Amgen Reports First Quarter 2020 Financial Results

THOUSAND OAKS, Calif., April 30, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2020 and discussed the company's response to the COVID-19 pandemic.

First Quarter Performance

Key results include:

    --  Total revenues increased 11% to $6.2 billion in comparison to the first
        quarter of 2019, driven by higher unit demand, offset partially by lower
        net selling prices.
        --  Product sales increased 12% globally, driven by volume growth across
            a number of our newer products, including Otezla(® )(apremilast),
            Repatha(®) (evolocumab), MVASI(® )(bevacizumab-awwb), KANJINTI(®)
            (trastuzumab-anns) and Evenity(®) (romosozumab-aqqg), offset
            partially by declines in select products from the impact of
            biosimilar and generic competition.
    --  GAAP earnings per share (EPS) decreased 3% to $3.07 driven by the
        amortization of costs associated with our Nov. 21, 2019 acquisition of
        Otezla, offset partially by increased revenues.
        --  GAAP operating income decreased 5% to $2.4 billion and GAAP
            operating margin decreased 6.8 percentage points to 40.0% driven by
            the amortization of intangible assets from our Otezla acquisition.
    --  Non-GAAP EPS increased 17% to $4.17 driven by increased revenues and
        fewer weighted-average shares outstanding.
        --  Non-GAAP operating income increased 15% to $3.2 billion and non-GAAP
            operating margin increased 1.5 percentage points to 53.9%.
    --  The Company generated $2.0 billion of free cash flow in the first
        quarter versus $1.7 billion in the first quarter of 2019.
    --  2020 total revenues guidance reaffirmed at $25.0-$25.6 billion; EPS
        guidance revised to $10.65-$11.45 on a GAAP basis and reaffirmed at
        $14.85-$15.60 on a non-GAAP basis.

"I am inspired by the many ways my colleagues at Amgen and others across the industry are stepping up to meet the greatest public health challenge of our lifetime," said Robert A. Bradway, chairman and chief executive officer. "We are committed to an uninterrupted supply of our medicines to patients; advancing potential new medicines to treat serious diseases, including COVID-19; making a difference in the communities where we live and work; and creating long-term value for shareholders."



       $Millions, except EPS, dividends paid per share and percentages Q1'20           Q1'19     YOY  


        Total Revenues                                                        $
      6,161       $
          5,557  11%


        GAAP Operating
         Income                                                               $
      2,355       $
          2,472 (5%)


        GAAP Net Income                                                       $
      1,825       $
          1,992 (8%)



       GAAP EPS                                                               $
      3.07        $
          3.18 (3%)


        Non-GAAP
         Operating Income                                                     $
      3,176       $
          2,770  15%


        Non-GAAP Net
         Income                                                               $
      2,476       $
          2,230  11%


        Non-GAAP EPS                                                           $
      4.17        $
          3.56  17%


        Dividends Paid
         Per Share                                                             $
      1.60        $
          1.45  10%

