Amgen Reports Second Quarter 2019 Financial Results

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

    --  Total revenues decreased 3% to $5.9 billion in comparison to the second
        quarter of 2018 reflecting increasing competition due to patent
        expirations.
        --  Product sales declined 2% globally. Prolia(®) (denosumab),
            Repatha(®) (evolocumab), Parsabiv(® )(etelcalcitide) and
            Aimovig(® )(erenumab-aooe) units grew double-digits or better.
    --  GAAP earnings per share (EPS) increased 3% to $3.57 benefited by lower
        weighted-average shares outstanding.
        --  GAAP operating income decreased 5% to $2.7 billion and GAAP
            operating margin decreased 1.9 percentage points to 48.0%.
    --  Non-GAAP EPS increased 4% to $3.97 benefited by lower weighted-average
        shares outstanding.
        --  Non-GAAP operating income decreased 5% to $3.0 billion and non-GAAP
            operating margin decreased 1.8 percentage points to 53.3%.
    --  The Company generated $1.3 billion of free cash flow in the second
        quarter versus $1.9 billion in the second quarter of 2018 driven
        primarily by an advanced tax deposit payment.
    --  2019 total revenues guidance revised to $22.4-$22.9 billion; EPS
        guidance to $12.10-$12.71 on a GAAP basis and $13.75-$14.30 on a
        non-GAAP basis.

"With our newer products generating strong volume gains globally and many first-in-class medicines advancing through our pipeline, we are well positioned to serve patients and deliver long-term growth for our shareholders," said Robert A. Bradway, chairman and chief executive officer.


                                  
     $Millions, except EPS and percentages Q2'19           Q2'18     YOY  



       Total Revenues                                                          $
      5,871       $
          6,059 (3%)



       GAAP Operating Income                                                   $
      2,678       $
          2,832 (5%)



       GAAP Net Income                                                         $
      2,179       $
          2,296 (5%)



       GAAP EPS                                                                 $
      3.57        $
          3.48   3%



       Non-GAAP Operating Income                                               $
      2,973       $
          3,131 (5%)



       Non-GAAP Net Income                                                     $
      2,423       $
          2,529 (4%)



       Non-GAAP EPS                                                             $
      3.97        $
          3.83   4%

    ---



                            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 2% for the second quarter of 2019 versus
        the second quarter of 2018.
    --  Prolia sales increased 14% driven by higher unit demand.
    --  EVENITY((TM) )(romosozumab-aqqg) generated $28 million of sales in the
        second quarter of 2019.
    --  Repatha sales increased 3% driven by higher unit demand, offset
        partially by net selling price.
    --  Aimovig was launched in the U.S. in the second quarter of 2018 and
        generated $83 million in sales in the second quarter of 2019.
    --  Parsabiv sales increased 130% driven by higher unit demand, offset
        partially by net selling price.
    --  KYPROLIS(®) (carfilzomib) sales increased 2% driven by higher unit
        demand.
    --  XGEVA(®) (denosumab) sales increased 10% driven primarily by higher
        unit demand.
    --  Vectibix(®) (panitumumab) sales increased 13% driven by higher unit
        demand.
    --  Nplate(®) (romiplostim) sales increased 12% driven by higher unit
        demand.
    --  BLINCYTO(®) (blinatumomab) sales increased 30% driven by higher unit
        demand.
    --  Biosimilar sales generated $82 million in the second quarter of 2019.
    --  Enbrel(®) (etanercept) sales increased 5% driven primarily by net
        selling price and favorable changes in inventory levels, offset
        partially by lower unit demand.
    --  Neulasta(®) (pegfilgrastim) sales decreased 25% driven by lower net
        selling price and the impact of biosimilar competition on unit demand.
    --  NEUPOGEN(®) (filgrastim) sales decreased 26% driven primarily by the
        impact of competition on unit demand and lower net selling price, offset
        partially by favorable changes in accounting estimates of sales
        deductions.
    --  EPOGEN(®) (epoetin alfa) sales decreased 11% driven by lower net
        selling price.
    --  Aranesp(®) (darbepoetin alfa) sales decreased 8% driven by the impact
        of competition on unit demand.
    --  Sensipar/Mimpara(®) (cinacalcet) sales decreased 71% driven by the
        impact of generic competition on unit demand.

