Amgen Reports Fourth Quarter And Full Year 2018 Financial Results

THOUSAND OAKS, Calif., Jan. 29, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2018 in comparison to comparable periods in 2017. Key results include:

    --  For the fourth quarter, total revenues increased 7 percent to $6.2
        billion.
        --  Product sales grew 8 percent globally. New and recently launched
            products including Repatha(®) (evolocumab), Prolia(®) (denosumab),
            KYPROLIS(®) (carfilzomib) and XGEVA(® )(denosumab) showed
            double-digit growth.
    --  For the full year, total revenues increased 4 percent to $23.7 billion,
        with 3 percent product sales growth.
    --  GAAP earnings per share (EPS) increased to $3.01 in the fourth quarter
        and to $12.62 for the full year driven by higher total revenues, a lower
        tax rate as the prior year was impacted by U.S. tax reform and lower
        weighted-average shares outstanding.
        --  For the fourth quarter, GAAP operating income increased 6 percent to
            $2.4 billion and GAAP operating margin decreased 0.6 percentage
            points to 39.7 percent. For the full year, GAAP operating income
            increased 3 percent to $10.3 billion and GAAP operating margin
            decreased 0.3 percentage points to 45.5 percent.
    --  Non-GAAP EPS increased 18 percent in the fourth quarter to $3.42 and 14
        percent for the full year to $14.40 driven by higher total revenues, a
        lower tax rate and lower weighted-average shares outstanding.
        --  For the fourth quarter, non-GAAP operating income increased 6
            percent to $2.7 billion and non-GAAP operating margin decreased 0.6
            percentage points to 45.3 percent. For the full year, non-GAAP
            operating income increased 2 percent to $11.9 billion and non-GAAP
            operating margin decreased 0.9 percentage points to 52.6 percent.
    --  The Company generated $10.6 billion of free cash flow for the full year
        versus $10.5 billion in 2017.
    --  2019 total revenues guidance of $21.8-$22.9 billion; EPS guidance of
        $11.55-$12.75 on a GAAP basis and $13.10-$14.30 on a non-GAAP basis.

"Through our continued solid operating performance in 2018, we met and exceeded our long-term financial commitments," said Robert A. Bradway, chairman and chief executive officer. "Looking to the future, we are encouraged by our long-term growth prospects driven by our portfolio of newer products, pipeline and ongoing success in international expansion."


                                            
     $Millions, except EPS and percentages Q4'18           Q4'17 YOY                 FY'18     FY'17   YOY  



            Total Revenues                                                               $
      6,230               $
        5,802                7%       $
      23,747 $
      22,849    4%



            GAAP Operating Income                                                        $
      2,382               $
        2,245                6%       $
      10,263  $
      9,973    3%



            GAAP Net Income (Loss)                                                       $
      1,928             $
        (4,264)       
     *               $
      8,394  $
      1,979  
      *



            GAAP Earnings (Loss) Per Share                                                $
      3.01              $
        (5.89)       
     *               $
      12.62   $
      2.69  
      *



            Non-GAAP Operating Income                                                    $
      2,717               $
        2,555                6%       $
      11,857 $
      11,658    2%



            Non-GAAP Net Income                                                          $
      2,186               $
        2,104                4%        $
      9,573  $
      9,246    4%



            Non-GAAP EPS                                                                  $
      3.42                $
        2.89               18%        $
      14.40  $
      12.58   14%