    ---



                            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 12% for the first quarter of 2020 versus
        the first quarter of 2019 driven by 15% volume growth.
    --  Prolia(®) (denosumab) sales increased 10% driven by higher unit demand.
    --  EVENITY launched in the U.S. and Japan in the first half of 2019,
        generating $100 million of sales in the first quarter of 2020.
    --  Repatha sales increased 62% driven by 98% volume growth, offset
        partially by lower net selling price. Repatha's net selling price was
        impacted by the removal of our original list price option to improve
        patient affordability, especially for Medicare patients.
    --  Aimovig(® )(erenumab-aooe) sales increased 20% driven by 46% volume
        growth, offset partially by lower net selling price as we expanded
        patient access.
    --  Parsabiv(® )(etelcalcetide) sales increased 39% driven by higher unit
        demand, offset partially by lower net selling price.
    --  Otezla was acquired on Nov. 21, 2019 and generated $479 million of sales
        in the first quarter of 2020.
    --  Enbrel(®) (etanercept) sales were flat as favorable changes to
        estimated sales deductions and inventory were offset by lower unit
        demand and lower net selling price.
    --  AMGEVITA((TM)) (adalimumab) generated $86 million of sales in the first
        quarter of 2020 and is the most prescribed adalimumab biosimilar in
        Europe.
    --  KYPROLIS(®) (carfilzomib) sales increased 14% driven by higher unit
        demand and to a lesser extent, higher net selling price.
    --  XGEVA(®) (denosumab) sales increased 2% driven by higher unit demand.
    --  Vectibix(®) (panitumumab) sales increased 19% driven by higher unit
        demand.
    --  Nplate(®) (romiplostim) sales increased 15% driven by higher unit
        demand.
    --  BLINCYTO(®) (blinatumomab) sales increased 36% driven by higher unit
        demand.
    --  KANJINTI(®) generated $119 million of sales in the first quarter of
        2020.
    --  MVASI(®) generated $115 million of sales in the first quarter of 2020.
    --  Neulasta(®) (pegfilgrastim) sales decreased 40% driven by the impact of
        competition on unit demand and net selling price.
    --  NEUPOGEN(®) (filgrastim) sales decreased 11% driven by the impact of
        competition on unit demand.
    --  EPOGEN(®) (epoetin alfa) sales decreased 29% driven by lower net
        selling price and unfavorable changes to estimated sales deductions.
    --  Aranesp(®) (darbepoetin alfa) sales increased 2% driven by higher unit
        demand and favorable changes in inventory, offset by lower net selling
        price.
    --  Sensipar/Mimpara(®) (cinacalcet) sales decreased 42% driven by the
        impact of competition on unit demand, offset partially by favorable
        changes to estimated sales deductions and inventory.

Product Sales Detail by Product and Geographic Region


                        
              $Millions, except percentages                             
       
     Q1'20                          Q1'19         YOY  



                                                                                   US                    ROW     TOTAL                  TOTAL         TOTAL




              Prolia(R)                                                                $
       422                         $
       232                  $
            654           $
        592 10%



              EVENITY(R)                                                          37                         63                            100                17  
             *



              Repatha(R)                                                         124                        105                            229               141    62%



              Aimovig(R)                                                          71                                                       71                59    20%



              Parsabiv(R)                                                        146                         29                            175               126    39%



              Otezla(R)                                                          377                        102                            479                   
             *



              Enbrel(R)                                                        1,117                         36                          1,153             1,151                -%



              AMGEVITA(TM)                                                                                  86                             86                31  
             *



              KYPROLIS(R)                                                        187                         93                            280               245    14%



              XGEVA(R)                                                           355                        126                            481               471     2%



              Vectibix(R)                                                         80                        122                            202               170    19%



              Nplate(R)                                                          127                         91                            218               189    15%



              BLINCYTO(R)                                                         57                         37                             94                69    36%



              KANJINTI(R)                                                         96                         23                            119                24  
             *



              MVASI(R)                                                           108                          7                            115                   
             *



              Neulasta(R)                                                        534                         75                            609             1,021  (40%)



              NEUPOGEN(R)                                                         45                         20                             65                73  (11%)



              EPOGEN(R)                                                          155                                                      155               219  (29%)



              Aranesp(R)                                                         175                        247                            422               414     2%



              Sensipar(R)/Mimpara(R)                                              42                         81                            123               213  (42%)



              Other**                                                             24                         40                             64                61     5%




              Total product sales                                                    $
       4,279                       $
       1,615                $
            5,894         $
        5,286 12%





    * Change in excess of 100%



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

    ---

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

    --  Total Operating Expenses increased 23% driven by Otezla-related
        expenses, including the amortization of intangible assets. Cost of Sales
        margin increased 5.7 percentage points driven by amortization of
        intangible assets acquired in the Otezla acquisition and an increase in
        milestone payments, offset partially by lower manufacturing costs.
        Research & Development (R&D) expenses increased 8% driven by higher
        late-stage development program support of our oncology portfolio,
        primarily AMG 510 (sotorasib), along with the recently acquired Otezla,
        offset partially by recoveries from our collaboration with BeiGene.
        Selling, General & Administrative (SG&A) expenses increased 14% due to
        our first full quarter of Otezla commercial-related expenses.
    --  Operating Margin decreased 6.8 percentage points to 40.0% driven by the
        amortization of intangible assets from our Otezla acquisition.
    --  Tax Rate decreased 4.2 percentage points due primarily to amortization
        related to the Otezla acquisition, changes in jurisdictional mix of
        earnings and an increase in net discrete tax benefits.

