Amgen Reports Second Quarter 2018 Financial Results

Amgen announced financial results for the second quarter of 2018.

THOUSAND OAKS, Calif., July 26, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2018. Key results include:

  • Total revenues increased 4 percent versus the second quarter of 2017 to $6.1 billion.
    • Product sales grew 2 percent globally. New and recently launched products including Repatha® (evolocumab), KYPROLIS® (carfilzomib), Prolia® (denosumab) and XGEVA® (denosumab), showed double-digit growth.
  • GAAP earnings per share (EPS) increased 20 percent to $3.48 driven by higher product sales, a lower tax rate and lower weighted-average shares outstanding.
    • GAAP operating income increased 5 percent to $2.8 billion and GAAP operating margin increased 1.5 percentage points to 49.9 percent.
  • Non-GAAP EPS increased 17 percent to $3.83 driven by higher product sales, a lower tax rate and lower weighted-average shares outstanding.
    • Non-GAAP operating income increased 2 percent to $3.1 billion and non-GAAP operating margin decreased 0.1 percentage points to 55.1 percent.
  • 2018 EPS guidance revised to $11.83-$12.62 on a GAAP basis and $13.30-$14.00 on a non-GAAP basis; total revenues guidance revised to $22.5-$23.2 billion.
  • The Company generated $1.9 billion of free cash flow in the second quarter versus $2.1 billion in the second quarter of 2017.

"Amgen's strong performance in the second quarter was driven by double-digit, volume-driven growth from our new and recently launched products," said Robert A. Bradway, chairman and chief executive officer. "Our two most recently launched products, Aimovig and Parsabiv, are off to a strong start."

    $Millions, except EPS and percentages Q2'18        Q2'17        YOY Δ


    Total Revenues                              $6,059       $5,810        4%

    GAAP Operating Income                       $2,832       $2,698        5%

    GAAP Net Income                             $2,296       $2,151        7%

    GAAP Earnings Per Share                      $3.48        $2.91       20%

    Non-GAAP Operating Income                   $3,131       $3,075        2%

    Non-GAAP Net Income                         $2,529       $2,410        5%

    Non-GAAP EPS                                 $3.83        $3.27       17%

    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 2 percent for the second quarter of 2018 versus the second quarter of 2017.
  • Repatha sales increased 78 percent driven primarily by higher unit demand, offset partially by net selling price.
  • BLINCYTO® (blinatumomab) sales increased 40 percent driven by higher unit demand.
  • KYPROLIS sales increased 25 percent driven by higher unit demand, offset partially by net selling price.
  • Prolia sales increased 21 percent driven primarily by higher unit demand and, to a lesser extent, net selling price.
  • XGEVA sales increased 14 percent driven primarily by higher unit demand and, to a lesser extent, net selling price.
  • Nplate® (romiplostim) sales increased 9 percent driven by higher unit demand, offset partially by net selling price.
  • Vectibix® (panitumumab) sales increased 3 percent driven primarily by higher unit demand, offset partially by net selling price.
  • Neulasta® (pegfilgrastim) sales increased 1 percent driven by an increase in net selling price and, to a lesser extent, favorable changes in inventory, offset partially by lower unit demand.
  • Sensipar/Mimpara® (cinacalcet) sales decreased 2 percent driven by unfavorable changes in inventory and lower unit demand as a function of Parsabiv uptake, offset partially by higher net selling price.
  • Parsabiv(etelcalcetide) was launched in the U.S. in the first quarter of 2018.
  • Enbrel® (etanercept) sales decreased 11 percent driven primarily by unfavorable changes in inventory and lower unit demand.
  • Aranesp® (darbepoetin alfa) sales decreased 12 percent driven primarily by the impact of competition on unit demand and, to a lesser extent, net selling price.
  • EPOGEN® (epoetin alfa) sales decreased 14 percent driven primarily by lower net selling price and, to a lesser extent, lower unit demand.
  • NEUPOGEN® (filgrastim) sales decreased 26 percent driven primarily by the impact of competition on unit demand and, to a lesser extent, net selling price.

