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DATA BREACH ALERT: Edelson Lechtzin LLP Is Investigating Claims On Behalf Of Artivion, Inc. Customers Whose Data May Have Been Compromised
GlobeNewswire News Room· 2025-07-14 03:02
Core Points - Artivion, Inc. experienced a data breach on or about November 20, 2024, involving unauthorized access to its network [3] - The breach potentially compromised sensitive personal data, including names, Social Security Numbers, driver's license numbers, and direct deposit details [3] - Edelson Lechtzin LLP is investigating the incident and considering a class action lawsuit for affected individuals [4] Company Overview - Artivion, Inc. is a global medical device company based in Kennesaw, Georgia, founded in 1984 and previously known as CryoLife [2] - The company specializes in manufacturing, processing, and distributing medical devices and implantable tissues for cardiac and vascular procedures [2]
Artivion (AORT) Earnings Call Presentation
2025-06-27 13:32
Financial Performance and Guidance - Artivion reported approximately $400 million in revenue and around $70 million in EBITDA for FY24[4] - The company projects revenue between $423 million and $435 million for 2025, representing constant currency revenue growth of 11%-14% compared to 2024[3] - Artivion anticipates Adjusted EBITDA between $84 million and $91 million in 2025, a growth of 18-28% over 2024[3] - The company expects net debt leverage to decrease to below 20x by the end of 2025[3] Market Opportunities and Growth Strategy - Artivion is focused on driving sustained double-digit revenue growth and 2x+ EBITDA growth[3, 13] - The company estimates a total addressable market of approximately $4 billion for E-vita OPEN NEO, AMDS, NEXUS, E-nside, Artivex and E-tegra, with market growth rates between mid-single and mid-teen digits[3] - Mechanical Heart Valves (On-X) hold the 2 position with 34% market share in a $250 million global market[16] - Preservation Services (CryoValve® SG) holds the 1 position with 65% market share in a $150 million global market[16] - Surgical Sealant (BioGlue) holds the 2 position with 28% market share in a $260 million global market[16] Clinical Trial Data and Product Development - AMDS PERSEVERE US IDE study data demonstrates a significant reduction in Major Adverse Events (MAEs) at 30 days compared to the hemiarch control group (269% vs 580%)[38] - Endospan NEXUS ® TRIOMPHE US IDE Trial 30-day data demonstrates a 63% reduction in major adverse event (MAE) rate compared to the reference performance goal (130% vs 350%, p<0001)[41] - On-X Aortic Heart Valve Post Approval Study (PAS) shows a 66% reduction in major events and an 87% reduction in major bleeding compared to the PROACT IDE study[19]
Artivion (AORT) 2025 Conference Transcript
2025-06-17 13:00
Summary of Artivion (AORT) Conference Call Company Overview - **Company**: Artivion (AORT) - **Industry**: Medical Devices, specifically focused on aortic treatments Key Points and Arguments Market Potential and Growth Strategy - Artivion operates in multiple Total Addressable Markets (TAMs) that, while individually smaller, collectively provide a durable growth runway [2][4] - The company is focused on the aortic segment, particularly advanced stent grafts, with a global market for stents and stent grafts estimated at $4 billion, of which $2 billion is in advanced stent grafts [5][6] - Artivion's pipeline includes several products with upcoming PMA submissions, including AMDS, NexSys, and Arecibo, which are expected to contribute to growth every 18 months [9][10] Product Pipeline and Innovations - **AMDS**: Expected PMA approval by mid-2026, with a TAM of over $500 million [12][13] - **NexSys**: A pivotal trial with 60 patients showed promising results, with a focus on chronic dissections [32][33] - **Arecibo**: A product for total replacement of the aortic arch, with trials expected to start later this year [8] - The company has a unique patented technology for aortic dissection that significantly reduces mortality rates [15][16] Financial Performance and Projections - Artivion aims for EBITDA growth at twice the rate of top-line growth, driven by margin expansion and operational efficiencies [69][71] - The company has successfully reduced leverage and improved cash flow, with a focus on maintaining reasonable debt levels while funding growth initiatives [45][46] Sales and Market Penetration - The existing sales force is deemed adequate for launching new products, with no immediate plans for expansion [21][22] - The company is actively working with over 150 accounts to navigate hospital bureaucracy for product adoption [23][24] Risks and Challenges - The primary risk to growth acceleration is the timing of hospital bureaucracy related to product adoption [68] - The company experienced a cyber attack that impacted supply chains, but recovery is expected by the end of Q3 [63][66] Competitive Landscape - Artivion's On X mechanical valve has shown a 14% CAGR over the past eight years, with a TAM of $250 million [54] - Recent studies indicate a mortality benefit for mechanical valves, opening up additional market opportunities [58][61] Conclusion - Artivion is positioned for significant growth in the aortic medical device market, with a strong pipeline of innovative products and a focus on operational efficiency and margin expansion. The company is navigating challenges related to market entry and hospital adoption but remains optimistic about future performance.
