Full Press Release Details
THOUSAND OAKS, Calif. , Nov. 2, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the third quarter of 2021. Key results include:
"Our newest product, LUMAKRAS ® , a first-in-class lung cancer treatment, is off to a strong start and our robust pipeline of potential new medicines across all stages of development sets us up well to drive growth over the long term," said Robert A. Bradway , chairman and chief executive officer. "We achieved solid growth in the quarter as our medicines reached an increasing number of patients around the world."
| $Millions, except EPS, dividends paid per share and percentages | Q3 '21 | Q3 '20 | YOY Δ | |||||||
| Total Revenues | $ | 6,706 | $ | 6,423 | 4% | |||||
| GAAP Operating Income | $ | 2,378 | $ | 2,453 | (3%) | |||||
| GAAP Net Income | $ | 1,884 | $ | 2,021 | (7%) | |||||
| GAAP EPS | $ | 3.31 | $ | 3.43 | (3%) | |||||
| Non-GAAP Operating Income | $ | 3,452 | $ | 3,183 | 8% | |||||
| Non-GAAP Net Income | $ | 2,664 | $ | 2,467 | 8% | |||||
| Non-GAAP EPS | $ | 4.67 | $ | 4.19 | 11% | |||||
| Dividends Paid Per Share | $ | 1.76 | $ | 1.60 | 10% |
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. For comparability of results to the prior year, non-GAAP net income and non-GAAP EPS amounts for 2020 have been revised to reflect the update to our non-GAAP policy that excludes gains and losses on certain equity investments. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
Total product sales increased 4% for the third quarter of 2021 versus the third quarter of 2020. Unit volumes grew 8% while net selling price declined 7%. In addition, this quarter includes $147 million of favorable changes to estimated sales deductions related to prior periods. In the third quarter last year, the favorable estimated sales deductions were $36 million , resulting in a $111 million year-over-year benefit in this quarter.
We continue to see gradual recovery from the impact of the COVID-19 pandemic. As we progressed through the third quarter, we saw improvement in patient visits and diagnoses. Healthcare professional activity also improved during the first half of 2021 and stabilized during the third quarter. Overall, the gap in diagnosis visits over the course of the pandemic has suppressed the number of new patients starting treatment, which we expect will continue to impact our business for the remainder of the year.
General Medicine
Hematology-Oncology
Established Products
Product Sales Detail by Product and Geographic Region
| $Millions, except percentages | Q3 '21 | Q3 '20 | YOY Δ | |||||||||||||||
| US | ROW | TOTAL | TOTAL | TOTAL | ||||||||||||||
| Prolia ® | $ | 530 | $ | 273 | $ | 803 | $ | 701 | 15% | |||||||||
| EVENITY ® | 94 | 55 | 149 | 59 | * | |||||||||||||
| Repatha ® | 139 | 133 | 272 | 205 | 33% | |||||||||||||
| Aimovig ® | 77 | 2 | 79 | 105 | (25%) | |||||||||||||
| Otezla ® | 495 | 114 | 609 | 538 | 13% | |||||||||||||
| Enbrel ® | 1,263 | 26 | 1,289 | 1,325 | (3%) | |||||||||||||
| AMGEVITA™ | — | 111 | 111 | 80 | 39% | |||||||||||||
| LUMAKRAS ®/ LUMYKRAS ™ | 33 | 3 | 36 | — | * | |||||||||||||
| KYPROLIS ® | 198 | 95 | 293 | 260 | 13% | |||||||||||||
| XGEVA ® | 372 | 145 | 517 | 481 | 7% | |||||||||||||
| Vectibix ® | 84 | 116 | 200 | 193 | 4% | |||||||||||||
| Nplate ® | 156 | 117 | 273 | 212 | 29% | |||||||||||||
| BLINCYTO ® | 74 | 51 | 125 | 89 | 40% | |||||||||||||
| MVASI ® | 187 | 87 | 274 | 231 | 19% | |||||||||||||