Product Sales Detail by Product and Geographic Region


                       
              $Millions, except percentages                                
       
     Q2'19                          Q2'18         YOY  



                                                                                     US                    ROW     TOTAL                  TOTAL         TOTAL




              Prolia(R)                                                                  $
       458                         $
       240                  $
            698           $
        610  14%



              EVENITY(TM)                                                            3                         25                             28                   
             *



              Repatha(R)                                                            91                         61                            152               148     3%



              Aimovig(R)                                                            83                                                       83                 2  
             *



              Parsabiv(R)                                                          148                         20                            168                73  
             *



              KYPROLIS(R)                                                          166                        101                            267               263     2%



              XGEVA(R)                                                             379                        120                            499               452    10%



              Vectibix(R)                                                           79                        117                            196               173    13%



              Nplate(R)                                                            122                         79                            201               179    12%



              BLINCYTO(R)                                                           39                         39                             78                60    30%



              Biosimilars**                                                                                   82                             82                 2  
             *



              Enbrel(R)                                                          1,315                         48                          1,363             1,302     5%



              Neulasta(R)                                                          719                        105                            824             1,100  (25%)



              NEUPOGEN(R)                                                           55                         20                             75               102  (26%)



              EPOGEN(R)                                                            223                                                      223               250  (11%)



              Aranesp(R)                                                           192                        244                            436               472   (8%)



              Sensipar(R)/Mimpara(R)                                                43                         79                            122               420  (71%)



              Other***                                                              27                         52                             79                71    11%




              Total product sales                                                      $
       4,142                       $
       1,432                $
            5,574         $
        5,679 (2%)





    * Change in excess of 100%



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



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

    ---

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

    --  Total Operating Expenses decreased 1%. Cost of Sales margin increased
        0.2 percentage points due primarily to product mix, offset partially by
        the benefit of Hurricane Maria insurance proceeds and lower
        manufacturing costs. Research & Development (R&D) expenses increased 6%
        driven primarily by increased spending in research and early pipeline in
        support of our oncology programs, offset partially by decreased spending
        in support of marketed products. Selling, General & Administrative
        (SG&A) expenses decreased 7% driven primarily by reduced discretionary
        general and administrative expenses and the end of certain
        acquisition-related intangible asset amortization charges in 2018.
    --  Operating Margin decreased 1.9 percentage points to 48.0%.
    --  Tax Rate increased 1.7 percentage points due primarily to a prior-year
        tax benefit associated with intercompany sales under U.S. corporate tax
        reform.

On a non-GAAP basis:

    --  Total Operating Expenses decreased 1%. Cost of Sales margin increased
        0.1 percentage points due primarily to product mix, offset partially by
        the benefit of Hurricane Maria insurance proceeds and lower
        manufacturing costs. R&D expenses increased 7% driven primarily by
        increased spending in research and early pipeline in support of our
        oncology programs, offset partially by decreased spending in support of
        marketed products. Selling, General & Administrative (SG&A) expenses
        decreased 6% driven primarily by reduced discretionary general and
        administrative expenses.
    --  Operating Margin decreased 1.8 percentage points to 53.3%.
    --  Tax Rate increased 1.1 percentage points due primarily to a prior-year
        tax benefit associated with intercompany sales under U.S. corporate tax
        reform.


        
             $Millions, except percentages          
         
         GAAP                                
      
                Non-GAAP


                                                Q2'19                     Q2'18             YOY                           Q2'19           Q2'18                YOY  




         Cost of Sales                                     $
       1,012                    $
          1,024                              (1%)                 $
       736                      $
              745     (1%)



         % of product sales                    18.2%                           18.0%                    
      0.2 pts.                      13.2%                      13.1%         
           0.1 pts.


