Artivion Reports Third Quarter 2024 Financial Results

Third Quarter Highlights: Achieved revenue of $95.8 million in the third quarter of 2024 versus $87.9 million in the third quarter of 2023, an increase of 9% on a GAAP basis and 10% on a non-GAAP constant currency basis Net loss was ($2.

3) million or ($0.05) per fully diluted share and non-GAAP net income was $5.0 million or $0.



12 per fully diluted share in the third quarter of 2024 Adjusted EBITDA increased 28% to $17.7 million in the third quarter of 2024 compared to $13.9 million in the third quarter of 2023 Submitted first module of the pre-market approval application (PMA) for AMDS Hybrid Prosthesis with the U.

S. Food and Drug Administration Enrollment completed in NEXUS TRIOMPHE clinical trial Received regulatory approval from the National Medical Products Administration (NMPA) to commercialize BioGlue Surgical Adhesive in China . Commercialization expected in the second half of 2025.

ATLANTA , Nov. 7, 2024 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT ), a leading cardiac and vascular surgery company focused on aortic disease, today announced financial results for the third quarter ended September 30, 2024 .

"We continued our strong financial performance through the third quarter as our team delivered revenue growth consistent with our expectations while executing on several initiatives designed to drive long-term profitable growth with our expanding, clinically differentiated product portfolio. Revenue growth in the third quarter was driven by year-over-year growth in On-X of 15%, BioGlue of 14% and stent grafts of 12%, all compared to the third quarter of 2023. On a constant currency basis, year-over-year On-X, BioGlue, and stent grafts grew 15%, 14% and 13%, respectively.

We also saw continued revenue strength across Asia Pacific and Latin America which grew 23% and 21%, respectively, and on a constant currency basis, 23% and 32%, compared to last year," said Pat Mackin , Chairman, President, and Chief Executive Officer. Mr. Mackin concluded, "We also achieved important milestones in our R&D pipeline this quarter.

First, BioGlue was approved in China . Second, we submitted our first module of the PMA application for AMDS with the FDA keeping us on track for an anticipated approval in Q4 2025. Third, our partner Endospan completed enrollment in its U.

S. IDE trial TRIOMPHE, putting it on track for PMA approval in the second half of 2026. Fourth, excellent clinical data on 161 patients from our Evita Open Neo trial was presented as a late breaker at EACTS.

That trial was larger than our upcoming Arcevo IDE trial, which gives us confidence the upcoming trial will be successful." Third Quarter 2024 Financial Results Total revenues for the third quarter of 2024 were $95.8 million , an increase of 9% on a GAAP basis and 10% on a non-GAAP constant currency basis, both compared to the third quarter of 2023.

Net loss for the third quarter of 2024 was ($2.3) million , or ($0.05) per fully diluted common share, compared to net loss of ($9.

8) million , or ($0.24) per fully diluted common share for the third quarter of 2023. Non-GAAP net income for the third quarter of 2024 was $5.

0 million , or $0.12 per fully diluted common share, compared to non-GAAP net income of $749,000 , or $0.02 per fully diluted common share for the third quarter of 2023.

Non-GAAP net income for the third quarter of 2024 includes pretax gains related to foreign currency revaluation of $2.4 million . 2024 Financial Outlook Artivion is narrowing its revenue guidance and continues to expect constant currency revenue growth of between 10% to 12% for the full year 2024 compared to 2023 and now expects a range of $389 to $396 million for 2024 compared to the previously articulated range of $388 to $396 million .

At current rates, the Company expects negligible year-over-year currency impact on the full year 2024 revenues. Additionally, Artivion continues to expect adjusted EBITDA growth of between 28% and 34% for the full year 2024 compared to 2023 resulting in an expected range of $69 to $72 million for 2024. The Company's financial performance for 2024 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, non-GAAP 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, non-GAAP adjusted EBITDA, non-GAAP general, administrative, and marketing, and free cash flows results exclude (as applicable) depreciation and amortization expense, interest income and expense, stock-based compensation expense, loss or gain on foreign currency revaluation, income tax expense or benefit, corporate rebranding expense, business development, integration, and severance income or expense, loss on extinguishment of debt, and non-cash interest expense. 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 stock-based compensation expense. The Company believes it is useful to exclude certain expenses 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. Webcast and Conference Call Information The company will hold a teleconference call and live webcast on November 7, 2024 , 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 13748263. 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, those regarding our full year revenue expectations and our confidence in our ability to meet or exceed our adjusted EBITDA target for 2024; the timeline for regulatory approval for AMDS and other products; that our revenues for the full year 2024 will be in the range of $389 and $396 million , representing revenue growth of between 10% to 12% compared to 2023 on a constant currency basis; expect, at current exchange rates, negligible currency impact on the 2024 full year revenues; and expect non-GAAP adjusted EBITDA to increase between 28% and 34% for the full year 2024 compared to 2023, resulting in non-GAAP adjusted EBITDA in the range of $69 to $72 million in 2024.

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, the benefits anticipated from 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; 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, 2023 , and our Form 10-Q for the quarter ended September 30, 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..