Penumbra, Inc. Reports Fourth Quarter and Full Year 2018 Financial Results

ALAMEDA, Calif., Feb. 26, 2019 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today reported financial results for the fourth quarter and full year ended December 31, 2018.

Financial Highlights:

    --  Revenue of $120.8 million for the fourth quarter of 2018, an increase of
        25.8%, or 26.9% in constant currency(1), over the fourth quarter of
        2017.
    --  Revenue of $444.9 million for the full year 2018, an increase of 33.3%,
        or 32.2% in constant currency(1), over the prior year.

"Penumbra had a strong fourth quarter which capped a tremendous year of exceptional growth and patient impact," said Adam Elsesser, Penumbra's chairman, president and chief executive officer. "In the fourth quarter, we saw our strongest sequential revenue growth of the year, which resulted in strong year over year growth against difficult fourth quarter comparisons, particularly in our neuro and international markets. We made great progress across the business, including the launch of our peripheral embolization products into new international markets, which resulted in a shift of revenue from neuro to vascular in the fourth quarter."

Fourth Quarter 2018 Financial Results
Total revenue grew to $120.8 million for the fourth quarter of 2018 compared to $96.1 million for the fourth quarter of 2017, an increase of 25.8%, or 26.9% on a constant currency basis. The United States represented 67% of total revenue and international represented 33% of total revenue for the fourth quarter of 2018. Revenue from sales of neuro products grew to $74.0 million for the fourth quarter of 2018, an increase of 9.9%, or 11.2% on a constant currency basis. Revenue from sales of vascular products grew to $46.8 million for the fourth quarter of 2018, an increase of 62.8%, or 63.6% on a constant currency basis.

Gross profit was $78.7 million, or 65.2% of total revenue, for the fourth quarter of 2018, compared to $63.7 million, or 66.3% of total revenue, for the fourth quarter of 2017.

Total operating expenses were $72.0 million, or 59.6% of total revenue, for the fourth quarter of 2018, compared to $59.9 million, or 62.3% of total revenue, for the fourth quarter of 2017. The fourth quarter of 2018 is the first full quarter following the acquisition of a controlling interest in MVI Health Inc. and is included in our total operating expenses. R&D expenses were $10.9 million for the fourth quarter of 2018, compared to $8.4 million for the fourth quarter of 2017. SG&A expenses were $61.2 million for the fourth quarter of 2018, compared to $51.5 million for the fourth quarter of 2017.

Operating income was $6.7 million for the fourth quarter of 2018, compared to an operating income of $3.9 million for the fourth quarter of 2017.

As of December 31, 2018, cash and cash equivalents and marketable investments totaled $200.9 million.

Full Year 2018 Financial Results
Total revenue grew to $444.9 million for the year ended December 31, 2018, compared to $333.8 million for 2017, an increase of 33.3%, or 32.2% in constant currency. The United States represented 65% of total revenue and international represented 35% of total revenue for the year ended December 31, 2018. Revenue from sales of neuro products grew to $294.3 million for 2018, an increase of 26.6%, or 25.3% on a constant currency basis. Revenue from sales of vascular products grew to $150.6 million for 2018, an increase of 48.6%, or 48.0% on a constant currency basis.

Gross profit was $292.5 million, or 65.7% of total revenue, for the year ended December 31, 2018, compared to $217.1 million, or 65.1% of total revenue, for the year ended December 31, 2017.

For the year ended December 31, 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 year ended December 31, 2018 were $293.4 million, or 65.9% of total revenue. Excluding the IPR&D charge, total non-GAAP operating expenses(1) were $262.6 million, or 59.0% of total revenue, for the year ended December 31, 2018. This compares to total operating expenses of $216.0 million, or 64.7% of total revenue, for the year ended December 31, 2017. R&D expenses were $36.2 million for the year ended December 31, 2018, compared to $31.7 million for the year ended December 31, 2017. SG&A expenses were $226.4 million for the year ended December 31, 2018, compared to $184.3 million for the year ended December 31, 2017.

Operating loss was $0.9 million for the year ended December 31, 2018. Excluding the IPR&D charge, non-GAAP operating income(1) was $30.0 million for the year ended December 31, 2018. This compares to operating income of $1.2 million for the year ended December 31, 2017.

