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Amgen's First Quarter 2013 Revenues Increased 5 Percent To $4.2 Billion And Adjusted Earnings Per Share (EPS) Increased 22 Percent To $1.96
Date:4/23/2013

THOUSAND OAKS, Calif., April 23, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the first quarter of 2013.  Key results for the quarter include:

  • Total revenues increased 5 percent to $4,238 million, with 6 percent product sales growth driven by Enbrel® (etanercept), XGEVA® (denosumab) and Prolia® (denosumab).
  • Adjusted EPS grew 22 percent to $1.96 driven by tax benefits and fewer shares outstanding in the quarter.  Adjusted net income increased 16 percent to $1,498 million.
  • GAAP EPS were $1.88 compared to $1.48 and GAAP net income was $1,434 million compared to $1,184 million.
  • Free cash flow was $0.9 billion compared to $0.8 billion.
  • "We are on track to deliver our full-year growth objectives," said Robert A. Bradway, chairman and chief executive officer at Amgen. "In addition, our key pipeline projects are progressing well and we are looking forward to clinical results from ongoing trials."Year-over-Year$Millions, except EPS and percentagesQ1 '13Q1 '12YOY ΔTotal Revenues$4,238$4,0485%Adjusted Net Income1,4981,28716%Adjusted EPS$1.96$1.6122%GAAP Net Income1,4341,18421%GAAP EPS$1.88$1.4827%References in this release to "adjusted" measures, measures presented "on an adjusted basis" or to free cash flow refer to non-GAAP financial measures. These adjustments and other items are presented on the attached reconciliations.Product Sales Performance

  • Total product sales increased 6 percent driven by ENBREL, XGEVA and Prolia.
  • Combined Neulasta® (pegfilgrastim) and NEUPOGEN® (Filgrastim) sales were in line with the prior year.
  • Global Neulasta sales were in line with the prior year as price increases were offset by modest unit declines.
  • Global NEUPOGEN sales declined 2 percent driven by lower units.
  • ENBREL sales increased 11 percent mainly driven by increases in the average net sales price and a favorable change in accounting estimates, partially offset by a slight decline in units and a reduction in wholesaler inventory.
  • Aranesp® (darbepoetin alfa) sales decreased 10 percent year over year and 4 percent sequentially.  Outside the U.S., sales were in line with the prior quarter.  In the U.S., segment share remained relatively stable, but overall demand declined sequentially.
  • EPOGEN®(epoetin alfa) sales decreased 2 percent year over year.  Sequentially, sales decreased 9 percent driven by a favorable change in accounting estimates in the fourth quarter and lower average net prices.
  • Sensipar®/Mimpara® (cinacalcet) sales increased 21 percent driven by increased unit demand and a favorable change in accounting estimates.
  • Combined sales of Vectibix® (panitumumab) and Nplate® (romiplostim) increased 2 percent.
  • XGEVA sales increased 46 percent year over year and 4 percent on a sequential basis, reflecting increased segment share.
  • Prolia sales increased 61 percent year over year reflecting increased segment share and declined 8 percent on a sequential basis primarily due to seasonality.
  • Product Sales Detail by Product and Geographic Region$Millions, except percentagesQ1 '13Q1 '12YOY ΔUSROWTOTALTOTALTOTALNeulasta®/ NEUPOGEN®$1,069

    $269

    $1,338$1,3440%Neulasta®827

    212

    1,0391,0390%NEUPOGEN®242

    57

    299305(2%)Enbrel®974

    65

    1,03993811%Aranesp®168

    300

    468518(10%)EPOGEN®435

    0

    435446(2%)Sensipar® / Mimpara®179

    85

    26421921%Vectibix®27

    60

    8790(3%)Nplate®55

    41

    96907%XGEVA®/ Prolia®

    265

    100

    36524151%XGEVA®178

    45

    22315346%Prolia®87

    55

    1428861%Other 0

    59

    5915*Total product sales$3,172

    $979

    $4,151$3,9016%* Change in excess of 100%Operating Expense and Tax Rate Analysis, on an Adjusted Basis

  • Cost of Sales, excluding the impact of the Puerto Rico excise tax, decreased 0.9 points.
  • Research & Development (R&D) expenses increased 18 percent in the first quarter of 2013 primarily in support of our later-stage clinical programs, including AMG 145.
  • Selling, General & Administrative (SG&A) expenses increased 8 percent in the first quarter of 2013 driven primarily by higher ENBREL profit share expenses. ENBREL profit share expenses increased 17 percent to $378 million in the first quarter. 
  • $Millions, except percentagesOn an Adjusted BasisQ1 '13Q1 '12YOY ΔCost of Sales

