Darbepoetin alfa

THOUSAND OAKS, Calif., May 2, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter 2024. "With many of our innovative products delivering strong growth and promising new medicines advancing through our pipeline, we are excited about delivering attractive long-term growth," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the first quarter, total revenues increased 22% to $7.4 billion in comparison to the first quarter of 2023. Product sales grew 22%, driven by 25% volume growth. Ten products delivered at least double-digit volume growth in the first quarter, including Repatha® (evolocumab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg), BLINCYTO® (blinatumomab), and TAVNEOS® (avacopan). U.S. volume grew 29% and ex-U.S. volume grew 17%. Our performance included $914 million of sales from our Horizon Therapeutics (Horizon) acquisition, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA® (teprotumumab-trbw), KRYSTEXXA® (pegloticase) and UPLIZNA® (inebilizumab-cdon). Excluding sales from Horizon, our product sales grew 6%, driven by volume growth of 9%. GAAP loss per share was $0.21 for the first quarter of 2024 compared with GAAP earnings per share (EPS) of $5.28 for the first quarter of 2023, driven by a mark-to-market loss on our BeiGene, Ltd. equity investment and higher operating expenses, including higher amortization expense from Horizon-acquired assets and incremental expenses from Horizon, partially offset by higher revenues. GAAP operating income decreased from $1.9 billion to $1.0 billion, and GAAP operating margin decreased 19.0 percentage points to 13.9%. Non-GAAP EPS decreased 1% from $3.98 to $3.96, due to higher operating and interest expenses driven by the Horizon acquisition, partially offset by higher revenues. Non-GAAP operating income increased from $2.8 billion to $3.1 billion, and non-GAAP operating margin decreased 5.1 percentage points to 43.2%. The Company generated $0.5 billion of free cash flow for the first quarter of 2024 versus $0.7 billion in the first quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by timing of working capital items. Product Sales Performance Total product sales increased 22% for the first quarter of 2024 versus the first quarter of 2023, driven by 25% volume growth. General Medicine Repatha® sales increased 33% year-over-year to $517 million in the first quarter, driven by 44% volume growth, partially offset by 13% lower net selling price. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 2.9 million patients treated since launch. Prolia® (denosumab) generated $999 million of sales in the first quarter. Sales increased 8% year-over-year primarily driven by volume growth. EVENITY® sales increased 35% year-over-year to $342 million for the first quarter, primarily driven by volume growth. Oncology BLINCYTO® sales increased 26% year-over-year to $244 million for the first quarter, driven by broad prescribing across academic and community segments for patients with B-cell precursor acute lymphoblastic leukemia (B-ALL). Vectibix® (panitumumab) generated $247 million of sales in the first quarter. Sales increased 6% year-over-year driven by higher net selling price and volume growth, partially offset by unfavorable foreign exchange impact. KYPROLIS® (carfilzomib) sales increased 5% year-over-year to $376 million for the first quarter, primarily driven by volume growth outside the U.S. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 11% year-over-year to $82 million for the first quarter, driven by volume growth. XGEVA® (denosumab) sales increased 5% year-over-year to $561 million for the first quarter, primarily driven by volume growth outside the U.S. and higher net selling price, partially offset by lower volume in the U.S. Nplate® (romiplostim) generated $317 million of sales in the first quarter. Sales decreased 12% year-over-year, primarily driven by volume decline in comparison to the first quarter of 2023, which included a U.S. government order of $82 million. Excluding the U.S. government order from this comparison, Nplate sales grew 13% year-over-year, primarily driven by volume growth. MVASI® (bevacizumab-awwb) generated $202 million of sales in the first quarter. Sales were flat year-over-year