Macular Edema

THOUSAND OAKS, Calif., May 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2025. "Demand for our products was strong globally in the first quarter. Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the first quarter, total revenues increased 9% to $8.1 billion in comparison to the first quarter of 2024. Product sales grew 11%, primarily driven by 14% volume growth, partially offset by 6% lower net selling price. U.S. sales grew 14%. Fourteen products delivered at least double-digit sales growth in the first quarter, including Repatha® (evolocumab), BLINCYTO® (blinatumomab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg), TAVNEOS® (avacopan) and UPLIZNA® (inebilizumab-cdon). Our launch of IMDELLTRA ® (tarlatamab-dlle) generated $81 million of sales in the quarter and the Phase 3 confirmatory study demonstrated improved overall survival compared to chemotherapy. IMDELLTRA ® launched in Japan in April 2025. GAAP earnings per share (EPS) were $3.20 for the first quarter of 2025 compared with a GAAP loss per share of $0.21 for the first quarter of 2024, resulting from an unrealized gain on our BeiGene, Ltd. equity investment during the first quarter of 2025 compared to an unrealized loss during the prior year period, partially offset by an Otezla® intangible asset impairment charge of $800 million recorded during the first quarter of 2025. GAAP operating income increased from $1.0 billion to $1.2 billion, and GAAP operating margin increased 1.1 percentage points to 15.0%. Non-GAAP EPS increased 24% from $3.96 to $4.90, driven by higher revenues, partially offset by higher operating expenses. Non-GAAP operating income increased from $3.1 billion to $3.6 billion and non-GAAP operating margin increased 2.5 percentage points to 45.7%. The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Repatha® (evolocumab) sales increased 27% year-over-year to $656 million in the first quarter, primarily driven by 41% volume growth, partially offset by 9% lower net selling price. EVENITY® (romosozumab-aqqg) sales increased 29% year-over-year to $442 million in the first quarter, driven by volume growth. Prolia® (denosumab) sales increased 10% year-over-year to $1.1 billion in the first quarter, primarily driven by 13% volume growth, partially offset by 5% lower net selling price. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year. Rare Disease TEPEZZA® (teprotumumab-trbw) sales decreased 10% year-over-year to $381 million in the first quarter, primarily driven by 9% lower volume and 8% from a decrease in inventory levels, partially offset by higher net selling price. KRYSTEXXA® (pegloticase) sales were flat year-over-year at $236 million in the first quarter, as 11% volume growth was offset by 10% from a decrease in inventory levels. UPLIZNA® (inebilizumab-cdon) sales increased 14% year-over-year to $91 million in the first quarter, primarily driven by volume growth. TAVNEOS® (avacopan) sales increased 76% year-over-year to $90 million in the first quarter, primarily driven by volume growth. Ultra-Rare products, which consist of RAVICTI® (glycerol phenylbutyrate), PROCYSBI® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), BUPHENYL® (sodium phenylbutyrate) and QUINSAIR® (levofloxacin), generated $179 million of sales in the first quarter. Sales increased 6% year-over-year for the first quarter, driven by volume growth. Inflammation TEZSPIRE® (tezepelumab-ekko) sales increased 65% year-over-year to $285 million in the first quarter, driven by volume growth. Otezla® (apremilast) sales increased 11% year-over-year to $437 million in the first quarter, driven by 12% favorable changes to estimated sales deductions, as volume growth of 4% was offset by 5% lower net selling price. Enbrel® (etanercept) sales decreased 10% year-over-year to $510 million in the first quarter, driven by 47% lower net selling price resulting from increased 340B Program mix and higher commercial discounts, partially offset by 19% favorable changes to estimated sales deductions, higher inventory levels and volume growth. The year-over-year impact on net selling price is expected to be less pronounced in future quarters. AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales decreased 19% year-over-year to $136 million in the first quarter, primarily driven by 33% lower net selling price, partially offset by 11% volume growth. WEZLANA™ (ustekinumab-auub)/WEZENLA™ (ustekinumab) generated $150 million of sales in the first quarter. WEZLANA launched in the U.S. in the first quarter of 2025 and is the first FDA-approved biosimilar for the treatment of adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. PAVBLU® (aflibercept-ayyh) generated $99 million of sales in the first quarter. PAVBLU launched in the U.S. in the fourth quarter of 2024 and is the first available aflibercept biosimilar for the treatment of retinal conditions, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. Oncology BLINCYTO® (blinatumomab) sales increased 52% year-over-year to $370 million in the first quarter, primarily driven by volume growth. Vectibix® (panitumumab) sales increased 8% year-over-year to $267 million in the first quarter, driven by volume growth. KYPROLIS® (carfilzomib) sales decreased 14% year-over-year to $324 million in the first quarter, driven by lower volumes due to increased competition. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 4% year-over-year to $85 million in the first quarter, driven by volume growth, partially offset by lower net selling price. XGEVA® (denosumab) sales increased 1% year-over-year to $566 million in the first quarter. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year. Nplate® (romiplostim) sales decreased 1% year-over-year to $313 million in the first quarter as volume growth was more than offset by unfavorable changes to estimated sales deductions and foreign exchange impact. IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) generated $81 million of sales in the first quarter. Sales increased 21% quarter-over-quarter driven by volume growth. MVASI® (bevacizumab-awwb) sales decreased 11% year-over-year to $179 million in the first quarter, primarily driven by lower volume. Going forward, we expect continued sales erosion driven by competition. Established Products Our established products, which consist of Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide) and Neulasta® (pegfilgrastim), generated $557 million of sales in the first quarter. Sales decreased 3% year-over-year for the first quarter, driven by 10% lower net selling price and 3% unfavorable foreign exchange impact, partially offset by favorable changes to estimated sales deductions. Product Sales Detail by Product and Geographic Region Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: Total Operating Expenses increased 8% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 7.3 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by changes in our sales mix. Research & Development (R&D) expenses increased 11% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. Selling, General & Administrative (SG&A) expenses decreased 7% driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses, partially offset by higher general and administrative expenses. Other operating expenses consisted primarily of the Otezla® intangible asset impairment charge of $800 million. Operating Margin as a percentage of product sales increased 1.1 percentage points in the first quarter to 15.0%. Tax Rate increased 78.5 percentage points in the first quarter due to the change in earnings mix as a result of the first quarter 2025 unrealized gains compared to the first quarter 2024 unrealized losses on our equity investments, primarily BeiGene. On a non-GAAP basis: Total Operating Expenses increased 4% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 0.8 percentage points driven by lower manufacturing costs, partially offset by changes in our sales mix. R&D expenses increased 12% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. SG&A expenses decreased 3% driven by lower commercial product-related expenses, partially offset by higher general and administrative expenses. Operating Margin as a percentage of product sales increased 2.5 percentage points in the first quarter to 45.7%. Tax Rate decreased 0.8 percentage points in the first quarter due to the change in earnings mix and net favorable items as compared to the prior year. Cash Flow and Balance Sheet The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures. The Company declared a first quarter 2025 dividend on December 10, 2024 of $2.38 that was paid on March 7, 2025 to all stockholders of record as of February 14, 2025, representing a 6% increase from the same period in 2024. During the first quarter of 2025, the Company reduced principal debt outstanding by $2.8 billion. During the first quarter, there were no repurchases of shares of common stock. Cash and cash equivalents totaled $8.8 billion and debt outstanding totaled $57.4 billion as of March 31, 2025. 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 $12.21 to $13.46, 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 14.5% to 16.0%. Capital expenditures to be approximately $2.3 billion. Share repurchases not to exceed $500 million. This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. First 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 the gastric inhibitory polypeptide receptor (GIPR). MARITIME-1, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, without Type 2 diabetes mellitus. MARITIME-2, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, with Type 2 diabetes mellitus. Planning for additional MARITIME Phase 3 studies across multiple indications remains on track, with additional studies expected to initiate throughout 2025. Part 2 of the Phase 2 chronic weight management study is ongoing in adults 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 has completed enrollment of adults living with and without obesity. Data readout is anticipated in H2 2025. AMG 513 A Phase 1 study of AMG 513 is enrolling people living with obesity following removal of the clinical hold by the U.S. Food and Drug Administration (FDA). 