          Research & Development                              $
       924                      $
          869                                6%                 $
       906                      $
              850       7%



         % of product sales                    16.6%                           15.3%                    
      1.3 pts.                      16.3%                      15.0%         
           1.3 pts.


          Selling, General &
           Administrative                                   $
       1,260                    $
          1,353                              (7%)               $
       1,256                    $
              1,333     (6%)



         % of product sales                    22.6%                           23.8%                   
      (1.2) pts.                     22.5%                      23.5%        
           (1.0) pts.



         Other                                               $
       (3)                    $
          (19)                            (84%)         
     $                        
     $                            -%


                       Total Operating Expenses       $
       
         3,193                $
     
            3,227                              (1%)           $
     
         2,898             $
        
                2,928     (1%)





         Operating Margin


          operating income as % of
           product sales                        48.0%                           49.9%                   
      (1.9) pts.                     53.3%                      55.1%        
           (1.8) pts.




                       Tax Rate                 15.0%                           13.3%                              1.7 pts.               15.3%                      14.2%                       1.1 pts.





         pts: percentage points

    ---

Cash Flow and Balance Sheet

    --  The Company generated $1.3 billion of free cash flow in the second
        quarter of 2019 versus $1.9 billion in the second quarter of 2018 driven
        primarily by an advanced tax deposit payment.
    --  The Company's second quarter 2019 dividend of $1.45 per share was
        declared on March 7, 2019, and was paid on June 7, 2019, to all
        stockholders of record as of May 17, 2019, representing a 10% increase
        from 2018.
    --  During the second quarter, the Company repurchased 13.1 million shares
        of common stock at a total cost of $2.3 billion. At the end of the
        second quarter, the Company had $4.7 billion remaining under its stock
        repurchase authorization.


                                              
       $Billions, except shares Q2'19        Q2'18      YOY  




       Operating Cash Flow                                                      $
     1.4                  $
     2.1       $
     (0.7)



       Capital Expenditures                                                 0.1               0.2                0.0



       Free Cash Flow                                                       1.3               1.9              (0.6)



       Dividends Paid                                                       0.9               0.9                0.0



       Share Repurchase                                                     2.3               3.2              (0.8)



       Average Diluted Shares (millions)                                    610               660               (50)





       Cash and Investments                                                21.8              29.4              (7.6)



       Debt Outstanding                                                    30.6              34.5              (3.9)



       Stockholders' Equity                                                10.8              14.9              (4.1)





       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 $22.4 billion to $22.9 billion.
        --  Previously, the Company expected total revenues in the range of
            $22.0 billion to $22.9 billion.
    --  On a GAAP basis, EPS in the range of $12.10 to $12.71 and a tax rate in
        the range of 13% to 14%.
        --  Previously, the Company expected GAAP EPS in the range of $11.68 to
            $12.73 and a tax rate in the range of 13% to 14%.
    --  On a non-GAAP basis, EPS in the range of $13.75 to $14.30 and a tax rate
        in the range of 14% to 15%.
        --  Previously, the Company expected non-GAAP EPS in the range of $13.25
            to $14.30 and a tax rate in the range of 14% to 15%.
    --  Capital expenditures to be approximately $700 million.

Second Quarter Product and Pipeline Update

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

Research

    --  In June, Intermountain Healthcare and deCODE genetics, a wholly-owned
        subsidiary of Amgen based in Iceland, announced a global collaboration
        that combines Intermountain's internationally-recognized expertise in
        precision medicine and clinical care with deCODE's world-class expertise
        in human population genetics and will involve the participation of up to
        half a million individuals.
    --  In July, the Company completed the acquisition of Nuevolution, and is
        rapidly integrating its world-class DNA-encoded library and other
        technologies.

Omecamtiv mecarbil

    --  In July, the Phase 3 GALACTIC-HF cardiovascular outcomes clinical trial
        completed enrollment.

