CryoLife Reports First Quarter 2019 Financial Results

ATLANTA, April 30, 2019 /PRNewswire/ --

First Quarter and Recent Business Highlights:

    --  Total revenues were $67.5 million in the first quarter of 2019,
        reflecting year over year growth of 9% and an 11% increase on a non-GAAP
        constant currency basis, both compared to the first quarter of 2018
        --  On-X(®) revenues increased 14%, and 15% on a non-GAAP constant
            currency basis, both compared to the first quarter of 2018
        --  JOTEC(®) revenues increased 10%, and 18% on a non-GAAP constant
            currency basis, both compared to the first quarter of 2018
    --  Net loss was ($297,000), or ($0.01) per fully diluted common share;
        non-GAAP net income was $1.5 million, or $0.04 per fully diluted common
        share

CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the first quarter ended March 31, 2019.

"We had a successful start to the year posting solid financial results and advancing our clinical and R&D programs. Our strategy of differentiated products focused on select markets, supported by a well-trained direct sales force, is allowing us to continue to take market share," said Pat Mackin, Chairman, President, and Chief Executive Officer. "Given our strong performance in the first quarter and the expected launch of the initial phase of our next generation products, we remain on track to deliver high single-digit top line growth in 2019. Our pipeline programs have increased our addressable market opportunity to $3.5 billion, positioning the Company for substantial growth in the coming years."

First Quarter 2019 Financial Results
Total revenues for the first quarter of 2019 were $67.5 million, reflecting growth of 9%, and 11% on a non-GAAP constant currency basis, both compared to the first quarter of 2018. The increase was driven by strong revenue growth from JOTEC, On-X, and BioGlue.

Net loss for the first quarter of 2019 was ($297,000), or ($0.01) per fully diluted common share, compared to a net loss of ($3.9) million, or ($0.11) per fully diluted common share for the first quarter of 2018. Non-GAAP net income for the first quarter of 2019 was $1.5 million, or $0.04 per fully diluted common share, compared to non-GAAP net income of $793,000, or $0.02 per fully diluted common share for the first quarter of 2018.

2019 Financial Outlook
CryoLife is reiterating its full-year financial guidance, with total revenues for 2019 expected to be in the range of $280 million to $284 million and non-GAAP earnings per share expected to be between $0.28 and $0.32.

All numbers are presented on a GAAP basis except where expressly referenced as non-GAAP. The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP.

The Company's financial guidance for 2019 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 results exclude (as applicable) business development and integration expenses, amortization expense, and inventory basis step-up expense. The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions, and 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. 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 does, however, expect to incur similar types of expenses 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, April 30, 2019 at 4:30 p.m. EDT 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 May 7, 2019 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13690095.

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 belief that our strategy of differentiated products focused on select markets, supported by a well-trained direct sales force, is allowing us to continue to take market share; the timing of our expected launch of the initial phase of our next generation products; our belief that we remain on track to deliver high single-digit top line growth in 2019; our belief that our addressable market opportunity is $3.5 billion; and our belief that we are positioned for substantial growth in the coming years. 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. 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, 2018. 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)


                                                                       Three Months Ended


                                                                            March 31,



                                                                                     2019                         2018




     
              Revenues:



     Products                                                                                         $
      48,401             $
       43,598



     Preservation services                                                                                19,104                  18,350



     
              Total revenues                                                                            67,505                  61,948





                 Cost of products and preservation
                  services:



     Products                                                                                             13,826                  14,157



     Preservation services                                                                                 9,406                   8,563



                 Total cost of products and preservation
                  services                                                                                 23,232                  22,720






     
              Gross margin                                                                              44,273                  39,228






     
              Operating expenses:


      General, administrative, and marketing                                                               36,520                  37,348



     Research and development                                                                              5,548                   5,370



                 Total operating expenses                                                                  42,068                  42,718



                                                                                                            2,205                 (3,490)

                 Operating income (loss)






     Interest expense                                                                                      3,894                   3,656



     Interest income                                                                                       (116)                   (59)



     Other expense (income), net                                                                              77                   (181)





                                                                                                          (1,650)                (6,906)

                 Loss before income taxes



     Income tax benefit                                                                                  (1,353)                (3,051)






     
              Net loss                                                                    $
            
        (297)      $
      
         (3,855)





                  Loss per common share:



     
              Basic                                                                      $
            
        (0.01)       $
      
         (0.11)




     
              Diluted                                                                    $
            
        (0.01)       $
      
         (0.11)





                 Weighted-average common shares
                  outstanding:



     Basic                                                                                                36,778                  36,146



     Diluted                                                                                              36,778                  36,146


                                                
        
          CRYOLIFE, INC. AND SUBSIDIARIES


                                               
        
          Fina
                ncial Highlights


                                                  
        
                (In thousands)




                                                            (Unaudited)


                                                        Three Months Ended


                                                             March 31,



                                                                      2019                            2018




     
                Products:



     BioGlue                                                                             $
     17,222            $
     15,970



     JOTEC                                                                                  15,954               14,460



     On-X                                                                                   11,731               10,309


      CardioGenesis cardiac laser therapy                                                     1,714                1,346



     PerClot                                                                                 1,050                  972



     PhotoFix                                                                                  730                  541




     
                Total Products                                                            48,401 43,598





                   Preservation services:



     Cardiac tissue                                                                          8,930                8,103



     Vascular tissue                                                                        10,174               10,247



                   Total preservation services                                               19,104               18,350






     
                Total revenues                                            $
              
       67,505        $
     
       61,948






     
                Revenues:



     U.S.                                                                                $
     37,325            $
     34,888



     International                                                                          30,180               27,060




     
                Total revenues                                            $
              
       67,505        $
     
       61,948


                                 (Unaudited)