    * Change in excess of 100%

    ---



                            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 increased 8 percent for the fourth quarter of 2018
        versus the fourth quarter of 2017. Product sales grew 3 percent for the
        full year.
    --  Repatha sales increased 62 percent for the fourth quarter and 72 percent
        for the full year driven by higher unit demand, offset partially by
        lower net selling price.
    --  BLINCYTO(®) (blinatumomab) sales increased 37 percent for the fourth
        quarter and 31 percent for the full year driven by higher unit demand.
    --  XGEVA sales increased 17 percent for the fourth quarter and 13 percent
        for the full year driven primarily by higher unit demand.
    --  Prolia sales increased 14 percent for the fourth quarter and 16 percent
        for the full year driven primarily by higher unit demand.
    --  KYPROLIS sales increased 11 percent for the fourth quarter and 16
        percent for the full year driven by higher unit demand, offset partially
        by net selling price.
    --  Nplate(®) (romiplostim) sales increased 10 percent for the fourth
        quarter and 12 percent for the full year driven by higher unit demand.
    --  Sensipar/Mimpara(®) (cinacalcet) increased 8 percent for the fourth
        quarter driven by favorable changes in accounting estimates related to
        prior periods and higher net selling price, offset partially by lower
        unit demand. Sales increased 3 percent for the full year driven
        primarily by higher net selling price, offset partially by lower unit
        demand.
    --  Vectibix(®) (panitumumab) sales increased 6 percent for the fourth
        quarter and 8 percent for the full year driven by higher unit demand.
    --  Neulasta(®) (pegfilgrastim) sales increased 5 percent for the fourth
        quarter driven by higher unit demand due primarily to an order from the
        U.S. government, offset partially by lower net selling price. Sales
        decreased 1 percent for the full year driven by favorable changes in
        accounting estimates in the prior year, offset partially by favorable
        changes in inventory.
    --  Parsabiv(® )(etelcalcetide) was launched in the U.S. in the first
        quarter of 2018 and sales grew 18 percent sequentially in the fourth
        quarter.
    --  Aimovig(® )(erenumab-aooe) was launched in the U.S. in the second
        quarter of 2018 and generated $95 million in sales in the fourth
        quarter.
    --  EPOGEN(®) (epoetin alfa) sales decreased 2 percent for the fourth
        quarter driven by lower net selling price, offset partially by higher
        unit demand. Sales decreased 8 percent for the full year driven
        primarily by lower net selling price.
    --  Aranesp(®) (darbepoetin alfa) sales decreased 3 percent for the fourth
        quarter driven primarily by unfavorable changes in inventory levels and
        lower net selling price. Sales decreased 9 percent for the full year
        driven by lower unit demand.
    --  Enbrel(®) (etanercept) sales decreased 8 percent for the fourth quarter
        and the full year driven by lower unit demand and lower net selling
        price.
    --  NEUPOGEN(®) (filgrastim) sales decreased 40 percent for the fourth
        quarter driven by lower net selling price and lower unit demand. Sales
        decreased 34 percent for the full year driven by lower unit demand and
        lower net selling price.

Product Sales Detail by Product and Geographic Region


                                          
              $Millions, except percentages              
       
     Q4'18                           Q4'17         YOY  



                                                                                      US                    ROW     TOTAL                   TOTAL         TOTAL




              Repatha(R)                                                                  $
       104                          $
        55                  $
            159             $
        98 62%



              BLINCYTO(R)                                                            37                         26                              63                46     37%



              XGEVA(R)                                                              344                        112                             456               391     17%



              Prolia(R)                                                             430                        225                             655               574     14%



              KYPROLIS(R)                                                           153                         98                             251               227     11%



              Nplate(R)                                                             112                         70                             182               165     10%



              Sensipar(R)/Mimpara(R)                                                367                         81                             448               413      8%



              Vectibix(R)                                                            74                         94                             168               159      6%



              Neulasta(R)                                                         1,012                        157                           1,169             1,114      5%



              Parsabiv(R)                                                           108                         12                             120                 3   
             *



              Aimovig(R)                                                             95                                                        95                    
             *



              Biosimilars**                                                                                    34                              34                    
             *



              EPOGEN(R)                                                             264                                                       264               270    (2%)



              Aranesp(R)                                                            228                        246                             474               491    (3%)



              Enbrel(R)                                                           1,263                         52                           1,315             1,423    (8%)



              NEUPOGEN(R)                                                            43                         32                              75               126   (40%)



              Other***                                                               21                         52                              73                69      6%




              Total product sales                                                       $
       4,655                       $
        1,346                $
            6,001          $
        5,569  8%





    * Change in excess of 100%



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



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



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

    ---


                                          
              $Millions, except percentages               
        
     FY'18                          FY'17         YOY  



                                                                                      US                      ROW     TOTAL                  TOTAL         TOTAL




              Repatha(R)                                                                   $
        358                         $
       192                  $
            550            $
         319 72%



              BLINCYTO(R)                                                           134                           96                            230               175    31%



              Prolia(R)                                                           1,500                          791                          2,291             1,968    16%



              KYPROLIS(R)                                                           583                          385                            968               835    16%



              XGEVA(R)                                                            1,338                          448                          1,786             1,575    13%



              Nplate(R)                                                             438                          279                            717               642    12%



              Vectibix(R)                                                           288                          403                            691               642     8%



              Sensipar(R)/Mimpara(R)                                              1,436                          338                          1,774             1,718     3%



              Parsabiv(R)                                                           302                           34                            336                 5   
             *



              Aimovig(R)                                                            119                                                        119                    
             *



              Biosimilars**                                                                                      55                             55                    
             *



