8-K

ARTIVION, INC. (AORT)

8-K 2022-08-04 For: 2022-08-04
View Original
Added on April 10, 2026

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): August 4, 2022

___________________________________________

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

___________________________________________________________________________________

(Former name or former address, if changed since last report)

Title of each class Trading Symbol(s) Name of each exchange <br>on which registered
Common Stock, $0.01 par value AORT NYSE

___________________________________________

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))

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 August 4, 2022, Artivion, Inc. (“Artivion” or the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2022. Artivion hereby incorporates by reference herein the information set forth in its press release dated August 4, 2022, 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 August 4, 2022
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

*Furnished herewith, not filed.

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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: August 4, 2022

ARTIVION, INC.
By: /s/ D. Ashley Lee
Name: D. Ashley Lee
Title: Executive Vice President, and<br><br>Chief Financial Officer

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Document

Exhibit 99.1

logo_oy2.jpg

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 Second Quarter 2022 Financial Results

Second Quarter and Recent Business Highlights:

•Achieved revenue of $80.3 million in the second quarter 2022 versus $76.1 million in the second quarter of 2021, an increase of 6% on a GAAP basis and 9% on a non-GAAP constant currency basis

•Enrolled first patients in U.S. AMDS clinical trial, PERSEVERE

•Completed on-site facility inspections for BioGlue CE Mark renewal

ATLANTA, GA – (August 4, 2022) – 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, 2022.

“During the second quarter we made substantial progress on each of our key three-year strategic growth initiatives. We delivered year-over-year revenue growth of 6% on a GAAP basis and 9% on a non-GAAP constant currency basis. These results were driven primarily by 23% growth in aortic stent graft revenue and 12% growth in On-X revenue, both on a constant currency basis. We also executed internationally, delivering 38% revenue growth on a constant currency basis in Asia Pacific and 59% revenue growth in Latin America. In those regions, we continue to work to further expand our commercial footprint and secure additional regulatory approvals. Importantly, we grew revenue 10% year-over-year on a constant currency basis through the first half of 2022. We expect our strong momentum to continue through the remainder of the year as we remain focused on executing on our key objectives,” said Pat Mackin, Chairman, President, and Chief Executive Officer.

Mr. Mackin added, “We also made good progress in advancing our product pipeline, which is expected to drive growth in both the near and long term. We continue to anticipate FDA PMA approval for PROACT Mitral and for PerClot this year. Meanwhile, we have now enrolled four patients in the PERSEVERE trial to secure FDA approval for AMDS, a simple, elegant stent graft

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solution to treat aortic arch disease. We also made significant progress toward completion of enrollment in our PROACT Xa trial, which we believe will revolutionize the use of mechanical heart valves in the United States and ultimately around the world.”

Second Quarter 2022 Financial Results

Total revenues for the second quarter of 2022 were $80.3 million, reflecting an increase of 6% on a GAAP basis and 9% on a non-GAAP constant currency basis, both compared to the second quarter of 2021.

Net loss for the second quarter of 2022 was ($4.3) million, or ($0.11) per fully diluted common share, compared to net loss of ($2.2) million, or ($0.06) per fully diluted common share for the second quarter of 2021. Non-GAAP net loss for the second quarter of 2022 was ($1.3) million, or ($0.03) per fully diluted common share, compared to non-GAAP net income of $4.8 million, or $0.12 per fully diluted common share for the second quarter of 2021. Net loss in the second quarter of 2022 includes pretax losses related to foreign currency revaluation of $3.8 million.

2022 Financial Outlook

Artivion continues to expect constant currency revenue growth of between 9% and 11% for the full year 2022 as compared to the full year 2021.

The Company's financial performance for 2022 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; business development, integration, and severance income or expense; loss or gain on foreign currency revaluation; income tax expense or benefit; corporate rebranding expense; 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

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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 non-GAAP to GAAP financial measures.

Webcast and Conference Call Information

The Company will hold a teleconference call and live webcast later today, August 4, 2022, 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 13730843.

