LUMAKRAS® COMBINED WITH VECTIBIX® SHOWS CONFIRMED 30% OBJECTIVE RESPONSE RATE IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER

Phase 1b Results Demonstrate Encouraging Median Progression-Free Survival of 5.7 Months in Difficult-to-Treat Patient Population

Amgen (NASDAQ: AMGN) today announced updated data from its Phase 1b CodeBreaK 101 study, one of the most comprehensive global clinical development programs in patients with KRAS G12C-mutated colorectal cancer (CRC). These data show that combining LUMAKRAS ® LUMYKRAS ® (sotorasib) with Vectibix ® (panitumumab), Amgen's monoclonal anti-epidermal growth factor receptor (anti-EGFR) antibody, demonstrated encouraging efficacy and safety. Overall, the confirmed objective response rate (ORR) was 30% in patients with chemo-refractory metastatic colorectal cancer (mCRC). These data were presented today during an oral session at the European Society for Medical Oncology (ESMO) Annual Meeting in Paris, France .

"We are thrilled to see these CodeBreaK 101 results, which show that LUMAKRAS plus Vectibix achieved a 30% confirmed objective response rate in patients with KRAS G12C-mutated metastatic colorectal cancer. Treatment response rates can be as low as 2% in this patient population, and the current standard of care offers a median progression-free survival benefit of two months, so developing new treatment options is critically important for patients," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "These data are encouraging as we continue to focus on combination approaches in colorectal cancer, including advancing CodeBreaK 300, the Phase 3 LUMAKRAS plus Vectibix trial in the chemotherapy-refractory patient population."

In total, 40 patients with heavily pre-treated (median of two prior lines of therapy; range 1-7) KRAS G12C-mutated chemo-refractory mCRC were enrolled in the dose expansion cohort for the combination of LUMAKRAS and Vectibix. Disease control was seen in 37 patients for a total of 92.5% with a median progression free survival (PFS) of 5.7 months. There were no apparent differences found in the efficacy between left-sided and right-sided tumors. Tumor shrinkage of any magnitude was observed in 88% of patients, based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and the median Duration of Treatment (DoT) was 5.9 months with 25% of patients remaining on treatment at the time of data cutoff. With a median follow up of 8.8 months, median overall survival (OS) was not yet reached. Treatment-related adverse events (TRAEs) reported with the combination were consistent with known safety profiles of the individual medicines, and no TRAEs resulted in discontinuation of either drug.

"These data are positive news for patients because they demonstrate encouraging efficacy and safety for sotorasib and panitumumab, as current treatments for chemo-refractory colorectal cancer provide limited survival benefits and can have notable safety issues," said Yasutoshi Kuboki , chief, Department of Experimental Therapeutics, National Cancer Center Hospital East, Japan . "There is a significant treatment gap for patients with KRAS G12C-mutated colorectal cancer and it is imperative that we continue to explore and develop precision therapies, like sotorasib, for these patients."

KRAS is a commonly mutated oncogene in CRC, with mutations in approximately 40% of all cases, with the KRAS G12C mutation present in approximately 3-5% of colorectal cancers. These patients face a dismal prognosis and have very limited treatment options.

*LUMAKRAS is marketed as LUMYKRAS ^® (sotorasib) in the European Union, the United Kingdom and Switzerland .

About LUMAKRAS ^® /LUMYKRAS ^® (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS/LUMYKRAS, a KRAS ^G12C inhibitor. ¹ LUMAKRAS/LUMYKRAS has demonstrated a positive benefit-risk profile with rapid, deep, and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. ²

Amgen is progressing the largest and broadest global KRAS ^G12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, with clinical trial sites spanning five continents. To date, over 6,500 patients around the world have received LUMAKRAS/LUMYKRAS through the clinical development program and commercial use.