Artivion Announces Closing of Transactions to Exchange $99.5 Million in Principal Amount of its 4.250% Convertible Notes Due 2025 for Common Stock
Prnewswire· 2025-05-28 21:51
Core Viewpoint - Artivion, Inc. has successfully closed transactions related to privately negotiated exchange agreements with holders of its 4.250% Convertible Senior Notes due 2025, significantly reducing its outstanding debt and enhancing its financial position [1][3]. Financial Transactions - The exchange agreements involved the conversion of approximately $99.54 million of Notes into 4,334,347 shares of common stock, along with a cash payment of approximately $1.7 million for accrued and unpaid interest [2]. - Following the transactions, only about $0.46 million in principal amount of the Notes remains outstanding [2]. Management Commentary - The CEO of Artivion highlighted that the retirement of the convertible notes is a significant milestone that reduces leverage ratios and enhances balance sheet flexibility [3]. Advisory Role - J. Wood Capital Advisors LLC served as the financial advisor to Artivion during these exchange transactions [4]. Company Overview - Artivion, Inc. is a medical device company focused on solutions for cardiac and vascular surgery, particularly in treating aortic diseases, with a product range that includes aortic stent grafts, surgical sealants, mechanical heart valves, and implantable tissues [7].
Artivion Announces Agreements to Exchange $95 Million in Principal Amount of its 4.250% Convertible Notes Due 2025 for Common Stock
Prnewswire· 2025-05-14 20:01
Core Viewpoint - Artivion, Inc. has entered into privately negotiated exchange agreements to repurchase approximately $95 million of its 4.250% Convertible Senior Notes due 2025 in exchange for shares of its common stock, with the transaction expected to close around May 28, 2025 [1] Group 1: Exchange Agreements - The company will repurchase approximately $95 million principal amount of Existing Convertible Notes in exchange for shares of common stock, with the number of shares to be determined based on the trading price over a four-day averaging period starting May 15, 2025 [1] - At the closing stock price of $28.91, the transaction would result in the issuance of approximately 4.1 million shares [1] - Cash will also be paid to note holders for accrued and unpaid interest as part of the exchange agreements [1] Group 2: Financial Advisory - J. Wood Capital Advisors LLC acted as the financial advisor to Artivion in connection with the exchange transactions [2] Group 3: Company Overview - Artivion, Inc. is a medical device company focused on developing solutions for cardiac and vascular surgeons, particularly in treating aortic diseases [5] - The company’s product groups include aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues, marketed in over 100 countries [5]
Artivion(AORT) - 2025 Q1 - Quarterly Report
2025-05-06 19:10
Part I [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements.) Artivion reported Q1 2025 revenues of **$99.0 million** (+2%), but a **net loss of $0.5 million** due to increased expenses [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20%28Loss%29%20Income) Q1 2025 revenues rose 2% to **$99.0 million**, but operating income sharply declined to **$2.1 million**, resulting in a **net loss of $0.5 million** Q1 2025 vs Q1 2024 Statement of Operations Highlights (In Thousands, Except Per Share Data) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$98,978** | **$97,431** | **+1.6%** | | - Products | $78,798 | $71,114 | +10.8% | | - Preservation services | $20,180 | $26,317 | -23.3% | | **Gross Margin** | **$63,577** | **$62,946** | **+1.0%** | | General, administrative, and marketing | $54,704 | $30,689 | +78.2% | | **Operating Income** | **$2,145** | **$25,311** | **-91.5%** | | **Net (Loss) Income** | **($505)** | **$7,533** | **-106.7%** | | **Diluted (Loss) Income Per Share** | **($0.01)** | **$0.18** | **-105.6%** | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets were **$791.2 million**, cash decreased to **$37.7 million**, and total liabilities declined to **$496.9 million** Balance Sheet Highlights (In Thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $37,693 | $53,463 | | Total current assets | $287,297 | $290,080 | | Total assets | $791,163 | $789,101 | | Total current liabilities | $51,940 | $66,823 | | Long-term debt, net | $314,611 | $314,152 | | Total liabilities | $496,911 | $512,901 | | Total stockholders' equity | $294,252 | $276,200 | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$17.0 million** in Q1 2025, leading to a **$15.8 million** decrease in cash and cash equivalents Q1 2025 vs Q1 2024 Cash Flow Summary (In Thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash flows used in operating activities | ($16,953) | ($5,493) | | Net cash flows used in investing activities | ($3,638) | ($3,611) | | Net cash flows provided by financing activities | $3,937 | $737 | | **Decrease in cash and cash equivalents** | **($15,770)** | **($7,822)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the 2024 debt refinancing, segment and geographic revenue trends, and a **$2.8 million** gain from contingent consideration fair value adjustment - In January 2024, the company entered into a new **$350.0 million** credit facility with Ares Management, using the proceeds to repay its old credit facilities. This resulted in a **$3.7 million** loss on extinguishment of debt in Q1 2024[49](index=49&type=chunk)[61](index=61&type=chunk) Revenue by Segment (Q1 2025 vs Q1 2024, In Thousands) | Segment | Q1 2025 Revenue | Q1 2024 Revenue | Change | | :--- | :--- | :--- | :--- | | Medical devices | $78,798 | $71,114 | +10.8% | | Preservation services | $20,180 | $26,317 | -23.3% | | **Total revenues** | **$98,978** | **$97,431** | **+1.6%** | Revenue by Geography (Q1 2025 vs Q1 2024, In Thousands) | Region | Q1 2025 Revenue | Q1 2024 Revenue | Change | | :--- | :--- | :--- | :--- | | North America | $47,793 | $50,928 | -6.2% | | EMEA | $37,045 | $33,588 | +10.3% | | APAC | $8,214 | $7,609 | +8.0% | | LATAM | $5,926 | $5,306 | +11.7% | | **Total revenues** | **$98,978** | **$97,431** | **+1.6%** | - The company recorded a net fair value gain of **$2.8 million** for the three months ended March 31, 2025, from a change in the fair value of contingent consideration related to the Ascyrus acquisition. This compares to a **$17.5 million** gain in the same period of 2024[37](index=37&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) MD&A highlights Q1 2025 revenue growth driven by Medical Devices, offset by Preservation Services decline due to a cyber incident, and discusses liquidity [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 revenues grew 2% (4% CC), driven by product sales, while Preservation Services declined 23% due to a cyber incident backlog, and G,A&M expenses surged Q1 2025 Revenue Growth by Product (As Reported vs. Constant Currency) | Product Line | As Reported Change | Constant Currency Change | | :--- | :--- | :--- | | Aortic stent grafts | +14% | +19% | | On-X | +10% | +11% | | Surgical sealants | +7% | +9% | | **Total products** | **+11%** | **+14%** | | Preservation services | -23% | -23% | | **Total Revenues** | **+2%** | **+4%** | - The decrease in Preservation Services revenue was primarily due to a backlog of tissues to be released for shipment as a result of the 2024 cybersecurity incident, which is expected to improve throughout 2025[103](index=103&type=chunk) - General, administrative, and marketing expenses increased by **$9.4 million** after excluding the impact of contingent consideration adjustments. This was driven by **$4.5 million** of expenses associated with the 2024 cybersecurity incident and higher non-cash stock compensation[110](index=110&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$37.7 million** in cash and **$320.1 million** in debt, with available credit facilities to support future liquidity needs - The company's liquidity position includes **$37.7 million** in cash, **$30.0 million** in unused revolving credit, and a **$100.0 million** delayed draw term loan facility[124](index=124&type=chunk) - The **$100.0 million** delayed draw term loan facility was established solely to make funds available for the repurchase or repayment of the Convertible Senior Notes due July 1, 2025[126](index=126&type=chunk) - Net cash used in operating activities increased by **$11.5 million** year-over-year, primarily due to professional fees from the 2024 cybersecurity incident and the timing of interest payments on new credit facilities[132](index=132&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company faces market risks from interest rates and foreign currency, with no material changes since fiscal year 2024 - As of March 31, 2025, there has been no material change in the company's market risk disclosures from its 2024 Annual Report on Form 10-K[140](index=140&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[143](index=143&type=chunk) - No changes in internal controls over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[144](index=144&type=chunk) Part II [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings.) The company is involved in routine legal actions, with no pending matters expected to have a material adverse effect - Based on current knowledge, the company does not believe there are any pending legal matters that could have a material, adverse effect on its business or financial condition[146](index=146&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors.) The company faces significant risks from geopolitical instability, supply chain dependencies, cybersecurity incidents, and regulatory hurdles like EU MDR and