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Last update 25 Apr 2025

Filgrastim (Amgen)

Last update 25 Apr 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Colony-stimulating factors

Synonyms

Filgrastim (Genetical Recombination), Human Granulocyte Colony-stimulating Factor, r-metHuG-CSF

+ [11]

Target

CSF-3R

Action

agonists

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [3]

Active Indication

NeuroblastomaFebrile NeutropeniaHIV Infections+ [3]

Inactive Indication

Acquired Immunodeficiency SyndromeAdvanced breast cancerAdvanced Lung Non-Small Cell Carcinoma+ [9]

Originator Organization

Amgen, Inc.

Active Organization

Amgen, Inc.

Kyowa Kirin Co., Ltd.

Pfizer Australia Pty Ltd.

+ [1]

Inactive Organization

GSK Plc

Pfizer Inc.

Bristol Myers Squibb Co.

Drug Highest PhaseApproved

First Approval Date

United States (20 Feb 1991),

Acute Myeloid LeukemiaBone marrow depressionNeutropenia

RegulationOrphan Drug (United States)

Structure/Sequence

Sequence Code 4190

Source: *****

978

Clinical Trials associated with Filgrastim (Amgen)

NCT06928662

/ Not yet recruitingPhase 1/2IIT

Sequential Decitabine in Combination With FLAG-Ida Followed Immediately by Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation (DEC-FLAG-Ida/RIC) for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1/2 Study

This phase I/II trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.

Start Date01 Sep 2025

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

NCT06738368

/ Not yet recruitingPhase 2IIT

Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma/Leukemia

This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Washington

[+1]

NCT06942039

/ Not yet recruitingEarly Phase 1

A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.

Start Date01 Jun 2025

Sponsor / Collaborator

C17 Council

100 Clinical Results associated with Filgrastim (Amgen)

100 Translational Medicine associated with Filgrastim (Amgen)

100 Patents (Medical) associated with Filgrastim (Amgen)

3,694

Literatures (Medical) associated with Filgrastim (Amgen)

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

A large cohort from an immunology reference center and an algorithm for the follow-up of chronic neutropenia

Article

Author: Ergenoğlu, Damla Nur ; Cagdas, Deniz ; Çiçek, Begüm ; Sinanoğlu, Nidanur ; Bildik, Hacer Neslihan ; Esenboga, Saliha ; Caka, Canan ; Tezcan, Ilhan ; Maslak, Ibrahim Cemal

Chronic neutropenia causes involve nutritional deficiencies and inborn errors of immunity(IEI), such as severe congenital neutropenia. To classify common chronic neutropenia causes in a pediatric immunology unit. We enrolled 109 chronic neutropenia patients admitted to a pediatric immunology department between 2002-2022. We recorded clinical/laboratory features and genetic characteristics. The male/female ratio was 63/46. Fifty-eight patients had parental consanguinity(57.4%). 26.6% (n = 29) patients had at least one individual in their family with neutropenia. Common symtpoms at presentation were upper respiratory tract infections(URTI)(31.1%), oral aphthae(23.6%), skin infections(23.6%), pneumonia(20.8%), and recurrent abscesses(12.3%). Common infections during follow-up were URTI(56.8%), pneumonia(33%), skin infections(25.6%), gastroenteritis(18.3%), and recurrent abscesses(14,6%). Common long-term complications were dental problems(n = 51), osteoporosis(n = 22), growth retardation(n = 14), malignancy(n = 16)[myelodysplastic syndrome(n = 10), large granulocytic leukemia(n = 1), acute lymphoblastic leukemia(n = 1), Hodgkin lymphoma(n = 1), EBV-related lymphoma(n = 1), leiomyosarcoma(n = 1), and thyroid neoplasm(n = 1)]. We performed a genetic study in 86 patients, and 69(71%) got a genetic diagnosis. Common gene defects were HAX-1(n = 26), ELA-2 (ELANE)(n = 10), AP3B1(n = 4), and ADA-2(n = 4) gene defects. The IEI ratio(70.6%) was high. GCSF treatment(93.4%), immunoglobulin replacement therapy(18.7%), and HSCT(15.9%) were the treatment options. The mortality rate was 12.9%(n = 14). The most common long term complications were dental problems that is three times more common in patients with known genetic mutations. We prepared an algorithm for chronic neutropenia depending on the present cohort. An important rate of inborn errors of immunity, especially combined immunodeficiency(11.9%) was presented in addition to congenital phagocytic cell defects. Early diagnosis will allow us tailor the disease-specific treatment options sooner, preventing irreversible consequences.

01 Aug 2025·Current Drug Safety

Treatment of Tislelizumab-Induced Toxic Epidermal Necrolysis and Agranulocytosis: A Case Report and Literature Review

Article

Author: Xu, Xiangqian ; Xue, Honghao ; Lu, Chenghua ; Guo, Xiaoyan ; Zhang, Yemin ; Zhou, Yanshi ; Zhang, Jun ; Wu, Qingyuan ; Xie, Shiyun

Background::

Non-small Cell Lung Cancer (NSCLC) makes up about 85% of lung cancer cases, mainly adenocarcinoma and squamous cell carcinoma. Recently, PD-1 inhibitors have become crucial in NSCLC treatment, significantly enhancing survival for some. However, side effects, like skin reactions and hematotoxicity, limit their use, with drug-induced TEN and immunotherapy-induced agranulocytosis as severe adverse effects.

Case Presentation::

Herein, we have reported the case of a 75-year-old male diagnosed with metastatic Lung Squamous cell Carcinoma (LUSC) in the left lung. He received first-line treatment with one cycle of tislelizumab in combination with nab-paclitaxel and carboplatin, after which he developed Toxic Epidermal Necrolysis (TEN) and granulocytopenia. To address these two serious immune-related Adverse Events (irAEs), the patient was administered methylprednisolone in combination with gamma globulin for TEN and dexamethasone in combination with G-CSF for agranulocytosis. Antibiotics were also administered according to the patient’s medication regimen. After treatment, the patient recovered and was discharged from the hospital. It was also noted that the lung tumor condition improved.

Conclusion::

Effective management of severe immune-related side effects from tislelizumab, including TEN and agranulocytosis, can be partly achieved through steroids, gamma globulin, GCSF, and antibiotics. This strategy not only alleviates these adverse effects, but also potentially improves tumor conditions, highlighting the crucial role of vigilant monitoring and management in immunotherapy.

