Amgen Reports First Quarter 2019 Financial Results

THOUSAND OAKS, Calif., April 30, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2019. Key results include:

    --  Total revenues were unchanged at $5.6 billion in comparison to the first
        quarter of 2018.
        --  Product sales declined 1 percent globally. New and recently launched
            products including Prolia(®) (denosumab), Repatha(®) (evolocumab)
            and KYPROLIS(®) (carfilzomib) showed double-digit growth.
    --  GAAP earnings per share (EPS) decreased 2 percent to $3.18 driven by
        higher total operating expenses, offset partially by lower
        weighted-average shares outstanding.
        --  GAAP operating income decreased 9 percent to $2.5 billion and GAAP
            operating margin decreased 4.2 percentage points to 46.8 percent.
    --  Non-GAAP EPS increased 3 percent to $3.56 benefited by lower
        weighted-average shares outstanding.
        --  Non-GAAP operating income decreased 9 percent to $2.8 billion and
            non-GAAP operating margin decreased 4.5 percentage points to 52.4
            percent.
    --  The Company generated $1.7 billion of free cash flow in the first
        quarter versus $2.6 billion in the first quarter of 2018.
    --  2019 total revenues guidance revised to $22.0-$22.9 billion; EPS
        guidance to $11.68-$12.73 on a GAAP basis and $13.25-$14.30 on a
        non-GAAP basis.

"We continue to generate strong, volume-driven growth for our newer products, while effectively defending our mature products," said Robert A. Bradway, chairman and chief executive officer. "We are also advancing a record number of first-in-class molecules targeting significant areas of unmet need through our pipeline."


                                  
     $Millions, except EPS and percentages Q1'19           Q1'18     YOY  



       Total Revenues                                                          $
      5,557       $
          5,554    -%



       GAAP Operating Income                                                   $
      2,472       $
          2,726  (9%)



       GAAP Net Income                                                         $
      1,992       $
          2,311 (14%)



       GAAP EPS                                                                 $
      3.18        $
          3.25  (2%)



       Non-GAAP Operating Income                                               $
      2,770       $
          3,038  (9%)



       Non-GAAP Net Income                                                     $
      2,230       $
          2,466 (10%)



       Non-GAAP EPS                                                             $
      3.56        $
          3.47    3%

    ---



                            References in this release to "non-GAAP"
                             measures, measures presented "on a non-
                             GAAP basis" and to "free cash flow"
                             (computed by subtracting capital
                             expenditures from operating cash flow)
                             refer to non-GAAP financial measures.
                             Adjustments to the most directly
                             comparable GAAP financial measures and
                             other items are presented on the
                             attached reconciliations.

Product Sales Performance

    --  Total product sales decreased 1 percent for the first quarter of 2019
        versus the first quarter of 2018.
    --  Repatha sales increased 15 percent driven primarily by higher unit
        demand, offset substantially by net selling price.
    --  Prolia sales increased 20 percent driven primarily by higher unit
        demand.
    --  Aimovig(® )(erenumab-aooe) recorded sales of $59 million in the
        quarter.
    --  Parsabiv(® )(etelcalcetide) sales increased 207 percent driven by
        higher unit demand, offset partially by net selling price.
    --  KYPROLIS sales increased 10 percent driven primarily by higher unit
        demand.
    --  XGEVA(®) (denosumab) sales increased 6 percent driven primarily by
        higher unit demand.
    --  Vectibix(®) (panitumumab) sales increased 1 percent.
    --  Nplate(®) (romiplostim) sales increased 6 percent driven by higher unit
        demand.
    --  BLINCYTO(®) (blinatumomab) sales increased 41 percent driven by higher
        unit demand.
    --  Enbrel(®) (etanercept) sales increased 4 percent driven primarily by
        favorable impacts from changes in accounting estimates of sales
        deductions and product returns and a slight increase in net selling
        price, offset partially by unfavorable changes in inventory.
    --  Neulasta(®) (pegfilgrastim) sales decreased 12 percent driven primarily
        by lower net selling price and, to a lesser extent, changes in
        inventory.
    --  NEUPOGEN(®) (filgrastim) sales decreased 29 percent driven primarily by
        the impact of competition on unit demand and net selling price.
    --  EPOGEN(®) (epoetin alfa) sales decreased 10 percent driven primarily by
        lower net selling price.
    --  Aranesp(®) (darbepoetin alfa) sales decreased 9 percent driven
        primarily by the impact of competition on unit demand.
    --  Sensipar(®)/Mimpara(®) (cinacalcet) sales decreased 57 percent driven
        primarily by the impact of competition on unit demand and, to a lesser
        extent, changes in inventory.