On a non-GAAP basis:

    --  Total Operating Expenses increased 7% driven by Otezla-related expenses.
        Cost of Sales margin decreased 1.6 percentage points driven by lower
        manufacturing costs, offset partially by an increase in milestone
        payments. R&D expenses increased 8% driven by higher late-stage
        development program support of our oncology portfolio, primarily AMG 510
        (sotorasib), along with the recently acquired Otezla, offset partially
        by recoveries from our collaboration with BeiGene. SG&A expenses
        increased 12% due to our first full quarter of Otezla commercial-related
        expenses.
    --  Operating Margin increased 1.5 percentage points to 53.9%.
    --  Tax Rate decreased 1.8 percentage points due primarily to changes in
        jurisdictional mix of earnings and an increase in net discrete tax
        benefits.


            
              $Millions, except percentages            
          
          GAAP                                
       
         Non-GAAP


                                                       Q1'20                       Q1'19              YOY                            Q1'20         Q1'19                  YOY  




              Cost of Sales                                       $
        1,513                      $
          1,055                            43%                     $
       771                       $
              779       (1%)



              % of product sales                       25.7                               20.0                      
       5.7 pts.                     13.1                        14.7
                                                           %                                 %                                                           %                          %         
            (1.6) pts.


               Research & Development                                $
        952                        $
          879                             8%                     $
       927                       $
              859         8%



              % of product sales                       16.2                               16.6                     
       (0.4) pts.                    15.7                        16.3
                                                           %                                 %                                                           %                          %         
            (0.6) pts.


               Selling, General &
                Administrative                                     $
        1,316                      $
          1,154                            14%                   $
       1,287                     $
              1,149        12%



              % of product sales                       22.3                               21.8                      
       0.5 pts.                     21.8                        21.7
                                                           %                                 %                                                           %                          %          
            0.1 pts.



              Other                                                  $
        25                        $
          (3)                          
      *            
     $                         
     $                               -%


                            Total Operating Expenses         $
       
          3,806                  $
     
            3,085                            23%               $
     
         2,985              $
        
                2,787         7%





              Operating Margin


               operating income as % of                 40.0                               46.8                     
       (6.8) pts.                    53.9                        52.4
                product sales                              %                                 %                                                           %                          %          
            1.5 pts.




                            Tax Rate                     9.7                               13.9                                (4.2) pts.             12.8                        14.6
                                                     
         %                             
       %                                                   
           %                      
       %                         (1.8) pts.




    * Change in excess of 100%



              pts: percentage points

    ---

Cash Flow and Balance Sheet

    --  The Company generated $2.0 billion of free cash flow in the first
        quarter of 2020 versus $1.7 billion in the first quarter of 2019.
    --  The Company's first quarter 2020 dividend of $1.60 per share was
        declared on Dec. 11, 2019, and was paid on March 6, 2020, to all
        stockholders of record as of Feb. 14, 2020, representing a 10% increase
        from the first quarter of 2019.
    --  During the first quarter, the Company repurchased 4.3 million shares of
        common stock at a total cost of $933 million. At the end of the first
        quarter, the Company had $5.5 billion remaining under its stock
        repurchase authorization.



       $Billions, except shares Q1'20        Q1'19      YOY  



        Operating
         Cash Flow                     $
     2.1                  $
     1.8        $
     0.3


        Capital
         Expenditures              0.1               0.1                 0.0


        Free Cash
         Flow                      2.0               1.7                 0.3


        Dividends
         Paid                      0.9               0.9                 0.0


        Share
         Repurchases               0.9               3.0               (2.1)


        Average
         Diluted
         Shares
         (millions)                594               626                (32)




        Cash and
         Investments               8.0              26.3              (18.3)


        Debt
         Outstanding              31.8              33.0               (2.1)


        Stockholders'
         Equity                    9.5              10.8               (1.3)




        Note: Numbers
         may not add
         due to
         rounding

    ---

2020 Guidance

    --  For the full year 2020, the Company reaffirmed total revenues and
        non-GAAP EPS guidance:
    --  Total revenues in the range of $25.0 billion to $25.6 billion, unchanged
        from previous guidance.
    --  On a GAAP basis, EPS in the range of $10.65 to $11.45 and a tax rate in
        the range of 10.5% to 11.5%.
    --  On a non-GAAP basis, EPS in the range of $14.85 to $15.60 and a tax rate
        in the range of 13.5% to 14.5%, unchanged from previous guidance.
    --  Capital expenditures to be approximately $600 million.

