On February 4, 2025 Amgen (NASDAQ:AMGN) reported financial results for the fourth quarter and full year of 2024 versus comparable periods in 2023 (Press release, Amgen, FEB 4, 2025, View Source [SID1234650022]).
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Key results include:
•For the fourth quarter, total revenues increased 11% to $9.1 billion in comparison to the fourth quarter of 2023.
◦Product sales grew 11%, primarily driven by 14% volume growth. Excluding sales from our Horizon Therapeutics (Horizon) acquisition, product sales grew 10%, driven by volume growth of 15%.
◦Ten products delivered at least double-digit sales growth in the fourth quarter, including Repatha (evolocumab), BLINCYTO (blinatumomab), TEZSPIRE (tezepelumab-ekko), EVENITY (romosozumab-aqqg), and TAVNEOS (avacopan).
◦Our performance included $1.2 billion of sales from our rare disease products, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA (teprotumumab-trbw), KRYSTEXXA (pegloticase), UPLIZNA (inebilizumab-cdon), and TAVNEOS.
•For the full year, total revenues increased 19% to $33.4 billion in comparison to the full year of 2023.
◦Product sales grew 19%, primarily driven by 23% volume growth, partially offset by 2% lower net selling price. Excluding sales from our Horizon acquisition, product sales grew 7%, driven by volume growth of 11%.
◦Ten products delivered at least double-digit sales growth for the full year, including Repatha, TEZSPIRE, EVENITY, BLINCYTO, and TAVNEOS.
◦21 products achieved record sales for the full year.
•GAAP earnings per share (EPS) decreased 18% from $1.42 to $1.16 for the fourth quarter, primarily driven by mark-to-market losses on our equity investments, partially offset by higher revenues. For the full year, GAAP EPS decreased 39% from $12.49 to $7.56, primarily
driven by higher operating expenses, including amortization expense from Horizon acquisition-related assets and incremental operating expenses from Horizon, and overall mark-to-market losses on our equity investments in 2024, partially offset by higher revenues.
◦For the fourth quarter, GAAP operating income increased from $1.3 billion to $2.3 billion, and GAAP operating margin increased 10.3 percentage points to 26.5%. For the full year, GAAP operating income decreased from $7.9 billion to $7.3 billion, and GAAP operating margin decreased 6.6 percentage points to 22.7%.
•Non-GAAP EPS increased 13% from $4.71 to $5.31 for the fourth quarter, driven by higher revenues, partially offset by higher operating expenses. For the full year, non-GAAP EPS increased 6% from $18.65 to $19.84, driven by higher revenues, partially offset by higher operating expenses, including incremental operating expenses from Horizon, and higher interest expense.
◦For the fourth quarter, non-GAAP operating income increased from $3.7 billion to $4.0 billion, and non-GAAP operating margin decreased 0.4 percentage points to 46.3%. For the full year, non-GAAP operating income increased from $13.4 billion to $15.0 billion, and non-GAAP operating margin decreased 2.9 percentage points to 46.9%.
•The Company generated $10.4 billion of free cash flow for the full year versus $7.4 billion in 2023, driven by business performance and timing of working capital items, primarily collections, partially offset by higher net interest expense.
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
•Repatha (evolocumab) sales increased 45% year-over-year to $606 million in the fourth quarter, primarily driven by volume growth. Full year sales increased 36%, primarily driven by 43% volume growth, partially offset by 10% lower net selling price. For 2025, we expect lower declines in net selling price.
•EVENITY (romosozumab-aqqg) sales increased 36% year-over-year to $431 million in the fourth quarter and 35% for the full year, driven by volume growth.
•Prolia (denosumab) sales increased 5% year-over-year to $1.2 billion in the fourth quarter and 8% for the full year, driven by volume growth. For 2025, we expect sales erosion driven by biosimilar competition.
Rare Disease
Except for TAVNEOS, the products listed below were added through the acquisition of Horizon on Oct. 6, 2023.
•TEPEZZA (teprotumumab-trbw) generated $460 million of sales in the fourth quarter and $1.9 billion for the full year. TEPEZZA is the first and only approved treatment for thyroid eye disease (TED) in the U.S. and Japan.
