Full Press Release Details
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:
"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 percentages | Q1 '13 | Q1 '12 | YOY Δ | |||
| Total Revenues | $4,238 | $4,048 | 5% | |||
| Adjusted Net Income | 1,498 | 1,287 | 16% | |||
| Adjusted EPS | $1.96 | $1.61 | 22% | |||
| GAAP Net Income | 1,434 | 1,184 | 21% | |||
| GAAP EPS | $1.88 | $1.48 | 27% |
Product Sales Performance
Product Sales Detail by Product and Geographic Region
| $Millions, except percentages | Q1 '13 | Q1 '12 | YOY Δ | |||||
| US | ROW | TOTAL | TOTAL | TOTAL | ||||
| Neulasta ® / NEUPOGEN ® | $1,069 | $269 | $1,338 | $1,344 | 0% | |||
| Neulasta ® | 827 | 212 | 1,039 | 1,039 | 0% | |||
| NEUPOGEN ® | 242 | 57 | 299 | 305 | (2%) | |||
| Enbrel ® | 974 | 65 | 1,039 | 938 | 11% | |||
| Aranesp ® | 168 | 300 | 468 | 518 | (10%) | |||
| EPOGEN ® | 435 | 0 | 435 | 446 | (2%) | |||
| Sensipar ® / Mimpara ® | 179 | 85 | 264 | 219 | 21% | |||
| Vectibix ® | 27 | 60 | 87 | 90 | (3%) | |||
| Nplate ® | 55 | 41 | 96 | 90 | 7% | |||
| XGEVA ® / Prolia ® | 265 | 100 | 365 | 241 | 51% | |||
| XGEVA ® | 178 | 45 | 223 | 153 | 46% | |||
| Prolia ® | 87 | 55 | 142 | 88 | 61% | |||
| Other | 0 | 59 | 59 | 15 | * | |||
| Total product sales | $3,172 | $979 | $4,151 | $3,901 | 6% | |||
| * Change in excess of 100% |
Operating Expense and Tax Rate Analysis, on an Adjusted Basis
| $Millions, except percentages | ||||||
| On an Adjusted Basis | Q1 '13 | Q1 '12 | YOY Δ | |||
| Cost of Sales | $671 | $666 | 1% | |||
| % of sales | 16.2% | 17.1% | (0.9) pts | |||
| % of sales (Excluding PR excise tax) | 14.1% | 15.0% | (0.9) pts | |||
| Research & Development | $851 | $723 | 18% | |||
| % of sales | 20.5% | 18.5% | 2.0 pts | |||
| Selling, General & Administrative | $1,144 | $1,057 | 8% | |||
| % of sales | 27.6% | 27.1% | 0.5 pts | |||
| TOTAL Operating Expenses | $2,666 | $2,446 | 9% | |||
| pts: percentage points |
| On an Adjusted Basis | Q1 '13 | Q1 '12 | YOY Δ | |||
| Tax Rate* | (0.9%) | 15.6% | (16.5) pts | |||
| Tax Rate (Excluding PR excise tax credits) | 4.2% | 20.2% | (16.0) pts | |||
| pts: percentage points | ||||||
| * Note: Q1 represents a net tax benefit of $13M |
Cash Flow and Balance Sheet Discussion
| $Billions, except shares | Q1 '13 | Q1 '12 | YOY Δ | |||
| Operating Cash Flow | $1.0 | $1.0 | $0.1 | |||
| Free Cash Flow | 0.9 | 0.8 | 0.1 | |||
| Dividend Paid | 0.4 | 0.3 | 0.1 | |||
| Cost of Shares Repurchased | 0.8 | 1.4 | (0.7) | |||
| Adjusted Avg. Diluted Shares (millions) | 764 | 799 | (35) | |||
| Cash Balance | 21.3 | 19.4 | 1.9 | |||
| Debt Outstanding | 23.9 | 21.4 | 2.5 | |||
| Stockholders' Equity | 19.5 | 18.9 | 0.6 | |||
| Note: Numbers may not add due to rounding |
For the full year 2013, the Company expects:
First Quarter Product and Pipeline Update
The Company provided the following information on clinical programs:
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.