First Quarter Product and Pipeline Update

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

AMG 510 (sotorasib)

    --  The Company will present the following clinical data as part of the
        ASCO20 Virtual Scientific Program, May 29-31:
        --  Updated results from the Phase 1 dose escalation study in patients
            with advanced colorectal cancer.
        --  Updated results from the Phase 1 dose escalation study in patients
            with advanced solid tumors other than non-small-cell lung cancer
            (NSCLC) and colorectal cancer.
    --  The Company reiterated its expectation of initial data in 2020 from a
        potentially pivotal Phase 2 monotherapy study in patients with advanced
        NSCLC, including at least six months of response data.

BiTE(®) Programs

    --  The Company expects initial data from Phase 1 dose escalation studies of
        the following half-life extended BiTE(®) molecules in H2 2020:
        --  AMG 160 targeting PSMA (prostate specific membrane antigen)
        --  AMG 701 targeting BCMA (B-cell maturation antigen)
        --  AMG 757 targeting DLL3 (Delta-like ligand 3)
    --  Updated results from the Phase 1 dose escalation study of AMG 330, a
        bispecific T-cell engager molecule targeting CD33, in patients with
        relapsed/refractory acute myeloid leukemia will be presented as part of
        the ASCO20 Virtual Scientific Program, May 29-31.

KYPROLIS

    --  The FDA has set a Prescription Drug User Fee Act (PDUFA) target action
        date of Nov. 15, 2020 for the supplemental New Drug Application (sNDA)
        to expand the Prescribing Information to include KYPROLIS in combination
        with dexamethasone and DARZALEX(®) (daratumumab) for patients with
        relapsed or refractory multiple myeloma based on data from the Phase 3
        CANDOR study.
    --  In February, a variation to the marketing authorization application was
        submitted to the European Medicines Agency to expand the indication for
        Kyprolis in relapsed multiple myeloma based on data from the Phase 3
        CANDOR study.

XGEVA

    --  In April, a marketing authorization for the treatment of skeletal
        related events was accepted for review by the Center for Drug Evaluation
        in China. XGEVA is included in our strategic collaboration with BeiGene.

ABP 798 (biosimilar rituximab)

    --  The FDA has set a Biosimilar User Fee Act target action date of Dec. 19,
        2020 for the Biologics License Application for ABP 798, a biosimilar
        candidate to Rituxan(®) (rituximab).

Otezla

    --  Data from the Phase 3 study in patients with mild-to-moderate psoriasis
        are expected in Q2 2020.
    --  In April, the U.S. Food and Drug Administration (FDA) approved the sNDA
        to add scalp psoriasis data to the U.S. Prescribing Information.
    --  In April, the European Commission (EC) approved an additional indication
        for the treatment of adult patients with oral ulcers associated with
        Behçet's Disease who are candidates for systemic therapy.

Tezepelumab

    --  The Company reiterated its expectation of data from the Phase 3
        NAVIGATOR study in patients with severe uncontrolled asthma by the end
        of 2020.

Omecamtiv mecarbil

    --  In February, the Data Monitoring Committee for the Phase 3 GALACTIC-HF
        study completed the second and final planned interim analysis for
        futility and superiority and recommended that the study continue without
        changes to its conduct.
    --  The Company reiterated its expectation of data from GALACTIC-HF in Q4
        2020.

Repatha

    --  In March, the Company announced that Repatha significantly reduced
        low-density lipoprotein cholesterol (LDL-C) in patients who are human
        immunodeficiency virus-positive and have high LDL-C despite stable
        background lipid-lowering therapy.

AMG 890

    --  A Phase 2 study is expected to begin in the second half of 2020 for AMG
        890, a small interfering RNA molecule that lowers lipoprotein(a).

