by 3% to $95.5 million, making up 22% of total revenues[270]. - The company reported a net income of $9.8 million for the year ended December 31, 2025[262]. - Total revenues for 2025 included a reduction of $2.3 million from Italian government payback reserves[270]. - Revenues from products increased by 19% for the year ended December 31, 2025, compared to 2024, driven by aortic stent grafts, On-X products, and surgical sealants[272]. - Revenues from aortic stent grafts increased by 29% for the year ended December 31, 2025, primarily due to an increase in volume of units sold[275]. - Revenues from On-X products increased by 21% for the year ended December 31, 2025, due to higher unit sales and average sales prices[278]. - Revenues from surgical sealants increased by 4% for the year ended December 31, 2025, attributed to higher average sales prices and volume sold[282]. - Other revenues decreased by 12% for the year ended December 31, 2025, primarily due to unfavorable impacts from Italian payback reserves[285]. - Revenues from tissue processing decreased by 3% for the year ended December 31, 2025, due to a backlog of tissues from a cybersecurity incident[289]. - Gross margin increased by 14% for the year ended December 31, 2025, with gross margin as a percentage of total revenues remaining at 64%[293]. Regulatory and Compliance Risks - The company is significantly dependent on revenues from tissue preservation services, which are subject to various regulatory risks[167]. - BioGlue is a significant revenue source, facing risks from competition and regulatory scrutiny due to its animal-derived components[169]. - The approval process for BioGlue in China took longer than expected, delaying revenue recognition until Q2 2025[172]. - Aortic stent grafts represent a significant revenue source, with risks related to market demand and regulatory approvals[173]. - Regulatory changes regarding tissue preservation could significantly reduce the supply of safe implantable human tissue, affecting revenues[168]. - The company is subject to stringent global quality and regulatory risks, including compliance with the European Union's Medical Device Regulation (MDR), which could delay or impede product commercialization[202]. - The transition to the MDR has faced significant challenges, including delays in audits and approvals, which may adversely affect the company's ability to supply products in certain jurisdictions[203]. - The company successfully renewed certain CE Marks under the MDR despite the extended timeline causing some MDD-based CE Marks to expire[204]. - Regulatory agencies may require changes to operations or issue product recalls, which could lead to increased scrutiny and impact business operations[203]. - The FDA's proposed reclassification of the CryoValve SG pulmonary heart valve to Class III could make its processing commercially infeasible, with a potential 30-month timeline to submit a PMA application[206][207]. - The company is subject to various healthcare compliance laws, and any violations could result in significant fines, penalties, and reputational harm[216][217]. - Increased environmental regulations regarding EtO and PFAS could impose significant compliance burdens and impact the company's ability to commercialize products[213][215]. Operational and Supply Chain Challenges - The company is exposed to public health crises, which can impact healthcare system capacity and demand for products[178]. - The global supply chain is vulnerable to disruptions from geopolitical and trade issues, particularly due to instability in Ukraine and the Middle East[181]. - The company faces intense competition from established medical device companies with greater resources, impacting its market position[164]. - The company relies on approximately 60 organ and tissue procurement organizations (OPOs) and tissue banks in the US for tissue donations, which are critical for its preservation services business[185]. - The company has three internal manufacturing facilities located in Austin, Texas; Hechingen, Germany; and Kennesaw, Georgia, with certain products manufactured by external suppliers[187]. - The company faces significant risks related to cybersecurity threats, having experienced a cybersecurity incident in Q4 2024 that disrupted operations and impacted revenue[198]. - The company has limited cyber-insurance coverage, which may not cover all potential events or financial losses associated with security breaches[200]. - The company continues to evaluate expansion through acquisitions and partnerships, which may carry significant risks and impact market value[190]. - The company faces challenges in attracting and retaining a specialized workforce, which is critical for its operations and future growth[189]. - The company may incur additional costs and risks associated with business development activities, including potential impairments and unfavorable financial adjustments[193]. Financial Position and Capital Management - The company has pledged substantially all of its US assets as collateral under its existing Credit Agreement, which could impact its ability to repay indebtedness if default occurs[229]. - The Cybersecurity Incident in Q4 2024 had a $4.6 million impact on the company's results for the year ended December 31, 2024, and a $4.3 million impact for the year ended December 31, 2025, net of recoveries of $3.2 million[244]. - The company has incurred expenses related to improving its global cybersecurity infrastructure following the Cybersecurity Incident, indicating ongoing investment in cybersecurity[243]. - The company may need to seek additional debt or equity financing to execute its strategic plan, but current levels of indebtedness could limit operational flexibility[228]. - Stockholder activism could disrupt the company's business and divert management's attention, potentially affecting business opportunities and stock price[230]. - As of December 31, 2025, total nominal indebtedness outstanding was approximately $220.0 million, with cash and cash equivalents of $64.9 million[308]. - The company entered into a credit agreement for $350.0 million, which includes a $190.0 million secured term loan facility and a $60.0 million revolving credit facility[311]. - As of December 31, 2025, Artivion's total assets increased to $884.8 million from $789.1 million in 2024, representing an increase of approximately 12.1%[356]. - The company's cash and cash equivalents rose to $64.9 million in 2025, up from $53.5 million in 2024, marking a growth of 21.9%[357]. - Trade receivables increased to $89.8 million in 2025, compared to $79.5 million in 2024, reflecting a growth of 12.9%[357]. - Inventories grew to $92.4 million in 2025, up from $79.8 million in 2024, indicating a rise of 15.8%[357]. - Deferred preservation costs reached $54.5 million in 2025, compared to $51.7 million in 2024, an increase of 5.5%[342]. - Total current liabilities increased to $101.6 million in 2025 from $66.8 million in 2024, a significant rise of 52.0%[359]. - Long-term debt decreased to $215.1 million in 2025 from $314.2 million in 2024, a reduction of 31.6%[359]. - Stockholders' equity increased to $448.2 million in 2025, up from $276.2 million in 2024, representing a growth of 62.2%[359]. Internal Controls and Audit - Artivion's internal controls over financial reporting were assessed as effective as of December 31, 2025, based on the COSO criteria[349]. - The independent auditor, Ernst & Young, issued an unqualified opinion on the effectiveness of Artivion's internal controls over financial reporting as of December 31, 2025[337].