Product Sales Detail by Product and Geographic Region

                      $Millions, except percentages             Q2'18                                  Q2'17        YOY Δ
                                                                -----                                  -----        -----

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


    Repatha(R)                                                             $98                     $50         $148          $83           78%

    BLINCYTO(R)                                                             34                      26           60           43           40%

    KYPROLIS(R)                                                            151                     112          263          211           25%

    Prolia(R)                                                              396                     214          610          505           21%

    XGEVA(R)                                                               339                     113          452          395           14%

    Nplate(R)                                                              107                      72          179          164            9%

    Vectibix(R)                                                             68                     105          173          168            3%

    Neulasta(R)                                                            948                     152        1,100        1,087            1%

    Sensipar(R) / Mimpara(R)                                               330                      90          420          427          (2%)

    Parsabiv(TM)                                                            66                       7           73            -      *

    Enbrel(R)                                                            1,252                      50        1,302        1,466         (11%)

    Aranesp(R)                                                             241                     231          472          535         (12%)

    EPOGEN(R)                                                              250                       -         250          292         (14%)

    NEUPOGEN(R)                                                             63                      39          102          137         (26%)

    Other**                                                                 24                      51           75           61           23%
                                                                                                  ---          ---          ---


    Total product sales                                                 $4,367                  $1,312       $5,679       $5,574            2%
                                                                        ======                  ======       ======       ======           ===


    * Change in excess of 100%

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


    KANJINTITM trade name is provisionally approved by the FDA
    ----------------------------------------------------------

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

  • Total Operating Expenses increased 4 percent due to investments in newer and recently launched products, and all expense categories also reflect savings from our transformation and process improvement efforts. Cost of Sales margin decreased by 0.4 points due to favorable royalty cost and lower acquisition-related intangible amortization, partially offset by higher manufacturing cost and unfavorable product mix. Research & Development (R&D) expenses were flat. Selling, General & Administrative (SG&A) expenses increased 12 percent due to investments in product launches and marketed product support.
  • Operating Margin improved by 1.5 percentage points to 49.9 percent.
  • Tax Rate decreased by 2.1 percentage points due to the impacts of U.S. corporate tax reform, offset partially by a prior year benefit associated with the effective settlement of certain state and federal tax matters.

On a non-GAAP basis:

  • Total Operating Expenses increased 7 percent due to investments in newer and recently launched products, and all expense categories also reflect savings from our transformation and process improvement efforts. Cost of Sales margin increased by 0.4 points driven by higher manufacturing cost and unfavorable product mix, partially offset by lower royalty expense. R&D expenses were flat. SG&A expenses increased 14 percent due to investments in product launches and marketed product support.
  • Operating Margin decreased by 0.1 percentage points to 55.1 percent.
  • Tax Rate decreased by 3.2 percentage points due to the impacts of U.S. corporate tax reform, offset partially by a prior year benefit associated with the effective settlement of certain state and federal tax matters.

 

                            $Millions, except percentages

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

                                                           Q2'18                Q2'17                            YOY Δ              Q2'18                  Q2'17                            YOY Δ
                                                           -----                -----                            -----              -----                  -----                            -----


    Cost of Sales                                                  $1,024                $1,024                            0%                   $745                    $710                          5%

                               % of
                               product
                               sales                 18.0%                18.4%                 (0.4) pts                     13.1%                  12.7%                    0.4 pts

    Research & Development                                        $869                  $873                            0%                   $850                    $851                          0%

                               % of
                               product
                               sales                 15.3%                15.7%                 (0.4) pts                     15.0%                  15.3%                   (0.3) pts

    Selling, General & Administrative                           $1,353                $1,209                           12%                 $1,333                  $1,174                         14%

                               % of
                               product
                               sales                 23.8%                21.7%                  2.1 pts                      23.5%                  21.1%                    2.4 pts

    Other                                                        ($19)                   $6                      *                            $0                      $0                      NM

