Full Press Release Details
THOUSAND OAKS, Calif. , April 22, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the first quarter of 2014. Key results include:
"Strong underlying demand for our products and growth in adjusted operating income make us confident in our full-year growth outlook," said Robert A. Bradway , chairman & chief executive officer. "We continue to advance our robust late stage pipeline and expect to submit global filings for evolocumab in 2014."
| Year-over-Year | ||||||
| $Millions, except EPS and percentages | Q1 '14 | Q1 '13 | YOY Δ | |||
| Total Revenues | $ 4,521 | $ 4,238 | 7% | |||
| Adjusted Operating Income | $ 1,860 | $ 1,572 | 18% | |||
| Adjusted Net Income | $ 1,438 | $ 1,498 | (4%) | |||
| Adjusted EPS | $ 1.87 | $ 1.96 | (5%) | |||
| GAAP Operating Income | $ 1,364 | $ 1,442 | (5%) | |||
| GAAP Net Income | $ 1,073 | $ 1,434 | (25%) | |||
| GAAP EPS | $ 1.40 | $ 1.88 | (26%) |
First Quarter 2014 Product Sales Performance
Product Sales Detail by Product and Geographic Region
| $Millions, except percentages | Q1 '14 | Q1 '13 | YOY Δ | |||||
| US | ROW | TOTAL | TOTAL | TOTAL | ||||
| Neulasta ® / NEUPOGEN ® | $1,066 | $313 | $1,379 | $1,338 | 3% | |||
| Neulasta ® | 852 | 238 | 1,090 | 1,039 | 5% | |||
| NEUPOGEN ® | 214 | 75 | 289 | 299 | (3%) | |||
| Enbrel ® | 924 | 64 | 988 | 1,039 | (5%) | |||
| Aranesp ® | 177 | 283 | 460 | 468 | (2%) | |||
| EPOGEN ® | 462 | 0 | 462 | 435 | 6% | |||
| Sensipar ® / Mimpara ® | 178 | 92 | 270 | 264 | 2% | |||
| Vectibix ® | 39 | 64 | 103 | 87 | 18% | |||
| Nplate ® | 62 | 51 | 113 | 96 | 18% | |||
| XGEVA ® / Prolia ® | 319 | 156 | 475 | 365 | 30% | |||
| XGEVA ® | 200 | 79 | 279 | 223 | 25% | |||
| Prolia ® | 119 | 77 | 196 | 142 | 38% | |||
| Kyprolis ® | 62 | 6 | 68 | 0 | * | |||
| Other | 0 | 38 | 38 | 59 | (36%) | |||
| Total product sales | $3,289 | $1,067 | $4,356 | $4,151 | 5% | |||
| * Not meaningful |
Operating Expense and Tax Rate Analysis, on an Adjusted Basis
| $Millions, except percentages | ||||||
| On an Adjusted Basis | Q1 '14 | Q1 '13 | YOY Δ | |||
| Cost of Sales | $684 | $671 | 2% | |||
| % of sales | 15.7% | 16.2% | (0.5) pts | |||
| % of sales (Excluding PR excise tax) | 13.6% | 14.1% | (0.5) pts | |||
| Research & Development | $994 | $851 | 17% | |||
| % of sales | 22.8% | 20.5% | 2.3 pts | |||
| Selling, General & Administrative | $983 | $1,144 | (14%) | |||
| % of sales | 22.6% | 27.6% | (5.0) pts | |||
| TOTAL Operating Expenses | $2,661 | $2,666 | (0%) | |||
| pts: percentage points | ||||||
| PR: Puerto Rico |
| On an Adjusted Basis | Q1 '14 | Q1 '13 | YOY Δ | ||
| Tax Rate | 15.4% | (0.9%) | 16.3 pts | ||
| Tax Rate (Excluding PR excise tax credits) | 18.9% | 4.2% | 14.7 pts | ||
| pts: percentage points | |||||
| PR: Puerto Rico |
Cash Flow and Balance Sheet Discussion
| $Billions, except shares | Q1 '14 | Q1 '13 | YOY Δ | ||
| Operating Cash Flow | $1.1 | $1.0 | $0.1 | ||
| Capital Expenditures | 0.2 | 0.2 | 0.0 | ||
| Free Cash Flow | 1.0 | 0.9 | 0.1 | ||
| Dividends Paid | 0.5 | 0.4 | 0.1 | ||
| Cost of Shares Repurchased | 0.0 | 0.8 | (0.8) | ||
| Avg. Diluted Shares (millions) | 768 | 764 | 4 | ||
| Cash and Investments* | 23.2 | 21.3 | 1.9 | ||
| Debt Outstanding | 32.0 | 23.9 | 8.1 | ||
| Stockholders' Equity | 22.7 | 19.5 | 3.2 | ||
| * Includes cash, cash equivalents and marketable securities, and long-term restricted investments. | |||||
| Note: Numbers may not add due to rounding |
For the full year 2014, the Company continues to expect:
First Quarter Product and Pipeline Update
2014 milestones for innovative pivotal programs:
| Clinical Program | Lead Indication | Milestone | Timing |
| Evolocumab | Dyslipidemia | Phase 3 data | Achieved |
| Evolocumab | Dyslipidemia | Global filing | 2014 |
| Talimogene laherparepvec | Metastatic melanoma | Phase 3 data* † | Achieved |
| Blinatumomab | Relapsed/refractory ALL | Phase 2 data | Achieved |
| Brodalumab** | Psoriatic arthritis | Phase 3 initiation | Achieved |
| Brodalumab** | Psoriasis | Phase 3 data | 2014 |
| Ivabradine | Chronic heart failure | U.S. filing | Q2 2014 |
| Kyprolis | Multiple myeloma | Phase 3 ASPIRE interim analysis* Phase 3 FOCUS data* | Q2/Q3 2014 |
| Trebananib | Recurrent ovarian cancer | Phase 3 data* † | H2 2014 |
| Velcalcetide (AMG 416) | Secondary hyperparathyroidism | Phase 3 data | H2 2014 |