Full Year 2019 Financial Outlook
Penumbra projects total revenue for 2019 to be in the range of $525 million to $535 million.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss financial results for the fourth quarter and year ended December 31, 2018 after market close on Tuesday, February 26, 2019 at 4:30 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: 6696873), 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) non-GAAP operating expenses and non-GAAP operating income, b) non-GAAP net income (loss) and non-GAAP diluted earnings per share ("EPS"), and c) constant currency.

Non-GAAP operating expenses and non-GAAP operating income. The Company defines non-GAAP operating expenses as total operating expenses, excluding the IPR&D charge in connection with the MVI Health Inc. asset acquisition. Non-GAAP operating income is defined as income (loss) from operations, excluding the same IPR&D charge.

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

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.

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 non-GAAP operating expenses, non-GAAP operating income, non-GAAP net income (loss), and non-GAAP 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 non-GAAP net income (loss) and non-GAAP diluted EPS, the income tax effects 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, 2018, which we expect to file with the SEC on or before March 1, 2019. 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 constant currency
                         and other non-GAAP
                         measures.


                                                
           
                Penumbra, Inc.


                                    
              
             Condensed Consolidated Balance Sheets


                                                 
           
                (unaudited)


                                                
           
                (in thousands)




                                                               
              
                December 31,


                                                              2018                               2017




     
                Assets



     Current assets:



          Cash and cash equivalents                                  $
              67,850                       $
       50,637



          Marketable investments                          133,039                                    163,954



          Accounts receivable, net                         81,896                                     58,007



          Inventories                                     115,741                                     94,901


           Prepaid expenses and other current assets        12,200                                     14,735



               Total current assets                       410,726                                    382,234



     Property and equipment, net                           35,407                                     30,899



     Intangible assets, net                                27,245                                     23,778



     Goodwill                                               7,813                                      8,178



     Long-term investments                                                                            3,872



     Deferred taxes                                        32,940                                     26,690



     Other non-current assets                                 875                                      1,016




               Total assets                                         $
              515,006                      $
       476,667



                   Liabilities and Stockholders' Equity



     Current liabilities:



          Accounts payable                                            $
              8,176                        $
       6,757



          Accrued liabilities                              57,886                                     44,825



                Total current liabilities                   66,062                                     51,582



     Deferred rent                                          7,586                                      6,199



     Other non-current liabilities                         18,943                                     18,478




               Total liabilities                           92,591                                     76,259



     Stockholders' equity:



     Preferred stock



     Common stock                                              34                                         33



     Additional paid-in capital                           415,084                                    396,810


      Accumulated other comprehensive (loss)
       income                                              (1,942)                                     1,569



     Retained earnings                                      9,064                                      1,996



      Total Penumbra, Inc. stockholders' equity            422,240                                    400,408




     Non-controlling interest                                 175



     Total stockholders' equity                                     $
              422,415                      $
       400,408



      Total liabilities and stockholders' equity                     $
              515,006                      $
       476,667


                                                                                   
              
                Penumbra, Inc.


                                                            
              
                Co
                ndensed Consolidated Statements of Operations


                                                                                    
              
                (unaudited)


                                                                 
              
                (in thousands, except share and per share amounts)




                                                          Three Months Ended December 31,                                           Year Ended December 31,


                                               2018                        2017                         2018                               2017




     Revenue                                       $
         120,793                                            $
              96,051                              $
          444,938      $
        333,764



     Cost of revenue                        42,081                                   32,324                                           152,405                         116,622




          Gross profit                      78,712                                   63,727                                           292,533                         217,142




     Operating expenses:


           Research and development          10,867                                    8,401                                            36,165                          31,661


           Sales, general and
            administrative                   61,176                                   51,470                                           226,385                         184,316


           Acquired in-process research
            and development                                                                                                           30,835



                Total operating expenses     72,043                                   59,871                                           293,385                         215,977



      Income (loss) from operations           6,669                                    3,856                                             (852)                          1,165



     Interest income, net                      724                                      727                                             2,964                           2,653



     Other expense, net                       (44)                                   (677)                                            (504)                        (1,342)


      Income before income taxes and
       equity in losses of
       unconsolidated investee                7,349                                    3,906                                             1,608                           2,476


      Provision for (benefit from)
       income taxes                             885                                  (5,904)                                          (4,403)                        (3,611)


      Income before equity in losses
       of unconsolidated investee             6,464                                    9,810                                             6,011                           6,087


      Equity in losses of
       unconsolidated investee                                                        (727)                                          (3,101)                        (1,430)


