Penumbra, Inc. Reports Third Quarter 2018 Financial Results

ALAMEDA, Calif., Nov. 5, 2018 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today reported financial results for the third quarter ended September 30, 2018.

    --  Revenue of $111.8 million in the third quarter of 2018, an increase of
        33.2% over the third quarter of 2017.

Third Quarter 2018 Financial Results
Total revenue grew to $111.8 million for the third quarter of 2018 compared to $83.9 million for the third quarter of 2017, an increase of 33.2%. The United States represented 65% of total revenue and international represented 35% of total revenue for the third quarter of 2018. Revenue from sales of neuro products grew to $74.7 million for the third quarter of 2018, an increase of 27.3%, from the third quarter of 2017. Revenue from sales of peripheral vascular products grew to $37.1 million for the third quarter of 2018, an increase of 47.1%, from the third quarter of 2017.

Gross profit was $75.0 million, or 67.1% of total revenue, for the third quarter of 2018, compared to $54.8 million, or 65.3% of total revenue, for the third quarter of 2017.

In the third quarter of 2018, total operating expenses include a $30.8 million acquired in-process research and development ("IPR&D") charge in connection with the acquisition of a controlling interest in MVI Health Inc. which was accounted for as an asset acquisition. Total operating expenses for the third quarter of 2018 were $95.9 million, or 85.7% of total revenue. Excluding the IPR&D charge, total adjusted operating expenses(1) (a non-GAAP measure) were $65.0 million, or 58.2% of total revenue, for the third quarter of 2018. This compares to total operating expenses of $54.1 million, or 64.5% of total revenue, for the third quarter of 2017. R&D expenses were $9.1 million for the third quarter of 2018, compared to $8.1 million for the third quarter of 2017. SG&A expenses were $55.9 million for the third quarter of 2018, compared to $46.0 million for the third quarter of 2017.

Operating loss for the third quarter of 2018 was $20.8 million. Excluding the IPR&D charge, adjusted operating income(1) (a non-GAAP measure) was $10.0 million for the third quarter of 2018. This compares to operating income of $0.7 million for the third quarter of 2017.

Full Year 2018 Financial Outlook
The Company is increasing its 2018 guidance for total revenue to be in the range of $437 million to $438 million. This new range compares to the previous range of $420 million to $425 million.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss the third quarter 2018 financial results after market close on Monday, November 5, 2018 at 5:00 PM Eastern Time. The conference call can be accessed live over the phone by dialing (866) 393-4306 for domestic callers or (734) 385-2616 for international callers (conference id: 8597766), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company's website at: www.penumbrainc.com. The webcast will be available on the Company's website for two weeks following the completion of the call.

About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. For more information, visit www.penumbrainc.com.

Non-GAAP Financial Measures
In addition to financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company uses the following non-GAAP financial measures in this press release: a) adjusted operating expenses and adjusted operating income (loss), b) adjusted net income (loss) and adjusted diluted earnings per share ("EPS"), and c) constant currency.

Constant Currency. The Company's constant currency revenue disclosures estimate the impact of changes in foreign currency rates on the translation of the Company's current period revenue as compared to the applicable comparable period in the prior year. This impact is derived by taking the current local currency revenue and translating it into U.S. dollars based upon the foreign currency exchange rates used to translate the local currency revenue for the applicable comparable period in the prior year, rather than the actual exchange rates in effect during the current period. It does not include any other effect of changes in foreign currency rates on the Company's results or business. Revenue growth was not reported on a constant currency basis for this period as the percentages were deemed not significant but revenue growth on a constant currency basis is included in the reconciliation below.

Adjusted operating expenses and adjusted operating income (loss). The Company defines adjusted operating expenses as total operating expenses, excluding the IPR&D charge in connection with the MVI Health Inc. asset acquisition. Adjusted operating income (loss) is defined as operating income (loss), excluding the same IPR&D charge.

Adjusted net income (loss) and adjusted diluted EPS. The Company defines adjusted net income (loss) as net income (loss), excluding a) the IPR&D charge in connection with the MVI Health Inc. asset acquisition, b) the one-time effect of the transition tax from the Tax Cuts and Jobs Act of 2017 (the "Tax Reform Act") in the first quarter of 2018, and c) the effects of the excess tax benefits associated with share-based compensation arrangements, net of any related valuation allowance. The Company defines adjusted diluted EPS as GAAP diluted EPS, excluding the effects of the same items above.

Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in the tables below.

