CryoLife Reports Third Quarter 2020 Financial Results

ATLANTA, Nov. 4, 2020 /PRNewswire/ --

Third Quarter and Recent Business Highlights:

    --  Achieved total revenues of $65.1 million in the third quarter 2020
        versus $67.9 million in the third quarter of 2019
        --  Total revenues decreased 4% on a GAAP and non-GAAP constant currency
            basis versus third quarter 2019
        --  Excluding TMR, third quarter revenues decreased 2% on a GAAP and
            non-GAAP constant currency basis versus third quarter 2019
    --  Achieved net loss of ($2.9) million, or ($0.08) per share
    --  Achieved non-GAAP net income of $4.9 million, or $0.13 per share
    --  Completed acquisition of Ascyrus Medical LLC

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, 2020.

"Our performance in the third quarter further validated our belief that the majority of products in our portfolio are used in procedures that cannot be postponed or delayed for long. We believe our business is weathering the pandemic well and we continue to progress on our strategic initiatives," commented Pat Mackin, Chairman, President, and Chief Executive Officer. "We saw an improvement in procedure volumes sequentially month to month from July to September with a corresponding increase in revenue growth over those months. Our manufacturing facilities continue to run at near capacity and our supply chain remains largely intact. We have continued to fund R&D programs related to products that we believe will deliver revenue in 2021 and 2022, including our regulatory approvals for U.S. PerClot PMA, BioGlue China and PROACT Mitral. Lastly, we completed the acquisition of Ascyrus Medical LLC, further strengthening our innovative portfolio of products focused on aortic repair and increasing our total addressable market opportunity to over $6 billion, providing us adequate opportunity to drive our financial performance for years to come. Given these achievements in the third quarter, we remain optimistic that we will deliver on our growth strategy and remain in a position of strength through 2021."

Third Quarter Financial Results
Total revenues for the third quarter of 2020 were $65.1 million, reflecting a decrease of (4%) on a GAAP and non-GAAP constant currency basis, both compared to the third quarter of 2019. Revenue performance across all product lines reflected the impact of the COVID-19 pandemic on the number of procedures using our products.

Net loss for the third quarter of 2020 was ($2.9) million, or ($0.08) per fully diluted common share, compared to net loss of ($134,000), or less than $0.01 per fully diluted common share for the third quarter of 2019. Non-GAAP net income for the third quarter of 2020 was $4.9 million, or $0.13 per fully diluted common share, compared to non-GAAP net income of $2.5 million, or $0.07 per fully diluted common share for the third quarter of 2019.

2020 Financial Outlook
Due to continued uncertainties resulting from the COVID-19 pandemic, the Company is not issuing 2020 financial guidance at this time.

The Company's financial performance for 2020 is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures. 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 net income and non-GAAP EBITDA results exclude (as applicable) business development, integration, and severance expense, amortization expense, non-cash interest expense, loss on foreign currency revaluation, stock-based compensation expense, and corporate rebranding expense. The Company 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 excluded the impact of changes in currency exchange from certain revenues to evaluate 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.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, November 4, 2020 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To listen to the live teleconference, please dial 201-689-8261. A replay of the teleconference will be available through November 11, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13712302.

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. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include our beliefs that the majority of products in our portfolio are used in procedures that cannot be postponed or delayed for long; our business is weathering the pandemic well; we continue to progress on our strategic initiatives; certain of our products will deliver revenue in 2021 and 2022; and, with the acquisition of Ascyrus Medical LLC, our portfolio of products focused on aortic repair is strengthened, increases our total addressable market opportunity to over $6 billion, and will provide us adequate opportunity to drive our financial performance for years to come. They also include that we remain optimistic that we will deliver on our growth strategy and remain in a position of strength through 2021. 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 may not be achieved and the continued effects of COVID-19 and government mandates implemented to address the pandemic. 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, 2019. CryoLife does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.


