BioMarin Announces First Quarter 2019 Financial Results

SAN RAFAEL, Calif., April 25, 2019 /PRNewswire/ --


                                                         
            
              Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)




                                       
     
              Three Months Ended March 31,



                                               2019                                                                                2018                                        % Change






     Total Revenues                                            $
            400.7                                                                                    $
        373.4             7%




      Net Product Revenues Marketed by
       BioMarin(1)                                                        349.2                                                                                          303.0            15%




      Vimizim Net Product Revenues                                        125.8                                                                                          117.1             7%


      Kuvan Net Product Revenues                                          106.9                                                                                           99.1             8%


      Naglazyme Net Product Revenues                                       86.9                                                                                           75.0            16%


      Palynziq Net Product Revenues                                        12.3                                                                                                          n/a


      Brineura Net Product Revenues                                        12.2                                                                                            6.9            77%




      Aldurazyme Net Product Revenues                                      45.3                                                                                           66.1          (31)%





     GAAP Net Loss                                            $
            (56.5)                                                                                  $
        (44.1)


      GAAP Net Loss per Share - Basic                          $
            (0.32)                                                                                  $
        (0.25)


      GAAP Net Loss per Share -
       Diluted                                                 $
            (0.32)                                                                                  $
        (0.26)





     Non-GAAP Income (2)                                        $
            24.8                                                                                     $
        21.3




                                          March 31,                                                                      December

                                                                                                                                   31,


                                               2019                                                                                2018



      Cash, cash equivalents and
       investments                                            $
            1,214.9                                                                                  $
        1,320.2




              (1)              Net Product Revenues Marketed by
                                  BioMarin is the sum of revenues
                                  from Vimizim, Kuvan, Naglazyme,
                                  Palynziq, Brineura and Firdapse,
                                  each calculated in accordance with
                                  Generally Accepted Accounting
                                  Principles in the United States
                                  (U.S. GAAP). Genzyme Corporation
                                  (Genzyme) is BioMarin's sole
                                  customer for Aldurazyme and is
                                  responsible for marketing and
                                  selling Aldurazyme to third-
                                  parties. Refer page 8 for a table
                                  showing Net Product Revenues by
                                  product, including Firdapse.





              (2)              Non-GAAP Income is defined by the
                                  Company as reported GAAP Net
                                  Income, excluding net interest
                                  expense, provision for (benefit
                                  from) income taxes, depreciation
                                  expense, amortization expense,
                                  stock-based compensation expense,
                                  contingent consideration expense
                                  and, in certain periods, certain
                                  other specified items. Refer to
                                  Non-GAAP Information beginning on
                                  page 8 of this press release for a
                                  complete discussion of the
                                  Company's Non-GAAP financial
                                  information and reconciliations to
                                  the comparable information
                                  reported under U.S. GAAP.

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) today announced financial results for the first quarter ended March 31, 2019.

Total Net Product Revenues for the first quarter 2019 increased to $394.5 million, compared to $369.1 million for the first quarter of 2018. Net Product Revenues Marketed by BioMarin increased to $349.2 million, compared to $303.0 million for the first quarter of 2018. The increase in Net Product Revenues Marketed by BioMarin was attributed to the following:

    --  Vimizim: increased $8.7 million, or 7%, primarily driven by government
        ordering patterns in certain Latin American, Middle Eastern and European
        countries. Patient growth in the quarter was robust with net patients
        growth increasing 12% year over year;
    --  Kuvan: increased $7.8 million, or 8%, primarily due to new patients
        initiating therapy in the U.S. and sales volume in Europe;
    --  Naglazyme: increased $11.9 million, or 16%, primarily due to increased
        sales volume driven by government ordering patterns from Brazil;
    --  Palynziq: received approval from the U.S. Food and Drug Administration
        (FDA) in May 2018, with commercial sales launching in the third quarter
        of 2018. Palynziq Net Product Revenues during the first quarter of 2019
        totaled $12.3 million driven primarily by the conversion of clinical
        patients to commercial Palynziq in the U.S.; and,
    --  Brineura: increased $5.3 million, or 77%, primarily attributed to new
        patients initiating therapy in Germany and the U.S.