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. 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 secondary prevention 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 first CV event is expected to be initiated in H2 2025/H1 2026. 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/low clinical activity score thyroid eye disease (TED). A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED. UPLIZNA In April, the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) in adult patients. In April, data from the UPLIZNA Phase 3 MINT study in patients with generalized myasthenia gravis (gMG) were presented and simultaneously published in the New England Journal of Medicine. These data demonstrated durable and sustained efficacy of UPLIZNA treatment compared to placebo (adjusted difference, -1.8 at week 26; −2.8 at week 52) as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the acetylcholine receptor autoantibody-positive (AChR+) subpopulation through week 52. Among the AChR+ patients in the UPLIZNA group, 72% had a ≥3 point improvement in the MG-ADL score, compared to 45% in placebo at week 52. No new safety signals were identified. The FDA has accepted the regulatory submission of the MINT Phase 3 data with a PDUFA date of December 14, 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. Inflammation TEZSPIRE Two Phase 3 studies of TEZSPIRE were initiated and are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. In March, data from the Phase 3 WAYPOINT study of TEZSPIRE in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) were presented and simultaneously published in the New England Journal of Medicine demonstrating that treatment with TEZSPIRE: significantly reduced Nasal Polyp Score (NPS) by -2.065 at week 52. significantly reduced nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 at week 52. Improvements in NPS were observed as early as week four, and NCS as early as week two, and were sustained through week 52. significantly reduced the need for nasal polyp surgery by 98%. significantly reduced the need for systemic corticosteroid treatment by 88%. had a safety profile consistent with its approved severe asthma indication. The FDA has accepted the regulatory submission of the WAYPOINT Phase 3 data with a PDUFA date of October 19, 2025. A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis. Rocatinlimab (AMG 451/KHK4083) Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells. The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete in seven studies. In March, detailed data were presented from the ROCKET HORIZON Phase 3 study, which met its co-primary and all key secondary endpoints. In March, data were announced from three additional ROCKET program Phase 3 studies: The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints at week 24: 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo. In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo. 23.6% of patients in the higher dose group achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1), a 14.9% difference vs. placebo. In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo. 22.7% of patients in the higher dose group achieved a revised Investigator's Global Assessment (rIGA™) score of 0/1 with a ≥2-point reduction from baseline (a more stringent measure of efficacy than vIGA-AD 0/1), a 14.4% difference vs. placebo. In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo. The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI), met its co-primary endpoints and all key secondary endpoints at week 24. The VOYAGER study, which successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations. Across ROCKET program results to date, safety findings were generally consistent with the previously observed safety profile of rocatinlimab. The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs. placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%. Key upcoming milestones from the ROCKET Phase 3 program: 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 (PN). Blinatumomab Blinatumomab is a bispecific T-cell engager (BiTE ®) molecule targeting CD19. A Phase 2 study of blinatumomab in autoimmune disease was initiated in adults with systemic lupus erythematosus (SLE). Inebilizumab Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19. A Phase 2 study of inebilizumab in autoimmune disease was initiated in adults with SLE. 