| KANJINTI ® | 92 | 24 | 116 | 167 | (31%) | |||||||||||||
| Neulasta ® | 360 | 55 | 415 | 555 | (25%) | |||||||||||||
| NEUPOGEN ® | 32 | 20 | 52 | 65 | (20%) | |||||||||||||
| EPOGEN ® | 138 | — | 138 | 149 | (7%) | |||||||||||||
| Aranesp ® | 149 | 247 | 396 | 384 | 3% | |||||||||||||
| Parsabiv ® | 24 | 37 | 61 | 183 | (67%) | |||||||||||||
| Sensipar ® /Mimpara™ | — | 19 | 19 | 39 | (51%) | |||||||||||||
| Other products** | 61 | 32 | 93 | 83 | 12% | |||||||||||||
| Total product sales | $ | 4,558 | $ | 1,762 | $ | 6,320 | $ | 6,104 | 4% | |||||||||
| * Change in excess of 100% | ||||||||||||||||||
| ** Other products includes Corlanor ® , GENSENTA, IMLYGIC ® , AVSOLA ® , Bergamo, and RIABNI™ |
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
On a non-GAAP basis:
| $Millions, except percentages | GAAP | Non-GAAP | ||||||||||||||||||
| Q3 '21 | Q3 '20 | YOY Δ | Q3 '21 | Q3 '20 | YOY Δ | |||||||||||||||
| Cost of Sales | $ | 1,609 | $ | 1,561 | 3% | $ | 997 | $ | 874 | 14% | ||||||||||
| % of product sales | 25.5% | 25.6% | (0.1) pts | 15.8% | 14.3% | 1.5 pts | ||||||||||||||
| Research & Development | $ | 1,422 | $ | 1,062 | 34% | $ | 997 | $ | 1,037 | (4%) | ||||||||||
| % of product sales | 22.5% | 17.4% | 5.1 pts | 15.8% | 17.0% | (1.2) pts | ||||||||||||||
| Selling, General & Administrative | $ | 1,305 | $ | 1,346 | (3%) | $ | 1,260 | $ | 1,329 | (5%) | ||||||||||
| % of product sales | 20.6% | 22.1% | (1.5) pts | 19.9% | 21.8% | (1.9) pts | ||||||||||||||
| Other | $ | (8) | $ | 1 | * | $ | — | $ | — | —% | ||||||||||
| Total Operating Expenses | $ | 4,328 | $ | 3,970 | 9% | $ | 3,254 | $ | 3,240 | —% | ||||||||||
| Operating Margin | ||||||||||||||||||||
| operating income as % of product sales | 37.6% | 40.2% | (2.6) pts | 54.6% | 52.1% | 2.5 pts | ||||||||||||||
| Tax Rate | 12.6% | 8.4% | 4.2 pts | 13.6% | 13.1% | 0.5 pts | ||||||||||||||
| pts: percentage points | ||||||||||||||||||||
| * Change in excess of 100% |
Cash Flow and Balance Sheet
| $Billions, except shares | Q3 '21 | Q3 '20 | YOY Δ | |||||||||
| Operating Cash Flow | $ | 2.4 | $ | 3.4 | $ | (1.0) | ||||||
| Capital Expenditures | $ | 0.2 | $ | 0.1 | $ | 0.1 | ||||||
| Free Cash Flow | $ | 2.2 | $ | 3.2 | $ | (1.1) | ||||||
| Dividends Paid | $ | 1.0 | $ | 0.9 | $ | 0.1 | ||||||
| Share Repurchases | $ | 1.1 | $ | 0.8 | $ | 0.3 | ||||||
| Average Diluted Shares (millions) | 570 | 589 | (19) | |||||||||
| Note: Numbers may not add due to rounding | ||||||||||||
| $Billions | 9/30/21 | 12/31/20 | YTD Δ | |||||||||
| Cash and Investments | $ | 12.9 | $ | 10.6 | $ | 2.3 | ||||||
| Debt Outstanding | $ | 37.6 | $ | 33.0 | $ | 4.6 | ||||||
| Note: Numbers may not add due to rounding |
For the full year 2021, the Company now expects:
Third Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
LUMAKRAS/LUMYKRAS
Acapatamab (AMG 160)
AMG 340 (formerly TNB-585)
Tarlatamab (AMG 757)
AMG 451 / KHK4083
Rozibafusp alfa (AMG 570)
Efavaleukin alfa (AMG 592)
AMG 714 / PRV-015
Olpasiran (AMG 890)
Amgenpipeline.com
Tezepelumab is being developed in collaboration with AstraZeneca AMG 451 (also known as KHK4083) is being developed in collaboration with Kyowa Kirin AMG 714 (also known as PRV-015) is being developed in collaboration with Provention Bio DARZALEX ® and STELARA ® are a registered trademarks of Janssen Pharmaceutica NV EYLEA ® is a registered trademark of Regeneron Pharmaceuticals, Inc. SOLIRIS ® is a registered trademark of Alexion Pharmaceuticals, Inc.
