Amgen Reports Fourth Quarter and Full Year 2017 Financial Results

 

Expects to Increase Investments in Growth, Including a New U.S. Manufacturing Plant
Announces 2018 Guidance
Additional $10 Billion of Share Repurchases Authorized

 
[01-February-2018]
 
 

THOUSAND OAKS, Calif., Feb. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2017. Key results include:

  • For the fourth quarter, total revenues decreased 3 percent versus the fourth quarter of 2016 to $5.8 billion. For the full year, total revenues decreased 1 percent to $22.8 billion.
  • GAAP loss per share of $5.89 for the fourth quarter and GAAP earnings per share (EPS) of $2.69 for the full year include a $6.1 billion charge related to impacts of U.S. corporate tax reform.
  • Non-GAAP EPS were flat in the fourth quarter at $2.89. Non-GAAP EPS increased 8 percent for the full year to $12.58, driven by higher operating margins and interest income and a lower share count.
  • Free cash flow for the full year grew 9 percent to $10.5 billion, driven by higher operating income and favorable changes in working capital. At year end, cash and investments totaled $41.7 billion.
  • The Company expects to increase investments to drive additional volume-driven growth of novel medicines in large patient populations. These plans include a new U.S. manufacturing plant.
  • Cash returned to shareholders totaled $6.5 billion in 2017 through dividends and share repurchases. The Company's Board of Directors authorized an additional $10 billion of share repurchases. This authorization is in addition to the existing $4.4 billion in share repurchase authorization as of Dec. 31, 2017.
  • 2018 total revenues guidance of $21.8-$22.8 billion; EPS guidance of $11.18-$12.36 on a GAAP basis and $12.60-$13.70 on a non-GAAP basis.

"With strong volume-driven growth for our recently launched products and a promising new product pipeline, we are well positioned for future growth," said Robert A. Bradway, chairman and chief executive officer. "We expect several developments to provide an additional boost for these products, most notably the recent inclusion of cardiovascular outcomes data in the Repatha® (evolocumab) prescribing information."

 

                                   $Millions, except EPS and percentages Q4'17          Q4'16         YOY Δ       FY '17         FY '16         YOY Δ


    Total Revenues                                                               $5,802        $5,965        (3%)        $22,849        $22,991         (1%)

    GAAP Operating Income                                                        $2,245        $2,485       (10%)         $9,973         $9,794           2%

    GAAP Net (Loss) Income                                                     $(4,264)       $1,935     *               $1,979         $7,722        (74%)

    GAAP (Loss) Earnings Per Share                                              $(5.89)        $2.59     *                $2.69         $10.24        (74%)

    Non-GAAP Operating Income                                                    $2,555        $2,859       (11%)        $11,658        $11,446           2%

    Non-GAAP Net Income                                                          $2,104        $2,160        (3%)         $9,246         $8,785           5%

    Non-GAAP EPS                                                                  $2.89         $2.89          0%         $12.58         $11.65           8%

    * 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 decreased 2 percent for the fourth quarter of 2017 versus the fourth quarter of 2016. Product sales were flat for the full year.
  • Repatha sales increased 69 percent for the fourth quarter and 126 percent for the full year driven by higher unit demand.
  • BLINCYTO® (blinatumomab) sales increased 59 percent for the fourth quarter and 52 percent for the full year driven by higher unit demand and, to a lesser extent, net selling price.
  • Prolia® (denosumab) sales increased 24 percent for the fourth quarter and 20 percent for the full year driven by higher unit demand.
  • KYPROLIS® (carfilzomib) sales increased 24 percent for the fourth quarter and 21 percent for the full year driven by higher unit demand.
  • Vectibix® (panitumumab) sales increased 11 percent for the fourth quarter and 5 percent for the full year driven by higher unit demand.
  • Nplate® (romiplostim) sales increased 10 percent for the fourth quarter and the full year driven by higher unit demand.
  • XGEVA® (denosumab) sales increased 4 percent for the fourth quarter driven by higher unit demand, favorable changes in inventory levels and net selling price. Sales increased 3 percent for the full year driven primarily by higher unit demand.
  • Sensipar/Mimpara® (cinacalcet) sales were flat for the fourth quarter as higher net selling price was offset by unfavorable changes in inventory levels. Sales increased 9 percent for the full year driven by net selling price and, to a lesser extent, higher unit demand.
  • Neulasta® (pegfilgrastim) sales were flat for the fourth quarter as lower unit demand was offset by favorable changes in accounting estimates. Sales decreased 2 percent for the full year driven by lower unit demand offset partially by net selling price.
  • Aranesp® (darbepoetin alfa) sales decreased 7 percent for the fourth quarter driven primarily by lower unit demand, favorable prior year changes in accounting estimates and unfavorable changes in foreign exchange rates. Sales decreased 2 percent for the full year as unfavorable changes in foreign exchange rates were offset partially by higher unit demand.
  • Enbrel® (etanercept) sales decreased 13 percent for the fourth quarter and 9 percent for the full year driven by lower unit demand and net selling price.
  • EPOGEN® (epoetin alfa) sales decreased 15 percent for the fourth quarter and the full year driven primarily by lower net selling price.
  • NEUPOGEN® (filgrastim) sales decreased 27 percent for the fourth quarter and 28 percent for the full year driven by lower unit demand.