      Consolidated net income                         $
         6,464                                             $
              9,083                                $
          2,910        $
        4,657


      Net loss attributable to non-
       controlling interest                           $
         (195)                            
              $                                                  $
          (3,691)    
     $



      Net income attributable to
       Penumbra, Inc.                                 $
         6,659                                             $
              9,083                                $
          6,601        $
        4,657



      Net income attributable to
       Penumbra, Inc. per share:



     Basic                                            $
         0.19                                              $
              0.27                                 $
          0.19         $
        0.14




     Diluted                                          $
         0.18                                              $
              0.25                                 $
          0.18         $
        0.13



      Weighted average shares
       outstanding:



     Basic                              34,378,415                               33,606,943                                        34,138,176                      32,978,065




     Diluted                            36,150,450                               35,833,621                                        36,086,821                      35,319,103


                                                                                                            
              
                Penumbra, Inc.


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


                                                                                                             
              
                (unaudited)


                                                                                                            
              
                (in thousands)




                               Three Months Ended December 31,                     Reported Change                                                               FX Impact                    Constant Currency Change



                      2018                   2017              
     
     $                           %              
              
                $                                        
              
     $             %




     United States         $
      80,645                               $
     61,615                                                                            $
              19,030                            30.9           
        $                  $
      19,030    30.9

                                                                                                                                                                                                        %                                                  %



     International 40,148                           34,436                                5,712                                                                         16.6                           1,062            6,774            19.7

                                                                                                                                                                         %                                                              %




          Total           $
      120,793                               $
     96,051                                                                            $
              24,742                            25.8                   $
     1,062         $
      25,804    26.9

                                                                                                                                                                                                        %                                                  %


                                                                                                          
              
                Penumbra, Inc.


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


                                                                                                            
              
                (unaudited)


                                                                                                          
              
                (in thousands)




                            Three Months Ended December 31,                     Reported Change                                                              FX Impact                     Constant Currency Change



                   2018                   2017              
     
     $                           %             
              
                $                                        
              
      $             %




     Neuro              $
      74,015                               $
     67,324                                                                            $
              6,691                              9.9                    $
       845         $
      7,536   11.2

                                                                                                                                                                                                     %                                                  %


      Vascular   46,778                           28,727                               18,051                                                                        62.8                              217          18,268              63.6

                                                                                                                                                                     %                                                                %



           Total        $
      120,793                               $
     96,051                                                                           $
              24,742                             25.8                  $
       1,062        $
      25,804   26.9

                                                                                                                                                                                                     %                                                  %


                                                                                                                        
              
                Penumbra, Inc.


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


                                                                                                                         
              
                (unaudited)


                                                                                                                        
              
                (in thousands)




                                Year Ended December 31,                          Reported Change                                                               FX Impact                                Constant Currency Change



                       2018                    2017             
     
     $                                 %               
              
                $                                        
              
       $                         %




     United States         $
     290,716                                $
     219,173                                                                                  $
              71,543                                          32.6  
          $                    $
      71,543   32.6

                                                                                                                                                                                                                              %                                            %



     International 154,222                             114,591                                  39,631                                                                          34.6                                       (3,749)   35,882              31.3

                                                                                                                                                                                 %                                                                      %




          Total            $
     444,938                                $
     333,764                                                                                 $
              111,174                                          33.3           $
     (3,749)        $
      107,425   32.2

                                                                                                                                                                                                                              %                                            %


                                                                                                                    
              
                Penumbra, Inc.


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


                                                                                                                      
              
                (unaudited)


                                                                                                                    
              
                (in thousands)




                             Year Ended December 31,                          Reported Change                                                            FX Impact                                   Constant Currency Change



                    2018                    2017             
     
     $                                 %            
              
                $                                        
              
          $                         %




     Neuro              $
     294,333                                $
     232,446                                                                               $
              61,887                                             26.6         $
     (3,076)         $
      58,811   25.3

                                                                                                                                                                                                                           %                                          %


      Vascular   150,605                             101,318                                  49,287                                                                       48.6                                            (673) 48,614              48.0

                                                                                                                                                                           %                                                                       %



           Total         $
     444,938                                $
     333,764                                                                              $
              111,174                                             33.3         $
     (3,749)        $
      107,425   32.2

                                                                                                                                                                                                                           %                                          %



                            (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.


                                                                             
              
                Penumbra, Inc.


