AMGEN INC (AMGN) FY 2021 MD&A
This page reproduces the company's own Item 7 MD&A text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following MD&A is intended to assist the reader in understanding Amgen’s business. MD&A is provided as a supplement to, and should be read in conjunction with, our consolidated financial statements and accompanying notes. Our results of operations discussed in MD&A are presented in conformity with GAAP. Amgen operates in one business segment: human therapeutics. Therefore, our results of operations are discussed on a consolidated basis.
Forward-looking statements
This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. In addition, we, or others on our behalf, may make forward-looking statements in press releases, written statements or our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Such words as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our respective risks, uncertainties and assumptions that could affect the outcome or results of operations in Part I, Item 1A. Risk Factors. We have based our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. Reference is made in particular to forward-looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS, liquidity and capital resources, trends, planned dividends, stock repurchases, collaborations and effects of pandemics. Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.
54
Overview
Amgen is a biotechnology company committed to unlocking the potential of biology for patients suffering from serious illnesses. 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.
Our principal products are ENBREL, Prolia, Otezla, XGEVA, Neulasta, Aranesp, Repatha, KYPROLIS and Nplate. We also market a number of other products, including MVASI, Vectibix, KANJINTI, EVENITY, EPOGEN, BLINCYTO, AMGEVITA, Aimovig, Parsabiv, NEUPOGEN, LUMAKRAS/LUMYKRAS, Sensipar/Mimpara and TEZSPIRE. For additional information about our products, see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products.
Our strategy includes integrated activities intended to maintain and strengthen our competitive position in the industry. We focus on six commercial areas: inflammation, oncology/hematology, bone health, CV disease, nephrology and neuroscience. And we conduct discovery research primarily in three therapeutic areas: inflammation, oncology/hematology and general medicine. In 2021, we advanced our innovative pipeline, launched new products, completed several strategic transactions to augment our pipeline and research capabilities, and continued providing uninterrupted supplies of our medicines globally through the second year of the COVID-19 pandemic. We accomplished these objectives while maintaining a strategic and disciplined approach to capital allocation and while advancing our ESG efforts.
In 2021, we continued to advance our pipeline, including achieving key regulatory approvals for LUMAKRAS and TEZSPIRE. Our external business development activities for 2021 included: (i) acquiring Five Prime, including a later-stage gastric cancer bemarituzumab program; (ii) entering into a license agreement with KKC to develop a later-stage molecule for atopic dermatitis and other diseases; and (iii) acquiring Teneobio for its proprietary technologies and oncology programs in development. We also continued to advance our biosimilar program with the launch of RIABNI in the United States and introduced our other biosimilars into new markets. Our biosimilars are expected to continue launching in new markets throughout 2022.
During 2021, while meeting the challenges of a global pandemic and facing increased competition from biosimilars and generics, total product sales were relatively flat as volume growth was offset by lower net selling prices. Product sales decreased 4% in the United States, driven by lower net selling prices, partially offset by volume growth, and increased 12% ROW, driven by volume growth, partially offset by lower net selling prices. Total operating expenses increased 13%, driven by IPR&D expense from the Five Prime acquisition and the upfront payment associated with the KKC licensing agreement.
Cash flows from operating activities totaled $9.3 billion, which supported investment in our business while returning capital to shareholders through the payment of cash dividends and stock repurchases. For 2021, we increased our quarterly cash dividend by 10% to $1.76 per share of common stock. In December 2021, we declared a cash dividend of $1.94 per share of common stock for the first quarter of 2022, an increase of 10% for this period, to be paid in March 2022. We also repurchased 21.7 million shares of our common stock during 2021 at an aggregate cost of $5.0 billion. In 2021, we issued $4.9 billion and repaid $4.2 billion of debt that was coming due in 2022.
Amgen’s approach to, and investment in, human capital resource management is directed at attracting, motivating, developing and retaining talent to tackle the challenges of running an enterprise focused on the discovery, development and commercialization of innovative medicines. Our compensation, benefits and development programs are designed to encourage performance, promote accountability and adherence to Company values, and align with the interests of the Company’s shareholders. Further, we believe that a diverse and inclusive culture fosters innovation, which supports our ability to serve patients. We are engaging in activities and setting goals to improve our focus on diversity, inclusion and belonging. For further information on these and other efforts, see Part I, Item 1. Business—Human Capital Resources.
We have a long-standing ambition to be environmentally responsible, and we regularly set targets to challenge ourselves to deliver further improvements. In 2020, we met or exceeded our environmental sustainability targets set out in 2013 that called for reducing fleet carbon output by up to 20%, facility carbon output by 10%, water consumption by 10% and waste disposal by 35%.2 We achieved our 2020 targets while growing revenues, increasing production capacity and expanding to approximately 100 countries over the same 2013–20 period. To continue on our path to greater environmental sustainability, in January 2021 we announced a new set of long-term environmental targets to achieve by 2027, including achieving carbon neutrality, reducing water consumption by 40% and reducing waste disposed by 75%.2, 3
2 Represents reductions against established baselines, taking into account only verified reduction projects, and does not take into account changes associated with contraction or expansion of the Company.
3 Carbon neutrality goal refers to Scope 1 and 2.
55
Our long-term success depends, to a great extent, on our ability to continue to discover, develop and commercialize innovative products and acquire or collaborate on therapies currently in development by other companies. We must develop new products to achieve revenue growth and to offset revenue losses from when products lose their exclusivity or when competing products are launched. Certain of our products face increasing pressure from competition, including biosimilars and generics. For additional information, including information on the expirations of patents for various products, see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Patents, and Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Competition. We devote considerable resources to R&D activities, but successful product development in the biotechnology industry is highly uncertain. We also face increasing regulatory scrutiny of safety and efficacy both before and after products launch.
Rising healthcare costs and uncertain economic conditions continue to pose challenges to our business, including increasing pressure by third-party payers, such as governments and private payers, to reduce healthcare expenditures. As a result of public and private healthcare-provider focus, the industry continues to be subject to cost containment measures and significant pricing pressures, including net price declines. Finally, wholesale and end-user buying patterns can affect our product sales. These buying patterns can cause fluctuations in quarterly product sales but have generally not been significant to date when comparing full-year product performance to the prior year. See Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products, and Part I, Item 1A. Risk Factors for further discussion of certain factors that could impact our future product sales.
COVID-19 pandemic
Since the onset of the pandemic in 2020, we have been closely monitoring the pandemic’s effects on our global operations. We continue to take appropriate steps to minimize risks to our employees, a significant number of whom have continued to work virtually. Employee access to company facilities has been in accordance with applicable government health and safety protocols and guidance issued in response to the COVID-19 pandemic. To date, our remote working arrangements have not significantly affected our ability to maintain critical business operations, and we have not experienced disruptions to or shortages of our supply of medicines.
Since the beginning of the COVID-19 pandemic, we have seen changes in demand for some of our products driven by changes in the frequency of patient visits to doctors’ offices that has impacted the provision of treatments to existing patients and reduced diagnoses in new patients. During 2021, there was gradual recovery in both patient visits and diagnoses that approached pre-COVID-19 levels early in the fourth quarter. However late in 2021, the Omicron variant began to impact the healthcare sector and as a result we expect ongoing variability in demand patterns in the first half of 2022. The cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business. We will continue to closely monitor the effects of emerging COVID-19 variants on patient behavior and access to care.
