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Amgen's Second Quarter 2013 Revenues Increased 5 Percent To $4.7 Billion And Adjusted Earnings Per Share (EPS) Increased 3 Percent To $1.89
Date:7/30/2013

THOUSAND OAKS, Calif., July 30, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the second quarter of 2013.  Key results for the quarter include:

  • Total revenues increased 5 percent to $4,679 million, with 9 percent product sales growth driven by Enbrel® (etanercept), Neulasta® (pegfilgrastim), XGEVA® (denosumab), and Prolia® (denosumab).  Product sales included a positive adjustment of $185 million to previous estimates for managed Medicaid rebates based on recent claims experience.  Other revenues were lower by $193 million as a result of a payment from Takeda recognized in the second quarter of 2012.
  • Adjusted EPS grew 3 percent to $1.89, with higher revenues and a lower tax rate partially offset by increased Research & Development (R&D) investment.  Adjusted net income increased 1 percent to $1,444 million.
  • GAAP EPS were $1.65 compared to $1.61 and GAAP net income was $1,258 million compared to $1,266 million.
  • The Company generated approximately $1.4 billion of free cash flow.
  • "We saw solid product trends during the second quarter and are carrying good momentum into the second half," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We continue to make excellent progress with our pipeline of innovative molecules and look forward to multiple data readouts in 2014, including pivotal Phase 3 data for our cholesterol-lowering agent, AMG 145, in the first quarter."Year-over-Year$Millions, except EPS and percentagesQ2 '13Q2 '12YOY ΔTotal Revenues$4,679$4,4775%Adjusted Net Income1,4441,4331%Adjusted EPS1.891.833%GAAP Net Income1,2581,266(1%)GAAP EPS$1.65$1.612%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 9 percent year-over-year.
  • Combined Neulasta and NEUPOGEN (filgrastim) sales increased 7 percent year-over-year.
  • Global Neulasta sales increased 10 percent driven by price increases, increases in wholesaler inventory and the Medicaid rebate adjustment, partially offset by unit declines.
  • Global NEUPOGEN sales declined 2 percent driven by lower units, partially offset by price increases and the Medicaid rebate adjustment. 
  • ENBREL sales increased 9 percent mainly driven by price increases.
  • Aranesp® (darbepoetin alfa) sales decreased 2 percent year-over-year.  Sequentially, sales were flat excluding the Medicaid rebate adjustment.
  • EPOGEN®(epoetin alfa) sales decreased 4 percent year-over-year.  Sequentially, sales increased 15 percent driven by an increase in units due to the peginesatide recall and the Medicaid rebate adjustment.
  • Sensipar®/Mimpara® (cinacalcet) sales increased 12 percent year-over-year driven by increases in unit demand.
  • Combined sales of Vectibix® (panitumumab) and Nplate® (romiplostim) increased 13 percent, mainly due to unit growth. 
  • XGEVA sales increased 39 percent year-over-year and 12 percent on a sequential basis, reflecting increased segment share.
  • Prolia sales increased 57 percent year-over-year and increased 32 percent on a sequential basis due to increased segment share, partially driven by seasonality.
  • Product Sales Detail by Product and Geographic Region 

    $Millions, except percentagesQ2 '13Q2 '12YOY ΔUSROWTOTALTOTALTOTALNeulasta®/ NEUPOGEN® $1,164

    $280

    $1,444$1,3477%Neulasta® 897

    223

    1,1201,01510%NEUPOGEN®267

    57

    324332(2%)Enbrel®1,089

    68

    1,1571,0589%Aranesp®228

    296

    524536(2%)EPOGEN®502

    0

    502525(4%)Sensipar® / Mimpara®178

    81

    25923212%Vectibix®31

    62

    93903%Nplate®62

    43

    1058622%XGEVA®/ Prolia®

    307

    130

    43729946%XGEVA®189

    60

    24917939%Prolia®118

    70

    18812057%Other 0

    74

    7427*Total product sales$3,561

    $1,034

    $4,595$4,2009%* Change in excess of 100%Operating Expense and Tax Rate Analysis, on an Adjusted Basis

  • Cost of Sales margin, excluding the impact of the Puerto Rico excise tax, was flat year-over-year.
  • R&D expenses increased 17 percent primarily in support of our later-stage clinical programs, including AMG 145.
  • Selling, General & Administrative (SG&A) expenses increased 3 percent driven primarily by higher ENBREL profit share expenses. ENBREL profit share expenses increased 15 percent to $425 million. 
  • $Millions, except percentagesOn an Adjusted BasisQ2 '13Q2 '12YOY ΔCost of Sales

    $714$6687%% of sales

    15.5%15.9%(0.4) pts.% of sales (Excluding PR excise tax)

    13.9%13.9%0 pts.Research & Development

    $944$80717%% of sales

    20.5%19.2%1.3 pts.Selling, General & Administrative

    $1,237$1,1993%% of sales

    26.9%28.5%(1.6) pts.TOTAL Operating Expenses$2,895$2,6748%pts: percentage points

  • Adjusted Tax Rate for the second quarter of 2013 reflects the favorable tax impacts of the federal R&D credit and changes in the jurisdictional mix of income and expenses.
  • On an Adjusted BasisQ2 '13Q2 '12YOY ΔTax Rate

    11.9%16.0%(4.1) pts.Tax Rate (Excluding PR excise tax credits)

    16.3%20.6%(4.3) pts.pts: percentage pointsCash Flow and Balance Sheet Discussion

  • The Company generated $1.4 billion of free cash flow in the second quarter of 2013 versus $2.2 billion in the second quarter of 2012. The decrease was primarily driven by cash received in the second quarter of 2012 from the termination of fixed to floating interest rate swap agreements and the collection of outstanding trade receivables in Spain.
  • The Company did not repurchase shares in the quarter and has $1.6 billion remaining under its stock repurchase authorization.
  • The Company previously announced that its Board of Directors declared a $0.47 per share dividend for the third quarter of 2013. The dividend will be paid on Sept. 6, 2013, to all stockholders of record as of the close of business on Aug. 16, 2013.
  • $Billions, except sharesQ2 '13Q2 '12YOY ΔOperating Cash Flow

    $1.6$2.4(0.8)Capital Expenditures

    (0.2)(0.2)0.0Free Cash Flow

    1.42.2(0.8)Dividend Paid

    0.40.30.1Cost of Shares Repurchased

    0.01.2(1.2)Adjusted Avg. Diluted Shares (millions)

    763784(21)Cash Balance

    22.022.5(0.5)Debt Outstanding

    23.924.4(0.5)Stockholders' Equity

    20.619.21.4Note: Numbers may not add due to rounding2013 Guidance For the full year 2013, the Company expects:

  • Total revenues to be at the upper end of $17.8 billion to $18.2 billion
  • Adjusted EPS to be in the range of $7.30 to $7.45
  • Adjusted tax rate to be in the range of 9 percent to 10 percent.  This reflects the favorable tax impact of changes in the jurisdictional mix of income and expenses.  Excluding the Puerto Rico excise tax, Amgen expects the adjusted tax rate for 2013 to be in the range of 13 percent to 14 percent.
  • Capital expenditures to be approximately $700 million, unchanged from previous guidance.
  • Second Quarter Product and Pipeline Update The Company provided the following information on selected products and clinical programs:

  • Talimogene laherparepvec:  The Company announced that primary analysis of the event-driven overall survival secondary endpoint from a Phase 3 study in melanoma is projected to occur in the first half of 2014.
  • Trebananib:  The Company announced that primary analysis of the event-driven overall survival secondary endpoint from a Phase 3 study in recurrent ovarian cancer is projected to occur in the second half of 2014.
  • XGEVA:  The Company discussed the FDA approval of XGEVA for the treatment of giant cell tumor of bone.
  • AMG 145: The Company announced that pivotal data from AMG 145 Phase 3 studies in subjects with elevated LDL cholesterol is expected in the first quarter of 2014.
  • Non-GAAP Financial MeasuresThe Adjusted non-GAAP (U.S. Generally Accepted Accounting Principles) financial measures included above for the second 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 second 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 endedSix months endedJune 30,June 30,2013201220132012Revenues:Product sales$ 4,595$ 4,200$ 8,746$ 8,101Other revenues84277171424Total revenues4,6794,4778,9178,525Operating expenses:Cost of sales7857521,5291,502Research and development9678261,8451,562Selling, general and administrative1,2561,2312,4142,310Other1217913785Total operating expenses3,1292,8885,9255,459Operating income1,5501,5892,9923,066Interest expense, net241256504491Interest and other income, net96124260248Income before income taxes1,4051,4572,7482,823Provision for income taxes14719156373Net income$ 1,258$ 1,266$ 2,692$ 2,450Earnings per share:Basic$ 1.67$ 1.63$ 3.58$ 3.13Diluted$ 1.65$ 1.61$ 3.52$ 3.09Average shares used in calculation of earnings per share:Basic752776752783Diluted764785764792Amgen Inc.Condensed Consolidated Balance Sheets - GAAP(In millions)(Unaudited)June 30,December 31,20132012AssetsCurrent assets:Cash, cash equivalents and marketable securities$ 22,018$ 24,061Trade receivables, net2,6742,518Inventories2,7732,744Other current assets2,2081,886Total current assets29,67331,209Property, plant and equipment, net5,2935,326Intangible assets, net3,7763,968Goodwill12,57812,662Other assets1,2901,133Total assets$ 52,610$ 54,298Liabilities and Stockholders' EquityCurrent liabilities:Accounts payable and accrued liabilities$ 4,777$ 5,696Current portion of long-term debt72,495Total current liabilities4,7848,191Long-term debt23,90824,034Other non-current liabilities3,3243,013Stockholders' equity20,59419,060Total liabilities and stockholders' equity$ 52,610$ 54,298Shares outstanding753756Amgen Inc.GAAP to "Adjusted" Reconciliations(In millions)(Unaudited)Three months endedSix months
    ended
    June 30, June 30, 2013201220132012GAAP cost of sales

    $ 785$ 752$ 1,529$ 1,502
    Adjustments to cost of sales:
    Non-cash amortization of product technology rights acquired in a prior year business combination

    (70)(70)(141)(141)Stock option expense (a)(1)(3)(3)(6)Certain charges pursuant to our continuing efforts to improve cost efficiencies in our operations

    -(11)-(21)
    Total adjustments to cost of sales

    (71)(84)(144)(168)Adjusted cost of sales

    $ 714$ 668$ 1,385$ 1,334GAAP research and development expenses

    $ 967$ 826$ 1,845$ 1,562
    Adjustments to research and development expenses:
    Acquisition-related expenses (b)(20)(13)(42)(20)Stock option expense (a)(3)(6)(8)(12)
    Total adjustments to research and development expenses

    (23)(19)(50)(32)Adjusted research and development expenses

    $ 944$ 807$ 1,795$ 1,530GAAP selling, general and administrative expenses

    $ 1,256$ 1,231$ 2,414$ 2,310
    Adjustments to selling, general and administrative expenses:
    Acquisition-related expenses (c)(16)(25)(26)(40)Stock option expense (a)(3)(7)(7)(14)
    Total adjustments to selling, general and administrative expenses

    (19)(32)(33)(54)Adjusted selling, general and administrative expenses

    $ 1,237$ 1,199$ 2,381$ 2,256GAAP operating expenses

    $ 3,129$ 2,888$ 5,925$ 5,459
    Adjustments to operating expenses:
    Adjustments to cost of sales

    (71)(84)(144)(168)Adjustments to research and development expenses

    (23)(19)(50)(32)Adjustments to selling, general and administrative expenses

    (19)(32)(33)(54)Expense resulting from changes in the estimated fair values of the contingent consideration obligations related to a prior year business combination

    (110)(1)(111)(3)Certain charges pursuant to our continuing efforts to improve cost efficiencies in our operations

    (11)(69)(11)(70)Expense related to various legal proceedings

    -(9)(15)(12)
    Total adjustments to operating expenses

    (234)(214)(364)(339)Adjusted operating expenses

    $ 2,895$ 2,674$ 5,561$ 5,120GAAP income before income taxes

    $ 1,405$ 1,457$ 2,748$ 2,823
    Adjustments to income before income taxes:
    Adjustments to operating expenses

    234214364339Non-cash interest expense associated with our convertible notes

    -351269
    Total adjustments to income before income taxes

    234249376408Adjusted income before income taxes

    $ 1,639$ 1,706$ 3,124$ 3,231GAAP provision for income taxes

    $ 147$ 191$ 56$ 373
    Adjustments to provision for income taxes:
    Income tax effect of the above adjustments (d)488288138Income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities

    --38-
    Total adjustments to provision for income taxes

    4882126138Adjusted provision for income taxes

    $ 195$ 273$ 182$ 511GAAP net income

    $ 1,258$ 1,266$ 2,692$ 2,450
    Adjustments to net income:
    Adjustments to income before income taxes, net of the tax effect of the above adjustments

    186167288270Income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities

    --(38)-
    Total adjustments to net income

    186167250270Adjusted net income

    $ 1,444$ 1,433$ 2,942$ 2,720Amgen 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 endedJune 30, 2013June 30, 2012GAAP"Adjusted"GAAP"Adjusted"Income (Numerator):Net income for basic and diluted EPS

    $ 1,258$ 1,444$ 1,266$ 1,433Shares (Denominator):Weighted-average shares for basic EPS

    752752776776Effect of dilutive securities

    1211(*)98(*)Weighted-average shares for diluted EPS

    764763785784Diluted EPS

    $ 1.65$ 1.89$ 1.61$ 1.83Six months endedSix months endedJune 30, 2013June 30, 2012GAAP"Adjusted"GAAP"Adjusted"Income (Numerator):Net income for basic and diluted EPS

    $ 2,692$ 2,942$ 2,450$ 2,720Shares (Denominator):Weighted-average shares for basic EPS

    752752783783Effect of dilutive securities

    1212(*)98(*)Weighted-average shares for diluted EPS

    764764792791Diluted EPS

    $ 3.52$ 3.85$ 3.09$ 3.44(*) Dilutive securities used to compute "Adjusted" diluted EPS for the three and six months ended June 30, 2013 and 2012 were computed under the treasury stock method assuming that we do not expense stock options(a)For the three and six months ended June 30, 2013, the total pre-tax expense for employee stock options was $7 million and $18 million, respectively, compared with $16 million and $32 million for the corresponding periods of the prior year"Adjusted" diluted EPS including the impact of stock option expense for the three and six months ended June 30, 2013 and 2012 was as follows:Three months endedSix months endedJune 30,June 30,2013201220132012"Adjusted" diluted EPS, excluding stock option expense

    $ 1.89$ 1.83$ 3.85$ 3.44Impact of stock option expense (net of tax)

    (0.01)(0.01)(0.02)(0.03)"Adjusted" diluted EPS, including stock option expense

    $ 1.88$ 1.82$ 3.83$ 3.41(b)The adjustments in 2013 related primarily to non-cash amortization of intangible assets acquired in prior year business combinations. The adjustments in 2012 related primarily to non-cash amortization of intangible assets as well as retention and severance expenses(c)The adjustments in 2013 related primarily to non-cash amortization of intangible assets acquired in prior year business combinations. The adjustments in 2012 related primarily to transaction costs and non-cash amortization of intangible assets(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 and six months ended June 30, 2013, were 20.5% and 23.4%, respectively, compared with 32.9% and 33.8% for the corresponding periods of the prior yearNote:For the three and six months ended June 30, 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 endedJune 30,20132012Cash Flows from Operations

    $ 1,600$ 2,375Capital Expenditures

    (159)(172)Free Cash Flow

    $ 1,441$ 2,203Reconciliation of GAAP EPS Guidance to "Adjusted"EPS Guidance for the Year Ending December 31, 2013(Unaudited)2013GAAP diluted EPS guidance$ 6.78

    -

    $ 6.93Known adjustments to arrive at "Adjusted" earnings*:Acquisition-related expenses

    (a)

    0.50Stock option expense0.03Expense related to a legal proceeding0.02Non-cash interest expense associated with our convertible notes0.01Charges associated with cost savings initiatives0.01Tax settlement

    (b)

    (0.05)"Adjusted" diluted EPS guidance$ 7.30

    -

    $ 7.45*The known adjustments are presented net of their related aggregate tax impact of approximately $0.21 per share(a)To exclude acquisition-related expenses related primarily to non-cash amortization of intangible assets and expense resulting from changes in the estimated fair values of the contingent consideration obligations related to prior year business combinations(b)To exclude income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities 

    Reconciliation 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 guidance7%

    -

    8%11%

    -

    12%Tax rate effect of known adjustments discussed above2%2%"Adjusted" tax rate guidance9%

    -

    10%13%

    -

    14%CONTACT: Amgen, Thousand Oaks
    Christine Regan, 805-447-5476 (media)
    Arvind Sood, 805-447-1060 (investors)

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


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