    TOTAL Operating Expenses                                    $3,227                $3,112                            4%                 $2,928                  $2,735                          7%


    Operating Margin

                              operating
                               income as
                               a % of
                               product
                               sales                 49.9%                48.4%                  1.5 pts                      55.1%                  55.2%                   (0.1) pts


    Tax Rate                                                     13.3%                15.4%                 (2.1) pts                     14.2%                  17.4%                 (3.2) pts


    * Change in excess of 100%

    NM: Not Meaningful

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

Cash Flow and Balance Sheet

  • The Company generated $1.9 billion of free cash flow in the second quarter of 2018 versus $2.1 billion in the second quarter of 2017 driven by higher cash taxes resulting from the first installment of the repatriation tax paid in the second quarter of 2018, partially offset by a lower ongoing income tax liability as well as higher net income.
  • The Company's second quarter 2018 dividend of $1.32 per share was paid on June 8, 2018, a 15 percent increase versus the second quarter of 2017.
  • During the second quarter, the Company repurchased 18.2 million shares of common stock at a total cost of $3.2 billion. At the end of the second quarter, the Company had $5.4 billion remaining under its stock repurchase authorization.

 

                                     $Billions, except shares Q2'18       Q2'17        YOY Δ
                                                              -----       -----        -----


    Operating Cash Flow                                              $2.1         $2.3         ($0.2)

    Capital Expenditures                                              0.2          0.2            0.0

    Free Cash Flow                                                    1.9          2.1          (0.2)

    Dividends Paid                                                  0.9          0.8            0.0

    Share Repurchase                                                3.2          1.0            2.2

    Avg. Diluted Shares
     (millions)                                                     660          738           (78)


    Cash and Investments                                           29.4         39.2          (9.8)

    Debt Outstanding                                               34.5         35.1          (0.6)

    Stockholders' Equity                                           14.9         31.7         (16.8)


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

2018 Guidance

For the full year 2018, the Company now expects:

  • Total revenues in the range of $22.5 billion to $23.2 billion.
    • Previously, the Company expected total revenues in the range of $21.9 billion to $22.8 billion.
  • On a GAAP basis, EPS in the range of $11.83 to $12.62 and a tax rate in the range of 12.5 percent to 13.5 percent.
    • Previously, the Company expected GAAP EPS in the range of $11.30 to $12.28. Tax rate guidance is unchanged.
  • On a non-GAAP basis, EPS in the range of $13.30 to $14.00 and a tax rate in the range of 13.5 percent to 14.5 percent.
    • Previously, the Company expected non-GAAP EPS in the range of $12.80 to $13.70. Tax rate guidance is unchanged.
  • Capital expenditures to be approximately $750 million.

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

AimovigTM (erenumab-aooe)

  • In May, the U.S. Food and Drug Administration (FDA) approved Aimovig for the preventive treatment of migraine in adults.
  • In June, the Company submitted a supplemental Biologics License Application (BLA) to the FDA for the 140 mg Sureclick® autoinjector device and 140 mg prefilled syringe.

KYPROLIS

  • In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a label variation for KYPROLIS to include the overall survival (OS) data from the Phase 3 ASPIRE trial.
  • In June, the FDA approved the supplemental New Drug Application to add the OS data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information.

BLINCYTO

  • In June, the European Commission (EC) granted a full marketing authorization for BLINCYTO based on the OS data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Repatha

  • In May, the EC approved a new indication for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering lipoprotein cholesterol (LDL-C) levels.

Prolia

  • In May and June, the FDA and EC, respectively, approved a new indication for the treatment of glucocorticoid-induced osteoporosis in adults.

EVENITYTM (romosozumab)

  • In July, Amgen and UCB announced the resubmission of the BLA to the FDA for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

KANJINTITM (ABP 980)

  • In May, the EC granted marketing authorization for KANJINTI, a biosimilar to Herceptin® (trastuzumab), for the treatment of HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
  • In May, the Company received a complete response letter from the FDA on its BLA.

