CryoLife Reports Third Quarter 2018 Results

ATLANTA, Oct. 31, 2018 /PRNewswire/ -- 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, 2018.

Third Quarter and Recent Business Highlights:

    --  Total revenues increased 47 percent to $64.6 million in the third
        quarter of 2018 compared to the third quarter of 2017
    --  Non-GAAP total revenues increased 17 percent in the third quarter of
        2018 compared to the third quarter of 2017; Non-GAAP total revenues
        increased 17 percent on a constant currency basis
    --  On-X(®) revenues increased 36 percent in the third quarter of 2018
        compared to the third quarter of 2017
    --  JOTEC(®) revenues were $15.0 million in the third quarter of 2018, a 32
        percent increase on a Non-GAAP basis compared to the third quarter of
        2017
    --  Net income was $1.6 million or $0.04 per fully diluted common share;
        Non-GAAP net income was $3.1 million, or $0.08 per fully diluted common
        share

"We had a very successful third quarter which included strong revenue growth, market share gains, new account growth and progress on our clinical and R&D programs," said Pat Mackin, Chairman, President, and Chief Executive Officer. "Our On-X and JOTEC products continue to gain momentum as our direct salesforce is effectively conveying the differentiating attributes of these products. We expect our business momentum to continue and we are therefore updating our full year guidance. Looking ahead, we have many internal initiatives that we believe can drive substantial future growth. Given our highly experienced leadership team, we are confident we can deliver on our goals and objectives for 2018."

Third Quarter 2018 Financial Results
Total revenues for the third quarter of 2018 increased 47 percent to $64.6 million, compared to $44.0 million for the third quarter of 2017. The increase was primarily driven by $15.0 million in revenues from JOTEC and strong revenue growth from On-X and tissue processing. Non-GAAP total revenues for the third quarter of 2018 increased 17 percent, compared to the third quarter of 2017, a 17 percent increase on a constant currency basis.

Net income for the third quarter of 2018 was $1.6 million, or $0.04 per fully diluted common share, compared to net income of $1.3 million, or $0.04 per fully diluted common share for the third quarter of 2017. Non-GAAP net income for the third quarter of 2018 was $3.1 million, or $0.08 per fully diluted common share, compared to non-GAAP net income of $3.1 million, or $0.09 per fully diluted common share for the third quarter of 2017.

2018 Financial Outlook
The Company is updating its full-year 2018 financial guidance, as summarized below, and expects total revenues in the fourth quarter of 2018 to be between $66.5 million and $67.5 million.


                            
            Previous                        
            Revised



         Total
          Revenues 
           $256.0 million - $260.0 million 
           $261.5 million - $262.5 million

    ---

         Gross
          Margins                            65.5% - 66.5%                          65.5% - 66.5%

                         (includes $3.5 million non-cash         (includes $2.8 million non-cash
                        charges related to acquired JOTEC       charges related to acquired JOTEC
                             inventory and distributor               inventory and distributor
                                inventory buy backs)                    inventory buy backs)

    ---

         R&D
          Expenses   
           $23.0 million - $25.0 million   
           $22.0 million - $23.0 million

    ---

         Non-GAAP
          Tax                                      Mid 20%           
            same
    Rate
                        (excludes effect of nondeductible
                           transaction costs and the tax
                           effect of stock compensation
                                     expenses)

    ---

         Non-GAAP
          EPS                       
            $0.29 - $0.32

                       (assumes approximately 37.5 million
                         fully diluted shares outstanding
                            and 25% effective tax rate)                     
            $0.30 - $0.33

                                                               (assumes approximately 37.5 million
                                                                 fully diluted shares outstanding
                                                                    and 25% effective tax rate)

    ---

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 2018 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 revenues include JOTEC revenues for the same nine-month period in 2017 prior to the closing of the acquisition of JOTEC on December 1, 2017. The Company did not own JOTEC during the nine-month period ended September 30, 2017, so the Company is unable to report its GAAP revenue growth for the nine-month period ended September 30, 2018 compared to the same period in 2017. The Company's other 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 tomorrow, November 1, 2018 at 8:30 a.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 8, 2018 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13684106.

