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Amgen's 2015 Revenues Increased 8 Percent To $21.7 Billion And Adjusted Earnings Per Share (EPS) Increased 19 Percent To $10.38 Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2015. Key results include: For the fourth quarter,...

Key Takeaway: THOUSAND OAKS, Calif. , Jan. 28, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the fourth quarter and full year of 2015. Key results include: "2015 was an exceptional year for Amgen with six innovative new launches, strong financial performance

Full Press Release Details

THOUSAND OAKS, Calif. , Jan. 28, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the fourth quarter and full year of 2015. Key results include:
"2015 was an exceptional year for Amgen with six innovative new launches, strong financial performance, continued pipeline advances and improved operating margins driven by our transformation efforts," said Robert A. Bradway , chairman and chief executive officer. "We remain on track to meet or exceed our 2018 commitments and deliver value for patients and shareholders."
$Millions, except EPS and percentages Q4 '15 Q4 '14 YOY Δ FY '15 FY '14 YOY Δ
Total Revenues $ 5,536 $ 5,331 4% $ 21,662 $ 20,063 8%
Adjusted Operating Income $ 2,366 $ 2,033 16% $ 10,052 $ 8,475 19%
Adjusted Net Income $ 1,985 $ 1,670 19% $ 7,954 $ 6,700 19%
Adjusted EPS $ 2.61 $ 2.16 21% $ 10.38 $ 8.70 19%
GAAP Operating Income $ 2,033 $ 1,459 39% $ 8,470 $ 6,191 37%
GAAP Net Income $ 1,800 $ 1,294 39% $ 6,939 $ 5,158 35%
GAAP EPS $ 2.37 $ 1.68 41% $ 9.06 $ 6.70 35%
Product Sales Performance
Product Sales Detail by Product and Geographic Region
$Millions, except percentages Q4 '15 Q4 '14 YOY Δ
US ROW TOTAL TOTAL TOTAL
Enbrel ® $1,375 $66 $1,441 $1,337 8%
Neulasta ® 960 196 1,156 1,180 (2%)
Aranesp ® 249 250 499 479 4%
Sensipar ® / Mimpara ® 299 85 384 317 21%
Prolia ® 247 133 380 315 21%
XGEVA ® 254 102 356 325 10%
EPOGEN ® 342 0 342 539 (37%)
NEUPOGEN ® 203 60 263 274 (4%)
Kyprolis ® 134 14 148 91 63%
Nplate ® 82 55 137 119 15%
Vectibix ® 51 84 135 132 2%
Other* 26 62 88 66 33%
Total product sales $4,222 $1,107 $5,329 $5,174 3%
* Other includes MN Pharma, BLINCYTO ® , Bergamo, Repatha ® , Corlanor ® , and IMLYGIC TM
$Millions, except percentages FY '15 FY '14 YOY Δ
US ROW TOTAL TOTAL TOTAL
Enbrel ® $5,099 $265 $5,364 $4,688 14%
Neulasta ® 3,891 824 4,715 4,596 3%
Aranesp ® 900 1,051 1,951 1,930 1%
EPOGEN ® 1,856 0 1,856 2,031 (9%)
Sensipar ® / Mimpara ® 1,069 346 1,415 1,158 22%
XGEVA ® 1,006 399 1,405 1,221 15%
Prolia ® 837 475 1,312 1,030 27%
NEUPOGEN ® 793 256 1,049 1,159 (9%)
Vectibix ® 204 345 549 505 9%
Nplate ® 317 208 525 469 12%
Kyprolis ® 467 45 512 331 55%
Other* 84 207 291 209 39%
Total product sales $16,523 $4,421 $20,944 $19,327 8%
* Other includes MN Pharma, BLINCYTO ® , Bergamo, Repatha ® , Corlanor ® , and IMLYGIC TM
Operating Expense, Operating Margin and Tax Rate Analysis, on an Adjusted Basis
$Millions, except percentages
On an Adjusted Basis Q4 '15 Q4 '14 YOY Δ FY '15 FY '14 YOY Δ
Cost of Sales* $764 $825 (7%) $3,033 $3,059 (1%)
% of sales 14.3% 15.9% (1.6) pts 14.5% 15.8% (1.3) pts
Research & Development $1,057 $1,168 (10%) $3,917 $4,121 (5%)
% of sales 19.8% 22.6% (2.8) pts 18.7% 21.3% (2.6) pts
Selling, General & Administrative $1,349 $1,305 3% $4,660 $4,408 6%
% of sales 25.3% 25.2% 0.1 pts 22.2% 22.8% (0.6) pts
TOTAL Operating Expenses $3,170 $3,298 (4%) $11,610 $11,588 0%
Operating Margin
operating income as a % of sales 44.4% 39.3% 5.1 pts 48.0% 43.9% 4.1 pts
Tax Rate* 11.6% 10.2% 1.4 pts 16.8% 14.9% 1.9 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 1.8 pts. and 1.9 pts. lower for full years 2015 and 2014, respectively; and the Tax Rate would be 2.7 pts. and 3.3 pts. higher for full years 2015 and 2014.
