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.

(PRNewsfoto/Artivion, Inc.)

"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


Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/artivion-reports-third-quarter-2024-financial-results-302299294.html

SOURCE Artivion, Inc.

Copyright 2024 PR Newswire

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