              Neulasta(R)                                                         3,866                          609                          4,475             4,534   (1%)



              Enbrel(R)                                                           4,807                          207                          5,014             5,433   (8%)



              EPOGEN(R)                                                           1,010                                                      1,010             1,096   (8%)



              Aranesp(R)                                                            942                          935                          1,877             2,053   (9%)



              NEUPOGEN(R)                                                           223                          142                            365               549  (34%)



              Other***                                                               85                          190                            275               251    10%



              Total product sales                                                       $
        17,429                       $
       5,104               $
            22,533         $
         21,795  3%





    * Change in excess of 100%



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



              *** Other includes Bergamo, MN Pharma, IMLYGIC(R) and Corlanor(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 8 percent in the fourth quarter and 5
        percent for the full year.  All expense categories benefited from
        savings from our transformation and process improvement efforts. Cost of
        Sales margin decreased 0.7 points in the fourth quarter due to lower
        royalty cost and the impact of Hurricane Maria charges in Q4 2017,
        offset partially by higher cost of manufacturing and higher
        acquisition-related intangibles amortization. For the full year, Cost of
        Sales margin decreased 0.5 points due to lower royalty cost, the
        favorable comparison to Hurricane Maria-related charges in 2017 and
        lower acquisition-related intangibles amortization, offset partially by
        higher cost of manufacturing. Research & Development (R&D) expenses
        increased 13 percent in the fourth quarter driven by higher spending on
        business development, our early oncology pipeline and late-stage
        development, offset partially by lower spending to support marketed
        products. For the full year, R&D expenses increased 5 percent driven by
        higher spending on our early pipeline, late-stage development and
        business development, offset partially by lower spending to support
        marketed products. Selling, General & Administrative (SG&A) expenses
        increased 9 percent in the fourth quarter due primarily to investments
        in product launches and marketed product support, offset partially by
        the favorable comparison to Hurricane Maria-related charges in Q4 2017.
        For the full year, SG&A expenses increased 9 percent due primarily to
        investments in product launches and marketed product support.
    --  Operating Margin decreased 0.6 percentage points in the fourth quarter
        to 39.7 percent, and decreased 0.3 percentage points for the full year
        to 45.5 percent.
    --  Tax Rate decreased in the fourth quarter and the full year due to the
        impacts of U.S. corporate tax reform.

On a non-GAAP basis:

    --  Total Operating Expenses increased 8 percent in the fourth quarter and 6
        percent for the full year. All expense categories benefited from savings
        from our transformation and process improvement efforts. Cost of Sales
        margin decreased 1.1 points in the fourth quarter due to lower royalty
        cost and the impact of Hurricane Maria charges in Q4 2017, offset
        partially by higher cost of manufacturing. For the full year, Cost of
        Sales margin decreased 0.2 points due to lower royalty cost and the
        favorable comparison to Hurricane Maria-related charges in 2017, offset
        partially by higher cost of manufacturing. R&D expenses increased 13
        percent in the fourth quarter driven by higher spending on business
        development, our early oncology pipeline and late-stage development,
        offset partially by lower spending to support marketed products.  For
        the full year, R&D expenses increased 5 percent driven by higher
        spending on our early pipeline, late-stage development and business
        development, offset partially by lower spending to support marketed
        products. SG&A expenses increased 9 percent in the fourth quarter
        primarily due to investments in product launches and marketed product
        support, offset partially by the favorable comparison of Hurricane
        Maria-related charges in Q4 2017. For the full year, SG&A expenses
        increased 10 percent due primarily to investments in product launches
        and marketed product support.
    --  Operating Margin decreased 0.6 percentage points in the fourth quarter
        to 45.3 percent, and decreased by 0.9 percentage points for the full
        year to 52.6 percent.
    --  Tax Rate decreased 3.3 percentage points in the fourth quarter and 4.5
        percentage points for the full year primarily due to the impacts of U.S.
        corporate tax reform.

                        
              $Millions, except percentages 
     
            GAAP        
     
     Non-GAAP



                                                                      Q4'18       Q4'17              
        
             YOY           Q4'18     Q4'17                  YOY  




       Cost of Sales                                                $1,096       $1,059                                     3%      $819       $816                        -%



       % of product sales                                            18.3%       19.0%                
        (0.7) pts.            13.6%     14.7%    
        (1.1) pts.



       Research & Development                                       $1,182       $1,043                                    13%    $1,162     $1,025                       13%



       % of product sales                                            19.7%       18.7%                 
        1.0 pts.             19.4%     18.4%     
        1.0 pts.