01 May 2025·Hepatology (Baltimore, Md.)

Vascular damage and excessive proliferation compromise liver function after extended hepatectomy in mice

Article

Author: Dili, Alexandra ; Leclercq, Isabelle A. ; De Rudder, Maxime ; Bertrand, Claude ; Coubeau, Laurent ; Manco, Rita ; Fontaine, Alix

Background and Aims::

Surgical resection remains the gold standard for liver tumor treatment, yet the emergence of postoperative liver failure, known as the small-for-size syndrome (SFSS), poses a significant challenge. The activation of hypoxia sensors in an SFSS liver remnant initiated early angiogenesis, improving the vascular architecture, safeguarding against liver failure, and reducing mortality. The study aimed to elucidate vascular remodeling mechanisms in SFSS and their impact on hepatocyte function and subsequent liver failure.

Approach and results::

Mice underwent extended partial hepatectomy to induce SFSS, with a subset exposed to hypoxia immediately after surgery. Hypoxia bolstered posthepatectomy survival rates. The early proliferation of liver sinusoidal cells, coupled with recruitment of putative endothelial progenitor cells, increased vascular density, improved lobular perfusion, and limited hemorrhagic events in the regenerating liver under hypoxia. Administration of granulocyte colony-stimulating factor in hepatectomized mice mimicked the effects of hypoxia on vascular remodeling and endothelial progenitor cell recruitment but failed to rescue survival. Compared to normoxia, hypoxia favored hepatocyte function over proliferation, promoting functional preservation in the regenerating remnant. Injection of Adeno-associated virus serotype 8-thyroxine-binding globulin-hepatocyte nuclear factor 4 alpha virus for hepatocyte-specific overexpression of hepatocyte nuclear factor 4 alpha, the master regulator of hepatocyte function, enforced functionality in proliferating hepatocytes but did not rescue survival. The combination of hepatocyte nuclear factor 4 alpha overexpression and granulocyte colony-stimulating factor treatment rescued survival after SFSS-setting hepatectomy.

Conclusions::

In summary, SFSS arises from an imbalance and desynchronized interplay between functional regeneration and vascular restructuring. To improve survival following SFSS hepatectomy, it is essential to adopt a 2-pronged strategy aimed at preserving the function of proliferating parenchymal cells and simultaneously attenuating vascular damage.

128

News (Medical) associated with Filgrastim (Amgen)

24 Mar 2025

·www.biospace.com

iStock, wildpixel Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue. On Dec. 26, 2008, after former President Barack Obama was elected but before he took office, I wrote him an email. Two days later, we met briefly in his interim office in Chicago. I elaborated on my plight: I and others had developed lifesaving biosimilars that could significantly reduce the cost of expensive biologics drugs. However, there was no regulatory pathway to bring them to market. Several bills had been introduced to Congress to provide this pathway, but none had passed, in part due to lobbying against biosimilars from Big Pharma. When I met with Obama, the latest variation of the legislation remained in limbo. The president-elect listened attentively and at the end of our meeting he said, “It will be done.” I wasn’t quite sure what he meant by that, but soon after, buried in the 11,000 pages of the Affordable Healthcare Act (ACA) was a revised version of the legislation dubbed the Biologics Price Competition and Innovation Act (BPCIA). A host of FDA guidances for biosimilars followed. Unfortunately, the BPCIA contained many compromises—strict requirements that essentially treated biosimilars as new biological drugs. These included extensive analytical, animal toxicology and clinical efficacy testing, most redundant and blown out of proportion. Ultimately, these requirements pushed the costs of developing a biosimilar to $100–300 million , with approval timelines of six to nine years. Indeed, the first biosimilar approved in the U.S.—Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen used to stimulate white blood cell production in cancer patients—didn’t hit the market until 2015, six years after the BPCIA paved the way. The FDA had no experience approving a product where even the reference product varies from batch to batch—and had no reason to take a risk. Still today, there is a lack of regulatory motivation. Moreover, many misconceptions swirled about the safety and efficacy of biosimilars— many broadly fanned by Big Pharma —just as when generic drugs were introduced. Making biosimilars affordable is more than a scientific challenge. Today, only 66 biological molecules are approved as biosimilars despite more than 300 approved biologics . But progress has been made. In 2024, the FDA made important and beneficial changes to its interchangeability guidelines. And I’m hopeful that the only remaining hurdle to affordable biosimilars, a clinical efficacy testing requirement that adds almost 70–80% of the development cost, will be resolved in 2025. My life’s mission has been to break down healthcare barriers to ensure global access to biological drugs. Big Pharma’s long opposition to the emergence of biosimilars has always been a stumbling block. Now, I believe I’m on the cusp of seeing my life’s work pay off. Besides Obama, I have met with numerous politicians, testified in front of Congress, authored dozens of books and scores of journal articles and filed multiple Citizen Petitions to push the FDA in the right direction. I will soon class action lawsuit against the U.S. Patent Office, on my own, since the biosimilar agencies such as Biosimilar Council have not shown any interest in my proposal to do so . I am determined to see this through. Not only do these issues remain a professional challenge for me as CTO of the biosimilars company ABYOLO, but more importantly, the world needs better regulatory requirements for biosimilars to incentivize their development. If made widely available, these generic versions of biologic drugs can make a massive difference in the global population’s health. Interchangeability: A Pointless Distinction Among the changes I helped initiate to the regulatory process for biosimilars is the recent removal of testing requirements for interchangeability . In 2022, I published a paper suggesting to Congress and the FDA that there should not be two classes of biosimilars —the so-called interchangeable ones, which are permitted to be given in place of the reference product without prescriber intervention and are provided with one year of market exclusivity, and the rest, which do require a doctor to sign off and are given no market protections. I also filed a Citizen Petition on this issue, and the FDA held an open meeting to discuss it in September 2023. Everyone at the meeting seemed to agree with my arguments that the two classes of biosimilars are illogical. However, soon after the meeting came —predictably—a deluge of opposition from Big Pharma. One example was Amgen’s Leah Christl, a former top FDA regulator of biosimilars, who, in an Endpoints News article, voiced her company’s opposition to the push to do away with interchangeability. At the time, Amgen sought the interchangeability designation for a biosimilar to Humira called Amjevita. I filed another Citizen Petition with the FDA, emphasizing that the agency can determine if repeated testing is necessary to award interchangeable status. In June 2024, the FDA updated its interchangeability status policy , allowing this status without conducting additional testing. This FDA guideline essentially removed an interchangeability distinction yet maintained its status and complications, such as determining exclusivity. I had the privilege of assisting the U.S. Senate in writing this bill, and while there is less pressure now, I anticipate this will come soon. These and other changes in the FDA biosimilar guidelines have substantially reduced the development cost. However, we still have one last step. Evening the Biosimilar-Generic Playing Field So far, the FDA and other agencies have waived clinical efficacy testing if these molecules demonstrate pharmacodynamic markers that can be compared within the comparative pharmacokinetic studies in healthy subjects. Regulators have not yet allowed for drugmakers to skip comparative clinical efficacy testing, however—a step that is unnecessary and adds almost 70% to the development cost of biosimilars . Recently, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) suggested in its biosimilars development guidelines that clinical efficacy testing may not be necessary, and the European Medicines Agency (EMA) is working on a concept paper for a similar recommendation. I have repeatedly advised the FDA in my publications to make such testing open for consideration—and sometimes not required. The FDA is planning a similar change but has yet to act. The change will come in the form of FDA guidance, such as recent documents from the agency on biosimilar interchangeability . The FDA has suggested that drug developers will have to request a waiver to secure interchangeable biosimilar status without conducting additional testing. Another significant cost saving will come if the FDA accepts my proposal to let the U.S. Pharmacopeia (USP) create product release specifications by characterizing branded reference products. These product release specifications could then be used by developers of biosimilars to qualify their drugs without the need to test multiple lots of the branded reference product. In 2018, the FDA blocked the USP from creating classical descriptions, or “monographs,” of pharmaceutical products that are based on standard formulations instead of branded products, saying that due to the variability in structure that is unique to biologics, such monographs would not be acceptable comparisons for biosimilar developers. My proposal overcomes this by having USP create specifications by testing commercial products. The FDA has responded to me asking for more time to evaluate my request. Should I succeed, the combination of this change and the removal of clinical efficacy testing will bring the total development cost of biosimilars to no more than the development of chemical generic drugs. Even then, there will still be one more constraint to be removed: the unethical double-patenting laws in the U.S. that can significantly delay the entry of biosimilars. The U.S. Patent and Tradmark Office (USPTO) recognized this and presented a bill to Congress to remove it; however, just when it was ready to go to vote, the USPTO withdrew it. As a patent law practitioner, I published a detailed paper showing why this change is tantamount to a conflict of interest. I also asked the Biosimilar Council to take this issue to court. Still, seeing no move, I have decided to class action lawsuit against the USPTO. I am inviting other stakeholders to join without any financial obligation as I fund this lawsuit. Once the cost of biosimilar development drops, as I anticipate it will, dozens of generic companies will enter the field. More than 100 molecules awaiting entry will arrive as biosimilars, and the world’s patients will benefit from these remarkable lifesaving treatments.