potential FDA reclassification - The NEXUS family of products are solely manufactured by Endospan in Herzliya, Israel, exposing the company to supply chain disruptions from instability in the Middle East[151](index=151&type=chunk) - The company experienced a cyber-attack in Q4 2024 that disrupted business operations and continues to incur related expenses. It remains subject to risks from this incident, including potential for scrap, inventory issues, and shipping delays[185](index=185&type=chunk) - The transition to the European Union's Medical Device Regulation (MDR) presents significant risks, including potential delays or prevention of commercializing products in Europe and other markets that rely on CE Marking[190](index=190&type=chunk)[191](index=191&type=chunk) - The FDA is considering reclassifying allograft heart valves, including the company's CryoValve SGPV, to Class III medical devices, which could make continued processing commercially infeasible due to the onerous PMA application process[192](index=192&type=chunk)[193](index=193&type=chunk) - The company is dependent on single-source suppliers for key components of its major products, including BioGlue, On-X, and aortic stent grafts, creating significant supply chain vulnerability[169](index=169&type=chunk)[171](index=171&type=chunk)[173](index=173&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company did not repurchase any equity securities in Q1 2025, with current credit facilities generally prohibiting such transactions - The Company did not repurchase any of its equity security during the three months ended March 31, 2025[221](index=221&type=chunk) [Other Information](index=46&type=section&id=Item%205.%20Other%20Information.) In March 2025, two officers adopted Rule 10b5-1 trading plans for future sales of company common stock - Chief Accounting Officer Amy D. Horton and Chief Medical Officer Marshall S. Stanton adopted Rule 10b5-1 trading plans in March 2025 for future sales of company stock[224](index=224&type=chunk) [Exhibits](index=47&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and XBRL data files
Artivion (AORT) Lags Q1 Earnings Estimates
ZACKS· 2025-05-05 22:51
Core Viewpoint - Artivion (AORT) reported quarterly earnings of $0.06 per share, missing the Zacks Consensus Estimate of $0.12 per share, representing a 50% earnings surprise [1] - The company posted revenues of $98.98 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 4.19% [2] Financial Performance - Artivion's earnings of $0.06 per share are unchanged from the same quarter last year, and the company has surpassed consensus EPS estimates two times over the last four quarters [1][2] - The company has topped consensus revenue estimates three times in the last four quarters, with year-ago revenues of $97.43 million [2] Stock Performance - Artivion shares have declined approximately 18.4% since the beginning of the year, compared to a decline of 3.3% for the S&P 500 [3] - The current Zacks Rank for Artivion is 3 (Hold), indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.16 on revenues of $108.7 million, and for the current fiscal year, it is $0.68 on revenues of $426.65 million [7] - The outlook for the Medical - Instruments industry is positive, ranking in the top 28% of over 250 Zacks industries, suggesting potential for outperformance [8]
Artivion(AORT) - 2025 Q1 - Earnings Call Transcript
2025-05-05 21:32
Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $99 million, representing a 4% increase compared to Q1 2024 [21] - Adjusted EBITDA increased approximately 1% from $17.3 million to $17.5 million in Q1 2025 [21] - Adjusted EBITDA margin was 17.7% in Q1 2025, relatively flat compared to Q1 2024 [22] - Gross margins decreased to 64.2% in Q1 2025 from 64.6% in Q1 2024 due to lower revenue from higher margin preservation services [23] Business Line Data and Key Metrics Changes - Strength graft revenues grew 19% on a constant currency basis in Q1 2025 compared to the same period last year [10] - On X revenue increased by 11% year over year on a constant currency basis [13] - BioGlue revenues grew 9% on a constant currency basis compared to the same period last year [14] - Tissue processing revenues declined 23% year over year on a constant currency basis due to the backlog caused by a cybersecurity incident [14] Market Data and Key Metrics Changes - Revenues in Latin America increased by 26%, EMEA increased by 14%, Asia Pacific increased by 8%, while North America declined by 6% compared to Q1 2024 [22] - Latin America and Asia Pacific delivered constant currency revenue growth of 268% respectively in Q1 2025 [15] Company Strategy and Development Direction - The company is focused on ramping up On X supply and clearing the tissue processing backlog, with expectations to fully catch up by the end of Q3 2025 [9][15] - The ongoing launch of AMDS in the