    $671$6661%% of sales

    16.2%17.1%(0.9) pts% of sales (Excluding PR excise tax)

    14.1%15.0%(0.9) ptsResearch & Development

    $851$72318%% of sales

    20.5%18.5%2.0 ptsSelling, General & Administrative

    $1,144$1,0578%% of sales

    27.6%27.1%0.5 ptsTOTAL Operating Expenses$2,666$2,4469%pts: percentage points

  • Adjusted Tax Rate for Q1 2013 reflects the federal and state tax benefits associated with the resolution of the Company's federal audit for tax years 2007-2009.  In addition, the American Taxpayer Relief Act of 2012 was enacted in the first quarter of 2013, resulting in recognition of the full 2012 federal R&D credit in the first quarter of 2013.
  • On an Adjusted BasisQ1 '13Q1 '12YOY ΔTax Rate*

    (0.9%)15.6%(16.5) ptsTax Rate (Excluding PR excise tax credits)

    4.2%20.2%(16.0) ptspts: percentage points* Note: Q1 represents a net tax benefit of $13MCash Flow and Balance Sheet Discussion

  • The Company generated $0.9 billion of free cash flow in the first quarter of 2013 versus $0.8 billion in the first quarter of 2012. The increase was driven primarily by higher revenues offset partially by higher cash taxes.
  • During the quarter, the Company repurchased approximately 9 million shares of common stock at a total cost of $0.8 billion and at an average price of $85.03. The Company has $1.6 billion remaining under its stock repurchase authorization.
  • During the quarter, the Company settled in cash $2.5 billion of 0.375 percent Convertible Senior Notes upon their maturity.
  • The Company previously announced that its Board of Directors declared a $0.47 per share dividend for the second quarter of 2013. The dividend will be paid on June 7, 2013, to all stockholders of record as of the close of business on May 16, 2013.
  • $Billions, except sharesQ1 '13Q1 '12YOY ΔOperating Cash Flow

    $1.0$1.0$0.1Free Cash Flow

    0.90.80.1Dividend Paid

    0.40.30.1Cost of Shares Repurchased

    0.81.4(0.7)Adjusted Avg. Diluted Shares (millions)

    764799(35)Cash Balance

    21.319.41.9Debt Outstanding

    23.921.42.5Stockholders' Equity

    19.518.90.6Note: Numbers may not add due to rounding2013 Guidance For the full year 2013, the Company expects:

  • Total revenue guidance range unchanged at $17.8 billion to $18.2 billion.
  • Adjusted EPS to be above the midpoint of the range of $7.05–$7.35.
  • Adjusted tax rate to be in the range of 11 percent to 12 percent.  This reflects the impact of a higher excise tax enacted by the Puerto Rico government, to be effective July 1 of this year. The tax, which is charged to Cost of Sales, is creditable against U.S. federal income taxes.  Excluding the Puerto Rico excise tax, Amgen expects the adjusted tax rate for 2013 to be in the range of 15 percent to 16 percent.
  • Capital expenditures guidance unchanged at approximately $700 million.
  • First Quarter Product and Pipeline Update The Company provided the following information on clinical programs:

  • Talimogene laherparepvec:  The Company discussed that data from a Phase 3 study in melanoma will be presented at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in June.  The Company also discussed that primary analysis of the overall survival secondary end point is expected in late 2013.
  • Trebananib:  The Company stated that progression-free survival results from a Phase 3 study in recurrent ovarian cancer are expected mid-year.
  • AMG 416:  The Company stated that it recently initiated Phase 3 studies for the treatment of secondary hyperparathyroidism.
  • Biosimilars:  The Company discussed plans to commence a pivotal study for biosimilar Herceptin® (trastuzumab) in the second quarter.
  • Note: Herceptin® is a product of Genentech, a member of the Roche group

    Non-GAAP Financial Measures
    The Adjusted non-GAAP (U.S. Generally Accepted Accounting Principles) financial measures included above for the first quarters of 2013 and 2012 exclude, for the applicable periods, certain expenses related to acquisitions, cost-savings initiatives, various legal proceedings, non-cash interest expense associated with our convertible notes and certain other adjustments, as applicable. These adjustments and other items are presented on the attached reconciliations.