Product Sales Detail by Product and Geographic Region


              
              $Millions, except percentages                                           
       
     Q1'19                           Q1'18         YOY  



                                                                                  US                         ROW     TOTAL                   TOTAL         TOTAL

                                                                                                                                                              ---


              Repatha(R)                                                                 $
          83                          $
        58                  $
            141            $
        123     15%



              Prolia(R)                                                         390                             202                             592               494     20%



              Aimovig(R)                                                         59                                                             59                    
             *



              Parsabiv(R)                                                       109                              17                             126                41   
             *



              KYPROLIS(R)                                                       154                              91                             245               222     10%



              XGEVA(R)                                                          356                             115                             471               445      6%



              Vectibix(R)                                                        78                              92                             170               169      1%



              Nplate(R)                                                         114                              75                             189               179      6%



              BLINCYTO(R)                                                        40                              29                              69                49     41%



              Enbrel(R)                                                       1,106                              45                           1,151             1,105      4%



              Neulasta(R)                                                       893                             128                           1,021             1,155   (12%)



              NEUPOGEN(R)                                                        50                              23                              73               103   (29%)



              EPOGEN(R)                                                         219                                                            219               244   (10%)



              Aranesp(R)                                                        182                             232                             414               454    (9%)



              Sensipar(R)/Mimpara(R)                                            135                              78                             213               497   (57%)



              Biosimilars**                                                       -                             55                              55                    
             *



              Other***                                                           23                              55                              78                63     24%




              Total product sales                                                     $
          3,991                       $
        1,295                $
            5,286          $
        5,343    (1%)

                                                                                                                                                                                           ===



    * Change in excess of 100%



              ** Biosimilars includes AMGEVITA(TM) and KANJINTI(TM).



              *** Other includes MN Pharma, Bergamo, EVENITY(TM), Corlanor(R) and IMLYGIC(R).



              KANJINTI(TM) trade name is provisionally approved by the FDA.

    ---

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

    --  Total Operating Expenses increased 9 percent. Cost of Sales margin
        increased 2.3 percentage points primarily due to product mix and higher
        costs of manufacturing, offset partially by lower royalty costs.
        Research & Development (R&D) expenses increased 16 percent driven
        primarily by increased spending in research and early pipeline in
        support of our oncology programs, as changes in late-stage programs and
        marketed products were not significant. Selling, General &
        Administrative (SG&A) expenses increased 2 percent primarily due to
        investments in launch products.
    --  Operating Margin decreased 4.2 percentage points to 46.8 percent.
    --  Tax Rate increased 2.1 percentage points primarily due to a prior-year
        tax benefit associated with intercompany sales under U.S. corporate tax
        reform.

On a non-GAAP basis:

    --  Total Operating Expenses increased 11 percent. Cost of Sales margin
        increased 2.0 percentage points primarily due to product mix and higher
        costs of manufacturing, offset partially by lower royalty costs. R&D
        expenses increased 16 percent driven primarily by increased spending in
        research and early pipeline in support of our oncology programs, as
        changes in late-stage programs and marketed products were not
        significant. SG&A expenses increased 5 percent primarily due to
        investments in launch products.
    --  Operating Margin decreased 4.5 percentage points to 52.4 percent.
    --  Tax Rate increased 0.9 percentage points primarily due to a prior-year
        tax benefit associated with intercompany sales under U.S. corporate tax
        reform.



       $Millions, except percentages          
         
         GAAP                               
       
         Non-GAAP


                                      Q1'19                     Q1'18             YOY                              Q1'19      Q1'18                YOY  

                                                                                                                                                         ---

        Cost of Sales                             $
       1,055                      $
          944                             12%                 $
       779                      $
              678        15%


        % of product sales            20.0%                           17.7%                      
       2.3 pts.                 14.7%                      12.7%         
           2.0 pts.


        Research &
         Development                                $
       879                      $
          760                             16%                 $
       859                      $
              739        16%


        % of product sales            16.6%                           14.2%                      
       2.4 pts.                 16.3%                      13.8%         
           2.5 pts.


        Selling, General &
         Administrative                           $
       1,154                    $
          1,127                              2%               $
       1,149                    $
              1,099         5%


        % of product sales            21.8%                           21.1%                      
       0.7 pts.                 21.7%                      20.6%         
           1.1 pts.