Drug ApprovalBiosimilarPatent Infringement

04 Feb 2025

·www.amgen.com

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS

THOUSAND OAKS, Calif. , Feb. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2024 versus comparable periods in 2023. "Robust growth in sales and earnings throughout 2024 reflects the momentum of our business. With strong performance globally, we are investing heavily in our rapidly advancing pipeline to deliver innovative therapies across our four therapeutic areas," said Robert A. Bradway, chairman and chief executive officer. Key results include: References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow), "EBITDA, or earnings before interest, taxes, depreciation and amortization" (computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income) and "debt leverage ratio" (calculated as the ratio of GAAP total debt to EBITDA) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Rare Disease Except for TAVNEOS ® , the products listed below were added through the acquisition of Horizon on Oct. 6, 2023. Inflammation Oncology Established Products Product Sales Detail by Product and $Millions, except percentages Q4 '24 Q4 '23 YOY Δ U.S ROW TOTAL TOTAL TOTAL Repatha ® $ 315 $ 291 $ 606 $ 417 45 % EVENITY ® 325 106 431 318 36 % Prolia ® 775 390 1,165 1,107 5 % TEPEZZA ®(1) 456 4 460 448 3 % KRYSTEXXA ®(1) 346 — 346 272 27 % UPLIZNA ®(1) 93 8 101 65 55 % TAVNEOS ® 76 5 81 44 84 % Ultra-Rare products (1) 205 9 214 164 30 % TEZSPIRE ® 296 — 296 177 67 % Otezla ® 514 110 624 629 (1 %) Enbrel ® 1,008 7 1,015 1,015 — % AMJEVITA ® /AMGEVITA ™ 153 141 294 160 84 % BLINCYTO ® 245 136 381 241 58 % Vectibix ® 134 112 246 251 (2 %) KYPROLIS ® 236 136 372 350 6 % LUMAKRAS ® /LUMYKRAS ™ 53 32 85 77 10 % XGEVA ® 369 192 561 527 6 % Nplate ® 221 116 337 386 (13 %) IMDELLTRA ® 67 — 67 — N/A MVASI ® 108 65 173 188 (8 %) EPOGEN ® 19 — 19 55 (65 %) Aranesp ® 90 218 308 319 (3 %) Parsabiv ® 39 36 75 89 (16 %) Neulasta ® 72 26 98 239 (59 %) Other products (2) 294 67 361 295 22 % Total product sales $ 6,509 $ 2,207 $ 8,716 $ 7,833 11 % N/A = not applicable (1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , QUINSAIR ® and BUPHENYL ® . (2) Consists of (i) Aimovig ® , KANJINTI ® , AVSOLA ® , RIABNI ® , PAVBLU ™ , NEUPOGEN ® , WEZLANA ™ /WEZENLA ™ , BEKEMV ™ , IMLYGIC ® , Corlanor ® and Sensipar ® /Mimpara ™ , where Biosimilars total $218 million in Q4 '24 and $135 million in Q4 '23; and (ii) Horizon-acquired products including RAYOS ® , PENNSAID ® and DUEXIS ® . $Millions, except percentages FY '24 FY '23 YOY Δ US ROW TOTAL TOTAL TOTAL Repatha ® $ 1,139 $ 1,083 $ 2,222 $ 1,635 36 % EVENITY ® 1,131 432 1,563 1,160 35 % Prolia ® 2,885 1,489 4,374 4,048 8 % TEPEZZA ®(1) 1,835 16 1,851 448 * KRYSTEXXA ®(1) 1,185 — 1,185 272 * UPLIZNA ®(1) 314 65 379 65 * TAVNEOS ® 256 27 283 134 * Ultra-Rare products (1) 726 32 758 164 * TEZSPIRE ® 972 — 972 567 71 % Otezla ® 1,699 427 2,126 2,188 (3 %) Enbrel ® 3,288 28 3,316 3,697 (10 %) AMJEVITA ® /AMGEVITA ™ 202 559 761 626 22 % BLINCYTO ® 800 416 1,216 861 41 % Vectibix ® 519 526 1,045 984 6 % KYPROLIS ® 948 555 1,503 1,403 7 % LUMAKRAS ® /LUMYKRAS ™ 214 136 350 280 25 % XGEVA ® 1,507 718 2,225 2,112 5 % Nplate ® 970 486 1,456 1,477 (1 %) IMDELLTRA ® 115 — 115 — N/A MVASI ® 449 278 727 800 (9 %) EPOGEN ® 125 — 125 226 (45 %) Aranesp ® 386 956 1,342 1,362 (1 %) Parsabiv ® 203 153 356 362 (2 %) Neulasta ® 318 113 431 848 (49 %) Other products (2) 1,115 230 1,345 1,191 13 % Total product sales $ 23,301 $ 8,725 $ 32,026 $ 26,910 19 % * Change in excess of 100% N/A = not applicable (1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , BUPHENYL ® and QUINSAIR ® . (2) Consists of (i)Aimovig ® ,KANJINTI ® ,RIABNI ® ,AVSOLA ® ,NEUPOGEN ® ,Corlanor ® , IMLYGIC ® ,BEKEMV ™ , PAVBLU ™ , WEZLANA ™ /WEZENLA ™ and Sensipar ® /Mimpara ™ , where Biosimilars total $725 million in FY '24 and $490 million in FY '23; and (ii) Horizon-acquired products including RAYOS ® , PENNSAID ® and DUEXIS ® . Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: On a non-GAAP basis: $Millions, except percentages GAAP Non-GAAP Q4 '24 Q4 '23 YOY Δ Q4 '24 Q4 '23 YOY Δ Cost of Sales $ 3,112 $ 3,112 — % $ 1,536 $ 1,278 20 % % of product sales 35.7 % 39.7 % (4.0) pts 17.6 % 16.3 % 1.3 pts Research & Development $ 1,724 $ 1,534 12 % $ 1,698 $ 1,494 14 % % of product sales 19.8 % 19.6 % 0.2 pts 19.5 % 19.1 % 0.4 pts Selling, General & Administrative $ 1,878 $ 2,274 (17 %) $ 1,819 $ 1,764 3 % % of product sales 21.5 % 29.0 % (7.5) pts 20.9 % 22.5 % (1.6) pts Other $ 61 $ 5 * $ — $ — N/A Total Operating Expenses $ 6,775 $ 6,925 (2 %) $ 5,053 $ 4,536 11 % Operating Margin operating income as % of product sales 26.5 % 16.2 % 10.3 pts 46.3 % 46.7 % (0.4) pts Tax Rate 19.8 % 10.0 % 9.8 pts 14.8 % 15.9 % (1.1) pts pts: percentage points * change in excess of 100% N/A = not applicable $Millions, except percentages GAAP Non-GAAP FY '24 FY '23 YOY Δ FY '24 FY '23 YOY Δ Cost of Sales $ 12,858 $ 8,451 52 % $ 5,736 $ 4,573 25 % % of product sales 40.1 % 31.4 % 8.7 pts 17.9 % 17.0 % 0.9 pts Research & Development $ 5,964 $ 4,784 25 % $ 5,878 $ 4,700 25 % % of product sales 18.6 % 17.8 % 0.8 pts 18.4 % 17.5 % 0.9 pts Selling, General & Administrative $ 7,096 $ 6,179 15 % $ 6,782 $ 5,518 23 % % of product sales 22.2 % 23.0 % (0.8) pts 