Cash Flow and Balance Sheet
$Billions, except shares Q4 '15 Q4 '14 YOY Δ FY '15 FY '14 YOY Δ
Operating Cash Flow $2.1 $2.4 ($0.4) $9.1 $8.6 $0.5
Capital Expenditures 0.2 0.2 0.0 0.6 0.7 0.1
Free Cash Flow 1.9 2.2 (0.4) 8.5 7.8 0.6
Dividends Paid 0.6 0.5 0.1 2.4 1.9 0.5
Share Repurchase 0.2 0.2 0.0 1.9 0.2 1.7
Avg. Diluted Shares (millions) 761 772 (11) 766 770 (4)
Cash and Investments 31.4 27.0 4.4 31.4 27.0 4.4
Debt Outstanding 31.6 30.7 0.9 31.6 30.7 0.9
Stockholders' Equity 28.1 25.8 2.3 28.1 25.8 2.3
Note: Numbers may not add due to rounding
For the full year 2016, the Company now expects:
Fourth Quarter Product and Pipeline Update
Key development milestones:
Clinical Program Indication Milestone
Repatha ® (evolocumab) Hyperlipidemia Phase 3 CV imaging data expected H2 2016 Phase 3 CV outcomes data expected H2 2016* Approved in Japan
Kyprolis Relapsed multiple myeloma Approved in U.S. (ENDEAVOR) Approved in EU (ASPIRE) EU regulatory review (ENDEAVOR)
IMLYGIC ™ (talimogene laherparepvec) Metastatic melanoma Approved in EU
Parsabiv ™ (etelcalcetide) † Secondary hyperparathyroidism Global regulatory reviews
XGEVA Prevention of SREs in multiple myeloma Phase 3 data expected Q4 2016*
Romosozumab ‡ Postmenopausal osteoporosis Phase 3 registrational data expected Q1 2016
AMG 334 ** Migraine Prophylaxis Phase 2b chronic migraine data expected H2 2016
ABP 215 (biosimilar bevacizumab) Oncology Global regulatory submissions expected 2016
ABP 501 (biosimilar adalimumab) Inflammatory diseases Global regulatory reviews
ABP 980 (biosimilar trastuzumab) Breast Cancer Phase 3 data expected H2 2016
The Company provided the following updates on selected product and pipeline programs:
BLINCYTO ® (blinatumomab)
Non-GAAP Financial Measures In this news release, management has presented its operating results for the fourth quarters and full years 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 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 fourth quarters and full years 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 news 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
Consolidated Statements of Income - GAAP
(In millions, except per share data)
(Unaudited)
Three months ended Years ended
December 31, December 31,
2015 2014 2015 2014
Revenues:
Product sales $ 5,329 $ 5,174 $ 20,944 $ 19,327
Other revenues 207 157 718 736
Total revenues 5,536 5,331 21,662 20,063
Operating expenses:
Cost of sales 1,071 1,183 4,227 4,422
Research and development 1,093 1,234 4,070 4,297
Selling, general and administrative 1,416 1,327 4,846 4,699
Other (77) 128 49 454
Total operating expenses 3,503 3,872 13,192 13,872
Operating income 2,033 1,459 8,470 6,191
Interest expense, net 284 261 1,095 1,071
Interest and other income, net 164 88 603 465
Income before income taxes 1,913 1,286 7,978 5,585
Provision for income taxes 113 (8) 1,039 427
Net income $ 1,800 $ 1,294 $ 6,939 $ 5,158
Earnings per share:
Basic $ 2.39 $ 1.70 $ 9.15 $ 6.80
Diluted $ 2.37 $ 1.68 $ 9.06 $ 6.70
Weighted average shares used in calculation of earnings per share:
Basic 754 761 758 759
Diluted 761 772 766 770
Amgen Inc
Consolidated Balance Sheets - GAAP
(In millions)
(Unaudited)
December 31, December 31,
2015 2014
Assets
Current assets:
Cash, cash equivalents and marketable securities $ 31,382 $ 27,026
Trade receivables, net 2,995 2,546
Inventories 2,435 2,647
Other current assets 1,706 2,494
Total current assets 38,518 34,713
Property, plant and equipment, net 4,907 5,223