U.S. is expected to penetrate a $150 million annual market opportunity [33] - The company aims to leverage positive clinical data to drive growth in the On X heart valve segment, targeting a $100 million market expansion opportunity [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth and twice that rate for EBITDA in 2025 [20][31] - The company anticipates strong revenue growth in the second half of 2025 due to ramping AMDS sales and an easier comparable in Q4 [28] - Management highlighted the positive reception from the clinical community regarding AMDS and the potential for significant market expansion [51] Other Important Information - The company incurred approximately $4.7 million in Q1 2025 associated with the cybersecurity incident, which is excluded from adjusted EBITDA [23] - The net leverage at the end of Q1 was 4.0, down from 4.5 in the prior year [26] - The company does not anticipate the need to raise additional capital to fund its debt obligations or investments in the foreseeable future [25] Q&A Session Summary Question: Contribution of AMDS to growth and onboarding of facilities - Management noted that AMDS contributed to the strong growth, but specific numbers were not disclosed. They are encouraged by the reception from the clinical community and the progress in onboarding facilities [38][40] Question: Tissue growth expectations for the year - Management expects to return to mid-single-digit growth for tissue processing for the full year, with the backlog being cleared by Q2 and Q3 [41][43] Question: Cash flow expectations for the year - Management expects to be free cash flow positive for the year, with Q1 typically being the worst quarter for cash flow due to seasonal expenses [53][54] Question: Growth rates for On X and stent grafts - Management expects On X to continue double-digit growth and stent grafts to grow at a mid-teens rate for the full year, with AMDS expected to improve overall growth rates by 1-2 percentage points [64] Question: Timing for acquiring Endospan - The option to acquire Endospan will trigger upon FDA approval, which is expected in the second half of 2026 [75] Question: Nexus data and its implications - Management expressed optimism about the Nexus data and its potential for FDA approval, which would trigger the acquisition option [76][81]
Artivion(AORT) - 2025 Q1 - Earnings Call Transcript
2025-05-05 20:30
Financial Data and Key Metrics Changes - The company reported total revenues of $99 million for Q1 2025, reflecting a 4% increase compared to Q1 2024 [21] - Adjusted EBITDA increased approximately 1% from $17.3 million to $17.5 million in Q1 2025 [21] - Adjusted EBITDA margin was 17.7% in Q1 2025, relatively flat compared to Q1 2024 [22] - Gross margins decreased to 64.2% in Q1 2025 from 64.6% in Q1 2024 due to lower revenue from higher margin preservation services [23] Business Line Data and Key Metrics Changes - Strength graft revenues grew 19% on a constant currency basis in Q1 2025 compared to the same period last year [10] - On X revenue increased by 11% year over year on a constant currency basis [13] - BioGlue revenues grew 9% on a constant currency basis compared to the same period last year [14] - Tissue processing revenues declined 23% year over year on a constant currency basis due to the backlog caused by a cybersecurity incident [14] Market Data and Key Metrics Changes - Revenues in Latin America increased by 26%, EMEA increased by 14%, Asia Pacific increased by 8%, while North America declined by 6% compared to Q1 2024 [22] - Latin America and Asia Pacific delivered constant currency revenue growth of 268% respectively in Q1 2025 [15] Company Strategy and Development Direction - The company is focused on ramping up On X supply and clearing the tissue processing backlog, with expectations to be fully caught up by the end of Q3 2025 [9][15] - The ongoing launch of AMDS in the U.S. is a key growth driver, with approximately 150 facilities actively seeking IRB and Value Analysis Committee approvals [12][13] - The company aims to capitalize on the $100 million market expansion opportunity for mechanical valves based on new clinical data [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion [20] - The company raised its full-year 2025 revenue guidance to expect constant currency growth of between 11% to 14% [26] - Management noted that the unfavorable impact of preservation services in Q1 will be fully caught up by the end of Q3, with AMDS sales expected to grow sequentially each quarter [27] Other Important Information - The company incurred approximately $4.7 million in Q1 2025 associated with the cybersecurity incident, which is excluded from adjusted EBITDA [23] - The net leverage at the end of Q1 was 4.0, down from 4.5 in the prior year [26] Q&A Session Summary Question: Contribution of AMDS to growth and onboarding of facilities - Management indicated that AMDS contributed to the growth but did not break out specific numbers, and the onboarding of facilities is progressing well with a 100% hit rate on targeted accounts [39][41] Question: Tissue growth expectations for the year - Management expects tissue growth to return to mid-single digits for the full year, with the backlog from the cybersecurity incident being cleared [43][45] Question: Cash flow expectations for the year - Management anticipates being free cash flow positive for the year, with Q1 typically being the worst quarter for cash flow due to seasonal expenses [56][58] Question: Growth rates for On X and stent grafts - Management expects On X to continue double-digit growth and stent grafts to grow at a mid-teens rate, with AMDS expected to improve overall growth rates by 1-2 percentage points [66] Question: Timing for potential acquisition of Endospan - The option to acquire Endospan will trigger upon FDA approval, with a decision required within 90 days of approval [76][78] Question: Nexus data and its implications - Management expressed optimism about the Nexus data and its potential for FDA approval, which would trigger the acquisition option [76][80]
Artivion(AORT) - 2025 Q1 - Earnings Call Transcript
2025-05-05 20:30
Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $99 million, reflecting a 4% increase compared to Q1 2024 [20] - Adjusted EBITDA increased approximately 1% from $17.3 million to $17.5 million in Q1 2025 [20] - Adjusted EBITDA margin was 17.7%, relatively flat compared to the previous year [21] - Gross margins decreased to 64.2% from 64.6% year over year due to lower revenue from higher margin products [22] Business Line Data and Key Metrics Changes - Strength graft revenues grew 19% on a constant currency basis in Q1 2025 [8] - On X revenue increased by 11% year over year on a constant currency basis [11] - BioGlue revenues grew 9% on a constant currency basis [12] - Tissue processing revenues declined 23% year over year due to the backlog caused by a cybersecurity incident [12] Market Data and Key Metrics Changes - Latin America and Asia Pacific saw constant currency revenue growth of 268% and 14% respectively in Q1 2025 [13] - North America revenues declined by 6% compared to Q1 2024 [21] - EMEA revenues increased by 14% year over year [21] Company Strategy and Development Direction - The company is focused on ramping up On X supply and clearing the tissue processing backlog, with expectations to be fully caught up by the end of Q3 2025 [7][13] - The ongoing launch of AMDS in the U.S. is a key growth driver, with approximately 150 facilities actively seeking approvals [10][11] - The company aims to leverage positive clinical data to expand market share for On X valves, particularly among younger patients [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit revenue growth and twice that rate for EBITDA in the future [19][29] - The company raised its full-year 2025 revenue guidance to a constant currency growth range of 11% to 14% [24] - Management noted that the impact of the cybersecurity incident is being resolved, with expectations for a return to normalcy in operations [6][29] Other Important Information - The company incurred approximately $4.7 million in Q1 related to the cybersecurity incident, which is excluded from adjusted EBITDA [22] - The net leverage ratio improved to 4.0 from 4.5 year over year [24] - The company does not anticipate the need to raise additional capital to fund its operations in the foreseeable future [22] Q&A Session Summary Question: Contribution of AMDS to growth and onboarding of facilities - Management indicated that AMDS contributed to the strong growth but did not break out specific numbers. They are encouraged by the reception from the clinical community and the onboarding process is progressing well [36][38] Question: Expectations for tissue growth recovery - Management expects to return to mid-single-digit growth for tissue processing by the end of the year, with the backlog being cleared in Q2 and Q3 [40][42] Question: Cash flow expectations for the year - Management expects to be free cash flow positive for the year, despite Q1 being seasonally high in expenses [54][56] Question: Growth rates for On X and stent grafts - Management expects On X to continue double-digit growth and stent grafts to grow at a mid-teens rate, with AMDS expected to improve overall growth rates [64][66] Question: Timing for acquiring Endospan - The option to acquire Endospan will trigger upon FDA approval, expected in the second half of 2026, with a decision required within 90 days of approval [72][74] Question: Feedback on Nexus data and market opportunity - Management expressed optimism about the Nexus data and its potential market impact, noting that the mortality benefits could lead to increased adoption [80][82]