                                                                       
         
              CryoLife, Inc. and Subsidiaries

                                                                         
            
              Financial Highlights

                                                                    
         
              (In thousands, except per share data)




                                                                   
         (Unaudited)                                       
          (Unaudited)


                                                                           Three Months Ended                                       Nine Months Ended


                                                                             September 30,                                            September 30,

                                                                                                                                 ---

                                                                                     2020                                             2019                              2020                    2019



                                                                   
         (Unaudited)                                       
          (Unaudited)



     
              Revenues:



     Products                                                             $
            45,109                                   $
          47,484                   $
          128,797         $
          147,053



     Preservation services                                                        20,022                                           20,397                            56,534                  59,472




     
              Total revenues                                                    65,131                                           67,881                           185,331                 206,525





                 Cost of products and preservation services:



     Products                                                                     12,998                                           12,706                            36,078                  41,021



     Preservation services                                                         9,001                                            9,953                            26,060                  29,043



                 Total cost of products and preservation services                  21,999                                           22,659                            62,138                  70,064






     
              Gross margin                                                      43,132                                           45,222                           123,193                 136,461






     
              Operating expenses:



     General, administrative, and marketing                                       33,743                                           34,259                           105,033                 105,402



     Research and development                                                      5,755                                            6,259                            17,633                  17,648




     
              Total operating expenses                                          39,498                                           40,518                           122,666                 123,050






     
              Operating income                                                   3,634                                            4,704                               527                  13,411






     Interest expense                                                              4,940                                            3,555                            11,980                  11,260



     Interest income                                                                (13)                                           (259)                            (181)                  (608)



     Other expense, net                                                            2,888                                            2,400                             5,810                   2,662





                 (Loss) income before income taxes                                (4,181)                                           (992)                         (17,082)                     97



     Income tax benefit                                                          (1,311)                                           (858)                          (3,858)                (2,304)






     
              Net (loss) income                                $
         
              (2,870)                            $
        
            (134)           $
       
            (13,224)    $
       
            2,401

                                                                                                                                                                                                ===



                 (Loss) income per common share:



     
              Basic                                             $
         
              (0.08)                           $
        
            (0.00)             $
       
            (0.35)     $
       
            0.06

                                                                                                                                                                                                ===


     
              Diluted                                           $
         
              (0.08)                           $
        
            (0.00)             $
       
            (0.35)     $
       
            0.06

                                                                                                                                                                                                ===



                 Weighted-average common shares outstanding:



     Basic                                                                        37,912                                           37,255                            37,608                  37,065



     Diluted                                                                      37,912                                           37,255                            37,608                  37,850





     
              Net (loss) income                                $
         
              (2,870)                            $
        
            (134)           $
       
            (13,224)    $
       
            2,401


                 Other comprehensive income (loss):



     Foreign currency translation adjustments                                      8,698                                          (8,017)                            8,669                 (8,803)



                 Comprehensive income (loss)                        $
         
              5,828                           $
        
            (8,151)            $
       
            (4,555)  $
       
            (6,402)

                                                                                                                                                                                                ===


                                                         
              
             CryoLife, Inc. and Subsidiaries

                                                              
              
             Financial Highlights

                                                                 
              
              (In thousands)




                                                      
      (Unaudited)                                      
            (Unaudited)


                                                           Three Months Ended                                         Nine Months Ended


                                                              September 30,                                             September 30,

                                                                                                                 ---

                                               2020                           2019                                         2020           2019

                                                                                                                                        ---


     
                Products:



     BioGlue                                            $
              15,811                                   $
            15,679                      $
        44,985      $
        50,834



     JOTEC                                                        15,290                                             15,774                            43,932            48,936



     On-X                                                         12,067                                             12,610                            34,385            36,751



     PhotoFix                                                      1,134                                              1,087                             3,056             2,752



     PerClot                                                         724                                                980                             2,081             2,814


      CardioGenesis cardiac laser therapy                              83                                              1,354                               358             4,966



                             Total products                        45,109                                             47,484                           128,797           147,053




                   Preservation services:



     Cardiac tissue                                     $
              10,679                                   $
            11,304                            28,758            30,734



     Vascular tissue                                               9,285                                              9,093                            27,657            28,738



     NeoPatch                                   58                                                                                      119



                   Total preservation services                     20,022                                             20,397                            56,534            59,472




                   Total revenues                   $
      
                65,131                      $
              
              67,881                 $
     
          185,331 $
     
          206,525

                                                                                                                                                                            ===




     
                Revenues:



     U.S.                                               $
              36,332                                   $
            37,981                     $
        103,171     $
        113,548



     International                                                28,799                                             29,900                            82,160            92,977



                   Total revenues                   $
      
                65,131                      $
              
              67,881                 $
     
          185,331 $
     
          206,525

                                                                                                                                                                            ===




                       (Unaudited)


                            September 30,            December 31,


                                     2020                     2019



     Cash, cash
      equivalents, and
      restricted
      securities                          $
      64,635               $
      34,294


     Total current
      assets                                 233,699                  187,390


     Total assets                            782,200                  605,654


     Total current
      liabilities                             53,667                   45,195


     Total liabilities                       456,434                  319,958


     Shareholders'
      equity                                 325,766                  285,696


                                                                                                               
        
                CryoLife, Inc. and Subsidiaries

                                                                                                             
        
                Reconciliation of GAAP to Non-GAAP

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

                                                                                                            
        
                (In thousands, except per share data)




                                                                                                                      
              (Unaudited)                                        
           (Unaudited)


                                                                                                                                    Three Months Ended                                         Nine Months Ended


                                                                                                                                      September 30,                                              September 30,

                                                                                                                                                                                          ---

                                                                                                                                              2020                                              2019                                       2020                      2019



                                           GAAP:


                            (Loss) income before
                             income taxes                                                                           $
              
                (4,181)                           $
         
             (992)                 $
           
           (17,082)      $
         
             97



              Income tax benefit                                                                                                          (1,311)                                            (858)                                   (3,858)                  (2,304)



                            Net (loss) income                                                                       $
              
                (2,870)                           $
         
             (134)                 $
           
           (13,224)   $
         
             2,401

                                                                                                                                                                                                                                                                     ===



                            Diluted (loss) income
                             per common share                                                                        $
              
                (0.08)                          $
         
             (0.00)                   $
           
           (0.35)    $
         
             0.06

                                                                                                                                                                                                                                                                     ---



                            Diluted weighted-average common
                                      
              shares
                                                outstanding                                                                                 37,912                                            37,255                                     37,608                    37,850




                                           Reconciliation of (loss) income
                                            before income taxes,
                                            
                
                  GAAP
                                                                      to adjusted net  income, non-
                                            GAAP


                            (Loss) income before
                             income taxes, GAAP:                                                                    $
              
                (4,181)                           $
         
             (992)                 $
           
           (17,082)      $
         
             97



              Adjustments:



              Amortization expense                                                                                                          3,397                                             2,660                                      9,430                     7,796


               Business development, integration,
                and severance expense                                                                                                        6,005                                             1,250                                      7,481                     2,562


               Non-cash interest expense                                                                                                     1,371                                               407                                      2,261                     1,225


               Corporate rebranding expense                                                                                                                                                                       321





                            Adjusted income before income
                             taxes, 
                non-GAAP                                                                                    6,592                                             3,325                                      2,411                    11,680






               Income tax benefit calculated at a


    pro forma tax rate of 25%                                                                                                              1,648                                               831                                        603                     2,920



                            Adjusted net  income,
                             non-GAAP                                                                                 $
              
                4,944                            $
         
             2,494                     $
          
            1,808    $
         
             8,760

                                                                                                                                                                                                                                                                     ===



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

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


                            Diluted (loss) income
                             per common share,
                             GAAP:                                                                                   $
              
                (0.08)                          $
         
             (0.00)                   $
           
           (0.35)    $
         
             0.06



              Adjustments:



              Amortization expense                                                                                                           0.09                                              0.07                                       0.25                      0.20