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 forecasted revenues, gross margins, R&D expenses, non-GAAP income tax rate and non-GAAP earnings per share; and our beliefs that our On-X and JOTEC products continue to gain momentum as our direct salesforce is effectively conveying the differentiating attributes of these products, that we expect our business momentum to continue, that we have many internal initiatives that we believe can drive substantial future growth and that we are confident we can deliver on our goals and objectives for 2018. 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, 2017. 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,



                                                               2018                                  2017                           2018        2017

                                                                                                                                              ---


              
                Revenues:



              Products                                                    $
              45,152                            $
          27,029                   $
        138,063      $
         84,519



              Preservation services                                                 19,446                                    16,970                          56,979             52,357



              
                Total revenues                                           64,598                                    43,999                         195,042            136,876






              
                Cost of products and preservation
    services:



              Products                                                              12,459                                     6,220                          40,166             21,196



              Preservation services                                                  9,425                                     7,917                          27,083             23,401




              
                Total cost of products and



              
                preservation services                                    21,884                                    14,137                          67,249             44,597






              
                Gross margin                                             42,714                                    29,862                         127,793             92,279






              
                Operating expenses:



              General, administrative, and marketing                                32,871                                    24,756                         104,946             71,016



              Research and development                                               5,225                                     4,277                          16,314             13,098




              
                Total operating expenses                                 38,096                                    29,033                         121,260             84,114




              
                Operating income                                          4,618                                       829                           6,533              8,165





                                                                                      4,104                                       851                          11,863              2,486


              Interest expense



              Interest income                                                         (52)                                     (64)                          (141)             (159)



              Other (income) expense, net                                          (1,542)                                       21                           (257)              (70)






              
                Income (loss) before income taxes                         2,108                                        21                         (4,932)             5,908



              Income tax expense (benefit)                                             543                                   (1,304)                        (2,868)             (803)






              
                Net income (loss)                       $
         
                1,565                        $
      
            1,325              $
      
          (2,064) $
      
           6,711

                                                                                                                                                                                    ===




              
                Income (loss) per common share:



              
                Basic                                    $
         
                0.04                         $
      
            0.04               $
      
          (0.06)  $
      
           0.20

                                                                                                                                                                                    ===


              
                Diluted                                  $
         
                0.04                         $
      
            0.04               $
      
          (0.06)  $
      
           0.19

                                                                                                                                                                                    ===




              
                Weighted-average common shares
    outstanding:



              Basic                                                                 36,526                                    32,887                          36,331             32,665



              Diluted                                                               37,610                                    34,057                          36,331             33,851


                                                                                            
           
                CRYOLIFE, INC. AND SUBSIDIARIES


                                                                                              
              
                Financial Highlights


                                                                                                 
              
                (In thousands)




                                                                      (Unaudited)                                                     (Unaudited)


                                                                  Three Months Ended                                               Nine Months Ended


                                                                     September 30,                                                   September 30,



                                                          2018                                       2017                                            2018                                          2017




     
                Products:



     BioGlue and BioFoam                                                $
              15,646                                $
              15,730                                   $
              48,685                  $
      48,094



     JOTEC                                             15,004                                                                                                                           46,669



     On-X                                              11,298                                        8,326                                                    33,495                                   27,048



     CardioGenesis cardiac laser therapy                1,590                                        1,489                                                     4,514                                    5,130



         PerClot                                          882                                          886                                                     2,822                                    2,641



     PhotoFix                                             732                                          598                                                     1,878                                    1,606



     
                          Total products             45,152                                       27,029                                                   138,063                                   84,519






     
                Preservation services:



     Cardiac tissue                                     9,502                                        7,932                                                    26,660                                   23,911



     Vascular tissue                                    9,944                                        9,038                                                    30,319                                   28,446




     
                Total preservation services          19,446                                       16,970                                                    56,979                                   52,357






     
                Total revenues                              $
           
                64,598                   $
              
                43,999                         $
          
                195,042             $
     
        136,876






     
                Revenues:



        U.S.                                                            $
              36,516                                $
              32,208                                  $
              108,123                 $
      100,454



     International                                     28,082                                       11,791                                                    86,919                                   36,422




     
                Total revenues                              $
           
                64,598                   $
              
                43,999                         $
          
                195,042             $
     
        136,876







                                                                                                                     (Unaudited)                                         December 31,

                                                                                                                    September 30,


                                                                                                                                  2018                                               2017






     Cash, cash equivalents, and restricted securities                                                              $
              35,311                                   $
              40,753



     Total current assets                                                                    173,952                                                   179,280



     Total assets                                                                            569,695                                                   589,693



     Total current liabilities                                                                30,749                                                    42,940



