CryoLife Reports Third Quarter 2021 Financial Results

Published: Oct. 20, 2021 at 12:10 PM AKDT|Updated: Nov. 4, 2021 at 12:05 PM AKDT

ATLANTA, Nov. 4, 2021 /PRNewswire/ --

Cryolife logo. (PRNewsFoto/CryoLife, Inc.) (PRNewsFoto/CRYOLIFE_ INC_) (PRNewsFoto/CRYOLIFE,...
Cryolife logo. (PRNewsFoto/CryoLife, Inc.) (PRNewsFoto/CRYOLIFE_ INC_) (PRNewsFoto/CRYOLIFE, INC.)

Third Quarter and Recent Business Highlights:

  • Achieved total revenues of $72.2 million in the third quarter 2021 versus $65.1 million in the third quarter of 2020, an increase of 11% on a GAAP basis and 9% on a non-GAAP proforma constant currency basis
  • Net income was $10.6 million, or $0.26 per share, in the third quarter of 2021
  • Non-GAAP net loss was ($1.2) million, or ($0.03) per share, in the third quarter of 2021

CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the third quarter ended September 30, 2021.

"Despite meaningful headwinds from the Delta variant in the third quarter, we still generated revenue growth on both a GAAP and pro forma constant currency basis compared to the prior year and compared to 2019, driven by our recent product launches and strength in our U.S. On-X aortic valve business. We've also made progress in driving growth across APAC and LATAM as we continue to expand our commercial footprint and seek new regulatory approvals," said Pat Mackin, Chairman, President, and Chief Executive Officer.

"Additionally, we have submitted PMAs to FDA for PerClot and PROACT Mitral and anticipate receiving approvals for both in 2022. We've also made significant progress with enrollment in our PROACT Xa clinical trial and continue to advance several other programs which are expected to deliver incremental growth beginning in 2024."

"Given our solid financial foundation, performance of our new products, market expansion opportunities and a strong pipeline, CryoLife is very well positioned now and for the future."

Third Quarter 2021 Financial Results
Total revenues for the third quarter of 2021 were $72.2 million, reflecting an increase of 11% on a GAAP basis and 9% on a non-GAAP proforma constant currency basis, both compared to the third quarter of 2020.

Net income for the third quarter of 2021 was $10.6 million, or $0.26 per fully diluted common share, compared to net loss of ($2.9) million, or ($0.08) per fully diluted common share for the third quarter of 2020. Non-GAAP net loss for the third quarter of 2021 was ($1.2) million, or ($0.03) per fully diluted common share, compared to non-GAAP net income of $4.9 million, or $0.13 per fully diluted common share for the third quarter of 2020.

The financial results reported in this earnings release are preliminary pending the Company's filing of its quarterly report on Form 10-Q, which it expects to file on November 5, 2021.

2021 Financial Outlook
The Company is maintaining its second half of 2021 proforma constant currency growth outlook of between 7 and 10% compared to the second half of 2019, but due to the strengthening dollar, revenues for the full year are expected to be between $296.0 and $299.0 million dollars and fourth quarter revenues are expected to be between $76.5 and $79.5 million dollars, reflecting pro forma constant currency growth of between 9.5% and 13.7% over the fourth quarter of 2019. This forecast is based on our estimates of the current and an anticipated diminishing impact of COVID-19 on our business.

The Company's financial performance for the remainder of 2021 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 adjusted operating income. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. 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 revenues of acquired and divested product lines and the impact of changes in currency exchange. The Company's non-GAAP net income, non-GAAP EBITDA, and non-GAAP adjusted operating income results exclude (as applicable) business development, integration, and severance expense; gain from sale of non-financial assets; depreciation and amortization expense; interest income and expense; non-cash interest expense; loss (gain) on foreign currency revaluation; stock-based compensation expense; corporate rebranding expense; and income tax expense (benefit). 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 acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company has adjusted for the impact of acquired and divested product lines and 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.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, November 4, 2021 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. An audio replay will be available through November 11, 2021 and can be accessed by dialing (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13724263.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