for the first quarter. Volume growth was largely offset by lower net selling price and unfavorable changes to estimated sales deductions. Going forward we expect continued net selling price erosion driven by competition. Inflammation TEZSPIRE® generated $173 million of sales in the first quarter. Sales increased 80% year-over-year, primarily driven by volume growth. Healthcare providers recognize TEZSPIRE's unique, differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe asthma who are uncontrolled, without any phenotypic or biomarker limitation. Otezla® (apremilast) generated $394 million of sales in the first quarter. Sales increased 1% year-over-year for the first quarter. Enbrel® (etanercept) generated $567 million of sales in the first quarter. Sales decreased 2% year-over-year driven by volume decline, partially offset by higher inventory levels. Moving forward, we expect modest volume growth offset by declining net selling price. Otezla and Enbrel typically have lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients work through deductibles. AMJEVITA®/AMGEVITA™ (adalimumab) generated $168 million of sales in the first quarter. Sales increased 2% year-over-year primarily driven by international growth, partially offset by lower inventory levels and unfavorable change to estimated sales deductions. Rare Disease Except for TAVNEOS®, the products listed below were added through the acquisition of Horizon on Oct. 6, 2023. TEPEZZA® (teprotumumab-trbw) generated $424 million of sales in the first quarter. TEPEZZA is the first and only FDA-approved treatment for thyroid eye disease (TED). KRYSTEXXA® (pegloticase) generated $235 million of sales in the first quarter. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout. UPLIZNA® (inebilizumab-cdon) generated $80 million of sales in the first quarter. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorders. TAVNEOS® generated $51 million of sales in the first quarter. Sales increased 122% year-over-year, 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 $169 million of sales in the first quarter. Established Products Our established products, which consist of EPOGEN® (epoetin alfa), Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide) and Neulasta® (pegfilgrastim), generated $613 million of sales. Sales decreased 19% year-over-year for the first quarter, driven by unfavorable changes to estimated sales deductions and volume declines. In the aggregate, we expect the year-over-year volume declines for this portfolio of products to continue. Product Sales Detail by Product and Geographic Region Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: Total Operating Expenses increased 54%. Cost of Sales as a percentage of product sales increased 15.6 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 27% due to higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs. Selling, General & Administrative (SG&A) expenses increased 44% primarily driven by commercial expenses related to Horizon-acquired products, general and administrative expenses, and acquisition-related costs. Other operating expenses consisted primarily of a net impairment charge for an in-process R&D asset and changes in contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. Operating Margin as a percentage of product sales decreased 19.0 percentage points in the first quarter to 13.9%. Tax Rate decreased 83.7 percentage points primarily due to the GAAP net loss described above and the change in earnings mix as a result of the inclusion of the Horizon business. On a non-GAAP basis: Total Operating Expenses increased 33%. Cost of Sales as a percentage of product sales increased 1.4 percentage points driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. R&D expenses increased 26% due to higher spend in later-stage clinical programs and marketed product support, including Horizon-acquired programs. SG&A expenses increased 40%, primarily driven by commercial expenses related to Horizon-acquired products, and general and administrative expenses. Operating Margin as a percentage of product sales decreased 5.1 percentage points in the first quarter to 43.2%. Tax Rate decreased 2.4 percentage points primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items