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      CryoLife Reports Third Quarter 2021 Financial Results

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

      News provided by

      CryoLife, Inc.

      Nov 04, 2021, 16:05 ET

      Share this article

      Share this article


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

      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

      SOURCE CryoLife, Inc.

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