Our management believes the non-GAAP financial measures disclosed in this press release are useful to investors in assessing the operating performance of our business and provide meaningful comparisons to prior periods and thus a more complete understanding of our business than could be obtained absent this disclosure. Specifically, we consider the change in constant currency revenue as a useful metric as it provides an alternative framework for assessing how our underlying business performed excluding the effect of foreign currency rate fluctuations. We consider adjusted operating expenses, adjusted operating income (loss), adjusted net income (loss), and adjusted diluted EPS useful metrics as they provide an alternative framework for assessing how our underlying business performed. These metrics exclude the effects of the IPR&D charge in connection with the MVI Health Inc. asset acquisition, and, in the case of adjusted net income (loss) and adjusted diluted EPS, the one-time effect of the transition tax from the Tax Reform Act, as well as the effects of excess tax benefits associated with share-based compensation arrangements, net of any related valuation allowance.

The non-GAAP financial measures included in this press release may be different from, and therefore may not be comparable to, similarly titled measures used by other companies. These non-GAAP measures should not be considered in isolation or as alternatives to GAAP measures. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business.

Forward-Looking Statements
Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on February 27, 2018. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.




                        (1)See "Non-GAAP Financial
                         Measures" below for important
                         information about our use of
                         non-GAAP measures and
                         further information about our
                         adjusted operating expenses
                         and adjusted operating income
                         (loss) measures.


                                                           
         
                Penumbra, Inc.


                                                        
     
           Condensed Consolidated Balance Sheets


                                                            
         
                (unaudited)


                                                           
         
                (in thousands)




                                                              September 30,                             December 31,
                                                                       2018                                      2017




     
                Assets



     Current assets:



          Cash and cash equivalents                                           $
              47,742                              $
       50,637



          Marketable investments                                   146,176                                           163,954



          Accounts receivable, net                                  80,435                                            58,007



          Inventories                                              109,706                                            94,901


           Prepaid expenses and other current assets                 13,536                                            14,735



               Total current assets                                397,595                                           382,234



     Property and equipment, net                                    34,133                                            30,899



     Intangible assets, net                                         27,284                                            23,778



     Goodwill                                                        7,923                                             8,178



     Long-term investments                                                                                            3,872



     Deferred taxes                                                 32,985                                            26,690



     Other non-current assets                                        1,085                                             1,016




              Total assets                                                   $
              501,005                             $
       476,667



                   Liabilities and Stockholders' Equity



     Current liabilities:



          Accounts payable                                                     $
              8,869                               $
       6,757



          Accrued liabilities                                       56,183                                            44,825



                Total current liabilities                            65,052                                            51,582



     Deferred rent                                                   7,510                                             6,199



     Other non-current liabilities                                  19,155                                            18,478




               Total liabilities                                    91,717                                            76,259



     Stockholders' equity:



     Common stock                                                       34                                                33



     Additional paid-in capital                                    407,881                                           396,810


      Accumulated other comprehensive (loss)
       income                                                         (899)                                            1,569



     Retained earnings                                               2,403                                             1,996


      Total Penumbra, Inc. stockholders' equity                     409,419                                           400,408




     Non-controlling interest                                        (131)



     Total stockholders' equity                                              $
              409,288                             $
       400,408



      Total liabilities and stockholders' equity                              $
              501,005                             $
       476,667


                                                                           
              
                Penumbra, Inc.


                                                           
              
                Condensed Consolidated Statements of Operations


                                                                             
              
                (unaudited)


                                                         
              
                (in thousands, except share and per share amounts)




                                                     Three Months Ended September 30,                                        Nine Months Ended September 30,


                                           2018                        2017                       2018                                       2017




     Revenue                                    $
        111,806                                          $
              83,911                                      $
         324,145    $
       237,713



     Cost of revenue                    36,794                                   29,134                                         110,324                                 84,298




     Gross profit                       75,012                                   54,777                                         213,821                                153,415




     Operating expenses:


      Research and development            9,092                                    8,132                                          25,298                                 23,260


      Sales, general and
       administrative                    55,934                                   45,962                                         165,209                                132,846


      Acquired in-process research
       and development                   30,835                                                                                  30,835



      Total operating expenses           95,861                                   54,094                                         221,342                                156,106



      (Loss) income from operations    (20,849)                                     683                                         (7,521)                               (2,691)



     Interest income, net                  771                                      658                                           2,240                                  1,926


      Other income (expense), net           170                                    (102)                                          (460)                                 (665)


      (Loss) income before income
       taxes and equity in losses of
       unconsolidated investee         (19,908)                                   1,239                                         (5,741)                               (1,430)


      Provision for (benefit from)
       income taxes                       1,598                                      456                                         (5,288)                                 2,293



      (Loss) income before equity in
       losses of unconsolidated
       investee                        (21,506)                                     783                                           (453)                               (3,723)


      Equity in losses of
       unconsolidated investee            (920)                                   (545)                                        (3,101)                                 (703)


      Consolidated net (loss) income            $
        (22,426)                                            $
              238                                      $
         (3,554)   $
       (4,426)



      Net loss attributable to non-
       controlling interest             (3,496)                                                                                (3,496)


      Net (loss) income attributable
       to Penumbra, Inc.                        $
        (18,930)                                            $
              238                                         $
         (58)   $
       (4,426)



      Net (loss) income attributable
       to Penumbra, Inc. per share:



     Basic                                       $
        (0.55)                                           $
              0.01                           
            $                   $
       (0.14)




     Diluted                                     $
        (0.55)                                           $
              0.01                           
            $                   $
       (0.14)



      Weighted average shares
       outstanding:



     Basic                          34,248,484                               33,446,841                                      34,057,216                             32,766,135




     Diluted                        34,248,484                               35,664,272                                      34,057,216                             32,766,135


                                                                                                                                   
              
                Penumbra, Inc.


