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Amgen Reports Second Quarter 2016 Financial Results Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2016. Key results include: Revenues increased 6 percent versus the...

Key Takeaway: THOUSAND OAKS, Calif. , July 27, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the second quarter of 2016. Key results include: "We delivered another strong quarter and are on track to meet or exceed our long-term objectives," said Robert A. Br

Full Press Release Details

THOUSAND OAKS, Calif. , July 27, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the second quarter of 2016. Key results include:
"We delivered another strong quarter and are on track to meet or exceed our long-term objectives," said Robert A. Bradway , chairman and chief executive officer. "We are in the early stages of a new product launch cycle and have several additional pipeline opportunities rapidly nearing regulatory milestones."
$Millions, except EPS and percentages Q2'16 Q2'15 YOY Δ
Total Revenues $ 5,688 $ 5,370 6%
GAAP Operating Income $ 2,380 $ 2,076 15%
GAAP Net Income $ 1,870 $ 1,653 13%
GAAP EPS $ 2.47 $ 2.15 15%
Non-GAAP Operating Income $ 2,812 $ 2,551 10%
Non-GAAP Net Income $ 2,146 $ 1,977 9%
Non-GAAP EPS $ 2.84 $ 2.57 11%
Product Sales Performance
Product Sales Detail by Product and Geographic Region
$Millions, except percentages Q2'16 Q2'15 YOY Δ
US ROW TOTAL TOTAL TOTAL
Enbrel ® $1,423 $61 $1,484 $1,348 10%
Neulasta ® 962 187 1,149 1,158 (1%)
Aranesp ® 260 244 504 479 5%
Prolia ® 286 155 441 340 30%
Sensipar ® / Mimpara ® 303 86 389 344 13%
XGEVA ® 275 106 381 331 15%
EPOGEN ® 331 0 331 491 (33%)
NEUPOGEN ® 141 55 196 256 (23%)
KYPROLIS ® 142 30 172 119 45%
Vectibix ® 52 108 160 160 0%
Nplate ® 84 58 142 125 14%
BLINCYTO ® 21 9 30 17 76%
Repatha ® 20 7 27 0 *
Other** 17 51 68 57 19%
Total product sales $4,317 $1,157 $5,474 $5,225 5%
* Not meaningful
** Other includes MN Pharma, Bergamo, IMLYGIC ® and Corlanor ®
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
On a non-GAAP basis:
$Millions, except percentages
GAAP Non-GAAP
Q2'16 Q2'15 YOY Δ Q2'16 Q2'15 YOY Δ
Cost of Sales $1,050 $1,089 (4%) $738 $789 (6%)
% of product sales 19.2% 20.8% (1.6) pts 13.5% 15.1% (1.6) pts
Research & Development $900 $964 (7%) $878 $918 (4%)
% of product sales 16.4% 18.4% (2.0) pts 16.0% 17.6% (1.6) pts
Selling, General & Administrative $1,292 $1,160 11% $1,260 $1,112 13%
% of product sales 23.6% 22.2% 1.4 pts 23.0% 21.3% 1.7 pts
Other $66 $81 (19%) $0 $0 0%
TOTAL Operating Expenses $3,308 $3,294 0% $2,876 $2,819 2%
Operating Margin
operating income as a % of product sales 43.5% 39.7% 3.8 pts 51.4% 48.8% 2.6 pts
Tax Rate 15.2% 17.2% (2.0) pts 18.6% 20.0% (1.4) pts
pts: percentage points
Cash Flow and Balance Sheet
$Billions, except shares Q2'16 Q2'15 YOY Δ
Operating Cash Flow $2.7 $3.3 ($0.6)
Capital Expenditures 0.2 0.1 0.1
Free Cash Flow 2.5 3.2 (0.7)
Dividends Paid 0.8 0.6 0.2
Share Repurchase 0.6 0.5 0.1
Avg. Diluted Shares (millions) 756 768 (12)
Cash and Investments 35.0 30.0 5.0
Debt Outstanding 33.2 32.0 1.2
Stockholders' Equity 30.1 27.5 2.6
Note: Numbers may not add due to rounding
For the full year 2016, the Company now expects:
Second Quarter Product and Pipeline Update
Key development milestones:
Clinical Program Indication Milestone
Repatha ® (evolocumab) Hyperlipidemia Phase 3 coronary imaging data expected H2 2016 Phase 3 CV outcomes data expected Q1 2017*
KYPROLIS Newly diagnosed multiple myeloma Phase 3 data expected H2 2016*