Core Viewpoint - Artivion (AORT) reported quarterly earnings of $0.17 per share, exceeding the Zacks Consensus Estimate of $0.14 per share, compared to break-even earnings per share a year ago, indicating a positive earnings surprise of +21.43% [1] Financial Performance - The company posted revenues of $115.99 million for the quarter ended December 2025, which missed the Zacks Consensus Estimate by 1.07%, but showed an increase from year-ago revenues of $97.31 million [2] - Over the last four quarters, Artivion has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times as well [2] Stock Performance - Artivion shares have declined approximately 12.1% since the beginning of the year, while the S&P 500 has gained 1.4% [3] - The current Zacks Rank for Artivion is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.06 on revenues of $114.9 million, and for the current fiscal year, it is $0.66 on revenues of $492.45 million [7] - The estimate revisions trend for Artivion was mixed ahead of the earnings release, which could change following the recent report [6] Industry Context - The Medical - Instruments industry, to which Artivion belongs, is currently in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]

Financial Data and Key Metrics Changes - For the full year 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow while investing in future growth [5][17] - Total adjusted revenues for Q4 2025 were $118.3 million, up 18.5% compared to Q4 2024, with adjusted EBITDA increasing approximately 29% from $17.6 million to $22.7 million [16][17] - Adjusted EBITDA margin was 19.2% in Q4 2025, an improvement of approximately 110 basis points over the prior year [17] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 2025, driven by AMDS in the U.S. and strong international growth [6][20] - On-X revenues increased 24% year-over-year on a constant currency basis, supported by global market share gains and new U.S. market opportunities [7][8] - Tissue processing revenue increased 6% year-over-year, while BioGlue revenues were flat compared to the same period last year [8][20] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 2024 [21] - Gross margins were 63% in both 2025 and 2024, with the 2024 margin negatively impacted by an idle plant charge due to a cybersecurity incident [21] Company Strategy and Development Direction - The company plans to replicate its strategy by introducing additional stent graft products from Europe to the U.S. and Japan, aiming to expand its total addressable market [7] - Key growth drivers include AMDS commercialization in the U.S., On-X heart valve data, NEXUS PMA, and the ARTISAN IDE trial [33][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth strategies, anticipating continued double-digit revenue growth and EBITDA margin expansion [14][28] - The company expects constant currency growth between 10%-14% for the full year 2026, with specific growth rates for different product lines [25][27] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [18][19] - Free cash flow for the full year was approximately $1 million, despite significant investments in the business [24] Q&A Session Summary Question: Impact of Italian clawback on growth - Management clarified that the Italian payback was specific to the EMEA line and did not impact major product lines [39] Question: Sell-in versus sell-through for AMDS - Management noted that implantations are continuing to grow and emphasized the importance of positive first experiences for surgeons [42] Question: Progress on AMDS target accounts - Management indicated that they are in the early stages of account openings and expect significant growth in 2026 [46] Question: Market opportunity for NEXUS - Management described the NEXUS market as nascent, with a U.S. market opportunity of $150 million, and expressed confidence in gaining market share [50] Question: Pricing for AMDS and NEXUS - Management affirmed that the pricing assumptions for AMDS and NEXUS remain appropriate due to favorable reimbursement conditions [56] Question: CapEx plans for 2026 - Management indicated that the increased CapEx is primarily for capacity expansion for On-X and internal IT investments [75]