COVID-19

    --  The Company announced that Otezla, an oral treatment approved in more
        than 50 countries for inflammatory diseases such as psoriasis and
        psoriatic arthritis, will be investigated as a potential
        immunomodulatory treatment in adult patients with COVID-19 in upcoming
        platform trials.
    --  In April, the Company announced a collaboration with Adaptive
        Biotechnologies to discover and develop fully human neutralizing
        antibodies targeting SARS-CoV-2 to potentially prevent or treat
        COVID-19.
    --  The Company provided the following updates on aspects of its R&D
        activities
        --  Study start-up activities are continuing where possible to allow
            rapid site activation and enrollment when that becomes feasible.
        --  Study procedures are being implemented consistent with recent
            guidance from regulators to maintain patient safety and study data
            integrity.
        --  Enrollment is paused in clinical trials where there is uncertainty
            around the ability of sites to ensure subject safety or data
            integrity.
        --  Research activities are increasing in various geographies as the
            situation safely permits.
        --  Medical conferences and journals are being engaged to ensure
            continued dissemination of important data in a timely manner.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.

DARZALEZX is a registered trademark of Janssen Biotech, Inc.

Rituxan is a registered trademark of Biogen Inc.

Tezepelumab is being developed in collaboration with AstraZeneca

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

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the first quarters of 2020 and 2019, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2020 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarters of 2020 and 2019. 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 any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including Adaptive Biotechnologies (including statements regarding such collaboration's ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19), BeiGene, Ltd., or the Otezla acquisition, including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as 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, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, 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. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. 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 collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology 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 Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)



     
                Amgen Inc.


     
                Consolidated Statements of Income - GAAP


     
                (In millions, except per-share data)


     
                (Unaudited)




                                                           Three months ended
                                                 March 31,


                                         2020                           2019

                                                                        ---


     Revenues:


       Product
       sales                                    $
              5,894                   $
      5,286


      Other
       revenues                           267                                   271



      Total
       revenues                         6,161                                 5,557





      Operating expenses:


      Cost
       of
       sales                            1,513                                 1,055


       Research
       and
       development                        952                                   879


       Selling,
       general
       and
       administrative                   1,316                                 1,154


      Other                                25                                   (3)



      Total
       operating
       expenses                         3,806                                 3,085





       Operating
       income                           2,355                                 2,472




       Interest
       expense,
       net                                346                                   343


       Interest
       and
       other
       income,
       net                                 11                                   185





      Income
       before
       income
       taxes                            2,020                                 2,314




       Provision
       for
       income
       taxes                              195                                   322





      Net
       income                                   $
              1,825                   $
      1,992





      Earnings per share:


      Basic                                      $
              3.09                    $
      3.20


      Diluted                                    $
              3.07                    $
      3.18




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


      Basic                               590                            622


      Diluted                             594                            626



     
                Amgen Inc.


     
                Consolidated Balance Sheets - GAAP


     
                (In millions)




                                                         March 31,             December 31,

                                                                                        ---

                                                               2020                     2019

                                                                                        ---

                                                        (Unaudited)



     
                Assets



     Current assets:


      Cash, cash
       equivalents and
       marketable
       securities                                                    $
      8,012                       $
      8,911


      Trade receivables,
       net                                                    5,009                           4,057


      Inventories                                             3,682                           3,584


      Other current
       assets                                                 2,110                           1,888



      Total current
       assets                                                18,813                          18,440




      Property, plant
       and equipment,
       net                                                    4,879                           4,928


      Intangible assets,
       net                                                   18,653                          19,413


      Goodwill                                               14,683                          14,703


      Other assets                                            4,641                           2,223



      Total assets                                                  $
      61,669                      $
      59,707






     
                Liabilities and Stockholders' Equity



     Current liabilities:


      Accounts payable
       and accrued
       liabilities                                                   $
      9,987                       $
      9,882


      Current portion of
       long-term debt                                         1,840                           2,953



      Total current
       liabilities                                           11,827                          12,835




      Long-term debt                                         30,008                          26,950


      Long-term
       deferred tax
       liabilities                                              427                             606


      Long-term tax
       liabilities                                            8,111                           8,037


      Other noncurrent
       liabilities                                            1,811                           1,606


      Total
       stockholders'
       equity                                                 9,485                           9,673



      Total liabilities
       and stockholders'
       equity                                                       $
      61,669                      $
      59,707





      Shares outstanding                                        588                             591



     
                Amgen Inc.


