aort-202411070000784199FALSE00007841992024-11-072024-11-07
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 7, 2024
___________________________________________
ARTIVION, INC.
(Exact name of registrant as specified in its charter)
___________________________________________
| | | | | | | | |
Delaware | 1-13165 | 59-2417093 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer 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):
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☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ | 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 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 7, 2024, Artivion, Inc. (“Artivion”) issued a press release announcing its financial results for the third quarter ended September 30, 2024. Artivion hereby incorporates by reference herein the information set forth in its press release dated November 7, 2024, 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 |
| Press Release dated November 7, 2024. |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
*Furnished herewith, not filed.
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 7, 2024
| | | | | | | | |
| ARTIVION, INC. |
| | |
| By: | /s/ Lance A. Berry |
| Name: | Lance A. Berry |
| Title: | Chief Financial Officer and Executive Vice President, Finance |
DocumentFOR IMMEDIATE RELEASE
Contacts: | | | | | |
Artivion | Gilmartin Group LLC |
Lance A. Berry | Brian Johnston / Laine Morgan |
Executive Vice President & | Phone: 332-895-3222 |
Chief Financial Officer | investors@artivion.com |
Phone: 770-419-3355 | |
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, GA – (November 7, 2024) – 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.
Artivion, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
In Thousands, Except Per Share Data
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Revenues: | | | | | | | |
Products | $ | 71,244 | | | $ | 63,747 | | | $ | 215,568 | | | $ | 192,041 | |
Preservation services | 24,535 | | | 24,107 | | | 75,661 | | | 68,293 | |
Total revenues | 95,779 | | | 87,854 | | | 291,229 | | | 260,334 | |
| | | | | | | |
Cost of products and preservation services: | | | | | | | |
Products | 24,412 | | | 21,574 | | | 72,707 | | | 62,084 | |
Preservation services | 10,358 | | | 10,010 | | | 31,243 | | | 30,169 | |
Total cost of products and preservation services | 34,770 | | | 31,584 | | | 103,950 | | | 92,253 | |
| | | | | | | |
Gross margin | 61,009 | | | 56,270 | | | 187,279 | | | 168,081 | |
| | | | | | | |
Operating expenses: | | | | | | | |
General, administrative, and marketing | 50,017 | | | 51,093 | | | 130,026 | | | 158,699 | |
Research and development | 6,605 | | | 6,421 | | | 21,048 | | | 21,062 | |
Total operating expenses | 56,622 | | | 57,514 | | | 151,074 | | | 179,761 | |
Gain from sale of non-financial assets | — | | | — | | | — | | | (14,250) | |
Operating income (loss) | 4,387 | | | (1,244) | | | 36,205 | | | 2,570 | |
| | | | | | | |
Interest expense | 8,405 | | | 6,603 | | | 24,535 | | | 19,055 | |
Interest income | (366) | | | (339) | | | (1,093) | | | (679) | |
Loss on extinguishment of debt | — | | | — | | | 3,669 | | | — | |
Other (income) expense, net | (2,386) | | | 1,911 | | | 6 | | | 5,189 | |
| | | | | | | |
(Loss) income before income taxes | (1,266) | | | (9,419) | | | 9,088 | | | (20,995) | |
Income tax expense | 1,022 | | | 382 | | | 5,964 | | | 5,720 | |
| | | | | | | |
Net (loss) income | $ | (2,288) | | | $ | (9,801) | | | $ | 3,124 | | | $ | (26,715) | |
| | | | | | | |
(Loss) income per share: | | | | | | | |
Basic | $ | (0.05) | | | $ | (0.24) | | | $ | 0.07 | | | $ | (0.65) | |