       Other                                       $
       (3)                     $
          (3)                             -%         
     $                        
     $                            
     NM


                     Total Operating
                      Expenses              $
       
         3,085                $
     
            2,828                              9%           $
     
         2,787             $
        
                2,516        11%





       Operating Margin


        operating income as
         % of product sales           46.8%                           51.0%                     
       (4.2) pts.                52.4%                      56.9%        
           (4.5) pts.




                     Tax Rate         13.9%                           11.8%                                 2.1 pts.          14.6%                      13.7%                       0.9 pts.





       NM: Not Meaningful



       pts: percentage points

    ---

Cash Flow and Balance Sheet

    --  The Company generated $1.7 billion of free cash flow in the first
        quarter of 2019 versus $2.6 billion in the first quarter of 2018 driven
        by higher sales deductions paid to customers and lower net income.
    --  The Company's first quarter 2019 dividend of $1.45 per share was
        declared on Dec. 7, 2018, and was paid on March 8, 2019, to all
        stockholders of record as of Feb. 15, 2019, representing a 10 percent
        increase from the dividend paid in each of the previous four quarters.
    --  During the first quarter, the Company repurchased 15.9 million shares of
        common stock at a total cost of $3.0 billion. At the end of the first
        quarter, the Company had $2.1 billion remaining under its stock
        repurchase authorization.


                                            
         $Billions, except shares Q1'19        Q1'18      YOY  




       Operating Cash Flow                                                      $
     1.8                  $
     2.7       $
     (0.9)



       Capital Expenditures                                                 0.1               0.2                0.0



       Free Cash Flow                                                       1.7               2.6              (0.8)



       Dividends Paid                                                       0.9               1.0              (0.1)



       Share Repurchase                                                     3.0              10.8              (7.8)



       Average Diluted Shares (millions)                                    626               711               (85)





       Cash and Investments                                                26.3              32.2              (5.9)



       Debt Outstanding                                                    33.0              35.5              (2.5)



       Stockholders' Equity                                                10.8              15.6              (4.8)





       Note: Numbers may not add due to rounding

    ---

2019 Guidance

For the full year 2019, the Company now expects:

    --  Total revenues in the range of $22.0 billion to $22.9 billion.
        --  Previously, the Company expected total revenues in the range of
            $21.8 billion to $22.9 billion.
    --  On a GAAP basis, EPS in the range of $11.68 to $12.73 and a tax rate in
        the range of 13.0 percent to 14.0 percent.
        --  Previously, the Company expected GAAP EPS in the range of $11.55 to
            $12.75 and a tax rate in the range of 12.5 percent to 13.5 percent.
    --  On a non-GAAP basis, EPS in the range of $13.25 to $14.30 and a tax rate
        in the range of 14.0 percent to 15.0 percent.
        --  Previously, the Company expected non-GAAP EPS in the range of $13.10
            to $14.30 and a tax rate in the range of 14.0 percent to 15.0
            percent.
    --  Capital expenditures to be approximately $700 million.

First Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

Oncology Pipeline

    --  In June 2019, the Company will present the following clinical data at
        the Annual Meeting of the American Society of Clinical Oncology in
        Chicago:
        --  Dose escalation data of AMG 510, a small molecule KRAS G12C
            inhibitor, in patients with solid tumors.
        --  Updated dose escalation data of AMG 420, a BiTE(® )(bi-specific
            T-cell engager) immunotherapy targeting B-cell maturation antigen
            (BCMA), in patients with relapsed/refractory multiple myeloma.
        --  Dose escalation data of AMG 212, a BiTE(®) immunotherapy targeting
            prostate-specific membrane antigen (PSMA), in patients with
            metastatic castration-resistant prostate cancer.

EVENITY(TM) (romosozumab-aqqg)

    --  In April, the U.S. Food and Drug Administration (FDA) approved EVENITY
        for the treatment of osteoporosis in postmenopausal women at high risk
        for fracture, defined as a history of osteoporotic fracture, or multiple
        risk factors for fracture; or patients who have failed or are intolerant
        to other available osteoporosis therapy.

Omecamtiv mecarbil

    --  In March, the Data Monitoring Committee recommended that the Phase 3
        GALACTIC-HF cardiovascular outcomes clinical trial continue without
        changes to its conduct after a planned interim analysis, which included
        consideration of pre-specified criteria for futility.

Corlanor(® )(ivabradine)

    --  In April, Corlanor was approved for the treatment of stable symptomatic
        heart failure due to dilated cardiomyopathy in pediatric patients aged 6
        months and older, who are in sinus rhythm with an elevated heart rate.

Aimovig

    --  In March, the FDA approved a supplemental Biologics License Application
        to add 140 mg/mL single-dose autoinjector and pre-filled syringe dosing
        options.

EVENITY is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan

Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier

Aimovig is developed in collaboration with Novartis

Non-GAAP Financial Measures
In this news release, management has presented its operating results for the first quarters of 2019 and 2018, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2019 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarters of 2019 and 2018. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. While we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of new indications for existing products will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)



     
                Amgen Inc.



     
                Consolidated Statements of Income - GAAP



     
                (In millions, except per-share data)



     
                (Unaudited)




                                                                                          Three months ended
                                                                                 March 31,


                                                                          2019                           2018

                                                                                                         ---


     Revenues:



     Product sales                                                            $
              5,286                    $
      5,343



     Other revenues                                                       271                                  211




     Total revenues                                                     5,557                                5,554






     Operating expenses:



     Cost of sales                                                      1,055                                  944



     Research and development                                             879                                  760



     Selling, general and administrative                                1,154                                1,127



     Other                                                                (3)                                 (3)




     Total operating expenses                                           3,085                                2,828






     Operating income                                                   2,472                                2,726





     Interest expense, net                                                343                                  338



     Interest and other income, net                                       185                                  231






     Income before income taxes                                         2,314                                2,619





     Provision for income taxes                                           322                                  308






     Net income                                                               $
              1,992                    $
      2,311






     Earnings per share:



     Basic                                                                     $
              3.20                     $
      3.27



     Diluted                                                                   $
              3.18                     $
      3.25





     Weighted-average shares used in calculation of earnings per share:



     Basic                                                                622                                  707



     Diluted                                                              626                                  711



     
                Amgen Inc.



     
                Consolidated Balance Sheets - GAAP



     
                (In millions)




                                                         March 31,                    December 31,


                                                               2019            2018

                                                                               ---

                                                        (Unaudited)



     
                Assets



     Current assets:



     Cash, cash equivalents and marketable securities              $
      26,301               $
        29,304



     Trade receivables, net                                  3,771             3,580



     Inventories                                             3,016             2,940



     Other current assets                                    2,063             1,794




     Total current assets                                   35,151            37,618





     Property, plant and equipment, net                      4,892             4,958



     Intangible assets, net                                  7,124             7,443



     Goodwill                                               14,692            14,699



     Other assets                                            2,138             1,698




     Total assets                                                  $
      63,997               $
        66,416






     
                Liabilities and Stockholders' Equity



     Current liabilities:



     Accounts payable and accrued liabilities                       $
      9,001                $
        9,069



     Current portion of long-term debt                       3,705             4,419




     Total current liabilities                              12,706            13,488





     Long-term debt                                         29,319            29,510



     Long-term deferred tax liabilities                        811               864



     Long-term tax liabilities                               8,869             8,770



     Other noncurrent liabilities                            1,460             1,284



     Total stockholders' equity                             10,832            12,500




     Total liabilities and stockholders' equity                    $
      63,997               $
        66,416






     Shares outstanding                                        614               630



     
                Amgen Inc.



     
                GAAP to Non-GAAP Reconciliations



     
                (Dollars in millions)



     
                (Unaudited)




                                                                            Three months ended
                                                                   March 31,


                                                            2019                            2018

                                                                                            ---

                   GAAP cost of sales                            $
              1,055                            $
       944


                   Adjustments to cost of sales:


      Acquisition-related expenses
       (a)                                                 (276)                                 (266)


                   Total adjustments to cost of
                    sales                                  (276)                                 (266)



                   Non-GAAP cost of sales                          $
              779                            $
       678





                   GAAP cost of sales as a                  20.0                                   17.7
                    percentage of product sales                %                                     %


      Acquisition-related expenses
       (a)                                                  -5.3                                   -5.0


                   Non-GAAP cost of sales as a              14.7                                   12.7
                    percentage of product sales                %                                     %

                                                                                                        ===



                   GAAP research and development
                    expenses                                       $
              879                            $
       760


                   Adjustments to research and development
                    expenses:


      Acquisition-related expenses
       (a)                                                  (20)                                  (21)