21.2 % 20.5 % 0.7 pts Other $ 248 $ 879 (72 %) $ — $ — N/A Total Operating Expenses $ 26,166 $ 20,293 29 % $ 18,396 $ 14,791 24 % Operating Margin operating income as % of product sales 22.7 % 29.3 % (6.6) pts 46.9 % 49.8 % (2.9) pts Tax Rate 11.3 % 14.5 % (3.2) pts 14.5 % 16.5 % (2.0) pts pts: percentage points N/A = not applicable Cash Flow and Balance Sheet $Billions, except shares Q4 '24 Q4 '23 YOY Δ FY '24 FY '23 YOY Δ Operating Cash Flow $ 4.8 $ 0.5 $ 4.2 $ 11.5 $ 8.5 $ 3.0 Capital Expenditures $ 0.4 $ 0.2 $ 0.1 $ 1.1 $ 1.1 $ 0.0 Free Cash Flow $ 4.4 $ 0.3 $ 4.1 $ 10.4 $ 7.4 $ 3.0 Dividends Paid $ 1.2 $ 1.1 $ 0.1 $ 4.8 $ 4.6 $ 0.3 Share Repurchases $ 0.2 $ — $ 0.2 $ 0.2 $ — $ 0.2 Average Diluted Shares (millions) 542 540 2 541 538 3 Note: Numbers may not add due to rounding $Billions 12/31/24 12/31/23 YTD Δ Cash and Investments $ 12.0 $ 10.9 $ 1.0 Debt Outstanding $ 60.1 $ 64.6 $ (4.5) Note: Numbers may not add due to rounding 2025 Guidance For the full year 2025, the Company expects: Fourth Quarter Product and Pipeline Update The Company provided the following updates on selected product and pipeline programs: General Medicine MariTide (maridebart cafraglutide, AMG 133) AMG 513 Olpasiran (AMG 890) Repatha Rare Disease TAVNEOS TEPEZZA KRYSTEXXA UPLIZNA Dazodalibep Daxdilimab Fipaxalparant Inflammation TEZSPIRE Rocatinlimab (AMG 451/KHK4083) Otezla Blinatumomab Inebilizumab Ordesekimab (AMG 714/PRV-015) AMG 104 (AZD8630) Oncology BLINCYTO IMDELLTRA Xaluritamig (AMG 509) AMG 193 Bemarituzumab LUMAKRAS/LUMYKRAS Nplate Biosimilars TEZSPIRE is being developed in collaboration with AstraZeneca. AMG 104 is being developed in collaboration with AstraZeneca. Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin. Ordesekimab, formerly AMG 714 and also known as PRV-015, is being developed in collaboration with Provention Bio , a Sanofi Company . For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. OCREVUS is a registered trademark of Genentech, Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the fourth quarters and full years of 2024 and 2023, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2025 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the fourth quarters and full years of 2024 and 2023. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and debt leverage ratio for 2024, both of which are non-GAAP financial measures. EBITDA is computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income. Debt leverage ratio is calculated as the ratio of GAAP total debt to EBITDA. 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 normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company believes its debt leverage ratio provides a supplemental operating metric for the full year period as it compares the amount of cash generated by our operations for the year. 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. 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. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube and Threads . 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. 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 (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, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), 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 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. 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, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems 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. CONTACT: Amgen , Thousand Oaks Elissa Snook, 609-251-1407 (media) Justin Claeys, 805-313-9775 (investors) Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per-share data) (Unaudited) Three months ended December 31, Twelve months ended December 31, 2024 2023 2024 2023 Revenues: Product sales $ 8,716 $ 7,833 $ 32,026 $ 26,910 Other revenues 370 363 1,398 1,280 Total revenues 9,086 8,196 33,424 28,190 Operating expenses: Cost of sales 3,112 3,112 12,858 8,451 Research and development 1,724 1,534 5,964 4,784 Selling, general and administrative 1,878 2,274 7,096 6,179 Other 61 5 248 879 Total operating expenses 6,775 6,925 26,166 20,293 Operating income 2,311 1,271 7,258 7,897 Other income (expense): Interest expense, net (747) (821) (3,155) (2,875) Other (expense) income, net (782) 402 506 2,833 Income before income taxes 782 852 4,609 7,855 Provision for income taxes 155 85 519 1,138 Net income $ 627 $ 767 $ 4,090 $ 6,717 Earnings per share: Basic $ 1.17 $ 1.43 $ 7.62 $ 12.56 Diluted $ 1.16 $ 1.42 $ 7.56 $ 12.49 Weighted-average shares used in calculation of earnings per share: Basic 537 535 537 535 Diluted 542 540 541 538 Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) December 31, December 31, 2024 2023 (Unaudited) Assets Current assets: Cash and cash equivalents $ 11,973 $ 10,944 Trade receivables, net 6,782 7,268 Inventories 6,998 9,518 Other current assets 3,277 2,602 Total current assets 29,030 30,332 Property, plant and equipment, net 6,543 5,941 Intangible assets, net 27,699 32,641 Goodwill 18,637 18,629 Other noncurrent assets 9,930 9,611 Total assets $ 91,839 $ 97,154 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued liabilities $ 19,549 $ 16,949 Current portion of long-term debt 3,550 1,443 Total current liabilities 23,099 18,392 Long-term debt 56,549 63,170 Long-term