       Selling, General & Administrative                            $1,559       $1,427                                     9%    $1,532     $1,406                        9%



       % of product sales                                            26.0%       25.6%                 
        0.4 pts.             25.5%     25.2%     
        0.3 pts.



       Other                                                           $11          $28                                  (61%) 
          $- 
          $-     
           NM



       
                TOTAL Operating Expenses                        $3,848       $3,557                                     8%    $3,513     $3,247                        8%





       Operating Margin



       operating income as % of product sales                        39.7%       40.3%                
        (0.6) pts.            45.3%     45.9%    
        (0.6) pts.





       
                Tax Rate                                         11.8%      292.6%                          (280.8) pts.     13.3%     16.6%               (3.3) pts.





       NM: Not Meaningful



       pts: percentage points

    ---


                        
              $Millions, except percentages 
           
     GAAP         
        
               Non-GAAP



                                                                   FY'18         FY'17                  YOY          FY'18     FY'17                  YOY  




       Cost of Sales                                             $4,101         $4,069                         1%    $3,001     $2,943                        2%



       % of product sales                                         18.2%         18.7%    
        (0.5) pts.            13.3%     13.5%    
        (0.2) pts.



       Research & Development                                    $3,737         $3,562                         5%    $3,657     $3,482                        5%



       % of product sales                                         16.6%         16.3%     
        0.3 pts.             16.2%     16.0%     
        0.2 pts.



       Selling, General & Administrative                         $5,332         $4,870                         9%    $5,232     $4,766                       10%



       % of product sales                                         23.7%         22.3%     
        1.4 pts.             23.2%     21.9%     
        1.3 pts.



       Other                                                       $314           $375                      (16%) 
          $- 
          $-     
           NM



       
                TOTAL Operating Expenses                    $13,484        $12,876                         5%   $11,890    $11,191                        6%





       Operating Margin



       operating income as % of product sales                     45.5%         45.8%    
        (0.3) pts.            52.6%     53.5%    
        (0.9) pts.





       
                Tax Rate                                      12.1%         79.4%               (67.3) pts.     13.5%     18.0%               (4.5) pts.





       NM: Not Meaningful



       pts: percentage points

    ---

Cash Flow and Balance Sheet

    --  The Company generated $3.0 billion of free cash flow in the fourth
        quarter of 2018 versus $2.9 billion in the fourth quarter of 2017. The
        Company generated $10.6 billion of free cash flow for the full year 2018
        versus $10.5 billion in 2017 due primarily to improvements in working
        capital, offset partially by higher tax payments.
    --  The Company's fourth quarter 2018 dividend of $1.32 per share was paid
        on Dec. 7, 2018, representing a 15 percent increase versus the fourth
        quarter of 2017.  The Company's first quarter 2019 dividend of $1.45 per
        share declared on Dec. 7, 2018, will be paid on March 8, 2019, to all
        stockholders of record as of Feb. 15, 2019, representing a 10 percent
        increase from that paid in each of the previous four quarters.
    --  During the fourth quarter, the Company repurchased 11.1 million shares
        of common stock at a total cost of $2.2 billion. For the full year, the
        Company repurchased 94.5 million shares of common stock at a total cost
        of $17.9 billion. At the end of the fourth quarter, the Company had $5.1
        billion remaining under its stock repurchase authorization.

        
             $Billions, except shares          Q4'18        Q4'17      YOY          FY'18   FY'17          YOY  



          Operating Cash Flow                             $
     3.2                  $
     3.0               $
      0.2              $
     11.3         $
     11.2 $
     0.1


          Capital Expenditures                        0.2               0.2                  0.1            0.7         0.7             0.1



         Free Cash Flow                              3.0               2.9                  0.1           10.6        10.5             0.0



         Dividends Paid                              0.8               0.8                  0.0            3.5         3.4             0.1



         Share Repurchase                            2.2               0.8                  1.4           17.9         3.1            14.7


          Avg. GAAP Diluted Shares
           (millions)                                 640               724                 (84)           665         735            (70)


          Avg. non-GAAP Diluted
           Shares (millions)                          640               729                 (89)           665         735            (70)




          Cash and Investments                       29.3              41.7               (12.4)          29.3        41.7          (12.4)



         Debt Outstanding                           33.9              35.3                (1.4)          33.9        35.3           (1.4)


          Stockholders' Equity                       12.5              25.2               (12.7)          12.5        25.2          (12.7)





         Note: Numbers may not add due to rounding

    ---

2019 Guidance
For the full year 2019, the Company expects:

    --  Total revenues in the range of $21.8 billion to $22.9 billion.
    --  On a GAAP basis, 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 $13.10 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.