Since early 2021, global vaccination efforts have been under way to control the pandemic. However, uncertainty remains as to the length of time required for vaccination of a meaningful portion of the population and as to the efficacy of such vaccinations with regard to the trajectory of the pandemic. Challenges to vaccination efforts, new variants and other causes of virus spread may require governments to issue additional restrictions and/or order shutdowns in various geographies. As a result, we expect to see continued volatility for at least the duration of the pandemic as governments respond to current local conditions.
With respect to our drug development activities, we are continuously monitoring COVID-19 infection rates, including changes from new variants, and working to mitigate effects on future study enrollment in our clinical trials and evaluating the impacts in all countries where our clinical trials occur. We remain focused on supporting our active clinical sites in their provision of care to patients and in our provision of investigational drug supply.
Despite the ongoing pandemic and business impacts noted above, we believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditures and debt service requirements as well as to engage in capital-return and other business initiatives that we plan to pursue. For a discussion of the risks the COVID-19 pandemic presents to our results, see Risk Factors in Part I, Item 1A. Risk Factors of this Form 10-K.
56
Selected Financial Information
The following is an overview of our results of operations (in millions, except percentages and per-share data):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Product sales: | |||||||||
| U.S. | $ | 17,286 | (4) | % | $ | 17,985 | |||
| ROW | 7,011 | 12 | % | 6,255 | |||||
| Total product sales | 24,297 | — | % | 24,240 | |||||
| Other revenues | 1,682 | 42 | % | 1,184 | |||||
| Total revenues | $ | 25,979 | 2 | % | $ | 25,424 | |||
| Operating expenses | $ | 18,340 | 13 | % | $ | 16,285 | |||
| Operating income | $ | 7,639 | (16) | % | $ | 9,139 | |||
| Net income | $ | 5,893 | (19) | % | $ | 7,264 | |||
| Diluted EPS | $ | 10.28 | (16) | % | $ | 12.31 | |||
| Diluted shares | 573 | (3) | % | 590 |
In the following discussion of changes in product sales, any reference to unit demand growth or decline refers to changes in the purchases of our products by healthcare providers (such as physicians or their clinics), dialysis centers, hospitals and pharmacies. In addition, any reference to increases or decreases in inventory refers to changes in inventory held by wholesaler customers and end users (such as pharmacies).
Total product sales were relatively flat for 2021, as volume growth was offset by declines in net selling prices. For 2022, we expect that net selling prices will continue to decline at a portfolio level driven by increased competition. Further, the first quarter of a year historically represents the lowest product sales quarter for the year, in part due to plan changes, insurance reverifications and higher co-pay expenses as U.S. patients work through deductibles, particularly for products acquired through pharmacy benefit programs.
Throughout the pandemic, we experienced changes in demand for some of our products. The pandemic has interrupted many physician–patient interactions, which has led to delays in diagnoses and treatments, with varying degrees of impact across our portfolio. In general, declines in the sales of our products that were impacted by the dynamics of the pandemic were most significant in the early months of the pandemic with product demand beginning to show some recovery in late 2020. During 2021, we observed gradual recovery from the COVID-19 pandemic, with patient visits and diagnosis rates that approached pre-pandemic levels early in the fourth quarter. However, late in the year, the Omicron variant began to impact the healthcare sector and as a result, we have seen some shift back to virtual engagement by our field staff and variability in demand patterns. The cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business. Given the unpredictable nature of the pandemic, we expect there could be ongoing intermittent disruptions in physician–patient interactions, and as a result, we continue to expect quarter-to-quarter variability. In addition, other changes in the healthcare ecosystem have the potential to introduce variability into product sales trends. For example, changes in U.S. employment have led to changes to the insured population. Growth in numbers of Medicaid enrollees and uninsured individuals may have a negative impact on product demand and sales. Overall, uncertainty remains around the timing and magnitude of our sales during the COVID-19 pandemic. See Risk Factors in Part I, Item 1A. of this Form 10-K.
Other revenues increased for 2021, primarily driven by the sale of COVID-19 antibody material resulting from our manufacturing collaboration.
Operating expenses increased for 2021, driven by IPR&D expense related to the bemarituzumab program acquired as part of the Five Prime acquisition and by the upfront payment associated with the KKC licensing agreement.
Although changes in foreign currency exchange rates result in increases or decreases in our reported international product sales, the benefit or detriment that such movements have on our international product sales is partially offset by corresponding increases or decreases in our international operating expenses and our related foreign currency hedging activities. Our hedging activities seek to offset the impacts, both positive and negative, that foreign currency exchange rate changes may have on our net income by hedging our net foreign currency exposure, primarily with respect to product sales denominated in euros. The net impact from changes in foreign currency exchange rates was not material in 2021, 2020 or 2019.
57
Results of Operations
Product sales
Worldwide product sales were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ENBREL | $ | 4,465 | (11) | % | $ | 4,996 | (4) | % | $ | 5,226 | ||||||
| Prolia | 3,248 | 18 | % | 2,763 | 3 | % | 2,672 | |||||||||
| Otezla | 2,249 | 2 | % | 2,195 | * | 178 | ||||||||||
| XGEVA | 2,018 | 6 | % | 1,899 | (2) | % | 1,935 | |||||||||
| Neulasta | 1,734 | (24) | % | 2,293 | (29) | % | 3,221 | |||||||||
| Aranesp | 1,480 | (6) | % | 1,568 | (9) | % | 1,729 | |||||||||
| Repatha | 1,117 | 26 | % | 887 | 34 | % | 661 | |||||||||
| KYPROLIS | 1,108 | 4 | % | 1,065 | 2 | % | 1,044 | |||||||||
| Nplate | 1,027 | 21 | % | 850 | 7 | % | 795 | |||||||||
| Other products | 5,851 | 2 | % | 5,724 | 21 | % | 4,743 | |||||||||
| Total product sales | $ | 24,297 | — | % | $ | 24,240 | 9 | % | $ | 22,204 | ||||||
| Total U.S. | $ | 17,286 | (4) | % | $ | 17,985 | 9 | % | $ | 16,531 | ||||||
| Total ROW | 7,011 | 12 | % | 6,255 | 10 | % | 5,673 | |||||||||
| Total product sales | $ | 24,297 | — | % | $ | 24,240 | 9 | % | $ | 22,204 |
* Change in excess of 100%.
Future sales of our products will depend in part on the factors discussed in the Overview, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Competition, in Part I, Item 1A. Risk Factors, and any additional factors discussed in the individual product sections below. In addition, for a list of our products’ significant competitors, see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Competition.
ENBREL
Total ENBREL sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ENBREL — U.S. | $ | 4,352 | (10) | % | $ | 4,855 | (4) | % | $ | 5,050 | ||||||
| ENBREL — Canada | 113 | (20) | % | 141 | (20) | % | 176 | |||||||||
| Total ENBREL | $ | 4,465 | (11) | % | $ | 4,996 | (4) | % | $ | 5,226 |
The decrease in ENBREL sales for 2021 was driven by lower net selling price, unit demand and unfavorable changes in inventory. For 2022, we expect ENBREL to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles. In addition, for 2022, we expect net selling price to decline.
