THOUSAND OAKS, Calif., April 27, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced financial results for the first quarter of 2022. Key results include:
"We achieved strong, volume-driven growth in the quarter, while launching two very promising first-in-class medicines," said Robert A. Bradway, chairman and chief executive officer. "We are also advancing a robust pipeline with data for several mid-to-late stage candidates expected during the year."
$Millions, except EPS, dividends paid per share and |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||
Total Revenues |
$ 6,238 |
$ 5,901 |
6% |
|||
GAAP Operating Income |
$ 2,500 |
$ 2,129 |
17% |
|||
GAAP Net Income |
$ 1,476 |
$ 1,646 |
(10%) |
|||
GAAP EPS |
$ 2.68 |
$ 2.83 |
(5%) |
|||
Non-GAAP Operating Income |
$ 3,140 |
$ 2,864 |
10% |
|||
Non-GAAP Net Income |
$ 2,343 |
$ 2,150 |
9% |
|||
Non-GAAP EPS |
$ 4.25 |
$ 3.70 |
15% |
|||
Dividends Paid Per Share |
$ 1.94 |
$ 1.76 |
10% |
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and "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. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
Total product sales increased 2% for the first quarter of 2022 versus the first quarter of 2021. Unit volumes grew 9%, offset by 7% lower net selling price and 2% negative impact from foreign exchange, and sales in the first quarter benefited 2% ($110 million) from year-over-year favorable changes to estimated sales deductions. Consistent with prior years, Enbrel® (etanercept) and Otezla® (apremilast) followed the pattern of lower Q1 sales relative to the remainder of the year due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients work through deductibles.
COVID-19 continued to affect our business around the world in the first quarter. In March and April, we have seen the impact of the pandemic recede in the U.S., which has led to improved demand patterns and allowed us to engage in increased field-facing activities.
General Medicine
Hematology-Oncology
Established Products
Product Sales Detail by Product and Geographic Region
$Millions, except percentages |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||||||
US |
ROW |
TOTAL |
TOTAL |
TOTAL |
||||||
Prolia® |
$ 582 |
$ 270 |
$ 852 |
$ 758 |
12% |
|||||
EVENITY® |
110 |
60 |
170 |
107 |
59% |
|||||
Repatha® |
165 |
164 |
329 |
286 |
15% |
|||||
Aimovig® |
98 |
3 |
101 |
66 |
53% |
|||||
TEZSPIRE™ |
7 |
— |
7 |
— |
* |
|||||
Otezla® |
350 |
101 |
451 |
476 |
(5%) |
|||||
Enbrel® |
843 |
19 |
862 |
924 |
(7%) |
|||||
AMGEVITA™ |
— |
108 |
108 |
106 |
2% |
|||||
LUMAKRAS®/LUMYKRAS™ |
48 |
14 |
62 |
— |
* |
|||||
KYPROLIS® |
196 |
91 |
287 |
251 |
14% |
|||||
XGEVA® |
368 |
134 |
502 |
468 |
7% |
|||||
Vectibix® |
85 |
116 |
201 |
191 |
5% |
|||||
Nplate® |
156 |
110 |
266 |
227 |
17% |
|||||
BLINCYTO® |
79 |
59 |
138 |
107 |
29% |
|||||
MVASI® |
168 |
76 |
244 |
294 |
(17%) |
|||||
KANJINTI® |
80 |
16 |
96 |
161 |
(40%) |
|||||
Neulasta® |
304 |
44 |
348 |
482 |
(28%) |
|||||
NEUPOGEN® |
23 |
15 |
38 |
34 |
12% |
|||||
EPOGEN® |
120 |
— |
120 |
125 |
(4%) |
|||||
Aranesp® |
137 |
221 |
358 |
355 |
1% |
|||||
Parsabiv® |
57 |
29 |
86 |
79 |
9% |
|||||
Sensipar®/Mimpara™ |
4 |
16 |
20 |
23 |
(13%) |
|||||
Other products** |
57 |
28 |
85 |
72 |
18% |
|||||
Total product sales |
$ 4,037 |
$ 1,694 |
$ 5,731 |
$ 5,592 |
2% |
|||||
* 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 |
||||||||||
Q1 '22 |
Q1 '21 |
YOY Δ |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||||||
Cost of Sales |
$ 1,561 |
$ 1,490 |
5% |
$ 951 |
$ 867 |
10% |
||||||
% of product sales |
27.2% |
26.6% |
0.6 pts |
16.6% |
15.5% |
1.1 pts |
||||||
Research & Development |
$ 959 |
$ 967 |
(1%) |
$ 934 |
$ 944 |
(1%) |
||||||
% of product sales |
16.7% |
17.3% |
(0.6) pts |
16.3% |
16.9% |
(0.6) pts |
||||||
Selling, General & Administrative |
$ 1,228 |
$ 1,254 |
(2%) |
$ 1,213 |
$ 1,226 |
(1%) |
||||||
% of product sales |
21.4% |
22.4% |
(1.0) pts |
21.2% |
21.9% |
(0.7) pts |
||||||
Other |
$ (10) |
$ 61 |
(116%) |
$ — |
$ — |
NM |
||||||
Total Operating Expenses |
$ 3,738 |
$ 3,772 |
(1%) |
$ 3,098 |
$ 3,037 |
2% |
||||||
Operating Margin |
||||||||||||
operating income as % of product sales |
43.6% |
38.1% |
5.5 pts |
54.8% |
51.2% |
3.6 pts |
||||||
Tax Rate |
11.9% |
11.4% |
0.5 pts |
14.1% |
13.6% |
0.5 pts |
||||||
pts: percentage points |
||||||||||||
NM: not meaningful |
Cash Flow and Balance Sheet
$Billions, except shares |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||
Operating Cash Flow |
$ 2.2 |
$ 2.1 |
$ 0.1 |
|||
Capital Expenditures |
$ 0.2 |
$ 0.2 |
$ 0.0 |
|||
Free Cash Flow |
$ 2.0 |
$ 1.9 |
$ 0.0 |
|||
Dividends Paid |
$ 1.1 |
$ 1.0 |
$ 0.1 |
|||
Share Repurchases |
$ 6.3 |
$ 0.9 |
$ 5.4 |
|||
Average Diluted Shares (millions) |
551 |
581 |
(30) |
|||
Note: Numbers may not add due to rounding |
||||||
$Billions |
3/31/22 |
12/31/21 |
YTD Δ |
|||
Cash and Investments |
$ 6.5 |
$ 8.0 |
$ (1.5) |
|||
Debt Outstanding |
$ 36.9 |
$ 33.3 |
$ 3.5 |
|||
Note: Numbers may not add due to rounding |
For the full year 2022, the Company now expects:
U.S. Tax Petition
On April 18, 2022, Amgen received a notice of deficiency from the IRS for the 2013-2015 period proposing adjustments primarily related to the allocation of profits between certain of the Company's entities in the United States and the U.S. territory of Puerto Rico similar to those previously proposed by the IRS for the 2010-2012 period. This notice seeks to increase Amgen's U.S. taxable income for the 2013-2015 period by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest. In addition, the notice proposes penalties of approximately $2 billion.