Fourth Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:

BLINCYTO

    --  In January, the European Commission approved an expanded current
        indication to include adult patients with Philadelphia chromosome
        negative CD19 positive B-cell precursor acute lymphoblastic leukemia in
        first or second complete remission with minimal residual disease (MRD).

Nplate

    --  In December, the Company submitted a supplemental Biologics License
        Application (sBLA) to the U.S. Food and Drug Administration (FDA) to
        include the treatment of adult patients with immune thrombocytopenia
        (ITP) who have had ITP for 12 months or less and an insufficient
        response to corticosteroids, immunoglobulins or splenectomy.
    --  In December, the FDA approved the sBLA for the treatment of pediatric
        patients one year of age and older with ITP for at least six months who
        have had an insufficient response to corticosteroids, immunoglobulins or
        splenectomy.

Repatha

    --  In January, the National Medical Products Administration approved a new
        indication for Repatha as the first PCSK9 inhibitor in China for adults
        with established atherosclerotic cardiovascular disease to reduce the
        risk of myocardial infarction, stroke and coronary revascularization.

EVENITY(TM) (romosozumab)

    --  In January, the Japanese Ministry of Health, Labor and Welfare granted a
        marketing authorization for the treatment of osteoporosis in men and
        postmenopausal women at high risk of fracture.
    --  In January, the FDA Bone, Reproductive and Urologic Drugs Advisory
        Committee voted in favor of approval for the treatment of osteoporosis
        in postmenopausal women at high risk for fracture.

KANJINTI(TM) (ABP 980)

    --  In December, a Biologics License Application (BLA) for KANJINTI, a
        biosimilar Herceptin (trastuzumab), was resubmitted to the FDA.

ABP 710

    --  In December and January, the Company submitted a BLA to the FDA, and a
        Marketing Authorization Application to the EMA, respectively, for ABP
        710, a biosimilar candidate to REMICADE(®) (infliximab).

EVENITY is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan
EVENITY and KANJINTI trade names provisionally approved by the FDA
Herceptin 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 fourth quarters and full years of 2018 and 2017, 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, including the repatriation tax on accumulated foreign earnings and other impacts of U.S. corporate tax reform, 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 fourth quarters and full years of 2018 and 2017. 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        
           
              Years ended
                                                December 31,                              December 31,


                                         2018                             2017         2018                            2017

                                                                                                                     ---


     Revenues:


      Product sales                             $
              6,001                              $
            5,569              $
     22,533  $
      21,795


      Other revenues                      229                                    233                                 1,214       1,054



      Total revenues                    6,230                                  5,802                                23,747      22,849






     Operating expenses:


      Cost of sales                     1,096                                  1,059                                 4,101       4,069


      Research and
       development                      1,182                                  1,043                                 3,737       3,562


      Selling, general and
       administrative                   1,559                                  1,427                                 5,332       4,870



     Other                                11                                     28                                   314         375



      Total operating
       expenses                         3,848                                  3,557                                13,484      12,876





      Operating income                  2,382                                  2,245                                10,263       9,973




      Interest expense, net               352                                    332                                 1,392       1,304


      Interest and other
       income, net                        155                                    301                                   674         928





      Income before income
       taxes                            2,185                                  2,214                                 9,545       9,597




      Provision for income
       taxes                              257                                  6,478                                 1,151       7,618





      Net income (loss)                         $
              1,928                            $
            (4,264)              $
     8,394   $
      1,979






     Earnings (loss) per share:



     Basic                                      $
              3.04                             $
            (5.89)              $
     12.70    $
      2.71



     Diluted                                    $
              3.01                             $
            (5.89)              $
     12.62    $
      2.69




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



     Basic                               635                                    724                                   661         731



     Diluted                             640                                    724                                   665         735



     
                Amgen Inc.