In May 2021 , LUMAKRAS was the first KRAS ^G12C inhibitor to receive regulatory approval with its approval in the U.S., under accelerated approval. LUMAKRAS/LUMYKRAS is also approved in the European Union, Japan , United Arab Emirates , South Korea , Hong Kong , Switzerland , Taiwan , Qatar , and in Australia , Brazil , Canada , Great Britain , Singapore , and Israel under the FDA's Project Orbis. Additionally, Amgen has submitted MAAs in Argentina , Colombia , Kuwait , Macao , Malaysia , Mexico , Russia , Saudi Arabia , Thailand and Turkey.

LUMAKRAS/LUMYKRAS is also being studied in multiple other solid tumors. ³

About Advanced Colorectal Cancer and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 10% of all cancer diagnoses. ⁴ It is also the third most commonly diagnosed cancer globally. ⁵

Patients with previously treated metastatic CRC need more effective treatment options. For patients in the third-line setting standard therapies yield median PFS times of about two months and patients' response rates are less than 2%. ^6,7

KRAS mutations are among the most common genetic alterations in colorectal cancers, with the KRAS G12C mutation present in approximately 3-5% of colorectal cancers. ^8,9,10

About CodeBreaK
The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to study patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. ¹¹ Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. ² The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been published. ¹²

CodeBreaK 200, the global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC completed enrollment of 345 patients. Eligible patients had previously treated, locally advanced and unresectable or metastatic KRAS G12C-mutated NSCLC. The primary endpoint is progression-free survival and key secondary endpoints include overall survival, objective response rate, and patient-reported outcomes. ¹³

Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. ¹⁴ A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201). ¹⁵

LUMAKRAS ^® (sotorasib) U.S. Indication

LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

LUMAKRAS ^® (sotorasib) Important U.S. Safety Information

Hepatotoxicity

LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
Monitor liver function tests (ALT, AST and total bilirubin) prior to the start of LUMAKRAS every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
Withhold, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.

Interstitial Lung Disease (ILD)/Pneumonitis

LUMAKRAS can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS in CodeBreaK 100, ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS was discontinued due to ILD/pneumonitis in 0.6% of patients.
Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS if no other potential causes of ILD/pneumonitis are identified.

Most Common Adverse Reactions

The most common adverse reactions occurring in ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.

Drug Interactions

Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
Inform patients to avoid proton pump inhibitors and H ₂ receptor antagonists while taking LUMAKRAS.
If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS 4 hours before or 10 hours after a locally acting antacid.

Please see LUMAKRAS full Prescribing Information .

About Vectibix ^® (panitumumab)
Vectibix is the first fully human monoclonal anti-EGFR antibody approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.

In June 2017, the FDA approved a refined indication for Vectibix for use in in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use ) mCRC.

INDICATION AND LIMITATION OF USE

Vectibix ^® is indicated for the treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): as first-line therapy in combination with FOLFOX, and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

Limitation of Use: Vectibix ^® is not indicated for the treatment of patients with RAS mutant mCRC or for whom RAS mutation status is unknown.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: DERMATOLOGIC TOXICITY

Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

In Study 20020408, dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients with mCRC receiving Vectibix ^® . The clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix ^® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix ^® . Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix ^® . It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune- related effects (e.g., Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix ^® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix ^® concerning dermatologic toxicity are provided in the product labeling.
Vectibix ^® is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as " RAS. "
Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS -mutant mCRC tumors received Vectibix ^® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis , OS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS -mutant mCRC who received Vectibix ^® and FOLFOX versus FOLFOX alone.
Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia occurred in up to 7% (in Study 20080763) of patients across clinical trials. Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix ^® treatment, periodically during Vectibix ^® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC grade 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix ^® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix ^® in combination with chemotherapy.
Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix ^® . Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix ^® . In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix ^® therapy. Discontinue Vectibix ^® therapy if ILD is confirmed.
In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix ^® versus the risk of pulmonary complications must be carefully considered.
Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix ^® .
Keratitis and ulcerative keratitis, known risk factors for corneal perforation, have been reported with Vectibix ^® use. Monitor for evidence of keratitis or ulcerative keratitis. Interrupt or discontinue Vectibix ^® for acute or worsening keratitis.
In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix ^® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC grade 3-4 adverse reactions occurring at a higher rate in Vectibix ^® -treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs
NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate in Vectibix ^® -treated patients (7% vs 3%) and included fatal events in three ( ® -treated patients. As a result of the toxicities experienced, patients randomized to Vectibix ^® , bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
Vectibix ^® can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix ^® .
In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix ^® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
The most commonly reported adverse reactions (≥ 20%) with Vectibix ^® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. The most common serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.