deferred tax liabilities 1,616 2,354 Long-term tax liabilities 2,349 4,680 Other noncurrent liabilities 2,349 2,326 Total stockholders' equity 5,877 6,232 Total liabilities and stockholders' equity $ 91,839 $ 97,154 Shares outstanding 537 535 Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited) Three months ended December 31, Twelve months ended December 31, 2024 2023 2024 2023 GAAP cost of sales $ 3,112 $ 3,112 $ 12,858 $ 8,451 Adjustments to cost of sales: Acquisition-related expenses (a) (1,576) (1,834) (7,122) (3,842) Certain net charges pursuant to our restructuring and cost-savings initiatives — — — (36) Total adjustments to cost of sales (1,576) (1,834) (7,122) (3,878) Non-GAAP cost of sales $ 1,536 $ 1,278 $ 5,736 $ 4,573 GAAP cost of sales as a percentage of product sales 35.7 % 39.7 % 40.1 % 31.4 % Acquisition-related expenses (a) (18.1) (23.4) (22.2) (14.3) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 0.0 0.0 (0.1) Non-GAAP cost of sales as a percentage of product sales 17.6 % 16.3 % 17.9 % 17.0 % GAAP research and development expenses $ 1,724 $ 1,534 $ 5,964 $ 4,784 Adjustments to research and development expenses: Acquisition-related expenses (b) (26) (28) (86) (55) Certain net charges pursuant to our restructuring and cost-savings initiatives — (12) — (29) Total adjustments to research and development expenses (26) (40) (86) (84) Non-GAAP research and development expenses $ 1,698 $ 1,494 $ 5,878 $ 4,700 GAAP research and development expenses as a percentage of product sales 19.8 % 19.6 % 18.6 % 17.8 % Acquisition-related expenses (b) (0.3) (0.3) (0.2) (0.2) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 (0.2) 0.0 (0.1) Non-GAAP research and development expenses as a percentage of product sales 19.5 % 19.1 % 18.4 % 17.5 % GAAP selling, general and administrative expenses $ 1,878 $ 2,274 $ 7,096 $ 6,179 Adjustments to selling, general and administrative expenses: Acquisition-related expenses (c) (59) (510) (314) (648) Certain net charges pursuant to our restructuring and cost-savings initiatives — — — (13) Total adjustments to selling, general and administrative expenses (59) (510) (314) (661) Non-GAAP selling, general and administrative expenses $ 1,819 $ 1,764 $ 6,782 $ 5,518 GAAP selling, general and administrative expenses as a percentage of product sales 21.5 % 29.0 % 22.2 % 23.0 % Acquisition-related expenses (c) (0.6) (6.5) (1.0) (2.4) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 0.0 0.0 (0.1) Non-GAAP selling, general and administrative expenses as a percentage of product sales 20.9 % 22.5 % 21.2 % 20.5 % GAAP operating expenses $ 6,775 $ 6,925 $ 26,166 $ 20,293 Adjustments to operating expenses: Adjustments to cost of sales (1,576) (1,834) (7,122) (3,878) Adjustments to research and development expenses (26) (40) (86) (84) Adjustments to selling, general and administrative expenses (59) (510) (314) (661) Certain net charges pursuant to our restructuring and cost-savings initiatives (d) (40) (2) (36) (185) Certain other expenses (e) (21) (3) (212) (694) Total adjustments to operating expenses (1,722) (2,389) (7,770) (5,502) Non-GAAP operating expenses $ 5,053 $ 4,536 $ 18,396 $ 14,791 Three months ended December 31, Twelve months ended December 31, 2024 2023 2024 2023 GAAP operating income $ 2,311 $ 1,271 $ 7,258 $ 7,897 Adjustments to operating expenses 1,722 2,389 7,770 5,502 Non-GAAP operating income $ 4,033 $ 3,660 $ 15,028 $ 13,399 GAAP operating income as a percentage of product sales 26.5 % 16.2 % 22.7 % 29.3 % Adjustments to cost of sales 18.1 23.4 22.2 14.4 Adjustments to research and development expenses 0.3 0.4 0.2 0.3 Adjustments to selling, general and administrative expenses 0.6 6.5 1.0 2.6 Certain net charges pursuant to our restructuring and cost-savings initiatives (d) 0.5 0.1 0.1 0.7 Certain other expenses (e) 0.3 0.1 0.7 2.5 Non-GAAP operating income as a percentage of product sales 46.3 % 46.7 % 46.9 % 49.8 % GAAP interest expense, net $ (747) $ (821) $ (3,155) $ (2,875) Adjustments to interest expense, net: Interest expense on acquisition-related debt (f) — 19 — 807 Non-GAAP interest expense, net $ (747) $ (802) $ (3,155) $ (2,068) GAAP other (expense) income, net $ (782) $ 402 $ 506 $ 2,833 Adjustments to other (expense) income, net Interest income and other expenses on acquisition-related debt (f) — (18) — (625) Net losses (gains) from equity investments (g) 875 (217) 182 (1,522) Total adjustments to other (expense) income, net 875 (235) 182 (2,147) Non-GAAP other income, net $ 93 $ 167 $ 688 $ 686 GAAP income before income taxes $ 782 $ 852 $ 4,609 $ 7,855 Adjustments to income before income taxes: Adjustments to operating expenses 1,722 2,389 7,770 5,502 Adjustments to interest expense, net — 19 — 807 Adjustments to other income, net 875 (235) 182 (2,147) Total adjustments to income before income taxes 2,597 2,173 7,952 4,162 Non-GAAP income before income taxes $ 3,379 $ 3,025 $ 12,561 $ 12,017 GAAP provision for income taxes $ 155 $ 85 $ 519 $ 1,138 Adjustments to provision for income taxes: Income tax effect of the above adjustments (h) 537 404 1,544 846 Other income tax adjustments (i) (192) (7) (236) (1) Total adjustments to provision for income taxes 345 397 1,308 845 Non-GAAP provision for income taxes $ 500 $ 482 $ 1,827 $ 1,983 GAAP tax as a percentage of income before taxes 19.8 % 10.0 % 11.3 % 14.5 % Adjustments to provision for income taxes: Income tax effect of the above adjustments (h) 0.7 6.1 5.1 2.0 Other income tax adjustments (i) (5.7) (0.2) (1.9) 0.0 Total adjustments to provision for income taxes (5.0) 5.9 3.2 2.0 Non-GAAP tax as a percentage of income before taxes 14.8 % 15.9 % 14.5 % 16.5 % GAAP net income $ 627 $ 767 $ 4,090 $ 6,717 Adjustments to net income: Adjustments to income before income taxes, net of the income tax effect 2,060 1,769 6,408 3,316 Other income tax adjustments (i) 192 7 236 1 Total adjustments to net income 2,252 1,776 6,644 3,317 Non-GAAP net income $ 2,879 $ 2,543 $ 10,734 $ 10,034 Note: Numbers may not add due to rounding Amgen Inc. GAAP to Non-GAAP Reconciliations (In millions, except per-share data) (Unaudited) The following table presents the computations for GAAP and non-GAAP diluted earnings per share: Three months ended December 31, 2024 Three months ended December 31, 2023 GAAP Non-GAAP GAAP Non-GAAP Net income $ 627 $ 2,879 $ 767 $ 2,543 Weighted-average shares for diluted EPS 542 542 540 540 Diluted EPS $ 1.16 $ 5.31 $ 1.42 $ 4.71 Twelve months ended December 31, 2024 Twelve months ended December 31, 2023 GAAP Non-GAAP GAAP Non-GAAP Net income $ 4,090 $ 10,734 $ 6,717 $ 10,034 Weighted-average shares for diluted EPS 541 541 538 538 Diluted EPS $ 7.56 $ 19.84 $ 12.49 $ 18.65 (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 and twelve months ended December 31, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three months ended December 31, 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the twelve months ended December 31, 2023, the adjustments related primarily to noncash amortization of intangible assets acquired from business acquisitions. (c) For the three and twelve months ended December 31, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. (d) For the three and twelve months ended December 31, 2024 and 2023, the adjustments related to separation costs associated with our restructuring plan and other cost-savings initiatives. (e) For the twelve months ended December 31, 2024, the adjustments related primarily to impairment charges for IPR&D intangible assets related to our Teneobio, Inc. acquisition from 2021. For the twelve months ended December 31, 2023, the adjustments related primarily to a net IPR&D intangible asset impairment charge for AMG 340. (f) For the three and twelve months ended December 31, 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 twelve months ended December 31, 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. For the twelve months ended December 31, 2023, the adjustments related primarily to our BeiGene equity fair value adjustment. (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 twelve months ended December 31, 2024, was 20.7% and 19.4%, respectively, compared to 18.6% and 20.3% 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 December 31, Twelve months ended December 31, 2024 2023 2024 2023 Net cash provided by operating activities $ 4,771 $ 538 $ 11,490 $ 8,471 Net cash used in investing activities (402) (27,089) (1,046) (26,204) Net cash (used in) provided by financing activities (1,407) 2,754 (9,415) 21,048 Increase (decrease) in cash and cash equivalents 2,962 (23,797) 1,029 3,315 Cash and cash equivalents at beginning of period 9,011 34,741 10,944 7,629 Cash and cash equivalents at end of period $ 11,973 $ 10,944 $ 11,973 $ 10,944 Three months ended December 31, Twelve months ended December 31, 2024 2023 2024 2023 Net cash provided by operating activities $ 4,771 $ 538 $ 11,490 $ 8,471 Capital expenditures (371) (249) (1,096) (1,112) Free cash flow $ 4,400 $ 289 $ 10,394 $ 7,359 Amgen Inc. Reconciliation of GAAP Net Income to EBITDA and Debt Leverage Ratio Calculation (Dollars in millions) (Unaudited) Twelve months ended December 31, 2024 GAAP Net Income $ 4,090 Depreciation and amortization 5,592 Interest expense, net 3,155 Provision for income taxes 519 EBITDA (a) $ 13,356 As of December 31, 2024 Current portion of long-term debt $ 3,550 Long-term debt 56,549 Total GAAP Debt $ 60,099 As of December 31, 2024 Total GAAP Debt $ 60,099 EBITDA $ 13,356 Debt leverage ratio 4.5 (a) 2024 EBITDA includes amortization of inventory step-up of $2.4 billion and net losses from equity investments of $182 million. Amgen Inc. Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2025 (Unaudited) GAAP diluted EPS guidance $ 10.89 — $ 12.14 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 9.06 — 9.11 Non-GAAP diluted EPS guidance $ 20.00 — $ 21.20 * The known adjustments are presented net of their related tax impact, which amount to approximately $1.54 per share. (a) The adjustments include noncash amortization of intangible assets and fair value step-up of inventory acquired in business acquisitions. Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. Reconciliation of GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for the Year Ending December 31, 2025 (Unaudited) GAAP tax rate guidance 11.0 % — 12.5 % Tax rate of known adjustments discussed above 3.5 % — 4.0 % Non-GAAP tax rate guidance 15.0 % — 16.0 % View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-reports-fourth-quarter-and-full-year-2024-financial-results-302367906.html SOURCE Amgen

AcquisitionFinancial StatementBiosimilarDrug ApprovalLicense out/in

23 Jan 2025

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McKesson’s Practice Insights Selected as a 2025 Qualified Clinical Data Registry by Centers for Medicare & Medicaid Services

IRVING, Texas--( BUSINESS WIRE )--For the ninth consecutive year, the Centers for Medicare & Medicaid Services (CMS) has named McKesson a Qualified Clinical Data Registry (QCDR) approved to participate in the Merit-based Incentive Payment System (MIPS). As a CMS-designated QCDR, McKesson can collect and report clinical data on behalf of clinicians utilizing iKnowMed℠ electronic health record and integrated module, Practice Insights℠, a performance analytics tool powered by Ontada ® , McKesson’s technology and insights business. The designation enables healthcare practices and providers utilizing iKnowMed to efficiently submit data directly for both MIPS and custom QCDR quality measures to CMS, eliminating the need to engage a separate registry vendor, streamlining data submission and minimizing administrative burden. “McKesson is committed to providing actionable insights to community oncology practices that can empower them to improve patient care, reduce practice burden, and grow access to care in the community setting,” said Jason Hammonds, chief operating officer, Oncology & Specialty, McKesson. “As a 2025 QCDR, Practice Insights enables providers to easily gather and report quality measures to CMS while offering ready access to practice data and analytics to help them improve operations and patient care.” Practice Insights supports nine oncology-specific QCDR measures to drive improvements in quality and cost of care. Seven of these measures were developed in collaboration with physicians in The US Oncology Network , a network of community-based providers supported by McKesson: Resolution or Improvement of a Health-Related Social Need Advance Care Planning in Metastatic Cancer Patients Hepatitis B Serology Testing and Prophylactic Treatment Prior to Receiving Anti-CD20 Targeting Drugs Patient-Reported Pain Improvement Supportive Care Drug Utilization in Last 14 Days of Life Mutation Testing for Stage IV Lung Cancer Completed Prior to the Start of Targeted Therapy Utilization of Prophylactic GCSF for Cancer Patients Receiving Low-Risk Chemotherapy The other two measures were developed by the American Society of Clinical Oncology and have been approved for the third year: Antiemetic Therapy for Low-and Minimal-Emetic-Risk Antineoplastic Agents in the Infusion Center - Avoidance of Overuse Appropriate Antiemetic Therapy for High-and Moderate-Emetic-Risk Antineoplastic Agents in the Infusion Center Recognizing the value of McKesson’s quality measures for improving cancer care, CMS selected two of the measures for inclusion in the 2024 Advancing Cancer Care MIPS Value Pathways (MVP): Mutation Testing for Stage IV Lung Cancer and Utilization of Prophylactic GCSF for Patients Receiving Low-Risk Chemotherapy. Practice Insights is the only QCDR that has had measures selected for inclusion in the Advancing Cancer Care MVP. Two of the QCDR measures included in Practice Insights are patient-reported outcomes measures, considered particularly impactful for outcomes improvement 1 . Especially noteworthy and new for 2025 is the first patient-reported outcomes measure available through MIPS assessing outcomes associated with addressing health-related social needs (HRSNs). While other quality measures screen for HRSNs, McKesson’s is the first to examine whether issues are resolved after being identified. “McKesson’s measure goes full circle, enabling clinicians to not only identify needs, but also efficiently track and report results,” noted Erin Crum, senior director, Quality Strategy and Innovation, McKesson and The US Oncology Network. “We are extremely proud of this advancement that supports a more holistic, patient-centered approach to treatment, and we will continue advocating for quality measures that are truly impactful to patients and oncology care.” About McKesson Corporation McKesson Corporation is a diversified healthcare services leader dedicated to advancing health outcomes for patients everywhere. Our teams partner with biopharma companies, care providers, pharmacies, manufacturers, governments, and others to deliver insights, products, and services to help make quality care more accessible and affordable. Learn more about how McKesson is impacting virtually every aspect of healthcare at McKesson.com and read Our Stories . About McKesson Oncology and Specialty Solutions It’s an unprecedented time for patients living with cancer as life sciences companies race to create new, cutting-edge therapies. With cancer care becoming more targeted, providers, life sciences companies, and payers face a multitude of challenges and complexity in the development of new treatments and making them accessible to patients in need. At McKesson , our unmatched portfolio of oncology businesses and partners provide research, insights, technologies, and services that are helping to address these hurdles and improve cancer and specialty care. McKesson is fueling discovery by helping patients participate in cutting-edge clinical trials closer to home through its joint venture, Sarah Cannon Research Institute . The US Oncology Network and McKesson Provider Solutions are advancing specialty care and high-quality cancer care in the communities where patients live by supporting the practices of thousands of independent, community-based providers. Ontada ® , a McKesson business dedicated to oncology, generates real-world data (RWD) and real-world evidence (RWE), and provides clinical education and provider technology to inform and improve cancer care. As one of the largest distributors of oncology and specialty medicines, we are ensuring medicines make their way to those who are counting on them. And through CoverMyMeds , Biologics by McKesson , and GPO services , our work continues to help patients access, afford, and adhere to their medicines. 1 Renard, Rik. “Patient-reported outcome measures (PROMs): the gold standard for outcome improvement.” awellhealth.com, 25 July 2024. https://www.awellhealth.com/blog/patient-reported-outcome-measures-proms-the-gold-standard-for-outcome-improvement#:~:text=PROMs%20allow%20patients%20to%20provide,of%20PROMs%20for%20cancer%20patients .