Product Sales Detail by Product and Geographic Region


                      $Millions, except percentages               Q4'17                        Q4'16         YOY Δ
                                                                  -----                        -----         -----

                                                                   US               ROW        TOTAL         TOTAL         TOTAL
                                                                   ---              ---        -----         -----         -----


    Repatha(R)                                                                $70          $28           $98           $58           69%

    BLINCYTO(R)                                                                29           17            46            29           59%

    Prolia(R)                                                                 369          205           574           463           24%

    KYPROLIS(R)                                                               150           77           227           183           24%

    Vectibix(R)                                                                63           96           159           143           11%

    Nplate(R)                                                                 100           65           165           150           10%

    XGEVA(R)                                                                  285          106           391           376            4%

    Sensipar(R) / Mimpara(R)                                                  322           91           413           411            0%

    Neulasta(R)                                                               969          145         1,114         1,116            0%

    Aranesp(R)                                                                263          228           491           526          (7%)

    Enbrel(R)                                                               1,368           55         1,423         1,644         (13%)

    EPOGEN(R)                                                                 270            0           270           316         (15%)

    NEUPOGEN(R)                                                                82           44           126           173         (27%)

    Other*                                                                     13           59            72            75          (4%)
                                                                                          ---           ---           ---


    Total product sales                                                    $4,353       $1,216        $5,569        $5,663          (2%)
                                                                           ======       ======        ======        ======           ===


    * Other includes Bergamo, MN Pharma, IMLYGIC(R), Corlanor(R), and Parsabiv(TM)
    -----------------------------------------------------------------------------





                      $Millions, except percentages               FY'17                        FY'16         YOY Δ
                                                                  -----                        -----         -----

                                                                   US               ROW        TOTAL         TOTAL         TOTAL
                                                                   ---              ---        -----         -----         -----


    Repatha(R)                                                               $225          $94          $319          $141       *

    BLINCYTO(R)                                                               114           61           175           115           52%

    Prolia(R)                                                               1,272          696         1,968         1,635           20%

    KYPROLIS(R)                                                               562          273           835           692           21%

    Nplate(R)                                                                 392          250           642           584           10%

    Sensipar(R) / Mimpara(R)                                                1,374          344         1,718         1,582            9%

    Vectibix(R)                                                               251          391           642           611            5%

    XGEVA(R)                                                                1,157          418         1,575         1,529            3%

    Aranesp(R)                                                              1,114          939         2,053         2,093          (2%)

    Neulasta(R)                                                             3,931          603         4,534         4,648          (2%)

    Enbrel(R)                                                               5,206          227         5,433         5,965          (9%)

    EPOGEN(R)                                                               1,096            0         1,096         1,282         (15%)

    NEUPOGEN(R)                                                               369          180           549           765         (28%)

    Other**                                                                    68          188           256           250            2%
                                                                                          ---           ---           ---


    Total product sales                                                   $17,131       $4,664       $21,795       $21,892            0%
                                                                          =======       ======       =======       =======           ===


    * Change in excess of 100%

    ** Other includes Bergamo, MN Pharma, IMLYGIC(R), Corlanor(R), and Parsabiv(TM)
    ------------------------------------------------------------------------------

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

  • Total Operating Expenses increased 2 percent in the fourth quarter and decreased 2 percent for the full year, with all expense categories reflecting savings from our transformation and process improvement efforts. Cost of Sales margin was unfavorable by 0.2 percentage points in the fourth quarter driven primarily by expenses related to Hurricane Maria in Puerto Rico, unfavorable product mix and other inventory costs, offset partially by lower amortization of intangible assets and royalties. For the full year, Cost of Sales margin improved 0.3 percentage points driven primarily by lower amortization of intangible assets, lower royalties and favorable manufacturing costs, offset partially by expenses related to Hurricane Maria, unfavorable product mix and other inventory costs. Research & Development (R&D) expenses decreased 3 percent for the fourth quarter and 7 percent for the full year driven primarily by lower spending required to support certain later-stage clinical programs and lower external business development expenses. Selling, General & Administrative (SG&A) expenses increased 8 percent in the fourth quarter due to investments in product launches and marketed product support, offset partially by the expiration of ENBREL residual royalty payments. For the full year, SG&A expenses decreased 4 percent due to the expiration of ENBREL residual royalty payments, offset partially by investments in product launches and marketed product support. Other expenses increased for the full year due primarily to net charges related to the Company's decision to discontinue internal development of AMG 899 in Q3 2017.
  • Operating Margin decreased by 3.6 percentage points in the fourth quarter to 40.3 percent, and improved by 1.1 percentage points for the full year to 45.8 percent.
  • Tax Rate increased in the fourth quarter and full year due to the impacts of U.S. corporate tax reform.