Non-GAAP Financial Measures In this news release, management has presented its operating results for the third quarters of 2021 and 2020, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2021 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 third quarters of 2021 and 2020. 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.
Beginning January 1, 2021 , we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that are recorded to Other income (expense). This exclusion will not apply to our share of the earnings and losses of our strategic investments in corporations accounted for under the equity method of accounting, such as our investment in BeiGene. The Company will be excluding gains and losses from equity investments for the purpose of calculating the non-GAAP financial measures presented because the Company believes the results of such gains and losses are not representative of our normal business operations. We are making this change beginning in 2021 because, as we have increased our investments in these companies, we recognized that the resulting variability can impede comparability between periods of our financial performance for our ongoing business operations. For comparability of results to the prior year, non-GAAP net income and non-GAAP EPS amounts for 2020 have been revised to reflect the update to our non-GAAP policy that excludes gains and losses on certain equity investments.
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.
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 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 any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition, as well as 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, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, 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 current reports on 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, including our devices, 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, including in Puerto Rico , 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. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. 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 or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product 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. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. 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 collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. 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. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks Trish Rowland , 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 September 30, | Nine months ended September 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Revenues: | |||||||||||||||
| Product sales | $ | 6,320 | $ | 6,104 | $ | 18,026 | $ | 17,906 | |||||||
| Other revenues | 386 | 319 | 1,107 | 884 | |||||||||||
| Total revenues | 6,706 | 6,423 | 19,133 | 18,790 | |||||||||||
| Operating expenses: | |||||||||||||||
| Cost of sales | 1,609 | 1,561 | 4,736 | 4,562 | |||||||||||
| Research and development | 1,422 | 1,062 | 3,471 | 2,978 | |||||||||||
| Acquired in-process research and development | — | — | 1,505 | — | |||||||||||
| Selling, general and administrative | 1,305 | 1,346 | 3,943 | 3,957 | |||||||||||
| Other | (8) | 1 | 143 | 162 | |||||||||||
| Total operating expenses | 4,328 | 3,970 | 13,798 | 11,659 | |||||||||||
| Operating income | 2,378 | 2,453 | 5,335 | 7,131 | |||||||||||
| Other income (expense): | |||||||||||||||
| Interest expense, net | (296) | (302) | (862) | (944) | |||||||||||
| Other income, net | 73 | 55 | 97 | 69 | |||||||||||
| Income before income taxes | 2,155 | 2,206 | 4,570 | 6,256 | |||||||||||
| Provision for income taxes | 271 | 185 | 576 | 607 | |||||||||||
| Net income | $ | 1,884 | $ | 2,021 | $ | 3,994 | $ | 5,649 | |||||||
| Earnings per share: | |||||||||||||||
| Basic | $ | 3.32 | $ | 3.45 | $ | 6.98 | $ | 9.61 | |||||||