To see the Vectibix ^® Prescribing Information, including Boxed Warning visit www.vectibix.com .

About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.

For more information, follow us on www.twitter.com/amgenoncology .

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

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

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's .

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen .

Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., 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, the Teneobio, Inc. acquisition, or the recently announced proposed acquisition of ChemoCentryx, Inc., 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, 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. 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, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human 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 authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through 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 products, 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 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. 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. 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. 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. 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.

The scientific information discussed in this news release 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 news release 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 news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT: Amgen, Thousand Oaks
Megan Fox , 805-447-1423 (media)
Jessica Akopyan , 805-440-5721 (media)
Arvind Sood , 805-447-1060 (investors)

LUMAKRAS, LUMYKRAS, and Vectibix are trademarks of Amgen Inc.

¹ Canon J, et al. Nature . 2019;575: 217–223.
² Skoulidis F, et al. N Engl J Med . 2021;384:2371-2381.
³ Hong DS, et al. N Engl J Med . 2020;383:1207-1217.
⁴ Rawla, P., Sunkara, T., & Barsouk, A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Gastroenterology Review . 2019;14(2):89-103.
⁵ World Health Organization. 2020 Statistics. Available at: https://www.who.int/en/news-room/fact-sheets/detail/cancer . Accessed on August 26, 2021 .
⁶ Mayer RJ, Van Cutsem E, Falcone A, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med . 2015;372(20):1909-1919. doi:10.1056/NEJMoa1414325.
⁷ Grothey A, Van Cutsem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet . 2013;381(9863):303-312. doi:10.1016/S0140-6736(12)61900-X.
⁸ Neumann J, Zeindl-Eberhart E, Kirchner T, Jung A. Frequency and type of KRAS mutations in routine diagnostic analysis of metastatic colorectal cancer. Pathol Res Pract . 2009;205(12):858-862. doi:10.1016/j.prp.2009.07.010.
⁹ Jones RP, Sutton PA, Evans JP, et al. Specific mutations in KRAS codon 12 are associated with worse overall survival in patients with advanced and recurrent colorectal cancer. Br J Cancer . 2017;116(7):923-929. doi:10.1038/bjc.2017.37.
¹⁰ Wiesweg M, Kasper S, Worm K, et al. Impact of RAS mutation subtype on clinical outcome-a cross-entity comparison of patients with advanced non-small cell lung cancer and colorectal cancer. Oncogene . 2019;38(16):2953-2966. doi:10.1038/s41388-018-0634-0.
¹¹ ClinicalTrials.gov. CodeBreaK 100. Available at: https://clinicaltrials.gov/ct2/show/NCT03600883 . Accessed on April 14, 2022 .
¹² Fakih MG, et al. Lancet Oncol . 2022;23:115-124.
¹³ ClinicalTrials.gov. CodebreaK 200. Available at: https://clinicaltrials.gov/ct2/show/NCT04303780 . Accessed on April 14, 2022 .
¹⁴ ClinicalTrials.gov. CodeBreaK 101. Available at: https://clinicaltrials.gov/ct2/show/NCT04185883 . Accessed on April 14, 2022 .
¹⁵ ClinicalTrials.gov. CodeBreaK 201. Available at: https://clinicaltrials.gov/ct2/show/NCT04933695 . Accessed on April 14, 2022 .

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AMGEN ANNOUNCES 2024 FOURTH QUARTER DIVIDEND

Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.25 per share dividend for the fourth quarter of 2024. The dividend will be paid on December 9, 2024 to all stockholders of record as of the close of business on November 18, 2024 .

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

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$Millions, except percentages	Q3 '24			Q3 '23	YOY Δ
	U.S.	ROW	TOTAL	TOTAL	TOTAL
Repatha ^®	$ 281	$ 286	$ 567	$ 406	40 %
EVENITY ^®	289	110	399	307	30 %
Prolia ^®	683	362	1,045	986	6 %
BLINCYTO ^®	237	90	327	220	49 %
Vectibix ^®	132	150	282	252	12 %
KYPROLIS ^®	238	140	378	349	8 %
LUMAKRAS ^® /LUMYKRAS ^™	53	45	98	52	88 %
XGEVA ^®	373	168	541	519	4 %
Nplate ^®	345	111	456	419	9 %
IMDELLTRA ^™	36	—	36	—	N/A
MVASI ^®	136	59	195	213	(8 %)
TEZSPIRE ^®	269	—	269	161	67 %
Otezla ^®	460	104	564	567	(1 %)
Enbrel ^®	817	8	825	1,035	(20 %)
AMJEVITA ^® /AMGEVITA ^™	28	138	166	152	9 %
TEPEZZA ^®(1)	482	6	488	—	N/A
KRYSTEXXA ^®(1)	310	—	310	—	N/A
UPLIZNA ^®(1)	74	32	106	—	N/A
TAVNEOS ^®	74	6	80	37	*
Ultra-Rare products ⁽¹⁾	180	8	188	—	N/A
EPOGEN ^®	33	—	33	50	(34 %)
Aranesp ^®	105	232	337	323	4 %
Parsabiv ^®	32	38	70	95	(26 %)
Neulasta ^®	84	26	110	124	(11 %)
Other products ⁽²⁾	228	53	281	281	— %
Total product sales	$ 5,979	$ 2,172	$ 8,151	$ 6,548	24 %

N/A = not applicable
*Change in excess of 100%
⁽¹⁾ Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ^® , PROCYSBI ^® , ACTIMMUNE ^® , QUINSAIR ^® and BUPHENYL ^®
⁽²⁾ Consists of (i) Aimovig ^® , RIABNI ^® , KANJINTI ^® , AVSOLA ^® , NEUPOGEN ^® , IMLYGIC ^® , BEKEMV ^™ , Corlanor ^® , WEZLANA ^™ /WEZENLA ^™ and Sensipar ^® /Mimpara ^™ , where Biosimilars total $148 million in Q3 '24 and $104 million in Q3 '23; and (ii) Horizon-acquired products including RAYOS ^® and PENNSAID ^®

$Millions, except percentages	GAAP			Non-GAAP
	Q3 '24	Q3 '23	YOY Δ	Q3 '24	Q3 '23	YOY Δ
Cost of Sales	$ 3,310	$ 1,806	83 %	$ 1,454	$ 1,137	28 %
% of product sales	40.6 %	27.6 %	13.0 pts	17.8 %	17.4 %	0.4 pts
Research & Development	$ 1,450	$ 1,079	34 %	$ 1,440	$ 1,070	35 %
% of product sales	17.8 %	16.5 %	1.3 pts	17.7 %	16.3 %	1.4 pts
Selling, General & Administrative	$ 1,625	$ 1,353	20 %	$ 1,565	$ 1,293	21 %
% of product sales	19.9 %	20.7 %	(0.8) pts	19.2 %	19.7 %	(0.5) pts
Other	$ 71	$ 644	(89 %)	$ —	$ —	N/A
Total Operating Expenses	$ 6,456	$ 4,882	32 %	$ 4,459	$ 3,500	27 %

Operating Margin
operating income as % of product sales	25.1 %	30.9 %	(5.8) pts	49.6 %	52.0 %	(2.4) pts

Tax Rate	8.7 %	11.1 %	(2.4) pts	13.4 %	16.1 %	(2.7) pts

pts: percentage points
N/A = not applicable

$Billions, except shares	Q3 '24	Q3 '23	YOYΔ
Operating Cash Flow	$ 3.6	$ 2.8	$ 0.8
Capital Expenditures	$ 0.3	$ 0.2	$ 0.0
Free Cash Flow	$ 3.3	$ 2.5	$ 0.8
Dividends Paid	$ 1.2	$ 1.1	$ 0.1
Share Repurchases	$ 0.0	$ —	$ 0.0
Average Diluted Shares (millions)	542	538	4

Note: Numbers may not add due to rounding

$Billions	9/30/24	12/31/23	YTD Δ
Cash and Investments	$ 9.0	$ 10.9	$ (1.9)
Debt Outstanding	$ 60.4	$ 64.6	$ (4.2)

Note: Numbers may not add due to rounding

Amgen Inc.
Consolidated Statements of Income - GAAP
(In millions, except per-share data)
(Unaudited)
	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Revenues:
Product sales	$ 8,151	$ 6,548	$ 23,310	$ 19,077
Other revenues	352	355	1,028	917
Total revenues	8,503	6,903	24,338	19,994

Operating expenses:
Cost of sales	3,310	1,806	9,746	5,339
Research and development	1,450	1,079	4,240	3,250
Selling, general and administrative	1,625	1,353	5,218	3,905
Other	71	644	187	874
Total operating expenses	6,456	4,882	19,391	13,368

Operating income	2,047	2,021	4,947	6,626

Other income (expense):
Interest expense, net	(776)	(759)	(2,408)	(2,054)
Other income, net	1,830	685	1,288	2,431

Income before income taxes	3,101	1,947	3,827	7,003

Provision for income taxes	271	217	364	1,053

Net income	$ 2,830	$ 1,730	$ 3,463	$ 5,950

Earnings per share:
Basic	$ 5.27	$ 3.23	$ 6.45	$ 11.12
Diluted	$ 5.22	$ 3.22	$ 6.40	$ 11.06

Weighted-average shares used in calculation of earnings per share:
Basic	537	535	537	535
Diluted	542	538	541	538

Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)
	September 30,	December 31,
	2024	2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$ 9,011	$ 10,944
Trade receivables, net	7,317	7,268
Inventories	7,362	9,518
Other current assets	3,076	2,602
Total current assets	26,766	30,332

Property, plant and equipment, net	6,156	5,941
Intangible assets, net	28,920	32,641
Goodwill	18,658	18,629
Other noncurrent assets	10,383	9,611
Total assets	$ 90,883	$ 97,154

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities	$ 16,768	$ 16,949
Current portion of long-term debt	3,544	1,443
Total current liabilities	20,312	18,392

Long-term debt	56,854	63,170
Long-term deferred tax liabilities	1,711	2,354
Long-term tax liabilities	2,280	4,680
Other noncurrent liabilities	2,199	2,326
Total stockholders' equity	7,527	6,232
Total liabilities and stockholders' equity	$ 90,883	$ 97,154

Shares outstanding	538	535

Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars in millions)
(Unaudited)
	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
GAAP cost of sales	$ 3,310	$ 1,806	$ 9,746	$ 5,339
Adjustments to cost of sales:
Acquisition-related expenses (a)	(1,856)	(668)	(5,546)	(2,008)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	(1)	—	(36)
Total adjustments to cost of sales	(1,856)	(669)	(5,546)	(2,044)
Non-GAAP cost of sales	$ 1,454	$ 1,137	$ 4,200	$ 3,295

GAAP cost of sales as a percentage of product sales	40.6 %	27.6 %	41.8 %	28.0 %
Acquisition-related expenses (a)	(22.8)	(10.2)	(23.8)	(10.5)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	0.0	0.0	(0.2)
Non-GAAP cost of sales as a percentage of product sales	17.8 %	17.4 %	18.0 %	17.3 %

GAAP research and development expenses	$ 1,450	$ 1,079	$ 4,240	$ 3,250
Adjustments to research and development expenses:
Acquisition-related expenses (b)	(10)	(9)	(60)	(27)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	—	—	(17)
Total adjustments to research and development expenses	(10)	(9)	(60)	(44)
Non-GAAP research and development expenses	$ 1,440	$ 1,070	$ 4,180	$ 3,206

GAAP research and development expenses as a percentage of product sales	17.8 %	16.5 %	18.2 %	17.0 %
Acquisition-related expenses (b)	(0.1)	(0.2)	(0.3)	(0.1)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	0.0	0.0	(0.1)
Non-GAAP research and development expenses as a percentage of product sales	17.7 %	16.3 %	17.9 %	16.8 %

GAAP selling, general and administrative expenses	$ 1,625	$ 1,353	$ 5,218	$ 3,905
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (c)	(60)	(47)	(255)	(138)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	(13)	—	(13)
Total adjustments to selling, general and administrative expenses	(60)	(60)	(255)	(151)
Non-GAAP selling, general and administrative expenses	$ 1,565	$ 1,293	$ 4,963	$ 3,754

GAAP selling, general and administrative expenses as a percentage of product sales	19.9 %	20.7 %	22.4 %	20.5 %
Acquisition-related expenses (c)	(0.7)	(0.8)	(1.1)	(0.7)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	(0.2)	0.0	(0.1)
Non-GAAP selling, general and administrative expenses as a percentage of product sales	19.2 %	19.7 %	21.3 %	19.7 %

GAAP operating expenses	$ 6,456	$ 4,882	$ 19,391	$ 13,368
Adjustments to operating expenses:
Adjustments to cost of sales	(1,856)	(669)	(5,546)	(2,044)
Adjustments to research and development expenses	(10)	(9)	(60)	(44)
Adjustments to selling, general and administrative expenses	(60)	(60)	(255)	(151)
Certain net charges pursuant to our restructuring and cost-savings initiatives (d)	—	(16)	4	(183)
Certain other expenses (e)	(71)	(628)	(191)	(691)
Total adjustments to operating expenses	(1,997)	(1,382)	(6,048)	(3,113)
Non-GAAP operating expenses	$ 4,459	$ 3,500	$ 13,343	$ 10,255



	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
GAAP operating income	$ 2,047	$ 2,021	$ 4,947	$ 6,626
Adjustments to operating expenses	1,997	1,382	6,048	3,113
Non-GAAP operating income	$ 4,044	$ 3,403	$ 10,995	$ 9,739

GAAP operating income as a percentage of product sales	25.1 %	30.9 %	21.2 %	34.7 %
Adjustments to cost of sales	22.8	10.2	23.8	10.7
Adjustments to research and development expenses	0.1	0.2	0.3	0.2
Adjustments to selling, general and administrative expenses	0.7	1.0	1.1	0.8
Certain net charges pursuant to our restructuring and cost-savings initiatives (d)	0.0	0.2	0.0	1.0
Certain other expenses (e)	0.9	9.5	0.8	3.7
Non-GAAP operating income as a percentage of product sales	49.6 %	52.0 %	47.2 %	51.1 %

GAAP interest expense, net	$ (776)	$ (759)	$ (2,408)	$ (2,054)
Adjustments to interest expense, net:
Interest expense on acquisition-related debt (f)	—	332	—	788
Non-GAAP interest expense, net	$ (776)	$ (427)	$ (2,408)	$ (1,266)

GAAP other income, net	$ 1,830	$ 685	$ 1,288	$ 2,431
Adjustments to other income, net
Interest income and other expenses on acquisition-related debt (f)	—	(313)	—	(607)
Net gains from equity investments (g)	(1,608)	(170)	(693)	(1,305)
Total adjustments to other income, net	(1,608)	(483)	(693)	(1,912)
Non-GAAP other income, net	$ 222	$ 202	$ 595	$ 519

GAAP income before income taxes	$ 3,101	$ 1,947	$ 3,827	$ 7,003
Adjustments to income before income taxes:
Adjustments to operating expenses	1,997	1,382	6,048	3,113
Adjustments to interest expense, net	—	332	—	788
Adjustments to other income, net	(1,608)	(483)	(693)	(1,912)
Total adjustments to income before income taxes	389	1,231	5,355	1,989
Non-GAAP income before income taxes	$ 3,490	$ 3,178	$ 9,182	$ 8,992

GAAP provision for income taxes	$ 271	$ 217	$ 364	$ 1,053
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	228	271	1,007	442
Other income tax adjustments (i)	(33)	23	(44)	6
Total adjustments to provision for income taxes	195	294	963	448
Non-GAAP provision for income taxes	$ 466	$ 511	$ 1,327	$ 1,501

GAAP tax as a percentage of income before taxes	8.7 %	11.1 %	9.5 %	15.0 %
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	5.6	4.2	5.4	1.6
Other income tax adjustments (i)	(0.9)	0.8	(0.4)	0.1
Total adjustments to provision for income taxes	4.7	5.0	5.0	1.7
Non-GAAP tax as a percentage of income before taxes	13.4 %	16.1 %	14.5 %	16.7 %

GAAP net income	$ 2,830	$ 1,730	$ 3,463	$ 5,950
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect	161	960	4,348	1,547
Other income tax adjustments (i)	33	(23)	44	(6)
Total adjustments to net income	194	937	4,392	1,541
Non-GAAP net income	$ 3,024	$ 2,667	$ 7,855	$ 7,491

Note: Numbers may not add due to rounding

(a)		The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions.

(b)		For the three months ended September 30, 2024, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions. For the nine months ended September 30, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three and nine months ended September 30, 2023, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions.

(c)		For the three and nine months ended September 30, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition.

(d)		For the three and nine months ended September 30, 2023, the adjustments related primarily to separation costs associated with our restructuring plan initiated in early 2023.

(e)		For the three and nine months ended September 30, 2024, the adjustments related primarily to impairment charges for in-process R&D assets and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. For the three and nine months ended September 30, 2023, the adjustments related primarily to a net impairment charge for AMG 340.

(f)		For the three and nine months ended September 30, 2023, the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our acquisition of Horizon.

(g)		For the three and nine months ended September 30, 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. For the three and nine months ended September 30, 2023, the adjustments related primarily to our Neumora Therapeutics, Inc. and BeiGene equity fair value adjustments, respectively.

(h)		The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and nine months ended September 30, 2024, was 58.6% and 18.8%, respectively, compared to 22.0% and 22.2% for the corresponding periods of the prior year.

(i)		The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings.

Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)

	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 3,571	$ 2,760	$ 6,719	$ 7,933
Net cash (used in) provided by investing activities	(210)	(262)	(644)	885
Net cash (used in) provided by financing activities	(3,651)	(2,005)	(8,008)	18,294
(Decrease) increase in cash and cash equivalents	(290)	493	(1,933)	27,112
Cash and cash equivalents at beginning of period	9,301	34,248	10,944	7,629
Cash and cash equivalents at end of period	$ 9,011	$ 34,741	$ 9,011	$ 34,741


	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 3,571	$ 2,760	$ 6,719	$ 7,933
Capital expenditures	(257)	(248)	(725)	(863)
Free cash flow	$ 3,314	$ 2,512	$ 5,994	$ 7,070

Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP diluted EPS guidance	$ 8.71	—	$ 9.56
*Known adjustments to arrive at non-GAAP:**
Acquisition-related expenses (a)	11.33	—	11.38
Net gains from equity investments		(1.01)
Other		0.12
Non-GAAP diluted EPS guidance	$ 19.20	—	$ 20.00

Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP tax rate guidance	9.0 %	—	10.5 %
Tax rate of known adjustments discussed above	4.5 %	—	5.0 %
Non-GAAP tax rate guidance	14.0 %	—	15.0 %

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