EVENITY

    --  In June, the Committee for Medicinal Products for Human Use (CHMP) of
        the European Medicines Agency adopted a negative opinion on the
        Marketing Authorization Application for EVENITY for the treatment of
        severe osteoporosis. In July, UCB submitted a written notice to the
        European Medicines Agency requesting a re-examination of the CHMP
        opinion.

Aimovig

    --  The Company discussed long-term efficacy and safety data recently
        presented at the meetings of the American Academy of Neurology and
        American Headache Society.

AMG 510

    --  The Company provided a clinical update, including tumor responses in
        colorectal and appendiceal cancer patients, completion of enrollment in
        the dose expansion arm and enrollment initiation in the checkpoint
        inhibitor combination arm of the first-in-human study. Initiation of a
        potentially registrational monotherapy study is planned for this year.

ABP 798 (biosimilar rituximab)

    --  Results from a Phase 3 study of ABP 798, a biosimilar candidate to
        Rituxan(® )(rituximab), in patients with Non-Hodgkin's lymphoma are
        expected in Q3 2019.

ABP 710 (biosimilar infliximab)

    --  The Company announced that the U.S. Food and Drug Administration (FDA)
        has set a Dec. 14, 2019, Biosimilar User Fee Act target action date for
        the Biologics License Application of ABP 710, a biosimilar candidate to
        REMICADE(®) (infliximab).

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

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

Aimovig is developed in collaboration with Novartis

Rituxan is a registered trademark of Genentech

REMICADE is a registered trademark of Johnson and Johnson

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the second 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 second 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. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, 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 a new indication for an existing product 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                                  Six months ended
                                           
                  June 30,                    
              June 30,


                                         2019                      2018                 2019                      2018

                                                                                                                ---


     Revenues:


      Product sales                             $
              5,574                            $
             5,679                           $
       10,860  $
       11,022


      Other revenues                      297                                 380                                 568                            591



      Total revenues                    5,871                               6,059                              11,428                         11,613






     Operating expenses:


      Cost of sales                     1,012                               1,024                               2,067                          1,968


      Research and
       development                        924                                 869                               1,803                          1,629


      Selling, general and
       administrative                   1,260                               1,353                               2,414                          2,480



     Other                               (3)                               (19)                                (6)                          (22)



      Total operating
       expenses                         3,193                               3,227                               6,278                          6,055





      Operating income                  2,678                               2,832                               5,150                          5,558




      Interest expense, net               332                                 347                                 675                            685


      Interest and other
       income, net                        218                                 162                                 403                            393





      Income before income
       taxes                            2,564                               2,647                               4,878                          5,266




      Provision for income
       taxes                              385                                 351                                 707                            659






     Net income                                $
              2,179                            $
             2,296                            $
       4,171   $
       4,607






     Earnings per share:



     Basic                                      $
              3.59                             $
             3.50                             $
       6.78    $
       6.76



     Diluted                                    $
              3.57                             $
             3.48                             $
       6.75    $
       6.73




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



     Basic                               607                       656                                    615                      682



     Diluted                             610                       660                                    618                      685



     
                Amgen Inc.



     
                Consolidated Balance Sheets - GAAP



     
                (In millions)




                                                          June 30,                    December 31,


                                                               2019            2018

                                                                               ---

                                                        (Unaudited)



     
                Assets



     Current assets:



     Cash, cash equivalents and marketable securities              $
      21,758               $
        29,304



     Trade receivables, net                                  3,801             3,580



     Inventories                                             3,176             2,940



     Other current assets                                    2,011             1,794




     Total current assets                                   30,746            37,618





     Property, plant and equipment, net                      4,882             4,958



     Intangible assets, net                                  6,813             7,443



     Goodwill                                               14,689            14,699



     Other assets                                            2,243             1,698




     Total assets                                                  $
      59,373               $
        66,416






     
                Liabilities and Stockholders' Equity



     Current liabilities:



     Accounts payable and accrued liabilities                       $
      7,806                $
        9,069



     Current portion of long-term debt                       2,816             4,419




     Total current liabilities                              10,622            13,488





     Long-term debt                                         27,798            29,510



     Long-term deferred tax liabilities                        763               864



     Long-term tax liabilities                               7,861             8,770



     Other noncurrent liabilities                            1,535             1,284



     Total stockholders' equity                             10,794            12,500




     Total liabilities and stockholders' equity                    $
      59,373               $
        66,416






     Shares outstanding                                        602               630



     
                Amgen Inc.