About CryoLife, Inc.
Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. CryoLife markets and sells products in more than 100 countries worldwide. For additional information about CryoLife, visit our website, www.cryolife.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.  Readers are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date of this press release and reflect the view of management as of the date of this press release. Forward-looking statements include statements related to future regulatory approvals, the progress and future results of clinical trials, future product launches, commercial footprint expansion, market performance of our current and future products, revenue and earnings growth related to current and newly introduced products, our forecasted revenue and earnings, and the effects of the COVID-19 pandemic on our business. 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 distribution agreement may not be achieved, that the benefits anticipated from our clinical trials may not be achieved or achieved on our anticipated timelines, that our product candidates may not receive regulatory approval or receive regulatory approval on our anticipated timelines, that our products that obtain regulatory approval may not be accepted by the market, and the continued effects of COVID-19, including decelerating vaccination or vaccine adoption rates, or government mandates implemented to address the effects of the pandemic, 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 year ended December 31, 2020. CryoLife does not assume any obligation, and expressly disclaims any duty to update any of its forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:


CryoLife

Gilmartin Group LLC

D. Ashley Lee

Brian Johnston / Lynn Lewis

Executive Vice President, Chief Financial Officer and

Phone: 631-807-1986

Chief Operating Officer

investors@cryolife.com 

Phone: 770-419-3355


CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income/(Loss)

(In thousands, except per share data)

(Unaudited)






Three Months Ended


Nine Months Ended


September 30,


September 30,



2021



2020



2021



2020

Revenues:












Products

$

53,107


$

45,109


$

162,528


$

128,797

Preservation services


19,100



20,022



56,914



56,534

Total revenues


72,207



65,131



219,442



185,331













Cost of products and preservation services:












Products


15,503



12,998



46,592



36,078

Preservation services


8,915



9,001



26,710



26,060

Total cost of products and preservation services


24,418



21,999



73,302



62,138













Gross margin


47,789



43,132



146,140



123,193













Operating expenses:












General, administrative, and marketing


39,053



33,743



118,521



105,033

Research and development


9,972



5,755



26,086



17,633

Total operating expenses


49,025



39,498



144,607



122,666

Gain from sale of non-financial assets


(15,923)



--



(15,923)



--

Operating income


14,687



3,634



17,456



527













Interest expense


4,100



4,940



12,995



11,980

Interest income


(18)



(13)



(60)



(181)

Other expense, net


2,661



2,888



3,261



5,810













Income (loss) before income taxes


7,944



(4,181)



1,260



(17,082)

Income tax benefit


(2,638)



(1,311)



(4,006)



(3,858)













Net income (loss)

$

10,582


$

(2,870)


$

5,266


$

(13,224)













Income (loss) per share:












Basic

$

0.27



(0.08)


$

0.13



(0.35)

Diluted

$

0.26


$

(0.08)


$

0.13


$

(0.35)













Weighted-average common shares outstanding:












Basic


39,086



37,912



38,924



37,608

Diluted


44,453



37,912



39,496



37,608













Net income (loss)

$

10,582


$

(2,870)


$

5,266


$

(13,224)

Other comprehensive income (loss):












Foreign currency translation adjustments


(5,010)



8,698



(12,327)



8,669

Comprehensive income (loss)

$

5,572


$

5,828


$

(7,061)


$

(4,555)

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands)



September 30,


December 31,


2021


2020


(Unaudited)




ASSETS






Current assets:






Cash and cash equivalents

$

64,587


$

61,412

Restricted securities


538



546

Trade receivables, net


49,682



45,964

Other receivables


5,494



2,788

Inventories, net


78,319



73,038

Deferred preservation costs


42,619



36,546

Prepaid expenses and other


16,104



14,295

Total current assets


257,343



234,589







Goodwill


252,441



260,061

Acquired technology, net


171,788



186,091

Operating lease right-of-use assets, net


46,913



18,571

Other intangibles, net


36,001



40,966

Property and equipment, net


36,973



33,077

Deferred income taxes


3,974



1,446

Other assets


13,221



14,603

Total assets

$

818,654


$

789,404







LIABILITIES AND SHAREHOLDERS' EQUITY






Current liabilities:






Current portion of contingent consideration

$

17,600


$

16,430

Accounts payable


9,528



9,623

Accrued compensation


11,990



10,192

Accrued expenses


9,091



7,472

Accrued procurement fees


3,296



3,619

Taxes payable


3,129



2,808

Current maturities of operating leases


3,053



5,763

Current portion of long-term debt


1,640



1,195

Other liabilities


1,803



3,366

Total current liabilities


61,130



60,468







Long-term debt


307,765



290,468

Non-current maturities of operating leases


45,765



14,034

Contingent consideration


47,300



43,500

Deferred income taxes


27,339



34,713

Deferred compensation liability


5,571



5,518

Other liabilities


12,243



11,990

Total liabilities

$

507,113


$

460,691







Commitments and contingencies












Shareholders' equity:






Preferred stock


--



--

Common stock (issued shares of 40,816 in 2021 and 40,394 in 2020)


408



404

Additional paid-in capital


309,290



316,192

Retained earnings


22,075



20,022

Accumulated other comprehensive (loss) income


(5,584)



6,743

Treasury stock, at cost, 1,487 shares as of September 30, 2021

 and December 31, 2020, respectively


(14,648)



(14,648)

Total shareholders' equity


311,541



328,713







Total liabilities and shareholders' equity

$

818,654


$

789,404

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statement of Cash Flows

(In thousands)

(Unaudited)



Nine Months Ended


September 30,



2021



2020

Net cash flows from operating activities:






Net income (loss)

$

5,266


$

(13,224)







Adjustments to reconcile net income (loss) to net cash from operating activities:






Depreciation and amortization


18,008



14,818

Non-cash compensation


7,471



7,432

Non-cash lease expense


5,566



5,324

Change in fair value of contingent consideration


4,970



--

Non-cash interest expense


2,025



2,261

Change in fair value of long-term loan


--



4,949

Deferred income taxes


(8,128)



(4,916)

Gain from sale of non-financial assets


(15,923)



--

Other


4,665



1,631

Changes in operating assets and liabilities:






Accounts payable, accrued expenses, and other liabilities


65



3,230

Prepaid expenses and other assets


(2,268)



(2,560)

Receivables


(8,032)



7,718

Inventories and deferred preservation costs


(16,986)



(19,744)

Net cash flows (used in) provided by operating activities


(3,301)



6,919







Net cash flows from investing activities:






Proceeds from sale of non-financial assets, net


19,000



--

Acquisition of Ascyrus, net of cash acquisition


--



(59,643)

Payments for Endospan agreements


--



(5,000)

Capital expenditures


(10,524)



(5,171)

Other


(4)



(968)

Net cash flows provided by (used in) investing activities


8,472



(70,782)







Net cash flows from financing activities:






Proceeds from exercise of stock options and issuance of common stock


3,531



2,079

Proceeds from issuance of convertible debt


--



100,000

Proceeds from revolving line of credit


--



30,000

Proceeds from financing insurance premiums


--



2,816

Repayment of revolving line of credit


--



(30,000)

Redemption and repurchase of stock to cover tax withholdings


(1,898)



(1,768)

Payment of debt issuance costs


(2,219)



(3,647)

Repayment of debt


(2,397)



(3,727)

Other


(439)



(463)

Net cash flows (used in) provided by financing activities


(3,422)



95,290







Effect of exchange rate changes on cash, cash equivalents, and restricted securities


1,418



(1,086)

Increase in cash, cash equivalents, and restricted securities


3,167



30,341







Cash, cash equivalents, and restricted securities beginning of period


61,958



34,294

Cash, cash equivalents, and restricted securities end of period

$

65,125


$

64,635

CryoLife, Inc. and Subsidiaries

Financial Highlights

 (In thousands)



(Unaudited)


(Unaudited)


Three Months Ended


Nine Months Ended


September 30,


September 30,


2021


2020


2021


2020

Products:












Aortic stents and stent grafts

$

20,896


$

15,290


$

62,165


$

43,932

Surgical sealants


16,544



15,811



52,236



44,985

On-X


14,022



12,067



41,843



34,385

Other


1,645



1,941



6,284



5,495

Total products


53,107



45,109



162,528



128,797













Preservation services


19,100



20,022



56,914



56,534

Total revenues

$

72,207


$

65,131


$

219,442


$

185,331













Revenues:








U.S.

$

36,205


$

36,332


$

111,529


$

103,171

International


36,002



28,799



107,913



82,160

Total revenues

$

72,207


$

65,131


$

219,442


$

185,331

CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Revenues and Adjusted EBITDA

(In thousands, except per share data)



(Unaudited)


(Unaudited)


Three Months Ended


Nine Months Ended


September 30,


September 30,


2021


2020

Growth Rate


2021


2020

Growth Rate

Reconciliation of total revenues, GAAP to














total revenues, non-GAAP:














Total revenues, GAAP

$

72,207


$

65,131

11%


$

219,442


$

185,331

18%

Including AMDS prior to acquisition  


--



691




--



2,088


Excluding PerClot post sale


--



(498)




--



(498)


Impact of changes in currency exchange


--



824




--



4,358


Total proforma constant currency revenue, non-
GAAP

$

72,207


$

66,148

9%


$

219,442


$

191,279

15%



























(Unaudited)