On a non-GAAP basis:

  • Total Operating Expenses increased 5 percent in the fourth quarter and decreased 3 percent for the full year, with all expense categories reflecting savings from our transformation and process improvement efforts. Cost of Sales margin was unfavorable by 1.4 percentage points in the fourth quarter driven primarily by expenses related to Hurricane Maria in Puerto Rico, unfavorable product mix and other inventory costs, offset partially by lower royalties. For the full year, Cost of Sales margin was unfavorable by 0.2 percentage points driven primarily by expenses related to Hurricane Maria, unfavorable product mix and other inventory costs, offset partially by lower royalties and favorable manufacturing costs. R&D expenses decreased 3 percent for the fourth quarter and 7 percent for the full year driven primarily by lower spending required to support certain later-stage clinical programs and lower external business development expenses. SG&A expenses increased 8 percent in the fourth quarter due to investments in product launches and marketed product support, offset partially by the expiration of ENBREL residual royalty payments. For the full year, SG&A expenses decreased 2 percent due to the expiration of ENBREL residual royalty payments, offset partially by investments in product launches and marketed product support.
  • Operating Margin decreased by 4.6 percentage points in the fourth quarter to 45.9 percent, and improved by 1.2 percentage points for the full year to 53.5 percent.
  • Tax Rate for the fourth quarter decreased 2.1 percentage points due primarily to favorable changes in the geographic mix of earnings. The full year tax rate decreased 0.8 percentage points driven by changes in the geographic mix of earnings, offset partially by lower tax benefits from share-based compensation payments.

 

 


                                               $Millions, except percentages

                                                                         GAAP                                     Non-GAAP
                                                                         ----                                     --------

                                                                 Q4'17              Q4'16                                YOY Δ            Q4'17               Q4'16                          YOY Δ
                                                                 -----              -----                                -----            -----               -----                          -----


    Cost of Sales                                                      $1,059              $1,067                              (1%)                $816                 $753                         8%

                               % of product
                               sales          19.0%                           18.8%                 0.2 pts.                        14.7%               13.3%                  1.4 pts.

    Research & Development                                             $1,043              $1,078                              (3%)              $1,025               $1,056                       (3%)

                               % of product
                               sales          18.7%                           19.0%               (0.3) pts.                        18.4%               18.6%                (0.2) pts.

    Selling, General &
     Administrative                                                    $1,427              $1,323                                8%              $1,406               $1,297                         8%

                               % of product
                               sales          25.6%                           23.4%                 2.2 pts.                        25.2%               22.9%                  2.3 pts.

    Other                                                                 $28                 $12                         *                          $0                   $0                    NM

    TOTAL Operating Expenses                                           $3,557              $3,480                                2%              $3,247               $3,106                         5%


    Operating Margin

                               operating
                               income as a
                               % of product
                               sales          40.3%                           43.9%               (3.6) pts.                        45.9%               50.5%                (4.6) pts.


    Tax Rate                                                           292.6%              15.2%                    277.4 pts.                  16.6%               18.7%               (2.1) pts.


    * Change in excess of 100%

    NM: Not Meaningful

    pts: percentage points
    ----------------------




                                            $Millions, except percentages

                                                                       GAAP                                  Non-GAAP
                                                                       ----                                  --------

                                                                 FY'17              FY'16                                YOY Δ            FY'17               FY'16                          YOY Δ
                                                                 -----              -----                                -----            -----               -----                          -----


    Cost of Sales                                                      $4,069              $4,162                              (2%)              $2,943               $2,913                         1%

                               % of product
                               sales          18.7%                           19.0%               (0.3) pts.                        13.5%               13.3%                  0.2 pts.

    Research & Development                                             $3,562              $3,840                              (7%)              $3,482               $3,755                       (7%)

                               % of product
                               sales          16.3%                           17.5%               (1.2) pts.                        16.0%               17.2%                (1.2) pts.

    Selling, General &
     Administrative                                                    $4,870              $5,062                              (4%)              $4,766               $4,877                       (2%)

                               % of product
                               sales          22.3%                           23.1%               (0.8) pts.                        21.9%               22.3%                (0.4) pts.

    Other                                                                $375                $133                         *                          $0                   $0                    NM

    TOTAL Operating Expenses                                          $12,876             $13,197                              (2%)             $11,191              $11,545                       (3%)


    Operating Margin

                               operating
                               income as a
                               % of product
                               sales          45.8%                           44.7%                 1.1 pts.                        53.5%               52.3%                  1.2 pts.