Amgen firmly believes that the adjustments proposed by the IRS for the 2010-2015 period and the penalties proposed by the IRS for the 2013-2015 period are without merit:
Further, the amount of the adjustments proposed by the IRS for the 2010-2015 period overstates by billions of dollars the magnitude of the dispute:
In addition, Amgen believes the IRS assertion of approximately $2 billion in penalties for the 2013-2015 period is wholly unwarranted. Amgen has applied a consistent transfer pricing methodology since 2002, has documented that transfer pricing methodology as required under relevant tax regulations, and has extensively discussed that methodology with the IRS across multiple tax audits over multiple years. The IRS has never previously proposed transfer pricing penalties.
Amgen believes that the Company has appropriate tax reserves. The Company filed a petition in the U.S. Tax Court in July 2021 to contest the adjustments previously proposed for the 2010-2012 period and plans to file another petition in the U.S. Tax Court to contest the adjustments proposed in the notice for the 2013-2015 period. Amgen will seek consolidation of the two periods into one case in Tax Court. The dispute is expected to take several years to resolve.
The IRS is currently auditing the 2016-2018 period. Amgen expects the audit to continue for several years, and it is possible the 2010-2015 dispute will be resolved before the conclusion of the 2016-2018 audit and administrative appeals process. Any transfer pricing adjustments the IRS may propose for this period will be lessened by the change in tax rates resulting from the 2017 tax reform law, which reduced the difference between the tax rates applicable in the U.S. and Puerto Rico by approximately two thirds beginning in 2018.
First Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
Rocatinlimab (AMG 451 / KHK4083)
Rozibafusp alfa (AMG 570)
Efavaleukin alfa (AMG 592)
Ordesekimab (AMG 714 / PRV-015)
LUMAKRAS/LUMYKRAS
Tarlatamab (AMG 757)
Acapatamab (AMG 160)
General Medicine
Olpasiran (AMG 890)
Environmental, Social & Governance Report Released Today
Amgen today released its latest Environmental, Social & Governance (ESG) report at amgen.com/responsibility, providing a comprehensive overview of the many ways the Company is building a better, healthier world. The report tracks the Company's progress across four categories:
1 Amgen Safety Net Foundation and The Amgen Foundation, Inc. are separate legal entities entirely funded by Amgen.2 Valued at Wholesale Acquisition Cost.3 Carbon neutrality goal refers to Scope 1 and 2 emissions.
TEZSPIRE is being developed in collaboration with AstraZeneca.Rocatinlimab, formerly AMG 451 / KHK4083 is being developed in collaboration with Kyowa Kirin.Ordesekimab formerly AMG 714 and also known as PRV-015 is being developed in collaboration with Provention Bio.AMG 509 is being developed in collaboration with Xencor.STELARA is a registered trademark 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 MeasuresIn this news release, management has presented its operating results for the first quarters of 2022 and 2021, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2022 EPS and tax 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 first quarters of 2022 and 2021. 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.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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., Generate Biomedicines, Inc., Arrakis Therapeutics, Inc., Plexium, Inc., 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 OaksJessica Akopyan, 805-440-5721 (media)Arvind Sood, 805-447-1060 (investors)
Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per-share data) (Unaudited) |
|||
Three months ended March 31, |
|||
2022 |
2021 |
||
Revenues: |
|||
Product sales |
$ 5,731 |
$ 5,592 |
|
Other revenues |
507 |
309 |
|
Total revenues |
6,238 |
5,901 |
|
Operating expenses: |
|||
Cost of sales |
1,561 |
1,490 |
|
Research and development |
959 |
967 |
|
Selling, general and administrative |
1,228 |
1,254 |
|
Other |
(10) |
61 |
|
Total operating expenses |
3,738 |
3,772 |
|
Operating income |
2,500 |
2,129 |
|
Other income (expense): |
|||
Interest expense, net |
(295) |
(285) |
|
Other (expense) income, net |
(530) |
13 |
|
Income before income taxes |
1,675 |
1,857 |
|
Provision for income taxes |
199 |
211 |
|
Net income |
$ 1,476 |
$ 1,646 |
|
Earnings per share: |
|||
Basic |
$ 2.69 |
$ 2.85 |
|
Diluted |
$ 2.68 |
$ 2.83 |
|
Weighted-average shares used in calculation of earnings per share: |
|||
Basic |
548 |
577 |
|
Diluted |
551 |
581 |
Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) |
|||
March 31, |
December 31, |
||
2022 |
2021 |
||
(Unaudited) |
|||
Assets |
|||
Current assets: |
|||
Cash, cash equivalents and marketable securities |
$ 6,544 |
$ 8,037 |
|
Trade receivables, net |
5,077 |
4,895 |
|
Inventories |
4,411 |
4,086 |
|
Other current assets |
2,488 |
2,367 |
|
Total current assets |
18,520 |
19,385 |
|
Property, plant and equipment, net |
5,142 |
5,184 |
|
Intangible assets, net |
14,567 |
15,182 |
|
Goodwill |
14,897 |
14,890 |
|
Other noncurrent assets |
6,070 |
6,524 |
|
Total assets |
$ 59,196 |
$ 61,165 |
|
Liabilities and Stockholders' Equity |
|||
Current liabilities: |
|||
Accounts payable and accrued liabilities |
$ 12,042 |
$ 12,097 |
|
Current portion of long-term debt |
844 |
87 |
|
Total current liabilities |
12,886 |
12,184 |
|
Long-term debt |
36,010 |
33,222 |
|
Long-term tax liabilities |
6,652 |
6,594 |
|
Other noncurrent liabilities |
2,732 |
2,465 |
|
Total stockholders' equity |
916 |
6,700 |
|
Total liabilities and stockholders' equity |
$ 59,196 |
$ 61,165 |
|
Shares outstanding |
534 |
558 |
Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited) |
|||
Three months ended March 31, |
|||
2022 |
2021 |
||
GAAP cost of sales |
$ 1,561 |
$ 1,490 |
|
Adjustments to cost of sales: |
|||
Acquisition-related expenses (a) |
(610) |
(623) |
|
Total adjustments to cost of sales |
(610) |
(623) |
|
Non-GAAP cost of sales |
$ 951 |
$ 867 |
|
GAAP cost of sales as a percentage of product sales |
27.2% |
26.6% |
|
Acquisition-related expenses (a) |
(10.6) |
(11.1) |
|
Non-GAAP cost of sales as a percentage of product sales |
16.6% |
15.5% |
|
GAAP research and development expenses |
$ 959 |
$ 967 |
|
Adjustments to research and development expenses: |
|||
Acquisition-related expenses (a) |
(25) |
(23) |
|
Total adjustments to research and development expenses |
(25) |
(23) |
|
Non-GAAP research and development expenses |
$ 934 |
$ 944 |
|
GAAP research and development expenses as a percentage of product sales |
16.7% |
17.3% |
|
Acquisition-related expenses (a) |
(0.4) |