•KRYSTEXXA (pegloticase) generated $346 million of sales in the fourth quarter and $1.2 billion for the full year. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout.
•UPLIZNA (inebilizumab-cdon) generated $101 million of sales in the fourth quarter and $379 million for the full year. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD).
•TAVNEOS (avacopan) generated $81 million of sales in the fourth quarter. Sales increased 84% year-over-year in the fourth quarter and 111% for the full year, primarily driven by volume growth. TAVNEOS is a first-in-class treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
•Ultra-Rare products, which consist of RAVICTI (glycerol phenylbutyrate), PROCYSBI (cysteamine bitartrate), ACTIMMUNE (interferon gamma-1b), QUINSAIR (levofloxacin), and BUPHENYL (sodium phenylbutyrate), generated $214 million of sales in the fourth quarter and $758 million for the full year.
Inflammation
•TEZSPIRE (tezepelumab-ekko) sales increased 67% year-over-year to $296 million in the fourth quarter and 71% for the full year, primarily driven by volume growth.
•Otezla (apremilast) sales decreased 1% year-over-year to $624 million in the fourth quarter, driven by 7% lower net selling price, partially offset by 5% volume growth. Sales decreased 3% for the full year, primarily driven by 8% lower net selling price, partially offset by 3% volume growth.
•Enbrel (etanercept) sales were flat year-over-year at $1.0 billion in the fourth quarter as 7% favorable changes to estimated sales deductions were offset by lower net selling price. Full year sales decreased 10%, driven by lower net selling price. For 2025, we expect continued declining net selling price and relatively flat volumes.
We expect Otezla and Enbrel to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles.
•AMJEVITA/AMGEVITA (adalimumab) sales increased 84% year-over-year to $294 million in the fourth quarter and 22% for the full year, driven by volume growth, partially offset by lower net selling price.
Oncology
•BLINCYTO (blinatumomab) sales increased 58% year-over-year to $381 million in the fourth quarter and 41% for the full year, primarily driven by volume growth.
•Vectibix (panitumumab) sales decreased 2% year-over-year to $246 million in the fourth quarter, driven by 5% unfavorable foreign exchange impact and 4% lower volume, partially offset by higher net selling price. Sales increased 6% for the full year, driven by 8% higher net selling price and 4% volume growth, partially offset by unfavorable foreign exchange impact.
•KYPROLIS (carfilzomib) sales increased 6% year-over-year to $372 million in the fourth quarter and 7% for the full year, driven by volume growth outside the U.S.
•LUMAKRAS/LUMYKRAS (sotorasib) sales increased 10% year-over-year to $85 million in the fourth quarter, primarily driven by volume growth. Sales increased 25% for the full year, driven by volume growth and favorable changes to estimated sales deductions.
•XGEVA (denosumab) sales increased 6% year-over-year to $561 million in the fourth quarter, driven by volume growth. Sales increased 5% for the full year, driven by higher net selling price. For 2025, we expect sales erosion driven by biosimilar competition.
•Nplate (romiplostim) sales decreased 13% year-over-year to $337 million in the fourth quarter. Excluding a fourth quarter 2023 U.S. government order of $62 million, Nplate sales grew 4% year-over-year in the fourth quarter, driven by volume growth. Full year sales decreased 1%. U.S. government orders were $128 million in 2024 compared to $286 million in 2023. Excluding these U.S. government orders, Nplate sales grew 12% year-over-year for the full year, driven by 8% volume growth and 6% higher net selling price.
•IMDELLTRA (tarlatamab-dlle) generated $67 million of sales in the fourth quarter. Sales increased 86% quarter-over-quarter, driven by volume growth and inventory levels. IMDELLTRA is the first and only FDA-approved bispecific T-cell engager (BiTE) therapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
•MVASI (bevacizumab-awwb) sales decreased 8% year-over-year to $173 million in the fourth quarter and 9% for the full year.