                   Total adjustments to research
                    and development expenses                (20)                                  (21)



                   Non-GAAP research and
                    development expenses                           $
              859                            $
       739





                   GAAP research and development
                    expenses as a percentage of                %                                     %
                    product sales                           16.6                                   14.2


      Acquisition-related expenses
       (a)                                                  -0.3                                   -0.4


                   Non-GAAP research and
                    development expenses as a                  %                                     %
                    percentage of product sales             16.3                                   13.8

                                                                                                        ===



                   GAAP selling, general and
                    administrative expenses                      $
              1,154                          $
       1,127


                   Adjustments to selling, general and
                    administrative expenses:


      Acquisition-related expenses
       (a)                                                   (4)                                  (25)


      Certain net charges pursuant to
       our restructuring initiative                          (1)                                   (3)


                   Total adjustments to selling,
                    general and administrative
                    expenses                                 (5)                                  (28)



                   Non-GAAP selling, general and
                    administrative expenses                      $
              1,149                          $
       1,099





                   GAAP selling, general and
                    administrative expenses as a               %                                     %
                    percentage of product sales             21.8                                   21.1


      Acquisition-related expenses
       (a)                                                  -0.1                                   -0.5


      Certain net charges pursuant to
       our restructuring initiative                          0.0                                    0.0


                   Non-GAAP selling, general and
                    administrative expenses as a               %                                     %
                    percentage of product sales             21.7                                   20.6

                                                                                                        ===



                   GAAP operating expenses                       $
              3,085                          $
       2,828


                   Adjustments to operating expenses:


      Adjustments to cost of sales                         (276)                                 (266)


      Adjustments to research and
       development expenses                                 (20)                                  (21)


      Adjustments to selling, general
       and administrative expenses                           (5)                                  (28)


      Certain net charges pursuant to
       our restructuring initiative                            1                                    (1)


      Acquisition-related
       adjustments                                             2                                      4


                   Total adjustments to operating
                    expenses                               (298)                                 (312)


                   Non-GAAP operating expenses                   $
              2,787                          $
       2,516





                   GAAP operating income                         $
              2,472                          $
       2,726


      Adjustments to operating
       expenses                                              298                                    312


                   Non-GAAP operating income                     $
              2,770                          $
       3,038





                   GAAP operating income as a               46.8                                   51.0
                    percentage of product sales                %                                     %


      Adjustments to cost of sales                           5.3                                    5.0


      Adjustments to research and
       development expenses                                  0.3                                    0.4


      Adjustments to selling, general
       and administrative expenses                           0.1                                    0.5


      Certain net charges pursuant to
       our restructuring initiative                          0.0                                    0.0


      Acquisition-related
       adjustments                                          -0.1                                    0.0


                   Non-GAAP operating income as a           52.4                                   56.9
                    percentage of product sales                %                                     %

                                                                                                        ===



                   GAAP interest and other income,
                    net                                            $
              185                            $
       231


      Adjustments to other income (b)                          -                                  (75)



                   Non-GAAP interest and other
                    income, net                                    $
              185                            $
       156





                   GAAP income before income taxes               $
              2,314                          $
       2,619


      Adjustments to operating
       expenses                                              298                                    312


      Adjustments to other income (b)                          -                                  (75)



                   Non-GAAP income before income
                    taxes                                        $
              2,612                          $
       2,856





                   GAAP provision for income taxes                 $
              322                            $
       308


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (c)                                        68                                     64


      Other income tax adjustments
       (d)                                                   (8)                                    18



                   Total adjustments to provision
                    for income taxes                          60                                     82


                   Non-GAAP provision for income
                    taxes                                          $
              382                            $
       390





                   GAAP tax as a percentage of              13.9                                   11.8
                    income before taxes                        %                                     %


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (c)                                       1.0                                    1.3


      Other income tax adjustments
       (d)                                                  -0.3                                    0.6



                   Total adjustments to provision
                    for income taxes                         0.7                                    1.9


                   Non-GAAP tax as a percentage             14.6                                   13.7
                    of income before taxes                     %                                     %

                                                                                                        ===



                   GAAP net income                               $
              1,992                          $
       2,311


                   Adjustments to net income:


      Adjustments to income before
       income taxes, net of the
       income tax effect                                     230                                    173


      Other income tax adjustments
       (d)                                                     8                                   (18)



                   Total adjustments to net income           238                                    155


                   Non-GAAP net income                           $
              2,230                          $
       2,466



     
                Amgen Inc.



