Artivion Reports Second Quarter 2023 Financial Results

2023-08-03

财报上市批准引进/卖出

Second Quarter and Recent Business Highlights:

Achieved revenue of $89.3 million in the second quarter of 2023 versus $80.3 million in the second quarter of 2022, an increase of 11% on both a GAAP and non-GAAP constant currency basis

Net loss was ($3.4) million or ($0.08) per share; non-GAAP net income was $2.3 million or $0.06 per share

Achieved EBITDA of $9.2 million in the second quarter of 2023; non-GAAP adjusted EBITDA increased 35% to $13.8 million in the second quarter of 2023 compared to the second quarter of 2022

Aortic stent graft revenues increased 19% on both a GAAP and non-GAAP constant currency basis in the second quarter of 2023 compared to the second quarter of 2022

On-X revenues increased 10% on a GAAP basis and 11% on a non-GAAP constant currency basis in the second quarter of 2023 compared to the second quarter of 2022

Received PerClot PMA approval and commenced shipping product to Baxter

Patient enrollment in the PERSEVERE clinical trial accelerated with enrollment completion expected in the third quarter of 2023

ATLANTA, Aug. 3, 2023 /PRNewswire/ --

Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced its financial results for the second quarter ended June 30, 2023.

"Our second quarter results reflect the strength of our business commercially, operationally, and financially. We delivered double-digit constant currency revenue growth year-over-year for the second consecutive quarter and remain on track to achieve or exceed the revenue and EBITDA growth targets for this year. Our exceptional second quarter performance was driven by year-over-year aortic stent graft revenue growth of 19%, On-X revenue growth of 10%, tissue processing growth of 9%, and BioGlue growth of 4%. On a constant currency basis, year-over-year aortic stent graft, On-X, tissue processing, and BioGlue revenue growth were 19%, 11%, 9%, and 4%, respectively. We also saw Asia Pacific and Latin American revenue grow 23% and 21%, respectively, and 23% and 24% on a constant currency basis, compared to last year," said Pat Mackin, Chairman, President, and Chief Executive Officer.

Mr. Mackin added, "In addition to our strong commercial results, we also obtained FDA approval for PerClot and, accordingly, received the net $14.3 million FDA approval milestone payment from Baxter. Immediately thereafter, we also began shipping PerClot to Baxter, pursuant to the terms of our agreement. Further, we had strong revenue growth in our aortic stent graft product line, driven by accelerating productivity levels at our German manufacturing facility. We improved patient enrollment for our PERSEVERE trial evaluating AMDS, a simple, elegant stent graft solution to treat aortic arch disease, and we still anticipate completing enrollment in that trial in the third quarter of this year.

Mr. Mackin concluded, "Given our solid execution in the first half of 2023 and strong business momentum, we are now on a path to meet or exceed our current year guidance, as well as to achieve our 2024 commitments to deliver double-digit compounded annual constant currency revenue growth and adjusted EBITDA in excess of $75.0 million."

Second Quarter 2023 Financial Results

Total revenues for the second quarter of 2023 were $89.3 million, an increase of 11% on both a GAAP and non-GAAP constant currency basis, both compared to the second quarter of 2022.

Net loss for the second quarter of 2023 was ($3.4) million, or ($0.08) per fully diluted common share, compared to net loss of ($4.3) million, or ($0.11) per fully diluted common share for the second quarter of 2022. Net loss for the second quarter of 2023 includes pretax charges of $10.9 million related to contingent consideration for the acquisition of AMDS and $5.0 million related to the final payment to Endospan under our September 2019 Loan Agreement with Endospan, partially offset by a net pretax gain of $14.3 million related to the PerClot PMA approval milestone net payment. Non-GAAP net income for the second quarter of 2023 was $2.3 million, or $0.06 per fully diluted common share, compared to non-GAAP net loss of ($1.3) million, or ($0.03) per fully diluted common share for the second quarter of 2022.

2023 Financial Outlook

Artivion is raising its revenue guidance range and now expects to achieve constant currency revenue growth of between 10% and 12%, compared to the previous range of 9% and 12%, for the full year 2023 compared to 2022. The Company expects revenues to be in a range of $342.0 million and $350.0 million, compared to the previous range of $337.0 million and $348.0 million.

Additionally, Artivion continues to expect adjusted EBITDA, as reported, to increase greater than 25% in 2023 compared to 2022, resulting in adjusted EBITDA in excess of $52.0 million for 2023.

The Company's financial performance for 2023 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 EBITDA, and non-GAAP general, administrative, and marketing expenses. 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 EBITDA; and non-GAAP general, administrative, and marketing 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; non-cash interest expense; gain from sale of non-financial assets, and abandonment of CardioGenesis cardiac laser therapy business. 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 later today, August 3, 2023, 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 13739398.

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 our beliefs that we remain on track to achieve or exceed the revenue and EBITDA growth targets for this year; and we are now on a path to meet or exceed our current year guidance, as well as to achieve our 2024 commitments to deliver double-digit compounded annual constant currency revenue growth and adjusted EBITDA in excess of $75.0 million. 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 that the benefits anticipated from the Ascyrus Medical LLC transaction and Endospan agreements may not be achieved at all or at the levels we had originally anticipated; the benefits anticipated from our clinical trials may not be achieved or achieved on our anticipated timeline; our products may not be able to consistently retain their existing regulatory approvals or special regulatory approvals in order to be commercialized; products in our pipeline may not receive regulatory approval at all or receive regulatory approval on our anticipated timelines; or our products that obtain regulatory approval may not be adopted by the market as much as we anticipate or at all. 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, 2022 and our Form 10-Q for the quarter ended June 31, 2023. Artivion does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

SOURCE Artivion, Inc.