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Amgen's Third Quarter 2015 Revenues Increased 14 Percent To $5.7 Billion And Adjusted Earnings Per Share (EPS) Increased 18 Percent To $2.72 Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2015. Key results include: Total revenues increased 14 percent versus...

Key Takeaway: THOUSAND OAKS, Calif. , Oct. 28, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the third quarter of 2015. Key results include: "We delivered record revenues, adjusted earnings and cash flow in the third quarter, while improving our operating ma

Full Press Release Details

THOUSAND OAKS, Calif. , Oct. 28, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the third quarter of 2015. Key results include:
"We delivered record revenues, adjusted earnings and cash flow in the third quarter, while improving our operating margins and investing in six exciting new product launches," said Robert A. Bradway , chairman and chief executive officer. "With several innovative medicines still in development, we are well on the way to achieving our long-term objectives for shareholders and patients alike."
Year-over-Year
$Millions, except EPS and percentages Q3 '15 Q3 '14 YOY Δ
Total Revenues $ 5,723 $ 5,031 14%
Adjusted Operating Income $ 2,686 $ 2,263 19%
Adjusted Net Income $ 2,081 $ 1,769 18%
Adjusted EPS $ 2.72 $ 2.30 18%
GAAP Operating Income $ 2,339 $ 1,466 60%
GAAP Net Income $ 1,863 $ 1,244 50%
GAAP EPS $ 2.44 $ 1.61 52%
Third Quarter 2015 Product Sales Performance
Product Sales Detail by Product and Geographic Region
$Millions, except percentages Q3 '15 Q3 '14 YOY Δ
US ROW TOTAL TOTAL TOTAL
Enbrel ® $1,392 $67 $1,459 $1,120 30%
Neulasta ® 1,056 211 1,267 1,193 6%
Aranesp ® 239 254 493 474 4%
EPOGEN ® 489 0 489 518 (6%)
XGEVA ® 273 105 378 318 19%
Sensipar ® / Mimpara ® 268 85 353 273 29%
Prolia ® 205 115 320 255 25%
NEUPOGEN ® 218 66 284 300 (5%)
Kyprolis ® 124 13 137 94 46%
Nplate ® 84 53 137 119 15%
Vectibix ® 54 78 132 138 (4%)
Other* 23 44 67 46 46%
Total product sales $4,425 $1,091 $5,516 $4,848 14%
* Other includes MN Pharma, BLINCYTO ® , Bergamo, Repatha™, Corlanor ®
Third Quarter Operating Expense, Operating Margin and Tax Rate Analysis, on an Adjusted Basis
$Millions, except percentages
On an Adjusted Basis Q3 '15 Q3 '14 YOY Δ
Cost of Sales* $745 $761 (2%)
% of sales 13.5% 15.7% (2.2) pts
Research & Development $1,086 $980 11%
% of sales 19.7% 20.2% (0.5) pts
Selling, General & Administrative $1,206 $1,027 17%
% of sales 21.9% 21.2% 0.7 pts
TOTAL Operating Expenses $3,037 $2,768 10%
Operating Margin
operating income as a % of sales 48.7% 46.7% 2 pts
Tax Rate* 18.0% 17.1% 0.9 pts
pts: percentage points
* Impact of Puerto Rico excise tax is included in Cost of Sales and Tax Rate. Excluding Puerto Rico excise tax, Cost of Sales would be 1.7 pts. and 1.8 pts. lower for 2015 and 2014, respectively; and the Tax Rate would be 2.9 pts. higher for both 2015 and 2014
Cash Flow and Balance Sheet Discussion
$Billions, except shares Q3 '15 Q3 '14 YOY Δ
Operating Cash Flow $2.9 $2.7 0.1
Capital Expenditures 0.1 0.2 0.0
Free Cash Flow 2.7 2.6 0.2
Dividends Paid 0.6 0.5 0.1
Share Repurchase 0.7 0.0 0.7
Avg. Diluted Shares (millions) 764 770 (6)
Cash and Investments 31.1 28.1 3.0
Debt Outstanding 31.8 33.0 (1.2)
Stockholders' Equity 28.0 25.3 2.7
Note: Numbers may not add due to rounding
For the full year 2015, the Company now expects:
2016 Preliminary Guidance
For the full year 2016, the Company expects:
Third Quarter Product and Pipeline Update
Key development milestones:
Clinical Program Indication Milestone
Repatha™ (evolocumab) Dyslipidemia Approved in U.S., EU and Canada Phase 3 CV imaging data expected H2 2016 Phase 3 CV outcomes data expected H2 2016*
Kyprolis Relapsed multiple myeloma Approved in U.S. (ASPIRE) CHMP Positive Opinion (ASPIRE) U.S Priority Review (ENDEAVOR)
IMLYGIC ™ (talimogene laherparepvec) Metastatic melanoma Approved in U.S. CHMP Positive Opinion
Etelcalcetide (AMG 416) Secondary hyperparathyroidism Global regulatory reviews
Omecamtiv mecarbil † Heart failure Phase 2 completed
Romosozumab** Postmenopausal osteoporosis Phase 3 registrational data expected H1 2016
AMG 334 ‡ Migraine Prophylaxis Phase 2b chronic migraine data expected 2016
ABP 215 (biosimilar bevacizumab) Non-small cell lung cancer Phase 3 completed
ABP 501 (biosimilar adalimumab) Inflammatory diseases Global regulatory submissions expected Q4 2015
ABP 980 (biosimilar trastuzumab) Breast Cancer Phase 3 data expected H2 2016
The Company provided the following updates on selected product and pipeline programs:
Omecamtiv mecarbil
BLINCYTO ® (blinatumomab)
Etelcalcetide (AMG 416)
Non-GAAP Financial Measures In this news release, management has presented its operating results for the third quarters of 2015 and 2014 in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on an adjusted (or non-GAAP) basis. In addition, management has presented its full year 2015 and 2016 EPS and tax rate guidance in accordance with GAAP and on an adjusted (or 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. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the third quarters of 2015 and 2014. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release.
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 core business activities by facilitating comparisons of results of core business operations among current, past and future periods. In addition, the Company believes that excluding the non-cash amortization of intangible assets, including developed product technology rights, acquired in business combinations treats those assets as if the Company had developed them internally in the past, and thus provides a supplemental measure of profitability in which the Company's acquired intellectual property is treated in a comparable manner to its internally developed intellectual property. 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 press release in connection with its own budgeting and financial planning. 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 biologics manufacturing 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.
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, 2014 , 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 efforts to integrate the operations of companies we have acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our ongoing restructuring plan. 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 ended Nine months ended
September 30, September 30,
2015 2014 2015 2014
Revenues:
Product sales $ 5,516 $ 4,848 $ 15,615 $ 14,153
Other revenues 207 183 511 579
Total revenues 5,723 5,031 16,126 14,732
Operating expenses:
Cost of sales 1,034 1,068 3,156 3,239
Research and development 1,119 1,018 2,977 3,063
Selling, general and administrative 1,244 1,213 3,430 3,372
Other (13) 266 126 326
Total operating expenses 3,384 3,565 9,689 10,000
Operating income 2,339 1,466 6,437 4,732
Interest expense, net 282 269 811 810
Interest and other income, net 135 140 439 377
Income before income taxes 2,192 1,337 6,065 4,299
Provision for income taxes 329 93 926 435
Net income $ 1,863 $ 1,244 $ 5,139 $ 3,864
Earnings per share:
Basic $ 2.46 $ 1.63 $ 6.76 $ 5.10
Diluted $ 2.44 $ 1.61 $ 6.70 $ 5.02
Weighted average shares used in calculation of earnings per share:
Basic 757 761 760 758
Diluted 764 771 767 769
Amgen Inc.
Condensed Consolidated Balance Sheets - GAAP
(In millions)
(Unaudited)
September 30, December 31,
2015 2014
Assets
Current assets:
Cash, cash equivalents and marketable securities $ 31,120 $ 27,026
Trade receivables, net 2,901 2,546
Inventories 2,531 2,647
Other current assets 2,292 2,494
Total current assets 38,844 34,713
Property, plant and equipment, net 4,988 5,223
Intangible assets, net 11,613 12,693
Goodwill 14,674 14,788
Other assets 1,750 1,592
Total assets $ 71,869 $ 69,009
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 5,915 $ 6,508
Current portion of long-term debt 1,250 500
Total current liabilities 7,165 7,008
Long-term debt 30,511 30,215
Long-term deferred tax liability 3,109 3,461
Other noncurrent liabilities 3,117 2,547
Stockholders' equity 27,967 25,778
Total liabilities and stockholders' equity $ 71,869 $ 69,009
Shares outstanding 755 760
Amgen Inc.
GAAP to Adjusted Reconciliations
(In millions)
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
2015 2014 2015 2014
GAAP cost of sales $1,034 $ 1,068 $3,156 $ 3,239
Adjustments to cost of sales:
Acquisition-related expenses (a) (276) (276) (845) (970)
Certain charges pursuant to our restructuring initiative (13) (28) (42) (28)
Stock option expense - (3) - (7)
Total adjustments to cost of sales (289) (307) (887) (1,005)
Adjusted cost of sales $ 745 $ 761 $2,269 $ 2,234
GAAP research and development expenses $1,119 $ 1,018 $2,977 $ 3,063
Adjustments to research and development expenses:
Acquisition-related expenses (b) (20) (23) (69) (92)
Certain charges pursuant to our restructuring initiative (13) (15) (48) (15)
Stock option expense - - - (3)
Total adjustments to research and development expenses (33) (38) (117) (110)
Adjusted research and development expenses $1,086 $ 980 $2,860 $ 2,953
GAAP selling, general and administrative expenses $1,244 $ 1,213 $3,430 $ 3,372
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (b) (27) (38) (84) (118)
Certain charges pursuant to our restructuring initiative (11) (3) (35) (3)
Expense resulting from clarified guidance on branded prescription drug fee (c) - (145) - (145)
Stock option expense - - - (3)
Total adjustments to selling, general and administrative expenses (38) (186) (119) (269)
Adjusted selling, general and administrative expenses $1,206 $ 1,027 $3,311 $ 3,103
GAAP operating expenses $3,384 $ 3,565 $9,689 $10,000
Adjustments to operating expenses:
Adjustments to cost of sales (289) (307) (887) (1,005)
Adjustments to research and development expenses (33) (38) (117) (110)
Adjustments to selling, general and administrative expenses (38) (186) (119) (269)
Certain net charges pursuant to our restructuring and other cost savings initiatives (d) 26 (330) (41) (368)
Benefit resulting from changes in the estimated fair values of the contingent consideration obligations related to prior year business combinations 18 62 17 47
(Expense)/Benefit related to various legal proceedings (2) - (73) 3
Other (e) (29) 2 (29) (8)
Total adjustments to operating expenses (347) (797) (1,249) (1,710)
Adjusted operating expenses $3,037 $ 2,768 $8,440 $ 8,290
GAAP operating income $2,339 $ 1,466 $6,437 $ 4,732
Adjustments to operating expenses 347 797 1,249 1,710
Adjusted operating income $2,686 $ 2,263 $7,686 $ 6,442
GAAP income before income taxes $2,192 $ 1,337 $6,065 $ 4,299
Adjustments to operating expenses 347 797 1,249 1,710
Adjusted income before income taxes $2,539 $ 2,134 $7,314 $ 6,009
GAAP provision for income taxes $ 329 $ 93 $ 926 $ 435
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (f) 114 251 404 530
Other income tax adjustments (g) 15 21 15 14
Total adjustments to provision for income taxes 129 272 419 544
Adjusted provision for income taxes $ 458 $ 365 $1,345 $ 979
GAAP net income $1,863 $ 1,244 $5,139 $ 3,864
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect of the above adjustments 233 546 845 1,180
Other income tax adjustments (g) (15) (21) (15) (14)
Total adjustments to net income 218 525 830 1,166
Adjusted net income $2,081 $ 1,769 $5,969 $ 5,030
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. Dilutive securities used to compute Adjusted diluted EPS were computed assuming that we do not expense stock options
Three months ended Three months ended
September 30, 2015 September 30, 2014
GAAP Adjusted GAAP Adjusted
Net income $ 1,863 $ 2,081 $ 1,244 $ 1,769
Weighted-average shares for diluted EPS 764 764 771 770
Diluted EPS $ 2.44 $ 2.72 $ 1.61 $ 2.30
Nine months ended Nine months ended
September 30, 2015 September 30, 2014
GAAP Adjusted GAAP Adjusted
Net income $ 5,139 $ 5,969 $ 3,864 $ 5,030
Weighted-average shares for diluted EPS 767 767 769 769
Diluted EPS $ 6.70 $ 7.78 $ 5.02 $ 6.54
(a) The adjustments related primarily to non-cash amortization of intangible assets, including developed product technology rights, acquired in business combinations. For the nine months ended September 30, 2014, the adjustments also included a $99-million charge related to the termination of a supply contract with F. Hoffmann-La Roche Ltd. as a result of acquiring the licenses to filgrastim and pegfilgrastim effective January 1, 2014.
(b) The adjustments related primarily to non-cash amortization of intangible assets acquired in business combinations.
(c) The adjustments related to the recognition of an additional year of the non-tax deductible branded prescription drug fee, as required by final regulations issued by the Internal Revenue Service.
(d) During the three months ended September 30, 2015, we recognized a gain from the sale of assets related to our site closures. The adjustments for 2014 and the nine months ended September 30, 2015, related primarily to severance expenses.
(e) The 2015 adjustments related primarily to the write-off of a non-key contract asset acquired in a prior year business combination. The 2014 adjustments related primarily to various acquisition-related items.
(f) 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, 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 nine months ended September 30, 2015, were 32.9% and 32.3%, respectively, compared with 31.5% and 31.0% for the corresponding periods of the prior year.
(g) The adjustments related to certain prior period items excluded from adjusted earnings. The 2015 adjustments also included the impact from a change in interpretation of tax law.
Amgen Inc.
Reconciliations of Free Cash Flow
(In millions)
(Unaudited)
Three months ended
September 30,
2015 2014
Operating Cash Flow $2,874 $2,741
Capital Expenditures (138) (170)
Free Cash Flow $2,736 $2,571
Reconciliation of GAAP EPS Guidance to Adjusted
EPS Guidance for the Years Ending December 31, 2015 and 2016
(Unaudited)
2015 2016
GAAP diluted EPS guidance $ 8.47 - $ 8.66 $ 8.89 - $ 9.34
Known adjustments to arrive at Adjusted earnings*:
Acquisition-related expenses (a) 1.18 1.32
Restructuring charges 0.19 - 0.23 0.09 - 0.14
Legal proceeding expense 0.09 -
Tax adjustments (b) (0.02) -
Adjusted diluted EPS guidance $ 9.95 - $ 10.10 $ 10.35 - $ 10.75
* The known adjustments are presented net of their related tax impact which amount to approximately $0.66 to $0.69 per share in 2015 and 2016, each in the aggregate.
(a) The adjustments relate primarily to non-cash amortization of intangible assets acquired in prior year business combinations.
(b) The adjustments relate to a change in interpretation of tax law and certain prior period items excluded from adjusted earnings.
Reconciliation of GAAP Tax Rate Guidance to Adjusted
Tax Rate Guidance for the Years Ending December 31, 2015 and 2016
(Unaudited)
2015 2016
GAAP tax rate guidance 14.0% - 16.0% 18.5% - 19.5%
Tax rate effect of known adjustments discussed above 3.0% - 4.0% 2.0%
Adjusted tax rate guidance 18.0% - 19.0% 20.5% - 21.5%
CONTACT: Amgen, Thousand Oaks Kristen Davis , 805-447-3008 (media) Trish Hawkins , 805-447-5631 (media) Arvind Sood , 805-447-1060 (investors)

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Last updated: Oct 28, 2015