BLINCYTO ® Pediatric Ph- R/R B-cell precursor ALL FDA priority review
Parsabiv ™ (etelcalcetide) † Secondary hyperparathyroidism Global regulatory reviews
XGEVA Prevention of SREs in multiple myeloma Phase 3 data expected H2 2016*
Romosozumab Postmenopausal osteoporosis US regulatory review Global regulatory submissions
Erenumab (AMG 334) Migraine Prophylaxis Phase 3 episodic migraine data expected H2 2016
ABP 215 (biosimilar bevacizumab) Oncology Global regulatory submissions
ABP 501 (biosimilar adalimumab) Inflammatory diseases Global regulatory reviews
ABP 980 (biosimilar trastuzumab) Breast Cancer Global regulatory submissions
The Company provided the following updates on selected product and pipeline programs:
Erenumab is developed in collaboration with Novartis Romosozumab is developed in collaboration with UCB globally, as well as Astellas in Japan
Non-GAAP Financial Measures
In this news release, management has presented its operating results for the second quarters of 2016 and 2015 in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2016 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 2016 and 2015. 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.
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.
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.
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. 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. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. 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.
CONTACT: Amgen, Thousand Oaks Trish Hawkins , 805-447-5631 (media) Arvind Sood , 805-447-1060 (investors)
Amgen Inc.
Consolidated Statements of Income - GAAP
(In millions, except per share data)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
2016 2015 2016 2015
Revenues:
Product sales $ 5,474 $ 5,225 $ 10,713 $ 10,099
Other revenues 214 145 502 304
Total revenues 5,688 5,370 11,215 10,403
Operating expenses:
Cost of sales 1,050 1,089 2,068 2,122
Research and development 900 964 1,772 1,858
Selling, general and administrative 1,292 1,160 2,495 2,186
Other 66 81 98 139
Total operating expenses 3,308 3,294 6,433 6,305
Operating income 2,380 2,076 4,782 4,098
Interest expense, net 313 277 607 529
Interest and other income, net 137 198 287 304
Income before income taxes 2,204 1,997 4,462 3,873
Provision for income taxes 334 344 692 597
Net income $ 1,870 $ 1,653 $ 3,770 $ 3,276
Earnings per share:
Basic $ 2.49 $ 2.18 $ 5.01 $ 4.30
Diluted $ 2.47 $ 2.15 $ 4.97 $ 4.26
Weighted average shares used in calculation of earnings per share:
Basic 751 760 753 761
Diluted 756 768 759 769
Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)
(Unaudited)
June 30, December 31,
2016 2015
Assets
Current assets:
Cash, cash equivalents and marketable securities $ 35,034 $ 31,382
Trade receivables, net 3,078 2,995
Inventories 2,671 2,435
Other current assets 2,164 1,703
Total current assets 42,947 38,515
Property, plant and equipment, net 4,884 4,907
Intangible assets, net 11,068 11,641
Goodwill 14,799 14,787
Other assets 1,773 1,599
Total assets $ 75,471 $ 71,449
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 5,536 $ 6,417
Current portion of long-term debt 5,294 2,247
Total current liabilities 10,830 8,664
Long-term debt 27,928 29,182
Long-term deferred tax liability 2,598 2,239
Other noncurrent liabilities 3,982 3,281
Stockholders' equity 30,133 28,083
Total liabilities and stockholders' equity $ 75,471 $ 71,449
Shares outstanding 749 754
Amgen Inc.