The decrease in ENBREL sales for 2020 was driven by lower unit demand and net selling price, partially offset by favorable changes to estimated sales deductions and inventory.
58
Prolia
Total Prolia sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prolia — U.S. | $ | 2,150 | 17 | % | $ | 1,830 | 3 | % | $ | 1,772 | ||||||
| Prolia — ROW | 1,098 | 18 | % | 933 | 4 | % | 900 | |||||||||
| Total Prolia | $ | 3,248 | 18 | % | $ | 2,763 | 3 | % | $ | 2,672 |
The increase in global Prolia sales for 2021 was primarily driven by higher unit demand.
The increase in global Prolia sales for 2020 was driven by higher unit demand and net selling price.
Otezla
Total Otezla sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otezla — U.S. | $ | 1,804 | 1 | % | $ | 1,790 | * | $ | 139 | ||||||
| Otezla — ROW | 445 | 10 | % | 405 | * | 39 | |||||||||
| Total Otezla | $ | 2,249 | 2 | % | $ | 2,195 | * | $ | 178 |
* Change in excess of 100%.
The increase in global Otezla sales for 2021 was driven by higher unit demand, partially offset by lower net selling price and unfavorable changes to inventory. For 2022, we expect Otezla to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles.
Otezla was acquired on November 21, 2019, and generated $2.2 billion and $178 million in global sales for the years ended December 31, 2020 and 2019, respectively.
For a discussion of ongoing litigation related to Otezla, see Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.
XGEVA
Total XGEVA sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| XGEVA — U.S. | $ | 1,434 | 2 | % | $ | 1,405 | (4) | % | $ | 1,457 | ||||||
| XGEVA — ROW | 584 | 18 | % | 494 | 3 | % | 478 | |||||||||
| Total XGEVA | $ | 2,018 | 6 | % | $ | 1,899 | (2) | % | $ | 1,935 |
The increase in global XGEVA sales for 2021 was primarily driven by higher unit demand, partially offset by lower net selling price.
The decrease in global XGEVA sales for 2020 was driven by lower unit demand as a result of the COVID-19 pandemic.
59
Neulasta
Total Neulasta sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neulasta — U.S. | $ | 1,514 | (24) | % | $ | 2,001 | (29) | % | $ | 2,814 | ||||||
| Neulasta — ROW | 220 | (25) | % | 292 | (28) | % | 407 | |||||||||
| Total Neulasta | $ | 1,734 | (24) | % | $ | 2,293 | (29) | % | $ | 3,221 |
The decreases in global Neulasta sales for 2021 and 2020 was primarily driven by lower net selling price and unit demand. Increased competition as a result of biosimilar versions of Neulasta has had and will continue to have a significant adverse impact on brand sales, including accelerating net price erosion and lower unit demand. We also expect other biosimilar versions, including biosimilars that will use an on-body injector that would compete with our Onpro injector, to be approved in the future.
For a discussion of ongoing patent litigations related to biosimilars, see Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.
Aranesp
Total Aranesp sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aranesp — U.S. | $ | 537 | (15) | % | $ | 629 | (17) | % | $ | 758 | ||||||
| Aranesp — ROW | 943 | — | % | 939 | (3) | % | 971 | |||||||||
| Total Aranesp | $ | 1,480 | (6) | % | $ | 1,568 | (9) | % | $ | 1,729 |
The decrease in global Aranesp sales for 2021 was primarily driven by lower net selling price due to competition.
The decrease in global Aranesp sales for 2020 was driven by declines in net selling price and unit demand.
Aranesp continues to face competition from a long-acting ESA and from a biosimilar version of EPOGEN, which will continue to impact sales in the future.
Repatha
Total Repatha sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Repatha — U.S. | $ | 557 | 21 | % | $ | 459 | 22 | % | $ | 376 | ||||||
| Repatha — ROW | 560 | 31 | % | 428 | 50 | % | 285 | |||||||||
| Total Repatha | $ | 1,117 | 26 | % | $ | 887 | 34 | % | $ | 661 |
The increases in global Repatha sales for 2021 and 2020 was driven by higher unit demand, partially offset by lower net selling price. Contracting changes to improve Medicare Part D patient access resulted in the decrease to net selling price.
For a discussion of ongoing litigation related to Repatha, see Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements.
60
KYPROLIS
Total KYPROLIS sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| KYPROLIS — U.S. | $ | 736 | 4 | % | $ | 710 | 9 | % | $ | 654 | ||||||
| KYPROLIS — ROW | 372 | 5 | % | 355 | (9) | % | 390 | |||||||||
| Total KYPROLIS | $ | 1,108 | 4 | % | $ | 1,065 | 2 | % | $ | 1,044 |
The increase in global KYPROLIS sales for 2021 was primarily driven by higher unit demand.
The increase in global KYPROLIS sales for 2020 was primarily driven by an increase in net selling price and favorable changes in inventory, partially offset by lower unit demand.
The FDA has reported that it has granted tentative or final approval of ANDAs for generic carfilzomib products filed by a number of companies. The date of approval of those ANDAs for generic carfilzomib products is governed by the Hatch–Waxman Act and any applicable settlement agreements between us and certain companies that seek to develop generic carfilzomib products.
Nplate
Total Nplate sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nplate — U.S. | $ | 566 | 17 | % | $ | 485 | 1 | % | $ | 480 | ||||||
| Nplate — ROW | 461 | 26 | % | 365 | 16 | % | 315 | |||||||||
| Total Nplate | $ | 1,027 | 21 | % | $ | 850 | 7 | % | $ | 795 |
The increases in global Nplate sales for 2021 and 2020 was primarily driven by higher unit demand.
61
Other products
Other product sales by geographic region were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MVASI — U.S. | $ | 826 | 26 | % | $ | 656 | * | $ | 121 | |||||||
| MVASI — ROW | 340 | * | 142 | * | 6 | |||||||||||
| Vectibix — U.S. | 347 | 1 | % | 342 | 8 | % | 316 | |||||||||
| Vectibix — ROW | 526 | 12 | % | 469 | 10 | % | 428 | |||||||||
| KANJINTI — U.S. | 479 | 1 | % | 475 | * | 118 | ||||||||||
| KANJINTI — ROW | 93 | 1 | % | 92 | (15) | % | 108 | |||||||||
| EVENITY — U.S. | 331 | 73 | % | 191 | * | 42 | ||||||||||
| EVENITY — ROW | 199 | 25 | % | 159 | 8 | % | 147 | |||||||||
| EPOGEN — U.S. | 521 | (13) | % | 598 | (31) | % | 867 | |||||||||
| BLINCYTO — U.S. | 278 | 20 | % | 231 | 31 | % | 176 | |||||||||
| BLINCYTO — ROW | 194 | 31 | % | 148 | 9 | % | 136 | |||||||||
| AMGEVITA — ROW | 439 | 33 | % | 331 | 54 | % | 215 | |||||||||
| Aimovig — U.S. | 313 | (17) | % | 378 | 24 | % | 306 | |||||||||
| Aimovig — ROW | 4 | N/A | — | N/A | — | |||||||||||
| Parsabiv — U.S. | 150 | (75) | % | 605 | 10 | % | 550 | |||||||||
| Parsabiv— ROW | 130 | 17 | % | 111 | 39 | % | 80 | |||||||||
| NEUPOGEN — U.S. | 101 | (30) | % | 144 | (19) | % | 178 | |||||||||
| NEUPOGEN — ROW | 67 | (17) | % | 81 | (6) | % | 86 | |||||||||
| LUMAKRAS — U.S. | 82 | N/A | — | N/A | — | |||||||||||
| LUMYKRAS — ROW | 8 | N/A | — | N/A | — | |||||||||||
| Sensipar — U.S. | 6 | (93) | % | 92 | (63) | % | 252 | |||||||||
| Sensipar/Mimpara — ROW | 78 | (60) | % | 196 | (34) | % | 299 | |||||||||
| Other — U.S. | 202 | 85 | % | 109 | 4 | % | 105 | |||||||||
| Other — ROW | 137 | (21) | % | 174 | (16) | % | 207 | |||||||||
| Total other product sales | $ | 5,851 | 2 | % | $ | 5,724 | 21 | % | $ | 4,743 | ||||||
| Total U.S. — other products | $ | 3,636 | (5) | % | $ | 3,821 | 26 | % | $ | 3,031 | ||||||
| Total ROW — other products | 2,215 | 16 | % | 1,903 | 11 | % | 1,712 | |||||||||
| Total other product sales | $ | 5,851 | 2 | % | $ | 5,724 | 21 | % | $ | 4,743 |
* Change in excess of 100%.