     Total liabilities                                                                       292,888                                                   312,635



     Shareholders' equity                                                                    276,807                                                   277,058


                                                                                               
         
                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,

                                                                                                                                                                             ---

                                                                                                    2018                                         2017                                2018                 2017

                                                                                                                                                                                                        ---


              
                
                  GAAP:



              
                Income (loss) before income taxes                                              $
              
                2,108                            $
        
              21                       $
        
           (4,932)         $
       
            5,908



              Income tax expense (benefit)                                                                                         543                                        (1,304)                                    (2,868)                       (803)




              
                Net income (loss)                                                              $
              
                1,565                         $
        
              1,325                       $
        
           (2,064)         $
       
            6,711

                                                                                                                                                                                                                                                           ===




              
                Diluted income (loss) per common share:                                         $
              
                0.04                          $
        
              0.04                        $
        
           (0.06)          $
       
            0.19

                                                                                                                                                                                                                                                           ===




              
                Diluted weighted-average common



              
                shares outstanding                                                                                   37,610                                         34,057                                      36,331                       33,851







              
                
                  Reconciliation of income (loss) before income



              
                
                  taxes, GAAP to adjusted net income,

                
              
              
                
                  non-GAAP:





              
                Income (loss) before income taxes, GAAP                                        $
              
                2,108                            $
        
              21                       $
        
           (4,932)         $
       
            5,908



              Adjustments:



              Business development and integration expenses                                                                      1,917                                          2,998                                       6,933                        4,380



              Amortization expense                                                                                               2,707                                          1,140                                       8,195                        3,423



              Gain on On-X escrow settlement                                                    (2,675)                                                                                            (2,675)



              Inventory basis step-up expense                                                                                       62                                             32                                       2,805                        2,144



              
                Adjusted income before income taxes,



              
                non-GAAP                                                                                              4,119                                          4,191                                      10,326                       15,855





              Income tax expense calculated at 25% pro forma



              tax rate                                                                                                           1,030                                          1,048                                       2,582                        3,964




              
                Adjusted net income, non-GAAP                                                  $
              
                3,089                         $
        
              3,143                         $
        
           7,744         $
       
            11,891





              
                
                  Reconciliation of diluted income (loss) per



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





              
                Diluted income (loss) per common share, GAAP:                                   $
              
                0.04                          $
        
              0.04                        $
        
           (0.06)          $
       
            0.19



              Adjustments:



              Amortization expense                                                                                                0.08                                           0.04                                        0.22                         0.10



              Business development and integration expenses                                                                       0.05                                           0.09                                        0.19                         0.13



              Gain on On-X escrow settlement                                                     (0.07)                                                                                             (0.07)



              Inventory basis step-up expense                                                                                                                                                         0.07                             0.06



              Tax effect of non-GAAP adjustments                                                                                (0.02)                                        (0.04)                                     (0.10)                      (0.07)



              Effect of 25% pro forma tax rate                                                                                                            (0.04)                                    (0.04)                          (0.07)




              
                Adjusted diluted income per common share,



              
                 non-GAAP:                                                                      $
              
                0.08                          $
        
              0.09                          $
        
           0.21           $
       
            0.34





              
                Diluted weighted-average common



              
                shares outstanding                                                                                   37,610                                         34,057                                      37,351                       33,851


                                                                                                                  
             
                CRYOLIFE, INC. AND SUBSIDIARIES


                                                                                                                
             
                Reconciliation of GAAP to Non-GAAP


                                                                                                  
              
               Revenues; Gross Margin; General, Administrative, and Marketing


                                                                                                               
             
                (In thousands, except per share data)




                                                                                       
            
            (Unaudited)                                           
              
                (Unaudited)


                                                                                    
            
            Three Months Ended                                   
              
                Nine Months Ended


                                                                                      
            
            September 30,                                         
              
                September 30,

                                                                                                                                                                               ---

                                                                                     2018                                     2017                                   Growth                           2018                                 2017        Growth
                                                                                                                                                       Rate                                                                                      Rate

                                                                                                                                                                                                                                                      ---


              
                
                  Reconciliation of total revenues, GAAP



              
                
                  to total revenues, non-GAAP:



              Total revenues, GAAP                                                                $
              64,598                                            $
              43,999          47%                                      $
     195,042                              $
      136,876 42%



              Plus: JOTEC pre-acquisition 
              revenues                                                                            11,339                                                                                                                36,439