Financial Data and Key Metrics Changes - For the full year of 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow while investing significantly in future growth [5][15] - Total adjusted revenues for Q4 of 2025 were $118.3 million, up 18.5% compared to Q4 of 2024, with adjusted EBITDA increasing approximately 29% from $17.6 million to $22.7 million [15][16] - Adjusted EBITDA margin was 19.2% in Q4 of 2025, an improvement of approximately 110 basis points over the prior year [16] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 compared to the same period last year, driven by AMDS in the U.S. and strong international growth [6][19] - On-X revenues increased 24% year-over-year on a constant currency basis, supported by global market share gains and new U.S. market opportunities [7][8] - Tissue processing revenue increased 6% year-over-year on a constant currency basis, while BioGlue revenues were flat compared to the same period last year [8][19] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 of 2024 [20] - Q4 gross margins were 63% in both 2025 and 2024, with the 2024 gross margin negatively impacted by an idle plant charge due to a cybersecurity incident [20] Company Strategy and Development Direction - The company plans to replicate its proven strategy by introducing additional stent graft products already generating revenue in Europe to the U.S. and Japan, aiming to expand the total addressable market [7] - Future growth is expected to be driven by AMDS commercialization in the U.S., On-X heart valve data, NEXUS PMA, and the ARTISAN IDE trial [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion, with expectations for constant currency growth between 10%-14% for 2026 [23][26] - The company anticipates challenges in the second and third quarters of 2026 due to tougher comparisons and recovery of the tissue backlog [25] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [17][18] - Free cash flow for the full year was approximately $1 million, despite significant investments in the business [22] Q&A Session Summary Question: Impact of Italian clawback on growth - The Italian clawback was specific to the EMEA line and did not impact major product lines, thus not skewing growth rates [36][38] Question: Commentary on AMDS sell-in versus sell-through - Management does not typically break out details on AMDS revenue but noted that implantations are continuing to grow positively [40][41] Question: Progress on AMDS target accounts - The company is in the early stages of AMDS rollout, with significant opportunities to open new accounts and increase implants in existing accounts in 2026 [44][45] Question: Market opportunity for NEXUS - The NEXUS device is positioned in a nascent market with a $150 million U.S. opportunity, and the company believes it is well-positioned against competitors [46][48] Question: Pricing for AMDS and NEXUS - The company sees strong demand for AMDS and NEXUS at their current price points, supported by favorable reimbursement dynamics [54] Question: CapEx plans for 2026 - CapEx is expected to be approximately $50 million in 2026, primarily for capacity expansion and IT system improvements [71][72]

Artivion (NYSE:AORT) Q4 2025 Earnings call February 12, 2026 04:30 PM ET Speaker3Good afternoon, and welcome to the Artivion fourth quarter and year-end 2025 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference o ...

4Q 2025 Earnings Presentation February 12, 2026 1 © 2026 Artivion, Inc. FORWARD-LOOKING STATEMENT Statements made in this presentation that look forward in time or that express management's beliefs, expectations, or forecasts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include our beliefs and expectations about our future revenu ...