                                                                    
              
                Reconciliation of GAAP Operating Expenses and Operating (Loss) Income to Adjusted Operating Expenses and Adjusted Operating Income (Loss)(1)


                                                                                                                                    
              
                (unaudited)


                                                                                                                                   
              
                (in thousands)




                                                                                                                                                           Three Months Ended September 30,                                     Nine Months Ended September 30,


                                                                                                                                         2018                                2017                    2018                                    2017




     GAAP operating expenses                                                                                                                     $
              95,861                                       $
              54,094                                    $
       221,342   $
       156,106


      GAAP total operating expenses and operating (loss) income from operations includes the effect of the following items:



     Acquired IPR&D in connection with an asset acquisition(2)                                                                        30,835                                                                                    30,835



     Adjusted operating expenses                                                                                                                 $
              65,026                                       $
              54,094                                    $
       190,507   $
       156,106






     GAAP operating (loss) income from operations                                                                                              $
              (20,849)                                         $
              683                                    $
       (7,521)  $
       (2,691)



     Adjusted operating income (loss) from operations                                                                                             $
              9,986                                          $
              683                                     $
       23,314   $
       (2,691)


                                                                                                  
              
                Penumbra, Inc.


                                                        
             
         Reconciliation of GAAP Net Income (Loss) and Diluted EPS to Adjusted Net Income (Loss) and Adjusted Diluted EPS(1)


                                                                                                    
              
                (unaudited)


                                                                                
              
                (in thousands, except share and per share amounts)




                                                                                            Three Months Ended September 30,                                        Nine Months Ended September 30,


                                                                          2018                                2017                        2018                             2017



      GAAP net (loss) income attributable to Penumbra, Inc.                      $
              (18,930)                                           $
              238                                        $
           (58)   $
        (4,426)


      GAAP net (loss) income includes the effect of the following
       items:


      Acquired IPR&D in connection with an asset acquisition(2)         27,393                                                                                         27,393


      Effect of the transition tax under the Tax Reform Act(3)                                                                                                            88


      Excess tax benefits related to stock compensation awards4        (2,156)                                         (2,602)                                      (13,610)                               (19,082)


      Valuation allowance on excess tax benefit related to stock
       compensation awards4                                                                                              2,602                                                                                19,082



     Adjusted net income (loss)                                                    $
              6,307                                            $
              238                                      $
           13,813    $
        (4,426)






     GAAP diluted EPS                                                             $
              (0.55)                                          $
              0.01                           
             $                   $
        (0.14)




     Adjusted diluted EPS                                                           $
              0.17                                           $
              0.01                                        $
           0.38     $
        (0.14)



      Weighted average shares outstanding used to compute:



     Adjusted diluted EPS5                                         36,125,198                                       35,664,272                                     36,064,996                              32,766,135



                            (1)See "Non-GAAP Financial Measures"
                             above for important information about
                             our use of non-GAAP measures and
                             further information about our
                             adjusted operating expenses, adjusted
                             operating income (loss), adjusted net
                             income (loss) and adjusted diluted
                             EPS measures.




                            (2)On August 31, 2018, the Company
                             acquired a controlling interest in
                             MVI Health Inc. which was accounted
                             for as an asset acquisition. In
                             connection with the transaction, the
                             Company recorded a $30.8 million
                             IPR&D charge during the three and
                             nine months ended September 30, 2018,
                             in the consolidated statements of
                             operations related to the acquired
                             technology under development from MVI




                            (3)On December 22, 2017, the Tax
                             Reform Act was enacted into law. This
                             new tax law, among other changes,
                             reduces the Company's U.S. federal
                             statutory corporate income tax rate
                             from 34% to 21% effective January 1,
                             2018. In the first quarter of 2018,
                             the Company recorded a provisional
                             tax charge for the one-time
                             transition tax on the undistributed
                             earnings of its foreign subsidiaries.




