Tag: Artivion

Artivion Amends Agreements with Endospan

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Provides Endospan with $25 million of Additional Debt Funding to Obtain FDA Approval for NEXUS
Upfront Payment Associated with Purchase Option Reduced to $135 million, inclusive of loan off-set, and $100 million earnout minimum eliminated 
ATLANTA, July 1, 2024 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced it has amended its credit facility and option purchase agreements with Endospan Ltd. (“Endospan”), an Israeli-based, privately-held developer of the NEXUS® Stent Graft System (“NEXUS”). In 2019, the Company provided a credit facility to Endospan and entered into an option agreement to purchase Endospan upon U.S. Food and Drug Administration (“FDA”) approval of NEXUS. The amendments announced today result in three major changes to the original credit facility and option purchase agreements:

Artivion will provide additional loans to Endospan of up to $25 million in three tranches and anticipates funding the loans with free cash flow;
The upfront payment associated with the purchase option is reduced from $250 million to $175 million, resulting in an upfront acquisition purchase price of $135 million, inclusive of loan off-set; and
The $100 million minimum payout for the earnout is eliminated.

Endospan has developed NEXUS, the first and only approved branched endovascular system to treat aortic arch disease, including both aortic aneurysms and dissections. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysms (TAA), aortic arch disease patients with aneurysms or dissections who receive treatment have previously had little choice but to undergo open-chest surgery with its associated invasiveness and risks, lengthy hospitalizations, and prolonged recuperation. NEXUS transforms a complex surgical aortic arch repair into a minimally invasive endovascular procedure and stands to address an annual global addressable market opportunity of $600 million according to latest estimates.
“Based on our experience with NEXUS in Europe since 2019, we continue to see a significant global opportunity for the NEXUS technology and expect that it will further solidify our position as a global leader in aortic repair,” said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. “We view our revised credit facility and option purchase agreements with Endospan as an investment in the next frontier of aortic arch surgery. Should we exercise our option to acquire Endospan, we believe we will be able to meaningfully expand our total addressable market at that time on terms more favorable than existed prior to these amendments.”
Terms of the Amendments Under the terms of the amended Endospan credit facility, Artivion will provide up to an additional $25 million in debt financing to Endospan over three tranches, with the first $7 million drawn at close and subsequent tranches subject to progress toward and achievement of the NEXUS PMA. The terms of the loan are nearly identical to the terms of the original $15 million loan, except that under the amended terms both original and new loans will benefit from a first priority lien in Endospan assets, pari passu with other first lien Endospan liabilities.
If Artivion elects to exercise its option to purchase Endospan as contemplated in the Securities Purchase Option Agreement, then the outstanding principal amount and all accrued interest on the original and new loans would be deducted from the acquisition proceeds paid at closing. Under the amended purchase option, Artivion has the right to acquire Endospan at any time up to 90 days after receiving notice of U.S. FDA approval of NEXUS, for an upfront payment of $175 million, less previously extended loans and accrued interest, and an additional payment in the form of an earnout at two years post exercise of two and one half times (2.5x) incremental year two revenue. There is no longer any minimum earnout payment, and the maximum payment is still $200 million. Additionally, Artivion at its sole discretion may use up to $12.5 million of Artivion equity as part of the upfront payment. 
The amendments to the credit facility and Securities Purchase Option Agreement have been approved by both companies’ boards of directors and Endospan’s Security Holders. There were no changes to the parties existing Exclusive Distribution Agreement. The purchase obligations of the Securities Purchase Option Agreement will become effective if, and only when, Artivion exercises its purchase option. Any purchase of Endospan by Artivion would be subject to customary closing conditions.
Financial CommentaryThe Company does not anticipate the amended agreement with Endospan to have a material impact on its full-year 2024 financial guidance.
About Artivion, Inc.Headquartered in suburban Atlanta, Georgia, Artivion 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.
About Endospan Ltd.Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of Aortic Arch Disease including aneurysms and dissections. Endospan has received CE-Mark to commercialize in Europe the NEXUS Stent Graft System, the first endovascular off-the-shelf system to treat Aortic Arch Disease which affects a greatly underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), Aortic Arch Disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website, www.endospan.com. 
Forward Looking Statements Statements made in this press release and the accompanying presentation that look forward in time or that express management’s beliefs, expectations, or hope 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 those regarding our estimates for the total addressable annual global market for the NEXUS technology; and our beliefs that we continue to see a significant global opportunity for the NEXUS technology and expect that it will further solidify our position as a global leader in aortic repair; we view our revised credit facility and option purchase agreements with Endospan as an investment in the next frontier of aortic arch surgery; and we believe that should we exercise our option to acquire Endospan, we will be able to meaningfully expand our total addressable market at that time on terms more favorable than existed prior to these amendments. 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. These risks and uncertainties include but are not limited to the risks that the TRIOMPHE clinical trial may not be completed or may fail, may not reach its endpoints, or may be completed on timeframes different than anticipated; that PMA approval for NEXUS may be not achieved at all or on the time frames anticipated or that there be developments in technology by competitors that reduce the total addressable market for the NEXUS technology. 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 subsequent filings with the SEC. Artivion does not undertake to update its forward-looking statements.

