8-K
ARTIVION, INC. (AORT)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
___________________________________________
FORM 8-K
___________________________________________
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 2, 2023
___________________________________________
ARTIVION, INC.
(Exact name of registrant as specified in its charter)
___________________________________________
| Delaware | 1-13165 | 59-2417093 | |||
|---|---|---|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) | 1655 Roberts Boulevard, N.W., Kennesaw, Georgia | 30144 | |
| --- | --- | ||||
| (Address of principal executive office) | (Zip Code) |
Registrant's telephone number, including area code: (770) 419-3355
___________________________________________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange <br>on which registered |
|---|---|---|
| Common Stock, $0.01 par value | AORT | NYSE |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition
On November 2, 2023, Artivion, Inc. (“Artivion”) issued a press release announcing its financial results for the third quarter ended September 30, 2023. Artivion hereby incorporates by reference herein the information set forth in its press release dated November 2, 2023, a copy of which is attached hereto as Exhibit 99.1. Except as otherwise provided in the press release, the press release speaks only as of the date of such press release and it shall not create any implication that the affairs of Artivion have continued unchanged since such date.
The information provided pursuant to this Item 2.02 is to be considered “furnished” pursuant to Item 2.02 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, nor shall it be deemed incorporated by reference into any of Artivion’s reports or filings with the Securities and Exchange Commission, whether made before or after the date hereof, except as expressly set forth by specific reference in such report or filing.
Except for the historical information contained in this report, the statements made by Artivion are forward-looking statements that involve risks and uncertainties. All such statements are subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Artivion’s future financial performance could differ significantly from the expectations of management and from results expressed or implied in the press release. Please refer to the last paragraph of the text portion of the press release for further discussion about forward-looking statements. For further information on risk factors, please refer to “Risk Factors” contained in Artivion’s most recently filed Form 10-K and its subsequent filings with the Securities and Exchange Commission, as well as in the press release attached as Exhibit 99.1 hereto. Artivion disclaims any obligation or duty to update or modify these forward-looking statements.
Item 9.01(d) Exhibits
(d)Exhibits.
| Exhibit Number | Description |
|---|---|
| 99.1* | Press Release dated November 2, 2023. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
*Furnished herewith, not filed.
-2-
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, Artivion, Inc. has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 2, 2023
| ARTIVION, INC. | |
|---|---|
| By: | /s/ D. Ashley Lee |
| Name: | D. Ashley Lee |
| Title: | Executive Vice President and<br><br>Chief Financial Officer |
-3-
Document
Exhibit 99.1
FOR IMMEDIATE RELEASE
Contacts:
| Artivion | Gilmartin Group LLC |
|---|---|
| D. Ashley Lee | Brian Johnston / Lynn Lewis |
| Executive Vice President & | Phone: 332-895-3222 |
| Chief Financial Officer | investors@artivion.com |
| Phone: 770-419-3355 |
Artivion Reports Third Quarter 2023 Financial Results
Third Quarter and Recent Business Highlights:
•Achieved revenue of $87.9 million in the third quarter of 2023 versus $76.8 million in the third quarter of 2022, an increase of 14% on a GAAP basis and 12% on a non-GAAP constant currency basis
•Net loss was ($9.8) million or ($0.24) per share; non-GAAP net income was $749,000 or $0.02 per share
•Non-GAAP adjusted EBITDA increased 34% to $13.9 million in the third quarter of 2023 compared to the third quarter of 2022
•Aortic stent graft revenues increased 30% on a GAAP basis and 22% on a non-GAAP constant currency basis in the third quarter of 2023 compared to the third quarter of 2022
•On-X revenues increased 14% on a GAAP basis and 13% on a non-GAAP constant currency basis in the third quarter of 2023 compared to the third quarter of 2022
•Nearing completion of enrollment in the PERSEVERE clinical trial
ATLANTA, GA – (November 2, 2023) – Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced its financial results for the third quarter ended September 30, 2023.