Diluted | $ | (0.05) | | | $ | (0.24) | | | $ | 0.07 | | | $ | (0.65) | |
| | | | | | | |
Weighted-average common shares outstanding: | | | | | | | |
Basic | 41,844 | | | 40,881 | | | 41,607 | | | 40,691 | |
Diluted | 41,844 | | | 40,881 | | | 42,621 | | | 40,691 | |
| | | | | | | |
Net (loss) income | $ | (2,288) | | | $ | (9,801) | | | $ | 3,124 | | | $ | (26,715) | |
Other comprehensive income (loss): | | | | | | | |
Foreign currency translation adjustments | 8,393 | | | (7,070) | | | 2,529 | | | $ | (1,423) | |
Unrealized (loss) gain from foreign currency intra-entity loans, net of tax | (2,060) | | | 2,060 | | | (47) | | | 1,855 | |
Comprehensive income (loss) | $ | 4,045 | | | $ | (14,811) | | | $ | 5,606 | | | $ | (26,283) | |
Artivion, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
In Thousands
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
| (Unaudited) | | |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 56,173 | | | $ | 58,940 | |
Trade receivables, net | 75,686 | | | 71,796 | |
Other receivables | 2,288 | | | 2,342 | |
Inventories, net | 84,123 | | | 81,976 | |
Deferred preservation costs, net | 50,421 | | | 49,804 | |
Prepaid expenses and other | 19,267 | | | 15,810 | |
Total current assets | 287,958 | | | 280,668 | |
| | | |
Goodwill | 248,745 | | | 247,337 | |
Acquired technology, net | 135,052 | | | 142,593 | |
Operating lease right-of-use assets, net | 41,206 | | | 43,822 | |
Property and equipment, net | 38,262 | | | 38,358 | |
Other intangibles, net | 29,527 | | | 29,638 | |
Deferred income taxes | 1,458 | | | 1,087 | |
Other long-term assets | 20,936 | | | 8,894 | |
Total assets | $ | 803,144 | | | $ | 792,397 | |
| | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
Current liabilities: | | | |
Accounts payable | $ | 11,146 | | | $ | 13,318 | |
Current portion of long-term debt | 99,698 | | | 1,451 | |
Accrued expenses | 15,888 | | | 12,732 | |
Accrued compensation | 15,236 | | | 18,715 | |
Current maturities of operating leases | 4,513 | | | 3,395 | |
Taxes payable | 3,521 | | | 3,840 | |
Accrued procurement fees | 1,456 | | | 1,439 | |
Other current liabilities | 1,380 | | | 2,972 | |
Total current liabilities | 152,838 | | | 57,862 | |
| | | |
Long-term debt | 214,270 | | | 305,531 | |
Contingent consideration | 51,720 | | | 63,890 | |
Non-current maturities of operating leases | 41,440 | | | 43,977 | |
Deferred income taxes | 18,538 | | | 21,851 | |
Deferred compensation liability | 7,930 | | | 6,760 | |
Non-current finance lease obligation | 3,194 | | | 3,405 | |
Other long-term liabilities | 8,475 | | | 7,341 | |
Total liabilities | $ | 498,405 | | | $ | 510,617 | |
| | | |
Commitments and contingencies | | | |
| | | |
Stockholders’ equity: | | | |
Preferred stock | — | | | — | |
Common stock (75,000 shares authorized, 43,392 and 42,569 shares issued in 2024 and 2023, respectively) | 434 | | | 426 | |
Additional paid-in capital | 373,264 | | | 355,919 | |
Retained deficit | (44,783) | | | (47,907) | |
Accumulated other comprehensive loss | (9,528) | | | (12,010) | |
Treasury stock, at cost, 1,487 shares as of September 30, 2024 and December 31, 2023 | (14,648) | | | (14,648) | |
Total stockholders’ equity | 304,739 | | | 281,780 | |
| | | |
Total liabilities and stockholders’ equity | $ | 803,144 | | | $ | 792,397 | |
Artivion, Inc. and Subsidiaries
Condensed Consolidated Statement of Cash Flows
In Thousands
(Unaudited)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2024 | | 2023 |
Net cash flows from operating activities: | | | |
Net income (loss) | $ | 3,124 | | | $ | (26,715) | |
| | | |
Adjustments to reconcile net income (loss) to net cash from operating activities: | | | |
Depreciation and amortization | 17,910 | | | 17,260 | |