     
                GAAP to Non-GAAP Reconciliations



     
                (Dollars in millions)



     
                (Unaudited)




                                                                                     Three months ended                                         Six months ended
                                                             
           June 30,                           
               June 30,


                                                           2019                       2018                2019                             2018

                                                                                                                                         ---

                   GAAP cost of sales                           $
         1,012                                   $
              1,024                                 $
         2,067      $
       1,968


                   Adjustments to cost of sales:


      Acquisition-related expenses
       (a)                                                (276)                                 (279)                                  (552)                          (545)


                   Total adjustments to cost of
                    sales                                 (276)                                 (279)                                  (552)                          (545)



                   Non-GAAP cost of sales                         $
         736                                     $
              745                                 $
         1,515      $
       1,423





                   GAAP cost of sales as a                 18.2                                   18.0                                    19.0                            17.9
                    percentage of product sales               %                                     %                                      %                              %


      Acquisition-related expenses
       (a)                                                 -5.0                                   -4.9                                    -5.0                            -5.0


                   Non-GAAP cost of sales as a             13.2                                   13.1                                    14.0                            12.9
                    percentage of product sales               %                                     %                                      %                              %

                                                                                                                                                                               ===



                   GAAP research and development
                    expenses                                      $
         924                                     $
              869                                 $
         1,803      $
       1,629


                   Adjustments to research and development
                    expenses:


      Acquisition-related expenses
       (a)                                                 (18)                                  (19)                                   (38)                           (40)


                   Total adjustments to research
                    and development expenses               (18)                                  (19)                                   (38)                           (40)



                   Non-GAAP research and
                    development expenses                          $
         906                                     $
              850                                 $
         1,765      $
       1,589





                   GAAP research and development
                    expenses as a percentage of               %                                     %                                      %                              %
                    product sales                          16.6                                   15.3                                    16.6                            14.8


      Acquisition-related expenses
       (a)                                                 -0.3                                   -0.3                                    -0.3                            -0.4


                   Non-GAAP research and
                    development expenses as a                 %                                     %                                      %                              %
                    percentage of product sales            16.3                                   15.0                                    16.3                            14.4

                                                                                                                                                                               ===



                   GAAP selling, general and
                    administrative expenses                     $
         1,260                                   $
              1,353                                 $
         2,414      $
       2,480


                   Adjustments to selling, general and
                    administrative expenses:


      Acquisition-related expenses
       (a)                                                  (5)                                  (20)                                    (9)                           (45)


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


                   Total adjustments to selling,
                    general and administrative
                    expenses                                (4)                                  (20)                                    (9)                           (48)



                   Non-GAAP selling, general and
                    administrative expenses                     $
         1,256                                   $
              1,333                                 $
         2,405      $
       2,432





                   GAAP selling, general and
                    administrative expenses as a              %                                     %                                      %                              %
                    percentage of product sales            22.6                                   23.8                                    22.2                            22.5


      Acquisition-related expenses
       (a)                                                 -0.1                                   -0.3                                    -0.1                            -0.4


      Certain net charges pursuant
       to our restructuring
       initiative                                           0.0                                    0.0                                     0.0                             0.0


                   Non-GAAP selling, general and
                    administrative expenses as a              %                                     %                                      %                              %
                    percentage of product sales            22.5                                   23.5                                    22.1                            22.1

                                                                                                                                                                               ===



                   GAAP operating expenses                      $
         3,193                                   $
              3,227                                 $
         6,278      $
       6,055


                   Adjustments to operating expenses:


      Adjustments to cost of sales                        (276)                                 (279)                                  (552)                          (545)


      Adjustments to research and
       development expenses                                (18)                                  (19)                                   (38)                           (40)