Intangible assets, net 11,641 12,693
Goodwill 14,787 14,788
Other assets 1,723 1,592
Total assets $ 71,576 $ 69,009
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 6,417 $ 6,508
Current portion of long-term debt 2,250 500
Total current liabilities 8,667 7,008
Long-term debt 29,306 30,215
Long-term deferred tax liability 2,239 3,461
Other noncurrent liabilities 3,281 2,547
Stockholders' equity 28,083 25,778
Total liabilities and stockholders' equity $ 71,576 $ 69,009
Shares outstanding 754 760
Amgen Inc.
GAAP to Adjusted Reconciliations
(In millions)
(Unaudited)
Three months ended Years ended
December 31, December 31,
2015 2014 2015 2014
GAAP cost of sales $ 1,071 $ 1,183 $ 4,227 $ 4,422
Adjustments to cost of sales:
Acquisition-related expenses (a) (297) (279) (1,142) (1,249)
Certain charges pursuant to our restructuring initiative (10) (76) (52) (104)
Stock option expense - (3) - (10)
Total adjustments to cost of sales (307) (358) (1,194) (1,363)
Adjusted cost of sales $ 764 $ 825 $ 3,033 $ 3,059
GAAP research and development expenses $ 1,093 $ 1,234 $ 4,070 $ 4,297
Adjustments to research and development expenses:
Acquisition-related expenses (b) (20) (32) (89) (124)
Certain charges pursuant to our restructuring initiative (16) (34) (64) (49)
Stock option expense - - - (3)
Total adjustments to research and development expenses (36) (66) (153) (176)
Adjusted research and development expenses $ 1,057 $ 1,168 $ 3,917 $ 4,121
GAAP selling, general and administrative expenses $ 1,416 $ 1,327 $ 4,846 $ 4,699
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (b) (46) (32) (130) (150)
Certain charges pursuant to our restructuring initiative (21) (6) (56) (9)
Expense resulting from clarified guidance on branded prescription drug fee (c) - 16 - (129)
Stock option expense - - - (3)
Total adjustments to selling, general and administrative expenses (67) (22) (186) (291)
Adjusted selling, general and administrative expenses $ 1,349 $ 1,305 $ 4,660 $ 4,408
GAAP operating expenses $ 3,503 $ 3,872 $ 13,192 $ 13,872
Adjustments to operating expenses:
Adjustments to cost of sales (307) (358) (1,194) (1,363)
Adjustments to research and development expenses (36) (66) (153) (176)
Adjustments to selling, general and administrative expenses (67) (22) (186) (291)
Certain net charges pursuant to our restructuring and other cost savings initiatives (d) 99 (66) 58 (434)
(Expense)/Benefit related to various legal proceedings (18) - (91) 3
(Expense)/Benefit resulting from changes in the estimated fair values of the contingent consideration obligations related to prior year business combinations (9) (17) 8 30
Write-off of non-key assets acquired in a prior year business combination - (46) (28) (46)
Other (e) 5 1 4 (7)
Total adjustments to operating expenses (333) (574) (1,582) (2,284)
Adjusted operating expenses $ 3,170 $ 3,298 $ 11,610 $ 11,588
GAAP operating income $ 2,033 $ 1,459 $ 8,470 $ 6,191
Adjustments to operating expenses 333 574 1,582 2,284
Adjusted operating income $ 2,366 $ 2,033 $ 10,052 $ 8,475
GAAP income before income taxes $ 1,913 $ 1,286 $ 7,978 $ 5,585
Adjustments to operating expenses 333 574 1,582 2,284
Adjusted income before income taxes $ 2,246 $ 1,860 $ 9,560 $ 7,869
GAAP provision for income taxes $ 113 $ (8) $ 1,039 $ 427
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (f) 92 187 496 717
Other income tax adjustments (g) 56 11 71 25
Total adjustments to provision for income taxes 148 198 567 742