    Tax Rate                                                            79.4%              15.7%                    63.7 pts.                   18.0%               18.8%               (0.8) pts.


    * Change in excess of 100%

    NM: Not Meaningful

    pts: percentage points
    ----------------------

Cash Flow and Balance Sheet

  • The Company generated $2.9 billion of free cash flow in the fourth quarter of 2017, flat versus the fourth quarter of 2016. The Company generated $10.5 billion of free cash flow for the full year versus $9.6 billion in 2016 driven by higher operating income and favorable changes in working capital.
  • The Company's first quarter 2018 dividend of $1.32 per share declared on Dec. 12, 2017, will be paid on March 8, 2018, to all stockholders of record as of Feb. 15, 2018. This represents a 15 percent increase from that paid in each of the previous four quarters.
  • During the fourth quarter, the Company repurchased 4.5 million shares of common stock at a total cost of $0.8 billion. For the full year, the Company repurchased 18.5 million shares of common stock at a total cost of $3.1 billion. In January 2018, the Company's Board of Directors authorized an additional $10 billion of share repurchases. This authorization is in addition to the existing $4.4 billion in share repurchase authorization as of Dec. 31, 2017.

 


                      $Billions, except shares   Q4'17        Q4'16        YOY Δ          FY'17          FY'16          YOY Δ
                                                 -----        -----        -----          -----          -----          -----


    Operating Cash Flow                                  $3.0         $3.1         ($0.1)         $11.2          $10.4            $0.8

    Capital Expenditures                                  0.2          0.2          (0.1)           0.7            0.7           (0.1)

    Free Cash Flow                                        2.9          2.9            0.0           10.5            9.6             0.9

    Dividends Paid                                     0.8          0.7            0.1            3.4            3.0             0.4

    Share Repurchase                                   0.8          1.0          (0.2)           3.1            3.0             0.1

    Avg. GAAP Diluted
     Shares (millions)                                 724          748           (24)           735            754            (19)

    Avg. Non-GAAP Diluted
     Shares (millions)                                 729          748           (19)           735            754            (19)


    Cash and Investments                              41.7         38.1            3.6           41.7           38.1             3.6

    Debt Outstanding                                  35.3         34.6            0.7           35.3           34.6             0.7

    Stockholders' Equity                              25.2         29.9          (4.6)          25.2           29.9           (4.6)


       Note: Numbers may not add due to rounding
       -----------------------------------------

Additional Capital Investments in the United States

The Company expects to invest approximately $3.5 billion in capital expenditures over the next five years, with approximately 75 percent of that investment in the U.S., up from about 50 percent in recent years. This investment includes committing up to $300 million to build a new manufacturing plant in the U.S. The new facility will employ Amgen's proven next-generation biomanufacturing capabilities, and manufacture products for the U.S. and export markets. Next-generation biomanufacturing requires less time and capital investment to build than a traditional biomanufacturing plant and is less costly to operate, with less environmental impact. The construction and validation work is expected to add 220 jobs to the local economy. In addition, Amgen expects this new facility to employ up to 300 highly skilled full-time employees. Amgen expects to finalize the exact location in the second quarter. The Company is also increasing the size of the Amgen Ventures fund, providing up to $300 million of growth capital for early-stage, innovative biotechnology companies in the U.S.

2018 Guidance

For the full year 2018, the Company expects:

  • Total revenues in the range of $21.8 billion to $22.8 billion.
  • On a GAAP basis, EPS in the range of $11.18 to $12.36 and a tax rate in the range of 13 percent to 14 percent.
  • On a non-GAAP basis, EPS in the range of $12.60 to $13.70 and a tax rate in the range of 14 percent to 15 percent.
  • Capital expenditures to be approximately $750 million.

Fourth Quarter Product and Pipeline Update

Key development milestones:

            Clinical Program                   Indication                          Projected Milestone
            ----------------                   ----------                          -------------------

                KYPROLIS         Relapsed or refractory multiple myeloma EU regulatory review (ENDEAVOR OS data)

                                                                           Regulatory reviews (ASPIRE OS data)
    ---                                                                     ----------------------------------

                BLINCYTO              Acute lymphoblastic leukemia         EU regulatory review (TOWER OS data)

                                                                            Regulatory reviews (MRD-positive)
    ---                                                                      --------------------------------

                 XGEVA           Prevention of SREs in multiple myeloma            EU regulatory review
                 -----           --------------------------------------            --------------------

                 Prolia            Glucocorticoid-induced osteoporosis            U.S. regulatory review
                 ------            -----------------------------------            ----------------------

        EVENITY(TM)(romosozumab)       Postmenopausal osteoporosis             U.S. regulatory resubmission

                                                                                   EU regulatory review
    ---                                                                            --------------------

         Aimovig(TM) (erenumab)            Migraine prevention                    U.S. regulatory review
         ---------------------             -------------------                    ----------------------