Aldurazyme Net Product Revenues decreased $20.8 million, or 31%, due to timing of shipments to Genzyme. Under the new revenue standards adopted in 2018, the Company records Aldurazyme Net Product Revenues when the product is released and control is transferred to Genzyme based on the estimated variable consideration payable it expects to earn when the product is sold through by Genzyme. Aldurazyme net product sales reported by Genzyme increased to $75.7 million, or up 20% in the first quarter of 2019, compared to $62.9 million the same period in 2018.

The increase in GAAP Net Loss for the first quarter of 2019, compared to the same period in 2018 was primarily due to the following:

    --  higher selling, general and administrative (SG&A) expense in support of
        continued U.S. commercial launch of Palynziq and European Union (EU)
        pre-launch activities, other administrative expenses, consulting fees
        and employee-related costs to support our operations;
    --  increased contingent consideration expense related to the progression of
        the Palynziq development program towards approval of the European
        Marketing Authorization Application, as a result of the positive opinion
        from the Committee for Medicinal Products for Human Use (CHMP) in the
        first quarter; partially offset by,
    --  increased gross profits of $20.4 million driven by increased sales
        revenue from products marketed by BioMarin.

Non-GAAP Income for the first quarter of 2019 increased $3.5 million, or 16%, to $24.8 million, compared to $21.3 million for the same period in 2018. The increase in Non-GAAP Income for the quarter was attributed to increased gross profit from sales partially offset by higher SG&A expenses as described above.

As of March 31, 2019, BioMarin had cash, cash equivalents and investments totaling approximately $1.2 billion, as compared to $1.3 billion on December 31, 2018.

Commenting on first quarter results, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "We begin 2019 well-positioned for potential significant achievements across our late-stage product pipeline, as well as record Total Revenues for the full year. Starting with valoctocogene roxaparvovec gene therapy for severe hemophilia A, our pivotal study is on track to complete enrollment in the third quarter. Based on draft guidance from the FDA for hemophilia gene therapy products published in 2018, we have the opportunity to pursue a potential accelerated approval path forward based on Factor VIII activity results from a subset of Phase 3 subjects. Based on the results from the subset of Phase 3 subjects, we will make and communicate our decision on whether or not to pursue an accelerated approval before the end of the year. We have observed a high level of interest and enthusiasm from the hemophilia community in support of valoctocogene roxaparvovec and are hopeful that it will be a potential treatment option for these patients in the very near future."

Mr. Bienaimé continued, "We have a number of other exciting catalysts on the horizon including the potential approval and launch of Palynziq in Europe later this year. We have been thrilled with the pace of the U.S. launch, as we ended the first quarter with 414 patients on reimbursed Palynziq. Building on this success and as part of our strategy to increase our leadership in the PKU market, we anticipate filing an IND for BMN 307, our gene therapy product for PKU, in the second half of 2019. BMN 307 demonstrated lifetime normalization of Phe in a validated PKU mouse model, and as a result we believe it has the potential to be an important new treatment and market expander as part of our PKU franchise. Finally, we look forward with great anticipation to the results of our global Phase 3 program with vosoritide for the treatment of achondroplasia. Our ongoing Phase 2 study has so far demonstrated an average additional cumulative height gain of 5.7 centimeters over 42 months. Based on data observed to date, we are very encouraged that vosoritide could potentially be the first approved treatment option for children with achondroplasia."

2019 Full-Year Financial Guidance unchanged (in millions, except %)



       
                Item                2019 Guidance

    ---




       Total Revenues                          $1,680  to $1,750


        Vimizim Net Product Revenues              $530  to   $570


        Kuvan Net Product Revenues                $420  to   $460


        Naglazyme Net Product Revenues            $350  to   $380


        Palynziq Net Product Revenues              $70  to   $100


        Brineura Net Product Revenues              $55  to    $75




        Cost of Sales (% of Total
         Revenues)                                 20% to    21%


        Research and Development Expense          $740  to   $780


        Selling, General and Admin.
         Expense                                  $650  to   $690





       GAAP Net Loss                            $(45) to  $(85)



       Non-GAAP Income *                         $130  to   $170



                            *All Financial Guidance items are
                             calculated based on U.S. GAAP with
                             the exception of Non-GAAP Income/
                             Loss. Refer to Non-GAAP
                             Information beginning on page 8 of
                             this press release for a complete
                             discussion of the Company's Non-
                             GAAP financial information and
                             reconciliations to the comparable
                             GAAP reported information.