“Our team delivered across the board in the third quarter, making substantial progress on our commercial, operational, and financial goals and initiatives. We delivered double-digit constant currency revenue growth year-over-year for the third consecutive quarter and remain on track to achieve or exceed our revenue and adjusted EBITDA growth targets for this year. Our robust third quarter performance was driven by exceptional year-over-year aortic stent graft revenue growth of 30%, strong On-X revenue growth of 14%, and solid tissue processing growth of 12%, while BioGlue revenue decreased 7% due to ordering patterns in Europe in the third quarter of 2022. On a constant currency basis, year-over-year aortic stent graft, On-X, tissue processing, and BioGlue revenue growth were 22%, 13%, 12%, and (8%), respectively. We also saw Latin American and Asia Pacific revenue grow 29% and 21%, respectively, and on a constant currency basis, 22% and 21%, compared to last year,” said Pat Mackin, Chairman, President, and Chief Executive Officer.
Page 1 of 11
Mr. Mackin added, “In addition to our strong commercial results, we have enrolled 90 of the 93 total patients in the PERSEVERE clinical trial putting us on track for 2025 approval. Additionally, positive results presented at EACTS in two late breaking presentations featuring PERSEVERE 30-day patient safety data and real-world data from a 510 patient On-X low INR post approval study should drive enhanced growth in both AMDS and On-X.”
Mr. Mackin concluded, “Given our solid execution in the first nine months of 2023 and strong business momentum, we are once again increasing our top-line guidance and continue on a path to achieve our commitments to deliver 2024 double-digit annual constant currency revenue growth and adjusted EBITDA in excess of $75.0 million.”
Third Quarter 2023 Financial Results
Total revenues for the third quarter of 2023 were $87.9 million, an increase of 14% on a GAAP basis and 12% on a non-GAAP constant currency basis, both compared to the third quarter of 2022.
Net loss for the third quarter of 2023 was ($9.8) million, or ($0.24) per fully diluted common share, compared to net loss of ($13.7) million, or ($0.34) per fully diluted common share for the third quarter of 2022. Net loss for the third quarter of 2023 includes pretax charges of $6.2 million related to contingent consideration for the acquisition of AMDS. Non-GAAP net income for the third quarter of 2023 was $749,000, or $0.02 per fully diluted common share, compared to non-GAAP net loss of ($1.9) million, or ($0.05) per fully diluted common share for the third quarter of 2022.
2023 Financial Outlook
Artivion is raising its revenue guidance range and now expects to achieve constant currency revenue growth of between 11% and 12%, compared to the previous range of 10% and 12%, for the full year 2023 compared to 2022. The Company expects revenues to be in a range of $349.0 million and $351.0 million, compared to the previous range of $342.0 million and $350.0 million.
Additionally, Artivion continues to expect non-GAAP adjusted EBITDA, as reported, to increase by more than 25% in 2023 compared to 2022, resulting in non-GAAP 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.
Page 2 of 11
Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including non-GAAP revenue, non-GAAP net income, non-GAAP adjusted 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 adjusted 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 on November 2, 2023, at 4:30 p.m. ET to discuss its third quarter financial results, followed by a question and answer session. To participate in the conference call dial (862) 298-0702 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 13741667.
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.
Page 3 of 11
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 our revenue and non-GAAP adjusted EBITDA growth targets for this year and to achieve AMDS PMA approval in 2025; the results from the PERSEVERE 30-day patient safety data and the 510 patient On-X low INR post approval study have begun to drive enhanced growth in both AMDS and On-X and will continue to do so; given our solid execution in the first nine months of 2023 and strong business momentum, we continue on a path to achieve our commitments to deliver 2024 double-digit annual constant currency revenue growth and non-GAAP adjusted EBITDA in excess of $75.0 million; and that we now expect to achieve for the full year 2023, constant currency revenue growth of between 11% and 12%, compared to 2022; revenues of $349.0 million and $351.0 million, and an increase of non-GAAP adjusted EBITDA, as reported, of more than 25% compared to 2022, resulting in non-GAAP adjusted EBITDA in excess of $52.0 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 but not limited to 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; and the benefits anticipated from our clinical trials may not be achieved or achieved on our anticipated timelines. These risks and uncertainties also 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 30, 2023. Artivion does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.