                            4In accordance with Accounting
                             Standards Update No. 2016-09,
                             Improvements to Employee Share-Based
                             Payment Accounting, all excess tax
                             benefits related to share-based
                             compensation be recognized as an
                             income tax benefit, instead of in
                             stockholders' equity. For the three
                             and nine months ended September 30,
                             2017, the Company determined that it
                             was not more-likely-than-not that




                            5GAAP diluted EPS for the three and
                             nine months ended September 30, 2018,
                             is calculated using diluted weighted
                             average shares of approximately 34.2
                             million and 34.1 million,
                             respectively, which is the same as
                             basic weighted average shares, due to
                             the GAAP net losses incurred in each
                             period. Adjusted diluted EPS for the
                             three and nine months ended September
                             30, 2018, is calculated using diluted


                                                                                                     
              
                Penumbra, Inc.


                                                                       
         
            Reconciliation of Revenue Growth by Geographic Regions to Constant Currency Revenue Growth(1)


                                                                                                       
              
                (unaudited)


                                                                                                     
              
                (in thousands)




                               Three Months Ended September 30,                           Reported Change                                                  FX Impact                          Constant Currency Change



                      2018                         2017         
        
           $                                 %                        
              
                $            
          
           $                          %



      United States         $
      72,991                            $
         55,652                                                                  $
              17,339                   31.2                             
         $                $
      17,339    31.2

                                                                                                                                                                                      %                                                                   %


      International 38,815                         28,259                       10,556                                                                          37.4                    118                              10,674          37.8

                                                                                                                                                                %                                                                      %




     Total                $
      111,806                            $
         83,911                                                                  $
              27,895                   33.2                                      $
     118         $
      28,013    33.4

                                                                                                                                                                                      %                                                                   %


                                                                                                             
              
                Penumbra, Inc.


                                                                             
         
             Reconciliation of Revenue Growth by Product Categories to Constant Currency Revenue Growth(1)


                                                                                                              
              
                (unaudited)


                                                                                                             
              
                (in thousands)




                                     Three Months Ended September 30,                            Reported Change                                                 FX Impact                           Constant Currency Change



                            2018                         2017         
        
           $                                 %                        
              
                $            
           
           $                          %




     Neuro                       $
      74,689                            $
         58,670                                                                  $
              16,019                    27.3                                       $
      76        $
     16,095   27.4

                                                                                                                                                                                             %                                                                  %


      Peripheral Vascular 37,117                         25,241                       11,876                                                                          47.1                      42                              11,918           47.2

                                                                                                                                                                      %                                                                        %




     Total                      $
      111,806                            $
         83,911                                                                  $
              27,895                    33.2                                      $
      118        $
     28,013   33.4

                                                                                                                                                                                             %                                                                  %


                                                                                                           
              
                Penumbra, Inc.


                                                                      
            
                Reconciliation of Revenue Growth by Geographic Regions to Constant Currency Revenue Growth(1)


                                                                                                             
              
                (unaudited)


                                                                                                           
              
                (in thousands)




                               Nine Months Ended September 30,                         Reported Change                                                   FX Impact                                  Constant Currency Change



                       2018                           2017     
        
           $                                   %                         
              
                $             
             
              $                       %




     United States         $
      210,070                          $
        157,559                                                                     $
              52,511                         33.3                            
          $                   $
     52,511   33.3

                                                                                                                                                                                              %                                                                    %



     International 114,075                           80,154                     33,921                                                                           42.3                      (4,732)                             29,189              36.4

                                                                                                                                                                  %                                                                               %




     Total                 $
      324,145                          $
        237,713                                                                     $
              86,432                         36.4                                     $
     (4,732)        $
     81,700   34.4

                                                                                                                                                                                              %                                                                    %


                                                                                                                 
              
                Penumbra, Inc.


                                                                            
            
                Reconciliation of Revenue Growth by Product Categories to Constant Currency Revenue Growth(1)


                                                                                                                   
              
                (unaudited)


                                                                                                                 
              
                (in thousands)




                                     Nine Months Ended September 30,                         Reported Change                                                   FX Impact                                Constant Currency Change



                             2018                           2017     
        
           $                                   %                         
              
                $             
             
            $                       %




     Neuro                       $
      220,318                          $
        165,122                                                                     $
              55,196                       33.4                                    $
     (3,857)        $
     51,339   31.1

                                                                                                                                                                                                  %                                                                   %


      Peripheral Vascular 103,827                           72,591                     31,236                                                                           43.0                      (875)                            30,361              41.8

                                                                                                                                                                        %                                                                            %




     Total                       $
      324,145                          $
        237,713                                                                     $
              86,432                       36.4                                    $
     (4,732)        $
     81,700   34.4

                                                                                                                                                                                                  %                                                                   %



                            (1)See "Non-GAAP Financial Measures"
                             above for important information about
                             our use of this non-GAAP measure and
                             further information about our
                             calculation of constant currency
                             results.

Investor Relations
Penumbra, Inc.
510-995-2461
investors@penumbrainc.com

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