ABP 710 (biosimilar infliximab)

  • In June, the Company announced results from the primary analysis of a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE® (infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm noninferiority compared to infliximab but could not rule out superiority based on the primary efficacy endpoint.

Amgen Announces Succession Plans for Two Executive Officers
As part of Amgen's planned executive succession to address upcoming retirements, the Company announced that Sean E. Harper, M.D., executive vice president of Research and Development, will be retiring from his current role at Amgen and will be succeeded by David M. Reese, M.D., currently senior vice president of Translational Sciences and Oncology at Amgen. The Company also announced that Anthony C. Hooper, executive vice president of Global Commercial Operations, will be retiring from his current role in September and will be succeeded by Murdo Gordon, chief commercial officer of Bristol-Myers Squibb Company. Details of these plans are the subject of a separate Amgen press release.

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

Non-GAAP Financial Measures
In this news release, management has presented its operating results for the second quarters of 2018 and 2017, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 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 from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2018 and 2017. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

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

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

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

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

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

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and 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 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 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. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

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

 

    Amgen Inc.

    Consolidated Statements of Income - GAAP

    (In millions, except per share data)

    (Unaudited)


                                                                       Three months ended   Six months ended

                                                                            June 30,            June 30,
                                                                            --------            --------

                                                                                       2018                 2017     2018     2017
                                                                                       ----                 ----     ----     ----

    Revenues:

                           Product sales                                             $5,679               $5,574  $11,022  $10,773

                           Other revenues                                               380                  236      591      501
                           ---------

                           Total revenues                                             6,059                5,810   11,613   11,274
                                                                                      -----                -----   ------   ------


    Operating expenses:

                           Cost of sales                                              1,024                1,024    1,968    2,020

                           Research and development                                     869                  873    1,629    1,642

                            Selling, general and
                            administrative                                            1,353                1,209    2,480    2,273

                           Other                                                       (19)                   6     (22)      50

                           Total operating expenses                                   3,227                3,112    6,055    5,985
                                                                                      -----                -----    -----    -----


    Operating income                                                                2,832                2,698    5,558    5,289


    Interest expense, net                                                             347                  321      685      647

    Interest and other income, net                                                    162                  165      393      360
                                                                                      ---                  ---      ---      ---


    Income before income taxes                                                      2,647                2,542    5,266    5,002


    Provision for income taxes                                                        351                  391      659      780


    Net income                                                                     $2,296               $2,151   $4,607   $4,222
                                                                                   ======               ======   ======   ======


    Earnings per share:

                           Basic                                                      $3.50                $2.93    $6.76    $5.74

                           Diluted                                                    $3.48                $2.91    $6.73    $5.71


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

                           Basic                                                        656                  734      682      736

                           Diluted                                                      660                  738      685      740

 

    Amgen Inc.

    Consolidated Balance Sheets - GAAP

    (In millions)


                                                 June 30,            December 31,

                                                                2018                    2017
                                                                ----                    ----


    Assets

    Current assets:

                         Cash, cash
                         equivalents and
                         marketable
                         securities                        $29,395                 $41,678

                         Trade
                         receivables, net                    3,504                   3,237

                        Inventories                          3,063                   2,834

                         Other current
                         assets                              2,008                   1,727


                                     Total
                                     current
                                     assets                   37,970                  49,476

    Property, plant and equipment,
     net                                                    4,922                   4,989

    Intangible assets, net                                  8,443                   8,609

    Goodwill                                               14,724                  14,761

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

    Total assets                                          $67,684                 $79,954
                                                          =======                 =======


    Liabilities and
     Stockholders' Equity

    Current liabilities:

                         Accounts payable
                         and accrued
                         liabilities                        $6,917                  $7,868

                         Current portion
                         of long-term
                         debt                                4,288                   1,152

                                     Total
                                     current
                                     liabilities              11,205                   9,020

    Long-term debt                                         30,209                  34,190

    Long-term deferred tax
     liabilities                                            1,155                   1,166

    Long-term tax liabilities                               8,763                   9,099

    Other noncurrent liabilities                            1,443                   1,238

    Stockholders' equity                                   14,909                  25,241
                                                           ------                  ------

    Total liabilities and
     stockholders' equity                                 $67,684                 $79,954
                                                          =======                 =======


    Shares outstanding                                        649                     722

 

 

    Amgen Inc.

