Core Insights - Artivion reported strong Q2 2025 results, with non-GAAP earnings per share of $0.24, significantly exceeding analyst estimates of approximately -$0.00 and up from $0.07 in Q2 2024, indicating a 243% year-over-year increase [1][2] - Revenue for Q2 2025 reached $113.0 million, surpassing the consensus estimate of $108.03 million and reflecting a 15% increase compared to the previous year [1][2] - The company raised its full-year 2025 revenue and adjusted EBITDA guidance, demonstrating confidence in its business trajectory and pipeline development [1][11] Financial Performance - Non-GAAP adjusted EBITDA for Q2 2025 was $24.8 million, a 33% increase from $18.6 million in Q2 2024 [2][8] - Free cash flow (non-GAAP) surged to $11.7 million from $3.6 million in Q2 2024, marking a 224% increase [2][8] - Net income flipped to a positive $1.3 million from a loss of $2.1 million in the prior year [2][8] Business Overview - Artivion specializes in cardiac and vascular surgical devices, including mechanical heart valves, aortic stent grafts, surgical sealants, and preservation services for transplant tissues [3] - The company focuses on innovation, investing heavily in new product development, particularly in aortic repair and advanced heart valves [4] Product Performance - The On-X mechanical heart valve line grew 24% on a constant currency basis compared to Q2 2024, supported by clinical trial data showing reduced major bleeding risk [6] - Aortic stent grafts segment posted 22% constant currency growth, indicating strong demand for these products [6] - BioGlue, a surgical sealant, grew 4% year-over-year, while preservation services for transplant tissue recovered 3% year-over-year [7] Regional Growth - Latin America achieved constant currency revenue growth of 26%, and Asia Pacific saw 8% growth, despite supply constraints [7] - North America rebounded with 18% growth after declines in Q1 2025, indicating broad multi-regional expansion [7] Strategic Initiatives - The U.S. launch of the AMDS hybrid prosthesis is progressing, with approximately 150 hospital accounts seeking necessary approvals [10] - The company achieved Investigational Device Exemption (IDE) approval from the FDA for the ARTIZEN trial, targeting long-term growth in aortic arch replacement devices [10] Future Guidance - Full-year 2025 revenue is now expected to be in the range of $435 million to $443 million, up from earlier guidance of $423 million to $435 million [11] - Adjusted EBITDA guidance was raised to $86 million to $91 million, reflecting confidence in operational recovery and margin expansion [11] - Segment guidance indicates mid-teens percentage growth for stent grafts and continued double-digit gains for On-X heart valves [11]

Financial Performance - Revenue for Q2 2025 reached $113 million, a 14% year-over-year constant currency growth[9] - Adjusted EBITDA for Q2 2025 was $24.8 million, a 33% year-over-year growth[9] - The company raised FY25 revenue guidance to a range of $435 to $443 million, representing 12% to 14% year-over-year constant currency growth[12] - FY25 adjusted EBITDA is expected to be in the range of $86 to $91 million, growing 21% to 28% over FY24[12] - The company effectively retired convertible senior notes due July 1, 2025, reducing net debt leverage to 2.2x EBITDA[13] Product & Geographic Growth - On-X product revenue grew 24% year-over-year in constant currency[10] - Aortic stent grafts revenue increased by 22% year-over-year in constant currency[10] - North America revenue grew by 18%, EMEA by 10%, APAC by 15%, and Latin America by 7% in constant currency[17] Clinical Studies & Approvals - The company received IDE approval from the U S FDA to initiate the Arcevo LSA pivotal trial, planning to enroll 132 patients[11] - Initial U S AMDS launch shows positive momentum with sequential sales growth expected each quarter in 2025 and PMA approval expected mid-2026[11] - AMDS use significantly lowers 30-day Major Adverse Events (MAEs) compared to hemiarch control group[21]