in the quarter. Cash Flow and Balance Sheet The Company generated $0.5 billion of free cash flow in the first quarter of 2024 versus $0.7 billion in the first quarter of 2023. This decrease was driven by an $800 million tax deposit, partially offset by timing of working capital items. The Company's first quarter 2024 dividend of $2.25 per share was declared on December 12, 2023, and was paid on March 7, 2024, to all stockholders of record as of February 16, 2024, representing a 6% increase from this same period in 2023. Cash and investments totaled $9.7 billion and debt outstanding totaled $64.0 billion as of March 31, 2024. 2024 Guidance For the full year 2024, the Company now expects: Total revenues in the range of $32.5 billion to $33.8 billion. On a GAAP basis, EPS in the range of $7.15 to $8.40, and a tax rate in the range of 9.5% to 11.0%. On a non-GAAP basis, EPS in the range of $19.00 to $20.20, and a tax rate in the range of 15.0% to 16.0%. Capital expenditures to be approximately $1.1 billion. Share repurchases not to exceed $500 million. 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) A Phase 2 study of MariTide, a multispecific molecule that inhibits the gastric inhibitory polypeptide receptor (GIPR) and activates the glucagon like peptide 1 (GLP-1) receptor, in adults with overweight or obesity with or without type 2 diabetes mellitus is ongoing, with topline data anticipated in late 2024. Planning for a comprehensive Phase 3 program across multiple indications remains on track. AMG 786 A Phase 1 study of AMG 786, a small molecule obesity program, is complete. Olpasiran (AMG 890) The Ocean(a)-Outcomes trial, a Phase 3 cardiovascular outcomes study of olpasiran in patients with atherosclerotic cardiovascular disease and elevated Lp(a), is fully enrolled. Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver. Repatha EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of cardiovascular (CV) events, continues to enroll patients. VESALIUS-CV, a Phase 3 CV outcomes study of Repatha in patients at high CV risk without prior myocardial infarction or stroke, is ongoing. In April, data were presented from the FOURIER trial demonstrating that intensive LDL-C lowering with Repatha may lead to greater relative and absolute CV event reduction in patients with autoimmune or inflammatory diseases. In April, data were presented from the FOURIER and FOURIER-OLE studies demonstrating that elderly patients (≥75 years) with atherosclerotic cardiovascular disease derived similar to greater CV benefit compared to younger patients (<75 years) with early initiation of Repatha and up to 8.6 years of treatment with no significant safety concerns. Oncology Tarlatamab (AMG 757) The U.S. Food and Drug Administration (FDA) review of the Biologics License Application (BLA) for tarlatamab, a first-in-class investigational delta-like ligand 3 (DLL3) targeting BiTE® (bispecific T-cell engager) molecule in previously treated small cell lung cancer (SCLC) continues under priority review with a Prescription Drug User Fee Act (PDUFA) date of June 12, 2024. Additional regulatory submissions are underway or complete in countries outside of the U.S. Advancing a comprehensive global clinical development program in SCLC: DeLLphi-304, a Phase 3 study comparing tarlatamab with standard of care chemotherapy in second-line SCLC, continues to enroll patients. DeLLphi-305, a Phase 3 study comparing tarlatamab and durvalumab with durvalumab alone in first-line, extensive-stage SCLC, was initiated. DeLLphi-306, a Phase 3 study comparing tarlatamab with placebo following concurrent chemoradiation therapy in limited-stage SCLC is enrolling patients. DeLLphi-300, a Phase 1 study of tarlatamab in relapsed/refractory SCLC is ongoing. DeLLphi-302, a Phase 1b study of tarlatamab in combination with AMG 404, an anti-programmed cell death protein 1 (PD1) monoclonal antibody, in second-line or later SCLC, is ongoing. DeLLphi-303, a Phase 1b study of tarlatamab in combination with standard of care in first-line SCLC, continues to enroll patients. DeLLpro-300, a Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer, is ongoing. Initial data from this study will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in June. Additional data from the DeLLphi-301 Phase 2 trial, highlighting the efficacy and safety of tarlatamab analyzed by the presence of brain metastasis, will be presented at the ASCO annual meeting in June. BLINCYTO The FDA review of the supplemental BLA for BLINCYTO in early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) continues under priority review, with a PDUFA date of June 21, 2024. Additional regulatory submissions are underway or complete in countries outside of the U.S. Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy in older adults with newly diagnosed Philadelphia chromosome-negative (Ph-) B-ALL, continues to enroll patients. The Company is planning to advance blinatumomab subcutaneous administration through a registration enabling study, with initiation anticipated H2 2024 to H1 2025. A Phase 1/2 study of subcutaneous blinatumomab in adults with relapsed or refractory Ph- B-ALL continues to enroll patients. Xaluritamig (AMG 509) A Phase 1 monotherapy dose-expansion study of xaluritamig, a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) in metastatic castrate resistant prostate cancer has completed initial enrollment in the monotherapy portion of the study and continues to enroll subjects to explore reduced monitoring after treatment administration. An outpatient treatment cohort has also been initiated to improve administration convenience. A Phase 1 combination with abiraterone or enzalutamide continues to enroll patients in the dose-escalation phase, with plans to initiate expansion cohorts. Two additional Phase 1 studies of xaluritamig to evaluate preliminary efficacy and safety in patients with early prostate cancer are planned. AMG 193 A Phase 1/1b/2 study of AMG 193, a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor, continues to enroll patients with advanced methylthioadenosine phosphorylase (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 in patients with advanced MTAP-null thoracic tumors was initiated. A Phase 1b study of AMG 193 in combination with other therapies in patients with advanced MTAP-null gastrointestinal, biliary tract, or pancreatic cancers was initiated. A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients. Nplate A Phase 3 study of Nplate in chemotherapy-induced thrombocytopenia in gastrointestinal, pancreatic, or colorectal malignancies is fully enrolled. Data readout is anticipated in H2 2024. LUMAKRAS/LUMYKRAS A Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI in first-line KRAS G12C–mutated CRC is enrolling patients. A U.S. regulatory submission for the Phase 3 CodeBreaK 300 trial is on track for H1 2024. This study evaluated two doses of LUMAKRAS (960 mg or 240 mg) in combination with Vectibix in patients with chemorefractory KRAS G12C–mutated metastatic colorectal cancer (CRC). Overall survival (OS) data from the Phase 3 CodeBreaK 300 study of LUMAKRAS plus Vectibix vs. investigator's choice of therapy in KRAS G12C–mutated metastatic CRC will be presented at the ASCO annual meeting in June. A Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy in first-line KRAS G12C–mutated and programmed cell death protein ligand-1 (PD-L1) negative advanced non-small cell lung cancer (NSCLC) is enrolling patients. Regulatory review by the European Medicines Agency (EMA) of the CodeBreaK 200 Phase 3 trial of adults with previously treated locally advanced or metastatic KRAS G12C–mutated NSCLC along with data from the Phase 2 dose-comparison substudy is ongoing. Updated analysis from the CodeBreaK 101 trial investigating LUMAKRAS plus carboplatin and pemetrexed in KRAS G12C advanced NSCLC will be presented at the ASCO annual meeting in June. Bemarituzumab FORTITUDE-101, a Phase 3 study of bemarituzumab, a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody, plus chemotherapy in first-line gastric cancer, continues to enroll patients. FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer, continues to enroll patients in the Phase 3 portion of the study. FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab in first-line gastric cancer, continues to enroll patients. FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression, is ongoing. Inflammation TEZSPIRE A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary disease (COPD) is complete. Overall, TEZSPIRE numerically reduced the annualized rate of moderate or severe COPD exacerbations vs. placebo by 17% (90% CI: −6, 36; p=0.1042). Of note, more reductions were observed in a subgroup of patients with baseline BEC ≥ 150 cells/μL (37% [95% CI: 7, 57]). The trend in reduction was greater in a small number of subjects with BEC ≥ 300 cells/µL. Data will be presented at the American Thoracic Society Conference (ATS) later this month. A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with nasal polyps is fully enrolled. Primary analysis is anticipated in H2 2024. In severe asthma, the WAYFINDER Phase 3b study is fully enrolled. The PASSAGE Phase 4 real-world effectiveness study and the SUNRISE Phase 3 study continue to enroll patients. A Phase 3 study of TEZSPIRE in eosinophilic esophagitis continues to enroll patients. Rocatinlimab (AMG 451/KHK4083) The ROCKET Phase 3 program, evaluating rocatinlimab, a first in class monoclonal antibody targeting OX40, in moderate to severe atopic dermatitis, is composed of eight studies enrolling adult and adolescent patients. To date, over 2,800 patients have been enrolled in the ROCKET program with three studies having completed enrollment. The Phase 3 HORIZON study (part of the ROCKET program), evaluating rocatinlimab monotherapy vs. placebo in adults with moderate to severe atopic dermatitis, is fully enrolled. Data readout is anticipated in H2 2024. A Phase 2 study of rocatinlimab in moderate to severe asthma was initiated. A Phase 3 study of rocatinlimab in prurigo nodularis will be initiated in H2 2024. Otezla In April, the FDA granted pediatric exclusivity and approved Otezla for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This is the first pediatric indication for Otezla. In March, data were presented from: the SPROUT Phase 3 study, where 52 weeks of treatment with Otezla demonstrated sustained efficacy and safety in pediatric patients with moderate to severe plaque psoriasis. a Phase 3 study in Japanese Palmoplantar Pustulosis (PPP) patients where 16 weeks of treatment with Otezla demonstrated statistical significance for the primary efficacy endpoint, PPPASI 50 response, and for all secondary endpoints. Otezla improved disease severity, symptoms, and quality of life, with no new safety signals identified. These data will be submitted to regulators in Japan. Efavaleukin alfa (AMG 592) A Phase 2b study of efavaleukin alfa, an interleukin 2 (IL 2) mutein Fc fusion protein, in ulcerative colitis continues to enroll patients. Ordesekimab (AMG 714/PRV-015) A Phase 2b study of AMG 714, a monoclonal antibody that binds interleukin-15, in nonresponsive celiac disease has completed enrollment. AMG 104 (AZD8630) The Company plans to present data from the Phase 1 study of AMG 104, an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab), in healthy volunteers and patients with asthma, at ATS later this month. Rare Disease TAVNEOS A Phase 3, open-label, uncontrolled single-arm study to evaluate the efficacy, pharmacokinetics, and safety of TAVNEOS in combination with Rituximab or a cyclophosphamide-containing regimen in children from 6 years to < 18 years of age with active ANCA-associated vasculitis will be initiated in H2 2024. TEPEZZA Regulatory review of the New Drug Application (NDA) for TEPEZZA in Japan continues. Regulatory submissions for TEPEZZA were completed in Australia, Canada, Great Britain and the European Medicines Agency (EMA). A Phase 3 study of TEPEZZA in Japan for chronic or low clinical activity score TED continues to enroll patients. A Phase 3 study evaluating the subcutaneous route of administration of TEPEZZA in patients with TED was initiated. KRYSTEXXA The Phase 4 AGILE study of KRYSTEXXA with methotrexate evaluating a shorter infusion duration was completed. At the 60-minute infusion duration, 67.2% of patients (78 of 116) achieved a response. The safety profile was in line with the current administration of KRYSTEXXA with methotrexate over no less than 120 minutes. Detailed data will be presented at a future medical conference. UPLIZNA A Phase 3 study of UPLIZNA in myasthenia gravis is fully enrolled. Data readout is anticipated in H2 2024. A Phase 3 study