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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 R

Key Takeaway: 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 2022 Financial Results Third Quarter and Recent Business Highlights

Full Press Release Details

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 2022 Financial Results
Third Quarter and Recent Business Highlights
Achieved revenue of $76.8 million in the third quarter of 2022 versus $72.2 million in the third quarter of 2021, an increase of 6% on a GAAP basis and 11% on a non-GAAP constant currency basis
On-X revenues increased 17% on a GAAP basis and 19% on a non-GAAP constant currency basis in the third quarter of 2022 compared to the third quarter of 2021
ATLANTA, GA - (November 3, 2022) - 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, 2022.
"We remain well positioned to deliver on our growth strategy, particularly given the continued fundamental strength of our business. During the third quarter we made substantial progress on each of our key three-year strategic growth initiatives delivering year-over-year total revenue growth of 6% on a GAAP basis and 11% on a non-GAAP constant currency basis. These results were driven by growth across all four of our major product lines, including 19% growth in On-X revenue and 13% growth in tissue processing, both on a constant currency basis. Internationally, we delivered 25% revenue growth in Asia Pacific and 22% revenue growth in Latin America, both on a constant currency basis, driven by the continued expansion of our commercial footprint and securement of additional regulatory approvals. Our third quarter performance continues the momentum we have built throughout the year, resulting in a constant currency revenue growth of 11% year-over-year for the first nine months of 2022. We expect continued strong performance 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 by year end. Meanwhile, we continue to make progress
on patient enrollment in the PERSEVERE trial to secure FDA approval for AMDS, a simple, elegant stent graft solution to treat aortic arch disease. Taken as a whole, we continue to see meaningful opportunities to grow our total addressable market through pipeline development as well as to maintain momentum with our existing portfolio in our current markets."
Third Quarter 2022 Financial Results
Total revenues for the third quarter of 2022 were $76.8 million, reflecting an increase of 6% on a GAAP basis and 11% on a non-GAAP constant currency basis, both compared to the third quarter of 2021.
R D expenses for the third quarter of 2022 include a $4.7 million charge for estimated costs associated with the termination and wind-down of the PROACT Xa study as recommended by the Data and Safety Monitoring Board ("DSMB"). The majority of these costs include future administrative costs that will be incurred during the fourth quarter of 2022 and the first quarter of 2023, as well as the estimated cost of clinical drugs purchased for patients participating in the study and not expected to be recovered. These costs are non-recurring and have been excluded for purposes of calculating adjusted EBITDA and non-GAAP earnings per share.
Net loss for the third quarter of 2022 was ($13.7) million, or ($0.34) per fully diluted common share, compared to net income of $10.6 million, or $0.26 per fully diluted common share for the third quarter of 2021. Non-GAAP net loss for the third quarter of 2022 was ($1.9) million, or ($0.05) per fully diluted common share, compared to non-GAAP net loss of ($1.2) million, or ($0.03) per fully diluted common share for the third quarter of 2021. Net loss in the third quarter of 2022 includes pretax losses related to foreign currency revaluation of $3.7 million.
2022 Financial Outlook
Artivion is narrowing its constant currency revenue growth to between 9% and 10% for the full year of 2022 compared to 2021. With the continued appreciation of the dollar versus other major currencies, full year revenues are now expected to be between $313.0 million and $316.0 million.
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 loss or gain on foreign currency revaluation expenses related to the DSMB recommended termination of the PROACT Xa clinical trial income tax expense or benefit corporate rebranding expense business development, integration, and severance income or expense non-cash interest expense and gain from sale of non-financial assets. The Company generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the company and as a basis for strategic planning. Company management believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions the operating expense structure of the Company's existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses, and the
transaction and integration expenses incurred in connection with recently acquired and divested product lines and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as impact of recent acquisitions, non-cash expense related to amortization of previously acquired tangible and intangible assets, and any related adjustments to their carrying values. The Company has adjusted for the impact of changes in currency exchange from certain revenues to evaluate comparable product growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur. Company management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety, including the reconciliation of GAAP to non-GAAP financial measures."
Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, November 3, 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 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 13733812.
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 believe there are meaningful opportunities to grow our total addressable market through pipeline development as well as to maintain momentum with our existing portfolio in our current markets we continue to anticipate FDA PMA approval for PROACT Mitral and for PerClot this year and we will deliver year-over-year constant currency revenue growth of 9-10% in 2022 versus 2021. 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 and macroeconomic factors such as inflation and currency exchange 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.
Artivion, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income
In Thousands, Except Per Share Data
Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
Revenues
Products $ 55,248 $ 53,107 $ 171,726 $ 162,528
Preservation services 21,590 19,100 62,665 56,914
Total revenues 76,838 72,207 234,391 219,442
Cost of products and preservation services
Products 17,743 15,503 53,381 46,592
Preservation services 10,351 8,915 29,375 26,710
Total cost of products and preservation services 28,094 24,418 82,756 73,302
Gross margin 48,744 47,789 151,635 146,140
Operating expenses
General, administrative, and marketing 41,051 39,053 118,989 118,521
Research and development 11,799 9,972 30,575 26,086
Total operating expenses 52,850 49,025 149,564 144,607
Gain from sale of non-financial assets - (15,923) $ - (15,923)
Operating (loss) income (4,106) 14,687 2,071 17,456
Interest expense 4,805 4,100 12,854 12,995
Interest income (40) (18) (86) (60)
Other expense, net 3,661 2,661 7,564 3,261
(Loss) income before income taxes (12,532) 7,944 (18,261) 1,260
Income tax expense (benefit) 1,181 (2,638) 3,100 (4,006)
Net (loss) income $ (13,713) $ 10,582 $ (21,361) $ 5,266
(Loss) income per share
Basic $ (0.34) $ 0.27 $ (0.53) $ 0.13
Diluted $ (0.34) $ 0.26 $ (0.53) $ 0.13
Weighted-average common shares outstanding
Basic 40,115 39,086 39,999 38,924
Diluted 40,115 44,453 39,999 39,496
Net (loss) income $ (13,713) $ 10,582 $ (21,361) $ 5,266
Other comprehensive loss
Foreign currency translation adjustments (16,895) (5,010) (35,466) (12,327)
Comprehensive (loss) income $ (30,608) $ 5,572 $ (56,827) $ (7,061)
Artivion, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
September 30, 2022 December 31, 2021
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents $ 37,572 $ 55,010
Trade receivables, net 57,159 53,019
Other receivables 7,880 5,086
Inventories, net 73,044 76,971
Deferred preservation costs, net 45,483 42,863
Prepaid expenses and other 16,851 14,748
Total current assets 237,989 247,697
Goodwill 234,773 250,000
Acquired technology, net 148,060 166,994
Operating lease right-of-use assets, net 41,320 45,714
Property and equipment, net 36,286 37,521
Other intangibles, net 31,112 34,502
Deferred income taxes 6,103 2,357
Other assets 7,088 8,267
Total assets $ 742,731 $ 793,052
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities
Accounts payable $ 10,721 $ 10,395
Accrued compensation 11,079 13,163
Accrued expenses 10,088 7,687
Taxes payable 5,293 3,634
Accrued procurement fees 2,302 3,689
Current maturities of operating leases 3,061 3,149
Current portion of long-term debt 1,562 1,630
Other liabilities 1,886 1,606
Total current liabilities 45,992 44,953
Long-term debt 306,674 307,493
Contingent consideration 44,800 49,400
Non-current maturities of operating leases 40,915 44,869