      Adjustments to selling,
       general and administrative
       expenses                                             (4)                                  (20)                                    (9)                           (48)


      Certain net charges pursuant
       to our restructuring
       initiative                                             1                                      7                                       2                               6


      Certain other expenses                                  -                                  (25)                                                                  (25)


      Acquisition-related
       adjustments                                            2                                     37                                       4                              41


                   Total adjustments to operating
                    expenses                              (295)                                 (299)                                  (593)                          (611)


                   Non-GAAP operating expenses                  $
         2,898                                   $
              2,928                                 $
         5,685      $
       5,444





                   GAAP operating income                        $
         2,678                                   $
              2,832                                 $
         5,150      $
       5,558


      Adjustments to operating
       expenses                                             295                                    299                                     593                             611


                   Non-GAAP operating income                    $
         2,973                                   $
              3,131                                 $
         5,743      $
       6,169





                   GAAP operating income as a              48.0                                   49.9                                    47.4                            50.4
                    percentage of product sales               %                                     %                                      %                              %


      Adjustments to cost of sales                          5.0                                    4.9                                     5.0                             5.0


      Adjustments to research and
       development expenses                                 0.3                                    0.3                                     0.3                             0.4


      Adjustments to selling,
       general and administrative
       expenses                                             0.1                                    0.3                                     0.1                             0.4


      Certain net charges pursuant
       to our restructuring
       initiative                                           0.0                                    0.0                                     0.0                             0.0


      Certain other expenses                                0.0                                    0.4                                     0.0                             0.2


      Acquisition-related
       adjustments                                         -0.1                                   -0.7                                     0.1                            -0.4


                   Non-GAAP operating income as            53.3                                   55.1                                    52.9                            56.0
                    a percentage of product sales             %                                     %                                      %                              %

                                                                                                                                                                               ===



                                                                      Three months ended                                Six months ended
                                                                                 June 30,                                           June 30,


                                                           2019                       2018                2019                             2018

                                                                                                                                         ---

                   GAAP interest and other
                    income, net                                   $
         218                                     $
              162                                   $
         403        $
       393


      Adjustments to other income
       (b)                                                    -                                                                                                        (75)



                   Non-GAAP interest and other
                    income, net                                   $
         218                                     $
              162                                   $
         403        $
       318





                   GAAP income before income
                    taxes                                       $
         2,564                                   $
              2,647                                 $
         4,878      $
       5,266


      Adjustments to operating
       expenses                                             295                                    299                                     593                             611


      Adjustments to other income
       (b)                                                    -                                                                                                        (75)



                   Non-GAAP income before income
                    taxes                                       $
         2,859                                   $
              2,946                                 $
         5,471      $
       5,802





                   GAAP provision for income
                    taxes                                         $
         385                                     $
              351                                   $
         707        $
       659


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (c)                                       70                                     74                                     138                             138


      Other income tax adjustments
       (d)                                                 (19)                                   (8)                                   (27)                             10



                   Total adjustments to provision
                    for income taxes                         51                                     66                                     111                             148


                   Non-GAAP provision for income
                    taxes                                         $
         436                                     $
              417                                   $
         818        $
       807





                   GAAP tax as a percentage of             15.0                                   13.3                                    14.5                            12.5
                    income before taxes                       %                                     %                                      %                              %


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (c)                                      0.9                                    1.2                                     1.0                             1.2


      Other income tax adjustments
       (d)                                                 -0.6                                   -0.3                                    -0.5                             0.2



                   Total adjustments to provision
                    for income taxes                        0.3                                    0.9                                     0.5                             1.4


                   Non-GAAP tax as a percentage            15.3                                   14.2                                    15.0                            13.9
                    of income before taxes                    %                                     %                                      %                              %

                                                                                                                                                                               ===



                   GAAP net income                              $
         2,179                                   $
              2,296                                 $
         4,171      $
       4,607


                   Adjustments to net income:


      Adjustments to income before
       income taxes, net of the
       income tax effect                                    225                                    225                                     455                             398


