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    CryoLife Reports Third Quarter 2021 Financial Results

    11/4/21 4:05:00 PM ET
    $CRY
    Medical/Dental Instruments
    Health Care
    Get the next $CRY alert in real time by email

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

    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

    [email protected] 

    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

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cryolife-reports-third-quarter-2021-financial-results-301416897.html

    SOURCE CryoLife, Inc.

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