Company Information [Contacts](index=1&type=section&id=Contacts) This section provides investor relations contact information for Artivion, Inc., including Lance A. Berry, Executive Vice President and CFO, and Brian Johnston and Laine Morgan of Gilmartin Group LLC - Investor contacts: Lance A. Berry (Artivion Executive Vice President and CFO) and Brian Johnston / Laine Morgan (Gilmartin Group LLC)[1](index=1&type=chunk) Second Quarter 2025 Financial Performance [Executive Summary & Key Achievements](index=1&type=section&id=Executive%20Summary%20%26%20Key%20Achievements) Artivion demonstrated strong performance in Q2 2025 with **14% constant currency revenue growth** and **33% adjusted EBITDA growth**, advancing strategic initiatives and improving capital structure - The company achieved **14% constant currency revenue growth** and **33% adjusted EBITDA growth** in Q2 2025, demonstrating business scalability and EBITDA margin expansion[4](index=4&type=chunk) - Both On-X and stent graft product lines achieved **over 20% growth** at constant currency[5](index=5&type=chunk) - Received US FDA Investigational Device Exemption (IDE) approval to initiate the ARTIZEN pivotal trial, evaluating Arcevo LSA for treating acute and chronic aortic arch pathologies[5](index=5&type=chunk) - Successfully exited previously issued notes by converting **$99.5 million** of 2025 convertible senior notes due July 1 into common stock, significantly improving the capital structure[5](index=5&type=chunk)[6](index=6&type=chunk) 2025 Second Quarter Key Financial Metrics | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | YOY Growth (GAAP) | YOY Growth (Constant Currency) | | :------------------- | :--------------- | :--------------- | :--------------- | :------------------- | | Revenue | $113.0 | $98.0 | 15% | 14% | | Net Income | $1.3 | $(2.1) | - | - | | Diluted Net Income Per Share (USD) | $0.03 | $(0.05) | - | - | | Non-GAAP Net Income | $10.7 | $2.9 | - | - | | Non-GAAP Diluted Net Income Per Share (USD) | $0.24 | $0.07 | - | - | | Adjusted EBITDA | $24.8 | $18.6 | 33% | - | [Detailed Financial Results](index=5&type=section&id=Detailed%20Financial%20Results) Artivion achieved **$113 million** in total revenue for Q2 2025, a 15% year-over-year increase, with growth in product and preservation services revenue, a gross margin of **$73.1 million**, and a net profit of **$1.3 million** 2025 Second Quarter and First Half Consolidated Operating Results | Metric (Thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :--------------- | :--------------- | :----------- | :----------- | | Product Revenue | 87,444 | 73,210 | 166,242 | 144,324 | | Preservation Services Revenue | 25,528 | 24,809 | 45,708 | 51,126 | | **Total Revenue** | **112,972** | **98,019** | **211,950** | **195,450** | | Cost of Product Revenue | 28,315 | 24,545 | 53,578 | 48,295 | | Cost of Preservation Services Revenue | 11,545 | 10,150 | 21,683 | 20,885 | | **Total Cost of Revenue** | **39,860** | **34,695** | **75,261** | **69,180** | | **Gross Margin** | **73,112** | **63,324** | **136,689** | **126,270** | | Operating Expenses | 64,728 | 56,817 | 126,160 | 94,452 | | **Operating Income** | **8,384** | **6,507** | **10,529** | **31,818** | | Net Income (Loss) | 1,345 | (2,121) | 840 | 5,412 | | Diluted Net Income (Loss) Per Share (USD) | 0.03 | (0.05) | 0.02 | 0.13 | 2025 Financial Outlook [Updated Guidance](index=2&type=section&id=Updated%20Guidance) Artivion raised its full-year 2025 revenue and adjusted EBITDA guidance midpoints, reflecting strong Q2 performance and confidence in future growth, projecting **12% to 14%** constant currency revenue growth and **21% to 28%** adjusted EBITDA growth - The company raised the midpoints of its full-year 2025 revenue and adjusted EBITDA guidance, reflecting strong Q2 performance and greater confidence in the overall growth outlook[8](index=8&type=chunk)[9](index=9&type=chunk) 2025 Full-Year Financial Guidance | Metric | New Guidance (2025) | Old Guidance (2025) | Growth Rate (vs 2024) | | :------------------- | :--------------- | :--------------- | :------------------- | | Reported Revenue (Million USD) | $435 - $443 | $423 - $435 | - | | Constant