Key Program Highlights

    --  Valoctocogene roxaparvovec gene therapy for hemophilia A: During the
        quarter, the Company announced that it had enrolled the subset of
        subjects from the ongoing Phase 3 study that could potentially be used
        to support submission of a marketing application through the accelerated
        approval pathway. In addition, BioMarin has completed the process
        qualification manufacturing campaigns required as part of a BLA
        submission for accelerated approval. The Company intends to make a
        decision on whether or not to pursue a potential accelerated approval
        path and communicate that decision before the end of 2019. In 2018, the
        Company updated the protocol for the Phase 3 GENEr8-1 study evaluating
        the 6e13 vg/kg dose and has statistically powered the study results to
        evaluate superiority to the current standard of care, Factor VIII
        prophylaxis. The complete Phase 3 GENEr8-1 study will include 130
        participants, and is expected to be fully enrolled in the third quarter
        of 2019.

    --  Palynziq for PKU: Palynziq, an injection to reduce blood Phe
        concentrations in adult patients with PKU, was added to BioMarin's
        commercial product portfolio upon its U.S. approval last May. As of
        March 31, 2019, 414 patients were on reimbursed Palynziq, with an
        additional 140 patients enrolled and awaiting their first treatment with
        commercial Palynziq. Of the 414 patients on therapy at the end of the
        first quarter, 278 were formerly naïve patients and 136 transitioned
        from clinical studies. Of the 125 PKU clinics in the U.S., 89 had at
        least one complete patient enrollment in the REMS program as of March
        31, 2019.BioMarin received a positive opinion from the Committee for
        Medicinal Products for Human Use (CHMP), the scientific committee of the
        European Medicines Agency (EMA), on Palynziq on March 1, 2019. Based on
        this positive opinion, the Company anticipates marketing authorization
        in the European Union by the end of the second quarter of this year.

    --  Vosoritide for children with achondroplasia: The Company expects top
        line results from the ongoing global, Phase 3 study by year-end 2019.
        The vosoritide development program includes four distinct areas of focus
        to support global approval, including a large contemporaneous natural
        history study which is underway. The global Phase 3 study, which is
        fully enrolled, is a randomized, placebo-controlled study of vosoritide
        in approximately 110 children with achondroplasia between the ages of 5
        to 14 years. The Company most recently updated its ongoing global Phase
        2 study in children ages 5 to 14, which demonstrated an average of 5.7
        centimeters of cumulative additional height gained at 42 months.
        BioMarin expects to have over 5 years of clinical data from this study
        to corroborate maintenance of effect at the time of anticipated
        marketing authorization submissions.In 2018, BioMarin began a global
        Phase 2 study with vosoritide in infants and young children (less than
        60 months old) with achondroplasia, to determine the impact of treatment
        in this age group. Three cohorts, segmented by age, are being enrolled
        in this study. Cohort 1 includes children ages 24 to 60 months old and
        will complete enrollment this year. Cohort 2 includes children ages 6 to
        24 months old and is currently enrolling. Following evaluation of safety
        and pharmacokinetics in sentinel subjects in cohort 2, cohort 3 will
        begin enrolling infants up to 6 months old.
    --  Tralesinidase alfa (formerly referred to as BMN 250) for MPS IIIB
        (Sanfilippo Syndrome, Type B): Tralesinidase alfa is currently being
        evaluated in ongoing natural history and clinical trials. Previously,
        encouraging signs of biochemical and clinical efficacy have been
        suggested. Trials are ongoing to collect further data in regard to the
        untreated natural history of the condition, as well as biochemical and
        clinical outcomes of therapy.
    --  BMN 307 gene therapy product candidate for phenylketonuria (PKU): As
        previously announced, the Company expects to submit an investigational
        new drug application (IND) and/or a clinical trial application (CTA) for
        a gene therapy product for the treatment of PKU in the second half of
        2019. At R&D Day 2018, BioMarin shared data with BMN 307 that
        demonstrated a lifetime Phe correction sustained at 80 weeks in
        preclinical mouse models. BMN 307 is an AAV vector containing the DNA
        sequence that codes for the phenylalanine hydroxylase enzyme that is
        deficient in people with PKU. Product to support clinical evaluation
        will be produced at BioMarin's Leveroni facility using a commercial
        scale manufacturing process to facilitate rapid clinical development.
    --  BMN 290 for Friedreich's Ataxia: BMN 290 is a selective chromatin
        modulation therapy intended for the treatment of Friedreich's ataxia.
        Currently, there are no approved disease modifying therapies for
        Friedreich's ataxia. The Company is currently conducting additional
        pre-clinical work on BMN 290 and will decide in the first half of 2019
        whether to file an IND based on the outcome of those data.