Page 4 of 11
Artivion, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
In Thousands, Except Per Share Data
(Unaudited)
| Three Months Ended<br>September 30, | Nine Months Ended<br>September 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | |||||
| Revenues: | ||||||||
| Products | $ | 63,747 | $ | 55,248 | $ | 192,041 | $ | 171,726 |
| Preservation services | 24,107 | 21,590 | 68,293 | 62,665 | ||||
| Total revenues | 87,854 | 76,838 | 260,334 | 234,391 | ||||
| Cost of products and preservation services: | ||||||||
| Products | 21,574 | 17,743 | 62,084 | 53,381 | ||||
| Preservation services | 10,010 | 10,351 | 30,169 | 29,375 | ||||
| Total cost of products and preservation services | 31,584 | 28,094 | 92,253 | 82,756 | ||||
| Gross margin | 56,270 | 48,744 | 168,081 | 151,635 | ||||
| Operating expenses: | ||||||||
| General, administrative, and marketing | 51,093 | 41,051 | 158,699 | 118,989 | ||||
| Research and development | 6,421 | 11,799 | 21,062 | 30,575 | ||||
| Total operating expenses | 57,514 | 52,850 | 179,761 | 149,564 | ||||
| Gain from sale of non-financial assets | — | — | (14,250) | — | ||||
| Operating (loss) income | (1,244) | (4,106) | 2,570 | 2,071 | ||||
| Interest expense | 6,603 | 4,805 | 19,055 | 12,854 | ||||
| Interest income | (339) | (40) | (679) | (86) | ||||
| Other expense, net | 1,911 | 3,661 | 5,189 | 7,564 | ||||
| Loss before income taxes | (9,419) | (12,532) | (20,995) | (18,261) | ||||
| Income tax expense | 382 | 1,181 | 5,720 | 3,100 | ||||
| Net loss | $ | (9,801) | $ | (13,713) | $ | (26,715) | $ | (21,361) |
| Loss per share: | ||||||||
| Basic | $ | (0.24) | $ | (0.34) | $ | (0.65) | $ | (0.53) |
| Diluted | $ | (0.24) | $ | (0.34) | $ | (0.65) | $ | (0.53) |
| Weighted-average common shares outstanding: | ||||||||
| Basic | 40,881 | 40,115 | 40,691 | 39,999 | ||||
| Diluted | 40,881 | 40,115 | 40,691 | 39,999 | ||||
| Net loss | $ | (9,801) | $ | (13,713) | $ | (26,715) | $ | (21,361) |
| Other comprehensive loss: | ||||||||
| Foreign currency translation adjustments | (5,010) | (16,895) | 432 | (35,466) | ||||
| Comprehensive loss | $ | (14,811) | $ | (30,608) | $ | (26,283) | $ | (56,827) |
Page 5 of 11
Artivion, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
In Thousands
| September 30,<br>2023 | December 31,<br>2022 | |||
|---|---|---|---|---|
| (Unaudited) | ||||
| ASSETS | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ | 53,481 | $ | 39,351 |
| Trade receivables, net | 64,277 | 61,820 | ||
| Other receivables | 3,993 | 7,764 | ||
| Inventories, net | 78,792 | 74,478 | ||
| Deferred preservation costs, net | 49,391 | 46,371 | ||
| Prepaid expenses and other | 17,175 | 17,550 | ||
| Total current assets | 267,109 | 247,334 | ||
| Goodwill | 242,936 | 243,631 | ||
| Acquired technology, net | 142,675 | 151,263 | ||
| Operating lease right-of-use assets, net | 43,345 | 41,859 | ||
| Property and equipment, net | 37,428 | 38,674 | ||
| Other intangibles, net | 29,398 | 31,384 | ||
| Deferred income taxes | 3,705 | 1,314 | ||
| Other assets | 8,191 | 7,339 | ||
| Total assets | $ | 774,787 | $ | 762,798 |