Currency Revenue Growth | 12% - 14% | 11% - 14% | - | | Adjusted EBITDA (Million USD) | $86 - $91 | $84 - $91 | 21% - 28% | - Full-year 2025 foreign currency impact is expected to be approximately flat compared to 2024[8](index=8&type=chunk) Non-GAAP Financial Measures [Explanation of Non-GAAP Measures](index=2&type=section&id=Explanation%20of%20Non-GAAP%20Measures) This section explains Artivion's non-GAAP financial measures, which provide useful insights into operational performance by excluding non-recurring or non-cash items to better assess core business results - Non-GAAP financial measures include non-GAAP revenue, non-GAAP net income, EBITDA, adjusted EBITDA, non-GAAP general, administrative, and marketing expenses, and free cash flow[10](index=10&type=chunk) - The company uses non-GAAP measures for management review of operating performance and strategic planning, providing useful information on unusual non-operating transactions, operating expense structure, and excluding foreign currency fluctuations and non-cash compensation expenses[11](index=11&type=chunk) - Non-GAAP measures primarily exclude depreciation and amortization, interest income and expense, non-cash compensation expense, foreign currency revaluation gains and losses, income tax expense or benefit, business development, integration and severance expenses, debt inducement/extinguishment losses, non-cash interest expense, capital expenditures, and other non-recurring items[10](index=10&type=chunk) - The company does not provide a reconciliation of forward-looking adjusted EBITDA to comparable GAAP measures due to the inherent uncertainty and unpredictability of the impact and timing of these potential expenses or benefits[12](index=12&type=chunk) Corporate Information [Webcast and Conference Call Information](index=3&type=section&id=Webcast%20and%20Conference%20Call%20Information) Artivion will host a conference call and webcast on August 7, 2025, to discuss Q2 results, with replay information and access details provided - The company will host a conference call and webcast on **August 7, 2025, at 4:30 PM ET** to discuss results[13](index=13&type=chunk) - A replay of the conference call will be available approximately one hour after the event via phone or the investor section of the company's website[13](index=13&type=chunk)[14](index=14&type=chunk) [About Artivion, Inc.](index=3&type=section&id=About%20Artivion%2C%20Inc.) Artivion, Inc. is a medical device company based near Atlanta, focused on providing solutions for cardiac and vascular surgeons treating aortic diseases, with products sold in over 100 countries worldwide - Artivion, Inc. is a medical device company focused on developing solutions for the most challenging problems faced by cardiac and vascular surgeons in treating aortic diseases[15](index=15&type=chunk) - Key products include aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues[15](index=15&type=chunk) - Artivion's products are sold in **over 100 countries** worldwide[15](index=15&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, reflecting management's expectations for future performance, which are subject to various risks and uncertainties that may cause actual results to differ materially - Forward-looking statements include expectations for revenue, year-over-year growth, profitability, foreign currency impact, capital requirements, competitive advantages, product portfolio, business strategy, and full-year 2025 revenue and adjusted EBITDA guidance[16](index=16&type=chunk) - These statements are subject to various risks, uncertainties, estimates, and assumptions that could cause actual results to differ materially from current expectations[16](index=16&type=chunk) - Key risks include the timing and outcome of regulatory decisions, international operational risks, anticipated benefits of clinical trials and regulatory approvals, potential unknown impacts of the 2024 cybersecurity incident, and benefits of market expansion in Asia Pacific and Latin America[16](index=16&type=chunk) - The company does not undertake to update its forward-looking