      Other income tax adjustments
       (d)                                                   19                                      8                                      27                            (10)



                   Total adjustments to net
                    income                                  244                                    233                                     482                             388


                   Non-GAAP net income                          $
         2,423                                   $
              2,529                                 $
         4,653      $
       4,995



     
                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
                                                                 
                  June 30, 2019                               
          June 30, 2018


                                                                         GAAP                                    Non-GAAP                      GAAP                 Non-GAAP

                                                                                                                                                                ---




     Net income                                                                $
              2,179                         $
      2,423                                         $
      2,296  $
      2,529




      Weighted-average shares for
       diluted EPS                                                        610                                610                          660                                      660





     Diluted EPS                                                                $
              3.57                          $
      3.97                                          $
      3.48   $
      3.83





                                                                                           Six months ended                                   Six months ended
                                                                 
                  June 30, 2019                               
          June 30, 2018


                                                                         GAAP                                    Non-GAAP                      GAAP                 Non-GAAP

                                                                                                                                                                ---




     Net income                                                                $
              4,171                         $
      4,653                                         $
      4,607  $
      4,995




      Weighted-average shares for
       diluted EPS                                                        618                                618                          685                                      685





     Diluted EPS                                                                $
              6.75                          $
      7.53                                          $
      6.73   $
      7.29



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




     (b) For the six months ended June 30,
          2018, the adjustment related to
          the net gain associated with the
          Kirin-Amgen 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 rates
          for the adjustments to our GAAP
          income before income taxes, for
          the three and six months ended
          June 30, 2019, were 23.7% and
          23.3%, compared with 24.7% and
          25.7% for the corresponding
          periods of the prior year.




     (d) The adjustments related primarily
          to certain acquisition items and
          prior-period items excluded from
          GAAP earnings.



     
                Amgen Inc.



     
                Reconciliations of Cash Flows



     
                (In millions)



     
                (Unaudited)




                                                            Three months ended                               Six months ended
                                           
           June 30,                          
          June 30,


                                     2019                   2018               2019                     2018



      Net cash provided
       by operating
       activities                           $
       1,414                               $
      2,102                               $
         3,259   $
      4,829


      Net cash provided
       by investing
       activities                   2,745                            2,938                            6,300                         17,844


      Net cash used in
       financing
       activities                 (5,992)                         (4,650)                         (10,979)                      (16,342)



      (Decrease)
       increase in cash
       and cash
       equivalents                (1,833)                             390                          (1,420)                         6,331


      Cash and cash
       equivalents at
       beginning of
       period                       7,358                            9,741                            6,945                          3,800



      Cash and cash
       equivalents at
       end of period                        $
       5,525                              $
      10,131                               $
         5,525  $
      10,131





                                                            Three months ended                               Six months ended
                                           
           June 30,                          
          June 30,


                                     2019                   2018               2019                     2018

                                                                                                      ---

      Net cash provided
       by operating
       activities                           $
       1,414                               $
      2,102                               $
         3,259   $
      4,829


      Capital
       expenditures                 (144)                           (187)                           (260)                         (342)


      Free cash flow                        $
       1,270                               $
      1,915                               $
         2,999   $
      4,487



     
                Reconciliation of GAAP EPS Guidance to Non-GAAP



     
                EPS Guidance for the Year Ending December 31, 2019



     
                (Unaudited)





     
                GAAP diluted EPS guidance                          $12.10      $12.71



     
                Known adjustment to arrive at non-GAAP*:



     Acquisition-related expenses (a)                                  1.55        1.61



     Tax adjustments                                                        0.04



     
                Non-GAAP diluted EPS guidance                      $13.75      $14.30



               * The known adjustments are
                presented net of their related tax
                impact, which amount to
                approximately $0.38 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%    14%



     Tax rate of known adjustments discussed above                            1%



     Non-GAAP diluted EPS guidance                                        14%    15%

View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-reports-second-quarter-2019-financial-results-300893512.html

SOURCE Amgen