                          
            
       Reconciliation of GAAP Operating Expenses and Income (Loss) from Operations to Non-GAAP Operating Expenses and Non-GAAP Operating Income(1)


                                                                               
              
                (unaudited)


                                                                             
              
                (in thousands)




                                                       Three Months Ended December 31,                                        Year Ended December 31,


                                     2018                              2017                      2018                              2017



     GAAP total operating expenses          $
              72,043                                         $
              59,871                                         $
              293,385 $
       215,977


     GAAP operating expenses
      includes the effect of the
      following items:


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


     Non-GAAP operating expenses            $
              72,043                                         $
              59,871                                         $
              262,550 $
       215,977





     GAAP income (loss) from
      operations                             $
              6,669                                          $
              3,856                                           $
              (852)  $
       1,165


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


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


     Non-GAAP operating income               $
              6,669                                          $
              3,856                                          $
              29,983   $
       1,165


                                                                                                                                                                                        
              
                Penumbra, Inc.


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


                                                                                                                                                                                          
              
                (unaudited)


                                                                                                                                                                           
              
                (in thousands, except per share amounts)




                                                                  Three Months Ended                                            Three Months Ended                            
              
                Year Ended                                                              
              
                Year Ended
                                                       December 31, 2018                                            December 31, 2017                                                  December 31, 2018                                                                              December 31, 2017


                                             Net income                                  Diluted               Net income                               Diluted                      Net income                                               Diluted                                    Net income                       Diluted
                                      (loss)                                         EPS                (loss)                                     EPS                     (loss)                                                   EPS                                        (loss)                                 EPS




     GAAP measures                                       $
              6,659                                                  $
              0.18                                                       $
              9,083                                                                                    $
          0.25                      $
      6,601            $
            0.18 $
     4,657    $
        0.13


      Items reconciling GAAP net
       income and EPS to non-GAAP
       net income (loss) and EPS:


      Acquired IPR&D in connection
       with an asset acquisition(2)                                                                                                                                                                                                                                                          27,393                                  0.76


      Effects of the transition tax
       and the rate change on the net
       deferred tax assets resulting
       from the Tax Reform Act(3)                  (13)                                                                                                  15,414                                                 0.43                                                                               75                                                    15,414          0.47


      Excess tax benefits related to
       stock compensation awards4               (1,965)                                          (0.05)                                                 (3,597)                                              (0.10)                                                                        (15,575)                               (0.43)            (22,679)       (0.69)


      Net valuation allowance5                                                                                                                         (17,356)                                              (0.48)                                                                                                                                    2,409          0.07


      Effect of dilutive shares on
       EPS6                                                                                                                                                                                                                                                                                                                                                          0.01




     Non-GAAP measures                                   $
              4,681                                                  $
              0.13                                                       $
              3,544                                                                                    $
          0.10                     $
      18,494            $
            0.51 $
     (199) $
        (0.01)



                            1 See "Non-GAAP Financial Measures"
                             above for important information about
                             our use of non-GAAP measures and
                             further information about our non-
                             GAAP operating expenses, non-GAAP
                             operating income, non-GAAP net income
                             (loss) and non-GAAP 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 year ended December 31,
                             2018, in the consolidated statements
                             of operations related to the acquired
                             technology under development from MVI
                             Health Inc. Of the total IPR&D charge,




                            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. During
                             the three months and year ended
                             December 31, 2017, the Company
                             recorded a one-time income tax
                             expense adjustment related to the
                             revaluation of its deferred taxes due




                            4 In accordance with Accounting
                             Standards Update No. 2016-09,
                             Improvements to Employee Share-Based
                             Payment Accounting, all excess tax
                             benefits related to share-based
                             compensation is recognized as an
                             income tax benefit, instead of in
                             stockholders' equity.




                            5
                 During the three months
                             and year ended December 31, 2017, the
                             Company recorded a tax benefit of
                             $19.8 million related to the release
                             of a valuation allowance, partially
                             offset by a tax expense of $2.4
                             million related to a valuation
                             allowance established against our
                             federal research and development
                             credit deferred tax assets.




                            6 For the purposes of calculating Non-
                             GAAP diluted EPS for the year ended
                             December 31, 2017, diluted weighted
                             average shares outstanding of
                             32,978,065 was used, which is the same
                             as basic weighted average shares
                             outstanding for that period, as a non-
                             GAAP net loss was incurred in the
                             period.

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

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