BioMarin will host a conference call and webcast to discuss first quarter 2019 financial results today, Thursday, April 25, 2019 at 4:30 p.m. ET. This event can be accessed on the investor section of the BioMarin website at www.biomarin.com.


        U.S. /Canada Dial-in Number:    Replay Dial-in Number:
         866.502.9859                    855.859.2056

    ---

        International Dial-in Number:   Replay International Dial-in
         574.990.1362                    Number: 404.537.3406

    ---


       Conference ID: 9996637        
     Conference ID: 9996637

    ---

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The Company's portfolio consists of several commercial products and multiple clinical and pre-clinical product candidates for the treatment of various diseases. For additional information, please visit www.biomarin.com.

Forward-Looking Statements

This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including, without limitation, statements about: the expectations of Total Revenues, Net Product Revenues and expenses for BioMarin's commercial products, GAAP Net Loss, Non-GAAP Income and other specified income statement guidance; the financial performance of BioMarin as a whole; BioMarin's potential for growth: BioMarin being well-position for significant achievements across its late-stage product pipeline, as well as record Total Revenues for the full year; BioMarin's commercial prospects, including the timing of (i) decisions by regulators, including the European Commission's decision regarding BioMarin's Marketing Authorization Application for Palynziq, (ii) BioMarin's clinical studies and trials, (iii) completion of enrollment of those studies and trials including enrollment in BioMarin's Phase 3 program with valoctocogene roxaparvovec, and (iv) announcements of data from those studies and trials, including BioMarin's Phase 3 program and Phase 1/2 study with valoctocogene roxaparvovec; the ongoing Phase 2 and Phase 3 studies of vosoritide; the continued clinical development and commercialization of BioMarin's commercial products and product candidates, including (i) BioMarin's plans to potentially decide in the first half of 2019 whether to file an IND for BMN 290 and potentially file an IND and/or a CTA for its new gene therapy candidate for the treatment of PKU in the second half of 2019; (ii) statements regarding the timing of BioMarin's decision on whether or not to pursue an accelerated approval pathway for valoctocogene roxaparvovec and the communication of that decision; (iii) statements regarding BioMarin's encouragement that vosoritide could potentially be the first approved treatment option for children with achondroplasia; and (iv) the possible approval and commercialization of BioMarin's product candidates.

These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: BioMarin's success in the commercialization of its commercial products; Genzyme Corporation's success in continuing the commercialization of Aldurazyme; results and timing of current and planned preclinical studies and clinical trials, BioMarin's ability to successfully manufacture its commercial products and product candidates; the content and timing of decisions by the FDA, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products; actual sales of BioMarin's commercial products; the introduction of generic versions of BioMarin's commercial products, in particular generic versions of Kuvan; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Annual Report on Form 10-K for the year ended December 31, 2018 as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

BioMarin(®), Brineura(®), Firdapse(®), Kuvan(®), Naglazyme(®), Palynziq(®) and Vimizim(®) are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Aldurazyme(®) is a registered trademark of BioMarin/Genzyme LLC.