GAAP to Non-GAAP Reconciliations
(In millions)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
2016 2015 2016 2015
GAAP cost of sales $ 1,050 $ 1,089 $ 2,068 $ 2,122
Adjustments to cost of sales:
Acquisition-related expenses (a) (312) (285) (623) (569)
Certain net charges pursuant to our restructuring initiative - (15) - (29)
Total adjustments to cost of sales (312) (300) (623) (598)
Non-GAAP cost of sales $ 738 $ 789 $ 1,445 $ 1,524
GAAP cost of sales as a percentage of product sales 19.2% 20.8% 19.3% 21.0%
Acquisition-related expenses -5.7 -5.4 -5.8 -5.6
Certain net charges pursuant to our restructuring initiative 0.0 -0.3 0.0 -0.3
Non-GAAP cost of sales as a percentage of product sales 13.5% 15.1% 13.5% 15.1%
GAAP research and development expenses $ 900 $ 964 $ 1,772 $ 1,858
Adjustments to research and development expenses:
Acquisition-related expenses (a) (19) (28) (38) (49)
Certain net charges pursuant to our restructuring initiative (3) (18) 2 (35)
Total adjustments to research and development expenses (22) (46) (36) (84)
Non-GAAP research and development expenses $ 878 $ 918 $ 1,736 $ 1,774
GAAP research and development expenses as a percentage of product sales 16.4% 18.4% 16.5% 18.4%
Acquisition-related expenses (a) -0.3 -0.5 -0.3 -0.5
Certain net charges pursuant to our restructuring initiative -0.1 -0.3 0.0 -0.3
Non-GAAP research and development expenses as a percentage of product sales 16.0% 17.6% 16.2% 17.6%
GAAP selling, general and administrative expenses $ 1,292 $ 1,160 $ 2,495 $ 2,186
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (b) (27) (28) (128) (57)
Certain net charges pursuant to our restructuring initiative (5) (20) (4) (24)
Total adjustments to selling, general and administrative expenses (32) (48) (132) (81)
Non-GAAP selling, general and administrative expenses $ 1,260 $ 1,112 $ 2,363 $ 2,105
GAAP selling, general and administrative expenses as a percentage of product sales 23.6% 22.2% 23.3% 21.6%
Acquisition-related expenses (a) -0.5 -0.5 -1.2 -0.6
Certain net charges pursuant to our restructuring initiative -0.1 -0.4 0.0 -0.2
Non-GAAP selling, general and administrative expenses as a percentage of product sales 23.0% 21.3% 22.1% 20.8%
GAAP operating expenses $ 3,308 $ 3,294 $ 6,433 $ 6,305
Adjustments to operating expenses:
Adjustments to cost of sales (312) (300) (623) (598)
Adjustments to research and development expenses (22) (46) (36) (84)
Adjustments to selling, general and administrative expenses (32) (48) (132) (81)
Certain net charges pursuant to our restructuring initiative (c) (8) (10) (10) (67)
Expense related to various legal proceedings (78) (71) (105) (71)
Acquisition-related adjustments 20 - 17 (1)
Total adjustments to operating expenses (432) (475) (889) (902)
Non-GAAP operating expenses $ 2,876 $ 2,819 $ 5,544 $ 5,403
GAAP operating income $ 2,380 $ 2,076 $ 4,782 $ 4,098
Adjustments to operating expenses 432 475 889 902
Non-GAAP operating income $ 2,812 $ 2,551 $ 5,671 $ 5,000
GAAP operating income as a percentage of product sales 43.5% 39.7% 44.6% 40.6%
Adjustments to cost of sales 5.7 5.7 5.8 5.9
Adjustments to research and development expenses 0.4 0.9 0.4 0.8
Adjustments to selling, general and administrative expenses 0.6 0.9 1.2 0.8
Certain net charges pursuant to our restructuring initiative (c) 0.2 0.2 0.1 0.7
Expense related to various legal proceedings 1.4 1.4 1.0 0.7
Acquisition-related adjustments -0.4 0.0 -0.2 0.0
Non-GAAP operating income as a percentage of product sales 51.4% 48.8% 52.9% 49.5%
GAAP income before income taxes $ 2,204 $ 1,997 $ 4,462 $ 3,873
Adjustments to operating expenses 432 475 889 902
Non-GAAP income before income taxes $ 2,636 $ 2,472 $ 5,351 $ 4,775
GAAP provision for income taxes $ 334 $ 344 $ 692 $ 597
Adjustments to provision for income taxes:
Income tax effect of the above adjustments to operating expenses (d) 146 151 285 290
Other income tax adjustments (e) 10 - 25 -
Total adjustments to provision for income taxes 156 151 310 290
Non-GAAP provision for income taxes $ 490 $ 495 $ 1,002 $ 887
GAAP tax rate as a percentage of income before taxes 15.2% 17.2% 15.5% 15.4%
Adjustments to provision for income taxes:
Income tax effect of the above adjustments to operating expenses (d) 3.0 2.8 2.7 3.2
Other income tax adjustments (e) 0.4 0.0 0.5 0.0
Total adjustments to provision for income taxes 3.4 2.8 3.2 3.2
Non-GAAP tax rate as a percentage of income before taxes 18.6% 20.0% 18.7% 18.6%
GAAP net income $ 1,870 $ 1,653 $ 3,770 $ 3,276
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect 286 324 604 612
Other income tax adjustments (e) (10) - (25) -
Total adjustments to net income 276 324 579 612
Non-GAAP net income $ 2,146 $ 1,977 $ 4,349 $ 3,888
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, 2016 June 30, 2015
GAAP Non-GAAP GAAP Non-GAAP
Net income $ 1,870 $ 2,146 $ 1,653 $ 1,977
Weighted-average shares for diluted EPS 756 756 768 768
Diluted EPS $ 2.47 $ 2.84 $ 2.15 $ 2.57
Six months ended Six months ended
June 30, 2016 June 30, 2015
GAAP Non-GAAP GAAP Non-GAAP
Net income $ 3,770 $ 4,349 $ 3,276 $ 3,888
Weighted-average shares for diluted EPS 759 759 769 769
Diluted EPS $ 4.97 $ 5.73 $ 4.26 $ 5.06
(a) The adjustments related primarily to non-cash amortization of intangible assets acquired in business combinations.
(b) For the three months ended June 20, 2016 as well as the three and six months ended June 30, 2015, the adjustments related primarily to non-cash amortization of intangible assets acquired in business combinations. For the six months ended June 30, 2016, the adjustments related primarily to a $73-million charge resulting from the reacquisition of Prolia ® , XGEVA ® and Vectibix ® license agreements in certain markets from Glaxo Group Limited, as well as non-cash amortization of intangible assets acquired in business combinations.
(c) The adjustments related primarily to severance expenses.
(d) 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, 2016, were 33.8% and 32.1%, respectively, compared with 31.8% and 32.2% for the corresponding periods of the prior year.
(e) The adjustments related to certain prior period items excluded from non-GAAP earnings, primarily the impact related to the stock options from the adoption of ASU 2016-09.
Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
2016 2015 2016 2015
Net cash provided by operating activities $ 2,677 $ 3,284 (a) $ 4,592 $ 4,766 (a)
Net cash used in investing activities (657) (2,359) (5,047) (3,311)
Net cash (used in) provided by financing activities (2,286) 6 (1,059) (1,391)
(Decrease) increase in cash and cash equivalents (266) 931 (1,514) 64
Cash and cash equivalents at beginning of period 2,896 2,864 4,144 3,731
Cash and cash equivalents at end of period $ 2,630 $ 3,795 $ 2,630 $ 3,795
Three months ended Six months ended
June 30, June 30,
2016 2015 2016 2015
Net cash provided by operating activities $ 2,677 $ 3,284 (a) $ 4,592 $ 4,766 (a)
Capital expenditures (188) (133) (344) (251)
Free cash flow $ 2,489 $ 3,151 $ 4,248 $ 4,515
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2016
(Unaudited)
GAAP diluted EPS guidance $ 9.55 - $ 9.90
Known adjustments to arrive at non-GAAP*:
Acquisition-related expenses (a) 1.35
Restructuring charges 0.09 - 0.14
Legal proceeding charge 0.09
Tax adjustments (b) (0.03)
Non-GAAP diluted EPS guidance $ 11.10 - $ 11.40
* The known adjustments are presented net of their related tax impact which amount to approximately $0.71 to $0.73 per share, 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 certain prior period items excluded from non-GAAP earnings.
Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2016
(Unaudited)
2016
GAAP tax rate guidance 16.5% - 17.5%
Tax rate effect of known adjustments discussed above 2.5%
Non-GAAP tax rate guidance 19.0% - 20.0%

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Last updated: Jul 27, 2016