| * Event driven studies |
| **Developed in collaboration with AstraZeneca/MedImmune |
| † Overall survival (secondary endpoint) |
| ALL = acute lymphoblastic leukemia |
The Company provided the following information on selected clinical programs:
Talimogene laherparepvec
Non-GAAP Financial Measures
In this press release, management has presented its operating results for the first quarters of 2014 and 2013 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 2014 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, cost-savings initiatives 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 first quarters of 2014 and 2013. 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 press 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 the world's largest independent biotechnology company, 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, 2013 , 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. 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, | ||||||
| 2014 | 2013 | |||||
| Revenues: | ||||||
| Product sales | $ 4,356 | $ 4,151 | ||||
| Other revenues | 165 | 87 | ||||
| Total revenues | 4,521 | 4,238 | ||||
| Operating expenses: | ||||||
| Cost of sales | 1,090 | 744 | ||||
| Research and development | 1,027 | 878 | ||||
| Selling, general and administrative | 1,023 | 1,158 | ||||
| Other | 17 | 16 | ||||
| Total operating expenses | 3,157 | 2,796 | ||||
| Operating income | 1,364 | 1,442 | ||||
| Interest expense, net | 259 | 263 | ||||
| Interest and other income, net | 99 | 164 | ||||
| Income before income taxes | 1,204 | 1,343 | ||||
| Provision (benefit) for income taxes | 131 | (91) | ||||
| Net income | $ 1,073 | $ 1,434 | ||||
| Earnings per share: | ||||||
| Basic | $ 1.42 | $ 1.91 | ||||
| Diluted | $ 1.40 | $ 1.88 | ||||
| Average shares used in calculation of earnings per share: | ||||||
| Basic | 757 | 751 | ||||
| Diluted | 768 | 764 |
| Amgen Inc. | ||||||
| Condensed Consolidated Balance Sheets - GAAP | ||||||
| (In millions) | ||||||
| (Unaudited) | ||||||
| March 31, | December 31, | |||||
| 2014 | 2013 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash, cash equivalents and marketable securities | $ 19,802 | $ 19,401 | ||||
| Trade receivables, net | 2,514 | 2,697 | ||||
| Inventories | 2,966 | 3,019 | ||||
| Other current assets | 3,020 | 2,250 | ||||
| Total current assets | 28,302 | 27,367 | ||||
| Property, plant and equipment, net | 5,365 | 5,349 | ||||
| Intangible assets, net | 13,566 | 13,262 | ||||
| Goodwill | 14,832 | 14,968 | ||||
| Restricted investments | 3,414 | 3,412 | ||||
| Other assets | 1,525 | 1,767 | ||||
| Total assets | $ 67,004 | $ 66,125 | ||||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable and accrued liabilities | $ 5,698 | $ 5,442 | ||||
| Current portion of long-term debt | 2,505 | 2,505 | ||||
| Total current liabilities | 8,203 | 7,947 | ||||
| Long-term debt | 29,519 | 29,623 | ||||
| Other non-current liabilities | 6,541 | 6,459 | ||||
| Stockholders' equity | 22,741 | 22,096 | ||||
| Total liabilities and stockholders' equity | $ 67,004 | $ 66,125 | ||||
| Shares outstanding | 757 | 755 |
| Amgen Inc. | ||||
| GAAP to Adjusted Reconciliations | ||||
| (In millions) | ||||
| (Unaudited) | ||||
| Three months ended | ||||
| March 31, | ||||
| 2014 | 2013 | |||
| GAAP cost of sales | $ 1,090 | $ 744 | ||
| Adjustments to cost of sales: | ||||
| Acquisition-related expenses (a) | (404) | (71) | ||
| Stock option expense | (2) | (2) | ||
| Total adjustments to cost of sales | (406) | (73) | ||
| Adjusted cost of sales | $ 684 | $ 671 | ||
| GAAP research and development expenses | $ 1,027 | $ 878 | ||
| Adjustments to research and development expenses: | ||||
| Acquisition-related expenses (b) | (31) | (22) | ||
| Stock option expense | (2) | (5) | ||
| Total adjustments to research and development expenses | (33) | (27) | ||
| Adjusted research and development expenses | $ 994 | $ 851 | ||
| GAAP selling, general and administrative expenses | $ 1,023 | $ 1,158 | ||
| Adjustments to selling, general and administrative expenses: | ||||
| Acquisition-related expenses (b) | (38) | (10) | ||
| Stock option expense | (2) | (4) | ||
| Total adjustments to selling, general and administrative expenses | (40) | (14) | ||
