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Artivion
ISIN: US2289031005
WKN: 900006
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Artivion · ISIN: US2289031005 · PR Newswire (ID: 20241107CL51020)
07 November 2024 10:05PM

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, Nov. 7, 2024 /PRNewswire/ -- 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

 

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



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SOURCE Artivion, Inc.

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