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 10,819 | $ | 12,004 |
| Accrued compensation | 13,861 | 13,810 | ||
| Accrued expenses | 9,930 | 12,374 | ||
| Taxes payable | 9,390 | 2,635 | ||
| Current maturities of operating leases | 3,940 | 3,308 | ||
| Accrued procurement fees | 1,860 | 2,111 | ||
| Current portion of long-term debt | 1,552 | 1,608 | ||
| Other liabilities | 3,607 | 1,825 | ||
| Total current liabilities | 54,959 | 49,675 | ||
| Long-term debt | 305,877 | 306,499 | ||
| Contingent consideration | 62,300 | 40,400 | ||
| Non-current maturities of operating leases | 42,862 | 41,257 | ||
| Deferred income taxes | 19,514 | 24,499 | ||
| Deferred compensation liability | 6,460 | 5,468 | ||
| Non-current finance lease obligation | 3,272 | 3,644 | ||
| Other liabilities | 7,568 | 7,027 | ||
| Total liabilities | $ | 502,812 | $ | 478,469 |
| Commitments and contingencies | ||||
| Shareholders' equity: | ||||
| Preferred stock | — | — | ||
| Common stock (75,000 shares authorized, 42,537 and 41,830 shares issued and outstanding in 2023 and 2022, respectively) | 425 | 418 | ||
| Additional paid-in capital | 351,307 | 337,385 | ||
| Retained deficit | (43,932) | (17,217) | ||
| Accumulated other comprehensive loss | (21,177) | (21,609) | ||
| Treasury stock, at cost, 1,487 shares as of September 30, 2023 and December 31, 2022 | (14,648) | (14,648) | ||
| Total shareholders' equity | 271,975 | 284,329 | ||
| Total liabilities and shareholders' equity | $ | 774,787 | $ | 762,798 |
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Artivion, Inc. and Subsidiaries
Condensed Consolidated Statement of Cash Flows
In Thousands
(Unaudited)
| Nine Months Ended<br>September 30, | ||||
|---|---|---|---|---|
| 2023 | 2022 | |||
| Net cash flows from operating activities: | ||||
| Net loss | $ | (26,715) | $ | (21,361) |
| Adjustments to reconcile net loss to net cash from operating activities: | ||||
| Change in fair value of contingent consideration | 21,900 | (4,600) | ||
| Depreciation and amortization | 17,260 | 17,016 | ||
| Non-cash compensation | 10,466 | 9,189 | ||
| Non-cash lease expense | 5,467 | 5,656 | ||
| Fair value adjustment of long-term loan | 5,000 | — | ||
| Write-down of inventories and deferred preservation costs | 3,726 | 3,116 | ||
| Deferred income taxes | (7,250) | 5,097 | ||
| Gain from sale of non-financial assets | (14,250) | — | ||
| Other | 2,325 | 1,523 | ||
| Changes in operating assets and liabilities: | ||||
| Receivables | 765 | (10,900) | ||
| Accounts payable, accrued expenses, and other liabilities | 412 | (2,103) | ||
| Prepaid expenses and other assets | (527) | (1,788) | ||
| Inventories and deferred preservation costs | (10,592) | (5,781) | ||
| Net cash flows provided by (used in) operating activities | 7,987 | (4,936) | ||
| Net cash flows from investing activities: | ||||
| Proceeds from sale of non-financial assets, net | 14,250 | — | ||
| Payments for Endospan Agreement | (5,000) | — | ||
| Capital expenditures | (5,503) | (6,924) | ||
| Other | (1,580) | (1,123) | ||
| Net cash flows provided by (used in) investing activities | 2,167 | (8,047) | ||