Change in fair value of contingent consideration | (12,170) | | | 21,900 | |
Non-cash compensation | 11,499 | | | 10,466 | |
Non-cash lease expense | 5,860 | | | 5,467 | |
Deferred income taxes | (4,187) | | | (7,250) | |
Non-cash debt extinguishment expense | 3,669 | | | — | |
Write-down of inventories and deferred preservation costs | 2,911 | | | 3,726 | |
Fair value adjustment of Endospan agreements | (195) | | | 5,000 | |
Gain from sale of non-financial assets | — | | | (14,250) | |
Other | 1,818 | | | 2,325 | |
Changes in operating assets and liabilities: | | | |
Accounts payable, accrued expenses, and other liabilities | (5,237) | | | 412 | |
Inventories and deferred preservation costs | (4,791) | | | (10,592) | |
Prepaid expenses and other assets | (4,758) | | | (527) | |
Receivables | (3,356) | | | 765 | |
Net cash flows provided by operating activities | 12,097 | | | 7,987 | |
| | | |
Net cash flows from investing activities: | | | |
Capital expenditures | (9,763) | | | (7,083) | |
Payments for Endospan agreements | (7,000) | | | (5,000) | |
Proceeds from sale of non-financial assets, net | — | | | 14,250 | |
Net cash flows (used in) provided by investing activities | (16,763) | | | 2,167 | |
| | | |
Net cash flows from financing activities: | | | |
Proceeds from issuance of debt | 190,000 | | | — | |
Proceeds from revolving credit facility | 30,000 | | | — | |
Proceeds from exercise of stock options and issuance of common stock | 5,285 | | | 3,467 | |
Proceeds from financing insurance premiums | — | | | 3,558 | |
Repayment of debt | (211,765) | | | (2,063) | |
Payment of debt issuance costs | (10,044) | | | — | |
Principal payments on short-term notes payable | (1,027) | | | (1,522) | |
Other | (420) | | | (945) | |
Net cash flows provided by financing activities | 2,029 | | | 2,495 | |
| | | |
Effect of exchange rate changes on cash and cash equivalents | (130) | | | 1,481 | |
(Decrease) increase in cash and cash equivalents | (2,767) | | | 14,130 | |
| | | |
Cash and cash equivalents beginning of period | 58,940 | | | 39,351 | |
Cash and cash equivalents end of period | $ | 56,173 | | | $ | 53,481 | |
Artivion, Inc. and Subsidiaries
Financial Highlights
In Thousands
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Products: | | | | | | | |
Aortic stent grafts | $ | 28,643 | | $ | 25,523 | | $ | 92,936 | | $ | 80,032 |
On-X | 21,478 | | 18,744 | | 61,804 | | 54,346 |
Surgical sealants | 18,437 | | 16,234 | | 53,963 | | 49,503 |
Other | 2,686 | | 3,246 | | 6,865 | | 8,160 |
Total products | 71,244 | | 63,747 | | 215,568 | | 192,041 |
| | | | | | | |
Preservation services | 24,535 | | 24,107 | | 75,661 | | 68,293 |
Total revenues | $ | 95,779 | | $ | 87,854 | | $ | 291,229 | | $ | 260,334 |
| | | | | | | |
North America | 49,089 | | 48,028 | | 148,679 | | 137,541 |
Europe, the Middle East, and Africa | 30,423 | | 26,536 | | 98,156 | | 84,608 |
Asia Pacific | 10,366 | | 8,402 | | 27,628 | | 24,655 |
Latin America | 5,901 | | 4,888 | | 16,766 | | 13,530 |
Total revenues | $ | 95,779 | | $ | 87,854 | | $ | 291,229 | | $ | 260,334 |
Artivion, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
Revenues
In Thousands
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Revenues for the Three Months Ended September 30, | | Percent Change From Prior Year |
| 2024 | | 2023 | |
| US GAAP | | US GAAP | | Exchange Rate Effect | | Constant Currency | | Constant Currency |
Products: | | | | | | | | | |
Aortic stent grafts | $ | 28,643 | | $ | 25,523 | | $ | (208) | | | $ | 25,315 | | 13% |
On-X | 21,478 | | 18,744 | | (103) | | | 18,641 | | 15% |
Surgical sealants | 18,437 | | 16,234 | | (128) | | | 16,106 | | 14% |