statements[16](index=16&type=chunk) Financial Statements [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) Artivion reported **$113 million** in total revenue for Q2 2025, a 15% year-over-year increase, with a net profit of **$1.3 million** and diluted EPS of **$0.03**, and **$212 million** in total revenue for the first half with **$0.84 million** net profit Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Thousand USD) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------------------- | :--------------- | :--------------- | :----------- | :----------- | | Total Revenue | 112,972 | 98,019 | 211,950 | 195,450 | | Gross Margin | 73,112 | 63,324 | 136,689 | 126,270 | | Operating Income | 8,384 | 6,507 | 10,529 | 31,818 | | Net Income (Loss) | 1,345 | (2,121) | 840 | 5,412 | | Diluted Net Income (Loss) Per Share (USD) | 0.03 | (0.05) | 0.02 | 0.13 | | Comprehensive Income (Loss) | 17,113 | (4,444) | 22,939 | 1,561 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Artivion's total assets increased to **$838 million**, total liabilities decreased to **$418 million**, and shareholders' equity significantly rose to **$419 million**, primarily due to increased additional paid-in capital Condensed Consolidated Balance Sheets (Thousand USD) | Metric | June 30, 2025 | December 31, 2024 | | :------------------- | :--------------- | :--------------- | | Cash and Cash Equivalents | 53,476 | 53,463 | | Accounts Receivable, Net | 91,440 | 79,462 | | Inventories | 86,723 | 79,766 | | **Total Current Assets** | **318,820** | **290,080** | | Goodwill | 253,802 | 240,958 | | **Total Assets** | **838,387** | **789,101** | | **Total Current Liabilities** | **66,670** | **66,823** | | Long-Term Debt, Net | 215,538 | 314,152 | | **Total Liabilities** | **418,485** | **512,901** | | Common Stock | 486 | 434 | | Additional Paid-in Capital | 497,318 | 376,607 | | **Total Stockholders' Equity** | **419,902** | **276,200** | [Condensed Consolidated Statement of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) In H1 2025, Artivion reported **$1.9 million** cash outflow from operating activities, **$6.9 million** outflow from investing activities, and **$6.5 million** inflow from financing activities, primarily from stock option exercises and common stock issuance Condensed Consolidated Statement of Cash Flows (Thousand USD) | Metric | H1 2025 | H1 2024 | | :----------------------- | :----------- | :----------- | | Net Cash Provided by (Used in) Operating Activities | (1,942) | 642 | | Net Cash Used in Investing Activities | (6,925) | (6,124) | | Net Cash Provided by Financing Activities | 6,535 | 556 | | Effect of Exchange Rate Changes | 2,345 | 1,005 | | Net Increase (Decrease) in Cash and Cash Equivalents | 13 | (3,921) | | Cash and Cash Equivalents at End of Period | 53,476 | 55,019 | Financial Highlights [Revenue Breakdown by Product and Geography](index=9&type=section&id=Revenue%20Breakdown%20by%20Product%20and%20Geography) In Q2 2025, Artivion's total revenue was **$113 million**, with strong performance from aortic stent grafts and On-X product lines, and North America as the largest revenue contributor 2025 Second Quarter and First Half Revenue Breakdown (Thousand USD) | Product Category | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------- | :--------------- | :--------------- | :----------- | :----------- | | Aortic Stent Grafts | 39,841 | 32,190 | 76,443 | 64,293 | | On-X | 25,572 | 20,645 | 47,146 | 40,326 | | Surgical Sealants | 19,288 | 18,545 | 37,394 | 35,526 | | Other Products | 2,743 | 1,830 | 5,259 | 4,179 | | **Total Product Revenue** | **87,444** | **73,210** | **166,242** | **144,324** | | Preservation Services | 25,528 | 24,809 | 45,708 | 51,126 | | **Total Revenue** | **112,972** | **98,019** | **211,950** | **195,450** | | Region | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :--------------- | :--------------- | :----------- | :----------- | | North America | 57,569 | 48,662 | 105,362 | 99,590 | | Europe, Middle East, and Africa | 38,713 | 34,145 | 75,758 | 67,733 | | Asia Pacific | 11,131 | 9,653 | 19,345 | 17,262 | | Latin America | 5,559 | 5,559 | 11,485 | 10,865 | | **Total Revenue** | **112,972** | **98,019** | **211,950** | **195,450** | GAAP to Non-GAAP Reconciliations [Reconciliation of Revenues](index=10&type=section&id=Reconciliation%20of%20Revenues) This section reconciles GAAP revenue to non-GAAP constant currency revenue, illustrating the impact of exchange rate changes on product and regional revenues, with **14%** constant currency total revenue growth in Q2 2025 2025 Second Quarter Revenue Reconciliation (Thousand USD) | Product Category | GAAP Revenue (2025) | GAAP Revenue (2024) | FX Impact | Constant Currency Revenue (2024) | Constant Currency YOY Change | | :----------------- | :---------------- | :---------------- | :------- | :-------------------- | :----------------- | | Aortic Stent Grafts | 39,841 | 32,190 | 584 | 32,774 | 22% | | On-X | 25,572 | 20,645 | 41 | 20,686 | 24% | | Surgical Sealants | 19,288 | 18,545 | 61 | 18,606 | 4% | | Other Products | 2,743 | 1,830 | 4 | 1,834 | 50% | | **Total Product Revenue** | **87,444** | **73,210** | **690** | **73,900** | **18%** | | Preservation Services | 25,528 | 24,809 | (17) | 24,792 | 3% | | **Total Revenue** | **112,972** | **98,019** | **673** | **98,692** | **14%** | | Region | GAAP Revenue (2025) | GAAP Revenue (2024) | FX Impact | Constant Currency Revenue (2024) | Constant Currency YOY Change | | :----------------------- | :---------------- | :---------------- | :------- | :-------------------- | :----------------- | | North America | 57,569 | 48,662 | (46) | 48,616 | 18% | | Europe, Middle East, and Africa | 38,713 | 34,145 | 1,091 | 35,236 | 10% | | Asia Pacific | 11,131 | 9,653 | — | 9,653 | 15% | | Latin America | 5,559 | 5,559 | (372) | 5,187 | 7% | | **Total Revenue** | **112,972** | **98,019** | **673** | **98,692** | **14%** | 2025 First Half Revenue Reconciliation (Thousand USD) | Product Category | GAAP Revenue (2025) | GAAP Revenue (2024) | FX Impact | Constant Currency Revenue (2024) | Constant Currency YOY Change | | :----------------- | :---------------- | :---------------- | :------- | :-------------------- | :----------------- | | Aortic Stent Grafts | 76,443 | 64,293 | (724) | 63,569 | 20% | | On-X | 47,146 | 40,326 | (231) | 40,095 | 18% | | Surgical Sealants | 37,394 | 35,526 | (256) | 35,270 | 6% | | Other Products | 5,259 | 4,179 | — | 4,179 | 26% | | **Total Product Revenue** | **166,242** | **144,324** | **(1,211)** | **143,113** | **16%** | | Preservation Services | 45,708 | 51,126 | (84) | 51,042 | -10% | | **Total Revenue** | **211,950** | **195,450** | **(1,295)** | **194,155** | **9%** | | Region | GAAP Revenue (2025) | GAAP Revenue (2024) | FX Impact | Constant Currency Revenue (2024) | Constant Currency YOY Change | | :----------------------- | :---------------- | :---------------- | :------- | :-------------------- | :----------------- | | North America | 105,362 | 99,590 | (198) | 99,392 | 6% | | Europe, Middle East, and Africa | 75,758 | 67,733 | (119) | 67,614 | 12% | | Asia Pacific | 19,345 | 17,262 | — | 17,262 | 12% | | Latin America | 11,485 | 10,865 | (978) | 9,887 | 16% | | **Total Revenue** | **211,950** | **195,450** | **(1,295)** | **194,155** | **9%** | [Reconciliation of General, Administrative, and Marketing Expense, EBITDA, Adjusted EBITDA, and Free Cash Flows](index=11&type=section&id=Reconciliation%20of%20General%2C%20Administrative%2C%20and%20Marketing%20Expense%2C%20EBITDA%2C%20Adjusted%20EBITDA%2C%20and%20Free%20Cash%20Flows) This section reconciles GAAP to non-GAAP general, administrative, and marketing expenses, EBITDA, adjusted EBITDA, and free cash flow, with Q2 2025 adjusted EBITDA reaching **$24.8 million**, a **33%** year-over-year increase 2025 Second Quarter and First Half Expense, EBITDA, and Free Cash Flow Reconciliation (Thousand USD) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :------------------------------------------------- | :--------------- | :--------------- | :----------- | :----------- | | GAAP General, Administrative, and Marketing Expenses | 57,665 | 49,320 | 112,369 | 80,009 | | Adjusted Non-GAAP