| Net cash flows from financing activities: | ||||
| Proceeds from financing insurance premiums | 3,558 | — | ||
| Proceeds from exercise of stock options and issuance of common stock | 3,467 | 3,344 | ||
| Redemption and repurchase of stock to cover tax withholdings | (563) | (1,791) | ||
| Principal payments on short-term notes payable | (1,522) | — | ||
| Repayment of term loan | (2,063) | (2,033) | ||
| Other | (382) | (300) | ||
| Net cash flows provided by (used in) financing activities | 2,495 | (780) | ||
| Effect of exchange rate changes on cash and cash equivalents | 1,481 | (3,675) | ||
| Increase (decrease) in cash and cash equivalents | 14,130 | (17,438) | ||
| Cash and cash equivalents beginning of period | 39,351 | 55,010 | ||
| Cash and cash equivalents end of period | $ | 53,481 | $ | 37,572 |
Page 7 of 11
Artivion, Inc. and Subsidiaries
Financial Highlights
In Thousands
(Unaudited)
| Three Months Ended<br>September 30, | Nine Months Ended<br>September 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | |||||
| Products: | ||||||||
| Aortic stent grafts | $ | 25,523 | $ | 19,674 | $ | 80,032 | $ | 69,013 |
| On-X | 18,744 | 16,456 | 54,346 | 47,082 | ||||
| Surgical sealants | 16,234 | 17,374 | 49,503 | 49,022 | ||||
| Other | 3,246 | 1,744 | 8,160 | 6,609 | ||||
| Total products | 63,747 | 55,248 | 192,041 | 171,726 | ||||
| Preservation services | 24,107 | 21,590 | 68,293 | 62,665 | ||||
| Total revenues | $ | 87,854 | $ | 76,838 | $ | 260,334 | $ | 234,391 |
| North America | 48,028 | 42,678 | 137,541 | 124,833 | ||||
| Europe, the Middle East, and Africa | 26,536 | 23,413 | 84,608 | 78,508 | ||||
| Asia Pacific | 8,402 | 6,952 | 24,655 | 20,492 | ||||
| Latin America | 4,888 | 3,795 | 13,530 | 10,558 | ||||
| Total revenues | $ | 87,854 | $ | 76,838 | $ | 260,334 | $ | 234,391 |
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Artivion, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
Revenues
In Thousands
(Unaudited)
| Revenues for the<br>Three Months Ended<br>September 30, | Percent<br>Change<br>From Prior<br>Year | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | ||||||||
| US GAAP | US GAAP | Exchange Rate Effect | Constant Currency | Constant Currency | |||||
| Products: | |||||||||
| Aortic stent grafts | $ | 25,523 | $ | 19,674 | $ | 1,193 | $ | 20,867 | 22% |
| On-X | 18,744 | 16,456 | 90 | 16,546 | 13% | ||||
| Surgical sealants | 16,234 | 17,374 | 318 | 17,692 | -8% | ||||
| Other | 3,246 | 1,744 | 8 | 1,752 | 85% | ||||
| Total products | 63,747 | 55,248 | 1,609 | 56,857 | 12% | ||||
| Preservation services | 24,107 | 21,590 | (12) | 21,578 | 12% | ||||
| Total | $ | 87,854 | $ | 76,838 | $ | 1,597 | $ | 78,435 | 12% |
| North America | 48,028 | 42,678 | (46) | 42,632 | 13% | ||||
| Europe, the Middle East, and Africa | 26,536 | 23,413 | 1,419 | 24,832 | 7% | ||||
| Asia Pacific | 8,402 | 6,952 | 2 | 6,954 | 21% | ||||
| Latin America | 4,888 | 3,795 | 222 | 4,017 | 22% | ||||
| Total | $ | 87,854 | $ | 76,838 | $ | 1,597 | $ | 78,435 | 12% |
| Revenues for the<br>Nine Months Ended<br>September 30, | Percent<br>Change<br>From Prior<br>Year | ||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2023 | 2022 | ||||||||
