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Artivion, Inc. (AORT) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference (Transcript)
Seeking Alpha· 2025-09-10 21:03
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]
Artivion (NYSE:AORT) FY Conference Transcript
2025-09-10 19:37
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]
Artivion to Participate in Morgan Stanley 23rd Annual Global Healthcare Conference
Prnewswire· 2025-09-05 20:10
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]
Artivion (AORT) FY Conference Transcript
2025-08-13 15:30
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]
Artivion(AORT) - 2025 Q2 - Quarterly Report
2025-08-08 15:30
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)
Artivion (AORT) Tops Q2 Earnings and Revenue Estimates
ZACKS· 2025-08-07 23:06
Company Performance - Artivion reported quarterly earnings of $0.24 per share, exceeding the Zacks Consensus Estimate of $0.11 per share, and up from $0.07 per share a year ago, representing an earnings surprise of +118.18% [1] - The company posted revenues of $112.97 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 4.36%, compared to $98.02 million in the same quarter last year [2] - Over the last four quarters, Artivion has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Artivion shares have increased approximately 12.9% since the beginning of the year, outperforming the S&P 500's gain of 7.9% [3] - The current consensus EPS estimate for the upcoming quarter is $0.15 on revenues of $108.75 million, and for the current fiscal year, it is $0.48 on revenues of $429.25 million [7] Industry Outlook - The Medical - Instruments industry, to which Artivion belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of Artivion's stock may be influenced by the overall outlook for the industry, as research shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]
Artivion(AORT) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $113 million, representing a year-over-year increase of over 14% compared to 2024 [17] - Adjusted EBITDA grew approximately 33% from $18.6 million to $24.8 million in Q2 2025 [17] - Adjusted EBITDA margin improved to 21.9%, reflecting a 300 basis point increase from the prior year [18] - Gross margins were 64.7% in Q2 2025, slightly up from 64.6% in 2024 [19] Business Line Data and Key Metrics Changes - On X revenue increased by 24% year-over-year on a constant currency basis [5] - Stent graft revenues grew by 22% on a constant currency basis [6] - BioGlue revenue grew by 4% year-over-year [10] - Tissue processing revenues increased by 3% year-over-year [10] Market Data and Key Metrics Changes - Revenues in North America increased by 18%, Asia Pacific by 15%, EMEA by 10%, and Latin America by 7%, all compared to 2024 [18] Company Strategy and Development Direction - The company is focused on expanding its addressable market through ongoing product launches, particularly the AMDS following FDA approval [4][12] - The strategy includes leveraging cross-selling opportunities and enhancing the product portfolio to drive growth [6][26] - The company aims to deliver sustainable double-digit revenue growth and drive EBITDA margin expansion [15][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth and expanding EBITDA margins, driven by strong product performance and market opportunities [15][26] - The company anticipates a full-year revenue growth rate of 12% to 14% for 2025, raising the midpoint of its guidance [22][23] - Management highlighted the positive reception of the AMDS launch and the potential for significant market opportunities [10][12] Other Important Information - The company successfully reduced its net leverage ratio from 4.1 to 2.2 by retiring convertible debt [21][22] - Free cash flow for Q2 2025 was $11.7 million, with expectations to remain positive for the full year [21][86] Q&A Session Summary Question: Update on AMDS and hospital adoption - Management noted that there are about 1,000 accounts capable of performing AMDS procedures, with ongoing training sessions leading to increased cross-selling opportunities [35][36] Question: BioGlue launch in China - Management indicated that BioGlue is expected to launch in the second half of 2025, with ongoing preparations [40] Question: Guidance dynamics and currency impact - Management explained that the guidance was adjusted due to strong Q2 performance and favorable currency movements, leading to an increase in revenue expectations [42][43] Question: Physician adoption of AMDS - Management reported positive feedback from physicians, noting that the device is simple to use and has been quickly integrated into practices [47][49] Question: Future expansion of the commercial team - Management stated that while they are evaluating expansion, the focus remains on the top 600 centers for the AMDS launch [54] Question: Next steps for Arecibo trial - Management confirmed that they expect to enroll the first patient in the Arecibo trial by the end of the year, pending hospital contracts and IRB approvals [57] Question: Pricing trends - Management indicated that there has been no significant price pressure, with modest inflationary price increases continuing [79] Question: Contribution of On X growth from cross-selling - Management acknowledged a meaningful uptick from new accounts, attributing growth to both cross-selling and new data [84]
Artivion (AORT) Q2 EPS Jumps 243%
The Motley Fool· 2025-08-07 21:23
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]
Artivion(AORT) - 2025 Q2 - Earnings Call Presentation
2025-08-07 20:30
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]
Artivion(AORT) - 2025 Q2 - Quarterly Results
2025-08-07 20:09
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)