Artivion Reports Fourth Quarter and Full Year 2024 Financial Results

Fourth Quarter Highlights:

• Achieved revenue of $97.3 million in the fourth quarter of 2024 versus $93.7 million in the fourth quarter of 2023, an increase of 4% on a GAAP basis and 3% on a non-GAAP constant currency basis
• Achieved revenue of $388.5 million for the full year of 2024 versus $354.0 million for the full year of 2023, an increase of 10% on a GAAP basis and 9% on a non-GAAP constant currency basis
• Net loss was $(16.5) million, or $(0.39) per fully diluted share and non-GAAP net income was $0.2 million, or $0.00 per fully diluted share in the fourth quarter of 2024. For the full year, net loss was $(13.4) million, compared to a net loss of $(30.7) million in the 2023 fiscal year
• Adjusted EBITDA increased 15% to $17.6 million in the fourth quarter of 2024 compared to $15.3 million in the fourth quarter of 2023. For the full year adjusted EBITDA increased 32% to $71.3 million
• Generated $22.2 million of operating cash flow and $11.0 million of non-GAAP free cash flow for the full year of 2024
• Granted Humanitarian Device Exemption (HDE) by the U.S. Food and Drug Administration (FDA) for the AMDS Hybrid Prosthesis
• Submitted second module of the pre-market approval application (PMA) to the FDA for AMDS Hybrid Prosthesis

ATLANTA, Feb. 24, 2025 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced financial results for the fourth quarter and year ended December 31, 2024.

"2024 was an excellent year for Artivion, marked by robust revenue and adjusted EBITDA growth, which enabled us to deliver positive free cash flow while making significant strides in key clinical and regulatory initiatives. Revenue growth in the fourth quarter was driven by year-over-year growth in On-X of 10%, stent grafts of 10%, and BioGlue of 8% all compared to the fourth quarter of 2023. On a constant currency basis, year-over-year, On-X, stent grafts, and BioGlue grew 10%, 8%, and 7%, respectively. We also saw continued revenue strength in Latin America which grew 26% both in the fourth quarter and for the full year 2024 on a constant currency basis compared to last year." said Pat Mackin, Chairman, President, and Chief Executive Officer.

Mr. Mackin continued, "In addition to our commercial results, we were also thrilled to receive a Humanitarian Device Exemption from the FDA for AMDS. This enables us to deliver our groundbreaking, life-saving technology to patients while we continue to work with the FDA toward PMA approval."  

Mr. Mackin added, "Q4 was a continuation of the outstanding progress we saw this year on multiple clinical and regulatory fronts. First, new clinical data from our AMDS PERSEVERE trial was presented in a Late-Breaking Science session at the Society of Thoracic Surgeons. It demonstrated sustained benefit of AMDS out to one-year, including a 50% reduction in mortality at one-year as compared to the reference cohort. Second, we submitted our second module of the PMA application to the FDA for AMDS."

Mr. Mackin concluded, "Finally, I'd like to thank our team members for their dedication to mitigating the late November 2024 cybersecurity incident and maintaining our ability to continue serving our customers and their patients. Thanks to their hard work, we are operating at normal levels across the business, with any remaining inefficiencies expected to be resolved in the near-term. While our Q4 revenues were negatively impacted, we do not expect this incident to meaningfully impact our business for the full year 2025. Looking ahead for 2025, we remain confident in our ability to execute on our best-in-class pipeline and drive sustained double-digit revenue growth and adjusted EBITDA growth at twice the pace of constant currency revenue growth."

Fourth Quarter 2024 Financial Results
Total revenues for the fourth quarter of 2024 were $97.3 million, an increase of 4% on a GAAP basis and 3% on a non-GAAP constant currency basis, both compared to the fourth quarter of 2023.

Net loss for the fourth quarter of 2024 was $(16.5) million, or $(0.39) per fully diluted common share, compared to net loss of $(4.0) million, or $(0.10) per fully diluted common share for the fourth quarter of 2023. Non-GAAP net income for the fourth quarter of 2024 was $0.2 million, or $0.00 per fully diluted common share, compared to non-GAAP net income of $4.6 million, or $0.11 per fully diluted common share for the fourth quarter of 2023. Non-GAAP net income for the fourth quarter of 2024 includes pretax losses related to foreign currency revaluation of $5.4 million.

Full Year 2024 Financial Results
Total revenues for 2024 were $388.5 million, an increase of 10% on a GAAP basis and 9% on a non-GAAP constant currency basis, both compared to the full year of 2023.

Net loss for 2024 was $(13.4) million, or $(0.32) per fully diluted common share, compared to net loss of $(30.7) million, or $(0.75) per fully diluted common share for the full year of 2023. Non-GAAP net income for the full year of 2024 was $10.8 million, or $0.25 per fully diluted common share, compared to non-GAAP net income of $8.4 million, or $0.20 per fully diluted common share for the full year of 2023. Non-GAAP net income for the full year of 2024 includes pretax losses related to foreign currency revaluation of $5.4 million.