General, Administrative, and Marketing Expenses | 53,372 | 47,287 | 106,410 | 95,363 | | GAAP Net Income (Loss) | 1,345 | (2,121) | 840 | 5,412 | | Non-GAAP EBITDA | 16,222 | 11,415 | 26,892 | 37,557 | | Non-GAAP Adjusted EBITDA | 24,764 | 18,643 | 42,312 | 35,955 | | Net Cash Provided by (Used in) Operating Activities (GAAP) | 15,011 | 6,135 | (1,942) | 642 | | Non-GAAP Free Cash Flow | 11,724 | 3,622 | (8,867) | (5,482) | - Adjustments to Adjusted EBITDA include non-cash compensation, business development, integration and severance expenses, cybersecurity incident-related expenses, debt inducement/extinguishment losses, and foreign currency revaluation gains and losses[29](index=29&type=chunk) [Reconciliation of Net Income and Diluted Income Per Common Share](index=12&type=section&id=Reconciliation%20of%20Net%20Income%20and%20Diluted%20Income%20Per%20Common%20Share) This section reconciles GAAP to non-GAAP net income and diluted EPS, with Q2 2025 non-GAAP adjusted net income at **$10.7 million** and non-GAAP diluted EPS at **$0.24**, significantly higher than GAAP figures 2025 Second Quarter and First Half Net Income and Diluted Income Per Common Share Reconciliation (Thousand USD, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------------------------- | :--------------- | :--------------- | :----------- | :----------- | | GAAP Net Income (Loss) | 1,345 | (2,121) | 840 | 5,412 | | GAAP Diluted Net Income (Loss) Per Share (USD) | 0.03 | (0.05) | 0.02 | 0.13 | | Non-GAAP Adjusted Net Income | 10,732 | 2,913 | 13,226 | 5,545 | | Non-GAAP Adjusted Diluted Net Income Per Share (USD) | 0.24 | 0.07 | 0.30 | 0.13 | | GAAP Diluted Weighted Average Common Shares | 45,378 | 41,683 | 44,503 | 42,405 | | Non-GAAP Diluted Weighted Average Common Shares | 45,378 | 42,624 | 44,503 | 42,405 | - Non-GAAP adjustments include amortization expense, business development, integration and severance expenses, non-cash interest expense, cybersecurity incident-related expenses, and debt inducement/extinguishment losses, along with the tax impact of these adjustments[31](index=31&type=chunk)

Core Points - Artivion, Inc. experienced a data breach on or about November 20, 2024, involving unauthorized access to its network [3] - The breach potentially compromised sensitive personal data, including names, Social Security Numbers, driver's license numbers, and direct deposit details [3] - Edelson Lechtzin LLP is investigating the incident and considering a class action lawsuit for affected individuals [4] Company Overview - Artivion, Inc. is a global medical device company based in Kennesaw, Georgia, founded in 1984 and previously known as CryoLife [2] - The company specializes in manufacturing, processing, and distributing medical devices and implantable tissues for cardiac and vascular procedures [2]

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.

Core Viewpoint - Artivion, Inc. has successfully closed transactions related to privately negotiated exchange agreements with holders of its 4.250% Convertible Senior Notes due 2025, significantly reducing its outstanding debt and enhancing its financial position [1][3]. Financial Transactions - The exchange agreements involved the conversion of approximately $99.54 million of Notes into 4,334,347 shares of common stock, along with a cash payment of approximately $1.7 million for accrued and unpaid interest [2]. - Following the transactions, only about $0.46 million in principal amount of the Notes remains outstanding [2]. Management Commentary - The CEO of Artivion highlighted that the retirement of the convertible notes is a significant milestone that reduces leverage ratios and enhances balance sheet flexibility [3]. Advisory Role - J. Wood Capital Advisors LLC served as the financial advisor to Artivion during these exchange transactions [4]. Company Overview - Artivion, Inc. is a medical device company focused on solutions for cardiac and vascular surgery, particularly in treating aortic diseases, with a product range that includes aortic stent grafts, surgical sealants, mechanical heart valves, and implantable tissues [7].