Established Products
•Our established products, which consist of EPOGEN (epoetin alfa), Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide), and Neulasta (pegfilgrastim), generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region
$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:
•Total Operating Expenses decreased 2% year-over-year for the fourth quarter and increased 29% for the full year. Cost of Sales as a percentage of product sales decreased 4.0 percentage points for the fourth quarter primarily driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon, partially offset by changes in our sales mix, and higher profit share and royalty expense. For the full year, cost of sales as a percentage of product sales increased 8.7 percentage points driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. Research & Development (R&D) expenses increased 12% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower research and early pipeline spend. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. Selling, General & Administrative (SG&A) expenses decreased 17% for the fourth quarter primarily driven by lower Horizon acquisition-related expenses. SG&A expenses increased 15% for the full year primarily driven by expenses from the acquired Horizon business and other commercial expenses, partially offset by lower Horizon acquisition-related expenses incurred in 2024. Other operating expenses for the full year primarily consisted of impairment charges associated with in-process R&D (IPR&D) intangible assets related to our Teneobio, Inc. acquisition in 2021 and expenses related to cost-savings initiatives incurred in 2024.
•Operating Margin as a percentage of product sales increased 10.3 percentage points to 26.5% for the fourth quarter and decreased 6.6 percentage points to 22.7% for the full year.
•Tax Rate increased 9.8 percentage points in the fourth quarter and decreased 3.2 percentage points for the full year. The fourth quarter tax rate increase was related to deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries and prior year favorable items, partially offset by the change in earnings mix as a result of the fourth quarter 2024 unrealized losses on our strategic equity investments (primarily BeiGene). The full year tax rate decrease was due to the change in earnings mix, including the net unrealized impacts of our strategic equity investments (primarily BeiGene), partially offset by the deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries.
On a non-GAAP basis:
•Total Operating Expenses increased 11% year-over-year for the fourth quarter and increased 24% for the full year. Cost of Sales as a percentage of product sales increased 1.3 percentage points for the fourth quarter driven by changes in our sales mix, and higher profit share and royalty expense. Cost of sales as a percentage of product sales increased 0.9 percentage points for the full year driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. R&D expenses increased 14% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower spend in research and early pipeline. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. SG&A expenses increased 3% for the fourth quarter driven by higher general and administrative expenses. SG&A expenses increased 23% for the full year primarily driven by expenses from the acquired Horizon business and other marketed product expenses.
•Operating Margin as a percentage of product sales decreased 0.4 percentage points to 46.3% for the fourth quarter and decreased 2.9 percentage points to 46.9% for the full year.
•Tax Rate decreased 1.1 percentage points for the fourth quarter and decreased 2.0 percentage points for the full year. The fourth quarter tax rate decrease was primarily due to the change in earnings mix and net favorable items as compared to the prior year. The full year tax rate decrease was primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items as compared to the prior year.
$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
•The Company generated a record $4.4 billion of free cash flow in the fourth quarter of 2024 versus $0.3 billion in the fourth quarter of 2023, driven by timing of tax payments, timing of working capital, primarily collections, lower transaction expenses compared to the fourth quarter of 2023, which included significant costs tied to the closing of the Horizon acquisition, and business performance. The Company generated $10.4 billion of free cash flow for the full year 2024 versus $7.4 billion in 2023.
•The Company’s fourth quarter 2024 dividend of $2.25 per share was declared on October 25, 2024, and was paid on December 9, 2024, to all stockholders of record as of November 18, 2024, representing a 6% increase from the same period in 2023.
•During the fourth quarter, there were no repayments or extinguishments of debt. For the full year 2024, the Company reduced principal debt outstanding by $4.5 billion.
•For the fourth quarter and full year, the Company repurchased 0.7 million shares of common stock at a total cost of $200 million.
•Cash and investments totaled $12.0 billion and debt outstanding totaled $60.1 billion as of December 31, 2024. Debt leverage was approximately 4.5 times EBITDA as of December 31, 2024.
$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:
•Total revenues in the range of $34.3 billion to $35.7 billion.
•On a GAAP basis, EPS in the range of $10.89 to $12.14, and a tax rate in the range of 11.0% to 12.5%.
•On a non-GAAP basis, EPS in the range of $20.00 to $21.20, and a tax rate in the range of 15.0% to 16.0%.
•Capital expenditures to be approximately $2.3 billion.
•Share repurchases not to exceed $500 million.
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)
•MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes gastric inhibitory polypeptide receptor (GIPR).