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 / blinatumomab In April, the FDA granted Breakthrough Therapy Designation for subcutaneous blinatumomab in the treatment of adults with relapsed/refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (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 Philadelphia chromosome (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. Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Ph-negative B-ALL. IMDELLTRA / tarlatamab IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE® molecule. In April, the Company announced that the global Phase 3 DeLLphi-304 study met its primary endpoint of improved overall survival at a planned interim analysis. This study evaluated IMDELLTRA compared to local standard-of-care chemotherapy as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy. The safety profile for IMDELLTRA was consistent with its known profile. Together these randomized data have the potential to establish IMDELLTRA as a new standard of care in second-line SCLC. Detailed data from DeLLphi-304 will be presented at the American Society of Clinical Oncology meeting (ASCO) in June. The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage SCLC: 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. 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, is enrolling patients. DeLLphi-310, a Phase 1b study, was initiated in patients with ES-SCLC evaluating IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without anti-PD-L1. DeLLphi-312, a Phase 3 study of first-line IMDELLTRA with carboplatin, etoposide and durvalumab is planned to initiate in patients with ES-SCLC by mid-2025. Xaluritamig (AMG 509) Xaluritamig is a first-in-class BiTE® 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 study of xaluritamig monotherapy has completed enrollment of patients with mCRPC who have not yet received taxane-based chemotherapy and has also completed enrollment of patients with mCPRC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. This study continues to enroll mCRPC patients into a combination treatment of xaluritamig and abiraterone. 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, will be discontinued following a wind-down period. 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 Q2 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 CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC. 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. Nplate The final analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. Data from this study will be presented at ASCO in June. Biosimilars A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO® (nivolumab) has completed enrollment of 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 compared to OCREVUS® (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis. 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. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink. 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 first quarters of 2025 and 2024, 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 first quarters of 2025 and 2024. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's 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 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 us on X (formerly known as Twitter), 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), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, 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, including those resulting from geopolitical relations and government actions. 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. 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, 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 sustainability 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) 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. The stated guidance also includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. SOURCE Amgen WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

PALO ALTO, Calif., May 1, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced today that seven scientific presentations on its research programs will be made at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting, being held from May 4-8 in Salt Lake City, Utah. "We are pleased to share new data from Kodiak's research and development efforts at this year's ARVO meeting. This body of work further highlights the power and versatility of Kodiak's ABC® (Antibody Biopolymer Conjugate) platform for the design and development of new medicines for complex multifactorial diseases with a high unmet need," said Dr. Victor Perlroth, MD and Chief Executive Officer. "Our bispecific protein platform, the basis for KSI-101 currently in clinical development for macular edema secondary to inflammation (MESI), is fueling two new research programs in two new therapeutic