2025 Financial Outlook
Artivion expects revenues for the full year 2025 to be in the range of $420 to $435 million, representing growth of 10% to 14% on a constant currency basis compared to 2024. At current exchange rates, the Company expects currency to negatively impact year-over-year as reported revenue growth rates by approximately 2%.

Additionally, Artivion expects adjusted EBITDA growth of between 18% and 28% for the full year 2025 compared to 2024, resulting in an expected range of $84 to $91 million for 2025.

The Company's financial performance for 2025 and future periods is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including non-GAAP revenue, non-GAAP net income, EBITDA, adjusted EBITDA, non-GAAP general, administrative, and marketing expenses, and free cash flows. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with US GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company's non-GAAP revenues are adjusted for the impact of changes in currency exchange. The Company's non-GAAP net income, EBITDA, adjusted EBITDA, general, administrative, and marketing, and free cash flows results primarily exclude (as applicable) depreciation and amortization expense, interest income and expense, non-cash compensation expense, loss or gain on foreign currency revaluation, income tax expense or benefit, business development, integration, and severance income or expense, loss on extinguishment of debt, non-cash interest expense, capital expenditures, and other non-recurring items.

The Company generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the Company and as a basis for strategic planning. Company management believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions, the operating expense structure of the Company's existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses, and the transaction and integration expenses incurred in connection with recently acquired and divested product lines, and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and non-cash compensation expense. The Company believes it is useful to exclude certain expenses and revenues because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as impact of recent acquisitions, non-cash expense related to amortization of previously acquired tangible and intangible assets, and any related adjustments to their carrying values. The Company has adjusted for the impact of changes in currency exchange from certain revenues to evaluate comparable product growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur. Company management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety, including the reconciliation of GAAP to non-GAAP financial measures.

The Company's adjusted EBITDA expectations for fiscal 2025 exclude potential charges or gains that may be recorded during the fiscal year, relating to, among other things, non-cash compensation; business development, integration, and severance income or expense; loss on extinguishment of debt; and foreign currency revaluations. The Company does not attempt to provide reconciliations of forward-looking adjusted EBITDA to the comparable GAAP measure because the impact and timing of these potential charges or gains are inherently uncertain and difficult to predict and are unavailable without unreasonable efforts. In addition, the Company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a material impact on GAAP measures of the Company's financial performance.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast on February 24, 2025, at 4:30 p.m. ET to discuss the results, followed by a question-and-answer session. To participate in the conference call dial 201-689-8261 a few minutes prior to 4:30 p.m. ET. The teleconference replay will be available approximately one hour following the completion of the event and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13749878.

The live webcast and replay can be accessed by going to the Investors section of the Artivion website at www.Artivion.com and selecting the heading Webcasts & Presentations.

About Artivion, Inc.
Headquartered in suburban Atlanta, Georgia, Artivion, Inc., is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, www.Artivion.com.

Forward-Looking Statements
Statements made in this press release that look forward in time or that express management's beliefs, expectations, or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include, but are not limited to, our beliefs and expectations about our revenue, year-over-year growth and growth drivers, earnings, currency impacts, and other financial measures and related information; our anticipated capital needs and capital structure; our beliefs about our competitive advantages and market opportunities; our expected product mix; anticipated quarterly fluctuations in our business; the timeline for regulatory approval for AMDS and other products; the benefits of receiving the Humanitarian Device Exemption and Breakthrough Designation for AMDS; our expected geographies and timeframes for commercializing our products; that our revenues for the full year 2025 will be in the range of $420 to $435 million, representing revenue growth of between 10% to 14% compared to 2024 on a constant currency basis; that we expect, at current exchange rates, a negative 2% currency impact on the 2025 full year revenues; our beliefs and expectations about the impact of the November 2024 cybersecurity incident; and that we expect non-GAAP adjusted EBITDA to increase between 18% and 28% for the full year 2025 compared to 2024, resulting in non-GAAP adjusted EBITDA in the range of $84 to $91 million in 2025. These forward-looking statements are subject to a number of risks, uncertainties, estimates and assumptions that may cause actual results to differ materially from current expectations, including, but not limited to, the unpredictability of the timing and outcome of regulatory decisions and other regulatory developments; risks relating to our international operations; the benefits anticipated from our new credit facility, the Ascyrus Medical LLC transaction and Endospan agreements, and our operational improvements in our tissue and stent graft business may not be achieved at all or at the levels we anticipate or had originally anticipated; the benefits anticipated from our clinical trials and regulatory approvals may not be achieved or achieved on our anticipated timelines; the uncertainty regarding potential unknown or future impacts of the November 2024 cybersecurity incident; and the benefits anticipated from our expansion into APAC and LATAM may not be achieved or achieved on our anticipated timelines. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2024. Artivion does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

SOURCE Artivion, Inc.