              
                Total revenues, non-GAAP                                      $
          
                64,598                               $
              
                55,338          17%                         $
              
       195,042                         $
      
        173,315 13%




              Impact of changes in currency exchange                                                                                      (203)                                                                                                                3,625




              
                Total constant currency                                       $
          
                64,598                               $
              
                55,135          17%                         $
              
       195,042                         $
      
        176,940 10%
    revenues, non-GAAP




                                                                                                         (Unaudited)                                                                                 
         
                (Unaudited)


                                                                                                      Three Months Ended                                                                                             Nine Months Ended


                                                                                                        September 30,                                                                                                  September 30,



                                                                                     2018                                     2017                                                                    2018                                 2017




              
                
                  Reconciliation of gross margin %,



              
                
                  GAAP to gross margin %,



              
                
                  non-GAAP:



              Total revenues, GAAP                                                                $
              64,598                                            $
              43,999                                                   $
     195,042                              $
      136,876



              Gross margin, GAAP                                                                  $
              42,714                                            $
              29,862                                                   $
     127,793                               $
      92,279



              Gross margin %, GAAP                                                   66%                                                    68%                                                                 66%                                              67%





              Gross margin, GAAP                                                                  $
              42,714                                            $
              29,862                                                   $
     127,793                               $
      92,279



              Plus: Inventory basis step- up



              expense                                                                 62                                                      32                                                                2,805                                             2,144




              
                Gross margin, non-GAAP                                        $
          
                42,776                               $
              
                29,894                                      $
              
       130,598                          $
      
        94,423




              
                Gross margin %, non-GAAP                                  66%                                                    68%                                                                 67%                                              69%




                                                                                                         (Unaudited)                                                                                 
         
                (Unaudited)


                                                                                                      Three Months Ended                                                                                             Nine Months Ended


                                                                                                        September 30,                                                                                                  September 30,



                                                                                     2018                                     2017                                                                    2018                                 2017




              
                
                  Reconciliation of general,



              
                
                  administrative, and marketing,



              
                
                  GAAP to general, administrative,



              
                
                  and marketing, non-GAAP:



              General, administrative, and marketing,



                     GAAP                                                                         $
              32,871                                            $
              24,756                                                   $
     104,946                               $
      71,016



              Less: Business development and



              integration expenses                                               (1,917)                                                (2,998)                                                             (6,933)                                          (4,380)



              
                General, administrative, and



              
                marketing, non-GAAP                                           $
          
                30,954                               $
              
                21,758                                       $
              
       98,013                          $
      
        66,636


                                                                                           
              
                CRYOLIFE, INC. AND SUBSIDIARIES


                                                                                          
              
                Reconciliation of GAAP to Non-GAAP


                                                                                         
              
                Net Income (Loss) to Adjusted EBITDA


                                                                                                    
              
                (In thousands)






                                                                                                (Unaudited)                                                          (Unaudited)


                                                                                             Three Months Ended                                                      Nine Months Ended


                                                                                               September 30,                                                         September 30,



                                                                                2018                                2017                                        2018            2017




           
                
                  Reconciliation of net income (loss),



           
                
                  GAAP to adjusted EBITDA,
      non-GAAP:



           Net income (loss), GAAP                                                   $
      
                1,565                            $
              
         1,325                       $
      
         (2,064) $
     
         6,711



           Adjustments:



           Interest income                                                                           (52)                                              (64)                                  (141)          (159)



           Interest expense                                                                         4,104                                                851                                  11,863           2,486



           Income tax expense (benefit)                                                               543                                            (1,304)                                (2,868)          (803)



           Depreciation and amortization expense                                                    4,530                                              2,331                                  13,636           6,683



           Loss (gain) on foreign currency                                                            683                                                 21                                   2,141            (78)
      
              revaluation



           Business development and integration                                                     1,917                                              2,998                                   6,933           4,380
      expenses



           Gain on On-X escrow settlement                                   (2,675)                                                                                      (2,675)



           Inventory basis step-up expense                                                             62                                                 32                                   2,805           2,144



           Stock-based compensation expense                                                         1,565                                              1,856                                   4,685           5,652




           
                Adjusted EBITDA, non-GAAP                                   $
      
                12,242                            $
              
         8,046                        $
      
         34,315 $
     
         27,016


                   Contacts:




                   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 
     
                investors@cryolife.com


      Phone: 770-419-3355

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SOURCE CryoLife, Inc.