    GAAP to Non-GAAP Reconciliations

    (Dollars in millions)

    (Unaudited)


                                                                         Three months ended           Six months ended

                                                                          June 30,                 June 30,
                                                                          --------                 --------

                                                                         2018               2017                    2018     2017
                                                                         ----               ----                    ----     ----


                    GAAP cost of sales                                   $1,024             $1,024                  $1,968   $2,020

                    Adjustments to cost of sales:

                    Acquisition-related expenses (a)                      (279)             (314)                  (545)   (628)

                    Total adjustments to cost of sales                    (279)             (314)                  (545)   (628)

                    Non-GAAP cost of sales                                 $745               $710                  $1,423   $1,392
                    ======================


                     GAAP cost of sales as a percentage of product
                     sales                                                18.0%             18.4%                  17.9%   18.8%

                    Acquisition-related expenses (a)                       -4.9               -5.7                    -5.0     -5.9

                     Non-GAAP cost of sales as a percentage of
                     product sales                                        13.1%             12.7%                  12.9%   12.9%
                                                                        =====


                    GAAP research and development expenses                 $869               $873                  $1,629   $1,642

                    Adjustments to research and development expenses:

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

                     Certain net charges pursuant to our restructuring
                     initiative                                               -               (3)                      -     (5)

                     Total adjustments to research and development
                     expenses                                              (19)              (22)                   (40)    (43)

                    Non-GAAP research and development expenses             $850               $851                  $1,589   $1,599
                    =========================


                     GAAP research and development expenses as a
                     percentage of product sales                          15.3%             15.7%                  14.8%   15.2%

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

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

                     Non-GAAP research and development expenses as a
                     percentage of product sales                          15.0%             15.3%                  14.4%   14.8%
                                                                        =====


                    GAAP selling, general and administrative expenses    $1,353             $1,209                  $2,480   $2,273

                     Adjustments to selling, general and
                     administrative expenses:

                    Acquisition-related expenses (a)                       (20)              (32)                   (45)    (57)

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

                    Other                                                     -               (3)                      -     (3)

                     Total adjustments to selling, general and
                     administrative expenses                               (20)              (35)                   (48)    (60)

                     Non-GAAP selling, general and administrative
                     expenses                                            $1,333             $1,174                  $2,432   $2,213
                                                                       ======


                     GAAP selling, general and administrative expenses
                     as a percentage of product sales                     23.8%             21.7%                  22.5%   21.1%

                    Acquisition-related expenses (a)                       -0.3               -0.5                    -0.4     -0.6

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

                    Other                                                   0.0               -0.1                     0.0      0.0

                     Non-GAAP selling, general and administrative
                     expenses as a percentage of product sales            23.5%             21.1%                  22.1%   20.5%
                                                                        =====


                    GAAP operating expenses                              $3,227             $3,112                  $6,055   $5,985

                    Adjustments to operating expenses:

                    Adjustments to cost of sales                          (279)             (314)                  (545)   (628)

                    Adjustments to research and development expenses       (19)              (22)                   (40)    (43)

                     Adjustments to selling, general and
                     administrative expenses                               (20)              (35)                   (48)    (60)

                     Certain net charges pursuant to our restructuring
                     initiative (b)                                           7                (9)                      6     (46)

                    Certain other expenses                                 (25)                 -                   (25)       -

                    Acquisition-related adjustments (c)                      37                  3                      41      (4)

                    Total adjustments to operating expenses               (299)             (377)                  (611)   (781)

                    Non-GAAP operating expenses                          $2,928             $2,735                  $5,444   $5,204
                                                                       ======