(Unaudited)



Three Months Ended



Nine Months Ended



September 30,



September 30,



2021


2020



2021


2020


Reconciliation of operating income, GAAP to














adjusted operating income, non-GAAP:














Operating income

$

14,687


$

3,634



$

17,456


$

527


Gain from sale of non-financial assets


(15,923)



--




(15,923)



--


Amortization expense


4,203



3,397




12,701



9,430


Operating business development, integration, and
severance expense


1,309



1,056




6,138



2,532


Corporate rebranding expense


461



--




523



321


Adjusted operating income, non-GAAP

$

4,737


$

8,087



$

20,895


$

12,810

















(Unaudited)



(Unaudited)



Three Months Ended



Nine Months Ended



September 30,



September 30,



2021


2020



2021


2020


Reconciliation of net income (loss), GAAP to














adjusted EBITDA, non-GAAP:














Net income (loss), GAAP

$

10,582


$

(2,870)



$

5,266


$

(13,224)


Adjustments:














Depreciation and amortization expense


6,009



5,176




18,008



14,818


Interest expense


4,100



4,940




12,995



11,980


Stock-based compensation expense


2,876



2,358




7,471



7,432


Business development, integration, and severance
expense


1,309



6,005




6,138



7,481


Loss (gain) on foreign currency revaluation


2,576



(2,073)




3,097



846


Corporate rebranding expense


461



--




523



321


Interest income


(18)



(13)




(60)



(181)


Income tax benefit


(2,638)



(1,311)




(4,006)



(3,858)


Gain from sale of non-financial assets


(15,923)



--




(15,923)



--


Adjusted EBITDA, non-GAAP

$

9,334


$

12,212



$

33,509


$

25,615


CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Net Income (Loss) and Diluted Income (Loss) Per Common Share

(In thousands, except per share data)



(Unaudited)


(Unaudited)


Three Months Ended


Nine Months Ended


September 30,


September 30,



2021



2020



2021



2020

GAAP:












Income (loss) before income taxes

$

7,944


$

(4,181)


$

1,260


$

(17,082)

Income tax benefit


(2,638)



(1,311)



(4,006)



(3,858)

Net income (loss)

$

10,582


$

(2,870)


$

5,266


$

(13,224)













Diluted income (loss) per common share:

$

0.26


$

(0.08)


$

0.13


$

(0.35)













Diluted weighted-average common shares outstanding


44,453



37,912



39,496



37,608













Reconciliation of income (loss) before income taxes,












GAAP to adjusted (loss) income, non-GAAP












Income (loss) before income taxes, GAAP:

$

7,944


$

(4,181)


$

1,260


$

(17,082)

Adjustments:












Amortization expense


4,203



3,397



12,701



9,430

Gain from sale of non-financial assets


(15,923)



--



(15,923)



--

Business development, integration, and severance expense


1,309



6,005



6,138



7,481

Non-cash interest expense


453



1,371



2,025



2,261

Corporate rebranding expense


461



--



523



321

Adjusted (loss) income before income taxes,












non-GAAP


(1,553)



6,592



6,724



2,411













Income tax (benefit) expense calculated at a












pro forma tax rate of 25%


(388)



1,648



1,681



603

Adjusted net (loss) income, non-GAAP

$

(1,165)


$

4,944


$

5,043


$

1,808













Reconciliation of diluted income (loss) per common share, GAAP












to adjusted diluted (loss) income per common share, non-GAAP:












Diluted income (loss) per common share, GAAP:

$

0.26


$

(0.08)


$

0.13


$

(0.35)

Adjustments:












Amortization expense


0.11



0.09



0.33



0.25

Gain from sale of non-financial assets


(0.41)



--



(0.40)



--

Business development, integration, and severance expense


0.04



0.16



0.15



0.20

Non-cash interest expense


0.01



0.04



0.05



0.06

Corporate rebranding expense


0.01



--



0.01



0.01

Tax effect of non-GAAP adjustments


0.06



(0.07)



(0.03)



(0.13)

Effect of 25% pro forma tax rate


(0.11)



(0.01)



(0.11)



0.01

Adjusted diluted (loss) income per common share,












non-GAAP

$

(0.03)


$

0.13


$

0.13


$

0.05













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:


44,453



37,912



39,496



37,608

Adjustments:












Effect of dilutive stock options and awards


(505)



445



--



543

Effect of convertible senior notes


(4,862)



--



--



--

Diluted weighted-average common shares outstanding, non-GAAP


39,086



38,357



39,496



38,151

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