     
                Consolidated Balance Sheets - GAAP


     
                (In millions)




                                                                        December 31,


                                                               2018                    2017

                                                                                       ---

                                                        (Unaudited)



     
                Assets



     Current assets:


      Cash, cash
       equivalents and
       marketable
       securities                                                   $
              29,304             $
      41,678


      Trade receivables,
       net                                                    3,580                          3,237


      Inventories                                             2,940                          2,834


      Other current
       assets                                                 1,794                          1,727



      Total current
       assets                                                37,618                         49,476




      Property, plant
       and equipment,
       net                                                    4,958                          4,989


      Intangible assets,
       net                                                    7,443                          8,609


      Goodwill                                               14,699                         14,761


      Other assets                                            1,698                          2,119



      Total assets                                                  $
              66,416             $
      79,954






     
                Liabilities and Stockholders' Equity



     Current liabilities:


      Accounts payable
       and accrued
       liabilities                                                   $
              9,069              $
      7,868


      Current portion of
       long-term debt                                         4,419                          1,152



      Total current
       liabilities                                           13,488                          9,020




      Long-term debt                                         29,510                         34,190


      Long-term
       deferred tax
       liabilities                                              864                          1,166


      Long-term tax
       liabilities                                            8,770                          9,099


      Other noncurrent
       liabilities                                            1,284                          1,238


      Total
       stockholders'
       equity                                                12,500                         25,241



      Total liabilities
       and stockholders'
       equity                                                       $
              66,416             $
      79,954





      Shares outstanding                                        630                            722



     
                Amgen Inc.


     
                GAAP to Non-GAAP Reconciliations


     
                (Dollars in millions)


     
                (Unaudited)




                                                                            Three months ended                          Years ended
                                                                    December 31,                           December 31,


                                                              2018                             2017             2018                      2017

                                                                                                                                        ---

                   GAAP cost of sales                              $
              1,096                  $
          1,059                             $
        4,101  $
        4,069


                   Adjustments to cost of sales:


      Acquisition-related expenses
       (a)                                                   (276)                           (243)         (1,099)                  (1,126)


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

                                                                                                                                        ---

                   Total adjustments to cost of
                    sales                                    (277)                           (243)         (1,100)                  (1,126)

                                                                                                                                        ---

                   Non-GAAP cost of sales                            $
              819                    $
          816                             $
        3,001  $
        2,943

                                                                                                                                                                  ===



                   GAAP cost of sales as a
                    percentage of product sales              18.3%                           19.0%           18.2%                    18.7%


      Acquisition-related expenses
       (a)                                                    -4.7                             -4.3             -4.9                      -5.2


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

                                                                                                                                        ---

                   Non-GAAP cost of sales as a
                    percentage of product sales              13.6%                           14.7%           13.3%                    13.5%

                                                                                                                                        ===



                   GAAP research and development
                    expenses                                       $
              1,182                  $
          1,043                             $
        3,737  $
        3,562


                   Adjustments to research and development
                    expenses:


      Acquisition-related expenses
       (a)                                                    (19)                            (20)            (78)                     (77)


      Certain net charges pursuant to
       our restructuring initiative                            (1)                               2              (2)                      (3)

                                                                                                                                        ---

                   Total adjustments to research
                    and development expenses                  (20)                            (18)            (80)                     (80)

                                                                                                                                        ---

                   Non-GAAP research and
                    development expenses                           $
              1,162                  $
          1,025                             $
        3,657  $
        3,482

                                                                                                                                                                  ===



                   GAAP research and development
                    expenses as a percentage of
                    product sales                            19.7%                           18.7%           16.6%                    16.3%


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


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

                                                                                                                                        ---

                   Non-GAAP research and
                    development expenses as a
                    percentage of product sales              19.4%                           18.4%           16.2%                    16.0%

                                                                                                                                        ===



                   GAAP selling, general and
                    administrative expenses                        $
              1,559                  $
          1,427                             $
        5,332  $
        4,870


                   Adjustments to selling, general and
                    administrative expenses:


      Acquisition-related expenses
       (a)                                                    (19)                            (20)            (84)                     (99)


      Certain net charges pursuant to
       our restructuring initiative                            (8)                             (1)            (16)                      (2)



     Other                                                      -                                                                      (3)

                                                                                                                                        ---

                   Total adjustments to selling,
                    general and administrative
                    expenses                                  (27)                            (21)           (100)                    (104)

                                                                                                                                        ---

                   Non-GAAP selling, general and
                    administrative expenses                        $
              1,532                  $
          1,406                             $
        5,232  $
        4,766

                                                                                                                                                                  ===



                   GAAP selling, general and
                    administrative expenses as a
                    percentage of product sales              26.0%                           25.6%           23.7%                    22.3%


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


      Certain net charges pursuant to
       our restructuring initiative                           -0.2                              0.0             -0.1                       0.0



     Other                                                    0.0                              0.0              0.0                       0.0

                                                                                                                                        ---

                   Non-GAAP selling, general and
                    administrative expenses as a
                    percentage of product sales              25.5%                           25.2%           23.2%                    21.9%

                                                                                                                                        ===



                   GAAP operating expenses                         $
              3,848                  $
          3,557                            $
        13,484 $
        12,876


                   Adjustments to operating expenses:


      Adjustments to cost of sales                           (277)                           (243)         (1,100)                  (1,126)


      Adjustments to research and
       development expenses                                   (20)                            (18)            (80)                     (80)


      Adjustments to selling, general
       and administrative expenses                            (27)                            (21)           (100)                    (104)


      Certain net charges pursuant to
       our restructuring initiative
       (b)                                                     (1)                            (27)               7                      (83)


      Certain other expenses                                     -                                            (25)


      Acquisition-related
       adjustments (c)                                        (10)                             (1)           (296)                    (292)


                   Total adjustments to operating
                    expenses                                 (335)                           (310)         (1,594)                  (1,685)


                   Non-GAAP operating expenses                     $
              3,513                  $
          3,247                            $
        11,890 $
        11,191

                                                                                                                                                                  ===



                   GAAP operating income                           $
              2,382                  $
          2,245                            $
        10,263  $
        9,973


      Adjustments to operating
       expenses                                                335                              310            1,594                     1,685



                   Non-GAAP operating income                       $
              2,717                  $
          2,555                            $
        11,857 $
        11,658

                                                                                                                                                                  ===



                   GAAP operating income as a
                    percentage of product sales              39.7%                           40.3%           45.5%                    45.8%


      Adjustments to cost of sales                             4.7                              4.3              4.9                       5.2


      Adjustments to research and
       development expenses                                    0.3                              0.3              0.4                       0.3


      Adjustments to selling, general
       and administrative expenses                             0.5                              0.4              0.5                       0.4


      Certain net charges pursuant to
       our restructuring initiative
       (b)                                                     0.0                              0.6              0.0                       0.4


      Certain other expenses                                   0.0                              0.0              0.0                       0.0


      Acquisition-related
       adjustments (c)                                         0.1                              0.0              1.3                       1.4

                                                                                                                                        ---

                   Non-GAAP operating income as a
                    percentage of product sales              45.3%                           45.9%           52.6%                    53.5%

                                                                                                                                        ===



                   GAAP interest and other income,
                    net                                              $
              155                    $
          301                               $
        674    $
        928


      Adjustments to other income (d)                            -                                            (68)

                                                                                                                                        ---

                   Non-GAAP interest and other
                    income, net                                      $
              155                    $
          301                               $
        606    $
        928

                                                                                                                                                                  ===



                   GAAP income before income taxes                 $
              2,185                  $
          2,214                             $
        9,545  $
        9,597


      Adjustments to operating
       expenses                                                335                              310            1,594                     1,685


      Adjustments to other income (d)                            -                                            (68)

                                                                                                                                        ---

                   Non-GAAP income before income
                    taxes                                          $
              2,520                  $
          2,524                            $
        11,071 $
        11,282

                                                                                                                                                                  ===



                   GAAP provision for income taxes                   $
              257                  $
          6,478                             $
        1,151  $
        7,618


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (e)                                          77                               98              362                       538


      Other income tax adjustments
       (f)                                                       -                         (6,156)            (15)                  (6,120)

                                                                                                                                        ---

                   Total adjustments to provision
                    for income taxes                            77                          (6,058)             347                   (5,582)


                   Non-GAAP provision for income
                    taxes                                            $
              334                    $
          420                             $
        1,498  $
        2,036

                                                                                                                                                                  ===



                   GAAP tax as a percentage of
                    income before taxes                      11.8%                          292.6%           12.1%                    79.4%


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (e)                                         1.5                            -32.1              1.6                      -7.1


      Other income tax adjustments
       (f)                                                     0.0                           -243.9             -0.2                     -54.3

                                                                                                                                        ---

                   Total adjustments to provision
                    for income taxes                           1.5                           -276.0              1.4                     -61.4


                   Non-GAAP tax as a percentage
                    of income before taxes                   13.3%                           16.6%           13.5%                    18.0%

                                                                                                                                        ===



                   GAAP net income (loss)                          $
              1,928                $
          (4,264)                            $
        8,394  $
        1,979


                   Adjustments to net income (loss):


      Adjustments to income before
       income taxes, net of the
       income tax effect                                       258                              212            1,164                     1,147


      Other income tax adjustments
       (f)                                                       -                           6,156               15                     6,120



                   Total adjustments to net income
                    (loss)                                     258                            6,368            1,179                     7,267


                   Non-GAAP net income                             $
              2,186                  $
          2,104                             $
        9,573  $
        9,246

                                                                                                                                                                  ===



     
                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 (loss) per share:




                                                                       Three months ended                                            Three months ended
                                                            December 31, 2018                                             December 31, 2017


                                                    GAAP                                               Non-GAAP       GAAP                              Non-GAAP

                                                                                                                                                             ---



      Net income                                           $
              1,928                                                  $
              2,186                    $
        (4,264)  $
      2,104





     Shares


      Weighted-
       average
       shares for
       basic EPS                                     635                                                        635                                            724            724


      Effect of
       dilutive
       shares                                          5                                                          5                                                            5



      Weighted-
       average
       shares for
       diluted EPS                                   640                                                        640                                            724            729





      Diluted EPS                                           $
              3.01                                                   $
              3.42                     $
        (5.89)   $
      2.89





                                                   
              
                Year ended                               
           
                Year ended
                                                            December 31, 2018                                             December 31, 2017


                                                    GAAP                                               Non-GAAP       GAAP                              Non-GAAP

                                                                                                                                                             ---



      Net income                                           $
              8,394                                                  $
              9,573                      $
        1,979   $
      9,246





     Shares


      Weighted-
       average
       shares for
       basic EPS                                     661                                                        661                                            731            731


      Effect of
       dilutive
       shares                                          4                                                          4                                              4              4



      Weighted-
       average
       shares for
       diluted EPS                                   665                                                        665                                            735            735





      Diluted EPS                                          $
              12.62                                                  $
              14.40                       $
        2.69   $
      12.58



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




     (b) For the three months and year ended
                   December 31, 2017, the adjustments
                   related primarily to severance
                   expenses associated with our
                   restructuring initiative.




     (c) For the years ended December 31, 2018
                   and 2017, the adjustments related
                   primarily to impairments of
                   intangible assets acquired in
                   business combinations.




     (d)          For the year ended December 31, 2018,
                   the adjustment related to the net
                   gain associated with the Kirin-Amgen
                   share acquisition.




     (e) 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 months and year ended December
                   31, 2018, were 23.0% and 23.7%,
                   compared with 31.6% and 31.9% for the
                   corresponding periods of the prior
                   year.




     (f) For the three months and year ended
                   December 31, 2017, the adjustments
                   related primarily to the impact of
                   U.S. Corporate tax reform, including
                   the repatriation tax on accumulated
                   foreign earnings and the
                   remeasurement of certain net deferred
                   and other tax liabilities.




     (g) During periods of net loss, diluted
                   loss per share is equal to basic loss
                   per share because the antidilutive
                   effect of potential common shares is
                   disregarded.



     
                Amgen Inc.


     
                Reconciliations of Cash Flows


     
                (In millions)


     
                (Unaudited)




                                                       Three months ended           
             
                Years ended
                                            December 31,                                   December 31,


                                     2018                             2017           2018                            2017



      Net cash provided
       by operating
       activities                           $
              3,194                             $
              3,012               $
         11,296  $
      11,177


      Net cash (used
       in) provided by
       investing
       activities                 (4,637)                                     (78)                              14,339         (4,024)


      Net cash used in
       financing
       activities                 (3,568)                                  (2,134)                            (22,490)        (6,594)



      (Decrease)
       increase in cash
       and cash
       equivalents                (5,011)                                      800                                3,145             559


      Cash and cash
       equivalents at
       beginning of
       period                      11,956                                     3,000                                3,800           3,241


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





                                                       Three months ended           
             
                Years ended
                                            December 31,                                   December 31,


                                     2018                             2017           2018                            2017

                                                                                                                   ---

      Net cash provided
       by operating
       activities                           $
              3,194                             $
              3,012               $
         11,296  $
      11,177


      Capital
       expenditures                 (225)                                    (153)                               (738)          (664)


      Free cash flow                        $
              2,969                             $
              2,859               $
         10,558  $
      10,513



     
                Reconciliation of GAAP EPS Guidance to Non-GAAP


     
                EPS Guidance for the Year Ending December 31, 2019


     
                (Unaudited)




                   GAAP diluted EPS guidance                 $
           11.55 $
     12.75


                   Known adjustment to arrive
                    at non-GAAP*:


      Acquisition-related
       expenses (a)                                                    1.55


                   Non-GAAP diluted EPS
                    guidance                                 $
           13.10 $
     14.30




              *                 The known adjustments are presented
                                  net of their related tax impact,
                                  which amount to approximately
                                  $0.43 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                  12.5%                             13.5%


      Tax rate of known adjustments
       discussed above                                                     1.5%


      Non-GAAP diluted EPS guidance           14.0%                             15.0%

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SOURCE Amgen