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 expect our strong momentum to continue through the remainder of the year as we remain focused on executing on our key objectives; our product pipeline is expected to drive growth in both the near and long term; we continue to anticipate FDA PMA approval for PROACT Mitral and for PerClot this year; we have made also made significant progress toward completion of enrollment in our PROACT Xa trial, which we believe will revolutionize the use of mechanical heart valves in the United States and ultimately around the world; and we will deliver year-over-year constant currency revenue growth of 9-11% in 2022. 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; 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; our products that obtain regulatory approval may not be adopted by the market as much as we anticipate or at all; and the continued effects of COVID-19, including new COVID-19 variants, and continued hospital staffing shortages could adversely impact our results. 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, 2021. Artivion does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

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Artivion, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income

In Thousands, Except Per Share Data

(Unaudited)

Three Months Ended<br>June 30, Six Months Ended<br>June 30,
2022 2021 2022 2021
Revenues:
Products $ 58,936 $ 56,076 $ 116,478 $ 109,421
Preservation services 21,404 20,072 41,075 37,814
Total revenues 80,340 76,148 157,553 147,235
Cost of products and preservation services:
Products 18,230 16,178 35,638 31,089
Preservation services 9,938 9,457 19,024 17,795
Total cost of products and preservation services 28,168 25,635 54,662 48,884
Gross margin 52,172 50,513 102,891 98,351
Operating expenses:
General, administrative, and marketing 38,983 40,830 77,938 79,468
Research and development 8,648 8,360 18,776 16,114
Total operating expenses 47,631 49,190 96,714 95,582
Operating income 4,541 1,323 6,177 2,769
Interest expense 4,101 4,855 8,049 8,895
Interest income (30) (18) (46) (42)
Other expense (income), net 3,770 (1,331) 3,903 600
Loss before income taxes (3,300) (2,183) (5,729) (6,684)
Income tax expense (benefit) 959 (5) 1,919 (1,368)
Net loss $ (4,259) $ (2,178) $ (7,648) $ (5,316)
Loss per share:
Basic $ (0.11) $ (0.06) $ (0.19) $ (0.14)
Diluted $ (0.11) $ (0.06) $ (0.19) $ (0.14)
Weighted-average common shares outstanding:
Basic 40,031 38,943 39,941 38,841
Diluted 40,031 38,943 39,941 38,841
Net loss $ (4,259) $ (2,178) $ (7,648) $ (5,316)
Other comprehensive (loss) income:
Foreign currency translation adjustments (14,796) 2,973 (18,571) (7,317)
Comprehensive (loss) income $ (19,055) $ 795 $ (26,219) $ (12,633)

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Artivion, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

In Thousands

June 30,<br>2022 December 31,<br>2021
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 40,382 $ 55,010
Trade receivables, net 57,558 53,019
Other receivables 7,995 5,086
Inventories, net 74,318 76,971
Deferred preservation costs, net 44,785 42,863
Prepaid expenses and other 15,390 14,748
Total current assets 240,428 247,697
Goodwill 240,939 250,000
Acquired technology, net 154,866 166,994
Operating lease right-of-use assets, net 42,659 45,714
Property and equipment, net 36,268 37,521
Other intangibles, net 32,470 34,502
Deferred income taxes 9,916 2,357
Other assets 7,318 8,267
Total assets $ 764,864 $ 793,052
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 10,545 $ 10,395
Accrued compensation 9,732 13,163
Accrued expenses 7,842 7,687
Taxes payable 4,709 3,634
Accrued procurement fees 2,130 3,689
Current maturities of operating leases 3,207 3,149
Current portion of long-term debt 1,590 1,630
Other liabilities 1,891 1,606
Total current liabilities 41,646 44,953
Long-term debt 306,941 307,493
Contingent consideration 44,400 49,400
Non-current maturities of operating leases 42,141 44,869
Non-current finance lease obligation 3,766 4,374
Deferred income taxes 32,609 28,799
Deferred compensation liability 5,154 5,952
Other liabilities 6,698 6,484
Total liabilities $ 483,355 $ 492,324
Commitments and contingencies
Shareholders' equity:
Preferred stock
Common stock (issued shares of 41,744 in 2022 and 41,397 in 2021) 417 414
Additional paid-in capital 329,871 322,874
Retained (deficit) earnings (5,673) 1,975
Accumulated other comprehensive loss (28,458) (9,887)
Treasury stock, at cost, 1,487 shares as of June 30, 2022 and December 31, 2021 (14,648) (14,648)
Total shareholders' equity 281,509 300,728
Total liabilities and shareholders' equity $ 764,864 $ 793,052