| Diluted | $ | 3.31 | $ | 3.43 | $ | 6.93 | $ | 9.54 | |||||||
| Weighted-average shares used in calculation of earnings per share: | |||||||||||||||
| Basic | 567 | 585 | 572 | 588 | |||||||||||
| Diluted | 570 | 589 | 576 | 592 |
| Amgen Inc. |
| Consolidated Balance Sheets - GAAP |
| (In millions) |
| September 30, | December 31, | ||||||
| 2021 | 2020 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash, cash equivalents and marketable securities | $ | 12,921 | $ | 10,647 | |||
| Trade receivables, net | 4,765 | 4,525 | |||||
| Inventories | 4,152 | 3,893 | |||||
| Other current assets | 2,542 | 2,079 | |||||
| Total current assets | 24,380 | 21,144 | |||||
| Property, plant and equipment, net | 4,982 | 4,889 | |||||
| Intangible assets, net | 14,659 | 16,587 | |||||
| Goodwill | 14,665 | 14,689 | |||||
| Other noncurrent assets | 6,307 | 5,639 | |||||
| Total assets | $ | 64,993 | $ | 62,948 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued liabilities | $ | 10,554 | $ | 11,562 | |||
| Current portion of long-term debt | 4,288 | 91 | |||||
| Total current liabilities | 14,842 | 11,653 | |||||
| Long-term debt | 33,291 | 32,895 | |||||
| Long-term tax liabilities | 6,483 | 6,968 | |||||
| Other noncurrent liabilities | 2,160 | 2,023 | |||||
| Total stockholders' equity | 8,217 | 9,409 | |||||
| Total liabilities and stockholders' equity | $ | 64,993 | $ | 62,948 | |||
| Shares outstanding | 565 | 578 |
| Amgen Inc. |
| GAAP to Non-GAAP Reconciliations |
| (Dollars in millions) |
| (Unaudited) |
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2021 | 2020* | 2021 | 2020* | ||||||||||||
| GAAP cost of sales | $ | 1,609 | $ | 1,561 | $ | 4,736 | $ | 4,562 | |||||||
| Adjustments to cost of sales: | |||||||||||||||
| Acquisition-related expenses (a) | (606) | (687) | (1,827) | (2,159) | |||||||||||
| Other | (6) | — | (11) | — | |||||||||||
| Total adjustments to cost of sales | (612) | (687) | (1,838) | (2,159) | |||||||||||
| Non-GAAP cost of sales | $ | 997 | $ | 874 | $ | 2,898 | $ | 2,403 | |||||||
| GAAP cost of sales as a percentage of product sales | 25.5 | % | 25.6 | % | 26.3 | % | 25.5 | % | |||||||
| Acquisition-related expenses (a) | (9.6) | (11.3) | (10.1) | (12.1) | |||||||||||
| Other | (0.1) | 0.0 | (0.1) | 0.0 | |||||||||||
| Non-GAAP cost of sales as a percentage of product sales | 15.8 | % | 14.3 | % | 16.1 | % | 13.4 | % | |||||||
| GAAP research and development expenses | $ | 1,422 | $ | 1,062 | $ | 3,471 | $ | 2,978 | |||||||
| Adjustments to research and development expenses: | |||||||||||||||
| Licensing- and acquisition-related expenses (b) | (425) | (24) | (494) | (77) | |||||||||||
| Certain net charges pursuant to our cost savings initiatives | — | (1) | — | (1) | |||||||||||
| Total adjustments to research and development expenses | (425) | (25) | (494) | (78) | |||||||||||
| Non-GAAP research and development expenses | $ | 997 | $ | 1,037 | $ | 2,977 | $ | 2,900 | |||||||
| GAAP research and development expenses as a percentage of product sales | 22.5 | % | 17.4 | % | 19.3 | % | 16.6 | % | |||||||
| Licensing- and acquisition-related expenses (b) | (6.7) | (0.4) | (2.8) | (0.4) | |||||||||||
| Certain net charges pursuant to our cost savings initiatives | 0.0 | 0.0 | 0.0 | 0.0 | |||||||||||
| Non-GAAP research and development expenses as a percentage of product sales | 15.8 | % | 17.0 | % | 16.5 | % | 16.2 | % | |||||||
| GAAP acquired IPR&D | $ | — | $ | — | $ | 1,505 | $ | — | |||||||
| Adjustments to acquired IPR&D: | |||||||||||||||
| Five Prime acquisition IPR&D expense | — | — | (1,505) | — | |||||||||||
| Non-GAAP acquired IPR&D | $ | — | $ | — | $ | — | $ | — | |||||||
| GAAP acquired IPR&D expenses as a percentage of product sales | — | % | — | % | 8.3 | % | — | % | |||||||
| Five Prime acquisition IPR&D expense | 0.0 | 0.0 | (8.3) | 0.0 | |||||||||||
| Non-GAAP acquired IPR&D expenses as a percentage of product sales | — | % | — | % | — | % | — | % | |||||||
| GAAP selling, general and administrative expenses | $ | 1,305 | $ | 1,346 | $ | 3,943 | $ | 3,957 | |||||||
| Adjustments to selling, general and administrative expenses: | |||||||||||||||
| Acquisition-related expenses (a) | (16) | (15) | (67) | (74) | |||||||||||
| Other | (29) | (2) | (45) | (2) | |||||||||||
| Total adjustments to selling, general and administrative expenses | (45) | (17) | (112) | (76) | |||||||||||
| Non-GAAP selling, general and administrative expenses | $ | 1,260 | $ | 1,329 | $ | 3,831 | $ | 3,881 | |||||||
| GAAP selling, general and administrative expenses as a percentage of product sales | 20.6 | % | 22.1 | % | 21.9 | % | 22.1 | % | |||||||
| Acquisition-related expenses (a) | (0.2) | (0.3) | (0.4) | (0.4) | |||||||||||
| Other | (0.5) | 0.0 | (0.2) | 0.0 | |||||||||||
| Non-GAAP selling, general and administrative expenses as a percentage of product sales | 19.9 | % | 21.8 | % | 21.3 | % | 21.7 | % | |||||||
| GAAP operating expenses | $ | 4,328 | $ | 3,970 | $ | 13,798 | $ | 11,659 | |||||||
| Adjustments to operating expenses: | |||||||||||||||
| Adjustments to cost of sales | (612) | (687) | (1,838) | (2,159) | |||||||||||
| Adjustments to research and development expenses | (425) | (25) | (494) | (78) | |||||||||||
| Adjustments to acquired IPR&D | — | — | (1,505) | — | |||||||||||
| Adjustments to selling, general and administrative expenses | (45) | (17) | (112) | (76) | |||||||||||
| Certain charges pursuant to our cost savings initiatives | (1) | — | (129) | 4 | |||||||||||
| Certain other expenses (c) | 9 | (1) | (14) | (166) | |||||||||||
| Total adjustments to operating expenses | (1,074) | (730) | (4,092) | (2,475) | |||||||||||
| Non-GAAP operating expenses | $ | 3,254 | $ | 3,240 | $ | 9,706 | $ | 9,184 | |||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2021 | 2020* | 2021 | 2020* | ||||||||||||
| GAAP operating income | $ | 2,378 | $ | 2,453 | $ | 5,335 | $ | 7,131 | |||||||
| Adjustments to operating expenses | 1,074 | 730 | 4,092 | 2,475 | |||||||||||
| Non-GAAP operating income | $ | 3,452 | $ | 3,183 | $ | 9,427 | $ | 9,606 | |||||||
| GAAP operating income as a percentage of product sales | 37.6 | % | 40.2 | % | 29.6 | % | 39.8 | % | |||||||
| Adjustments to cost of sales | 9.7 | 11.3 | 10.2 | 12.1 | |||||||||||
| Adjustments to research and development expenses | 6.7 | 0.4 | 2.8 | 0.4 | |||||||||||
| Acquired IPR&D | 0.0 | 0.0 | 8.3 | 0.0 | |||||||||||
| Adjustments to selling, general and administrative expenses | 0.7 | 0.3 | 0.6 | 0.4 | |||||||||||
| Certain charges pursuant to our cost savings initiatives | 0.0 | 0.0 | 0.7 | 0.0 | |||||||||||
| Certain other expenses (c) | (0.1) | 0.0 | 0.1 | 0.9 | |||||||||||
| Non-GAAP operating income as a percentage of product sales | 54.6 | % | 52.1 | % | 52.3 | % | 53.6 | % | |||||||
| GAAP other income, net | $ | 73 | $ | 55 | $ | 97 | $ | 69 | |||||||
| Adjustments to other income (expense), net: | |||||||||||||||
| Equity method investment basis difference amortization | 44 | 36 | 128 | 72 | |||||||||||
| Net (gains)/losses from equity investments | (191) | (134) | (335) | (139) | |||||||||||
| Gain from legal judgment proceeds | — | — | — | (72) | |||||||||||
| Total adjustments to other income (expense), net | (147) | (98) | (207) | (139) | |||||||||||
| Non-GAAP other income (expense), net | $ | (74) | (43) | $ | (110) | (70) | |||||||||
| GAAP income before income taxes | $ | 2,155 | $ | 2,206 | $ | 4,570 | $ | 6,256 | |||||||
| Adjustments to income before income taxes: | |||||||||||||||
| Adjustments to operating expenses | 1,074 | 730 | 4,092 | 2,475 | |||||||||||
| Adjustments to other income, net | (147) | (98) | (207) | (139) | |||||||||||
| Total adjustments to income before income taxes | 927 | 632 | $ | 3,885 | $ | 2,336 | |||||||||