Adjusted provision for income taxes $ 261 $ 190 $ 1,606 $ 1,169
GAAP net income $ 1,800 $ 1,294 $ 6,939 $ 5,158
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect of the above adjustments 241 387 1,086 1,567
Other income tax adjustments (g) (56) (11) (71) (25)
Total adjustments to net income 185 376 1,015 1,542
Adjusted net income $ 1,985 $ 1,670 $ 7,954 $ 6,700
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
Three months ended Three months ended
December 31, 2015 December 31, 2014
GAAP Adjusted GAAP Adjusted
Net income $ 1,800 $ 1,985 $ 1,294 $ 1,670
Weighted-average shares for diluted EPS 761 761 772 772
Diluted EPS $ 2.37 $ 2.61 $ 1.68 $ 2.16
Year ended Year ended
December 31, 2015 December 31, 2014
GAAP Adjusted GAAP Adjusted
Net income $ 6,939 $ 7,954 $ 5,158 $ 6,700
Weighted-average shares for diluted EPS 766 766 770 770
Diluted EPS $ 9.06 $ 10.38 $ 6.70 $ 8.70
(a) The adjustments related primarily to non-cash amortization of intangible assets, including developed product technology rights, acquired in business combinations.
(b) The adjustments related primarily to non-cash amortization of intangible assets acquired in business combinations.
(c) The adjustments related to the Internal Revenue Service issuing final regulations that required the recognition of an additional year of the non-tax deductible branded prescription drug fee.
(d) The adjustments for the three months ended December 31, 2015, related primarily to a gain recognized on the sale of assets related to our site closures. The adjustments for the year ended December 31, 2015, related primarily to gains recognized on the sale of assets related to our site closures, partially offset by severance expenses. The 2014 adjustments related primarily to severance expenses.
(e) The adjustments related 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 months and year ended December 31, 2015, were 27.6% and 31.4%, respectively, compared with 32.6% and 31.4% for the corresponding periods of the prior year.
(g) The adjustments related primarily to certain prior period items excluded from adjusted earnings.
Amgen Inc
Reconciliations of Free Cash Flow
(In millions)
(Unaudited)
Three months ended Years ended
December 31, December 31,
2015 2014 2015 2014
Operating Cash Flow $ 2,060 $ 2,445 $ 9,077 $ 8,555
Capital Expenditures (205) (203) (594) (718)
Free Cash Flow $ 1,855 $ 2,242 $ 8,483 $ 7,837
Reconciliation of GAAP EPS Guidance to Adjusted
EPS Guidance for the Year Ending December 31, 2016
(Unaudited)
2016
GAAP diluted EPS guidance $ 9.13 - $ 9.58
Known adjustments to arrive at Adjusted earnings*:
Acquisition-related expenses (a) 1.33
Restructuring charges 0.09 - 0.14
Adjusted diluted EPS guidance $ 10.60 - $ 11.00
* The known adjustments are presented net of their related tax impact which amount to approximately $0.66 to $0.68 pre share, in the aggregate.
(a) The adjustments relate primarily to non-cash amortization of intangible assets acquired in prior year business combinations.
Reconciliation of GAAP Tax Rate Guidance to Adjusted
Tax Rate Guidance for the Year Ending December 31, 2016
(Unaudited)
2016
GAAP tax rate guidance 17.5% - 18.5%
Tax rate effect of known adjustments discussed above 2.0%
Adjusted tax rate guidance 19.5% - 20.5%
CONTACT: Amgen, Thousand Oaks Trish Hawkins , 805-447-5631 (media) Arvind Sood , 805-447-1060 (investors)

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Last updated: Jan 28, 2016