Financial Performance - GAAP revenue for Q4 2025 was $116.0 million, up from $97.3 million in Q4 2024, while full year GAAP revenue reached $441.3 million compared to $388.5 million in 2024[3]. - Adjusted revenue for Q4 2025 was $118.3 million, reflecting an 18% increase on an adjusted constant currency basis compared to Q4 2024, and full year adjusted revenue was $443.6 million, a 13% increase[3]. - GAAP net income for Q4 2025 was $2.4 million, or $0.05 per fully diluted share, compared to a net loss of $(16.5) million, or $(0.39) per fully diluted share in Q4 2024; full year net income was $9.8 million versus a net loss of $(13.4) million in 2024[3][8]. - Non-GAAP net income for Q4 2025 was $8.6 million, or $0.17 per fully diluted share, compared to $0.2 million, or $0.00 per fully diluted share in Q4 2024; full year non-GAAP net income was $29.7 million compared to $10.8 million in 2024[7][8]. - Adjusted EBITDA for Q4 2025 increased 29% to $22.7 million from $17.6 million in Q4 2024, and for the full year, adjusted EBITDA rose 26% to $89.6 million[3][5]. - Total revenues for the year ended December 31, 2025, increased to $441.33 million, up 13.5% from $388.54 million in 2024[29]. - Net income for the year ended December 31, 2025, was $9.77 million, compared to a net loss of $13.36 million in 2024[29]. - Total revenues for the three months ended December 31, 2025, were $118.305 million, an 18% increase from $99.840 million in the prior year[32]. - Adjusted EBITDA for the three months ended December 31, 2025, was $22.722 million, compared to $17.606 million in the same period of 2024[34]. - Adjusted net income for the year ended December 31, 2025, reached $29,741 million, compared to $10,768 million in 2024, reflecting a year-over-year increase of approximately 175%[36]. Revenue Growth - Stent grafts revenue grew by 44%, On-X by 25%, and preservation services by 6% in Q4 2025 compared to Q4 2024, driving overall revenue growth[5]. - North America contributed $221.742 million to total revenues for the year, a 12% increase from $197.724 million in the prior year[31]. - Aortic stent grafts generated $43.343 million in revenue for the three months ended December 31, 2025, up 36% from $31.987 million in the prior year[31]. - On-X products saw a revenue increase of 24%, reaching $27.797 million compared to $22.474 million in the previous year[31]. Future Projections - Artivion expects 2026 revenues to be between $486 million and $504 million, representing a growth of 10% to 14% on an adjusted constant currency basis compared to 2025[9]. - The company anticipates adjusted EBITDA growth of 18% to 22% for 2026, resulting in an expected range of $105 million to $110 million[9]. Expenses and Costs - Operating income for the year ended December 31, 2025, was $33.75 million, a decrease of 13.5% from $38.87 million in 2024[29]. - Research and development expenses for the year ended December 31, 2025, were $30.99 million, up from $28.45 million in 2024, indicating a growth of 8.9%[29]. - General, administrative, and marketing expenses for the three months ended December 31, 2025, were $56.841 million, up from $51.429 million in the prior year[34]. - The company incurred $3,484 million in amortization expenses for the three months ended December 31, 2025, down from $4,205 million in the same period of 2024[36]. - Business development, integration, and severance costs amounted to $5,151 million for the three months ended December 31, 2025, compared to $5,821 million in 2024[36]. Balance Sheet and Cash Flow - Cash and cash equivalents at the end of 2025 increased to $64.91 million, up from $53.46 million at the end of 2024[27]. - Total current assets rose to $358.08 million in 2025, compared to $290.08 million in 2024, reflecting a growth of 23.4%[23]. - Total liabilities decreased to $436.56 million in 2025 from $512.90 million in 2024, a reduction of 15.0%[25]. - The company’s total stockholders' equity increased to $448.23 million in 2025, up from $276.20 million in 2024, reflecting a growth of 62.2%[25]. - Free cash flows for the year ended December 31, 2025, were $839 thousand, a decrease from $11.048 million in 2024[34]. Clinical and Regulatory Developments - Positive clinical data from Endospan's NEXUS TRIOMPHE IDE trial showed 94% patient survival and 91% free from disabling stroke at one year post-treatment[6]. - The company filed the fourth and final module of the pre-market approval application (PMA) to the FDA for the AMDS Hybrid Prothesis[3]. Other Notable Events - The company experienced a cybersecurity incident with a net impact of $(2,880) million for the three months ended December 31, 2025, compared to a positive recovery of $4,583 million in the same period of 2024[36]. - The tax expense calculated at a 25% tax rate for adjusted income was $2,858 million for the three months ended December 31, 2025, compared to $66 million in 2024[36].