Contacts:

Artivion, Inc.
Gilmartin Group LLC

Lance A. Berry
Brian Johnston / Laine Morgan

Executive Vice President & Chief Financial Officer
Phone: 332-895-3222

Phone: 770-419-3355
[email protected]

SOURCE Artivion, Inc.

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Artivion Announces Release Date and Teleconference Call Details for Fourth Quarter and Full Year 2023 Financial Results

Financial by Comments are Disabled

ATLANTA, Feb. 1, 2024 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, announced today that fourth quarter and full year 2023 financial results will be released on Thursday, February 15, 2024 after the market closes. On…

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Artivion Appoints Lance A. Berry as Executive Vice President, Chief Financial Officer; Announces Retirement of D. Ashley Lee, Chief Financial Officer

Financial by Comments are Disabled

Reaffirms Financial Guidance Provided on November 2, 2023
ATLANTA, Dec. 6, 2023 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease today announced the appointment of Lance A. Berry as the Company’s Chief Financial Officer, effective as of December 4, 2023. In this role, Mr. Berry joins Artivion’s executive leadership team and replaces Mr. D. Ashley Lee, who will retire at the end of the year after a successful and long tenure with the Company and a distinguished career in the medical device industry. Artivion also reaffirmed its full-year 2023 financial guidance that was provided on November 2, 2023.
Mr. Berry, 51, most recently served from January 2019 until November 2020 as the Executive Vice President, Chief Financial and Operations Officer of Wright Medical Group N.V. (“Wright”), until Wright was acquired by Stryker in November 2020. Before that, Mr. Berry served as the Senior Vice President, Chief Financial Officer for Wright from 2009 to 2018, successfully spear-heading its merger with Tornier N.V. Additionally, Mr. Berry served as Wright’s Vice President, Corporate Controller from 2002-2009. Mr. Berry also currently serves on the Boards of two public companies, Treace Medical Concepts, Inc. and Vapotherm. Throughout his eleven years as the Chief Financial Officer and a senior executive at Wright, working with Wright’s Board and Chief Executive Officer, Mr. Berry led the Company’s strategic transformation and execution to drive shareholder value and cultivated an extensive background in, among other areas, strategy, M&A, financing, business development, digital strategy and investor relations.
“I am thrilled to welcome Lance to Artivion’s leadership team as Chief Financial Officer,” said Pat Mackin, Chairman, President, and Chief Executive Officer. “His broad experience and proven leadership in growth MedTech companies make him an ideal addition to our leadership team, and he will add significant value in advancing Artivion and its strategy through our next stage of growth.”
“I am excited to join Artivion as Chief Financial Officer and continue my commitment to driving focus, execution and significant shareholder value,” said Mr. Berry. “I look forward to working with Artivion’s exceptional team to continue to grow Artivion into a powerhouse leader in aortic technology and innovation.”
Mr. Lee, 59, who has served as the Company’s Chief Financial Officer since 2004, will retire after a transitional period. Mr. Lee, a proven leader and a winner of Georgia BioTech’s CFO of the Year award in 2018, has decades of medical device experience. He helped lead the Company’s efforts that resulted in a more than doubling of the Company’s size since 2015. Mr. Lee will remain with Artivion in an advisory capacity to ensure a seamless transition. Mr. Lee expressed his confidence in Mr. Berry’s abilities to take on the role, stating, “I have no doubt that Lance will be an excellent addition to the Artivion leadership team. His deep financial expertise and experience in the medical device industry make him ideal to lead the Company’s finance, information technology, human resources and business development functions.” 
“I want to extend my heartfelt thanks to Ashley for his leadership at Artivion during a period of incredible growth and transformation,” added Mr. Mackin. “Artivion would not be where it is today without Ashley’s deep expertise and experience, and we wish him the very best on the next leg of his journey.”
Mr. Berry officially began his role as Chief Financial Officer on December 4, 2023.
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 StatementsStatements 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 remain 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 September 31, 2023. Artivion does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

Artivion
Gilmartin Group LLC

D. Ashley Lee
Brian Johnston / Lynn Lewis

       Executive Vice President,                  
Phone:  332-895-3222

Finance
[email protected] 

Phone: 770-419-3355

SOURCE Artivion, Inc.

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