                ABP 710                         Oncology                               Phase 3 data
        (biosimilar infliximab)
         ----------------------

                ABP 980                         Oncology                            Regulatory reviews

        (biosimilar trastuzumab)
        -----------------------

OS = overall survival; MRD = minimal residual disease; SRE = skeletal-related event

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

Repatha

  • Repatha is the first and only PCSK9 inhibitor approved to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.
  • In December, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) to include data from the Phase 3 Repatha cardiovascular outcomes study in the prescribing information (PI).
  • The FDA also approved Repatha to be used as an adjunct to diet, alone or in combination with other lipid-lowering therapies, such as statins, for the treatment of adults with primary hyperlipidemia to lower LDL-C.

Tezepelumab

  • In December, patients began enrolling in a Phase 3 study to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe uncontrolled asthma.

Aimovig

  • In January, a Phase 3b study met its primary endpoint and all secondary endpoints in patients with episodic migraine who had experienced two to four previous preventive treatment failures due to lack of efficacy or intolerable side effects.

KYPROLIS

  • In January, the FDA approved a supplemental New Drug Application (sNDA) to include OS data from the Phase 3 head-to-head ENDEAVOR study in the PI.
  • In January, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a label variation to include updated OS data from the Phase 3 head-to-head ENDEAVOR study in patients with relapsed or refractory multiple myeloma.
  • In December, the Company submitted an sNDA to the FDA and a variation to the marketing authorization to the EMA to include the OS data from the ASPIRE study in the product labeling.

XGEVA

  • In January, the FDA approved an sBLA to expand the currently approved indication to include the prevention of SREs in patients with multiple myeloma.
  • A Phase 3 study of XGEVA as an experimental adjuvant treatment for women with high-risk, early stage breast cancer receiving standard of care neoadjuvant or adjuvant cancer therapy did not meet its primary endpoint of bone metastasis-free survival.

Nplate

  • In January, the European Commission (EC) approved an expanded indication to include the treatment of chronic immune (idiopathic) thrombocytopenic purpura in patients one year of age and older who are refractory to other treatments.

BLINCYTO

  • In December, the Company announced that the FDA accepted for priority review an sBLA for the treatment of MRD in patients with acute lymphoblastic leukemia (ALL). The Prescription Drug User Fee Act target action date is March 29, 2018.
  • In January, the CHMP of the EMA adopted a positive opinion recommending a label variation to include OS data from the Phase 3 TOWER study, supporting the conversion of the conditional marketing authorization to a full marketing authorization in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.

EVENITY

  • In January, the Company announced that the EMA accepted the Marketing Authorization Application (MAA) for EVENITY for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.

MVASI™ (biosimilar bevacizumab)

  • In January, the EC granted marketing authorization for MVASI, a biosimilar to Avastin®, for the treatment of certain types of cancer.

EVENITY and Aimovig trade names provisionally approved by FDA
EVENITY is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan
Tezepelumab is developed in collaboration with AstraZeneca
Aimovig is developed in collaboration with Novartis
Avastin is a registered trademark of Genentech

Non-GAAP Financial Measures
In this news release, management has presented its operating results for the fourth quarters and full years of 2017 and 2016, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2018 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 2017 and 2016. 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 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. 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 cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate 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. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. 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.

 

 

    Amgen Inc.

    Consolidated Statements of Income - GAAP

    (In millions, except per share data)

    (Unaudited)


                                                   Three months ended         Years ended

                                                      December 31,            December 31,
                                                      ------------            ------------

                                                                         2017                    2016       2017       2016
                                                                         ----                    ----       ----       ----

    Revenues:

                          Product sales                                $5,569                  $5,663    $21,795    $21,892

                          Other revenues                                  233                     302      1,054      1,099


                          Total revenues                                5,802                   5,965     22,849     22,991
                                                                        -----                   -----     ------     ------


    Operating expenses:

                          Cost of sales                                 1,059                   1,067      4,069      4,162

                           Research and
                           development                                  1,043                   1,078      3,562      3,840

                           Selling,
                           general and
                           administrative                               1,427                   1,323      4,870      5,062

                          Other                                            28                      12        375        133

                          Total operating expenses                      3,557                   3,480     12,876     13,197
                                                                        -----                   -----     ------     ------


    Operating income                                                 2,245                   2,485      9,973      9,794


    Interest expense, net                                              332                     328      1,304      1,260

    Interest and other income, net                                     301                     126        928        629
                                                                       ---                     ---        ---        ---


    Income before income taxes                                       2,214                   2,283      9,597      9,163


    Provision for income taxes                                       6,478                     348      7,618      1,441


    Net (loss) income                                             $(4,264)                 $1,935     $1,979     $7,722
                                                                   =======                  ======     ======     ======


    (Loss) earnings per share:

                          Basic                                       $(5.89)                  $2.61      $2.71     $10.32

                          Diluted                                     $(5.89)                  $2.59      $2.69     $10.24


    Weighted average shares used in
     calculation of (loss) earnings per
     share:

                          Basic                                           724                     742        731        748

                          Diluted                                         724                     748        735        754

 

    Amgen Inc.