     Contact:



     
            Investors:                   
     
     Media:



     
            Traci McCarty                    Debra Charlesworth


               BioMarin Pharmaceutical Inc.     BioMarin Pharmaceutical Inc.



     
            (415) 455-7558               
     
     (415) 455-7451


                                                                                      
              
                BIOMARIN PHARMACEUTICAL INC.




                                                                                 
              
                CONDENSED CONSOLIDATED BALANCE SHEETS


                                                                                  
              
                March 31, 2019 and December 31, 2018


                                                                            
     
                (In thousands of U.S. dollars, except share and per share amounts)




                                                                                   March 31, 2019                                                             December 31, 2018

                                                                                                    (1)                                                                         (2)



                        
              
                ASSETS                        (unaudited)



     Current assets:



     Cash and cash equivalents                                                                                         $
              364,369                                           $
          493,982



     Short-term investments                                                                                                        530,485                                                   590,326



     Accounts receivable, net                                                                                                      393,429                                                   342,633



     Inventory                                                                                                                     534,696                                                   530,871



     Other current assets                                                                                                           93,876                                                    98,403




     Total current assets                                                                                                        1,916,855                                                 2,056,215




     Noncurrent assets:



     Long-term investments                                                                                                         320,000                                                   235,864



     Property, plant and equipment, net                                                                                            951,890                                                   948,682



     Intangible assets, net                                                                                                        485,981                                                   491,808



     Goodwill                                                                                                                      197,039                                                   197,039



     Deferred tax assets                                                                                                           467,333                                                   460,952



     Other assets                                                                                                                   96,300                                                    36,568




     Total assets                                                                                                    $
              4,435,398                                         $
          4,427,128



                   LIABILITIES AND STOCKHOLDERS
                '
           EQUITY



     Current liabilities:



     Accounts payable and accrued liabilities                                                                          $
              412,830                                           $
          437,290



     Short-term contingent consideration                                                                                            88,156                                                    85,951




     Total current liabilities                                                                                                     500,986                                                   523,241



     Noncurrent liabilities:



     Long-term convertible debt, net                                                                                               834,766                                                   830,417



     Long-term contingent consideration                                                                                             48,461                                                    46,883



     Other long-term liabilities                                                                                                   114,558                                                    58,647




     Total liabilities                                                                                                           1,498,771                                                 1,459,188




     Stockholders' equity:


      Common stock, $0.001 par value: 500,000,000 shares authorized;
       
              179,033,104 and 178,252,954 shares issued and
                 outstanding, respectively.                                                                                             179                                                       178



     Additional paid-in capital                                                                                                  4,682,900                                                 4,669,926


      Company common stock held by Nonqualified Deferred
       Compensation Plan                                                                                                           (12,912)                                                 (13,301)



     Accumulated other comprehensive income                                                                                         19,794                                                     5,271



     Accumulated deficit                                                                                                       (1,753,334)                                              (1,694,134)




     Total stockholders' equity                                                                                                  2,936,627                                                 2,967,940




     Total liabilities and stockholders' equity                                                                      $
              4,435,398                                         $
          4,427,128




              (1)              As of January 1, 2019, the
                                  Company adopted the requirements
                                  of Accounting Standards
                                  Codification 842, Leases, using
                                  the modified retrospective
                                  method as of the effective date,
                                  and as a result, Other Assets
                                  and Liabilities are not
                                  comparable to the prior periods
                                  presented.





              (2)              December 31, 2018 balances were
                                  derived from the audited
                                  Consolidated Financial
                                  Statements included in the
                                  Company's Annual Report on Form
                                  10-K for the year ended December
                                  31, 2018, filed with the U.S.
                                  Securities and Exchange
                                  Commission (SEC) on February 28,
                                  2018.


                                                        
              
                BIOMARIN PHARMACEUTICAL INC.