categories: ocular inflammatory disease and geographic atrophy. We also present new data from our ABC® platform extension in which we embed diverse therapeutic payloads, such as oligonucleotides and peptides, into the biopolymer backbone at a high drug-antibody ratio (DAR) and deliver these payloads into targeted cells. We believe this is a promising strategy to power a next generation of targeted, high-DAR, multi-specific and multi-modality therapeutic candidates with relevance for retinal and systemic diseases." The seven poster presentations are listed below, grouped by topic. The posters will also be made available under Kodiak's "Scientific Presentations" page on kodiak.com. Ocular Inflammatory Disease Ocular inflammatory disease, often called uveitis, is the fourth leading cause of vision loss for working aged adults in the developed world. One-third of patients with ocular inflammation develop macular edema, which is the leading cause of vision loss among patients with ocular inflammation. Steroids remain the mainstay treatment but can cause significant and permanent ocular adverse effects especially with long-term use or high doses. This body of work demonstrates Kodiak's strong protein engineering expertise to design innovative therapies, including KSI-101 (currently in Phase 1b) and KSI-102, by targeting the underlying and complex cytokine interactions underlying chronic inflammatory ocular diseases. 1. Title: Development of Anti-inflammatory Bispecific anti-TNF-α VHH anti-IL-6 Antibody Fusion for the Treatment of Inflammatory Retinal Diseases Session Title: Anti-inflammatory agents, ocular toxicity, cytokines and growth factors Presentation Date and Time: May 4, 2025; 8:00 – 9:45 AM (MT) Presentation Type: Poster Session Poster Number: 195-A0416 Elevated levels of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) play distinct yet complementary roles in driving inflammatory retinal diseases such as non-infectious uveitis. Treatments targeting these cytokines individually may fail to control inflammation in a comprehensive manner. Here we present preclinical data of KSI-102, a novel bispecific antibody that potently inhibits both TNF-α and IL-6 simultaneously, offering enhanced therapeutic potential for inflammatory ocular diseases. 2. Title: Preserving Endothelial Barrier Function with Novel Bispecific Anti-Inflammatory Agents for the Treatment of Retinal Inflammatory Diseases Session Title: Anti-inflammatory agents, ocular toxicity, cytokines and growth factors Presentation Date and Time: May 4, 2025; 8:00 – 9:45 AM (MT) Presentation Type: Poster Session Poster Number: 196-A0417 Inflammation contributes to ocular disease by triggering a cascade of pathological events, including disruption of the blood-retinal-barrier and recruitment of immune cells to retinal tissues. These processes can lead to edema and tissue damage, which are hallmark features of conditions such as macular edema and uveitis. Adalimumab is an anti-TNF-α biologic approved as a steroid-sparing agent for the treatment of non-infectious uveitis (NIU). However, more than 50% of patients with NIU experienced treatment failure over 85 weeks in the VISUAL I trial. This preclinical presentation demonstrates that Kodiak's anti-TNF-α, anti-IL-6 fusion protein normalizes human endothelial morphology and junctional proteins better than monotherapy agents. 3. Title: Ocular Toxicity Study of KSI-101 Demonstrates Tolerability after Intravitreal Administration in Cynomolgus Monkeys Session Title: Retina/RPE: New drugs, mechanisms of action, and toxicity Presentation Date and Time: May 8, 2025; 11:45 AM – 1:30 PM (MT) Presentation Type: Poster Session Poster Number: 5998-A0183 KSI-101 is a first-in-class, local, high-strength bispecific protein in clinical development for the treatment of macular edema secondary to inflammation (MESI). Early clinical data of KSI-101 in the Phase 1b APEX study, which is enrolling patients with MESI, demonstrates that at all dose levels, KSI-101 rapidly normalizes macular edema and improves vision. To inform and support further clinical development of KSI-101, which has demonstrated a positive safety profile in patients, here we demonstrate that repeated bilateral intravitreal administration of KSI-101 in non-human primates was safe and well tolerated. The following poster was developed in collaboration with Chang Gung Memorial Hospital, Department of Ophthalmology: 4. Title: Systemic Review of Uveitic Macular Edema (UME) Outcomes in Children Versus Adults Session Title: Uveitis Epidemiology and Clinical Characterization Presentation Date and Time: May 6, 2025; 8:30-10:15 AM (MT) Presentation Type: Poster Session Poster Number: 2849-A0142 Macular edema secondary to inflammation affects adults and children, with differing underlying causes, inflammation patterns and clinical presentations. Treatment options vary by etiology, and steroids are generally avoided in children due to serious adverse effects. This study highlights the serious impact UME in particular has on vision, especially in children, and underscores the critical need for dedicated research and the development of safe and effective therapies tailored for pediatric UME. Geographic Atrophy Geographic atrophy (GA), the advanced form of dry age-related macular degeneration, affects approximately one million patients in the U.S. and is characterized by atrophic lesions in the retina that progressively expand to the central macular and fovea, leading to irreversible vision loss. Currently there are two approved therapies for GA, both are anti-complement therapies that offer modest therapeutic benefit and require monthly or every other month intravitreal injections. 5. Title: Development of Potent Bispecific Inhibitors Targeting Complement Activation and Cytokines for the Treatment of Geographic Atrophy (GA) Session Title: New drugs, delivery systems, and mechanisms of action II Presentation Date and Time: May 7, 2025; 10:15 AM – 12:00 PM (MT) Presentation Type: Poster Session Poster Number: 4337-A0493 Here we present new data on a promising therapeutic strategy to treat GA by combining complement regulators with an anti-VEGF antibody to prevent wet AMD conversion and anti-IL-6 antibody to further reduce GA progression, to achieve potent concurrent inhibition of complement pathway activation and VEGF pathway signaling. Enhancing Therapeutic Efficacy with the ABCD Platform Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs) are promising platforms for targeted drug delivery but have a limited drug-antibody ratio (DAR), which poses significant challenges in optimizing therapeutic efficacy. Kodiak's Antibody Biopolymer Conjugate Drug (ABCD) platform addresses this limitation by utilizing a customizable biopolymer to enable the design and development of multifunctional, high DAR therapeutics for ophthalmic and systemic applications. 6. Title: Delivery of Therapeutic Oligonucleotides by Antibody Biopolymer Conjugates (ABC®) Session Title: New drugs, delivery systems, and mechanisms of action II Presentation Date and Time: May 7, 2025; 10:15 AM – 12:00 PM (MT) Presentation Type: Poster Session Poster Number: 4334-A0490 Here we demonstrate the intracellular drug delivery capability and target knockdown potency of Antibody Biopolymer Conjugate Oligonucleotides (ABCO) in the target cells, providing a proof of concept for ABC® mediated intracellular delivery of oligonucleotide therapeutics. We demonstrate that (a) anti-TfR1 ABCO maintains high binding affinity to TfR1, (b) the antibody and its conjugates exhibit concentration dependent uptake in HepG2 cells, enabling delivery of RNA payloads, and (c) anti-TfR1 ABCOs with siRNA or ASO effectively modulate target gene expression. 7. Title: Effect of Polymer Architecture on Properties of Antibody Biopolymer Conjugates Session Title: New drugs, delivery systems, and mechanisms of action II Presentation Date and Time: May 7, 2025; 10:15 AM – 12:00 PM (MT) Presentation Type: Poster Session Poster Number: 4325-A0481 This study demonstrates how polymer architecture, specifically molar mass and number of arms in homopolymers, influences conjugate properties and explores the role of structural design. These findings guide optimization and further development of biopolymer conjugated therapeutic candidates with Kodiak's ABCD platform. About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform® uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfolio of three clinical programs, two of which are late-stage today and derived from our ABC Platform and one which is platform-independent and which we believe can progress rapidly into pivotal studies. Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases. Tarcocimab is currently being studied in two Phase 3 clinical trials, GLOW2 in patients with diabetic retinopathy and DAYBREAK in patients with wet AMD. GLOW2 enrollment is complete, and DAYBREAK is actively enrolling patients. KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy. The Phase 3 DAYBREAK study of KSI-501 in wet AMD is actively enrolling patients. KSI-101, our third product candidate, is a novel anti-IL-6, VEGF-trap bispecific protein. Kodiak is developing KSI-101 for the treatment of retinal inflammatory diseases, as currently there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina. The Phase 1b APEX study of KSI-101 is actively enrolling patients, as a precursor to activating the Phase 2b/3 PEAK and PINNACLE studies in patients with macular edema secondary to inflammation ("MESI"). Kodiak is advancing its platform technology to embed small molecules and other active pharmaceutical ingredients ("APIs") into Kodiak's proprietary biopolymer backbone to enable high drug-antibody-ratio ("DAR") medicines. The diverse APIs are designed to be released over time to achieve targeted, multi-specific and tailored modulation of biological pathways. The unique combination of high DAR and tailored therapeutic benefit offers potential for broad application to multifactorial diseases and builds directly from our Antibody Biopolymer Conjugate technology and its 15 years of design, development and manufacturing experience. We call this platform extension our Antibody Biopolymer Conjugate Drug ("ABCD") Platform because we are extending our platform capabilities to include the conjugation of small molecule drugs and other APIs whereas historically, we primarily conjugated biologics such as antibodies. For more information, please visit www.kodiak.com. Kodiak®, Kodiak Sciences®, ABC®, ABC Platform®, ABCD™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions Forward-Looking Statements This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: the power and versatility of Kodiak's ABC® platform; the enhanced therapeutic potential of KSI-102 for inflammatory ocular diseases; the potential of KSI-101 for the treatment of MESI; the potential for Kodiak's ABCD platform to enable the design and development of multifunctional, high DAR therapeutics for ophthalmic and systemic applications; and the optimization and further development of biopolymer conjugated therapeutic candidates with Kodiak's ABCD platform. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "could," "expect," "plan," "believe," "intend," "pursue," and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that cessation, modification or delay of any of the ongoing clinical studies may occur; the risk that our research and development efforts and our ability to advance our product candidates into later stages of development may fail; the risk that any one or more of our product candidates may not be successfully developed, approved or commercialized; the risk that adverse economic conditions may significantly impact our business and operations, including our clinical trial sites, and those of our manufacturers, contract research organizations or others with whom we conduct business; the risk that sufficient capital may not be available as expected, or at all, to complete the development of any products; as well as the other risks identified in our filings with the Securities and Exchange Commission (SEC). For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. View original content:https://www.prnewswire.com/news-releases/kodiak-sciences-data-at-arvo-2025-highlight-power-and-versatility-of-abc-platform-in-addressing-complex-multifactorial-ocular-diseases-302444839.html SOURCE Kodiak Sciences Inc. John Borgeson, Chief Financial Officer, Tel (650) 281-0850, ir@kodiak.com

Regeneron’s higher-dose version of Eylea, Eylea HD, grew U.S. sales 54% in the first quarter to $307 million. Still, those gains weren’t enough to offset a significant sales decline for the original version of the drug. After consecutive setbacks at the FDA, Regeneron's string of recent troubles with its Eylea franchise is continuing to pull down the drugmaker.Over the first three months of 2025, Regeneron's sales from the Eylea franchise—approved in a range of retinal conditions like macular degeneration and diabetic retinopathy—fell 26% versus 2024’s first quarter, the company said in a Tuesday press release. Overall, the franchise generated $1.04 billion during the quarter.Digging into the numbers, standard Eylea’s U.S. sales dropped 39% in the first quarter to $736 million, missing Wall Street’s consensus sales estimate by nearly $100 million, analysts at Evercore ISI wrote in a note to clients Tuesday.Meanwhile, Regeneron’s newer and higher-dose version of the eye med, Eylea HD, grew U.S. sales 54% over the same period in 2024 to $307 million. Still, those gains weren’t enough to offset a significant sales decline for the franchise overall between January and March. On a conference call Tuesday, CEO Leonard Schleifer, M.D., Ph.D., was quick to admit that Regeneron’s performance in the first quarter was “mixed.”The New York drugmaker endured “some difficult news related to our retinal franchise,” which was otherwise “offset by encouraging news relating to the rest of our commercial portfolio,” Schleifer explained.Commenting on the Eylea franchise’s struggles in the quarter, the CEO noted that the overall size of the branded anti-VEGF category “contracted” during the first three months of the year. Schleifer attributed the shift to more patients using off-label bevacizumab—aka Avastin—to treat their retinal conditions, which is likely being driven by affordability issues linked to funding gaps at copay assistance foundations, he argued. Avastin, while mainly used to treat cancer, works similarly to Eylea by blocking the vascular endothelial growth