Core Insights - Artivion reported strong financial performance for the full year 2025, with adjusted revenue growth of 13% and adjusted EBITDA growth of 26% compared to 2024 [1][2] - The company expects continued growth in 2026, projecting revenues between $486 million and $504 million, representing a growth of 10% to 14% on an adjusted constant currency basis [1][3] Financial Performance - Fourth quarter 2025 total revenues were $116.0 million, up from $97.3 million in Q4 2024, with adjusted revenues of $118.3 million, an 18% increase on an adjusted constant currency basis [1][2] - For the full year 2025, total revenues reached $441.3 million, compared to $388.5 million in 2024, with adjusted revenues of $443.6 million, reflecting a 13% increase on an adjusted constant currency basis [1][3] - Non-GAAP net income for Q4 2025 was $8.6 million, or $0.17 per fully diluted share, compared to $0.2 million in Q4 2024 [1][2] - Full year 2025 non-GAAP net income was $29.7 million, or $0.63 per fully diluted share, compared to $10.8 million in 2024 [1][3] Product Performance - Revenue growth in Q4 2025 was driven by a 44% increase in stent grafts, a 25% increase in On-X mechanical heart valves, and a 6% increase in preservation services compared to Q4 2024 [1][2] - The company highlighted positive clinical data from Endospan's NEXUS TRIOMPHE IDE trial, showing 94% patient survival and 91% of patients free from disabling stroke at one year post-treatment [1][3] Future Outlook - Artivion anticipates adjusted EBITDA growth of 18% to 22% for the full year 2026, resulting in an expected range of $105 million to $110 million [2][3] - The company aims to maintain double-digit constant currency revenue growth and adjusted EBITDA growth at twice the pace of revenue growth over the long term [1][3]

Core Insights - Artivion, Inc. presented new clinical data from the NEXUS TRIOMPHE IDE trial and AMDS PERSEVERE IDE trial, showcasing high patient survival rates and low morbidity in patients with aortic disease [1][2]. NEXUS TRIOMPHE IDE Trial - The trial involved 94 patients, revealing a 94% survival rate from lesion-related death and 91% freedom from disabling stroke at one year post-treatment [2][3]. - 97% of patients were free from reintervention due to endoleaks, with no occurrences of renal failure and only one case of paraplegia reported [2][3]. - The patient cohort was classified as high risk for open surgery, with 40% in ASA risk class III and 57% in class IV [3]. AMDS PERSEVERE IDE Trial - The trial included 93 participants, demonstrating a 94% survival rate from lesion-related death and 91% freedom from disabling stroke at both one and two years [4][5]. - No reinterventions were required for device integrity loss, migration, or aortic rupture, and 97% of patients were free from reintervention due to endoleaks [4][5]. - The trial reported minimal additional mortality, with only four deaths due to unrelated causes, and a stable total aortic diameter with a mean change of less than 2mm [5][6]. Company Overview - Artivion, Inc. is focused on developing solutions for cardiac and vascular surgeons addressing aortic diseases, with a product portfolio that includes aortic stent grafts, surgical sealants, mechanical heart valves, and implantable tissues [8]. - The company markets its products in over 100 countries worldwide [8].

Core Viewpoint - Artivion, Inc. is set to release its fourth quarter 2025 financial results on February 12, 2026, after market close, followed by a teleconference to discuss the results [1]. Financial Results Announcement - The financial results will be released on February 12, 2026, after market close [1]. - A teleconference call and live webcast will take place at 4:30 p.m. ET on the same day, hosted by Pat Mackin, the Chairman, President, and CEO of Artivion [1]. Teleconference Details - To participate in the live teleconference, interested parties should dial 201-689-8261 a few minutes before the scheduled time [2]. - A replay of the teleconference will be available approximately one hour after the event, accessible by calling toll-free 877-660-6853 or 201-612-7415, with the conference number 13758212 [2]. Webcast and Earnings Release Access - The live webcast and its replay can be accessed through the Investors section of Artivion's website [3]. - A copy of the earnings press release, containing financial and statistical information for the quarter and full year, will also be available in the Investors section of the website [3]. Company Overview - Artivion, Inc. is headquartered in suburban Atlanta, Georgia, and focuses on developing solutions for cardiac and vascular surgeons dealing with aortic diseases [4]. - The company offers four major product groups: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues [4]. - Artivion markets its products in over 100 countries worldwide [4].