EX-99.1 2 d575894dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

 

News Release

 

  

One Amgen Center Drive

Thousand Oaks, CA 91320-1799

Telephone 805-447-1000

www.amgen.com

AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

THOUSAND OAKS, Calif. (July 26, 2018) – 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 D

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.


AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 2

 

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.


AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 3

 

Product Sales Detail by Product and Geographic Region

 

     Q2’18      Q2’17      YOY D
$Millions, except percentages    US      ROW      TOTAL      TOTAL      TOTAL

Repatha®

   $ 98      $ 50      $ 148      $ 83      78%

BLINCYTO®

     34        26        60        43      40%

KYPROLIS®

     151        112        263        211      25%

Prolia®

     396        214        610        505      21%

XGEVA®

     339        113        452        395      14%

Nplate®

     107        72        179        164      9%

Vectibix®

     68        105        173        168      3%

Neulasta®

     948        152        1,100        1,087      1%

Sensipar® / Mimpara®

     330        90        420        427      (2%)

Parsabiv™

     66        7        73        —        *

Enbrel®

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

Aranesp®

     241        231        472        535      (12%)

EPOGEN®

     250        —          250        292      (14%)

NEUPOGEN®

     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®, Corlanor®, 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.


AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 4

 

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.

 

     GAAP     Non-GAAP  
$Millions, except percentages    Q2’18     Q2’17     YOY D     Q2’18     Q2’17     YOY D  

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       *     $ —       $ —         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


AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 5

 

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 D  

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.


AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 6

 

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 REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 7

 

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


AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 8

 

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.


AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 9

 

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 REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 10

 

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 REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 11

 

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 REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 12

 

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 REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 13

 

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 REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 14

 

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*:

        

Acquisition-related expenses (a)

        1.35     

Restructuring charges

     0.02        —          0.11  

Certain other expenses

        0.03     

Tax adjustments (b)

        (0.02   
  

 

 

 

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