                                                 
           
                CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


                                                   
            
                Three Months Ended March 31, 2019 and 2018


                                               
         
                (In thousands of U.S. dollars, except per share amounts)




                                                                    Three Months Ended March 31,



                                                              2019                                                             2018



                                                       (unaudited)                                                     (unaudited)



     
                REVENUES:



     Net product revenues                                                $
              394,483                                         $
       369,099



     Royalty and other revenues                                                        6,262                                                4,348




     Total net revenues                                                              400,745                                              373,447



                   OPERATING EXPENSES:



     Cost of sales                                                                    89,182                                               82,333



     Research and development                                                        183,591                                              183,948


      Selling, general and administrative                                             162,158                                              138,336


      Intangible asset amortization and
       contingent 
              consideration                                             19,765                                               13,202



     Total operating expenses                                                        454,696                                              417,819



                   LOSS FROM OPERATIONS                                              (53,951)                                            (44,372)




      Equity in the income (loss) of
       BioMarin/Genzyme LLC                                                             (185)                                                  68



     Interest income                                                                   6,298                                                5,234



     Interest expense                                                                (6,727)                                            (11,562)



     Other income (expense), net                                                       1,608                                                (172)



                   LOSS BEFORE INCOME TAXES                                          (52,957)                                            (50,804)


      Provision for (benefit from) income
       taxes                                                                            3,516                                              (6,655)




     
                NET LOSS                                              $
              (56,473)                                       $
       (44,149)



                   NET LOSS PER SHARE, BASIC                               $
              (0.32)                                         $
       (0.25)



                   NET LOSS PER SHARE, DILUTED                             $
              (0.32)                                         $
       (0.26)



      Weighted average common shares
       outstanding, basic                                                             178,271                                              175,932



      Weighted average common shares
       outstanding, diluted                                                           178,271                                              176,150

The following table presents the Net Product Revenues by Product:


                                    
         
           Net Product Revenues By Product


                                     
         
           (In millions of U.S. dollars)


                                         
          
               (unaudited)






                                                         Three Months Ended


                                                             March 31,



                                        2019                                      2018




     Brineura                                          $
              12.2                          $
        6.9



     Firdapse                           5.1                                             4.9



     Kuvan                            106.9                                            99.1



     Naglazyme                         86.9                                            75.0



     Palynziq                          12.3



     Vimizim                          125.8                                           117.1



      Net Product Revenues
       Marketed by
       BioMarin                        349.2                                           303.0


      Aldurazyme Net Product
       Revenues Marketed by Genzyme                               45.3                               66.1



                   Total Net Product
                    Revenues                 $
           
                394.5                     $
     
         369.1

Non-GAAP Information

The results presented in this press release include both GAAP information and Non-GAAP information. As used in this release, Non-GAAP Income is defined by the Company as GAAP Net Loss excluding net interest expense, provision for (benefit from) income taxes, depreciation expense, amortization expense, stock-based compensation expense, contingent consideration expense and, in certain periods, certain other specified items, as detailed below when applicable. In addition, BioMarin includes in this press release the effects of these adjustments on certain components of GAAP Net Loss for each of the periods presented. In this regard, Non-GAAP Income and its components, including Non-GAAP Cost of Sales, Non-GAAP Research and Development expenses, Non-GAAP Selling, General and Administrative expense, Non-GAAP Intangible Asset Amortization and Contingent Consideration, Non-GAAP Gain on the Sale of Intangible Asset and Non-GAAP Benefit From Income Taxes are statement of operations line items prepared on the same basis as, and therefore components of, the overall Non-GAAP measures.

BioMarin regularly uses both GAAP and Non-GAAP results and expectations internally to assess its financial operating performance and evaluate key business decisions related to its principal business activities: the discovery, development, manufacture, marketing and sale of innovative biologic therapies. Because Non-GAAP Income and its components are important internal measurements for BioMarin, the Company believes that providing this information in conjunction with BioMarin's GAAP information enhances investors' and analysts' ability to meaningfully compare the Company's results from period to period and to its forward looking guidance, and to identify operating trends in the Company's principal business. BioMarin also uses Non-GAAP Income internally to understand, manage and evaluate its business and to make operating decisions, and compensation of executives is based in part on this measure.