ASCO

100 Deals associated with Filgrastim (Amgen)

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KEGG	Wiki	ATC	Drug Bank
D03235	Filgrastim (Amgen)	L03AA02	DB00099

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuroblastoma	Japan	Kyowa Kirin Co., Ltd.	23 Jun 2021
Febrile Neutropenia	Australia	Pfizer Australia Pty Ltd.	16 Sep 2010
HIV Infections	Australia	Pfizer Australia Pty Ltd.	16 Sep 2010
Acute Myeloid Leukemia	United States	Amgen, Inc.	20 Feb 1991
Bone marrow depression	United States	Amgen, Inc.	20 Feb 1991
Neutropenia	United States	Amgen, Inc.	20 Feb 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Early Stage Breast Carcinoma	Phase 2	South Korea	Kyowa Kirin Co., Ltd.	01 Feb 2016
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 2	-	Amgen, Inc.	01 Jul 2002
Hodgkin's Lymphoma	Phase 2	United States	Amgen, Inc.	31 Aug 2001
Metastatic breast cancer	Phase 2	United States	Bristol Myers Squibb Co.	01 Mar 2001
Metastatic breast cancer	Phase 2	United States	GSK Plc	01 Mar 2001
Metastatic breast cancer	Phase 2	United States	Amgen, Inc.	01 Mar 2001
Advanced Lung Non-Small Cell Carcinoma	Phase 2	United States	Amgen, Inc.	01 Oct 1999
Bladder Cancer	Phase 2	United States	Amgen, Inc.	01 Oct 1999
Renal Pelvis and Ureter Urothelial Carcinoma	Phase 2	United States	Amgen, Inc.	01 Oct 1999
Multiple Myeloma	Phase 2	Denmark	Amgen, Inc.	01 Jan 1999

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04514692 (CTgov)	Phase 1/2	Endometrial Carcinoma \| Uterine Cervical Cancer \| Recurrent Endometrial Cancer	7	GCSF (Phase I -Dose Finding, Cohort 1)	ookcpmhksu = szqfxxkumv dnqnyremrl (rahyjztosu, egovnqadxw - ydpbdcyrom) View more	-	23 Apr 2025
				GCSF (Phase I -Dose Finding, Cohort 2)	ookcpmhksu = anrzghhmaq dnqnyremrl (rahyjztosu, ilttisqeyp - qmkaczjjef) View more
NCT04294641 (CTgov)	Phase 2	Chronic graft-versus-host disease	10	Ibrutinib	dhgxycspvj = zawiggawjx aoghfzmpev (ssqfgwyead, njdgsgypru - jqsugtsdmk) View more	-	22 Jan 2025
ESMO_ASIA2024	Not Applicable	Early Stage Breast Carcinoma Adjuvant	93	Filgrastim	iqyqofawhv(uppqzxzpvt) = uorsnmfobx ttguliymbz (opepensazg ) View more	Positive	07 Dec 2024
NCT02880293 (CTgov)	Not Applicable	Hematologic Neoplasms	44	Mesna+Fludarabine+cyclophosphamide+melphalan+Filgrastim+Tacrolimus+Mycophenolate Mofetil+thiotepa	bbsmgicjtx = fcflgfadwu ysqrdvdspa (uyqziomwwd, piqwmhhnex - tznwxxblza) View more	-	06 Dec 2024
EHA2024	Not Applicable	CD34+	-	G-CSF during cytapheresis	igotoepbqx(qppnfyzjxg) = xhmzycgtds ooeitwxsgj (fuqvhighmr ) View more	Positive	14 May 2024
				No G-CSF during cytapheresis	igotoepbqx(qppnfyzjxg) = prtugvmape ooeitwxsgj (fuqvhighmr ) View more
NCT02331134 (CTgov)	Not Applicable	Squamous Cell Carcinoma of Head and Neck \| Melanoma	9	Filgrastim	rdkyndgujl = rwhjehubkk srjgwckgml (ujpsrzdcsj, gzcimbzvod - iqfsznapfi) View more	-	31 Oct 2023
WCD2023	Not Applicable	Leishmaniasis, Cutaneous	32	Sbv + G-CSF	noqbuuayzp(olpysmhmxn) = tkuxpcfgdb pqiezhdmou (dgcnkwmvol )	Positive	03 Jul 2023
				Sbv + Placebo	noqbuuayzp(olpysmhmxn) = iusixvfxzt pqiezhdmou (dgcnkwmvol )
NCT01572662 (CTgov)	Phase 2	Hodgkin's Lymphoma \| Acute Myeloid Leukemia \| Acute Lymphoblastic Leukemia ... View more	201	Fludarabine+Busulfan (Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l)	khyhumytwx = kaufovnykr oblnioeubp (axuslvooqf, pelrpsndkf - fnfuimzmkp) View more	-	29 Jun 2023
				Fludarabine+Busulfan (Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.)	khyhumytwx = lyjaqxtszv oblnioeubp (axuslvooqf, covdtnxboi - zqkkyppsqx) View more
P304 (EBMT2023)	Not Applicable	Myeloid Tumor Maintenance	24	rhG-CSF+Decitabine	savwvecawq(bqwyoxtsnz) = ikhvigaemf hzntiwriwn (jtqyqlilya, 9.57 - NA)	-	23 Apr 2023
EBMT2023	Not Applicable	-	-	Filgrastim (Neupogen)	vthddwhfik(jvjexjrcxt) = The most common AEs were headache, fatigue and bone pain. There were two grade 4 AEs in the NP group (fatigue and HA) and one in the NV group (subdural hemorrhage); all have been reported previously and expected. iasbonxwkj (eqehyxoqru )	-	23 Apr 2023
				Filgrastim-aafi (Nivestym)

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