                    GAAP operating income                                $2,832             $2,698                  $5,558   $5,289

                    Adjustments to operating expenses                       299                377                     611      781

                    Non-GAAP operating income                            $3,131             $3,075                  $6,169   $6,070
                                                                       ======


                     GAAP operating income as a percentage of product
                     sales                                                49.9%             48.4%                  50.4%   49.1%

                    Adjustments to cost of sales                            4.9                5.7                     5.0      5.9

                    Adjustments to research and development expenses        0.3                0.4                     0.4      0.4

                     Adjustments to selling, general and
                     administrative expenses                                0.3                0.6                     0.4      0.6

                     Certain net charges pursuant to our restructuring
                     initiative (b)                                         0.0                0.2                     0.0      0.3

                    Certain other expenses                                  0.4                0.0                     0.2      0.0

                    Acquisition-related adjustments (c)                    -0.7               -0.1                    -0.4      0.0

                     Non-GAAP operating income as a percentage of
                     product sales                                        55.1%             55.2%                  56.0%   56.3%
                                                                        =====


                    GAAP interest and other income, net                    $162               $165                    $393     $360

                    Adjustments to other income (d)                           -                 -                   (75)       -

                    Non-GAAP interest and other income, net                $162               $165                    $318     $360
                    =========================


                    GAAP income before income taxes                      $2,647             $2,542                  $5,266   $5,002

                    Adjustments to operating expenses                       299                377                     611      781

                    Adjustments to other income (d)                           -                 -                   (75)       -

                    Non-GAAP income before income taxes                  $2,946             $2,919                  $5,802   $5,783
                                                                       ======


                    GAAP provision for income taxes                        $351               $391                    $659     $780

                    Adjustments to provision for income taxes:

                    Income tax effect of the above adjustments (e)           74                117                     138      236

                    Other income tax adjustments (f)                        (8)                 1                      10       24

                    Total adjustments to provision for income taxes          66                118                     148      260

                    Non-GAAP provision for income taxes                    $417               $509                    $807   $1,040
                    =========================


                    GAAP tax as a percentage of income before taxes       13.3%             15.4%                  12.5%   15.6%

                    Adjustments to provision for income taxes:

                    Income tax effect of the above adjustments (e)          1.2                2.0                     1.2      2.0

                    Other income tax adjustments (f)                       -0.3                0.0                     0.2      0.4

                    Total adjustments to provision for income taxes         0.9                2.0                     1.4      2.4

                     Non-GAAP tax as a percentage of income before
                     taxes                                                14.2%             17.4%                  13.9%   18.0%
                                                                        =====


                    GAAP net income                                      $2,296             $2,151                  $4,607   $4,222

                    Adjustments to net income:

                     Adjustments to income before income taxes, net of
                     the income tax effect                                  225                260                     398      545

                    Other income tax adjustments (f)                          8                (1)                   (10)    (24)

                    Total adjustments to net income                         233                259                     388      521

                    Non-GAAP net income                                  $2,529             $2,410                  $4,995   $4,743
                                                                       ======

 

    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

                                                   June 30, 2018          June 30, 2017
                                                   -------------          -------------

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


               Net income                                       $2,296                    $2,529      $2,151          $2,410

                Weighted-average shares for
                diluted EPS                                        660                       660         738             738

               Diluted EPS                                       $3.48                     $3.83       $2.91           $3.27
                                                               =====


                                                  Six months ended      Six months ended

                                                   June 30, 2018          June 30, 2017
                                                   -------------          -------------

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


               Net income                                       $4,607                    $4,995      $4,222          $4,743

                Weighted-average shares for
                diluted EPS                                        685                       685         740             740

               Diluted EPS                                       $6.73                     $7.29       $5.71           $6.41
                                                               =====
    (a)              The adjustments related
                     primarily to non-cash
                     amortization of
                     intangible assets
                     acquired in business
                     combinations.