| US GAAP | US GAAP | Exchange Rate Effect | Constant Currency | Constant Currency | |||||
| Products: | |||||||||
| Aortic stent grafts | $ | 80,032 | $ | 69,013 | $ | (17) | $ | 68,996 | 16% |
| On-X | 54,346 | 47,082 | (129) | 46,953 | 16% | ||||
| Surgical sealants | 49,503 | 49,022 | (36) | 48,986 | 1% | ||||
| Other | 8,160 | 6,609 | (10) | 6,599 | 24% | ||||
| Total products | 192,041 | 171,726 | (192) | 171,534 | 12% | ||||
| Preservation services | 68,293 | 62,665 | (81) | 62,584 | 9% | ||||
| Total | $ | 260,334 | $ | 234,391 | $ | (273) | $ | 234,118 | 11% |
| North America | 137,541 | 124,833 | (253) | 124,580 | 10% | ||||
| Europe, the Middle East, and Africa | 84,608 | 78,508 | (120) | 78,388 | 8% | ||||
| Asia Pacific | 24,655 | 20,492 | (79) | 20,413 | 21% | ||||
| Latin America | 13,530 | 10,558 | 179 | 10,737 | 26% | ||||
| Total | $ | 260,334 | $ | 234,391 | $ | (273) | $ | 234,118 | 11% |
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Artivion, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
General, Administrative, and Marketing Expense and Adjusted EBITDA
In Thousands
(Unaudited)
| Three Months Ended<br>September 30, | Nine Months Ended<br>September 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | |||||
| Reconciliation of G&A expense, GAAP to adjusted G&A, non-GAAP: | ||||||||
| General, administrative, and marketing expense, GAAP | $ | 51,093 | $ | 41,051 | $ | 158,699 | $ | 118,989 |
| Business development, integration, and severance expense (income) | 6,363 | 864 | 22,461 | (3,816) | ||||
| Corporate rebranding expense | 65 | 251 | 283 | 1,423 | ||||
| Adjusted G&A, non-GAAP | $ | 44,665 | $ | 39,936 | $ | 135,955 | $ | 121,382 |
| Three Months Ended<br>September 30, | Nine Months Ended<br>September 30, | |||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2023 | 2022 | 2023 | 2022 | |||||
| Reconciliation of net loss, GAAP to adjusted EBITDA, non-GAAP: | ||||||||
| Net loss, GAAP | $ | (9,801) | $ | (13,713) | $ | (26,715) | $ | (21,361) |
| Adjustments: | ||||||||
| Business development, integration, and severance expense (income) | 6,122 | 864 | 26,844 | (3,816) | ||||
| Interest expense | 6,603 | 4,805 | 19,055 | 12,854 | ||||
| Depreciation and amortization expense | 5,759 | 5,519 | 17,260 | 17,016 | ||||
| Stock-based compensation expense | 3,187 | 3,089 | 10,466 | 9,189 | ||||
| Income tax expense | 382 | 1,181 | 5,720 | 3,100 | ||||
| Abandonment of CardioGenesis cardiac laser therapy business | — | — | 390 | — | ||||
| Corporate rebranding expense | 65 | 251 | 283 | 1,423 | ||||
| Loss on foreign currency revaluation | 1,882 | 3,668 | 112 | 7,555 | ||||
| Clinical trial termination expense | — | 4,741 | — | 4,741 | ||||
| Interest income | (339) | (40) | (679) | (86) | ||||
| Gain from sale of non-financial assets | — | — | (14,250) | — | ||||
| Adjusted EBITDA, non-GAAP | $ | 13,860 | $ | 10,365 | $ | 38,486 | $ | 30,615 |
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Artivion Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
Net Income and Diluted Income Per Common Share