(0.4) |
|
Non-GAAP research and development expenses as a percentage of product sales |
16.3% |
16.9% |
|
GAAP selling, general and administrative expenses |
$ 1,228 |
$ 1,254 |
|
Adjustments to selling, general and administrative expenses: |
|||
Acquisition-related expenses (a) |
(15) |
(12) |
|
Other |
— |
(16) |
|
Total adjustments to selling, general and administrative expenses |
(15) |
(28) |
|
Non-GAAP selling, general and administrative expenses |
$ 1,213 |
$ 1,226 |
|
GAAP selling, general and administrative expenses as a percentage of product sales |
21.4% |
22.4% |
|
Acquisition-related expenses (a) |
(0.2) |
(0.2) |
|
Other |
0.0 |
(0.3) |
|
Non-GAAP selling, general and administrative expenses as a percentage of product sales |
21.2% |
21.9% |
|
GAAP operating expenses |
$ 3,738 |
$ 3,772 |
|
Adjustments to operating expenses: |
|||
Adjustments to cost of sales |
(610) |
(623) |
|
Adjustments to research and development expenses |
(25) |
(23) |
|
Adjustments to selling, general and administrative expenses |
(15) |
(28) |
|
Certain charges pursuant to our cost savings initiatives |
(2) |
(52) |
|
Certain other expenses (b) |
12 |
(9) |
|
Total adjustments to operating expenses |
(640) |
(735) |
|
Non-GAAP operating expenses |
$ 3,098 |
$ 3,037 |
|
Three months ended March 31, |
|||
2022 |
2021 |
||
GAAP operating income |
$ 2,500 |
$ 2,129 |
|
Adjustments to operating expenses |
640 |
735 |
|
Non-GAAP operating income |
$ 3,140 |
$ 2,864 |
|
GAAP operating income as a percentage of product sales |
43.6% |
38.1% |
|
Adjustments to cost of sales |
10.6 |
11.1 |
|
Adjustments to research and development expenses |
0.4 |
0.4 |
|
Adjustments to selling, general and administrative expenses |
0.2 |
0.5 |
|
Certain charges pursuant to our cost savings initiatives |
0.1 |
0.9 |
|
Certain other expenses (b) |
(0.1) |
0.2 |
|
Non-GAAP operating income as a percentage of product sales |
54.8% |
51.2% |
|
GAAP other income (expense), net |
$ (530) |
$ 13 |
|
Adjustments to other income (expense), net: |
|||
Equity method investment basis difference amortization |
47 |
42 |
|
Net gains from equity investments |
365 |
(145) |
|
Total adjustments to other income (expense), net |
412 |
(103) |
|
Non-GAAP other income (expense), net |
$ (118) |
$ (90) |
|
GAAP income before income taxes |
$ 1,675 |
$ 1,857 |
|
Adjustments to income before income taxes: |
|||
Adjustments to operating expenses |
640 |
735 |
|
Adjustments to other income, net |
412 |
(103) |
|
Total adjustments to income before income taxes |
1,052 |
632 |
|
Non-GAAP income before income taxes |
$ 2,727 |
$ 2,489 |
|
GAAP provision for income taxes |
$ 199 |
$ 211 |
|
Adjustments to provision for income taxes: |
|||
Income tax effect of the above adjustments (c) |
189 |
131 |
|
Other income tax adjustments (d) |
(4) |
(3) |
|
Total adjustments to provision for income taxes |
185 |
128 |
|
Non-GAAP provision for income taxes |
$ 384 |
$ 339 |
|
GAAP tax as a percentage of income before taxes |
11.9% |
11.4% |
|
Adjustments to provision for income taxes: |
|||
Income tax effect of the above adjustments (c) |
2.3 |
2.3 |
|
Other income tax adjustments (d) |
(0.1) |
(0.1) |
|
Total adjustments to provision for income taxes |
2.2 |
2.2 |
|
Non-GAAP tax as a percentage of income before taxes |
14.1% |
13.6% |
|
GAAP net income |
$ 1,476 |
$ 1,646 |
|
Adjustments to net income: |
|||
Adjustments to income before income taxes, net of the income tax effect |
863 |
501 |
|
Other income tax adjustments (d) |
4 |
3 |
|
Total adjustments to net income |
867 |
504 |
|
Non-GAAP net income |
$ 2,343 |
$ 2,150 |
|
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 March 31, 2022 |
Three months ended March 31, 2021 |
||||||
GAAP |
Non-GAAP |
GAAP |
Non-GAAP |
||||
Net income |
$ 1,476 |
$ 2,343 |
$ 1,646 |
$ 2,150 |
|||
Weighted-average shares for diluted EPS |
551 |
551 |
581 |
581 |
|||
Diluted EPS |
$ 2.68 |
$ 4.25 |
$ 2.83 |
$ 3.70 |
|||
(a) |
The adjustments related primarily to noncash amortization of intangible assets from business acquisitions. |
||
(b) |
For the three months ended March 31, 2022, the adjustments related primarily to an in-process research and development asset adjustment. |
||
(c) |
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. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes, for the three months ended March 31, 2022, was 18.0%, compared to 20.7% for the corresponding period of the prior year. |
||
(d) |
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 March 31, |
|||
2022 |
2021 |
||
Net cash provided by operating activities |
$ 2,164 |
$ 2,104 |
|
Net cash used in investing activities |
(111) |
(319) |
|
Net cash used in financing activities |
(3,514) |
(1,939) |
|
Decrease in cash and cash equivalents |
(1,461) |
(154) |
|
Cash and cash equivalents at beginning of period |
7,989 |
6,266 |
|
Cash and cash equivalents at end of period |
$ 6,528 |
$ 6,112 |
|
Three months ended March 31, |
|||
2022 |
2021 |
||
Net cash provided by operating activities |
$ 2,164 |
$ 2,104 |
|
Capital expenditures |
(190) |
(166) |
|
Free cash flow |
$ 1,974 |
$ 1,938 |
Amgen Inc. Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2022 (Unaudited) |
||||
GAAP diluted EPS guidance |
$ 12.53 |
— |
$ 13.58 |
|
Known adjustments to arrive at non-GAAP*: |
||||
Acquisition-related expenses (a) |
3.89 |
— |
3.94 |
|
Net (gains)/losses from equity investments |
0.53 |
|||
Non-GAAP diluted EPS guidance |
$ 17.00 |
— |
$ 18.00 |
|
* The known adjustments are presented net of their related tax impact, which amount to approximately $1.19 per share. |
||||
(a) The adjustments relate primarily to noncash amortization of intangible assets acquired in business acquisitions. |
||||
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 fair value of our contingent consideration obligations and changes in fair value of our equity investments. |
||||
Reconciliation of GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for the Year Ending December 31, 2022 (Unaudited) |
||||
GAAP tax rate guidance |
10.5% |
— |
12.0% |
|
Tax rate of known adjustments discussed above |
2.5% |
— |
3.0% |
|
Non-GAAP tax rate guidance |
13.5% |
— |
14.5% |
ТЫСЯЧА ДУБОВ, Калифорния, 27 апреля 2022 года /PRNewswire/ -- Amgen (NASDAQ: AMGN) сегодня объявила финансовые результаты за первый квартал 2022 года. Ключевые результаты включают:
"В этом квартале мы добились значительного роста, обусловленного объемами продаж, одновременно запустив два очень перспективных первоклассных препарата", - сказал Роберт А. Брэдуэй, председатель и главный исполнительный директор. "Мы также продвигаем надежный конвейер с данными по нескольким кандидатам средней и поздней стадии, ожидаемым в течение года".
$Millions, except EPS, dividends paid per share and |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||
Total Revenues |
$ 6,238 |
$ 5,901 |
6% |
|||
GAAP Operating Income |
$ 2,500 |
$ 2,129 |
17% |
|||
GAAP Net Income |
$ 1,476 |
$ 1,646 |
(10%) |
|||
GAAP EPS |
$ 2.68 |
$ 2.83 |
(5%) |
|||
Non-GAAP Operating Income |
$ 3,140 |
$ 2,864 |
10% |
|||
Non-GAAP Net Income |
$ 2,343 |
$ 2,150 |
9% |
|||
Non-GAAP EPS |
$ 4.25 |
$ 3.70 |
15% |
|||
Dividends Paid Per Share |
$ 1.94 |
$ 1.76 |
10% |
Ссылки в этом выпуске на показатели, не относящиеся к GAAP, показатели, представленные "на основе, не относящейся к GAAP", и "свободный денежный поток" (рассчитанный путем вычитания капитальных затрат из операционного денежного потока) относятся к финансовым показателям, не относящимся к GAAP. Корректировки к наиболее непосредственно сопоставимым финансовым показателям GAAP и другим статьям представлены в прилагаемых выверках. Обратитесь к Финансовым показателям, не относящимся к GAAP, ниже для дальнейшего обсуждения.
Показатели продаж Продукции
Общий объем продаж продукции увеличился на 2% в первом квартале 2022 года по сравнению с первым кварталом 2021 года. Объемы продаж выросли на 9%, что было компенсировано снижением чистой цены продажи на 7% и негативным влиянием иностранной валюты на 2%, а продажи в первом квартале выиграли на 2% (110 миллионов долларов) от положительных изменений в оценочных отчислениях от продаж по сравнению с прошлым годом. Как и в предыдущие годы, продажи Enbrel® (этанерцепт) и Otezla® (апремиласт) в 1 квартале снизились по сравнению с остальной частью года из-за влияния изменений в плане льгот, отмены страховки и увеличения расходов на доплату, поскольку пациенты в США работают за счет франшиз.
В первом квартале COVID-19 продолжал оказывать влияние на наш бизнес по всему миру. В марте и апреле мы наблюдали ослабление последствий пандемии в США, что привело к улучшению структуры спроса и позволило нам активизировать деятельность на местах.
Общая медицина
Гематология-Онкология
Установленные Продукты
Подробная информация о продажах продукции в разбивке по продуктам и географическим регионам
$Millions, except percentages |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||||||
US |
ROW |
TOTAL |
TOTAL |
TOTAL |
||||||
Prolia® |
$ 582 |
$ 270 |
$ 852 |
$ 758 |
12% |
|||||
EVENITY® |
110 |
60 |
170 |
107 |
59% |
|||||
Repatha® |
165 |
164 |
329 |
286 |
15% |
|||||
Aimovig® |
98 |
3 |
101 |
66 |
53% |
|||||
TEZSPIRE™ |
7 |
— |
7 |
— |
* |
|||||
Otezla® |
350 |
101 |
451 |
476 |
(5%) |
|||||
Enbrel® |
843 |
19 |
862 |
924 |
(7%) |
|||||
AMGEVITA™ |
— |
108 |
108 |
106 |
2% |
|||||
LUMAKRAS®/LUMYKRAS™ |
48 |
14 |
62 |
— |
* |
|||||
KYPROLIS® |
196 |
91 |
287 |
251 |
14% |
|||||
XGEVA® |
368 |
134 |
502 |
468 |
7% |
|||||
Vectibix® |
85 |
116 |
201 |
191 |
5% |
|||||
Nplate® |
156 |
110 |
266 |
227 |
17% |
|||||
BLINCYTO® |
79 |
59 |
138 |
107 |
29% |
|||||
MVASI® |
168 |
76 |
244 |
294 |
(17%) |
|||||
KANJINTI® |
80 |
16 |
96 |
161 |
(40%) |
|||||
Neulasta® |
304 |
44 |
348 |
482 |
(28%) |
|||||
NEUPOGEN® |
23 |
15 |
38 |
34 |
12% |
|||||
EPOGEN® |
120 |
— |
120 |
125 |
(4%) |
|||||
Aranesp® |
137 |
221 |
358 |
355 |
1% |
|||||
Parsabiv® |
57 |
29 |
86 |
79 |
9% |
|||||
Sensipar®/Mimpara™ |
4 |
16 |
20 |
23 |
(13%) |
|||||
Other products** |
57 |
28 |
85 |
72 |
18% |
|||||
Total product sales |
$ 4,037 |
$ 1,694 |
$ 5,731 |
$ 5,592 |
2% |
|||||
* Change in excess of 100% |
||||||||||
** Other products includes Corlanor®, GENSENTA, IMLYGIC®, AVSOLA®, Bergamo, and RIABNI™ |
Анализ операционных расходов, операционной маржи и налоговых ставок
На основе ОПБУ:
На основе, отличной от ОПБУ:
$Millions, except percentages |
GAAP |
Non-GAAP |
||||||||||
Q1 '22 |
Q1 '21 |
YOY Δ |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||||||
Cost of Sales |
$ 1,561 |
$ 1,490 |
5% |
$ 951 |
$ 867 |
10% |
||||||
% of product sales |
27.2% |
26.6% |
0.6 pts |
16.6% |
15.5% |
1.1 pts |
||||||
Research & Development |
$ 959 |
$ 967 |
(1%) |
$ 934 |
$ 944 |
(1%) |
||||||
% of product sales |
16.7% |
17.3% |
(0.6) pts |
16.3% |
16.9% |
(0.6) pts |
||||||
Selling, General & Administrative |
$ 1,228 |
$ 1,254 |
(2%) |
$ 1,213 |
$ 1,226 |
(1%) |
||||||
% of product sales |
21.4% |
22.4% |
(1.0) pts |
21.2% |
21.9% |
(0.7) pts |
||||||
Other |
$ (10) |
$ 61 |
(116%) |
$ — |
$ — |
NM |
||||||
Total Operating Expenses |
$ 3,738 |
$ 3,772 |
(1%) |
$ 3,098 |
$ 3,037 |
2% |
||||||
Operating Margin |
||||||||||||
operating income as % of product sales |
43.6% |
38.1% |
5.5 pts |
54.8% |
51.2% |
3.6 pts |
||||||
Tax Rate |
11.9% |
11.4% |
0.5 pts |
14.1% |
13.6% |
0.5 pts |
||||||
pts: percentage points |
||||||||||||
NM: not meaningful |
Движение денежных средств и Бухгалтерский баланс
$Billions, except shares |
Q1 '22 |
Q1 '21 |
YOY Δ |
|||
Operating Cash Flow |
$ 2.2 |
$ 2.1 |
$ 0.1 |
|||
Capital Expenditures |
$ 0.2 |
$ 0.2 |
$ 0.0 |
|||
Free Cash Flow |
$ 2.0 |
$ 1.9 |
$ 0.0 |
|||
Dividends Paid |
$ 1.1 |
$ 1.0 |
$ 0.1 |
|||
Share Repurchases |
$ 6.3 |
$ 0.9 |
$ 5.4 |
|||
Average Diluted Shares (millions) |
551 |
581 |
(30) |
|||
Note: Numbers may not add due to rounding |
||||||
$Billions |
3/31/22 |
12/31/21 |
YTD Δ |
|||
Cash and Investments |
$ 6.5 |
$ 8.0 |
$ (1.5) |
|||
Debt Outstanding |
$ 36.9 |
$ 33.3 |
$ 3.5 |
|||
Note: Numbers may not add due to rounding |
В течение всего 2022 года Компания теперь ожидает:
Налоговая петиция США
18 апреля 2022 года Amgen получил уведомление о недостатках от Налогового управления США за период 2013-2015 годов, в котором предлагались корректировки, в первую очередь связанные с распределением прибыли между некоторыми юридическими лицами Компании в Соединенных Штатах и на территории США Пуэрто-Рико, аналогичные тем, которые ранее предлагало Налоговое управление США на период 2010-2012 годов. Это уведомление направлено на увеличение налогооблагаемого дохода Amgen в США за период 2013-2015 годов на сумму, которая приведет к дополнительному федеральному налогу в размере примерно 5,1 миллиарда долларов плюс проценты. Кроме того, в уведомлении предлагаются штрафы в размере примерно 2 миллиардов долларов.
Amgen твердо убежден, что корректировки, предложенные Налоговым управлением США на период 2010-2015 годов, и штрафы, предложенные Налоговым управлением США на период 2013-2015 годов, не имеют под собой оснований:
Кроме того, сумма корректировок, предложенных Налоговым управлением США на период 2010-2015 годов, на миллиарды долларов завышает масштабы спора:
Кроме того, Amgen считает, что утверждение Налогового управления США о штрафах в размере примерно 2 миллиардов долларов за период 2013-2015 годов совершенно необоснованно. Amgen применяет последовательную методологию трансфертного ценообразования с 2002 года, задокументировала эту методологию трансфертного ценообразования в соответствии с требованиями соответствующего налогового законодательства и подробно обсуждала эту методологию с Налоговым управлением США в ходе многочисленных налоговых проверок в течение нескольких лет. Налоговое управление США ранее никогда не предлагало штрафов за трансфертное ценообразование.
Amgen считает, что у Компании есть соответствующие налоговые резервы. Компания подала петицию в Налоговый суд США в июле 2021 года, чтобы оспорить корректировки, ранее предложенные на период 2010-2012 годов, и планирует подать еще одну петицию в Налоговый суд США, чтобы оспорить корректировки, предложенные в уведомлении на период 2013-2015 годов. Amgen будет добиваться объединения двух периодов в одно дело в Налоговом суде. Ожидается, что разрешение спора займет несколько лет.
Налоговое управление США в настоящее время проводит аудит за период 2016-2018 годов. Amgen ожидает, что аудит будет продолжаться в течение нескольких лет, и, возможно, спор 2010-2015 годов будет разрешен до завершения процесса аудита и административных апелляций 2016-2018 годов. Любые корректировки трансфертного ценообразования, которые Налоговое управление США может предложить на этот период, будут уменьшены изменением налоговых ставок в результате закона о налоговой реформе 2017 года, который сократил разницу между налоговыми ставками, применимыми в США и Пуэрто-Рико, примерно на две трети, начиная с 2018 года.
Обновление продуктов и конвейера за первый квартал
Компания предоставила следующие обновления по выбранным продуктам и конвейерным программам:
Рокатинлимаб (AMG 451 / KHK4083)
Розибафусп альфа (AMG 570)
Эфавалейкин альфа (AMG 592)
Ордесекимаб (AMG 714 / PRV-015)
лумакрас/лумикрас
Тарлатамаб (AMG 757)
Акапатамаб (AMG 160)
Общая медицина
Олпасиран (AMG 890)
Опубликованный сегодня Отчет по окружающей среде, Социальной сфере и управлению
Amgen сегодня опубликовал свой последний отчет по экологическим, социальным и управленческим вопросам (ESG) на Amgen.com/responsibility , предоставляющий всесторонний обзор многих способов, которыми Компания строит лучший и более здоровый мир. В отчете отслеживается прогресс Компании по четырем категориям:
1 Фонд социальной защиты Amgen и Фонд Amgen, Inc. являются отдельными юридическими лицами, полностью финансируемыми Amgen.2, оцениваемыми по оптовой стоимости приобретения.3 Цель углеродной нейтральности относится к выбросам в областях 1 и 2.
TEZSPIRE разрабатывается в сотрудничестве с AstraZeneca. Rocatinlimab, ранее AMG 451 / KHK4083, разрабатывается в сотрудничестве с Kyowa Kirin.Ордесекимаб, ранее AMG 714, также известный как PRV-015, разрабатывается в сотрудничестве с Provention Bio.AMG 509 разрабатывается в сотрудничестве с Xencor.STELARA является зарегистрированной торговой маркой Janssen Pharmaceuticals NV.EYLEA является зарегистрированной торговой маркой Regeneron Pharmaceuticals, Inc.SOLIRIS является зарегистрированной торговой маркой Alexion Pharmaceuticals, Inc.
Финансовые показатели, не относящиеся к GAAP В этом пресс-релизе руководство представило свои операционные результаты за первые кварталы 2022 и 2021 годов в соответствии с Общепринятыми принципами бухгалтерского учета США (GAAP) и на основе, не относящейся к GAAP. Кроме того, руководство представило свои данные о прибылях и убытках за весь 2022 год и налоговые рекомендации в соответствии с GAAP и на основе, отличной от GAAP. Эти финансовые показатели, не относящиеся к GAAP, рассчитываются путем исключения определенных статей, связанных с приобретениями, реструктуризацией и некоторыми другими статьями, из соответствующих финансовых показателей GAAP. Сверки этих финансовых показателей, не относящихся к GAAP, с наиболее непосредственно сопоставимыми финансовыми показателями GAAP включены в пресс-релиз. Руководство также представило данные о свободном денежном потоке (FCF), который является финансовым показателем, не относящимся к GAAP, за первые кварталы 2022 и 2021 годов. FCF рассчитывается путем вычитания капитальных затрат из операционного денежного потока, каждый из которых определяется в соответствии с GAAP.
Компания считает, что ее представление финансовых показателей, не относящихся к GAAP, предоставляет полезную дополнительную информацию и облегчает дополнительный анализ инвесторами. Компания использует определенные финансовые показатели, не относящиеся к GAAP, для улучшения общего понимания инвестором финансовых показателей и перспектив на будущее текущей хозяйственной деятельности Компании путем облегчения сравнения результатов текущей хозяйственной деятельности между текущим, прошлым и будущим периодами. Компания считает, что FCF обеспечивает дополнительный показатель ликвидности Компании.
Компания использует финансовые показатели, не относящиеся к GAAP, изложенные в пресс-релизе, в связи с собственным составлением бюджета и внутренним финансовым планированием для оценки эффективности бизнеса, в том числе для распределения ресурсов и оценки результатов относительно целевых показателей вознаграждения. Финансовые показатели, не относящиеся к ОПБУ, являются дополнением, а не заменой или превосходят показатели финансовой деятельности, подготовленные в соответствии с ОПБУ.
Amgen стремится раскрыть потенциал биологии для пациентов, страдающих серьезными заболеваниями, путем открытия, разработки, производства и предоставления инновационных терапевтических средств для человека. Этот подход начинается с использования таких инструментов, как продвинутая генетика человека, чтобы разгадать сложности болезней и понять основы биологии человека.
Amgen фокусируется на областях с высокой неудовлетворенной медицинской потребностью и использует свой опыт для поиска решений, которые улучшают показатели здоровья и значительно улучшают жизнь людей. Являясь пионером биотехнологий с 1980 года, Amgen превратилась в одну из ведущих независимых биотехнологических компаний в мире, охватила миллионы пациентов по всему миру и разрабатывает линейку лекарств с прорывным потенциалом.
Amgen является одной из 30 компаний, входящих в индекс Dow Jones Industrial Average, а также является частью индекса Nasdaq-100. В 2021 году Amgen был назван одним из 25 лучших рабочих мест в мире™ по версии Fortune и Great Place to Work™, а также одной из 100 самых устойчивых компаний в мире по версии Barron's.
Для получения дополнительной информации посетите веб-сайт www.Amgen.com и следуйте за нами дальше www.twitter.com/Amgen .
Прогнозные заявления
Этот пресс-релиз содержит прогнозные заявления, основанные на текущих ожиданиях и убеждениях Amgen. Все заявления, кроме заявлений об исторических фактах, являются заявлениями, которые можно считать прогнозными заявлениями, включая любые заявления о результатах, преимуществах и синергии сотрудничества или потенциального сотрудничества с любой другой компанией (включая BeiGene, Ltd., Kyowa-Kirin Co., Ltd., Generate Biomedicines, Inc., Arrakis Therapeutics, Inc., Plexium, Inc. или любое сотрудничество по производству терапевтических антител против COVID-19), эффективность Otezla® (апремиласт) (включая ожидаемый рост продаж Otezla и сроки увеличения EPS, не учитываемых GAAP), the Five Prime Therapeutics, Inc. приобретение или приобретение Teneobio, Inc., а также оценки доходов, операционной прибыли, капитальных затрат, денежных средств, других финансовых показателей, ожидаемых юридических, арбитражных, политических, нормативных или клинических результатов или практики, моделей или практики клиентов и назначающих врачей, мероприятий по возмещению расходов и результатов, последствий пандемий или других широко распространенные проблемы со здоровьем, такие как продолжающаяся пандемия COVID-19, влияют на наш бизнес, результаты, прогресс и другие подобные оценки и результаты. Прогнозные заявления сопряжены со значительными рисками и неопределенностями, в том числе обсуждаемыми ниже и более подробно описанными в отчетах Комиссии по ценным бумагам и биржам, представленных Amgen, включая наш последний годовой отчет по форме 10-K и любые последующие периодические отчеты по форме 10-Q и текущие отчеты по Форме 8-K. Если не указано иное, Amgen предоставляет эту информацию на дату этого выпуска новостей и не берет на себя никаких обязательств по обновлению любых прогнозных заявлений, содержащихся в этом документе, в результате новой информации, будущих событий или иным образом.
Никакое прогнозное заявление не может быть гарантировано, и фактические результаты могут существенно отличаться от тех, которые мы прогнозируем. На наши результаты могут повлиять наша способность успешно продавать как новые, так и существующие продукты внутри страны и за рубежом, клинические и нормативные изменения, касающиеся текущих и будущих продуктов, рост продаж недавно выпущенных продуктов, конкуренция со стороны других продуктов, включая биоаналоги, трудности или задержки в производстве наших продуктов и глобальные экономические условия. Кроме того, на продажи наших продуктов влияют ценовое давление, политический и общественный контроль, а также политика возмещения расходов, навязанная сторонними плательщиками, включая правительства, частные страховые планы и поставщиков управляемых медицинских услуг, и на них могут повлиять изменения в нормативных, клинических и руководящих принципах, а также внутренние и международные тенденции в области управляемого ухода и сдерживания расходов на здравоохранение.. Кроме того, наши исследования, тестирование, ценообразование, маркетинг и другие операции подлежат строгому регулированию со стороны отечественных и зарубежных государственных регулирующих органов. Мы или другие лица можем выявить безопасность, побочные эффекты или производственные проблемы с нашими продуктами, включая наши устройства, после того, как они появятся на рынке. На наш бизнес могут повлиять правительственные расследования, судебные разбирательства и иски об ответственности за продукцию. Кроме того, на наш бизнес может повлиять принятие нового налогового законодательства или возникновение дополнительных налоговых обязательств. Если мы не выполним обязательства по соблюдению требований соглашения о корпоративной честности между нами и правительством США, мы можем подвергнуться значительным санкциям. Кроме того, в то время как мы регулярно получаем патенты на наши продукты и технологии, защита, предлагаемая нашими патентами и патентными заявками, может быть оспорена, признана недействительной или обойдена нашими конкурентами, или мы можем не одержать победу в нынешних и будущих судебных разбирательствах по интеллектуальной собственности. Мы осуществляем значительную часть нашей коммерческой производственной деятельности на нескольких ключевых объектах, в том числе в Пуэрто-Рико, а также зависим от третьих сторон в части нашей производственной деятельности, и ограничения на поставки могут ограничить продажи некоторых наших текущих продуктов и разработку продуктов-кандидатов. Вспышка заболевания или аналогичная угроза общественному здоровью, такая как COVID-19, а также усилия общественности и правительства по смягчению последствий распространения такого заболевания могут оказать значительное негативное влияние на поставки материалов для нашей производственной деятельности, распространение нашей продукции, коммерциализацию наших продуктов-кандидатов, и наши операции по клиническим испытаниям, и любые подобные события могут оказать существенное негативное влияние на разработку нашей продукции, продажи продукции, бизнес и результаты деятельности. Мы полагаемся на сотрудничество с третьими сторонами для разработки некоторых наших продуктов-кандидатов, а также для коммерциализации и продажи некоторых наших коммерческих продуктов. Кроме того, мы конкурируем с другими компаниями в отношении многих наших продаваемых продуктов, а также за открытие и разработку новых продуктов. Обнаружение или идентификация новых продуктов-кандидатов или разработка новых показаний для существующих продуктов не могут быть гарантированы, и движение от концепции к продукту является неопределенным; следовательно, не может быть никакой гарантии, что какой-либо конкретный продукт-кандидат или разработка нового показания для существующего продукта будут успешными и станут коммерческим продуктом. Кроме того, некоторые сырьевые материалы, медицинские приборы и комплектующие для нашей продукции поставляются единственными сторонними поставщиками. Некоторые из наших дистрибьюторов, клиентов и плательщиков имеют значительные покупательские возможности в своих отношениях с нами. Обнаружение значительных проблем с продуктом, похожим на один из наших продуктов, которые затрагивают целый класс продуктов, может оказать существенное негативное влияние на продажи затронутых продуктов, а также на наш бизнес и результаты деятельности. Наши усилия по сотрудничеству или приобретению других компаний, продуктов или технологий, а также по интеграции операций компаний или поддержке приобретенных нами продуктов или технологий могут оказаться безуспешными. Сбой, кибератака или нарушение информационной безопасности могут поставить под угрозу конфиденциальность, целостность и доступность наших систем и наших данных. Цена наших акций волатильна и может быть подвержена влиянию ряда событий. Глобальные экономические условия могут усилить определенные риски, которые влияют на наш бизнес. Результаты нашей деятельности могут повлиять или ограничить способность нашего Совета директоров объявлять дивиденды или нашу способность выплачивать дивиденды или выкупать наши обыкновенные акции. Возможно, мы не сможем получить доступ к рынкам капитала и кредитов на выгодных для нас условиях или вообще не сможем.
КОНТАКТНОЕ ЛИЦО: Amgen, Тысяча дубов Есика Акопян, 805-440-5721 (СМИ)Арвинд Суд, 805-447-1060 (инвесторы)
Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per-share data) (Unaudited) |
|||
Three months ended March 31, |
|||
2022 |
2021 |
||
Revenues: |
|||
Product sales |
$ 5,731 |
$ 5,592 |
|
Other revenues |
507 |
309 |
|
Total revenues |
6,238 |
5,901 |
|
Operating expenses: |
|||
Cost of sales |
1,561 |
1,490 |
|
Research and development |
959 |
967 |
|
Selling, general and administrative |
1,228 |
1,254 |
|
Other |
(10) |
61 |
|
Total operating expenses |
3,738 |
3,772 |
|
Operating income |
2,500 |
2,129 |
|
Other income (expense): |
|||
Interest expense, net |
(295) |
(285) |
|
Other (expense) income, net |
(530) |
13 |
|
Income before income taxes |
1,675 |
1,857 |
|
Provision for income taxes |
199 |
211 |
|
Net income |
$ 1,476 |
$ 1,646 |
|
Earnings per share: |
|||
Basic |
$ 2.69 |
$ 2.85 |
|
Diluted |
$ 2.68 |
$ 2.83 |
|
Weighted-average shares used in calculation of earnings per share: |
|||
Basic |
548 |
577 |
|
Diluted |
551 |
581 |
Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) |
|||
March 31, |
December 31, |
||
2022 |
2021 |
||
(Unaudited) |
|||
Assets |
|||
Current assets: |
|||
Cash, cash equivalents and marketable securities |
$ 6,544 |
$ 8,037 |
|
Trade receivables, net |
5,077 |
4,895 |
|
Inventories |
4,411 |
4,086 |
|
Other current assets |
2,488 |
2,367 |
|
Total current assets |
18,520 |
19,385 |
|
Property, plant and equipment, net |
5,142 |
5,184 |
|
Intangible assets, net |
14,567 |
15,182 |
|
Goodwill |
14,897 |
14,890 |
|
Other noncurrent assets |
6,070 |
6,524 |
|
Total assets |
$ 59,196 |
$ 61,165 |
|
Liabilities and Stockholders' Equity |
|||
Current liabilities: |
|||
Accounts payable and accrued liabilities |
$ 12,042 |
$ 12,097 |
|
Current portion of long-term debt |
844 |
87 |
|
Total current liabilities |
12,886 |
12,184 |
|
Long-term debt |
36,010 |
33,222 |
|
Long-term tax liabilities |
6,652 |
6,594 |
|
Other noncurrent liabilities |
2,732 |
2,465 |
|
Total stockholders' equity |
916 |
6,700 |
|
Total liabilities and stockholders' equity |
$ 59,196 |
$ 61,165 |
|
Shares outstanding |
534 |
558 |
Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited) |
|||
Three months ended March 31, |
|||
2022 |
2021 |
||
GAAP cost of sales |
$ 1,561 |
$ 1,490 |
|
Adjustments to cost of sales: |
|||
Acquisition-related expenses (a) |
(610) |
(623) |
|
Total adjustments to cost of sales |
(610) |
(623) |
|
Non-GAAP cost of sales |
$ 951 |
$ 867 |
|
GAAP cost of sales as a percentage of product sales |
27.2% |
26.6% |
|
Acquisition-related expenses (a) |
(10.6) |
(11.1) |
|
Non-GAAP cost of sales as a percentage of product sales |
16.6% |
15.5% |
|
GAAP research and development expenses |
$ 959 |
$ 967 |
|
Adjustments to research and development expenses: |
|||
Acquisition-related expenses (a) |
(25) |
(23) |
|
Total adjustments to research and development expenses |
(25) |
(23) |
|
Non-GAAP research and development expenses |
$ 934 |
$ 944 |
|
GAAP research and development expenses as a percentage of product sales |
16.7% |
17.3% |
|
Acquisition-related expenses (a) |
(0.4) |
(0.4) |
|
Non-GAAP research and development expenses as a percentage of product sales |
16.3% |
16.9% |
|
GAAP selling, general and administrative expenses |
$ 1,228 |
$ 1,254 |
|
Adjustments to selling, general and administrative expenses: |
|||
Acquisition-related expenses (a) |
(15) |
(12) |
|
Other |
— |
(16) |
|
Total adjustments to selling, general and administrative expenses |
(15) |
(28) |
|
Non-GAAP selling, general and administrative expenses |
$ 1,213 |
$ 1,226 |
|
GAAP selling, general and administrative expenses as a percentage of product sales |
21.4% |
22.4% |
|
Acquisition-related expenses (a) |
(0.2) |
(0.2) |
|
Other |
0.0 |
(0.3) |
|
Non-GAAP selling, general and administrative expenses as a percentage of product sales |
21.2% |
21.9% |
|
GAAP operating expenses |
$ 3,738 |
$ 3,772 |
|
Adjustments to operating expenses: |
|||
Adjustments to cost of sales |
(610) |
(623) |
|
Adjustments to research and development expenses |
(25) |
(23) |
|
Adjustments to selling, general and administrative expenses |
(15) |
(28) |
|
Certain charges pursuant to our cost savings initiatives |
(2) |
(52) |
|
Certain other expenses (b) |
12 |
(9) |
|
Total adjustments to operating expenses |
(640) |
(735) |
|
Non-GAAP operating expenses |
$ 3,098 |
$ 3,037 |
|
Three months ended March 31, |
|||
2022 |
2021 |
||
GAAP operating income |
$ 2,500 |
$ 2,129 |
|
Adjustments to operating expenses |
640 |
735 |
|
Non-GAAP operating income |
$ 3,140 |
$ 2,864 |
|
GAAP operating income as a percentage of product sales |
43.6% |
38.1% |
|
Adjustments to cost of sales |
10.6 |
11.1 |
|
Adjustments to research and development expenses |
0.4 |
0.4 |
|
Adjustments to selling, general and administrative expenses |
0.2 |
0.5 |
|
Certain charges pursuant to our cost savings initiatives |
0.1 |
0.9 |
|
Certain other expenses (b) |
(0.1) |
0.2 |
|
Non-GAAP operating income as a percentage of product sales |
54.8% |
51.2% |
|
GAAP other income (expense), net |
$ (530) |
$ 13 |
|
Adjustments to other income (expense), net: |
|||
Equity method investment basis difference amortization |
47 |
42 |
|
Net gains from equity investments |
365 |
(145) |
|
Total adjustments to other income (expense), net |
412 |
(103) |
|
Non-GAAP other income (expense), net |
$ (118) |
$ (90) |
|
GAAP income before income taxes |
$ 1,675 |
$ 1,857 |
|
Adjustments to income before income taxes: |
|||
Adjustments to operating expenses |
640 |
735 |
|
Adjustments to other income, net |
412 |
(103) |
|
Total adjustments to income before income taxes |
1,052 |
632 |
|
Non-GAAP income before income taxes |
$ 2,727 |
$ 2,489 |
|
GAAP provision for income taxes |
$ 199 |
$ 211 |
|
Adjustments to provision for income taxes: |
|||
Income tax effect of the above adjustments (c) |
189 |
131 |
|
Other income tax adjustments (d) |
(4) |
(3) |
|
Total adjustments to provision for income taxes |
185 |
128 |
|
Non-GAAP provision for income taxes |
$ 384 |
$ 339 |
|
GAAP tax as a percentage of income before taxes |
11.9% |
11.4% |
|
Adjustments to provision for income taxes: |
|||
Income tax effect of the above adjustments (c) |
2.3 |
2.3 |
|
Other income tax adjustments (d) |
(0.1) |
(0.1) |
|
Total adjustments to provision for income taxes |
2.2 |
2.2 |
|
Non-GAAP tax as a percentage of income before taxes |
14.1% |
13.6% |
|
GAAP net income |
$ 1,476 |
$ 1,646 |
|
Adjustments to net income: |
|||
Adjustments to income before income taxes, net of the income tax effect |
863 |
501 |
|
Other income tax adjustments (d) |
4 |
3 |
|
Total adjustments to net income |
867 |
504 |
|
Non-GAAP net income |
$ 2,343 |
$ 2,150 |
|
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 March 31, 2022 |
Three months ended March 31, 2021 |
||||||
GAAP |
Non-GAAP |
GAAP |
Non-GAAP |
||||
Net income |
$ 1,476 |
$ 2,343 |
$ 1,646 |
$ 2,150 |
|||
Weighted-average shares for diluted EPS |
551 |
551 |
581 |
581 |
|||
Diluted EPS |
$ 2.68 |
$ 4.25 |
$ 2.83 |
$ 3.70 |
|||
(a) |
The adjustments related primarily to noncash amortization of intangible assets from business acquisitions. |
||
(b) |
For the three months ended March 31, 2022, the adjustments related primarily to an in-process research and development asset adjustment. |
||
(c) |
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. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes, for the three months ended March 31, 2022, was 18.0%, compared to 20.7% for the corresponding period of the prior year. |
||
(d) |
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 March 31, |
|||
2022 |
2021 |
||
Net cash provided by operating activities |
$ 2,164 |
$ 2,104 |
|
Net cash used in investing activities |
(111) |
(319) |
|
Net cash used in financing activities |
(3,514) |
(1,939) |
|
Decrease in cash and cash equivalents |
(1,461) |
(154) |
|
Cash and cash equivalents at beginning of period |
7,989 |
6,266 |
|
Cash and cash equivalents at end of period |
$ 6,528 |
$ 6,112 |
|
Three months ended March 31, |
|||
2022 |
2021 |
||
Net cash provided by operating activities |
$ 2,164 |
$ 2,104 |
|
Capital expenditures |
(190) |
(166) |
|
Free cash flow |
$ 1,974 |
$ 1,938 |
Amgen Inc. Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2022 (Unaudited) |
||||
GAAP diluted EPS guidance |
$ 12.53 |
— |
$ 13.58 |
|
Known adjustments to arrive at non-GAAP*: |
||||
Acquisition-related expenses (a) |
3.89 |
— |
3.94 |
|
Net (gains)/losses from equity investments |
0.53 |
|||
Non-GAAP diluted EPS guidance |
$ 17.00 |
— |
$ 18.00 |
|
* The known adjustments are presented net of their related tax impact, which amount to approximately $1.19 per share. |
||||
(a) The adjustments relate primarily to noncash amortization of intangible assets acquired in business acquisitions. |
||||
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 fair value of our contingent consideration obligations and changes in fair value of our equity investments. |
||||
Reconciliation of GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for the Year Ending December 31, 2022 (Unaudited) |
||||
GAAP tax rate guidance |
10.5% |
— |
12.0% |
|
Tax rate of known adjustments discussed above |
2.5% |
— |
3.0% |
|
Non-GAAP tax rate guidance |
13.5% |
— |
14.5% |