     
                GAAP to Non-GAAP Reconciliations


     
                (Dollars in millions)


     
                (Unaudited)




                                                                            Three months ended
                                                                   March 31,


                                                            2020                            2019

                                                                                            ---

                   GAAP cost of sales                            $
              1,513                          $
       1,055


                   Adjustments to cost of sales:


      Acquisition-related expenses
       (a)                                                 (742)                                 (276)


                   Total adjustments to cost of
                    sales                                  (742)                                 (276)



                   Non-GAAP cost of sales                          $
              771                            $
       779





                   GAAP cost of sales as a                  25.7                                   20.0
                    percentage of product sales                %                                     %


      Acquisition-related expenses
       (a)                                                 -12.6                                   -5.3


                   Non-GAAP cost of sales as a              13.1                                   14.7
                    percentage of product sales                %                                     %

                                                                                                        ===



                   GAAP research and development
                    expenses                                       $
              952                            $
       879


                   Adjustments to research and development
                    expenses:


      Acquisition-related expenses
       (a)                                                  (25)                                  (20)


                   Total adjustments to research
                    and development expenses                (25)                                  (20)



                   Non-GAAP research and
                    development expenses                           $
              927                            $
       859





                   GAAP research and development
                    expenses as a percentage of                %                                     %
                    product sales                           16.2                                   16.6


      Acquisition-related expenses
       (a)                                                  -0.5                                   -0.3


                   Non-GAAP research and
                    development expenses as a                  %                                     %
                    percentage of product sales             15.7                                   16.3

                                                                                                        ===



                   GAAP selling, general and
                    administrative expenses                      $
              1,316                          $
       1,154


                   Adjustments to selling, general and
                    administrative expenses:


      Acquisition-related expenses
       (a)                                                  (29)                                   (4)


      Certain net charges pursuant to
       our restructuring initiatives                           -                                   (1)



                   Total adjustments to selling,
                    general and administrative
                    expenses                                (29)                                   (5)



                   Non-GAAP selling, general and
                    administrative expenses                      $
              1,287                          $
       1,149





                   GAAP selling, general and
                    administrative expenses as a               %                                     %
                    percentage of product sales             22.3                                   21.8


      Acquisition-related expenses
       (a)                                                  -0.5                                   -0.1


      Certain net charges pursuant to
       our restructuring initiatives                         0.0                                    0.0



                   Non-GAAP selling, general and
                    administrative expenses as a               %                                     %
                    percentage of product sales             21.8                                   21.7

                                                                                                        ===



                   GAAP operating expenses                       $
              3,806                          $
       3,085


                   Adjustments to operating expenses:


      Adjustments to cost of sales                         (742)                                 (276)


      Adjustments to research and
       development expenses                                 (25)                                  (20)


      Adjustments to selling, general
       and administrative expenses                          (29)                                   (5)


      Certain net charges pursuant to
       our restructuring initiatives                           2                                      1


      Acquisition-related
       adjustments (b)                                      (27)                                     2



                   Total adjustments to operating
                    expenses                               (821)                                 (298)


                   Non-GAAP operating expenses                   $
              2,985                          $
       2,787





                   GAAP operating income                         $
              2,355                          $
       2,472


      Adjustments to operating
       expenses                                              821                                    298



                   Non-GAAP operating income                     $
              3,176                          $
       2,770























                                                                            Three months ended
                                                                   March 31,


                                                            2020                            2019

                                                                                            ---

                   GAAP operating income as a               40.0                                   46.8
                    percentage of product sales                %                                     %


      Adjustments to cost of sales                          12.6                                    5.3


      Adjustments to research and
       development expenses                                  0.5                                    0.3


      Adjustments to selling, general
       and administrative expenses                           0.5                                    0.1


      Certain net charges pursuant to
       our restructuring initiatives                        -0.1                                    0.0


      Acquisition-related
       adjustments (b)                                       0.4                                   -0.1


                   Non-GAAP operating income as a           53.9                                   52.4
                    percentage of product sales                %                                     %

                                                                                                        ===



                   GAAP income before income taxes               $
              2,020                          $
       2,314


      Adjustments to operating
       expenses                                              821                                    298


                   Non-GAAP income before income
                    taxes                                        $
              2,841                          $
       2,612





                   GAAP provision for income taxes                 $
              195                            $
       322


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (c)                                       171                                     68