•In November 2024, data were presented from Part 1 of a Phase 2 chronic weight management study in adults who are living with overweight or obesity, with or without
Type 2 diabetes mellitus. MariTide demonstrated robust weight loss at 52 weeks without a weight loss plateau, significant improvements in cardiometabolic parameters, and is the first obesity treatment with monthly or less frequent dosing to demonstrate safe and effective weight loss in a Phase 2 study.
•Part 2 of the Phase 2 chronic weight management study is ongoing in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025.
•A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus is enrolling adults living with and without obesity. Data readout is anticipated in H2 2025.
•Planning for MARITIME, a broad Phase 3 program across multiple indications remains on track with the first studies expected to begin in H1 2025.
AMG 513
•A Phase 1 study of AMG 513 in people living with obesity was placed on clinical hold by the U.S. Food and Drug Administration (FDA). Discussions are underway on a path forward to reopen the study.
Olpasiran (AMG 890)
•Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
•The OCEAN(a)-Outcomes trial, a Phase 3 cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a).
•A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a CV event is expected to be initiated in H2 2025 / H1 2026.
Repatha
•VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025.
•EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing.
Rare Disease
TAVNEOS
•A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA) / Microscopic Polyangiitis (MPA)).
TEPEZZA
•Regulatory review is underway in multiple additional geographies including with the European Medicines Agency (EMA) where approval is anticipated in H2 2025.
•A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic or low clinical activity score TED.
•A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED.
KRYSTEXXA
•Data were presented in November 2024 from the AGILE study evaluating the safety, tolerability and efficacy of KRYSTEXXA administered with a shorter infusion duration in patients with uncontrolled gout receiving methotrexate as co-administration:
◦Safety and efficacy data from the 60-minute infusion duration cohort of the AGILE trial are similar to the MIRROR randomized clinical trial and current administration of KRYSTEXXA with methotrexate over at least 120 minutes.
•U.S. Regulatory filing for AGILE is underway.
UPLIZNA
•In January 2025, the FDA granted UPLIZNA Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG) based upon data from the Phase 3 MINT study. Regulatory filing activities are underway with submission anticipated to be complete in H1 2025.
•In November 2024, data were presented and simultaneously published in the New England Journal of Medicine from the Phase 3 MITIGATE study evaluating UPLIZNA compared to placebo in patients with immunoglobin G4-related disease (IgG4-RD). In this study, UPLIZNA demonstrated a statistically significant 87% reduction in IgG4-RD flares, this primary endpoint and all key secondary endpoints were met. The safety results in the placebo-controlled period were consistent with the established safety profile of UPLIZNA.
•The FDA accepted the regulatory submission for the Phase 3 MITIGATE study under priority review with a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2025.
Dazodalibep
•Dazodalibep is a fusion protein that inhibits CD40L.
•Two Phase 3 studies of dazodalibep in Sjögren’s disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab
•Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
•A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
•A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
Fipaxalparant
•Fipaxalparant is a lysophosphatidic acid receptor 1 (LPAR1) antagonist.
•A Phase 2 study of fipaxalparant in patients with diffuse cutaneous systemic sclerosis is complete. The study did not meet the primary or secondary endpoints. Further development of fipaxalparant in this indication will be discontinued.
Inflammation
TEZSPIRE
•The Company is planning to initiate Phase 3 studies in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. Study initiation is anticipated in H1 2025.
•In December, the Company announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps:
◦Patients treated with TEZSPIRE had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
◦The safety profile and tolerability of TEZSPIRE in the trial were consistent with the known profile of the medicine.
◦Regulatory submission is anticipated in H1 2025.
•A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis.
•In severe asthma, the WAYFINDER Phase 3b study is complete and the PASSAGE Phase 4 real-world effectiveness study is ongoing. The SUNRISE Phase 3 study will be discontinued due to limited enrollment.
Rocatinlimab (AMG 451/KHK4083)
•Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor.
•The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3300 patients. Enrollment is now complete in seven studies.
•Key milestones from the ROCKET Phase 3 program:
◦ROCKET SHUTTLE is a 24-week study evaluating rocatinlimab in combination with topical corticosteroids and/or topical calcineurin inhibitors in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
◦ROCKET IGNITE is a 24-week study evaluating rocatinlimab monotherapy in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
◦ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
◦ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
•A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma.
•A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis.