    Consolidated Balance Sheets - GAAP

    (In millions)


                                                                    December 31,

                                                                                  2017                2016
                                                                                  ----                ----


    Assets

    Current assets:

                        Cash, cash
                        equivalents
                        and marketable
                        securities              $41,678                       $38,085

                        Trade
                        receivables,
                        net                       3,237                         3,165

                       Inventories                2,834                         2,745

                        Other current
                        assets                    1,727                         2,015


                        Total
                        current
                        assets           49,476              46,010

    Property, plant and equipment, net                                     4,989                4,961

    Intangible assets, net                                                 8,609               10,279

    Goodwill                                                              14,761               14,751

    Other assets                                                           2,119                1,625
                                                                           -----                -----

    Total assets                                                         $79,954              $77,626
                                                                         =======              =======


    Liabilities and Stockholders' Equity

    Current liabilities:

                        Accounts
                        payable and
                        accrued
                        liabilities                     $7,868                         $6,801

                       Short-term
                        borrowings and
                        current
                        portion of
                        long-term
                        debt                      1,152                         4,403

                        Total
                        current
                        liabilities       9,020              11,204

    Long-term debt                                                        34,190               30,193

    Long-term deferred tax liabilities                                     1,166                2,436

    Long-term tax liabilities                                              9,099                2,419

    Other noncurrent liabilities                                           1,238                1,499

    Stockholders' equity                                                  25,241               29,875
                                                                          ------               ------

    Total liabilities and stockholders'
     equity                                                              $79,954              $77,626
                                                                         =======              =======


    Shares outstanding                                                       722                  738

 

    Amgen Inc.

    GAAP to Non-GAAP Reconciliations

    (Dollars in millions)

    (Unaudited)


                                                                   Three months ended               Years ended

                                                                    December 31,              December 31,
                                                                    ------------              ------------

                                                                     2017                2016                     2017       2016
                                                                     ----                ----                     ----       ----


    GAAP cost of sales                                             $1,059              $1,067                   $4,069     $4,162

    Adjustments to cost of sales:

    Acquisition-related expenses (a)                                (243)              (314)                 (1,126)   (1,248)

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

    Total adjustments to cost of sales                              (243)              (314)                 (1,126)   (1,249)

    Non-GAAP cost of sales                                           $816                $753                   $2,943     $2,913
                                                                     ====                ====                   ======     ======


    GAAP cost of sales as a percentage
     of product sales                                               19.0%              18.8%                   18.7%     19.0%

    Acquisition-related expenses (a)                                 -4.3                -5.5                     -5.2       -5.7

    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                                    14.7%              13.3%                   13.5%     13.3%
                                                                     ====                ====                     ====       ====


    GAAP research and development
     expenses                                                      $1,043              $1,078                   $3,562     $3,840

    Adjustments to research and development expenses:

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

    Certain net charges pursuant to
     our restructuring initiative                                       2                 (2)                     (3)       (7)

    Total adjustments to research and
     development expenses                                            (18)               (22)                    (80)      (85)

    Non-GAAP research and development
     expenses                                                      $1,025              $1,056                   $3,482     $3,755
                                                                   ======              ======                   ======     ======


    GAAP research and development
     expenses as a percentage of
     product sales                                                  18.7%              19.0%                   16.3%     17.5%

    Acquisition-related expenses (a)                                 -0.3                -0.4                     -0.3       -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                                                  18.4%              18.6%                   16.0%     17.2%
                                                                     ====                ====                     ====       ====


    GAAP selling, general and
     administrative expenses                                       $1,427              $1,323                   $4,870     $5,062

    Adjustments to selling, general and administrative expenses:

    Acquisition-related expenses (b)                                 (20)               (26)                    (99)     (180)

    Certain net charges pursuant to
     our restructuring initiative                                     (1)                  -                     (2)       (5)

    Other                                                               -                  -                     (3)         -

    Total adjustments to selling,
     general and administrative
     expenses                                                        (21)               (26)                   (104)     (185)

    Non-GAAP selling, general and
     administrative expenses                                       $1,406              $1,297                   $4,766     $4,877
                                                                   ======              ======                   ======     ======


    GAAP selling, general and
     administrative expenses as a
     percentage of product sales                                    25.6%              23.4%                   22.3%     23.1%

    Acquisition-related expenses (b)                                 -0.4                -0.5                     -0.4       -0.8

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

    Other                                                             0.0                 0.0                      0.0        0.0