Other | 2,686 | | 3,246 | | 1 | | | 3,247 | | -17% |
Total products | 71,244 | | 63,747 | | (438) | | 63,309 | | 13% |
| | | | | | | | | |
Preservation services | 24,535 | | 24,107 | | (22) | | | 24,085 | | 2% |
Total | $ | 95,779 | | $ | 87,854 | | $ | (460) | | $ | 87,394 | | 10% |
| | | | | | | | | |
North America | 49,089 | | | 48,028 | | | (50) | | | 47,978 | | | 2% |
Europe, the Middle East, and Africa | 30,423 | | | 26,536 | | | 12 | | | 26,548 | | | 15% |
Asia Pacific | 10,366 | | | 8,402 | | | 1 | | | 8,403 | | | 23% |
Latin America | 5,901 | | | 4,888 | | | (423) | | | 4,465 | | | 32% |
Total | $ | 95,779 | | $ | 87,854 | | $ | (460) | | $ | 87,394 | | 10% |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Revenues for the Nine Months Ended September 30, | | Percent Change From Prior Year |
| 2024 | | 2023 | |
| US GAAP | | US GAAP | | Exchange Rate Effect | | Constant Currency | | Constant Currency |
Products: | | | | | | | | | |
Aortic stent grafts | $ | 92,936 | | $ | 80,032 | | 688 | | | $ | 80,720 | | 15% |
On-X | 61,804 | | 54,346 | | (2) | | | 54,344 | | 14% |
Surgical sealants | 53,963 | | 49,503 | | (10) | | | 49,493 | | 9% |
Other | 6,865 | | 8,160 | | 4 | | | 8,164 | | -16% |
Total products | 215,568 | | 192,041 | | 680 | | 192,721 | | 12% |
| | | | | | | | | |
Preservation services | 75,661 | | 68,293 | | (26) | | | 68,267 | | 11% |
Total | $ | 291,229 | | $ | 260,334 | | $ | 654 | | $ | 260,988 | | 12% |
| | | | | | | | | |
North America | 148,679 | | | 137,541 | | | (57) | | | 137,484 | | | 8% |
Europe, the Middle East, and Africa | 98,156 | | | 84,608 | | | 994 | | | 85,602 | | | 15% |
Asia Pacific | 27,628 | | | 24,655 | | | — | | | 24,655 | | | 12% |
Latin America | 16,766 | | | 13,530 | | | (283) | | | 13,247 | | | 27% |
Total | $ | 291,229 | | $ | 260,334 | | $ | 654 | | $ | 260,988 | | 12% |
Artivion, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
General, Administrative, and Marketing Expense, Adjusted EBITDA, and Free Cash Flows
In Thousands
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Reconciliation of G&A expense, GAAP to adjusted G&A, non-GAAP: | | | | | | | |
General, administrative, and marketing expense, GAAP | $ | 50,017 | | | $ | 51,093 | | | $ | 130,026 | | | $ | 158,699 | |
Business development, integration, and severance expense (income) | 3,431 | | | 6,363 | | | (11,923) | | | 22,461 | |
Corporate rebranding expense | — | | | 65 | | | — | | | 283 | |
Adjusted G&A, non-GAAP | $ | 46,586 | | | $ | 44,665 | | | $ | 141,949 | | | $ | 135,955 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Reconciliation of net loss, GAAP to adjusted EBITDA, non-GAAP: | | | | | | | |
Net (loss) income, GAAP | $ | (2,288) | | | $ | (9,801) | | | $ | 3,124 | | | $ | (26,715) | |
Adjustments: | | | | | | | |
Interest expense | 8,405 | | | 6,603 | | | 24,535 | | | 19,055 | |
Depreciation and amortization expense | 6,110 | | | 5,759 | | | 17,910 | | | 17,260 | |
Business development, integration, and severance expense (income) | 3,431 | | | 6,122 | | | (11,923) | | | 26,844 | |
Stock-based compensation expense | 3,769 | | | 3,187 | | | 11,499 | | | 10,466 | |
Income tax expense | 1,022 | | | 382 | | | 5,964 | | | 5,720 | |
Loss on extinguishment of debt | — | | | — | | | 3,669 | | | — | |
Interest income | (366) | | | (339) | | | (1,093) | | | (679) | |
(Gain) loss on foreign currency revaluation | (2,382) | | | 1,882 | | | (29) | | | 112 | |
Abandonment of CardioGenesis Cardiac laser therapy business | — | | | — | | | — | | | 390 | |
Corporate rebranding expense | — | | | 65 | | | — | | | 283 | |
Gain from sale of non-financial assets | — | | | — | | | — | | | (14,250) | |