Non-GAAP Income and its components are not meant to be considered in isolation, as a substitute for, or superior to comparable GAAP measures and should be read in conjunction with the consolidated financial information prepared in accordance with GAAP. Investors should note that the Non-GAAP information is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP measures; likewise, the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP measures. Because of the non-standardized definitions, the Non-GAAP measure as used by BioMarin in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

The following table presents the reconciliation of GAAP Net Loss to Non-GAAP Income:


                                                                        
            
         Reconciliation of GAAP Net Loss to Non-GAAP Income


                                                                                
        
               (In millions of U.S. dollars)


                                                                                   
             
                (unaudited)




                                                Three Months Ended                                                           Guidance


                                                     March 31,                                                               Year Ending



                                     2019                          2018                                                                     December 31, 2019





                  GAAP Net Loss           $
     
               (56.5)               $
        
               (44.1)                                             $
             
         (45.0)        -             $
     
         (85.0)




        Interest expense, net         0.4                                 6.3                                                                                                  -           10.0


        Provision for (Benefit from)
         income taxes                                     3.5                                   (6.7)                                                              (50.0)        -                      (30.0)


        Depreciation expense                             14.9                                    16.0                                                                 45.0         -                        60.0


        Amortization expense                              7.5                                     7.6                                                                 40.0         -                        55.0


        Stock-based compensation
         expense                                         42.7                                    36.6                                                                150.0         -                       175.0


        Contingent consideration
         expense                                         12.3                                     5.6                                                                 20.0         -                        30.0


        Gain on sale of intangible
         assets                                                                                                                           (30.0)                             -         (45.0)


     Non-GAAP Income                           $
              24.8                        $
              21.3                                                         $
         130.0         -               $
          170.0

The following reconciliation of the GAAP reported to the Non-GAAP information provides the details of the effects of the Non-GAAP adjustments on certain components of the Company's operating results for each of the periods presented.


                                                                                                                            
      
             Reconciliation Of Certain GAAP Reported Information To Non-GAAP Information


                                                                                                                                        
              
                (In millions of U.S. dollars)


                                                                                                                                                 
              
                (Unaudited)




                                                                               
          
           Three Months Ended March 31,



                                                                                        2019                                                                                                                          2018



                                                                                                      Adjustments                                                                                                                                                                        Adjustments



                                     GAAP                          Interest,                                    Stock-Based                   Non-GAAP                                                   GAAP                          Interest,                            Stock-Based              Non-GAAP
                                                             Taxes,                                     Compensation,                                                                                                            Taxes,                             Compensation,
                                   Reported                 Depreciation                                   Contingent                                                                                  Reported                 Depreciation                           Contingent
                                                               and                                      Consideration                                                                                                              and                              Consideration
                                                          Amortization                                    and Other                                                                                                           Amortization                            and Other
                                                                                                         Adjustments                                                                                                                                                 Adjustments





     Cost of sales                          $
     
         89.2                    
          $                                                 $
              (4.8)                                                            $
        84.4                          $
     
        82.3                     
              $                  $
        (3.1) $
        79.2


     Research and development                     183.6                                     (9.3)                                              (13.8)                                                                 160.5                                 183.9                                        (10.5)          (13.3)      160.1


     Selling, general and
      administrative                              162.2                                     (5.6)                                              (24.1)                                                                 132.5                                 138.3                                         (5.5)          (20.2)      112.6


     Intangible asset amortization
      
              and contingent
                consideration          19.8                                     (7.5)                                         (12.3)                                                                                                              13.2                                        (7.6)             (5.6)


     Interest expense, net            (0.4)                                      0.4                                                                                                                                                             (6.3)                                         6.3


     Provision for (Benefit from)
      income taxes                      3.5                                     (3.5)                                                                                                                                                            (6.7)                                         6.7


     GAAP Net Loss/
              Non-
      GAAP Income                                (56.5)                                     26.3                                     $
              55.0                                                                   24.8                                (44.1)                                         23.2             42.2        21.3

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SOURCE BioMarin Pharmaceutical Inc.