    Non-GAAP selling, general and
     administrative expenses as a
     percentage of product sales                                    25.2%              22.9%                   21.9%     22.3%
                                                                     ====                ====                     ====       ====


    GAAP operating expenses                                        $3,557              $3,480                  $12,876    $13,197

    Adjustments to operating expenses:

    Adjustments to cost of sales                                    (243)              (314)                 (1,126)   (1,249)

    Adjustments to research and
     development expenses                                            (18)               (22)                    (80)      (85)

    Adjustments to selling, general
     and administrative expenses                                     (21)               (26)                   (104)     (185)

    Certain net charges pursuant to
     our restructuring initiative (c)                                (27)                (9)                    (83)      (24)

    Acquisition-related adjustments
     (d)                                                              (1)                (3)                   (292)       (4)

    Expense related to legal
     proceedings                                                        -                  -                       -     (105)

    Total adjustments to operating
     expenses                                                       (310)              (374)                 (1,685)   (1,652)

    Non-GAAP operating expenses                                    $3,247              $3,106                  $11,191    $11,545
                                                                   ======              ======                  =======    =======


    GAAP operating income                                          $2,245              $2,485                   $9,973     $9,794

    Adjustments to operating expenses                                 310                 374                    1,685      1,652

    Non-GAAP operating income                                      $2,555              $2,859                  $11,658    $11,446
                                                                   ======              ======                  =======    =======


    GAAP operating income as a
     percentage of product sales                                    40.3%              43.9%                   45.8%     44.7%

    Adjustments to cost of sales                                      4.3                 5.5                      5.2        5.7

    Adjustments to research and
     development expenses                                             0.3                 0.4                      0.3        0.3

    Adjustments to selling, general
     and administrative expenses                                      0.4                 0.5                      0.4        0.8

    Certain net charges pursuant to
     our restructuring initiative (c)                                 0.6                 0.2                      0.4        0.2

    Acquisition-related adjustments
     (d)                                                              0.0                 0.0                      1.4        0.0

    Expense related to legal
     proceedings                                                      0.0                 0.0                      0.0        0.6

    Non-GAAP operating income as a
     percentage of product sales                                    45.9%              50.5%                   53.5%     52.3%
                                                                     ====                ====                     ====       ====


    GAAP income before income taxes                                $2,214              $2,283                   $9,597     $9,163

    Adjustments to operating expenses                                 310                 374                    1,685      1,652

    Non-GAAP income before income
     taxes                                                         $2,524              $2,657                  $11,282    $10,815
                                                                   ======              ======                  =======    =======


    GAAP provision for income taxes                                $6,478                $348                   $7,618     $1,441

    Adjustments to provision for income taxes:

    Income tax effect of the above
     adjustments to operating expenses
     (e)                                                               98                 113                      538        525

    Other income tax adjustments (f)                              (6,156)                 36                  (6,120)        64

    Total adjustments to provision for
     income taxes                                                 (6,058)                149                  (5,582)       589

    Non-GAAP provision for income
     taxes                                                           $420                $497                   $2,036     $2,030
                                                                     ====                ====                   ======     ======


    GAAP tax as a percentage of income
     before taxes                                                  292.6%              15.2%                   79.4%     15.7%

    Adjustments to provision for income taxes:

    Income tax effect of the above
     adjustments to operating expenses
     (e)                                                            -32.1                 2.1                     -7.1        2.5

    Other income tax adjustments (f)                               -243.9                 1.4                    -54.3        0.6

    Total adjustments to provision for
     income taxes                                                  -276.0                 3.5                    -61.4        3.1

    Non-GAAP tax as a percentage of
     income before taxes                                            16.6%              18.7%                   18.0%     18.8%
                                                                     ====                ====                     ====       ====


    GAAP net (loss) income                                       $(4,264)             $1,935                   $1,979     $7,722

    Adjustments to net (loss) income:

    Adjustments to income before
     income taxes, net of the income
     tax effect                                                       212                 261                    1,147      1,127

    Other income tax adjustments (f)                                6,156                (36)                   6,120       (64)

    Total adjustments to net (loss)
     income                                                         6,368                 225                    7,267      1,063

    Non-GAAP net income                                            $2,104              $2,160                   $9,246     $8,785
                                                                   ======              ======                   ======     ======

 

    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 EPS.


                                               Three months ended                    Three months ended

                                               December 31, 2017                      December 31, 2016
                                               -----------------                      -----------------

                                                      GAAP                                Non-GAAP             GAAP         Non-GAAP
                                                      ----                                --------             ----         --------


    Net (loss) income                                       $(4,264)                                   $2,104       $1,935           $2,160
                                                             =======                                    ======       ======           ======


    Shares (Denominator)

    Weight-average
     shares for basic
     EPS                                                         724                                       724          742              742

    Effect of dilutive
     securities                                                    -                                        5            6                6

    Weighted-average
     shares for diluted
     EPS                                                         724                                       729          748              748
                                                                 ===                                       ===          ===              ===


    Diluted (loss)
     earnings per share
     (g)                                                     $(5.89)                                    $2.89        $2.59            $2.89
                                                              ======                                     =====        =====            =====


                                                   Year ended                            Year ended

                                               December 31, 2017                      December 31, 2016
                                               -----------------                      -----------------

                                                      GAAP                                Non-GAAP             GAAP         Non-GAAP
                                                      ----                                --------             ----         --------


    Net income                                                $1,979                                    $9,246       $7,722           $8,785
                                                              ======                                    ======       ======           ======


    Shares (Denominator)

    Weight-average
     shares for basic
     EPS                                                         731                                       731          748              748

    Effect of dilutive
     securities                                                    4                                         4            6                6

    Weighted-average
     shares for diluted
     EPS                                                         735                                       735          754              754
                                                                 ===                                       ===          ===              ===


    Diluted EPS                                                $2.69                                    $12.58       $10.24           $11.65
                                                               =====                                    ======       ======           ======

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


    (b)              The adjustments related primarily to
                     non-cash amortization of intangible
                     assets acquired in business
                     combinations. For the year ended
                     December 31, 2016, the adjustment
                     also included a $73 million charge
                     resulting from the reacquisition of
                     Prolia(R), XGEVA(R) and Vectibix(R)
                     license agreements in certain markets
                     from Glaxo Group Limited.


    (c)              For the three months and year ended
                     December 31, 2017, the adjustments
                     related primarily to severance
                     expenses associated with our
                     restructuring initiative. For the
                     three months and year ended December
                     31, 2016, the adjustments related
                     primarily to asset-related charges
                     associated with our site closures.


    (d)              For the year ended December 31, 2017,
                     the adjustment included net charges
                     associated with the discontinuance of
                     the internal development of AMG 899.


    (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, 2017, were 31.6% and 31.9%,
                     respectively, compared with 30.2% and
                     31.8% 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. For the
                     three months and year ended December
                     31, 2016, the adjustments related to
                     certain acquisition items and prior
                     period items excluded from GAAP
                     earnings.


    (g)              During periods of net loss, diluted
                     loss per share is equal to basic loss
                     per share as the anti-dilutive
                     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,
                                                        ------------               ------------

                                                          2017                2016                   2017       2016
                                                          ----                ----                   ----       ----

    Net cash provided by operating activities           $3,012              $3,100                $11,177    $10,354

    Net cash used in investing activities                 (78)            (1,222)               (4,024)   (8,658)

    Net cash used in financing activities              (2,134)            (2,122)               (6,594)   (2,599)
                                                        ------              ------                 ------     ------

    Increase (decrease) in cash and cash equivalents       800               (244)                   559      (903)

    Cash and cash equivalents at beginning of period     3,000               3,485                  3,241      4,144

    Cash and cash equivalents at end of period          $3,800              $3,241                 $3,800     $3,241
                                                        ======              ======                 ======     ======



                                                     Three months ended            Years ended

                                                        December 31,               December 31,
                                                        ------------               ------------

                                                          2017                2016                   2017       2016
                                                          ----                ----                   ----       ----

    Net cash provided by operating activities           $3,012              $3,100                $11,177    $10,354

    Capital expenditures                                 (153)              (227)                 (664)     (738)

    Free cash flow                                      $2,859              $2,873                $10,513     $9,616
                                                        ======              ======                =======     ======

 

    Reconciliation of GAAP EPS Guidance to Non-GAAP

    EPS Guidance for the Year Ending December 31, 2018

    (Unaudited)



    GAAP diluted EPS guidance                                 $11.18     -    $12.36


    Known adjustments to arrive at non-GAAP*:

                       Acquisition-related expenses    (a)      1.31

                       Restructuring charges                    0.03     -      0.11


    Non-GAAP diluted EPS guidance                          $12.60      -   $13.70
                                                           ======    ===   ======


    *                The known adjustments are presented
                     net of their related tax impact
                     which amount to approximately
                     $0.40 per share, in the aggregate


    (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 non-
                     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 of our contingent
                     consideration

    Reconciliation of GAAP Tax Rate Guidance to Non-GAAP

    Tax Rate Guidance for the Year Ending December 31, 2018

    (Unaudited)


                                                                2018
                                                                ----


    GAAP tax rate guidance                                  13.0%     -    14.0%


                                   Tax rate
                                    effect of
                                    known
                                    adjustments
                                    discussed
                                    above                             1.0%



    Non-GAAP tax rate guidance                              14.0%     -    15.0%
                                                             ====    ===     ====

 

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

View original content with multimedia:http://www.prnewswire.com/news-releases/amgen-reports-fourth-quarter-and-full-year-2017-financial-results-300592305.html

SOURCE Amgen

 
 
Company Codes: NASDAQ-NMS:AMGN
 

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