In Thousands, Except Per Share Data
(Unaudited)
| Three Months Ended<br>September 30, | Nine Months Ended<br>September 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | |||||
| GAAP: | ||||||||
| Loss before income taxes | $ | (9,419) | $ | (12,532) | $ | (20,995) | $ | (18,261) |
| Income tax expense | 382 | 1,181 | 5,720 | 3,100 | ||||
| Net loss | $ | (9,801) | $ | (13,713) | $ | (26,715) | $ | (21,361) |
| Diluted loss per common share | $ | (0.24) | $ | (0.34) | $ | (0.65) | $ | (0.53) |
| Diluted weighted-average common shares outstanding | 40,881 | 40,115 | 40,691 | 39,999 | ||||
| Reconciliation of loss before income taxes, GAAP to adjusted income (loss), non-GAAP: | ||||||||
| Loss before income taxes, GAAP: | $ | (9,419) | $ | (12,532) | $ | (20,995) | $ | (18,261) |
| Adjustments: | ||||||||
| Business development, integration, and severance expense (income) | 6,122 | 864 | 26,844 | (3,816) | ||||
| Amortization expense | 3,766 | 3,686 | 11,453 | 11,675 | ||||
| Non-cash interest expense | 465 | 459 | 1,391 | 1,372 | ||||
| Abandonment of CardioGenesis cardiac laser therapy business | — | — | 390 | — | ||||
| Corporate rebranding expense | 65 | 251 | 283 | 1,423 | ||||
| Clinical trial termination expense | — | 4,741 | — | 4,741 | ||||
| Gain from sale of non-financial assets | — | — | (14,250) | — | ||||
| Adjusted income (loss) before income taxes, non-GAAP | 999 | (2,531) | 5,116 | (2,866) | ||||
| Income tax expense (benefit) calculated at a tax rate of 25% | 250 | (633) | 1,279 | (717) | ||||
| Adjusted net income (loss), non-GAAP | $ | 749 | $ | (1,898) | $ | 3,837 | $ | (2,149) |
| Reconciliation of diluted loss per common share, GAAP to adjusted diluted income (loss) per common share, non-GAAP: | ||||||||
| Diluted loss per common share, GAAP: | $ | (0.24) | $ | (0.34) | $ | (0.65) | $ | (0.53) |
| Adjustments: | ||||||||
| Business development, integration, and severance expense (income) | 0.15 | 0.03 | 0.65 | (0.09) | ||||
| Amortization expense | 0.09 | 0.09 | 0.28 | 0.29 | ||||
| Non-cash interest expense | 0.01 | 0.01 | 0.03 | 0.03 | ||||
| Abandonment of CardioGenesis cardiac laser therapy business | — | — | 0.01 | — | ||||
| Corporate rebranding expense | — | — | 0.01 | 0.03 | ||||
| Clinical trial termination expense | — | 0.12 | — | 0.12 | ||||
| Tax effect of non-GAAP adjustments | (0.06) | (0.06) | (0.17) | (0.09) | ||||
| Gain from sale of non-financial assets | — | — | (0.34) | — | ||||
| Effect of 25% tax rate | 0.07 | 0.10 | 0.27 | 0.19 | ||||
| Adjusted diluted income (loss) per common share, non-GAAP | $ | 0.02 | $ | (0.05) | $ | 0.09 | $ | (0.05) |
| Reconciliation of diluted weighted-average common shares outstanding GAAP to diluted weighted-average common shares outstanding, non-GAAP: | ||||||||
| Diluted weighted-average common shares outstanding, GAAP: | 40,881 | 40,115 | 40,691 | 39,999 | ||||
| Adjustments: | ||||||||
| Effect of dilutive stock options and awards | 662 | — | 512 | — | ||||
| Diluted weighted-average common shares outstanding, non-GAAP | 41,543 | 40,115 | 41,203 | 39,999 |
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