Part I [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements.) Artivion reported Q1 2025 revenues of **$99.0 million** (+2%), but a **net loss of $0.5 million** due to increased expenses [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20%28Loss%29%20Income) Q1 2025 revenues rose 2% to **$99.0 million**, but operating income sharply declined to **$2.1 million**, resulting in a **net loss of $0.5 million** Q1 2025 vs Q1 2024 Statement of Operations Highlights (In Thousands, Except Per Share Data) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$98,978** | **$97,431** | **+1.6%** | | - Products | $78,798 | $71,114 | +10.8% | | - Preservation services | $20,180 | $26,317 | -23.3% | | **Gross Margin** | **$63,577** | **$62,946** | **+1.0%** | | General, administrative, and marketing | $54,704 | $30,689 | +78.2% | | **Operating Income** | **$2,145** | **$25,311** | **-91.5%** | | **Net (Loss) Income** | **($505)** | **$7,533** | **-106.7%** | | **Diluted (Loss) Income Per Share** | **($0.01)** | **$0.18** | **-105.6%** | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets were **$791.2 million**, cash decreased to **$37.7 million**, and total liabilities declined to **$496.9 million** Balance Sheet Highlights (In Thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $37,693 | $53,463 | | Total current assets | $287,297 | $290,080 | | Total assets | $791,163 | $789,101 | | Total current liabilities | $51,940 | $66,823 | | Long-term debt, net | $314,611 | $314,152 | | Total liabilities | $496,911 | $512,901 | | Total stockholders' equity | $294,252 | $276,200 | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$17.0 million** in Q1 2025, leading to a **$15.8 million** decrease in cash and cash equivalents Q1 2025 vs Q1 2024 Cash Flow Summary (In Thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash flows used in operating activities | ($16,953) | ($5,493) | | Net cash flows used in investing activities | ($3,638) | ($3,611) | | Net cash flows provided by financing activities | $3,937 | $737 | | **Decrease in cash and cash equivalents** | **($15,770)** | **($7,822)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the 2024 debt refinancing, segment and geographic revenue trends, and a **$2.8 million** gain from contingent consideration fair value adjustment - In January 2024, the company entered into a new **$350.0 million** credit facility with Ares Management, using the proceeds to repay its old credit facilities. This resulted in a **$3.7 million** loss on extinguishment of debt in Q1 2024[49](index=49&type=chunk)[61](index=61&type=chunk) Revenue by Segment (Q1 2025 vs Q1 2024, In Thousands) | Segment | Q1 2025 Revenue | Q1 2024 Revenue | Change | | :--- | :--- | :--- | :--- | | Medical devices | $78,798 | $71,114 | +10.8% | | Preservation services | $20,180 | $26,317 | -23.3% | | **Total revenues** | **$98,978** | **$97,431** | **+1.6%** | Revenue by Geography (Q1 2025 vs Q1 2024, In Thousands) | Region | Q1 2025 Revenue | Q1 2024 Revenue | Change | | :--- | :--- | :--- | :--- | | North America | $47,793 | $50,928 | -6.2% | | EMEA | $37,045 | $33,588 | +10.3% | | APAC | $8,214 | $7,609 | +8.0% | | LATAM | $5,926 | $5,306 | +11.7% | | **Total revenues** | **$98,978** | **$97,431** | **+1.6%** | - The company recorded a net fair value gain of **$2.8 million** for the three months ended March 31, 2025, from a change in the fair value of contingent consideration related to the Ascyrus acquisition. This compares to a **$17.5 million** gain in the same period of 2024[37](index=37&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) MD&A highlights Q1 2025 revenue growth driven by Medical Devices, offset by Preservation Services decline due to a cyber incident, and discusses liquidity [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 revenues grew 2% (4% CC), driven by product sales, while Preservation Services declined 23% due to a cyber incident backlog, and G,A&M expenses surged Q1 2025 Revenue Growth by Product (As Reported vs. Constant Currency) | Product Line | As Reported Change | Constant Currency Change | | :--- | :--- | :--- | | Aortic stent grafts | +14% | +19% | | On-X | +10% | +11% | | Surgical sealants | +7% | +9% | | **Total products** | **+11%** | **+14%** | | Preservation services | -23% | -23% | | **Total Revenues** | **+2%** | **+4%** | - The decrease in Preservation Services revenue was primarily due to a backlog of tissues to be released for shipment as a result of the 2024 cybersecurity incident, which is expected to improve throughout 2025[103](index=103&type=chunk) - General, administrative, and marketing expenses increased by **$9.4 million** after excluding the impact of contingent consideration adjustments. This was driven by **$4.5 million** of expenses associated with the 2024 cybersecurity incident and higher non-cash stock compensation[110](index=110&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$37.7 million** in cash and **$320.1 million** in debt, with available credit facilities to support future liquidity needs - The company's liquidity position includes **$37.7 million** in cash, **$30.0 million** in unused revolving credit, and a **$100.0 million** delayed draw term loan facility[124](index=124&type=chunk) - The **$100.0 million** delayed draw term loan facility was established solely to make funds available for the repurchase or repayment of the Convertible Senior Notes due July 1, 2025[126](index=126&type=chunk) - Net cash used in operating activities increased by **$11.5 million** year-over-year, primarily due to professional fees from the 2024 cybersecurity incident and the timing of interest payments on new credit facilities[132](index=132&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company faces market risks from interest rates and foreign currency, with no material changes since fiscal year 2024 - As of March 31, 2025, there has been no material change in the company's market risk disclosures from its 2024 Annual Report on Form 10-K[140](index=140&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[143](index=143&type=chunk) - No changes in internal controls over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[144](index=144&type=chunk) Part II [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings.) The company is involved in routine legal actions, with no pending matters expected to have a material adverse effect - Based on current knowledge, the company does not believe there are any pending legal matters that could have a material, adverse effect on its business or financial condition[146](index=146&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors.) The company faces significant risks from geopolitical instability, supply chain dependencies, cybersecurity incidents, and regulatory hurdles like EU MDR and potential FDA reclassification - The NEXUS family of products are solely manufactured by Endospan in Herzliya, Israel, exposing the company to supply chain disruptions from instability in the Middle East[151](index=151&type=chunk) - The company experienced a cyber-attack in Q4 2024 that disrupted business operations and continues to incur related expenses. It remains subject to risks from this incident, including potential for scrap, inventory issues, and shipping delays[185](index=185&type=chunk) - The transition to the European Union's Medical Device Regulation (MDR) presents significant risks, including potential delays or prevention of commercializing products in Europe and other markets that rely on CE Marking[190](index=190&type=chunk)[191](index=191&type=chunk) - The FDA is considering reclassifying allograft heart valves, including the company's CryoValve SGPV, to Class III medical devices, which could make continued processing commercially infeasible due to the onerous PMA application process[192](index=192&type=chunk)[193](index=193&type=chunk) - The company is dependent on single-source suppliers for key components of its major products, including BioGlue, On-X, and aortic stent grafts, creating significant supply chain vulnerability[169](index=169&type=chunk)[171](index=171&type=chunk)[173](index=173&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company did not repurchase any equity securities in Q1 2025, with current credit facilities generally prohibiting such transactions - The Company did not repurchase any of its equity security during the three months ended March 31, 2025[221](index=221&type=chunk) [Other Information](index=46&type=section&id=Item%205.%20Other%20Information.) In March 2025, two officers adopted Rule 10b5-1 trading plans for future sales of company common stock - Chief Accounting Officer Amy D. Horton and Chief Medical Officer Marshall S. Stanton adopted Rule 10b5-1 trading plans in March 2025 for future sales of company stock[224](index=224&type=chunk) [Exhibits](index=47&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL data files

Core Viewpoint - Artivion (AORT) reported quarterly earnings of $0.06 per share, missing the Zacks Consensus Estimate of $0.12 per share, representing a 50% earnings surprise [1] - The company posted revenues of $98.98 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 4.19% [2] Financial Performance - Artivion's earnings of $0.06 per share are unchanged from the same quarter last year, and the company has surpassed consensus EPS estimates two times over the last four quarters [1][2] - The company has topped consensus revenue estimates three times in the last four quarters, with year-ago revenues of $97.43 million [2] Stock Performance - Artivion shares have declined approximately 18.4% since the beginning of the year, compared to a decline of 3.3% for the S&P 500 [3] - The current Zacks Rank for Artivion is 3 (Hold), indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.16 on revenues of $108.7 million, and for the current fiscal year, it is $0.68 on revenues of $426.65 million [7] - The outlook for the Medical - Instruments industry is positive, ranking in the top 28% of over 250 Zacks industries, suggesting potential for outperformance [8]

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]