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Artivion, Inc. and Subsidiaries

Condensed Consolidated Statement of Cash Flows

In Thousands

(Unaudited)

Six Months Ended<br>June 30,
2022 2021
Net cash flows from operating activities:
Net loss $ (7,648) $ (5,316)
Adjustments to reconcile net loss to net cash from operating activities:
Depreciation and amortization 11,497 11,999
Non-cash compensation 6,100 4,595
Non-cash lease expense 3,803 3,575
Write-down of inventories and deferred preservation costs 2,177 2,988
Change in fair value of contingent consideration (5,000) 4,270
Deferred income taxes (1,611) (4,269)
Other 940 2,174
Changes in operating assets and liabilities:
Prepaid expenses and other assets (205) (2,076)
Inventories and deferred preservation costs (3,653) (11,712)
Receivables (9,635) (5,454)
Accounts payable, accrued expenses, and other liabilities (5,677) (1,166)
Net cash flows used in operating activities (8,912) (392)
Net cash flows from investing activities:
Capital expenditures (4,055) (7,249)
Other (939) 205
Net cash flows used in investing activities (4,994) (7,044)
Net cash flows from financing activities:
Proceeds from exercise of stock options and issuance of common stock 2,318 2,321
Payment of debt issuance costs (2,219)
Redemption and repurchase of stock to cover tax withholdings (1,739) (1,831)
Repayment of term loan (1,370) (1,405)
Other (241) (603)
Net cash flows used in financing activities (1,032) (3,737)
Effect of exchange rate changes on cash and cash equivalents 310 242
Decrease in cash and cash equivalents (14,628) (10,931)
Cash and cash equivalents beginning of period 55,010 61,958
Cash and cash equivalents end of period $ 40,382 $ 51,027

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Artivion, Inc. and Subsidiaries

Financial Highlights

In Thousands

(Unaudited)

Three Months Ended<br>June 30, Six Months Ended<br>June 30,
2022 2021 2022 2021
Products:
Aortic stent grafts $ 23,833 $ 21,064 $ 49,339 $ 41,269
Surgical sealants 15,967 17,864 31,648 35,692
On-X 16,255 14,726 30,626 27,821
Other 2,881 2,422 4,865 4,639
Total products 58,936 56,076 116,478 109,421
Preservation services 21,404 20,072 41,075 37,814
Total revenues $ 80,340 $ 76,148 $ 157,553 $ 147,235

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Artivion, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Revenues and General, Administrative, and Marketing Expense

In Thousands

(Unaudited)

Three Months Ended<br>June 30, Six Months Ended<br>June 30,
2022 2021 Growth Rate 2022 2021 Growth Rate
Reconciliation of total revenues, GAAP to total revenues, non-GAAP:
Total revenues, GAAP $ 80,340 $ 76,148 6% $ 157,553 $ 147,235 7%
Impact of changes in currency exchange (2,442) (4,071)
Total constant currency revenue, non-GAAP $ 80,340 $ 73,706 9% $ 157,553 $ 143,164 10%
Three Months Ended<br>June 30, Six Months Ended<br>June 30,
--- --- --- --- --- --- --- --- ---
2022 2021 2022 2021
Reconciliation of G&A expenses, GAAP to adjusted G&A, non-GAAP:
General, administrative, and marketing expense,<br>GAAP $ 38,983 $ 40,830 $ 77,938 $ 79,468
Business development, integration, and severance (income) expense (3,101) 3,359 (4,680) 4,829
Corporate rebranding expense 289 47 1,172 62
Adjusted G&A, non-GAAP $ 41,795 $ 37,424 $ 81,446 $ 74,577