Otezla
•In November 2024, we made six data presentations at the American College of Rheumatology (ACR). Notable highlights include:
◦Otezla reduces axial inflammation in patients with psoriatic arthritis (PsA) as assessed by CANDEN Magnetic Resonance Imaging Scoring, results From the Phase 4 MOSAIC study.
◦FOREMOST oligoarticular PsA data presentations (4 posters), including 48-week data and data at 16 weeks showing that Otezla was associated with fewer patients progressing from < 4 to > 4 active joints when compared to placebo suggesting that Otezla reduced the progression from oligoarticular to polyarticular PsA.
Blinatumomab
•Blinatumomab is a BiTE molecule targeting CD19.
•A Phase 2 study of blinatumomab in autoimmune disease was initiated in patients with systemic lupus erythematosus (SLE).
Inebilizumab
•Inebilizumab is a monoclonal antibody targeting CD19.
•A Phase 2 study of inebilizumab in autoimmune disease was initiated in patients with SLE.
Ordesekimab (AMG 714/PRV-015)
•Ordesekimab is a monoclonal antibody that binds interleukin-15.
•A Phase 2b study of ordesekimab, conducted by Provention Bio, a Sanofi Company, in patients with nonresponsive celiac disease was completed as planned and did not meet primary or secondary endpoints. No safety concerns were noted.
AMG 104 (AZD8630)
•AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab).
•A Phase 2 study is enrolling patients with asthma.
Oncology
BLINCYTO
•In December 2024, data from a Phase 3 study (AALL1731) conducted by the Children’s Oncology Group, were presented and simultaneously published in the New England Journal of Medicine. These data demonstrated that BLINCYTO added to chemotherapy significantly improves disease-free survival in newly diagnosed pediatric patients with National Cancer Institute standard risk B-cell precursor acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse.
•Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Philadelphia chromosome (Ph)-negative B-ALL.
•A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Ph-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025.
IMDELLTRA
•IMDELLTRA is a first-in-class delta-like ligand 3 (DLL3) targeting BiTE molecule.
•In 2024, IMDELLTRA received accelerated approval in the U.S. for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Marketing authorizations have subsequently been granted in Japan and in additional countries, including Canada, Brazil, Israel and Great Britain.
•The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage small cell lung cancer (SCLC):
◦DeLLphi-304, a Phase 3 study of IMDELLTRA in second-line ES-SCLC, is ongoing. Data readout is anticipated in H1 2025.
◦DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is enrolling patients with first-line ES-SCLC in the maintenance setting.
◦DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC.
◦DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
◦DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, was initiated.
◦DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC.
Xaluritamig (AMG 509)
•Xaluritamig is a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
•A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
•A Phase 1 monotherapy dose-expansion study of xaluritamig is enrolling mCRPC patients who have not yet received taxane-based chemotherapy and to enroll patients in a fully outpatient treatment setting to further improve administration convenience.
•A Phase 1 combination of xaluritamig with enzalutamide or abiraterone is enrolling patients with mCRPC in dose-escalation and dose-expansion respectively.
•A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high‐risk prostate cancer.
•A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
AMG 193
•AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
•A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
•A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
•A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies.
•A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract, and pancreatic cancers.
•A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients with advanced MTAP-null solid tumors.
Bemarituzumab
•Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
•FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in H1 2025.
•FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025.
•FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer.
•FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
LUMAKRAS/LUMYKRAS
•In January 2025, the FDA approved LUMAKRAS in combination with Vectibix as a targeted, biomarker-driven combination therapy for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-
approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
•CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC.
•Regulatory review by the EMA of the CodeBreaK 200 Phase 3 study of adults with previously treated locally advanced or metastatic KRAS G12C–mutated NSCLC concluded with the conditional status of marketing authorization maintained.
•CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
•The ongoing CB202 study is being conducted to serve as confirmatory study and to support conversion of accelerated/conditional approval to full approval, in the US, EU and other regions where applicable.
Nplate
•The primary analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. The Company continues to follow patients through a planned final analysis in H1 2025. Data presentation at a medical congress is anticipated in mid-2025.
Biosimilars
•A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO (nivolumab) is enrolling patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025.
•A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
•A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment.
•A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer.
•A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 and OCREVUS (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis.