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]

Core Insights - Artivion, Inc. will participate in the Stifel 2025 Healthcare Conference on November 12, 2025, with a fireside chat scheduled for 8:00 a.m. ET [1] Company Overview - Artivion, Inc. is headquartered in suburban Atlanta, Georgia, and focuses on developing solutions for cardiac and vascular surgeons addressing aortic diseases [2] - The company offers four major product groups: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues [2] - Artivion markets and sells its products in over 100 countries worldwide [2]

Core Insights - The Alger Weatherbie Specialized Growth Fund's Class A shares underperformed the Russell 2500 Growth Index in Q3 2025, despite the S&P 500 Index rising by 8.12% [1] Company Overview - Artivion, Inc. (NYSE:AORT) is a global manufacturer and distributor of medical devices and implantable human tissues, focusing on cardiac and vascular surgeries for patients with aortic disease [3] - The company reported total revenues of $113 million for Q2 2025, marking an increase of over 14% compared to Q2 2024 [4] Stock Performance - Artivion, Inc. experienced a one-month return of 6.90% and a significant 69.32% increase in share value over the last 52 weeks, closing at $45.26 per share on October 28, 2025, with a market capitalization of $2.136 billion [2] Fund Performance and Holdings - The Alger Weatherbie Specialized Growth Fund highlighted Artivion, Inc. as a positive contributor during the quarter, driven by strong fiscal second-quarter earnings and an improved full-year outlook [3] - The fund's top five holdings can provide insights into its best investment picks for 2025 [1]

Core Insights - Artivion, Inc. will release its third quarter 2025 financial results on November 6, 2025, after market close, followed by a teleconference at 4:30 p.m. ET [1] - The company specializes in cardiac and vascular surgery, focusing on aortic disease, and offers a range of products including aortic stent grafts and mechanical heart valves [3] Financial Results Announcement - The financial results will be discussed in a teleconference led by Pat Mackin, the Chairman, President, and CEO of Artivion [1] - A replay of the teleconference will be available shortly after the event, with specific access numbers provided [2] Company Overview - Artivion is headquartered in suburban Atlanta, Georgia, and operates in over 100 countries [3] - The company develops solutions for cardiac and vascular surgeons, addressing challenges in treating aortic diseases [3]

Core Insights - The AMDS PERSEVERE trial demonstrated a resolution of visceral malperfusion in 83% and renal malperfusion in 74% of affected subjects after AMDS implantation, indicating significant clinical efficacy [2][4][7] - Real-world data from the AMDS PROTECT trial corroborated the positive outcomes observed in the PERSEVERE trial, showcasing excellent clinical results consistent with previous studies [6][9] AMDS PERSEVERE Trial Findings - The trial focused on patients with acute DeBakey Type I aortic dissection and assessed the effectiveness of the AMDS hybrid prosthesis in resolving visceral and renal malperfusion [4][8] - Among the 40 study participants, 83% with pre-operative visceral malperfusion did not experience significant gastrointestinal events, and 74% with renal malperfusion did not require dialysis [7][8] AMDS PROTECT Trial Findings - The PROTECT trial included 141 patients and reported outcomes such as a 12.6% rate of disabling stroke and a 4.2% rate of renal failure requiring dialysis, both of which are significantly lower than the rates in the STS Adult Cardiac Surgery Database [6][9] - The trial also noted no occurrences of paralysis, aortic rupture, or myocardial infarction, with 95.3% to 100% of patients experiencing positive remodeling of the aorta [6][9] Company Statements - Dr. Michael Moon emphasized the importance of the AMDS technology in improving outcomes for critically ill patients [3] - Pat Mackin highlighted the strong presence of the company at the EACTS meeting and reaffirmed the commitment to innovation in aortic disease treatment [3] Market Opportunity - Approximately 48,000 patients suffer from acute DeBakey Type I aortic dissections annually, representing a market opportunity of $150 million in the U.S. and $540 million globally [11]

Company Overview - Artivion is an aorta-focused company that specializes in heart valves for patients under the age of 65, along with products to treat aortic aneurysms and dissections [3] - The company has a revenue of over $400 million, with a midpoint guidance of $440 million for the current year and an EBITDA margin of approximately 20% [3] Financial Objectives - The company's goal is to achieve double-digit growth for the business in the foreseeable future and to grow EBITDA at twice the rate of sales [4] - Artivion has significant leverage opportunities, particularly in general and administrative expenses, which is common for companies of its size [4]

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]

Company Overview - Artivion, Inc. is a leading cardiac and vascular surgery company focused on aortic disease [2] - The company is headquartered in suburban Atlanta, Georgia and markets products in over 100 countries worldwide [2] Product Offerings - Artivion's major product groups include aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues [2] Upcoming Events - Artivion will participate in the Morgan Stanley 23 Annual Global Healthcare Conference on September 10, 2025, with a fireside chat scheduled at 2:35 pm ET [1] - A live webcast of the event will be available on Artivion's website, with an archived copy accessible for 90 days [2]

Summary of Artivion (AORT) FY Conference Call - August 13, 2025 Company Overview - **Company**: Artivion (AORT) - **Focus Areas**: Aortic valves for patients aged 65 and older, aneurysms, and dissections, particularly in the aortic arch [2][69] Core Business Model - **Business Model**: Highly differentiated, profitable, and growing base business with a focus on aortic valves and stents [3][70] - **Revenue Growth**: Expected to grow revenue in double digits on the top line and twice as fast on the bottom line for the foreseeable future [4][71] Financial Performance - **On X Valves Growth**: Grew 24% in the quarter; historically, it has grown at 13% over the last decade [5][72] - **Clinical Evidence**: Unique position due to clinical evidence supporting lower INR (less blood thinner) usage, leading to a significant market share increase [5][72] - **Market Opportunity**: Targeting a $100 million tissue valve market opportunity based on recent clinical findings [7][74] - **Stent Business Growth**: Stent business grew 22% in the quarter, with a strong pipeline for future growth [8][75] Product Pipeline - **Pipeline Overview**: Five PMAs (Premarket Approvals) in the pipeline with a total market opportunity of approximately $1 billion [18][86] - **Upcoming Products**: - **AMDS**: Stent for acute type A dissection, showing significant mortality reduction in trials [12][79] - **Nexus**: Total catheter delivery system for aortic arch replacement, expected FDA approval in 2026 [14][82] - **SIVO**: Next-generation frozen elephant trunk device, trial approved and expected to start enrollment soon [16][83] Financial Guidance - **2025 Revenue Guidance**: Initially projected at 10% to 14%, now narrowed to 12% to 14% growth [17][84] - **EBITDA Guidance**: Adjusted EBITDA expected to be between $86 million and $91 million, with a positive cash flow outlook [18][85] Competitive Landscape - **Competition**: Limited direct competition in the AMDS space; standard of care is outdated [29][96] - **Market Position**: Approximately 60% market share in mechanical valves in the U.S. and 15% in the tissue valve market [64][112] Key Takeaways - **Strong Leadership**: Experienced leadership team contributing to the company's growth and innovation [2][70] - **Positive Physician Feedback**: Excellent feedback on AMDS technology, highlighting ease of use and significant clinical benefits [31][100] - **Future Focus**: Continued emphasis on training and cross-selling to expand market presence and drive new account creation [47][113] Additional Insights - **Deleveraging Strategy**: Rapid deleveraging of the balance sheet, with a current leverage ratio of around 2.2 [17][84] - **Cash Flow Utilization**: Future cash flow expected to be used for debt reduction and potential acquisition of Endospan [24][91]

Part I – FINANCIAL INFORMATION [Item 1. Financial Statements.](index=3&type=section&id=Item%201.%20Financial%20Statements.) This section presents Artivion, Inc.'s unaudited condensed consolidated financial statements for the three and six months ended June 30, 2025 and 2024, including statements of operations, balance sheets, cash flows, and stockholders' equity, along with detailed notes explaining significant accounting policies, financial instruments, debt, and segment information [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) Three Months Ended June 30, 2025 vs. 2024 (in thousands) | Metric | 2025 | 2024 | Change | % Change | | :--------------------------------- | :----- | :----- | :----- | :------- | | Total Revenues | $112,972 | $98,019 | $14,953 | 15.25% | | Gross Margin | $73,112 | $63,324 | $9,788 | 15.46% | | Operating Income | $8,384 | $6,507 | $1,877 | 28.85% | | Net Income (Loss) | $1,345 | $(2,121) | $3,466 | -163.41% | | Basic EPS | $0.03 | $(0.05) | $0.08 | -160.00% | | Diluted EPS | $0.03 | $(0.05) | $0.08 | -160.00% | | Comprehensive Income (Loss) | $17,113 | $(4,444) | $21,557 | -485.09% | Six Months Ended June 30, 2025 vs. 2024 (in thousands) | Metric | 2025 | 2024 | Change | % Change | | :--------------------------------- | :----- | :----- | :----- | :------- | | Total Revenues | $211,950 | $195,450 | $16,500 | 8.44% | | Gross Margin | $136,689 | $126,270 | $10,419 | 8.25% | | Operating Income | $10,529 | $31,818 | $(21,289) | -66.91% | | Net Income (Loss) | $840 | $5,412 | $(4,572) | -84.48% | | Basic EPS | $0.02 | $0.13 | $(0.11) | -84.62% | | Diluted EPS | $0.02 | $0.13 | $(0.11) | -84.62% | | Comprehensive Income (Loss) | $22,939 | $1,561 | $21,378 | 1369.51% | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights (in thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Total Current Assets | $318,820 | $290,080 | $28,740 | | Total Assets | $838,387 | $789,101 | $49,286 | | Total Current Liabilities | $66,670 | $66,823 | $(153) | | Long-term Debt, net | $215,538 | $314,152 | $(98,614) | | Total Liabilities | $418,485 | $512,901 | $(94,416) | | Total Stockholders' Equity | $419,902 | $276,200 | $143,702 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | Change | | :------------------------------------ | :----- | :----- | :----- | | Net cash flows from operating activities | $(1,942) | $642 | $(2,584) | | Net cash flows from investing activities | $(6,925) | $(6,124) | $(801) | | Net cash flows from financing activities | $6,535 | $556 | $5,979 | | Effect of exchange rate changes | $2,345 | $1,005 | $1,340 | | Increase (decrease) in cash | $13 | $(3,921) | $3,934 | | Cash and cash equivalents end of period | $53,476 | $55,019 | $(1,543) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' Equity Changes (Six Months Ended June 30, 2025, in thousands) | Item | Amount | | :-------------------------------- | :----- | | Balance at December 31, 2024 | $276,200 | | Net income | $840 | | Other comprehensive income, net of tax | $22,099 | | Settlement of convertible senior notes | $102,137 | | Equity compensation | $14,167 | | Exercise of options | $3,498 | | Employee stock purchase plan | $961 | | Balance at June 30, 2025 | $419,902 | - Total stockholders' equity increased from **$276.2 million** at December 31, 2024, to **$419.9 million** at June 30, 2025, primarily driven by the settlement of convertible senior notes and other comprehensive income[18](index=18&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [1. Basis of Presentation and Summary of Significant Accounting Policies](index=9&type=section&id=1.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) - The financial statements are prepared in accordance with US GAAP for interim information and SEC rules, with all necessary adjustments included. Operating results for the three and six months ended June 30, 2025, are not indicative of the full year[23](index=23&type=chunk) - Foreign currency translation adjustments resulted in a net gain of **$4.5 million** and **$7.4 million** for the three and six months ended June 30, 2025, respectively, compared to net losses in the prior year[24](index=24&type=chunk) - Artivion early adopted ASU 2024-04, 'Induced Conversions of Convertible Debt Instruments,' as of June 30, 2025, on a prospective basis, as part of the Convertible Senior Notes settlement[26](index=26&type=chunk) [2. Agreements with Endospan](index=10&type=section&id=2.%20Agreements%20with%20Endospan) - Artivion holds an exclusive distribution agreement for the NEXUS family of products in certain European countries, which was fully amortized by December 31, 2024[29](index=29&type=chunk) - An amendment to the Endospan Option in July 2024 reduced the acquisition price for Endospan's securities or assets from **$250.0 million** to **$175.0 million**, with an upfront acquisition purchase price of **$135.0 million**[31](index=31&type=chunk) Endospan Loan Fair Value (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Endospan Loan Fair Value | $0.3 | $0.3 | | Additional Endospan Loan Fair Value | $10.0 | $9.2 | | Total Endospan Loans | $10.3 | $9.5 | [3. Financial Instruments](index=11&type=section&id=3.%20Financial%20Instruments) Fair Value of Financial Instruments (June 30, 2025, in thousands) | Item | Level 1 | Level 2 | Level 3 | Total | | :---------------------- | :------ | :------ | :------ | :------ | | Money market funds | $5,715 | — | — | $5,715 | | Certificates of deposit | $2,074 | — | — | $2,074 | | Endospan Loans | — | — | $10,290 | $10,290 | | Contingent consideration | — | — | $52,670 | $52,670 | - The contingent consideration liability for the Ascyrus acquisition was **$52.7 million** as of June 30, 2025, and is estimated using a probability-weighted scenario approach with a discount rate of approximately **17%**[40](index=40&type=chunk)[41](index=41&type=chunk) Changes in Level 3 Fair Value (in thousands) | Item | Balance Dec 31, 2024 | Change in Valuation | Balance June 30, 2025 | | :----------------------- | :------------------- | :------------------ | :-------------------- | | Contingent Consideration | $52,880 | $(210) | $52,670 | | Endospan Loans | $9,535 | $755 | $10,290 | [4. Inventories and Deferred Preservation Costs](index=13&type=section&id=4.%20Inventories%20and%20Deferred%20Preservation%20Costs) Inventories (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Raw materials and supplies | $36,246 | $35,295 | | Work-in-process | $17,821 | $13,926 | | Finished goods | $32,656 | $30,545 | | Total Inventories | $86,723 | $79,766 | | Deferred preservation costs | $52,817 | $51,701 | - Consignment inventory of On-X heart valves, aortic stent grafts, and AMDS products totaled **$12.6 million** as of June 30, 2025, with **65%** in international locations[44](index=44&type=chunk) [5. Goodwill and Other Intangible Assets](index=13&type=section&id=5.%20Goodwill%20and%20Other%20Intangible%20Assets) Indefinite Lived Intangible Assets (in thousands) | Asset | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Goodwill | $253,802 | $240,958 | | In-process R&D | $2,285 | $2,026 | | Procurement contracts and agreements | $2,013 | $2,013 | - Goodwill increased by **$12.8 million** due to foreign currency translation, all related to the Medical Devices segment[48](index=48&type=chunk) Definite Lived Intangible Assets (Net Carrying Value, in thousands) | Asset Class | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Acquired technology | $129,257 | $128,051 | | Customer lists and relationships | $16,463 | $16,994 | | Patents | $1,104 | $968 | | Other | $7,318 | $6,331 | | Total Other intangibles, net | $24,885 | $24,293 | Amortization Expense (in thousands) | Period | 2025 | 2024 | | :------------------- | :----- | :----- | | Three Months Ended June 30 | $3,427 | $3,793 | | Six Months Ended June 30 | $6,815 | $7,660 | [6. Income Taxes](index=15&type=section&id=6.%20Income%20Taxes) Effective Income Tax Rate | Period | 2025 | 2024 | | :------------------- | :--- | :--- | | Three Months Ended June 30 | 61% | (13)% | | Six Months Ended June 30 | 29% | 48% | - The effective income tax rate was significantly impacted by state income taxes, non-deductible executive compensation, changes in valuation allowance against net deferred tax assets, and foreign provision to return adjustments[51](index=51&type=chunk) - The company is assessing the impact of the recently enacted 'One Big Beautiful Bill Act' (OBBBA) on its consolidated financial statements, with provisions effective from 2025 through 2027[52](index=52&type=chunk) [7. Debt](index=15&type=section&id=7.%20Debt) Debt Composition (in thousands) | Debt Type | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Term Loan Facility | $190,000 | $190,000 | | Revolving Credit Facility | $30,000 | $30,000 | | Convertible Senior Notes | $460 | $100,000 | | Other | $73 | $195 | | Total Principal Debt | $220,533 | $320,195 | | Long-term Debt, net | $215,538 | $314,152 | - The company entered into new credit facilities in January 2024, consisting of a **$190.0 million** Term Loan Facility, a **$100.0 million** Delayed Draw Term Loan Facility, and a **$60.0 million** Revolving Credit Facility, with proceeds used to repay old credit facilities[55](index=55&type=chunk) - In May 2025, Artivion settled approximately **$99.5 million** of Convertible Senior Notes by exchanging them for **4,334,347 shares** of common stock and a cash payment of **$1.7 million** for accrued interest, resulting in a **$2.7 million** inducement expense[63](index=63&type=chunk)[64](index=64&type=chunk) - The remaining **$0.5 million** Convertible Senior Notes were settled on July 1, 2025, and the Delayed Draw Term Loan Facility was terminated on July 2, 2025[65](index=65&type=chunk) [8. Commitments and Contingencies](index=18&type=section&id=8.%20Commitments%20and%20Contingencies) - Artivion is involved in legal proceedings in the normal course of business and maintains claims-made insurance policies to mitigate financial exposure to product and tissue processing liability claims[69](index=69&type=chunk) - The company estimates probable losses and anticipated recoveries for incurred but not reported claims related to products sold and services performed prior to the balance sheet date[69](index=69&type=chunk) [9. Revenue Recognition](index=18&type=section&id=9.%20Revenue%20Recognition) Net Revenues by Geographic Location (in thousands) | Region | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | North America | $57,569 | $48,662 | $105,362 | $99,590 | | EMEA | $38,713 | $34,145 | $75,758 | $67,733 | | APAC | $11,131 | $9,653 | $19,345 | $17,262 | | LATAM | $5,559 | $5,559 | $11,485 | $10,865 | | Total Revenues | $112,972 | $98,019 | $211,950 | $195,450 | - North America and EMEA are key markets for direct sales, while APAC and LATAM primarily involve sales through distributors, except for Brazil where direct sales also occur[71](index=71&type=chunk) [10. Stock Compensation](index=19&type=section&id=10.%20Stock%20Compensation) - During the six months ended June 30, 2025, the company authorized equity awards totaling **897,000 shares** with an aggregate grant date fair value of **$23.2 million**, an increase from **762,000 shares** and **$15.7 million** in the prior year[73](index=73&type=chunk)[74](index=74&type=chunk) - Employees purchased **44,000 shares** through the ESPP in the six months ended June 30, 2025, compared to **51,000 shares** in the prior year[75](index=75&type=chunk) [11. Income (Loss) Per Common Share](index=19&type=section&id=11.%20Income%20%28Loss%29%20Per%20Common%20Share) Basic and Diluted Income (Loss) Per Common Share | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) allocated to common stockholders | $1,343 | $(2,117) | $839 | $5,399 | | Basic weighted-average common shares outstanding | 44,296 | 41,683 | 43,270 | 41,487 | | Basic income (loss) per common share | $0.03 | $(0.05) | $0.02 | $0.13 | | Diluted weighted-average common shares outstanding | 45,378 | 41,683 | 44,503 | 42,405 | | Diluted income (loss) per common share | $0.03 | $(0.05) | $0.02 | $0.13 | - Stock options and awards were excluded from diluted EPS calculations if their inclusion would be antidilutive, affecting **178,000** and **150,000** potential common shares for the three and six months ended June 30, 2025, respectively[77](index=77&type=chunk) [12. Segment Information](index=20&type=section&id=12.%20Segment%20Information) - Artivion operates in two reportable segments: Medical Devices (aortic stent grafts, On-X products, surgical sealants, other) and Preservation Services (cardiac and vascular tissues)[78](index=78&type=chunk) Segment Revenues and Gross Margins (Three Months Ended June 30, in thousands) | Segment | 2025 Revenues | 2024 Revenues | 2025 Gross Margin | 2024 Gross Margin | | :------------------ | :------------ | :------------ | :---------------- | :---------------- | | Medical Devices | $87,444 | $73,210 | $59,129 | $48,665 | | Preservation Services | $25,528 | $24,809 | $13,983 | $14,659 | | Total | $112,972 | $98,019 | $73,112 | $63,324 | Segment Revenues and Gross Margins (Six Months Ended June 30, in thousands) | Segment | 2025 Revenues | 2024 Revenues | 2025 Gross Margin | 2024 Gross Margin | | :------------------ | :------------ | :------------ | :---------------- | :---------------- | | Medical Devices | $166,242 | $144,324 | $112,664 | $96,029 | | Preservation Services | $45,708 | $51,126 | $24,025 | $30,241 | | Total | $211,950 | $195,450 | $136,689 | $126,270 | Product Revenues (Three Months Ended June 30, in thousands) | Product | 2025 | 2024 | | :------------------ | :----- | :----- | | Aortic stent grafts | $39,841 | $32,190 | | On-X | $25,572 | $20,645 | | Surgical sealants | $19,288 | $18,545 | | Other | $2,743 | $1,830 | | Preservation services | $25,528 | $24,809 | | Total Revenues | $112,972 | $98,019 | Product Revenues (Six Months Ended June 30, in thousands) | Product | 2025 | 2024 | | :------------------ | :----- | :----- | | Aortic stent grafts | $76,443 | $64,293 | | On-X | $47,146 | $40,326 | | Surgical sealants | $37,394 | $35,526 | | Other | $5,259 | $4,179 | | Preservation services | $45,708 | $51,126 | | Total Revenues | $211,950 | $195,450 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on Artivion's financial performance, condition, and operational results for the three and six months ended June 30, 2025, compared to the prior year. It details revenue drivers, cost changes, operating expenses, liquidity, and capital resources, including the impact of foreign exchange rates and recent debt restructuring [Overview](index=24&type=section&id=Overview) - Artivion, Inc. is a leader in medical devices and implantable human tissues for cardiac and vascular surgical procedures, with major product families including aortic stent grafts, On-X mechanical heart valves, surgical sealants, and implantable tissues[86](index=86&type=chunk) Total Revenues (in thousands) | Period | 2025 | 2024 | % Change | | :------------------- | :----- | :----- | :------- | | Three Months Ended June 30 | $112,972 | $98,019 | 15% | | Constant Currency (3 months) | $98,692 | $98,019 | 14% | | Six Months Ended June 30 | $211,950 | $195,450 | 8% | | Constant Currency (6 months) | $194,155 | $195,450 | 9% | [Presentation](index=24&type=section&id=Presentation) - Management uses non-GAAP constant currency revenues to assess operational performance and for strategic planning, defining it as revenues adjusted for year-over-year foreign currency movements[129](index=129&type=chunk)[130](index=130&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) [Revenues](index=24&type=section&id=Revenues) - Product revenues increased **19%** and **15%** for the three and six months ended June 30, 2025, respectively, driven by increases across all product categories[93](index=93&type=chunk) - Foreign currency fluctuations impacted reported revenues; the US Dollar weakened against major currencies in Q2 2025, increasing reported revenues, but strengthened over the six-month period, decreasing reported revenues[94](index=94&type=chunk) Revenues by Product (Three Months Ended June 30, in thousands) | Product | 2025 | 2024 | % Change | | :---------------- | :----- | :----- | :------- | | Aortic stent grafts | $39,841 | $32,190 | 24% | | On-X | $25,572 | $20,645 | 24% | | Surgical sealants | $19,288 | $18,545 | 4% | | Other | $2,743 | $1,830 | 50% | | Total products | $87,444 | $73,210 | 19% | | Preservation services | $25,528 | $24,809 | 3% | | Total | $112,972 | $98,019 | 15% | Revenues by Product (Six Months Ended June 30, in thousands) | Product | 2025 | 2024 | % Change | | :---------------- | :----- | :----- | :------- | | Aortic stent grafts | $76,443 | $64,293 | 19% | | On-X | $47,146 | $40,326 | 17% | | Surgical sealants | $37,394 | $35,526 | 5% | | Other | $5,259 | $4,179 | 26% | | Total products | $166,242 | $144,324 | 15% | | Preservation services | $45,708 | $51,126 | -11% | | Total | $211,950 | $195,450 | 8% | [Aortic Stent Grafts](index=27&type=section&id=Aortic%20Stent%20Grafts) - Aortic stent graft revenues increased **24%** for the three months and **19%** for the six months ended June 30, 2025, primarily due to increased unit volume[96](index=96&type=chunk) - Constant currency revenues for aortic stent grafts increased **22%** and **20%** for the three and six months, respectively, with significant growth in North America (due to AMDS HDE approval) and EMEA (higher-priced products)[97](index=97&type=chunk) [On-X Products](index=27&type=section&id=On-X%20Products) - On-X product revenues increased **24%** for the three months and **17%** for the six months ended June 30, 2025, driven by increased unit volume and average sales price[98](index=98&type=chunk)[99](index=99&type=chunk) - Constant currency revenues for On-X products increased **24%** and **18%** for the three and six months, respectively, with North America showing market share gains and EMEA increasing unit sales in indirect markets[100](index=100&type=chunk) [Surgical Sealants](index=28&type=section&id=Surgical%20Sealants) - Surgical sealant revenues increased **4%** for the three months and **5%** for the six months ended June 30, 2025, primarily due to increased volume of milliliters sold and higher average sales prices[103](index=103&type=chunk)[104](index=104&type=chunk) - Constant currency revenues for surgical sealants increased **4%** and **6%** for the three and six months, respectively, with North America and APAC driving three-month growth, and LATAM driving six-month growth[105](index=105&type=chunk) [Other](index=28&type=section&id=Other) - Other revenues, including PhotoFix and PerClot, increased **50%** and **26%** for the three and six months ended June 30, 2025, respectively, due to increased sales of both products[107](index=107&type=chunk) [Preservation Services](index=28&type=section&id=Preservation%20Services) - Preservation services revenues increased **3%** for the three months ended June 30, 2025, primarily due to the release of a backlog of higher-priced tissues following the 2024 cybersecurity incident[110](index=110&type=chunk) - For the six months ended June 30, 2025, preservation services revenues decreased **11%**, mainly due to the tissue backlog from the cybersecurity incident, which began to release in Q2[111](index=111&type=chunk) [Cost of Products and Preservation Services](index=29&type=section&id=Cost%20of%20Products%20and%20Preservation%20Services) [Cost of Products](index=29&type=section&id=Cost%20of%20Products) Cost of Products (in thousands) | Period | 2025 | 2024 | % Change | | :------------------- | :----- | :----- | :------- | | Three Months Ended June 30 | $28,315 | $24,545 | 15% | | Six Months Ended June 30 | $53,578 | $48,295 | 11% | - The increase in cost of products for both periods was primarily due to an increase in the volume of all products shipped[113](index=113&type=chunk) [Cost of Preservation Services](index=29&type=section&id=Cost%20of%20Preservation%20Services) Cost of Preservation Services (in thousands) | Period | 2025 | 2024 | % Change | | :------------------- | :----- | :----- | :------- | | Three Months Ended June 30 | $11,545 | $10,150 | 14% | | Six Months Ended June 30 | $21,683 | $20,885 | 4% | - The increase in cost of preservation services for the three months was due to higher costs of certain tissues shipped, while the six-month increase was due to higher tissue costs partially offset by lower volume[115](index=115&type=chunk) [Gross Margin](index=29&type=section&id=Gross%20Margin) Gross Margin (in thousands) | Period | 2025 | 2024 | % Change | | :------------------- | :----- | :----- | :------- | | Three Months Ended June 30 | $73,112 | $63,324 | 15% | | Six Months Ended June 30 | $136,689 | $126,270 | 8% | Gross Margin as a Percentage of Total Revenues | Period | 2025 | 2024 | | :------------------- | :--- | :--- | | Three Months Ended June 30 | 65% | 65% | | Six Months Ended June 30 | 64% | 65% | - Gross margin increased **15%** for the three months and **8%** for the six months, driven by increased volume, higher average sales prices, and favorable product mix, partially offset by unfavorable costs[117](index=117&type=chunk)[118](index=118&type=chunk) [Operating Expenses](index=30&type=section&id=Operating%20Expenses) [General, Administrative, and Marketing Expenses](index=30&type=section&id=General%2C%20Administrative%2C%20and%20Marketing%20Expenses) General, Administrative, and Marketing Expenses (in thousands) | Period | 2025 | 2024 | % Change | | :------------------- | :----- | :----- | :------- | | Three Months Ended June 30 | $57,665 | $49,320 | 17% | | Six Months Ended June 30 | $112,369 | $80,009 | 40% | As a Percentage of Total Revenues | Period | 2025 | 2024 | | :------------------- | :--- | :--- | | Three Months Ended June 30 | 51% | 50% | | Six Months Ended June 30 | 53% | 41% | - Increases were due to investments in sales and marketing (including AMDS launch), information technology (including **$1.2M** and **$5.7M** for 2024 cybersecurity incident for three and six months respectively), and increased non-cash stock compensation[119](index=119&type=chunk)[120](index=120&type=chunk) [Research and Development Expenses](index=30&type=section&id=Research%20and%20Development%20Expenses) Research and Development Expenses (in thousands) | Period | 2025 | 2024 | % Change | | :------------------- | :----- | :----- | :------- | | Three Months Ended June 30 | $7,063 | $7,497 | -6% | | Six Months Ended June 30 | $13,791 | $14,443 | -5% | As a Percentage of Total Revenues | Period | 2025 | 2024 | | :------------------- | :--- | :--- | | Three Months Ended June 30 | 6% | 8% | | Six Months Ended June 30 | 7% | 7% | - R&D expenses decreased **6%** and **5%** for the three and six months, respectively, with focus on clinical work for aortic stent graft regulatory approvals[122](index=122&type=chunk) [Interest Expense](index=31&type=section&id=Interest%20Expense) Interest Expense (in thousands) | Period | 2025 | 2024 | % Change | | :------------------- | :----- | :----- | :------- | | Three Months Ended June 30 | $7,270 | $8,304 | -12.5% | | Six Months Ended June 30 | $14,933 | $16,130 | -7.4% | - Interest expense decreased due to lower variable interest rates on credit facilities[123](index=123&type=chunk) [Losses on Inducement/Extinguishment of Debt](index=31&type=section&id=Losses%20on%20Inducement%2FExtinguishment%20of%20Debt) - A **$2.7 million** loss on inducement of convertible debt was recorded for the three and six months ended June 30, 2025, related to the settlement of Convertible Senior Notes[124](index=124&type=chunk) - A **$3.7 million** loss on extinguishment of debt was recorded for the six months ended June 30, 2024, due to the repayment of previously existing credit facilities[125](index=125&type=chunk) [Other (Income) Expense, Net](index=31&type=section&id=Other%20%28Income%29%20Expense%2C%20Net) Other (Income) Expense, Net (in thousands) | Period | 2025 | 2024 | | :------------------- | :----- | :----- | | Three Months Ended June 30 | $5,000 (income) | $1,000 (expense) | | Six Months Ended June 30 | $8,000 (income) | $2,400 (expense) | - Income for 2025 periods primarily included net gains from foreign currency effects (**$4.5M** and **$7.4M**) and fair value adjustments to Endospan loans (**$0.5M** and **$0.8M**)[126](index=126&type=chunk) [Income Tax Expense](index=31&type=section&id=Income%20Tax%20Expense) Effective Income Tax Rate | Period | 2025 | 2024 | | :------------------- | :--- | :--- | | Three Months Ended June 30 | 61% | (13)% | | Six Months Ended June 30 | 29% | 48% | - The effective tax rate was influenced by state income taxes, non-deductible executive compensation, changes in valuation allowance, and foreign provision to return adjustments[127](index=127&type=chunk) [Non-GAAP Measures of Financial Performance](index=32&type=section&id=Non-GAAP%20Measures%20of%20Financial%20Performance) - Artivion uses constant currency revenues, a non-GAAP measure, to provide a more accurate assessment of ongoing operations and consistent performance measurement across periods, adjusting for foreign currency exchange rate effects[129](index=129&type=chunk)[130](index=130&type=chunk) [Seasonality](index=32&type=section&id=Seasonality) - Demand for aortic stent grafts and surgical sealants is typically seasonal, declining in Q3 due to European summer holidays, with surgical sealants seeing stronger demand in Q4[132](index=132&type=chunk) - Cardiac preservation services traditionally peak in Q3 for school-aged patient surgeries, while vascular preservation services see lowest demand in Q4 due to winter holidays[134](index=134&type=chunk)[135](index=135&type=chunk) - Demand for On-X and other products is not believed to be seasonal[133](index=133&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, liquidity included **$53.5 million** in cash and cash equivalents, **$30.0 million** unused revolving credit, and **$100.0 million** unused delayed draw term loan facility[137](index=137&type=chunk) - The company believes cash from operations and available credit facilities will meet obligations for the next twelve months, but significant business development activities may require additional debt or equity financing[137](index=137&type=chunk)[138](index=138&type=chunk) [Significant Sources and Uses of Liquidity](index=33&type=section&id=Significant%20Sources%20and%20Uses%20of%20Liquidity) [Credit Facilities](index=33&type=section&id=Credit%20Facilities) - In January 2024, Artivion secured **$350.0 million** in senior secured credit facilities, including a **$190.0 million** Term Loan, a **$100.0 million** Delayed Draw Term Loan, and a **$60.0 million** Revolving Credit Facility[139](index=139&type=chunk) - The Delayed Draw Term Loan Facility was terminated on July 2, 2025, after the Convertible Senior Notes were settled[139](index=139&type=chunk) - The Credit Facilities mature on January 18, 2030, with no scheduled principal repayments before maturity, and bear interest at Adjusted Term SOFR plus applicable margins (**10.55%** for Term Loan, **8.30%** for Revolving Credit as of June 30, 2025)[140](index=140&type=chunk) [Convertible Senior Notes](index=33&type=section&id=Convertible%20Senior%20Notes) - Artivion issued **$100.0 million** of **4.25%** Convertible Senior Notes in June 2020, maturing July 1, 2025, convertible into cash, stock, or a combination at the company's discretion[141](index=141&type=chunk) - In May 2025, approximately **$99.5 million** of these notes were exchanged for **4,334,347 shares** of common stock and a **$1.7 million** cash payment for accrued interest[142](index=142&type=chunk) - The remaining **$0.5 million** in principal was settled on July 1, 2025, by issuing **19,605 shares** of common stock[143](index=143&type=chunk) [Cash Flows](index=34&type=section&id=Cash%20Flows) Cash Flow Summary (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | Change | | :------------------------------------ | :----- | :----- | :----- | | Operating activities | $(1,942) | $642 | $(2,584) | | Investing activities | $(6,925) | $(6,124) | $(801) | | Financing activities | $6,535 | $556 | $5,979 | | Effect of exchange rate changes | $2,345 | $1,005 | $1,340 | | Increase (decrease) in cash | $13 | $(3,921) | $3,934 | [Net Cash Flows from Operating Activities](index=34&type=section&id=Net%20Cash%20Flows%20from%20Operating%20Activities) - Net cash used in operating activities increased by **$2.6 million** for the six months ended June 30, 2025, primarily due to increased working capital, professional fees for the 2024 cybersecurity incident, and changes in interest payment timing[145](index=145&type=chunk) [Net Cash Flows from Investing Activities](index=34&type=section&id=Net%20Cash%20Flows%20from%20Investing%20Activities) - Net cash used in investing activities was **$6.9 million** for the six months ended June 30, 2025, mainly for capital expenditures[146](index=146&type=chunk) [Net Cash Flows from Financing Activities](index=34&type=section&id=Net%20Cash%20Flows%20from%20Financing%20Activities) - Net cash provided by financing activities was **$6.5 million** for the six months ended June 30, 2025, primarily from stock option exercises (**$4.5M**) and financing insurance premiums (**$3.1M**), partially offset by debt payments[147](index=147&type=chunk) [Scheduled Contractual Obligations and Future Payments](index=34&type=section&id=Scheduled%20Contractual%20Obligations%20and%20Future%20Payments) - No material changes to contractual obligations outside the ordinary course of business were reported as of June 30, 2025, compared to the Annual Report on Form 10-K for December 31, 2024[148](index=148&type=chunk) [Capital Expenditures](index=34&type=section&id=Capital%20Expenditures) - Capital expenditures were **$6.9 million** for the six months ended June 30, 2025, primarily for manufacturing and tissue processing equipment, computer software, and leasehold improvements[149](index=149&type=chunk) [Off-Balance Sheet Commitments and Arrangements](index=34&type=section&id=Off-Balance%20Sheet%20Commitments%20and%20Arrangements) - No material changes to indemnification obligations were reported as of June 30, 2025[150](index=150&type=chunk) [Recent Accounting Pronouncements](index=35&type=section&id=Recent%20Accounting%20Pronouncements) - Refer to Note 1 for a discussion of recent accounting pronouncements, including the early adoption of ASU 2024-04[151](index=151&type=chunk) [Risks and Uncertainties](index=35&type=section&id=Risks%20and%20Uncertainties) - Refer to Item 1A, 'Risk Factors,' for a comprehensive discussion of risks and uncertainties affecting the company[152](index=152&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk.](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) Artivion is exposed to market risks from changes in interest rates and foreign currency exchange rates, which are managed through operating and financing activities. No material changes in market risk disclosures were reported as of June 30, 2025, compared to the prior annual report - The company is exposed to market risks from changes in interest rates (including credit spreads) and foreign currency exchange rates[153](index=153&type=chunk) - No material changes in market risk disclosures were reported as of June 30, 2025, compared to the Annual Report on Form 10-K for December 31, 2024[153](index=153&type=chunk) [Item 4. Controls and Procedures.](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management, including the CEO and CFO, concluded that Artivion's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025. No material changes in internal controls over financial reporting occurred during the quarter [Evaluation of Disclosure Controls and Procedures](index=35&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Artivion maintains disclosure controls designed to ensure timely and accurate reporting of information required in Exchange Act reports[154](index=154&type=chunk) - As of June 30, 2025, the CEO and CFO concluded that the disclosure controls were effective at a reasonable assurance level, based on criteria from the COSO 'Internal Control-Integrated Framework (2013)'[156](index=156&type=chunk) [Changes to Disclosure Controls and Procedures](index=35&type=section&id=Changes%20to%20Disclosure%20Controls%20and%20Procedures) - No material changes in internal controls over financial reporting occurred during the three months ended June 30, 2025[157](index=157&type=chunk) Part II – OTHER INFORMATION [Item 1. Legal Proceedings.](index=36&type=section&id=Item%201.%20Legal%20Proceedings.) Artivion is involved in various legal proceedings arising from its business activities but does not believe any pending matters will have a material adverse effect on its financial condition or operations. However, adverse outcomes in any legal proceeding could be material - Artivion is involved in legal proceedings in the normal course of business and regularly evaluates their status to assess potential losses[158](index=158&type=chunk) - Based on current knowledge, no pending matters are believed to have a material adverse effect on the business, financial condition, results of operations, or cash flows[159](index=159&type=chunk) [Item 1A. Risk Factors.](index=36&type=section&id=Item%201A.%20Risk%20Factors.) This section outlines various risks and uncertainties that could materially and adversely impact Artivion's business, including international operations, intense market competition, dependence on specific product lines (tissue preservation, BioGlue, aortic stent grafts, On-X), supply chain vulnerabilities, regulatory compliance, and financial risks related to indebtedness and common stock ownership [Risks Relating to Our Business](index=36&type=section&id=Risks%20Relating%20to%20Our%20Business) [Business and Economic Risks](index=36&type=section&id=Business%20and%20Economic%20Risks) - International operations expose Artivion to risks such as staffing difficulties, compliance obligations (e.g., FCPA, GDPR), conflicting regulatory requirements, longer collection cycles, currency exchange rate fluctuations, inflationary pressures, and geopolitical conflicts (e.g., Ukraine war, Middle East instability)[162](index=162&type=chunk)[164](index=164&type=chunk) - The company faces intense competition from larger medical device companies and tissue service providers with greater resources, potentially impacting its ability to compete effectively[165](index=165&type=chunk)[166](index=166&type=chunk) - Significant dependence on tissue preservation services means risks related to tissue sourcing, processing, contamination, and regulatory changes (e.g., FDA guidances on tuberculosis transmission)[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) - Dependence on BioGlue, aortic stent grafts, and On-X products means risks related to regulatory approvals, animal-based components, market adoption, and competition[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk) - Fluctuations in foreign currencies, particularly the Euro against the US Dollar, could materially and adversely affect revenues, financial condition, profitability, and cash flows[175](index=175&type=chunk) - Intellectual property risks include maintaining trade secrets, patent validity, potential infringement by others, and dependence on in-licensed IP, with disputes being costly[176](index=176&type=chunk)[177](index=177&type=chunk) - Public health crises can negatively impact healthcare system capacity, procedure volumes, staffing, and R&D timelines, similar to the COVID-19 pandemic[178](index=178&type=chunk) [Operational Risks](index=39&type=section&id=Operational%20Risks) - Heavy dependence on suppliers and contract manufacturers for quality products means risks from regulatory non-compliance, material failures, recalls, and supply chain disruptions (e.g., geopolitical issues, labor shortages)[179](index=179&type=chunk)[180](index=180&type=chunk)[182](index=182&type=chunk) - Reliance on single and sole-source suppliers for critical materials (e.g., BioGlue components, On-X grafts, collagen suspension) and single manufacturing facilities (Austin, Hechingen, Kennesaw, Slovakia, North Carolina, Israel) poses significant disruption risks[183](index=183&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk] - Dependence on a specialized workforce, including key personnel and qualified staff, means risks from talent loss, inadequate performance, and competition for skilled employees[190](index=190&type=chunk) - Growth through acquisitions, licenses, and distribution arrangements carries risks such as equity dilution, cash usage, debt incurrence, unfavorable tax consequences, inability to realize anticipated benefits, and assumption of unknown liabilities[191](index=191&type=chunk)[193](index=193&type=chunk) - Significant disruptions of IT systems or breaches of information security, like the 2024 cybersecurity incident, can disrupt business operations, impact revenue, manufacturing, and incur ongoing expenses, with limited insurance coverage[197](index=197&type=chunk)[199](index=199&type=chunk)[201](index=201&type=chunk) - Environmental, social, and governance (ESG) matters pose risks due to evolving and sometimes contradictory regulations and stakeholder expectations, potentially impacting reputation, employee retention, customer relationships, and financial results[202](index=202&type=chunk) [Legal, Quality, and Regulatory Risks](index=43&type=section&id=Legal%2C%20Quality%2C%20and%20Regulatory%20Risks) - Products and tissues are highly regulated, leading to risks of product recalls, liability claims, regulatory scrutiny of operations, reclassification or suspension of approvals, and adverse publicity[203](index=203&type=chunk) - The EU Medical Device Regulation (MDR) imposes stricter requirements, causing delays and uncertainties in product classifications, clinical studies, and CE Mark renewals, potentially impacting product supply in Europe[204](index=204&type=chunk)[205](index=205&type=chunk) - Potential FDA reclassification of CryoValve SG pulmonary heart valve to Class III medical device could make continued processing commercially infeasible due to significant PMA application costs and delays[206](index=206&type=chunk)[207](index=207&type=chunk) - Failure to obtain clinical results or regulatory approvals for new/existing products, or achieve market acceptance, could materially affect financial performance, as seen with the PROACT Xa and PROACT Mitral trials[209](index=209&type=chunk)[210](index=210&type=chunk)[213](index=213&type=chunk) - Increased environmental regulations and litigation related to EtO sterilization and PFAS substances could lead to facility closures, supply disruptions, and financial/reputational harm[214](index=214&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) - Risks of fines and sanctions for promoting unapproved ('off-label') uses of products, and breaches of US and international bribery, anti-kickback, false claims, and data privacy laws (e.g., GDPR)[217](index=217&type=chunk)[218](index=218&type=chunk)[226](index=226&type=chunk) - US policy changes (e.g., international trade, tariffs, tax policy, federal spending, regulatory agency capabilities) could negatively impact business operations and financial performance[220](index=220&type=chunk)[221](index=221&type=chunk)[222](index=222&type=chunk) - Exposure to product liability claims, with existing claims-made insurance potentially insufficient to cover all losses or punitive damages, could lead to costly litigation and reputational harm[223](index=223&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk) [Risks Relating to Our Indebtedness](index=48&type=section&id=Risks%20Relating%20to%20Our%20Indebtedness) - Debt agreements contain restrictive covenants limiting operational flexibility, including restrictions on incurring additional debt, paying dividends, disposing of assets, and making investments[228](index=228&type=chunk)[231](index=231&type=chunk) - High indebtedness could adversely affect the ability to raise additional capital, limit operational flexibility, and expose the company to interest rate fluctuations due to variable rate borrowings[229](index=229&type=chunk) - Defaulting on credit agreements could lead to acceleration of debt repayment and seizure of substantially all US assets pledged as collateral, with no assurance of sufficient assets to repay in full[230](index=230&type=chunk)[232](index=232&type=chunk) [Risks Relating to Ownership of our Common Stock](index=49&type=section&id=Risks%20Relating%20to%20Ownership%20of%20our%20Common%20Stock) - Stockholder activism could disrupt business, divert management attention, create uncertainty, and impact stock price or talent retention[233](index=233&type=chunk) - No dividends are anticipated for the foreseeable future, meaning stockholders may only receive returns through stock appreciation, and credit facility restrictions limit future dividend payments[234](index=234&type=chunk) - Delaware law and anti-takeover provisions in organizational documents may discourage or prevent a change of control, even if beneficial to stockholders, potentially affecting share price and management removal attempts[235](index=235&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) Artivion did not repurchase any equity securities during the three months ended June 30, 2025. Repurchases are generally prohibited under credit facilities, with exceptions for stock tendered in payment of taxes or stock option exercise prices - The Company did not repurchase any of its equity securities during the three months ended June 30, 2025[236](index=236&type=chunk) - Repurchases of common stock are prohibited under credit facilities, except for stock tendered by employees/directors for taxes or stock option exercise prices, subject to certain requirements[236](index=236&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) There were no defaults upon senior securities reported - No defaults upon senior securities were reported[237](index=237&type=chunk) [Item 4. Mine Safety Disclosures.](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to Artivion, Inc. - Mine Safety Disclosures are not applicable to the registrant[238](index=238&type=chunk) [Item 5. Other Information.](index=50&type=section&id=Item%205.%20Other%20Information.) This section provides other information, including details on insider trading arrangements and policies [Insider Trading Arrangements and Policies](index=50&type=section&id=Insider%20Trading%20Arrangements%20and%20Policies) - No director or officer notified the company of the adoption or termination of a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the three months ended June 30, 2025[240](index=240&type=chunk) [Item 6. Exhibits.](index=50&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the Form 10-Q, including certifications, XBRL documents, and other required filings - The exhibit index includes certifications by J. Patrick Mackin and Lance A. Berry, XBRL Instance Document, Taxonomy Extension Schema, Calculation Linkbase, Definition Linkbase, Label Linkbase, Presentation Linkbase, and Cover Page Interactive Data File[243](index=243&type=chunk) [Signatures](index=52&type=section&id=Signatures) The report is duly signed on behalf of Artivion, Inc. by its Chairman, President, and Chief Executive Officer, J. Patrick Mackin, and its Chief Financial Officer and Executive Vice President, Finance, Lance A. Berry, on August 8, 2025 - The report is signed by J. Patrick Mackin, Chairman, President, and Chief Executive Officer, and Lance A. Berry, Chief Financial Officer and Executive Vice President, Finance, on August 8, 2025[247](index=247&type=chunk)