                                  March 31,             December 31,


                                        2019                     2018





      Cash, cash equivalents,
       and restricted securities             $
      41,075               $
      42,236


      Total current assets                      178,652                  179,168



     Total assets                              586,928                  571,091


      Total current liabilities                  36,423                   34,523


      Total liabilities                         314,306                  296,024


      Shareholders' equity                      272,622                  275,067


                                                                                
        
                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)


                                                                                                       Three Months Ended


                                                                                                            March 31,



                                                                                                                     2019                                2018





                                           GAAP:


                            Loss before income taxes                                                                        $
              
            (1,650)      $
          
         (6,906)



              Income tax benefit                                                                                                                (1,353)                    (3,051)




              
                Net loss                                                                                          $
              
            (297)      $
          
         (3,855)





                            Diluted loss per common share:                                                                   $
              
            (0.01)       $
          
         (0.11)





                                           Reconciliation of income before
                                            income taxes,


                                           GAAP to adjusted net income,
                                            non-GAAP:




                            Loss before income taxes, GAAP                                                                  $
              
            (1,650)      $
          
         (6,906)



              Adjustments:


               Business development and
                integration expenses                                                                                                               1,109                       3,722



              Amortization expense                                                                                                                2,579                       2,735


                  Inventory basis step-up expense                                                                                                                             1,506


                            Adjusted income before income
                             taxes,


                             non-GAAP                                                                                                              2,038                       1,057




               Income tax expense calculated at
                a


    pro forma tax rate of 25%                                                                                                                      510                         264



                            Adjusted net income, non-GAAP                                                                     $
              
            1,528           $
         
          793





                                           Reconciliation of diluted (loss)
                                            income per common


                                                  share, GAAP to adjusted diluted
                                                   (loss) income per


                                           common share, non-GAAP:




                            Diluted loss per common share -
                             GAAP                                                                                            $
              
            (0.01)       $
          
         (0.11)



              Adjustments:


                  Business development and
                   integration expenses                                                                                                             0.03                        0.10



              Amortization expense                                                                                                                 0.07                        0.07


               Inventory basis step-up expense                                                                                                                                 0.04


               Tax effect of non-GAAP
                adjustments                                                                                                                       (0.03)                     (0.05)


               Effect of 25% pro forma tax rate                                                                                                   (0.02)                     (0.03)


                            Adjusted diluted income per
                             common share,


                                non-GAAP:                                                                                      $
              
            0.04          $
         
          0.02





                            Diluted weighted-average common


                                   shares outstanding:                                                                                            37,711                      36,985


                                                                                         
        
                CRYOLIFE, INC. AND SUBSIDIARIES


                                                                                       
        
                Reconciliation of GAAP to Non-GAAP


                                                                                  
     
          Revenues; Gross Margin; General, Administrative, and Marketing


                                                                                           
              
                Adjusted EBITDA


                                                                                      
        
                (In thousands, except per share data)




                                                                                                                     
              
                (Unaudited)


                                                                                                                  
              
                Three Months Ended


                                                                                                                      
              
                March 31,



                                                                                                                                  2019                               2018          Growth Rate






     
                
                  Reconciliation of total revenues, GAAP to



     
                
                  total revenues, non-GAAP:



     Total revenues, GAAP                                                                                                                            $
          67,505            $
         61,948   9%



     Impact of changes in currency exchange                                                                                                                                         (1,337)




     
                Total constant currency revenues, non-GAAP                                                                            $
              
            67,505      $
       
           60,611  11%








     
                
                  Reconciliation of total JOTEC revenues, GAAP to



     
                
                  total JOTEC revenues, non-GAAP:



     Total JOTEC revenues, GAAP                                                                                                                      $
          15,954            $
         14,460  10%



     Impact of changes in currency exchange                                                                                                                                           (986)




     
                Total constant currency JOTEC revenues, non-GAAP                                                                      $
              
            15,954      $
       
           13,474  18%








     
                
                  Reconciliation of total On-X revenues, GAAP to



     
                
                  total On-X revenues, non-GAAP:



     Total On-X revenues, GAAP                                                                                                                       $
          11,731            $
         10,309  14%



     Impact of changes in currency exchange                                                                                                                                            (77)




     
                Total constant currency On-X revenues, non-GAAP                                                                       $
              
            11,731      $
       
           10,232  15%





                                                                                                                        (Unaudited)


                                                                                                                    Three Months Ended


                                                                                                 
              
                March 31,



                                                                                                                                                                2019                     2018




     
                
                  Reconciliation of net (loss) income, GAAP



     
                
                  to adjusted EBITDA, non-GAAP:



     Net (loss) income, GAAP                                                                                                                          $
          (297)          $
         (3,855)



     Adjustments:



     Depreciation and amortization expense                                                                                                                    4,350                    4,376



     Income tax benefit                                                                                                                                     (1,353)                 (3,051)



     Interest income                                                                                                                                          (116)                    (59)



     Interest expense                                                                                                                                         3,894                    3,656



     Inventory basis step-up expense                                                                                                                                                  1,506



     Business development and integration expenses                                                                                                            1,109                    3,722



     Loss (gain) on foreign currency revaluation                                                                                                                 74                     (32)



     Stock-based compensation expense                                                                                                                         1,853                    1,248




     
                Adjusted EBITDA, non-GAAP                                                                                              $
              
            9,514       $
       
           7,511



              
                CryoLife                     
     
                Gilmartin Group LLC


              D. Ashley Lee                             
     Greg Chodaczek / Lynn Lewis

               Executive Vice President, Chief Financial
                Officer                                  
     Phone:  646-924-1769
    and Chief Operating Officer
    Phone: 770-419-3355                                  
     
                investors@cryolife.com

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SOURCE CryoLife, Inc.