Non-current finance lease obligation 3,450 4,374
Deferred income taxes 34,058 28,799
Deferred compensation liability 5,082 5,952
Other liabilities 6,652 6,484
Total liabilities $ 487,623 $ 492,324
Commitments and contingencies
Shareholders' equity
Preferred stock - -
Common stock (issued shares of 41,816 in 2022 and 41,397 in 2021) 418 414
Additional paid-in capital 334,077 322,874
Retained (deficit) earnings (19,386) 1,975
Accumulated other comprehensive loss (45,353) (9,887)
Treasury stock, at cost, 1,487 shares as of September 30, 2022 and December 31, 2021 (14,648) (14,648)
Total shareholders' equity 255,108 300,728
Total liabilities and shareholders' equity $ 742,731 $ 793,052
Artivion, Inc. and Subsidiaries
Condensed Consolidated Statement of Cash Flows
Nine Months Ended September 30,
2022 2021
Net cash flows from operating activities
Net (loss) income $ (21,361) $ 5,266
Adjustments to reconcile net (loss) income to net cash from operating activities
Depreciation and amortization 17,016 18,008
Non-cash compensation 9,189 7,471
Non-cash lease expense 5,656 5,566
Deferred income taxes 5,097 (8,128)
Write-down of inventories and deferred preservation costs 3,116 3,987
Non-cash interest expense 1,372 2,025
Change in fair value of contingent consideration (4,600) 4,970
Gain from sale of non-financial assets - (15,923)
Other 151 678
Changes in operating assets and liabilities
Prepaid expenses and other assets (1,788) (2,268)
Accounts payable, accrued expenses, and other liabilities (2,103) 65
Inventories and deferred preservation costs (5,781) (16,986)
Receivables (10,900) (8,032)
Net cash flows used in operating activities (4,936) (3,301)
Net cash flows from investing activities
Acquisition of intangible assets (1,123) (726)
Capital expenditures (6,924) (10,524)
Proceeds from sale of non-financial assets, net - 19,000
Other - 722
Net cash flows (used in) provided by investing activities (8,047) 8,472
Net cash flows from financing activities
Proceeds from exercise of stock options and issuance of common stock 3,344 3,531
Redemption and repurchase of stock to cover tax withholdings (1,791) (1,898)
Repayment of term loan (2,033) (2,397)
Payment of debt issuance costs - (2,219)
Other (300) (439)
Net cash flows used in financing activities (780) (3,422)
Effect of exchange rate changes on cash and cash equivalents (3,675) 1,418
(Decrease) increase in cash and cash equivalents (17,438) 3,167
Cash and cash equivalents beginning of period 55,010 61,958
Cash and cash equivalents end of period $ 37,572 $ 65,125
Artivion, Inc. and Subsidiaries
Financial Highlights
Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
Products
Aortic stent grafts $ 19,674 $ 20,896 $ 69,013 $ 62,165
Surgical sealants 17,374 16,544 49,022 52,236
On-X 16,456 14,022 47,082 41,843
Other 1,744 1,645 6,609 6,284
Total products 55,248 53,107 171,726 162,528
Preservation services 21,590 19,100 62,665 56,914
Total revenues $ 76,838 $ 72,207 $ 234,391 $ 219,442
Revenues
US $ 41,250 $ 36,205 $ 119,938 $ 111,529
International 35,588 36,002 114,453 107,913
Total revenues $ 76,838 $ 72,207 $ 234,391 $ 219,442
Artivion, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
Revenues and General, Administrative, and Marketing Expense
Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 Growth Rate 2022 2021 Growth Rate
Reconciliation of total revenues, GAAP to total revenues, non-GAAP
Total revenues, GAAP $ 76,838 $ 72,207 6% $ 234,391 $ 219,442 7%
Impact of changes in currency exchange - (3,287) - (7,358)
Total constant currency revenue, non-GAAP $ 76,838 $ 68,920 11% $ 234,391 $ 212,084 11%
Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
Reconciliation of G A expenses, GAAP to adjusted G A, non-GAAP
General, administrative, and marketing expense, GAAP $ 41,051 $ 39,053 $ 118,989 $ 118,521
Corporate rebranding expense 251 461 1,423 523
Business development, integration, and severance expense (income) 864 1,309 (3,816) 6,138
Adjusted G A, non-GAAP $ 39,936 $ 37,283 $ 121,382 $ 111,860
Artivion, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
Reconciliation of net (loss) income, GAAP to adjusted EBITDA, non-GAAP
Net (loss) income, GAAP $ (13,713) $ 10,582 $ (21,361) $ 5,266
Adjustments
Depreciation and amortization expense 5,519 6,009 17,016 18,008
Interest expense 4,805 4,100 12,854 12,995
Stock-based compensation expense 3,089 2,876 9,189 7,471
Loss on foreign currency revaluation 3,668 2,576 7,555 3,097
Clinical trial termination expense 4,741 - 4,741 -
Income tax expense (benefit) 1,181 (2,638) 3,100 (4,006)
Corporate rebranding expense 251 461 1,423 523
Gain from sale of non-financial assets - (15,923) - (15,923)
Interest income (40) (18) (86) (60)
Business development, integration, and severance expense (income) 864 1,309 (3,816) 6,138
Adjusted EBITDA, non-GAAP $ 10,365 $ 9,334 $ 30,615 $ 33,509
Artivion Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP
Net (Loss) Income and Diluted (Loss) Income Per Common Share
In Thousands, Except Per Share Data
Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
GAAP
(Loss) income before income taxes $ (12,532) $ 7,944 $ (18,261) $ 1,260
Income tax expense (benefit) 1,181 (2,638) 3,100 (4,006)
Net (loss) income $ (13,713) $ 10,582 $ (21,361) $ 5,266
Diluted (loss) income per common share $ (0.34) $ 0.26 $ (0.53) $ 0.13
Diluted weighted-average common shares outstanding 40,115 44,453 39,999 39,496
Reconciliation of (loss) income before income taxes, GAAP to adjusted (loss) income, non-GAAP
(Loss) income before income taxes, GAAP $ (12,532) $ 7,944 $ (18,261) $ 1,260
Adjustments
Amortization expense 3,686 4,203 11,675 12,701
Clinical trial termination expense 4,741 - 4,741 -
Corporate rebranding expense 251 461 1,423 523
Non-cash interest expense 459 453 1,372 2,025
Gain from sale of non-financial assets - (15,923) - (15,923)
Business development, integration, and severance expense (income) 864 1,309 (3,816) 6,138
Adjusted (loss) income before income taxes, non-GAAP (2,531) (1,553) (2,866) 6,724
Income tax (benefit) expense calculated at a pro forma tax rate of 25% (633) (388) (717) 1,681
Adjusted net (loss) income, non-GAAP $ (1,898) $ (1,165) $ (2,149) $ 5,043
Reconciliation of diluted (loss) income per common share, GAAP to adjusted diluted (loss) income per common share, non-GAAP
Diluted (loss) income per common share, GAAP $ (0.34) $ 0.26 $ (0.53) $ 0.13
Adjustments
Amortization expense 0.09 0.11 0.29 0.33
Effect of 25% pro forma tax rate 0.10 (0.11) 0.19 (0.11)
Clinical trial termination expense 0.12 - 0.12 -
Non-cash interest expense 0.01 0.01 0.03 0.05
Corporate rebranding expense - 0.01 0.03 0.01
Gain from sale of non-financial assets - (0.41) - (0.40)
Business development, integration, and severance expense (income) 0.03 0.04 (0.09) 0.15
Tax effect of non-GAAP adjustments (0.06) 0.06 (0.09) (0.03)
Adjusted diluted (loss) income per common share, non-GAAP $ (0.05) $ (0.03) $ (0.05) $ 0.13
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 40,115 44,453 39,999 39,496
Adjustments
Effect of dilutive stock options and awards - (505) - -
Effect of convertible senior notes - (4,862) - -
Diluted weighted-average common shares outstanding, non-GAAP 40,115 39,086 39,999 39,496
Last updated: Nov 3, 2022