factor (VEGF) protein, which plays a key role in the formation of blood vessels.Executives at Roche—which offers its own VEGF inhibitor, Vabysmo, that competes directly with Eylea in many indications—also commented on a branded VEGF market contraction in 2025’s first quarter during an earnings call last week, the Evercore analysts pointed out in their note.Roche's Vabysmo sales reached 1.02 billion Swiss francs ($1.2 billion) during the first quarter, an 18% increase worldwide.The other shoe drops While Regeneron remains confident that Eylea HD sales will continue to grow over time, copay problems and off-label Avastin use aren’t all there is to the saga of the VEGF franchise’s recent stumbles.Alongside the financial details on its first-quarter performance, Regeneron also revealed that the FDA last week rejected the company’s application for a prefilled syringe version of Eylea HD. Just days before that complete response letter, the FDA also rebuffed Regeneron’s bid to win extended dosing intervals for Eylea HD across all the med’s approved indications.Transitioning U.S. Eylea HD patients to a prefilled syringe—versus the current vial and needle format—forms a “critical component” in the product’s evolution and is “necessary to be competitive with Roche’s Vabysmo,” the Evercore analysts said in Tuesday’s note.Schleifer, for his part, expressed disappointment with the FDA's decision and sought to provide clarity on the situation following “several teleconferences” with the agency in the aftermath of last week’s rejection.The FDA’s issue appears to come down to a “third-party component supplier,” Schleifer said, referring to a contractor responsible for, at least in part, producing the prefilled syringe device itself.“Based on our conversations with the FDA, we believe that there’s one key issue that is left to resolve,” Schleifer said, without identifying the contractor by name. “There are a few other minor ones, which I think were just clarification, but the one key issue relates to a supplier, and the supplier has told us that the FDA asked for some data.”The supplier already had the data needed and turned the information over to the FDA posthaste following the rejection, Schleifer said.Eylea HD is already approved in the EU as a prefilled syringe using the same device, design and components that are included in Regeneron’s U.S. application, the Evercore team noted.Although Regeneron expects the Eylea HD prefilled syringe will eventually win approval in the U.S., Schleifer admitted that there remains “a little bit of uncertainty on how fast this could all get resolved.”The Evercore team noted that the prefilled syringe rejection represents the latest in a “laundry list of CRLs” that Regeneron’s Eylea HD has received since an initial FDA rebuff over third-party manufacturing issues in June 2023.Still, Schleifer was quick to defend his company, noting that he feels Regeneron’s regulatory and manufacturing teams are “first rate.”“The kinds of issues that have come up are reflecting, in my view, an increased scrutiny by the FDA—post-COVID—on contract manufacturers,” Schleifer said.“I think the FDA is trying to step up the game, if you will, of these contract manufacturers,” the CEO added. “And since we’re so active, we see more.”The long view Despite Eylea HD’s recent setbacks, Regeneron is far from throwing in the towel, with additional reviews currently underway at the FDA to attempt to push the medicine into macular edema following retinal vein occlusion and to secure a potential shift to monthly dosing.“While we expect competitive pressures for Eylea to persist, our focus remains on promoting the ongoing adoption of Eylea HD, which has the potential to become the new standard of care,” Regeneron’s executive vice president of commercial, Marion McCourt, said on the company’s conference call.“With these label enhancements and anticipated approval of the prefilled syringe, we expect to see an acceleration in Eylea HD demand,” McCourt said.Regeneron posted its Eylea updates as the company reported total first-quarter sales of $3 billion, a 4% decrease compared to the same period last year. As for the rest of Regeneron’s commercial medicine chest, cancer med Libtayo grew total sales—both in the U.S. and beyond—by 8% to $285 million for the quarter. Regeneron’s next highest-earning drug, cholesterol med Praluent, suffered a 19% sales decline to $57 million in the U.S.The company also shares sales on the immunology megablockbuster Dupixent with French drugmaker Sanofi. Last week, Sanofi reported first-quarter Dupixent sales of 3.5 billion euros (roughly $4 billion). Sanofi is anticipating that annual sales of Dupixent could reach a whopping $22 billion by the end of the decade. After Regeneron reported its first-quarter results, the company's share price dropped by about 6% on Tuesday afternoon.