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 ended | ||||||
| March 31, | ||||||
| 2013 | 2012 | |||||
| Revenues: | ||||||
| Product sales | $ 4,151 | $ 3,901 | ||||
| Other revenues | 87 | 147 | ||||
| Total revenues | 4,238 | 4,048 | ||||
| Operating expenses: | ||||||
| Cost of sales | 744 | 750 | ||||
| Research and development | 878 | 736 | ||||
| Selling, general and administrative | 1,158 | 1,079 | ||||
| Other | 16 | 6 | ||||
| Total operating expenses | 2,796 | 2,571 | ||||
| Operating income | 1,442 | 1,477 | ||||
| Interest expense, net | 263 | 235 | ||||
| Interest and other income, net | 164 | 124 | ||||
| Income before income taxes | 1,343 | 1,366 | ||||
| Provision for income taxes | (91) | 182 | ||||
| Net income | $ 1,434 | $ 1,184 | ||||
| Earnings per share: | ||||||
| Basic | $ 1.91 | $ 1.50 | ||||
| Diluted | $ 1.88 | $ 1.48 | ||||
| Average shares used in calculation of earnings per share: | ||||||
| Basic | 751 | 791 | ||||
| Diluted | 764 | 800 |
| Amgen Inc. | ||||||
| Condensed Consolidated Balance Sheets - GAAP | ||||||
| (In millions) | ||||||
| (Unaudited) | ||||||
| March 31, | December 31, | |||||
| 2013 | 2012 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash, cash equivalents and marketable securities | $ 21,271 | $ 24,061 | ||||
| Trade receivables, net | 2,528 | 2,518 | ||||
| Inventories | 2,737 | 2,744 | ||||
| Other current assets | 2,159 | 1,886 | ||||
| Total current assets | 28,695 | 31,209 | ||||
| Property, plant and equipment, net | 5,296 | 5,326 | ||||
| Intangible assets, net | 3,897 | 3,968 | ||||
| Goodwill | 12,604 | 12,662 | ||||
| Other assets | 1,148 | 1,133 | ||||
| Total assets | $ 51,640 | $ 54,298 | ||||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable and accrued liabilities | $ 5,135 | $ 5,696 | ||||
| Current portion of long-term debt | 7 | 2,495 | ||||
| Total current liabilities | 5,142 | 8,191 | ||||
| Long-term debt | 23,885 | 24,034 | ||||
| Other non-current liabilities | 3,122 | 3,013 | ||||
| Stockholders' equity | 19,491 | 19,060 | ||||
| Total liabilities and stockholders' equity | $ 51,640 | $ 54,298 | ||||
| Shares outstanding | 750 | 756 |
| Amgen Inc. | ||||
| GAAP to "Adjusted" Reconciliations | ||||
| (In millions) | ||||
| (Unaudited) | ||||
| Three months ended | ||||
| March 31, | ||||
| 2013 | 2012 | |||
| GAAP cost of sales | $ 744 | $ 750 | ||
| Adjustments 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 | $ 671 | $ 666 | ||
| GAAP research and development expenses | $ 878 | $ 736 | ||
| Adjustments 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 | $ 723 | ||
| GAAP selling, general and administrative expenses | $ 1,158 | $ 1,079 | ||
| Adjustments 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 | $ 1,144 | $ 1,057 | ||
| GAAP operating expenses | $ 2,796 | $ 2,571 | ||
| Adjustments 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 | $ 2,446 | ||
| GAAP income before income taxes | $ 1,343 | $ 1,366 | ||
| Adjustments to income before income taxes: | ||||
| Adjustments to operating expenses | 130 | 125 | ||
| Non-cash interest expense associated with our convertible notes | 12 | 34 | ||
| Total adjustments to income before income taxes | 142 | 159 | ||
| Adjusted income before income taxes | $ 1,485 | $ 1,525 | ||
| GAAP provision for income taxes | $ (91) | $ 182 | ||
| Adjustments to provision for income taxes: | ||||
| Income tax effect of the above adjustments (d) | 40 | 56 | ||
| Income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities | 38 | - | ||
| Total adjustments to provision for income taxes | 78 | 56 | ||
| Adjusted provision for income taxes | $ (13) | $ 238 | ||
| GAAP net income | $ 1,434 | $ 1,184 | ||
| Adjustments to net income: | ||||
| Adjustments to income before income taxes, net of the tax effect of the above adjustments | 102 | 103 | ||
| Income tax benefit from resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities | (38) | - | ||
| Total adjustments to net income | 64 | 103 | ||
| Adjusted net income | $ 1,498 | $ 1,287 |
| 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 ended | Three months ended | ||||||||
| March 31, 2013 | March 31, 2012 | ||||||||
| GAAP | "Adjusted" | GAAP | "Adjusted" | ||||||
| Income (Numerator): | |||||||||
| Net income for basic and diluted EPS | $ 1,434 | $ 1,498 | $ 1,184 | $ 1,287 | |||||
| Shares (Denominator): | |||||||||
| Weighted-average shares for basic EPS | 751 | 751 | 791 | 791 | |||||
| Effect of dilutive securities | 13 | 13 | (*) | 9 | 8 | (*) | |||
| Weighted-average shares for diluted EPS | 764 | 764 | 800 | 799 | |||||
| Diluted EPS | $ 1.88 | $ 1.96 | $ 1.48 | $ 1.61 | |||||
| (*) 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 ended | |||||||||
| March 31, | |||||||||
| 2013 | 2012 | ||||||||
| "Adjusted" diluted EPS, excluding stock option expense | $ 1.96 | $ 1.61 | |||||||
| Impact of stock option expense (net of tax) | (0.01) | (0.02) | |||||||
| "Adjusted" diluted EPS, including stock option expense | $ 1.95 | $ 1.59 | |||||||
| (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%, respectively | ||||||||
| Note: | 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 presentation |
| Amgen Inc. | ||||||
| Reconciliation of Free Cash Flow | ||||||
| (In millions) | ||||||
| (Unaudited) | ||||||
| Three months ended | ||||||
| March 31, | ||||||
| 2013 | 2012 | |||||
| Cash Flows from Operations | $ 1,049 | $ 972 | ||||
| Capital 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 $7.35 | ||||||||||||
| 2013 | ||||||||||||
| GAAP diluted EPS guidance | $ 6.68 | - | $ 6.98 | |||||||||
| Known adjustments to arrive at "Adjusted" earnings*: | ||||||||||||
| Acquisition-related expenses | (a) | 0.36 | ||||||||||
| Stock option expense | 0.03 | |||||||||||
| Expense related to a legal proceeding | 0.02 | |||||||||||
| Non-cash interest expense associated with our convertible notes | 0.01 | |||||||||||
| Tax 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 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 credit | 2013 without PR excise tax credit | |||||||||||
| GAAP tax rate guidance | 9% | - | 10% | 13% | - | 14% | ||||||
| Tax rate effect of known adjustments discussed above | 2% | 2% | ||||||||||
| "Adjusted" tax rate guidance | 11% | - | 12% | 15% | - | 16% |
CONTACT: Amgen, Thousand Oaks Ashleigh Koss , 805-313-6151 (media) Arvind Sood , 805-447-1060 (investors)