     
                GAAP to Non-GAAP Reconciliations



     
                (In millions, except per-share data)



     
                (Unaudited)





     The following table presents the computations for GAAP and non-GAAP diluted earnings per share:




                                                                                    Three months ended                              Three months ended
                                                                          March 31, 2019                                  March 31, 2018


                                                                           GAAP                            Non-GAAP                      GAAP              Non-GAAP

                                                                                                                                                       ---




     Net income                                                                  $
              1,992                 $
      2,230                                      $
      2,311  $
      2,466




      Weighted-average shares for diluted
       EPS                                                                  626                        626                          711                                   711





     Diluted EPS                                                                  $
              3.18                  $
      3.56                                       $
      3.25   $
      3.47



     (a) The adjustments related primarily
          to noncash amortization of
          intangible assets acquired in
          business combinations.




     (b) For three months ended March 31,
          2018, the adjustment related to
          the net gain associated with the
          Kirin-Amgen (K-A) share
          acquisition.




     (c) The tax effect of the adjustments
          between our GAAP and non-GAAP
          results takes into account the tax
          treatment and related tax rate(s)
          that apply to each adjustment in
          the applicable tax
          jurisdiction(s). Generally, this
          results in a tax impact at the
          U.S. marginal tax rate for certain
          adjustments, including the
          majority of amortization of
          intangible assets, whereas the tax
          impact of other adjustments,
          including restructuring expense,
          depends on whether the amounts are
          deductible in the respective tax
          jurisdictions and the applicable
          tax rate(s) in those
          jurisdictions. Due to these
          factors, the effective tax rate
          for the adjustments to our GAAP
          income before income taxes, for
          the three months ended March 31,
          2019, was 22.8%, compared with
          27.0% for the corresponding period
          of the prior year.




     (d) For three months ended March 31,
          2019, the adjustment related to
          prior-period items excluded from
          GAAP earnings. For three months
          ended March 31, 2018, the
          adjustment related primarily to
          the K-A acquisition.



     
                Amgen Inc.



     
                Reconciliations of Cash Flows



     
                (In millions)



     
                (Unaudited)




                                                                          Three months ended
                                                                 March 31,


                                                          2019                           2018



     Net cash provided by operating activities                $
              1,845                        $
     2,727



     Net cash provided by investing activities          3,555                                   14,906



     Net cash used in financing activities            (4,987)                                (11,692)




     Increase in cash and cash equivalents                413                                    5,941



     Cash and cash equivalents at beginning of period   6,945                                    3,800



     Cash and cash equivalents at end of period               $
              7,358                        $
     9,741





                                                                          Three months ended
                                                                 March 31,


                                                          2019                           2018

                                                                                         ---


     Net cash provided by operating activities                $
              1,845                        $
     2,727



     Capital expenditures                               (116)                                   (155)



     Free cash flow                                           $
              1,729                        $
     2,572



     
                Reconciliation of GAAP EPS Guidance to Non-GAAP



     
                EPS Guidance for the Year Ending December 31, 2019



     
                (Unaudited)





     
                GAAP diluted EPS guidance                          $
     11.68 $
     12.73



     
                Known adjustment to arrive at non-GAAP*:



     Acquisition-related expenses (a)                                    1.56



     Tax adjustments                                                     0.01



     
                Non-GAAP diluted EPS guidance                      $
     13.25 $
     14.30



               * The known adjustments are
                presented net of their related tax
                impact, which amount to
                approximately $0.41 per share.




               (a) The adjustments relate
                primarily to non-cash
                amortization of intangible assets
                acquired in business combinations.




               Our GAAP diluted EPS guidance does
                not include the effect of GAAP
                adjustments triggered by events
                that may occur subsequent to this
                press release such as
                acquisitions, asset impairments,
                litigation and changes in the fair
                value or our contingent
                consideration.



     
                Reconciliation of GAAP Tax Rate Guidance to Non-GAAP



     
                Tax Rate Guidance for the Year Ending December 31, 2019



     
                (Unaudited)





     GAAP tax rate guidance                                               13.0      14.0

                                                                              %        %



     Tax rate of known adjustments discussed above                             1.0%



     Non-GAAP diluted EPS guidance                                        14.0      15.0

                                                                              %        %

View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-reports-first-quarter-2019-financial-results-300841101.html

SOURCE Amgen