N/A = not applicable
62
Operating expenses
Operating expenses were as follows (dollar amounts in millions):
| Year ended December 31, 2021 | Change | Year ended December 31, 2020 | Change | Year ended December 31, 2019 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cost of sales | $ | 6,454 | 5 | % | $ | 6,159 | 41 | % | $ | 4,356 | ||||||
| % of product sales | 26.6 | % | 25.4 | % | 19.6 | % | ||||||||||
| % of total revenues | 24.8 | % | 24.2 | % | 18.6 | % | ||||||||||
| Research and development | $ | 4,819 | 15 | % | $ | 4,207 | 2 | % | $ | 4,116 | ||||||
| % of product sales | 19.8 | % | 17.4 | % | 18.5 | % | ||||||||||
| % of total revenues | 18.5 | % | 16.5 | % | 17.6 | % | ||||||||||
| Acquired in-process research and development | $ | 1,505 | N/A | $ | — | N/A | $ | — | ||||||||
| % of product sales | 6.2 | % | — | % | — | % | ||||||||||
| % of total revenues | 5.8 | % | — | % | — | % | ||||||||||
| Selling, general and administrative | $ | 5,368 | (6) | % | $ | 5,730 | 11 | % | $ | 5,150 | ||||||
| % of product sales | 22.1 | % | 23.6 | % | 23.2 | % | ||||||||||
| % of total revenues | 20.7 | % | 22.5 | % | 22.0 | % | ||||||||||
| Other | $ | 194 | 3 | % | $ | 189 | * | $ | 66 | |||||||
| Total operating expenses | $ | 18,340 | 13 | % | $ | 16,285 | 19 | % | $ | 13,688 |
* Change in excess of 100%
N/A = not applicable
Cost of sales
Cost of sales increased to 24.8% of total revenues for 2021, driven by unfavorable product mix and higher profit share and royalties, partially offset by lower amortization expense from acquisition-related assets and lower manufacturing costs.
Cost of sales increased to 24.2% of total revenues for 2020, primarily driven by the amortization of expenses related to our acquisition of Otezla and by higher royalty expenses and profit share, partially offset by lower manufacturing costs.
Research and development
The Company groups all of its R&D activities and related expenditures into three categories: (i) research and early pipeline, (ii) later-stage clinical programs and (iii) marketed products. These categories are described below:
| Category | Description | |
|---|---|---|
| Research and early pipeline | R&D expenses incurred in activities substantially in support of early research through the completion of phase 1 clinical trials, including drug discovery, toxicology, pharmacokinetics and drug metabolism, and process development | |
| Later-stage clinical programs | R&D expenses incurred in or related to phase 2 and phase 3 clinical programs intended to result in registration of a new product or a new indication for an existing product primarily in the United States or the EU | |
| Marketed products | R&D expenses incurred in support of the Company’s marketed products that are authorized to be sold primarily in the United States or the EU. Includes clinical trials designed to gather information on product safety (certain of which may be required by regulatory authorities) and their product characteristics after regulatory approval has been obtained, as well as the costs of obtaining regulatory approval of a product in a new market after approval in either the United States or the EU has been obtained |
63
R&D expense by category was as follows (in millions):
| Years ended December 31, | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2019 | ||||||||
| Research and early pipeline | $ | 1,670 | $ | 1,405 | $ | 1,649 | ||||
| Later-stage clinical programs | 1,726 | 1,365 | 1,062 | |||||||
| Marketed products | 1,423 | 1,437 | 1,405 | |||||||
| Total R&D expense | $ | 4,819 | $ | 4,207 | $ | 4,116 |
The increase in R&D expense for 2021 was driven by a licensing-related expense from our collaboration with KKC included in later-stage clinical programs and higher spend in research and early pipeline, including other business development activities.
The increase in R&D expense for 2020 was driven by higher spend for later-stage clinical programs, including LUMAKRAS, biosimilar programs and Otezla, and higher spend for Otezla included in marketed-product support. These increases were partially offset by recoveries from our collaboration with BeiGene that reduced expenses in later-stage clinical programs and in research and early pipeline, and lower spend in certain oncology programs included in research and early pipeline.
Acquired in-process research and development
Acquired IPR&D expense for 2021 was related to the bemarituzumab program acquired as part of the Five Prime acquisition.
Selling, general and administrative
The decrease in SG&A expense for 2021 was primarily driven by lower spend for marketed products and lower general and administrative expenses.
The increase in SG&A expense for 2020 was driven by investments in certain marketed products, primarily Otezla, and preparation for product launches, partially offset by a reduction in conference-related expenses due to the impact of COVID-19.
Other
Other operating expenses for 2021 primarily consisted of expenses related to cost-savings initiatives and a legal judgment.
Other operating expenses for 2020 primarily consisted of legal settlement expenses.
Other operating expenses for 2019 primarily consisted of expenses related to cost-savings initiatives.
Nonoperating expenses/income and income taxes
Nonoperating expenses/income and income taxes were as follows (dollar amounts in millions):
| Years ended December 31, | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2019 | ||||||||
| Interest expense, net | $ | (1,197) | $ | (1,262) | $ | (1,289) | ||||
| Other income, net | $ | 259 | $ | 256 | $ | 753 | ||||
| Provision for income taxes | $ | 808 | $ | 869 | $ | 1,296 | ||||
| Effective tax rate | 12.1 | % | 10.7 | % | 14.2 | % |
Interest expense, net
The decrease in Interest expense, net, for 2021 was primarily due to net higher costs associated with the early retirement of debt in 2020 and lower LIBOR rates in 2021 on debt for which we effectively pay a variable rate of interest through the use of interest rate swaps, partially offset by higher overall debt outstanding.
The decrease in Interest expense, net, for 2020 was primarily due to lower LIBOR rates on debt for which we effectively pay a variable rate of interest, partially offset by net costs associated with the early retirement of debt.
64
Other income, net
The increase in Other income, net, for 2021 was primarily due to lower losses incurred in connection with our BeiGene investment compared with 2020, partially offset by lower income on our interest-bearing investments in 2021 and other nonrecurring gains recognized in 2020.
The decrease in Other income, net, for 2020 was primarily due to reduced interest income as a result of lower average cash balances and a decline in interest yields and losses incurred in connection with our BeiGene investment, partially offset by gains recognized on our investments in publicly traded equity securities and limited partnerships. See Part IV—Note 9, Investments, to the Consolidated Financial Statements.
Income taxes
The increase in our effective tax rate for 2021 compared with 2020 was primarily driven by the non-deductible IPR&D expense arising from the acquisition of Five Prime, partially offset by earnings mix and adjustments to prior-year tax liabilities.
The decrease in our effective tax rate for 2020 compared with 2019 was primarily driven by favorable items, including audit settlements, adjustments to prior-year tax liabilities, lower interest expense on uncertain tax positions and amortization related to the Otezla acquisition, partially offset by changes in valuation allowance.
The Administration proposed and Congress is considering significant changes to existing tax law. These changes, if enacted, could substantially increase taxes we pay to the U.S. government. Further, the OECD recently reached agreement to align countries on a minimum corporate tax rate and an expansion of the taxing rights of market countries. If enacted, this agreement could result in tax increases in both the United States and foreign jurisdictions. The U.S. Treasury recently released final foreign tax credit regulations that eliminate U.S. creditability of the Puerto Rico Excise Tax beginning in 2023, which will increase our U.S. tax liability. The U.S. territory of Puerto Rico is considering changes to its tax system that may minimize or eliminate this impact, but the outcome of such potential changes is uncertain. Changes to existing tax law in the United States, the U.S. territory of Puerto Rico, or other jurisdictions, including the potential changes discussed above, could result in tax increases where we do business and could have a material adverse effect on the results of our operations.
In 2017, we received an RAR and a modified RAR from the IRS for the years 2010, 2011 and 2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Notices for 2010, 2011 and 2012 that we received in May and July 2021 which seek to increase our U.S. taxable income. The Notices seek to increase our U.S. taxable income by an amount that would result in additional federal tax of approximately $3.6 billion plus interest. Any additional tax that could be imposed would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings. We firmly believe that the IRS’s positions set forth in the Notices are without merit, and we are contesting the Notices through the judicial process.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013, 2014 and 2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010, 2011 and 2012. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office. We were unable to reach resolution at the administrative appeals level, and we anticipate that we will receive a statutory notice of deficiency for these years as well. We expect to contest any such notice related to 2013–15 through the judicial process. We are also currently under examination by the IRS for the years 2016, 2017 and 2018 and by a number of state and foreign tax jurisdictions.
Final resolution of these complex matters is not likely within the next 12 months. We believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and the uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our consolidated financial statements.
See Part I, Item 1A. Risk Factors—The adoption and interpretation of new tax legislation or exposure to additional tax liabilities could affect our profitability; Part II, Item 7. MD&A—Critical Accounting Policies and Estimates—Income taxes; and Part IV—Note 6, Income taxes, to the Consolidated Financial Statements for further discussion.
65
Financial Condition, Liquidity and Capital Resources
Selected financial data was as follows (in millions):
| December 31, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | |||||
| Cash, cash equivalents and marketable securities | $ | 8,037 | $ | 10,647 | ||
| Total assets | $ | 61,165 | $ | 62,948 | ||
| Current portion of long-term debt | $ | 87 | $ | 91 | ||
| Long-term debt | $ | 33,222 | $ | 32,895 | ||
| Stockholders’ equity | $ | 6,700 | $ | 9,409 |
Cash, cash equivalents and marketable securities
Our balance of cash, cash equivalents and marketable securities was $8.0 billion at December 31, 2021. The primary objective of our investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.
Capital allocation
Consistent with the objective to optimize our capital structure, we deploy our accumulated cash balances in a strategic manner and consider a number of alternatives, including strategic transactions (including those that expand our portfolio of products in areas of therapeutic interest), repayment of debt, payment of dividends and stock repurchases.
We intend to continue investing in our business while returning capital to stockholders through the payment of cash dividends and stock repurchases, thereby reflecting our confidence in the future cash flows of our business and our desire to optimize our cost of capital. The timing and amount of future dividends and stock repurchases will vary based on a number of factors, including future capital requirements for strategic transactions, availability of financing on acceptable terms, debt service requirements, our credit rating, changes to applicable tax laws or corporate laws, changes to our business model and periodic determination by our Board of Directors that cash dividends and/or stock repurchases are in the best interests of stockholders and are in compliance with applicable laws and the Company’s agreements. In addition, the timing and amount of stock repurchases may also be affected by our overall level of cash, stock price and blackout periods, during which we are restricted from repurchasing stock. The manner of stock repurchases may include block purchases, tender offers, accelerated share repurchases and market transactions.
The Board of Directors declared quarterly cash dividends of $1.76, $1.60 and $1.45 per share of common stock paid in 2021, 2020 and 2019, respectively, an increase of 10% over the prior year in both 2021 and 2020. In December 2021, the Board of Directors declared a cash dividend of $1.94 per share of common stock for the first quarter of 2022, an increase of 10% for this period, to be paid in March 2022.
We also returned capital to stockholders through our stock repurchase program. During 2021, we repurchased and had cash settlements of $5.0 billion of common stock. In 2020, we repurchased and had cash settlements of $3.5 billion of common stock. In 2019, we repurchased $7.6 billion of common stock and had cash settlements of $7.7 billion. In March 2021, October 2021 and December 2021, the Board of Directors increased the amount authorized under our stock repurchase program by $3.4 billion, $4.5 billion and $5.0 billion, respectively. As of December 31, 2021, $10.9 billion remained available under the stock repurchase program.
As a result of stock repurchases and quarterly dividend payments, we have an accumulated deficit as of December 31, 2021 and 2020. Our accumulated deficit is not anticipated to affect our future ability to operate, repurchase stock, pay dividends or repay our debt given our expected continued profitability and strong financial position.
We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditure and debt service requirements, our plans to pay dividends and repurchase stock, and other business initiatives we plan to strategically pursue, including acquisitions and licensing activities. We anticipate that our liquidity needs can be met through a variety of sources, including cash provided by operating activities, sales of marketable securities, borrowings through commercial paper and/or syndicated credit facilities, and access to other domestic and foreign debt markets and equity markets. See Part I, Item 1A. Risk Factors—Global economic conditions may negatively affect us and may magnify certain risks that affect our business.
66
Financing arrangements
To help meet our liquidity requirements, we have entered into various financing arrangements. The noncurrent portions of our long-term borrowings as of December 31, 2021 and 2020, were $33.2 billion and $32.9 billion, respectively. The carrying values of our long-term borrowings are net of fair value adjustments for interest rate swaps and unamortized discounts, premiums and offering costs. As of December 31, 2021, S&P, Moody’s and Fitch assigned credit ratings to our outstanding senior notes of A– with a stable outlook, Baa1 with a stable outlook and BBB+ with a stable outlook, respectively, which are considered investment grade. Unfavorable changes to these ratings may have an adverse impact on future financings.
During 2021 and 2020, we issued debt with aggregate principal amounts of $5.0 billion and $9.0 billion, respectively. During 2019, we did not issue any debt or debt securities. During 2021, 2020 and 2019, we repaid/redeemed debt of $4.2 billion, $6.5 billion and $4.5 billion, respectively. In addition, during 2020, we exchanged $0.7 billion of certain of our outstanding note issuances with $0.9 billion of newly issued notes with a lower interest rate and later maturity date.
To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that effectively converted a fixed-rate interest coupon for certain of our debt issuances to a floating, LIBOR-based coupon over the lives of the respective notes. These interest rate swap contracts qualify and are designated as fair value hedges. As of December 31, 2021 and 2020, we had interest rate swap contracts with aggregate notional amounts of $6.7 billion and $5.9 billion, respectively.
To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term notes denominated in foreign currencies, we entered into cross-currency swap contracts, which effectively convert the interest payments and principal repayment of the respective notes from euros, pounds sterling and Swiss francs to U.S. dollars. These cross-currency swap contracts qualify and are designated as cash flow hedges. As of both December 31, 2021 and 2020, we had cross-currency swap contracts with aggregate notional amounts of $3.4 billion and $4.8 billion, respectively.
As of December 31, 2021, we had a commercial paper program that allows us to issue up to $2.5 billion of unsecured commercial paper to fund our working-capital needs. During 2021, 2020 and 2019, we did not issue any commercial paper. No commercial paper was outstanding as of December 31, 2021 and 2020.
In 2019, we amended and restated our $2.5 billion syndicated, unsecured, revolving credit agreement, which is available for general corporate purposes or as a liquidity backstop to our commercial paper program. The commitments under the revolving credit agreement may be increased by up to $750 million with the agreement of the banks. Each bank that is a party to the agreement has an initial commitment term of five years. This term may be extended for up to two additional one-year periods with the agreement of the banks. Annual commitment fees for this agreement are 0.09% of the unused portion of the facility based on our current credit rating. Generally, we would be charged interest for any amounts borrowed under this facility, based on our current credit rating, at (i) LIBOR plus 1% or (ii) the highest of (A) the syndication agent bank base commercial lending rate, (B) the overnight federal funds rate plus 0.50% or (C) one-month LIBOR plus 1%. The agreement contains provisions related to the determination of successor rates to address the possible phaseout or unavailability of designated reference rates. As of December 31, 2021 and 2020, no amounts were outstanding under this facility.
It is anticipated that the U.S. dollar LIBOR rate will be phased out and replaced by 2023. The Alternative Reference Rates Committee, a group of private-market participants convened by the Federal Reserve Board and the Federal Reserve Bank of New York to help ensure a successful transition from U.S. dollar LIBOR to a more robust reference rate, recommends SOFR as the U.S. dollar LIBOR alternative. As such, we expect SOFR to become widely adopted by market participants. We do not expect this change to have a material impact on our financial statements. See Part I, Item 1A. Risk Factors—Our sales and operations are subject to the risks of doing business internationally, including in emerging markets.
In February 2020, we filed a shelf registration statement with the SEC that allows us to issue unspecified amounts of debt securities; common stock; preferred stock; warrants to purchase debt securities, common stock, preferred stock or depositary shares; rights to purchase common stock or preferred stock; securities purchase contracts; securities purchase units; and depositary shares. Under this shelf registration statement, all of the securities available for issuance may be offered from time to time with terms to be determined at the time of issuance. This shelf registration statement expires in February 2023.
Certain of our financing arrangements contain nonfinancial covenants. In addition, our revolving credit agreement includes a financial covenant that requires us to maintain a specified minimum interest coverage ratio of (i) the sum of consolidated net income, interest expense, provision for income taxes, depreciation expense, amortization expense, unusual or nonrecurring charges and other noncash items (Consolidated EBITDA) to (ii) Consolidated Interest Expense, each as defined and described in the credit agreement. We were in compliance with all applicable covenants under these arrangements as of December 31, 2021.
These financing arrangements are more fully discussed in Part IV—Note 15, Financing arrangements, and Note 18, Derivative instruments, to the Consolidated Financial Statements.
67
Cash flows
Our summarized cash flow activity was as follows (in millions):
| Years ended December 31, | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2019 | ||||||||
| Net cash provided by operating activities | $ | 9,261 | $ | 10,497 | $ | 9,150 | ||||
| Net cash provided by (used in) investing activities | $ | 733 | $ | (5,401) | $ | 5,709 | ||||
| Net cash used in financing activities | $ | (8,271) | $ | (4,867) | $ | (15,767) |
Operating
Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds. Cash provided by operating activities decreased during 2021 primarily due to the monetization of interest rate swaps that occurred in 2020 and the timing of payments for sales incentives and discounts. Cash provided by operating activities increased during 2020 primarily due to higher Net income after adding back the noncash amortization related to the acquisition of Otezla, the monetization of interest rate swap contracts and working-capital adjustments.
Investing
Cash provided by investing activities during 2021 was primarily due to net cash inflows related to marketable securities of $4.3 billion, partially offset by cash used in the acquisitions of Teneobio and Five Prime of $2.5 billion. Cash used in investing activities during 2020 was primarily due to our $3.2 billion of purchases of equity method investments, primarily BeiGene, and net cash outflows related to marketable securities of $1.5 billion. Cash provided by investing activities during 2019 was primarily due to net cash inflows related to marketable securities of $20.0 billion which occurred primarily to fund our acquisition of Otezla and investment in BeiGene. Capital expenditures were $880 million, $608 million and $618 million in 2021, 2020 and 2019, respectively. We currently estimate 2022 spending on capital projects to be approximately $950 million. A majority of the increase in expenditures relates to expansion of manufacturing capacity to enable supply of products and product candidates.
Financing
Cash used in financing activities during 2021 was primarily due to payments to repurchase our common stock of $5.0 billion and the payment of dividends of $4.0 billion, partially offset by proceeds from the issuance of debt, net of repayments of $0.8 billion. Cash used in financing activities during 2020 was primarily due to the payment of dividends of $3.8 billion and payments to repurchase our common stock of $3.5 billion, partially offset by proceeds from issuance of debt, net of repayments of $2.5 billion. Cash used in financing activities during 2019 was primarily due to payments to repurchase our common stock of $7.7 billion, repayment of debt of $4.5 billion and payments of dividends of $3.5 billion.
See Part IV—Note 9, Investments; Note 15, Financing arrangements; and Note 16, Stockholders’ equity, to the Consolidated Financial Statements.
Capital requirements
We have material cash requirements to pay third parties under various contractual obligations discussed below.
We are obligated to pay interest and repay principal under our various financing arrangements, including amounts under interest rate swap and cross-currency swap contracts related to certain of our long-term debt obligations. For information on scheduled debt maturities and payments under derivative contracts associated with our long-term debt obligations, see Part IV—Note 15, Financing arrangements, and Note 18, Derivative instruments, to the Consolidated Financial Statements.
We are obligated to make payments for operating leases, including rental commitments on abandoned leases and leases that have not yet commenced. For information on these obligations, see Part IV—Note 13, Leases, to the Consolidated Financial Statements.
Under the 2017 Tax Act, we elected to pay in eight annual installments the repatriation tax related primarily to prior indefinitely invested earnings of our foreign operations. For information on the remaining scheduled repatriation tax installments, see Part IV—Note 19, Contingencies and commitments—Commitments—U.S. Repatriation tax, to the Consolidated Financial Statements.
68
We have purchase obligations of $3.2 billion primarily related to (i) R&D commitments (including those related to clinical trials) for new and existing products, (ii) capital expenditures and (iii) open purchase orders for the acquisition of goods and services in the ordinary course of business. Most of these obligations are expected to be paid within one year, and payment of certain of these amounts may be reduced based on certain future events.
In addition to the purchase obligations noted above, we are contractually obligated to pay additional amounts that in the aggregate are significant, upon the achievement of various development, regulatory and commercial milestones for agreements we have entered into with third parties, including contingent consideration incurred in the acquisitions of Teneobio and K-A. These payments are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring, and any resulting cash requirements are managed through our operational budgeting processes. Except with respect to the fair value of the contingent consideration of approximately $0.3 billion, these obligations are not recorded on our Consolidated Balance Sheets. As of December 31, 2021, the maximum amount that may be payable in the future for agreements we have entered into with third parties is $7.4 billion, including $1.6 billion of contingent consideration payments in connection with our Teneobio acquisition.
We have recorded liabilities for UTBs that, because of their nature, have a high degree of uncertainty regarding the timing of future cash payment and other events that extinguish these liabilities. See Part IV—Note 6, Income taxes, to the Consolidated Financial Statements.
Critical Accounting Policies and Estimates
The preparation of our consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. Our significant accounting policies are included in Part IV—Note 1, Summary of significant accounting policies. The following are considered critical to our consolidated financial statements because they require the most difficult, subjective or complex judgments, often because of the need to make estimates about matters that are inherently uncertain.
Product sales and sales deductions
Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, based on an amount that reflects the consideration to which we expect to be entitled, net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions (collectively, sales deductions) and returns established at the time of sale.
We analyze the adequacy of our accruals for sales deductions quarterly. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that adjustment is appropriate. Accruals are also adjusted to reflect actual results. Amounts recorded in Accrued liabilities in the Consolidated Balance Sheets for sales deductions were as follows (in millions):
| Rebates | Chargebacks | Other deductions | Total | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance as of December 31, 2018 | $ | 2,589 | $ | 454 | $ | 127 | $ | 3,170 | ||||||
| Amounts charged against product sales | 6,825 | 7,090 | 1,292 | 15,207 | ||||||||||
| Payments | (6,249) | (6,985) | (1,263) | (14,497) | ||||||||||
| Balance as of December 31, 2019 | 3,165 | 559 | 156 | 3,880 | ||||||||||
| Amounts charged against product sales | 9,167 | 8,223 | 1,818 | 19,208 | ||||||||||
| Payments | (8,353) | (8,191) | (1,735) | (18,279) | ||||||||||
| Balance as of December 31, 2020 | 3,979 | 591 | 239 | 4,809 | ||||||||||
| Amounts charged against product sales | 10,195 | 9,619 | 2,065 | 21,879 | ||||||||||
| Payments | (10,027) | (9,413) | (2,074) | (21,514) | ||||||||||
| Balance as of December 31, 2021 | $ | 4,147 | $ | 797 | $ | 230 | $ | 5,174 |
For the years ended December 31, 2021, 2020 and 2019, total sales deductions were 47%, 44% and 41% of gross product sales, respectively. The increase in the total sales deductions balance as of December 31, 2021, compared with December 31, 2020, was primarily driven by the impact of higher U.S. chargeback and commercial rebate discount rates and an increase in gross sales, partially offset by timing of payments. Included in the amounts are immaterial net adjustments related to prior-year sales due to changes in estimates.
69
In the United States, we use wholesalers as the principal means of distributing our products to healthcare providers such as physicians or their clinics, dialysis centers, hospitals and pharmacies. Products we sell in Europe are distributed principally to hospitals and/or wholesalers depending on the distribution practice in each country where the products are sold. We monitor the inventory levels of our products at our wholesalers by using data from our wholesalers and other third parties, and we believe wholesaler inventories have been maintained at appropriate levels (generally two to three weeks) given end-user demand. Accordingly, historical fluctuations in wholesaler inventory levels have not significantly affected our method of estimating sales deductions and returns.
Accruals for sales deductions are based primarily on estimates of the amounts earned or to be claimed on the related sales. These estimates take into consideration current contractual and statutory requirements, specific known market events and trends, internal and external historical data and forecasted customer buying patterns. Sales deductions are substantially product specific and therefore, for any given year, can be affected by the mix of products sold.
Rebates include primarily amounts paid to payers and providers in the United States, including those paid to state Medicaid programs, and are based on contractual arrangements or statutory requirements that vary by product, by payer and by individual payer plans. As we sell products, we estimate the amount of rebate we will pay based on the product sold, contractual terms, estimated patient population, historical experience and wholesaler inventory levels; and we accrue these rebates in the period the related sales are recorded. We then adjust the rebate accruals as more information becomes available and to reflect actual claims experience. Estimating such rebates is complicated, in part because of the time delay between the date of sale and the actual settlement of the liability. We believe the methodology we use to accrue for rebates is reasonable and appropriate given current facts and circumstances, but actual results may differ.
Wholesaler chargebacks relate to our contractual agreements to sell products to healthcare providers in the United States at fixed prices that are lower than the prices we charge wholesalers. When healthcare providers purchase our products through wholesalers at these reduced prices, wholesalers charge us for the difference between their purchase prices and the contractual prices between Amgen and the healthcare providers. The provision for chargebacks is based on expected sales by our wholesaler customers to healthcare providers. Accruals for wholesaler chargebacks are less difficult to estimate than rebates are, and they closely approximate actual results because chargeback amounts are fixed at the date of purchase by the healthcare providers and because we generally settle the liability for these deductions within a few weeks.
Product returns
Returns are estimated by comparison of historical return data to their related sales on a production lot basis. Historical rates of return are determined for each product and are adjusted for known or expected changes in the marketplace specific to each product, when appropriate. In each of the past three years, sales return provisions have amounted to less than 1% of gross product sales. Changes in estimates for prior-year sales return provisions have historically been immaterial.
Income taxes
We provide for income taxes based on pretax income and applicable tax rates in the various jurisdictions in which we operate.
We recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is measured based on the largest benefit that is more likely than not to be realized. The amount of UTBs is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by tax authorities, new information obtained during a tax examination or resolution of an examination. We believe our estimates for uncertain tax positions are appropriate and sufficient for any assessments that may result from examinations of our tax returns. We recognize both accrued interest and penalties, when appropriate, related to UTBs in income tax expense.
Certain items are included in our tax return at different times than they are reflected in the financial statements, and they cause temporary differences between the tax bases of assets and liabilities and their reported amounts. Such temporary differences create deferred tax assets and liabilities. Deferred tax assets are generally items that can be used as tax deductions or credits in tax returns in future years but for which we have already recorded the tax benefit in the consolidated financial statements. We establish valuation allowances against our deferred tax assets when the amount of expected future taxable income is not likely to support the use of the deduction or credit. Deferred tax liabilities are either (i) tax expenses recognized in the consolidated financial statements for which payment has been deferred, (ii) expenses for which we have already taken a deduction on the tax return but have not yet recognized in the consolidated financial statements or (iii) liabilities for the difference between the book basis and the tax basis of the intangible assets acquired in many business combinations, because future expenses associated with these assets most often will not be tax deductible.