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Artivion, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Adjusted EBITDA

In Thousands

(Unaudited)

Three Months Ended<br>June 30, Six Months Ended<br>June 30,
2022 2021 2022 2021
Reconciliation of net loss, GAAP to adjusted EBITDA, non-GAAP:
Net loss, GAAP $ (4,259) $ (2,178) $ (7,648) $ (5,316)
Adjustments:
Depreciation and amortization expense 5,616 5,993 11,497 11,999
Interest expense 4,101 4,855 8,049 8,895
Stock-based compensation expense 2,934 2,115 6,100 4,595
Loss (gain) on foreign currency revaluation 3,754 (1,364) 3,887 522
Income tax expense (benefit) 959 (5) 1,919 (1,368)
Corporate rebranding expense 289 47 1,172 62
Interest income (30) (18) (46) (42)
Business development, integration, and severance (income) expense (3,101) 3,359 (4,680) 4,829
Adjusted EBITDA, non-GAAP $ 10,263 $ 12,804 $ 20,250 $ 24,176

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Artivion Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Net Loss and Diluted Loss Per Common Share

In Thousands, Except Per Share Data

(Unaudited)

Three Months Ended<br>June 30, Six Months Ended<br>June 30,
2022 2021 2022 2021
GAAP:
Loss before income taxes $ (3,300) $ (2,183) $ (5,729) $ (6,684)
Income tax expense (benefit) 959 (5) 1,919 (1,368)
Net loss $ (4,259) $ (2,178) $ (7,648) $ (5,316)
Diluted loss per common share $ (0.11) $ (0.06) $ (0.19) $ (0.14)
Diluted weighted-average common shares outstanding 40,031 38,943 39,941 38,841
Reconciliation of loss before income taxes, GAAP to adjusted (loss) income, non-GAAP:
Loss before income taxes, GAAP: $ (3,300) $ (2,183) $ (5,729) $ (6,684)
Adjustments:
Amortization expense 3,905 4,238 7,989 8,498
Corporate rebranding expense 289 47 1,172 62
Non-cash interest expense 457 1,004 913 1,572
Business development, integration, and severance (income) expense (3,101) 3,359 (4,680) 4,829
Adjusted (loss) income before income taxes, non-GAAP (1,750) 6,465 (335) 8,277
Income tax (benefit) expense calculated at a pro forma tax rate of 25% (438) 1,616 (84) 2,069
Adjusted net (loss) income, non-GAAP $ (1,312) $ 4,849 $ (251) $ 6,208
Reconciliation of diluted loss per common share, GAAP to adjusted diluted (loss) income per common share, non-GAAP:
Diluted loss per common share, GAAP: $ (0.11) $ (0.06) $ (0.19) $ (0.14)
Adjustments:
Amortization expense 0.10 0.11 0.20 0.22
Effect of 25% pro forma tax rate 0.05 0.01 0.08 0.01
Corporate rebranding expense 0.01 0.03
Non-cash interest expense 0.01 0.03 0.02 0.04
Tax effect of non-GAAP adjustments (0.01) (0.05) (0.03) (0.09)
Business development, integration, and severance (income) expense (0.08) 0.08 (0.12) 0.12
Adjusted diluted (loss) income per common share, non-GAAP $ (0.03) $ 0.12 $ (0.01) $ 0.16
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: 40,031 38,943 39,941 38,841
Adjustments:
Effect of dilutive stock options and awards 554 599
Diluted weighted-average common shares outstanding, non-GAAP 40,031 39,497 39,941 39,440

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