Adjusted EBITDA, non-GAAP | $ | 17,701 | | | $ | 13,860 | | | $ | 53,656 | | | $ | 38,486 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Reconciliation of cash flows from operating activities, GAAP to free cash flows, non-GAAP: | | | | | | | |
Net cash flows provided by operating activities | $ | 11,455 | | | $ | 7,232 | | | $ | 12,097 | | | $ | 7,987 | |
Capital expenditures | (3,639) | | | (2,068) | | | (9,763) | | | (7,083) | |
Free cash flows, non-GAAP | $ | 7,816 | | | $ | 5,164 | | | $ | 2,334 | | | $ | 904 | |
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 September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
GAAP: | | | | | | | |
(Loss) income before income taxes | $ | (1,266) | | | $ | (9,419) | | | $ | 9,088 | | | $ | (20,995) | |
Income tax expense | 1,022 | | | 382 | | | 5,964 | | | 5,720 | |
Net (loss) income | $ | (2,288) | | | $ | (9,801) | | | $ | 3,124 | | | $ | (26,715) | |
| | | | | | | |
Diluted (loss) income per common share | $ | (0.05) | | | $ | (0.24) | | | $ | 0.07 | | | $ | (0.65) | |
| | | | | | | |
Diluted weighted-average common shares outstanding | 41,844 | | | 40,881 | | | 42,621 | | | 40,691 | |
| | | | | | | |
Reconciliation of (loss) income before income taxes, GAAP to adjusted income, non-GAAP: | | | | | | | |
(Loss) income before income taxes, GAAP: | $ | (1,266) | | | $ | (9,419) | | | $ | 9,088 | | | $ | (20,995) | |
Adjustments: | | | | | | | |
Business development, integration, and severance expense (income) | 3,431 | | | 6,122 | | | (11,923) | | | 26,844 | |
Amortization expense | 3,990 | | | 3,766 | | | 11,650 | | | 11,453 | |
Loss on extinguishment of debt | — | | | — | | | 3,669 | | | — | |
Non-cash interest expense | 546 | | | 465 | | | 1,610 | | | 1,391 | |
Abandonment of CardioGenesis Cardiac laser therapy business | — | | | — | | | — | | | 390 | |
Corporate rebranding expense | — | | | 65 | | | — | | | 283 | |
Gain from sale of non-financial assets | — | | | — | | | — | | | (14,250) | |
Adjusted income before income taxes, non-GAAP | 6,701 | | | 999 | | | 14,094 | | | 5,116 | |
| | | | | | | |
Income tax expense calculated at a tax rate of 25% | 1,675 | | | 250 | | | 3,523 | | | 1,279 | |
Adjusted net income, non-GAAP | $ | 5,026 | | | $ | 749 | | | $ | 10,571 | | | $ | 3,837 | |
| | | | | | | |
Reconciliation of diluted income (loss) per common share, GAAP to adjusted diluted income per common share, non-GAAP: | | | | | | | |
Diluted (loss) income per common share, GAAP: | $ | (0.05) | | | $ | (0.24) | | | $ | 0.07 | | | $ | (0.65) | |
Adjustments: | | | | | | | |
Business development, integration, and severance expense (income) | 0.08 | | | 0.15 | | | (0.28) | | | 0.65 | |
Amortization expense | 0.09 | | | 0.09 | | | 0.27 | | | 0.28 | |
Loss on extinguishment of debt | — | | | — | | | 0.09 | | | — | |
Non-cash interest expense | 0.02 | | | 0.01 | | | 0.04 | | | 0.03 | |
Abandonment of CardioGenesis Cardiac laser therapy business | — | | | — | | | — | | | 0.01 | |
Corporate rebranding expense | — | | | — | | | — | | | 0.01 | |
Gain from sale of non-financial assets | — | | | — | | | — | | | (0.34) | |
Tax effect of non-GAAP adjustments | (0.05) | | | (0.06) | | | (0.03) | | | (0.17) | |
Effect of 25% tax rate | 0.03 | | | 0.07 | | | 0.09 | | | 0.27 | |
Adjusted diluted income per common share, non-GAAP | $ | 0.12 | | | $ | 0.02 | | | $ | 0.25 | | | $ | 0.09 | |
| | | | | | | |
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: | 41,844 | | | 40,881 | | | 42,621 | | | 40,691 | |
Adjustments: | | | | | | | |
Effect of dilutive stock options and awards | 1,160 | | | 662 | | | — | | | 512 | |
Diluted weighted-average common shares outstanding, non-GAAP | 43,004 | | | 41,543 | | | 42,621 | | | 41,203 | |