70
We are a vertically integrated enterprise with operations in the United States and various foreign jurisdictions. In the jurisdictions where we conduct operations, we are subject to income tax based on the tax laws and principles of such jurisdictions and on the functions, risks and activities performed therein. Our pretax income is therefore attributed to domestic or foreign sources based on the operations performed and risks assumed in each location and the tax laws and principles of the respective taxing jurisdictions. For example, we conduct significant operations in Puerto Rico, a territory of the United States that is treated as a foreign jurisdiction for U.S. tax purposes, pertaining to manufacturing, distribution and other related functions to meet our worldwide product demand. Income from our operations in Puerto Rico is subject to tax incentive grants through 2035.
In 2017, we received an RAR and a modified RAR from the IRS for the years 2010, 2011 and 2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Notices for 2010, 2011 and 2012 that we received in May and July 2021, which seek to increase our U.S. taxable income. The Notices seek to increase our U.S. taxable income by an amount that would result in additional federal tax of approximately $3.6 billion plus interest. Any additional tax that could be imposed would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings. We firmly believe that the IRS’s positions set forth in the Notices are without merit, and we are contesting the Notices through the judicial process.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013, 2014 and 2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico and that are similar to those proposed for the years 2010, 2011 and 2012. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office. We were unable to reach resolution at the administrative appeals level, and we anticipate that we will receive a statutory notice of deficiency for these years as well. We expect to contest any such notice related to 2013–15 through the judicial process. We are also currently under examination by the IRS for the years 2016, 2017 and 2018 and by a number of state and foreign tax jurisdictions.
Final resolution of these complex matters is not likely within the next 12 months. We believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our consolidated financial statements. See Part I, Item 1A. Risk Factors—The adoption and interpretation of new tax legislation or exposure to additional tax liabilities could affect our profitability; Part II, Item 7. MD&A—Income Taxes; and Part IV—Note 6, Income taxes, to the Consolidated Financial Statements for further discussion.
Our operations are subject to the tax laws, regulations and administrative practices of the United States, the U.S. territory of Puerto Rico, U.S. state jurisdictions and other countries in which we do business. Significant changes in these rules could have a material adverse effect on our results of operations. See Part I, Item 1A. Risk Factors—The adoption and interpretation of new tax legislation or exposure to additional tax liabilities could affect our profitability.
Contingencies
In the ordinary course of business, we are involved in various legal proceedings, government investigations and other matters such as intellectual property disputes, contractual disputes and class action suits that are complex in nature and have outcomes that are difficult to predict. We describe our legal proceedings and other matters that are significant or that we believe could become significant in Part IV—Note 19, Contingencies and commitments, to the Consolidated Financial Statements. We record accruals for loss contingencies to the extent that we conclude it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. We evaluate, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously.
While it is not possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows.
71
Valuation of assets and liabilities in connection with acquisitions
We have acquired and continue to acquire intangible assets in connection with business combinations and asset acquisitions. These intangible assets consist primarily of technology associated with currently marketed human therapeutic products and IPR&D product candidates. Discounted cash flow models are typically used to determine the fair values of these intangible assets for purposes of allocating consideration paid to the net assets acquired in an acquisition. See Part IV—Note 2, Acquisitions, to the Consolidated Financial Statements. These models require the use of significant estimates and assumptions, including but not limited to:
•determining the timing and expected costs to complete in-process projects, taking into account the stage of completion at the acquisition date;
•projecting the probability and timing of obtaining marketing approval from the FDA and other regulatory agencies for product candidates;
•estimating the timing of and future net cash flows from product sales resulting from completed products and in-process projects; and
•developing appropriate discount rates to calculate the present values of the cash flows.
Significant estimates and assumptions are also required to determine the business combination date fair values of any contingent consideration obligations incurred in connection with business combinations. In addition, we must revalue these obligations each subsequent reporting period until the related contingencies are resolved and record changes in their fair values in earnings. The acquisition date fair values of contingent consideration obligations incurred or assumed in the acquisitions were determined using a combination of valuation techniques. Significant estimates and assumptions required for these valuations included but were not limited to the timing and probability of achieving regulatory milestones, product sales projections under various scenarios and discount rates used to calculate the present value of the required payments. These estimates and assumptions are required to be updated in order to revalue these contingent consideration obligations each reporting period. Accordingly, subsequent changes in underlying facts and circumstances could result in changes in these estimates and assumptions, which could have a material impact on the estimated future fair values of these obligations.
We believe the fair values used to record intangible assets acquired and contingent consideration obligations incurred in connection with business combinations and asset acquisitions are based on reasonable estimates and assumptions given the facts and circumstances as of the related valuation dates.
Impairment of long-lived assets
We review the carrying value of our property, plant and equipment and our finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such circumstances exist, an estimate of undiscounted future cash flows to be generated by the long-lived asset is compared with the carrying value to determine whether an impairment exists. If an asset is determined to be impaired, the loss is measured based on the difference between the asset’s fair value and its carrying value.
Indefinite-lived intangible assets, composed of IPR&D projects acquired in a business combination that have not reached technological feasibility or that lack regulatory approval at the time of acquisition, are reviewed for impairment annually, whenever events or changes in circumstances indicate that the carrying amount may not be recoverable and upon establishment of technological feasibility or regulatory approval. We determine impairment by comparing the fair value of the asset to its carrying value. If the asset’s carrying value exceeds its fair value, an impairment charge is recorded for the difference, and its carrying value is reduced accordingly.
Estimating future cash flows of an IPR&D product candidate for purposes of an impairment analysis requires us to make significant estimates and assumptions regarding the amount and timing of costs to complete the project and the amount, timing and probability of achieving revenues from the completed product similar to how the acquisition date fair value of the project was determined, as described above. There are often major risks and uncertainties associated with IPR&D projects as we are required to obtain regulatory approvals in order to be able to market these products. Such approvals require completing clinical trials that demonstrate a product candidate is safe and effective. Consequently, the eventual realized value of the acquired IPR&D project may vary from its fair value at the date of acquisition, and IPR&D impairment charges may occur in future periods which could have a material adverse effect on our results of operations.
We believe our estimations of future cash flows used for assessing impairment of long-lived assets are based on reasonable assumptions given the facts and circumstances as of the related dates of the assessments.
72
Impairment of equity method investments
We review the carrying value of our equity method investments whenever events or changes in circumstances indicate that the carrying amount of an investment may not be recoverable. We record impairment losses on our equity method investments if we deem the impairment to be other-than-temporary. We deem an impairment to be other-than-temporary based on various factors, including but not limited to, the length of time and the extent to which the fair value is below the carrying value, volatility of the security price, the financial condition of the issuer, changes in technology that may impair the earnings potential of the investment and our intent and ability to retain the investment to allow for a recovery in fair value.
We believe our judgments used in assessing impairment of equity method investments are based on reasonable assumptions given the facts and circumstances as of the related dates of the assessments.
Recently Issued Accounting Standards
See Part IV—Note 1, Summary of significant accounting policies, to the Consolidated Financial Statements for a discussion of recently issued accounting pronouncements not yet adopted as of December 31, 2021.