               Business development, integration,
                and severance expense                                                                                                         0.16                                              0.03                                       0.20                      0.06


               Non-cash interest expense                                                                                                      0.04                                              0.01                                       0.06                      0.03


               Corporate rebranding expense                                                                                                                                                                      0.01


               Tax effect of non-GAAP
                adjustments                                                                                                                 (0.07)                                           (0.02)                                    (0.13)                   (0.06)


               Effect of 25% pro forma tax rate                                                                                             (0.01)                                           (0.02)                                      0.01                    (0.06)



                            Adjusted diluted income
                             per common share, non-
                             GAAP                                                                                      $
              
                0.13                             $
         
             0.07                      $
          
            0.05     $
         
             0.23

                                                                                                                                                                                                                                                                     ===



                            Diluted weighted-average common
                                      
              shares
                                                outstanding                                                                                 38,357                                            37,940                                     38,151                    37,850


                                                                                                               
              
           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,

                                                                                                                                                                                ---

                                                                                            2020                                2019                                  Growth                          2020                  2019               Growth
                                                                                                                                                         Rate                                                                     Rate

                                                                                                                                                                                                                                       ---

                                  Reconciliation of total revenues, GAAP to
                                             
                
                  total
                                                                       revenues, non-GAAP:



     Total revenues, GAAP                                                                               $
              65,131                                        $
             67,881          -4%                    $
       185,331                       $
       206,525  -10%


      Impact of changes in currency exchange                                                                                                     4                                                                                      (1,719)



                   Total constant currency
                    revenues, non-GAAP                                                           $
         
                65,131                           $
              
               67,885          -4%                $
     
         185,331                   $
     
         204,806  -10%





                                  Reconciliation of total revenues, GAAP to
                                             
                
                  total
                                                                       revenues, non-GAAP:



     Total revenues, GAAP                                                                               $
              65,131                                        $
             67,881          -4%                    $
       185,331                       $
       206,525  -10%


      Less CardioGenesis cardiac laser therapy                                              (83)                                           (1,354)                                                         (358)                       (4,966)



                   Total GAAP revenues excluding CardioGenesis                                                     65,048                                                   66,527          -2%                         184,973                            201,559   -8%


      Impact of changes in currency exchange                                                                                                     4                                                                                      (1,719)



                   Total constant currency
                    revenues excluding
                    CardioGenesis, non-GAAP                                                      $
         
                65,048                           $
              
               66,531          -2%                $
     
         184,973                   $
     
         199,840   -7%




                                                                         
     (Unaudited)                              
     (Unaudited)


                                                                              Three Months Ended                         Nine Months Ended


                                                                                 September 30,                             September 30,



                                                                                            2020               2019                                      2020 2019



                                  Reconciliation of net
                                   (loss) income, GAAP to


                                                   adjusted EBITDA, non-
                                   GAAP:


      Net (loss) income, GAAP                                                                       $
     (2,870)                                 $
     (134)               $
       (13,224)      $
       2,401



     Adjustments:


      Depreciation and
       amortization expense                                                                              5,176                                     4,526                       14,818           13,257


      Interest expense                                                                                   4,940                                     3,555                       11,980           11,260


      Business development,
       integration, and
       severance expense                                                                                 6,005                                     1,250                        7,481            2,562


      Stock-based
       compensation expense                                                                              2,358                                     2,462                        7,432            6,581


      (Income) loss on
       foreign currency
       revaluation                                                                                     (2,073)                                    2,419                          846            2,669


      Corporate rebranding
       expense                                                                                                                                                                  321


      Income tax benefit                                                                               (1,311)                                    (858)                     (3,858)         (2,304)


      Interest income                                                                                     (13)                                    (259)                       (181)           (608)



                   Adjusted EBITDA, non-
                    GAAP                                                                         $
     
       12,212                             $
     
       12,961           $
        
         25,615 $
      
         35,818


                   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

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SOURCE CryoLife, Inc.