AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2021 versus comparable periods in 2020. Key results...

THOUSAND OAKS, Calif. , Feb. 7, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced financial results for the fourth quarter and full year 2021 versus comparable periods in 2020. Key results include:

"We realized strong volume growth for many of our key products during last year," said Robert A. Bradway , chairman and chief executive officer. "These products, combined with our many pipeline opportunities, position us well for long-term growth."

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. For comparability of results to the prior year, non-GAAP net income and non-GAAP EPS amounts for 2020 have been revised to reflect the update to our non-GAAP policy that excludes gains and losses on certain equity investments. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

Total product sales decreased 1% for the fourth quarter of 2021 versus the fourth quarter of 2020. Unit volumes grew 7% but were more than offset by lower net selling price and lower inventory levels. Product sales for the full year were flat versus 2020 with 7% growth in unit volumes offset by a 7% decline in net selling price. Full-year product sales in the U.S. declined 4%, with unit volumes increasing by 3% and net selling price declining by 6%. Full-year product sales outside the U.S. grew 12%, including 36% sales growth in the Asia-Pacific region.

During 2021 there has been a gradual recovery from the COVID-19 pandemic, with patient visits and diagnosis rates approaching pre-pandemic levels by early in the fourth quarter. Late in the year, the Omicron variant began to impact the healthcare sector. As a result, we have seen some shift back to virtual engagement by our field staff, delayed healthcare procedures, and variability in demand patterns.

General Medicine

Hematology-Oncology

Established Products

Product Sales Detail by Product and Geographic Region

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

On a non-GAAP basis:

Cash Flow and Balance Sheet

Fourth Quarter Product and Pipeline Update

The Company provided the following updates on selected transactions, product and pipeline programs:

Recent business development transactions further strengthen Amgen's Research capabilities

LUMAKRAS/LUMYKRAS

Tarlatamab (AMG 757)

Acapatamab (AMG 160)

AMG 340 (formerly TNB-585)

Pavurutamab (AMG 701)

TEZSPIRE ™ (tezepelumab)

AMG 451 / KHK4083

Efavaleukin alfa (AMG 592) 1

Rozibafusp alfa (AMG 570)

Ordesekimab (AMG 714 / PRV-015)

AMG 104 / AZD8630

Olpasiran (AMG 890)

Amgenpipeline.com

Amgen Business Review

On Tuesday, Feb. 8, 2022 , Amgen will host a virtual Business Review to share its growth strategy through 2030 and beyond. Members of Amgen's senior leadership team will discuss plans to grow the many innovative medicines and biosimilars in the Company's currently marketed portfolio; to advance numerous potential new medicines through its pipeline; and to capitalize on advances in science and technology to build a set of differentiated discovery research capabilities. Additionally, the Company will provide financial guidance for 2022 and longer-term financial guidance through the end of the decade.

Financial analysts, investors, members of the news media and the general public may access the business review and other webcasts and presentations regarding developments in Amgen's business given at investor and medical conferences via www.amgen.com under the Investors tab. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

At the conclusion of the meeting, Amgen will issue a press release reviewing the content of the meeting that provided a comprehensive overview of the Company's strategy, commercial operations, pipeline, research and development capabilities.

TEZSPIRE and AMG 104 / AZD8630 are being developed in collaboration with AstraZeneca AMG 451 (also known as KHK4083) is being developed in collaboration with Kyowa Kirin AMG 714 (also known as PRV-015) is being developed in collaboration with Provention Bio AMG 509 is being developed in collaboration with Xencor DARZALEX FASPRO ® and STELARA ® are registered trademarks of Janssen Pharmaceutica NV EYLEA ® is a registered trademark of Regeneron Pharmaceuticals, Inc. SOLIRIS ® is a registered trademark of Alexion Pharmaceuticals, Inc. 1 A phase 1b study of AMG 592 for chronic graft vs. host disease has stopped enrollment and will be discontinued.

Non-GAAP Financial Measures In this news release, management has presented its operating results for the fourth quarters and full years of 2021 and 2020, in accordance with U.S. Generally Accepted Accounting Principles (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 fourth quarters and full years of 2021 and 2020. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity.

Beginning January 1, 2021 , we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that are recorded to Other income (expense). This exclusion will not apply to our share of the earnings and losses of our strategic investments in corporations accounted for under the equity method of accounting, such as our investment in BeiGene. The Company will be excluding gains and losses from equity investments for the purpose of calculating the non-GAAP financial measures presented because the Company believes the results of such gains and losses are not representative of our normal business operations. We are making this change beginning in 2021 because, as we have increased our investments in these companies, we recognized that the resulting variability can impede comparability between periods of our financial performance for our ongoing business operations. For comparability of results to the prior year, non-GAAP net income and non-GAAP EPS amounts for 2020 have been revised to reflect the update to our non-GAAP policy that excludes gains and losses on certain equity investments.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., 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 Oaks Megan Fox , 805-447-1423 (media) Arvind Sood , 805-447-1060 (investors)