      Other income tax adjustments
       (d)                                                   (1)                                   (8)



                   Total adjustments to provision
                    for income taxes                         170                                     60


                   Non-GAAP provision for income
                    taxes                                          $
              365                            $
       382





                   GAAP tax as a percentage of               9.7                                   13.9
                    income before taxes                        %                                     %


                   Adjustments to provision for income taxes:


      Income tax effect of the above
       adjustments (c)                                       3.1                                    1.0


      Other income tax adjustments
       (d)                                                   0.0                                   -0.3



                   Total adjustments to provision
                    for income taxes                         3.1                                    0.7


                   Non-GAAP tax as a percentage             12.8                                   14.6
                    of income before taxes                     %                                     %

                                                                                                        ===



                   GAAP net income                               $
              1,825                          $
       1,992


                   Adjustments to net income:


      Adjustments to income before
       income taxes, net of the
       income tax effect                                     650                                    230


      Other income tax adjustments
       (d)                                                     1                                      8



                   Total adjustments to net income           651                                    238


                   Non-GAAP net income                           $
              2,476                          $
       2,230



     
                Amgen Inc.


     
                GAAP to Non-GAAP Reconciliations


     
                (In millions, except per-share data)


     
                (Unaudited)





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




                                                                       Three months ended                                         Three months ended
                                                             March 31, 2020                                             March 31, 2019


                                                    GAAP                                              Non-GAAP     GAAP                              Non-GAAP

                                                                                                                                                          ---

      Net income                                           $
              1,825                                               $
              2,476                    $
      1,992  $
      2,230




      Weighted-
       average
       shares for
       diluted EPS                                   594                                                       594                                          626        626




      Diluted EPS                                           $
              3.07                                                $
              4.17                     $
      3.18   $
      3.56



     (a) The adjustments related primarily
          to noncash amortization of
          intangible assets from business
          acquisitions.




     (b) For the three months ended March
          31, 2020 the adjustment related
          primarily to an impairment charge
          associated with an in-process
          research and development asset.




     (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
          initiatives, 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 ended March 31,
          2020, was 20.8%, compared with
          22.8% for the corresponding period
          of the prior year.




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



     
                Amgen Inc.


     
                Reconciliations of Cash Flows


     
                (In millions)


     
                (Unaudited)




                                                       Three months ended
                                              March 31,


                                     2020                             2019


      Net
       cash
       provided
       by
       operating
       activities                           $
              2,134                       $
     1,845


      Net
       cash
       (used
       in)
       provided
       by
       investing
       activities                   (230)                                    3,555


      Net
       cash
       used
       in
       financing
       activities                   (254)                                  (4,987)



       Increase
       in
       cash
       and
       cash
       equivalents                  1,650                                       413


      Cash
       and
       cash
       equivalents
       at
       beginning
       of
       period                       6,037                                     6,945



      Cash
       and
       cash
       equivalents
       at
       end
       of
       period                               $
              7,687                       $
     7,358





                                                       Three months ended
                                              March 31,


                                     2020                             2019

                                                                      ---

      Net
       cash
       provided
       by
       operating
       activities                           $
              2,134                       $
     1,845


       Capital
       expenditures                 (142)                                    (116)


      Free
       cash
       flow                                 $
              1,992                       $
     1,729



     
                Amgen Inc.


     
                Reconciliation of GAAP EPS Guidance to Non-GAAP


     
                EPS Guidance for the Year Ending December 31, 2020


     
                (Unaudited)




                   GAAP diluted EPS
                    guidance                          $
              10.65      $
     11.45


                   Known adjustments
                    to arrive at
                    non-GAAP*:


      Acquisition-
       related expenses
       (a)                                     4.25                     4.30


      Legal settlement
       proceeds                                                  (0.10)



                   Non-GAAP diluted
                    EPS guidance                      $
              14.85      $
     15.60




               * The known adjustments are
                presented net of their related tax
                impact, which amount to
                approximately $0.97 per share.




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




               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, 2020


     
                (Unaudited)





     GAAP tax rate guidance                   10.5                        11.5
                                                  %                          %


      Tax rate of known adjustments
       discussed above                                      3.0%


      Non-GAAP diluted EPS guidance            13.5                        14.5
                                                  %                          %

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SOURCE Amgen