Amgen : Hematology/Oncology Update ESMO Presentation

Hematology/Oncology Update ESMO 2023

October 24, 2023

SAFE HARBOR STATEMENT

This presentation 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 (inc luding BeiGene, Ltd. or Kyowa-Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, o perating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or cli nical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or othe r widespread health problems 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 Secur ities 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 presentation 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. Discovery or iden tification 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, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the hu man body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authori ties may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and t hrough licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our prod ucts, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internation ally, 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 econom ic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursem ent 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 exten sive regulation by domestic and foreign government regulatory authorities. 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 pate nts 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 litigat ion. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Ric o, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certa in of our current products and product candidate development. An outbreak of disease or similar public health threat, such as CO VID- 19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse e ffect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of ou r 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 co mpete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. 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 co uld have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts t o collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to suppo rt the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, sy nergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and suc h acquisition or integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or informa tion security breach of our information technology systems could compromise the confidentiality, integrity and availability of o ur systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Globa l economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the abi lity of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not b e able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this presentation related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this presen tation relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this presentation, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved

AGENDA

David Reese, MD

Exec. VP, Research & Development, Amgen

Introduction ● BLINCYTO® ● Concluding Remarks

Taofeek Owinikoko, MD, PhD

Div. of Hematology-Oncology, UPMC Hillman Cancer Ctr.

Tarlatamab

William K. Kelly, DO

Ch. of the Dept. of Medical Oncology,

Sidney Kimmel Medical Coll., 2

Xaluritamig

Jean-Charles Soria, MD

Sr. VP, Global Development Oncology, Amgen

AMG 193 ● LUMAKRAS® ● Bemarituzumab

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved

ONCOLOGY EFFORTS FOCUSED ON HIGH CONVICTION TARGETS, DIFFERENTIATED THERAPIES AND LARGE EFFECT SIZE

IMMUNO-ONCOLOGY		PRECISION ONCOLOGY
T-Cell Engagers	Novel IO		Cell	Antibody-Drug
	Intrinsic Targets	Conjugates

Inflame: T-cell		Enhance: Next		Debulk:		Debulk: Combines the
mediated killing		generation		Cell-intrinsic		specificity of mAb with
to eradicate tumors		bi-functionals		therapeutics		potency of payloads

Combinations required for durable responses in most settings

BiTE® = bispecific T-cell engager; CD3 = cluster of differentiation 3; IO = immuno-oncology; mAb = monoclonal antibody.

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved

AMGEN'S ONCOLOGY PORTFOLIO IS POISED TO POTENTIALLY ALTER THE NATURAL HISTORY OF DISEASE ACROSS MULTIPLE CANCERS

Broad portfolio anchored in first-in-class and best-in-class medicines

• Bispecific T-cell engagers with promising efficacy results in both hematologic malignancies and solid tumors

1. Goal is to target the bispecific "sweet spot" of enhanced efficacy and reduced toxicity in early-stage disease with lower tumor burden

• 1. BLINCYTO® (Approved in B-ALL), tarlatamab (P3 in SCLC), xaluritamig (P1/2 in mCRPC)
• Precision oncology molecules with potential to treat multiple solid tumors
• 1. Goal is to address novel targets in tough-to-treat cancers

1. AMG 193 (P1/2 in solid tumors), LUMAKRAS® (approved in NSCLC, P3 in NSCLC and P3 in CRC), bemarituzumab (P3 in gastric)

B-ALL=B-cell precursor acute lymphoblastic leukemia; P3 = Phase 3; SCLC = small cell lung cancer; P1/2 = Phase 1/2; mCRPC = metastatic castrate-resistant prostate cancer; NSCLC = non-small cell lung cancer; CRC = colorectal cancer

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved

BLINCYTO®

B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA REMAINS AN AREA OF HIGH UNMET NEED

Disease	Relapsed/Refractory	Adult Minimal Residual	First-Line Adult B-ALL	First-Line Ph- Adult B-ALL
Progression	Disease Positive	Consolidation (30+)	(55+) Chemo-sparing
Adults	Peds
				Ph-	Ph+
U.S. Drug-					~400
Treated	~1,600	~850	~600	~1,400	~1,000
Population

BLINCYTO®	FDA-	FDA-	FDA-Approved1	E1910 Phase 3 study	Golden Gate Phase 3
Status	Approved1	Approved1	complete, (FDA filing)	study (enrolling)

1 BLINCYTO® USPI

B-ALL = B-cell precursor acute lymphoblastic leukemia; Ph- = Philadelphia chromosome negative; Ph+ = Philadelphia chromosome positive; FDA = U.S. Food and Drug Administration. Epi source: CfOR Epi forecast model 2022 | Overlap exist in first-line adult patient populations.

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved

BLINCYTO® COMBINED WITH CHEMOTHERAPY DEMONSTRATED AN OVERALL SURVIVAL ADVANTAGE IN FIRST-LINEB-ALL CONSOLIDATION IN THE PHASE 3 ECOG-ACRIN & NCI E1910 TRIAL

Overall Survival Comparison:	Overall Survival Comparison:
MRD negative patients	MRD positive patients

B-ALL=B-cell precursor acute lymphoblastic leukemia; ECOG-ACRIN = Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network; NCI =National Cancer Institute; MRD = minimal residual disease; OS = overall survival; Blin = BLINCYTO®; CNSR = censor.

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved

BLINCYTO® DEMONSTRATED PROMISING OVERALL SURVIVAL BENEFIT ACROSS MULTIPLE SUBGROUPS IN FIRST-LINEB-ALL

Adults	Pediatrics	Infants
Interfant BLINCYTO®	Study vs.
ECOG-ACRIN, NCI E1910 Study1	Amgen 20120215 Study2
Interfant-06 Historical Control3

T	A	T	D	CNSR M
C				.

Greater benefit in settings of lower disease burden with potential for improved tolerability

B-ALL=B-cell precursor acute lymphoblastic leukemia; ECOG-ACRIN = Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network; NCI =National Cancer Institute; CNSR = censor.

1. Litzow MR, et al. Oral presented at: American Society of Hematology Annual Meeting; December 10-13, 2022; New Orleans, LA. 2. Locatelli F, et al. Poster presented at: European Hematology Association Congress; June 9-12, 2022; Vienna, Austria. 3. Van der Sluis IM, et al. N Engl J Med. 2023 Apr 27;388(17):1572-1581.

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved

LONG-TERM ASPIRATION IS TO EXPAND BLINCYTO® ACROSS ALL SUBSETS OF B-ALL AND TO UTILIZE SUB-Q DELIVERY WHERE POSSIBLE

TODAY		NEAR-TERM		FUTURE
Relapsed/		1L B-ALL	Chemo-Sparing	Convert
MRD+ B-ALL	Consolidation
Refractory B-ALL	1L B-ALL (55+)	cIV to Sub-Q
	(30+)

2014	2018	2023-2024
First approval; now	FDA accelerated	1L consolidation E1910
approved in 67 countries	approval in MRD	(FDA filing)
	2023
	FDA full approval in MRD

Golden Gate Phase 3 Study

Redefine SOC in 1L induction, consolidation and maintenance

(enrolling)

Utilize Sub-Q approach whenever possible

B-ALL=B-cell precursor acute lymphoblastic leukemia; Sub-Q = subcutaneous; MRD = minimal residual disease; 1L = first-line; cIV = continuous intravenous infusion; FDA = U.S. Food and Drug Administration; SOC = standard of care.

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Provided October 24, 2023, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update. © 2023 Amgen Inc. All Rights Reserved