    (b)              For the six months ended
                     June 30, 2017, the
                     adjustment related
                     primarily to severance
                     expenses associated with
                     our restructuring
                     initiative.


    (c)              For the three and six
                     months ended June 30,
                     2018, the adjustment
                     related primarily to the
                     change in fair values of
                     contingent consideration
                     liabilities.


    (d)              For the six months ended
                     June 30, 2018, the
                     adjustment related to
                     the net gain associated
                     with the Kirin-Amgen
                     share acquisition.


    (e)              The tax effect of the
                     adjustments between our
                     GAAP and non-GAAP
                     results takes into
                     account the tax
                     treatment and related
                     tax rate(s) that apply
                     to each adjustment in
                     the applicable tax
                     jurisdiction(s).
                     Generally, this results
                     in a tax impact at the
                     U.S. marginal tax rate
                     for certain adjustments,
                     including the majority
                     of amortization of
                     intangible assets,
                     whereas the tax impact
                     of other adjustments,
                     including restructuring
                     expense, depends on
                     whether the amounts are
                     deductible in the
                     respective tax
                     jurisdictions and the
                     applicable tax rate(s)
                     in those jurisdictions.
                     Due to these factors,
                     the effective tax rates
                     for the adjustments to
                     our GAAP income before
                     income taxes, for the
                     three and six months
                     ended June 30, 2018 were
                     24.7% and 25.7%,
                     compared with 31.0% and
                     30.2% for the
                     corresponding periods of
                     the prior year.


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

 

    Amgen Inc.

    Reconciliations of Cash Flows

    (In millions)

    (Unaudited)


                                                               Three months ended         Six months ended

                                                                 June 30,                June 30,
                                                                 --------                --------

                                                                              2018        2017                 2018       2017
                                                                              ----        ----                 ----       ----

                 Net cash provided by operating activities                    $2,102      $2,326               $4,829     $4,711

                  Net cash provided by (used in) investing
                  activities                                                   2,938     (1,813)              17,844    (1,970)

                 Net cash used in financing activities                       (4,650)    (1,242)            (16,342)   (3,353)
                                                                           -------

                  Increase (decrease) in cash and cash
                  equivalents                                                    390       (729)               6,331      (612)

                  Cash and cash equivalents at beginning of
                  period                                                       9,741       3,358                3,800      3,241

                 Cash and cash equivalents at end of period                  $10,131      $2,629              $10,131     $2,629
                                                                           =======



                                                            Three months ended       Six months ended

                                                                 June 30,                June 30,
                                                                 --------                --------

                                                                              2018        2017                 2018       2017
                                                                              ----        ----                 ----       ----

                 Net cash provided by operating activities                    $2,102      $2,326               $4,829     $4,711

                 Capital expenditures                                          (187)      (185)               (342)     (353)

                 Free cash flow                                               $1,915      $2,141               $4,487     $4,358
                                                                            ======

 

 

    Reconciliation of GAAP EPS Guidance to Non-GAAP

    EPS Guidance for the Year Ending December 31, 2018

    (Unaudited)



    GAAP diluted EPS guidance                                                             $11.83      -   $12.62


    Known adjustments to arrive at non-GAAP*:

                                                                                              1.35

                                                        Acquisition-related expenses
                                                        (a)

                                                                                     0.02         -  0.11

                                                       Restructuring charges

                                                                                              0.03

                                                       Certain other expenses

                                                                                            (0.02)

                                                       Tax adjustments (b)

    Non-GAAP diluted EPS guidance                                                         $13.30      -   $14.00
                                                                                          ======    ===   ======
    *                           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.


    (b)                         The adjustments relate primarily to
                                certain acquisition items and
                                prior period items excluded from
                                GAAP earnings.


                     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 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                                  12.5%    -   13.5%


                                            Tax rate
                                             effect of
                                             known
                                             adjustments
                                             discussed
                                             above                  1.0%



    Non-GAAP tax rate guidance                              13.5%    -   14.5%
                                                             ====   ===    ====

 

 

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SOURCE Amgen

 

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