    Management has presented its operating results in accordance with GAAP and on an "adjusted" (or non-GAAP) basis and Free Cash Flow which is a non-GAAP financial measure for the first quarters of 2013 and 2012.  In addition, management has presented its full year 2013 EPS and tax rate guidance in accordance with GAAP and on an "adjusted" (or non-GAAP) basis.  The Company believes that the presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors.  The Company uses these non-GAAP financial measures in connection with its own budgeting and financial planning.  These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP.

    About Amgen
    Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. 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 involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended Dec. 31, 2012, and in any subsequent periodic reports on Form 10-Q and Form 8-K.  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.  The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign), and difficulties or delays in manufacturing our products.  In addition, sales of our products are affected by reimbursement policies imposed by third-party payors, 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 as well as U.S. legislation affecting pharmaceutical pricing and reimbursement.  Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products.  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.  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.  We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products 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 some 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.  Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.  Amgen Inc.Condensed Consolidated Statements of Income - GAAP(In millions, except per share data)(Unaudited)Three months endedMarch 31, 20132012Revenues:Product sales$ 4,151$ 3,901Other revenues87147Total revenues4,2384,048Operating expenses:Cost of sales744750Research and development878736Selling, general and administrative1,1581,079Other166Total operating expenses2,7962,571Operating income1,4421,477Interest expense, net263235Interest and other income, net164124Income before income taxes1,3431,366Provision for income taxes(91)182Net income$ 1,434$ 1,184Earnings per share:Basic$   1.91$   1.50Diluted$   1.88$   1.48Average shares used in calculation of earnings per share:Basic751791Diluted764800 

     Amgen Inc.Condensed Consolidated Balance Sheets - GAAP (In millions)(Unaudited)March 31, December 31, 20132012AssetsCurrent assets:Cash, cash equivalents and marketable securities$
    21,271$
    24,061Trade receivables, net2,5282,518Inventories2,7372,744Other current assets2,1591,886Total current assets28,69531,209Property, plant and equipment, net5,2965,326Intangible assets, net3,8973,968Goodwill12,60412,662Other assets1,1481,133Total assets$
    51,640$
    54,298Liabilities and Stockholders' EquityCurrent liabilities:Accounts payable and accrued liabilities$
    5,135$
    5,696Current portion of long-term debt72,495Total current liabilities5,1428,191Long-term debt23,88524,034Other non-current liabilities3,1223,013Stockholders' equity19,49119,060Total liabilities and stockholders' equity$
    51,640$
    54,298Shares outstanding750756 

     Amgen Inc.GAAP to "Adjusted" Reconciliations(In millions)(Unaudited)Three months endedMarch 31, 20132012GAAP cost of sales$
    744$
    750Adjustments to cost of sales:Non-cash amortization of product technology rights acquired in a prior year business combination

    (71)(71)Stock option expense (a)(2)(3)Certain charges pursuant to our continuing efforts to improve cost efficiencies in our operations

    -(10)Total adjustments to cost of sales(73)(84)Adjusted cost of sales$
    71$GAAP research and development expenses$
    878$
    736Adjustments to research and development expenses:Acquisition-related expenses (b)(22)(7)Stock option expense (a)(5)(6)Total adjustments to research and development expenses(27)(13)Adjusted research and development expenses$
    851$
    723GAAP selling, general and administrative expenses$
    ,158$
    ,079Adjustments to selling, general and administrative expenses:Acquisition-related expenses (c)(10)(15)Stock option expense (a)(4)(7)Total adjustments to selling, general and administrative expenses(14)(22)Adjusted selling, general and administrative expenses$
    ,144$
    ,057GAAP operating expenses$
    2,796$
    2,571Adjustments to operating expenses:Adjustments to cost of sales

    (73)(84)Adjustments to research and development expenses

    (27)(13)Adjustments to selling, general and administrative expenses

    (14)(22)Expense resulting from changes in the estimated fair values of the contingent consideration obligations related to a prior year business combination

    (1)(2)Certain charges pursuant to our continuing efforts to improve cost efficiencies in our operations

    -(1)Expense related to various legal proceedings

    (15)(3)Total adjustments to operating expenses(130)(125)Adjusted operating expenses$
    2,666$
    2,446GAAP income before income taxes$
    ,343$
    ,366Adjustments to income before income taxes:Adjustments to operating expenses

    130125Non-cash interest expense associated with our convertible notes

    1234Total adjustments to income before income taxes142159Adjusted income before income taxes$
    ,485$
    ,525GAAP provision for income taxes$
    (91)$
    82Adjustments to provision for income taxes:Income tax effect of the above adjustments (d)4056Income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities

    38-Total adjustments to provision for income taxes7856Adjusted provision for income taxes$
    (13)$
    238GAAP net income$
    ,434$
    ,184Adjustments to net income:Adjustments to income before income taxes, net of the tax effect of the above adjustments

    102103Income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities

    (38)-Total adjustments to net income64103Adjusted net income$
    ,498$
    ,287 

     Amgen Inc.GAAP to "Adjusted" Reconciliations(In millions, except per share data)(Unaudited)The following table presents the computations for GAAP and "Adjusted" diluted EPS, computed under the treasury stock method"Adjusted" EPS presented below excludes stock option expense:Three months endedThree months endedMarch 31, 2013March 31, 2012GAAP"Adjusted"GAAP"Adjusted"Income (Numerator):Net income for basic and diluted EPS

    $
    ,434$
    ,498$
    ,184$
    ,287Shares (Denominator):Weighted-average shares for basic EPS

    751751791791Effect of dilutive securities

    1313(*)98(*)Weighted-average shares for diluted EPS

    764764800799Diluted EPS

    $
    .88$
    .96$
    .48$
    .61(*)  Dilutive securities used to compute "Adjusted" diluted EPS for the three months ended March 31, 2013 and 2012 were computed under the treasury stock method assuming that we do not expense stock options. (a)For the three months ended March 31, 2013 and 2012, the total pre-tax expense for employee stock options was $11 million and $16 million, respectively"Adjusted" diluted EPS including the impact of stock option expense for the three months ended March 31, 2013 and 2012 was as follows: Three months endedMarch 31, 20132012"Adjusted" diluted EPS, excluding stock option expense

    $
    .96$
    .61Impact of stock option expense (net of tax)

    (0.01)(0.02)"Adjusted" diluted EPS, including stock option expense

    $
    .95$
    .59(b)The adjustments in 2013 related primarily to non-cash amortization of intangible assets acquired in prior year business combinations. The adjustments in 2012 included non-cash amortization of intangible assets acquired in a prior year business combination and other acquisition-related expenses(c)The adjustments in 2013 related to non-cash amortization of intangible assets acquired in prior year business combinations. The adjustments in 2012 related primarily to transaction costs as well as non-cash amortization of intangible assets acquired in prior year business combinations(d)The tax effect of the adjustments between our GAAP and "Adjusted" 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 and non-cash interest expense associated with our convertible notes, whereas the tax impact of other adjustments, including stock option expense, depends on whether the amounts are deductible in the tax jurisdictions where the expenses are incurred or the asset is located and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rates for the adjustments to our GAAP income before income taxes, for the three months ended March 31, 2013 and 2012, were 28.2% and 35.2%, respectivelyNote:For the three months ended March 31, 2012, expenses related to amortization of certain acquired intangible assets within operating expenses have been reclassified to conform to the current year presentationAmgen Inc.Reconciliation of Free Cash Flow(In millions)(Unaudited)Three months endedMarch 31, 20132012Cash Flows from Operations

    $
    ,049$
    972Capital Expenditures

    (158)(144)Free Cash Flow

    $
    891$
    828 

     Reconciliation of GAAP EPS Guidance to "Adjusted" EPS Guidance for the Year Ending December 31, 2013(Unaudited)The Company updated its "Adjusted" EPS guidance to be above the midpoint of the range of $7.05 to $7.352013GAAP diluted EPS guidance$  6.68

    -

    $  6.98Known adjustments to arrive at "Adjusted" earnings*:Acquisition-related expenses

    (a)0.36Stock option expense0.03Expense related to a legal proceeding0.02Non-cash interest expense associated with our convertible notes0.01Tax settlement

    (b)(0.05)"Adjusted" diluted EPS guidance$  7.05

    -

    $  7.35*The known adjustments are presented net of their related aggregate tax impact of approximately $0.20 per share. (a)To exclude acquisition-related expenses related primarily to non-cash amortization of intangible assets acquired in prior year business combinations(b)To exclude income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authoritiesReconciliation of GAAP Tax Rate Guidance to "Adjusted" Tax Rate Guidance for the Year Ending December 31, 2013(Unaudited)2013 with PR excise tax credit2013 without PR excise tax creditGAAP tax rate guidance9%

    -

    10%13%

    -

    14%Tax rate effect of known adjustments discussed above2%2%"Adjusted" tax rate guidance11%

    -

    12%15%

    -

    16% 

    CONTACT: Amgen, Thousand Oaks
    Ashleigh Koss, 805-313-6151 (media)
    Arvind Sood, 805-447-1060 (investors)

    (Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)


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