| Non-GAAP income before income taxes | $ | 3,082 | $ | 2,838 | $ | 8,455 | $ | 8,592 | |||||||
| GAAP provision for income taxes | $ | 271 | $ | 185 | $ | 576 | $ | 607 | |||||||
| Adjustments to provision for income taxes: | |||||||||||||||
| Income tax effect of the above adjustments (d) | 118 | 131 | 526 | 465 | |||||||||||
| Other income tax adjustments (e) | 29 | 55 | 17 | 63 | |||||||||||
| Total adjustments to provision for income taxes | 147 | 186 | 543 | 528 | |||||||||||
| Non-GAAP provision for income taxes | $ | 418 | $ | 371 | $ | 1,119 | $ | 1,135 | |||||||
| GAAP tax as a percentage of income before taxes | 12.6 | % | 8.4 | % | 12.6 | % | 9.7 | % | |||||||
| Adjustments to provision for income taxes: | |||||||||||||||
| Income tax effect of the above adjustments (d) | 0.1 | 2.8 | 0.4 | 2.8 | |||||||||||
| Other income tax adjustments (e) | 0.9 | 1.9 | 0.2 | 0.7 | |||||||||||
| Total adjustments to provision for income taxes | 1.0 | 4.7 | 0.6 | 3.5 | |||||||||||
| Non-GAAP tax as a percentage of income before taxes | 13.6 | % | 13.1 | % | 13.2 | % | 13.2 | % | |||||||
| GAAP net income | $ | 1,884 | $ | 2,021 | $ | 3,994 | $ | 5,649 | |||||||
| Adjustments to net income: | |||||||||||||||
| Adjustments to income before income taxes, net of the income tax effect | 809 | 501 | 3,359 | 1,871 | |||||||||||
| Other income tax adjustments (e) | (29) | (55) | (17) | (63) | |||||||||||
| Total adjustments to net income | 780 | 446 | 3,342 | 1,808 | |||||||||||
| Non-GAAP net income | $ | 2,664 | 2,467 | $ | 7,336 | $ | 7,457 | ||||||||
| Note: Numbers may not add due to rounding |
| 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 earnings per share: |
| Three months ended September 30, 2021 | Three months ended September 30, 2020* | ||||||||||||||
| GAAP | Non-GAAP | GAAP | Non-GAAP | ||||||||||||
| Net income | $ | 1,884 | $ | 2,664 | $ | 2,021 | $ | 2,467 | |||||||
| Weighted-average shares for diluted EPS | 570 | 570 | 589 | 589 | |||||||||||
| Diluted EPS | $ | 3.31 | $ | 4.67 | $ | 3.43 | $ | 4.19 | |||||||
| Nine months ended September 30, 2021 | Nine months ended September 30, 2020* | ||||||||||||||
| GAAP | Non-GAAP | GAAP | Non-GAAP | ||||||||||||
| Net income | $ | 3,994 | $ | 7,336 | $ | 5,649 | $ | 7,457 | |||||||
| Weighted-average shares for diluted EPS | 576 | 576 | 592 | 592 | |||||||||||
| Diluted EPS | $ | 6.93 | $ | 12.74 | $ | 9.54 | $ | 12.60 |
| (a) | The adjustments related primarily to noncash amortization of intangible assets from business acquisitions. | |
| (b) | The adjustments for the three and nine months ended September 30, 2021, related primarily to licensing-related expense from the upfront payment to Kyowa Kirin Co., Ltd. and noncash amortization of intangible assets from business acquisitions. The adjustments for the three and nine months ended September 30, 2020, related primarily to noncash amortization of intangible assets from business acquisitions. | |
| (c) | For the three and nine months ended September 30, 2021, the adjustments related primarily to the change in fair values of contingent consideration liabilities. For the nine months ended September 30, 2020, the adjustment related primarily to legal settlement expenses and an impairment charge associated with an in-process research and development asset. | |
| (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 initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Acquired IPR&D expense from the Five Prime acquisition was not tax deductible. 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, 2021, were 12.7% and 13.5%, compared to 20.7% and 19.9% for the corresponding periods of the prior year. | |
| (e) | The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings. |
| Amgen Inc. |
| Reconciliations of Cash Flows |
| (In millions) |
| (Unaudited) |
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Net cash provided by operating activities | $ | 2,418 | $ | 3,368 | $ | 6,453 | $ | 8,344 | |||||||
| Net cash provided by (used in) investing activities | 73 | (1,628) | 963 | (4,017) | |||||||||||
| Net cash provided by (used in) financing activities | 2,848 | (1,798) | (1,713) | (1,277) | |||||||||||
| Increase (decrease) in cash and cash equivalents | 5,339 | (58) | 5,703 | 3,050 | |||||||||||
| Cash and cash equivalents at beginning of period | 6,630 | 9,145 | 6,266 | 6,037 | |||||||||||
| Cash and cash equivalents at end of period | $ | 11,969 | $ | 9,087 | $ | 11,969 | $ | 9,087 | |||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Net cash provided by operating activities | $ | 2,418 | $ | 3,368 | $ | 6,453 | $ | 8,344 | |||||||
| Capital expenditures | (242) | (135) | (593) | (435) | |||||||||||
| Free cash flow | $ | 2,176 | $ | 3,233 | $ | 5,860 | $ | 7,909 |
| Amgen Inc. |
| Reconciliation of GAAP EPS Guidance to Non-GAAP |
| EPS Guidance for the Year Ending December 31, 2021 |
| (Unaudited) |
| GAAP diluted EPS guidance | $ | 9.55 | — | $ | 10.21 | |||
| Known adjustments to arrive at non-GAAP*: | ||||||||
| Acquisition-related and licensing expenses (a) | 4.46 | — | 4.52 | |||||
| Acquired IPR&D (b) | 2.62 | |||||||
| Certain charges pursuant to our cost savings initiatives | 0.21 | |||||||
| Net gains from equity investments | (0.46) | |||||||
| Legal proceedings | 0.06 | |||||||
| Non-GAAP diluted EPS guidance | $ | 16.50 | — | $ | 17.10 |
| * The known adjustments are presented net of their related tax impact, which amount to approximately $1.13 per share. |
| (a) The adjustments relate primarily to noncash amortization of intangible assets acquired in business acquisitions and licensing-related expense related to an upfront payment to enter into a license and collaboration agreement. |
| (b) The adjustment relates to in-process research & development (IPR&D) expense as a result of acquiring Five Prime Therapeutics. The acquired IPR&D is not tax deductible. |
| Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in the fair value of our contingent consideration and changes in fair value of our equity investments. The GAAP adjustments from the recently announced acquisition of Teneobio, Inc. (that closed in October 2021) are included in the GAAP diluted EPS guidance. |
| Reconciliation of GAAP Tax Rate Guidance to Non-GAAP |
| Tax Rate Guidance for the Year Ending December 31, 2021 |
| (Unaudited) |
| GAAP tax rate guidance | 12.5 | % | — | 14.0 | % | |
| Tax rate of known adjustments discussed above | 0.0 | % | — | 0.5 | % | |
| Non-GAAP tax rate guidance | 13.0 | % | — | 14.0 | % |
| Reconciliation of 2020 Non-GAAP Financial Information As Reported to Updated Non-GAAP Policy |
| 2020 Non-GAAP Financial Results - Excluding gains and losses from equity investments |
| (Unaudited) |
| Effective January 2021, we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that are recorded to Other income, net pursuant to an update to our non-GAAP policy. This policy update excludes our share of the earnings and losses of our strategic investments in corporations accounted for under the equity method of accounting, such as our investment in BeiGene. This updated non-GAAP policy is the basis for our comparisons starting in 2021 and is reflected in our 2021 guidance. The reconciliations below show the effects of the application of the new policy as if it had been adopted at the beginning of 2020. |
| $Millions, except EPS | Q1 '20 | Q2 '20 | Q3 '20 | Q4 '20 | FY '20 | |||||
| Net income (as reported) | $2,476 | $2,518 | $2,572 | $2,229 | $9,795 | |||||
| Equity securities losses (gains) | 39 | (44) | (134) | (265) | (404) | |||||
| Tax impact | (9) | 10 | 29 | 58 | 88 | |||||
| Net income (adjusted) | $2,506 | $2,484 | $2,467 | $2,022 | $9,479 | |||||
| Diluted shares | 594 | 592 | 589 | 585 | 590 | |||||
| Diluted EPS (as reported) | $4.17 | $4.25 | $4.37 | $3.81 | $16.60 | |||||
| Diluted EPS (adjusted) | $4.22 | $4.20 | $4.19 | $3.46 | $16.07 |