| Adjusted selling, general and administrative expenses | $ 983 | $ 1,144 | ||
| GAAP operating expenses | $ 3,157 | $ 2,796 | ||
| Adjustments to operating expenses: | ||||
| Adjustments to cost of sales | (406) | (73) | ||
| Adjustments to research and development expenses | (33) | (27) | ||
| Adjustments to selling, general and administrative expenses | (40) | (14) | ||
| Certain charges pursuant to our efforts to improve cost efficiencies in our operations (c) | (15) | - | ||
| Other (d) | (2) | (16) | ||
| Total adjustments to operating expenses | (496) | (130) | ||
| Adjusted operating expenses | $ 2,661 | $ 2,666 | ||
| GAAP operating income | $ 1,364 | $ 1,442 | ||
| Adjustments to operating expenses | 496 | 130 | ||
| Adjusted operating income | $ 1,860 | $ 1,572 | ||
| GAAP income before income taxes | $ 1,204 | $ 1,343 | ||
| Adjustments to income before income taxes: | ||||
| Adjustments to operating expenses | 496 | 130 | ||
| Non-cash interest expense associated with our convertible notes | - | 12 | ||
| Total adjustments to income before income taxes | 496 | 142 | ||
| Adjusted income before income taxes | $ 1,700 | $ 1,485 | ||
| GAAP provision/(benefit) for income taxes | $ 131 | $ (91) | ||
| Adjustments to provision/(benefit) for income taxes: | ||||
| Income tax effect of the above adjustments (e) | 131 | 40 | ||
| Other income tax adjustments (f) | - | 38 | ||
| Total adjustments to provision/(benefit) for income taxes | 131 | 78 | ||
| Adjusted provision/(benefit) for income taxes | $ 262 | $ (13) | ||
| GAAP net income | $ 1,073 | $ 1,434 | ||
| Adjustments to net income: | ||||
| Adjustments to income before income taxes, net of the income tax effect of the above adjustments | 365 | 102 | ||
| Other income tax adjustments (f) | - | (38) | ||
| Total adjustments to net income | 365 | 64 | ||
| Adjusted net income | $ 1,438 | $ 1,498 |
| 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 | |||||||
| March 31, 2014 | March 31, 2013 | |||||||
| GAAP | Adjusted | GAAP | Adjusted | |||||
| Net income | $ 1,073 | $ 1,438 | $ 1,434 | $ 1,498 | ||||
| Weighted-average shares for diluted EPS | 768 | 768 | 764 | 764 | ||||
| Diluted EPS | $ 1.40 | $ 1.87 | $ 1.88 | $ 1.96 |
| (a) | The adjustments related primarily to non-cash amortization of intangible assets, including developed product technology rights, acquired in business combinations. The 2014 adjustments also include a $99 million charge related to the closing of an agreement associated with our 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 primarily to severance expenses. |
| (d) | The 2013 adjustments related primarily to various legal proceedings. |
| (e) | 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 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, 2014 and 2013, were 26.4% and 28.2%, respectively. |
| (f) | The adjustments in 2013 related to resolving certain non-routine transfer-pricing and acquisition-related issues with tax authorities. |
| Amgen Inc. | ||||
| Reconciliations of Free Cash Flow | ||||
| (In millions) | ||||
| (Unaudited) | ||||
| Three months ended | ||||
| March 31, | ||||
| 2014 | 2013 | |||
| Operating Cash Flow | $ 1,142 | $ 1,049 | ||
| Capital Expenditures | (172) | (158) | ||
| Free Cash Flow | $ 970 | $ 891 |
| Reconciliation of GAAP EPS Guidance to Adjusted | ||||
| EPS Guidance for the Year Ending December 31, 2014 | ||||
| (Unaudited) | ||||
| 2014 | ||||
| GAAP diluted EPS guidance | $ 6.65 | - | $ 6.95 | |
| Known adjustments to arrive at Adjusted earnings*: | ||||
| Acquisition-related expenses | (a) | 1.24 | ||
| Other | (b) | 0.01 | ||
| Adjusted diluted EPS guidance | $ 7.90 | - | $ 8.20 |
| * | The known adjustments are presented net of their related tax impact which amount to approximately $0.63 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 include stock option expense, cost savings initiatives and various legal proceedings. |
| Reconciliation of GAAP Tax Rate Guidance to Adjusted | ||||
| Tax Rate Guidance for the Year Ending December 31, 2014 | ||||
| (Unaudited) | ||||
| 2014 | ||||
| GAAP tax rate guidance | 11% | - | 12% | |
| Tax rate effect of known adjustments discussed above | 4% | |||
| Adjusted tax rate guidance | 15% | - | 16% |
CONTACT: Amgen, Thousand Oaks Kristen Davis , 805-447-3008 (media) Arvind Sood , 805-447-1060 (investors)