of UPLIZNA for the prevention of flare in immunoglobulin G4- (IgG4) related disease is fully enrolled. Data readout is anticipated in H2 2024. Dazodalibep Two Phase 3 studies of dazodalibep, a CD40 (cluster of differentiation 40) ligand inhibitor fusion protein, 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 to no systemic disease activity. A manuscript based on data from the Phase 2 Dazodalibep Sjogren's disease study has been accepted for publication in Nature Medicine. Daxdilimab A Phase 2 study of daxdilimab, a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7), in moderate to severe active primary discoid lupus erythematosus refractory to standard of care is enrolling patients. A Phase 2 study of daxdilimab in dermatomyositis and antisynthetase inflammatory myositis is enrolling patients. Fipaxalparant (formerly AMG 670/HZN 825) A Phase 2 study of fipaxalparant, a lysophosphatidic acid receptor 1 (LPAR1) antagonist, in idiopathic pulmonary fibrosis has completed enrollment. Data readout is anticipated in H2 2024. A Phase 2 study of fipaxalparant in diffuse cutaneous systemic sclerosis is enrolling patients. Biosimilars The clinical comparative study portion of a randomized, double-blind pivotal study evaluating pharmacokinetic (PK) similarity of ABP 206 compared with OPDIVO® (nivolumab) in resected stage III or stage IV melanoma patients in the adjuvant setting is enrolling patients. The Company initiated a randomized, double-blind Phase 3 study to compare efficacy, pharmacokinetics, safety, and immunogenicity between ABP 234 and Keytruda® (pembrolizumab) in subjects with advanced or metastatic non-squamous non-small cell lung cancer. TEZSPIRE is being developed in collaboration with AstraZeneca. AMG 104 is being developed in collaboration with AstraZeneca Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin. Ordesekimab, formerly AMG 714 and also known as PRV-015, is being developed in collaboration with Provention Bio, a Sanofi Company. For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the first quarters of 2024 and 2023, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2024 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 2024 and 2023. 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 Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.  Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. ### CONTACT: Amgen, Thousand Oaks Jessica Akopyan, 805-440-5721 (media) Justin Claeys, 805-313-9775 (investors) * The known adjustments are presented net of their related tax impact, which amount to approximately $2.61 per share. (a) The adjustments primarily include noncash amortization of intangible assets and fair value step-up of inventory acquired in business combinations. 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. SOURCE Amgen

「  本文共：16条资讯，阅读时长约：3分钟 」今日头条安斯泰来ADC报sBLA。安斯泰来靶向Nectin-4的ADC药物Padcev（enfortumab vedotin）的上市申请获CDE受理，联合PD-1抑制剂Keytruda一线治疗局部晚期或转移性尿路上皮癌（la/mUC）。在Ⅲ期EV-302临床中，与化疗相比，Padcev/Keytruda组合显著延长了患者的PFS和OS，使疾病进展或死亡风险降低55%，死亡风险降低53%。目前，该药用于治疗既往接受PD-1/L1和含铂化疗的la/mUC患者的上市申请也正接受CDE审查。国内药讯1.荣昌眼科新药完成Ⅲ期临床入组。荣昌生物宣布其VEGF/FGF双靶点融合蛋白RC28-E治疗糖尿病性黄斑水肿（DME）的Ⅲ期临床已完成全部患者入组。目前，荣昌生物正在开展RC28-E与阿柏西普头对头的两项Ⅲ期临床试验，分别用于糖尿病性黄斑水肿（DME）和湿性年龄相关性黄斑变性（wAMD）。RC28-E同时拮抗VEGF和成纤维细胞生长因子（FGF），有望基于FGF与VEGF的协同作用，发挥更强的治疗作用同时延长给药间隔。2.友芝友双抗上恶性腹水III期临床。武汉友芝友生物自主研发的EpCAM/CD3双抗M701在用于肿瘤所致恶性腹水的支持性治疗的III期临床完成了首例患者入组。M701可通过CD3招募患者自身免疫T细胞，继而通过EpCAM引导免疫细胞靶向肿瘤细胞，最后启动T细胞杀伤肿瘤细胞，从而达到治疗腹水的效果。在Ⅰ期临床中，M701总体客观反应率达到62.5%，疾病控制率为100%，总生存时间中位数（mOS）为152天。3.O药联合治疗结直肠癌优先审评。百时美施贵宝PD-1抑制剂Opdivo（nivolumab）与CTLA-4抗体Yervoy（ipilimumab）组合方案获CDE拟纳入优先审批，用于一线治疗不可切除或转移性微卫星高度不稳定性（MSI-H）或错配修复缺陷型（dMMR）结直肠癌（CRC）患者。在III期CheckMate-8HW研究中，与化疗相比，这一组合方案使这类患者的疾病进展或死亡风险降低了79%（p<0.0001）。本月初，这两款新药用于治疗上述适应症已被纳入突破性治疗品种。4.上海甫康TKI获胃癌孤儿药资格。甫康药业自主研发高脑渗透性HER2 TKI创新药CVL009获FDA授予孤儿药资格，用于治疗胃癌（包括胃食管交界处癌）。CVL009属于不可逆的作用于泛HER家族的药物，不仅可以抗HER2，也可以抑制HER1和HER 4，从而阻止HER家族之间形成二聚体后的下游传导通道，作用机制更强效。在国内，CVL009治疗胃食管癌脑转移患者的II期临床即将在河南省肿瘤医院等中心开展。5.国产十五价HPV疫苗启动I期临床。康乐卫士与成大生物合作开发的重组十五价人乳头瘤病毒疫苗（大肠埃希菌）已登记启动一项I期临床，拟评价用于9-45周岁健康女性受试者接种该种疫苗的安全性、耐受性和免疫原性。据悉，这是全球价型最高的在研HPV疫苗，覆盖WHO指出的全部13个HPV高危型，以及与尖锐湿疣高相关的HPV6/11型。该项试验主要研究者为江苏省疾控中心李靖欣主任医师。国际药讯1.肾性贫血创新药获FDA批准上市。Akebia公司口服缺氧诱导因子脯氨酰羟化酶抑制剂（HIF-PHI） Vafseo（vadadustat）片剂获FDA批准上市，用于治疗接受透析至少三个月的慢性肾病（CKD）相关贫血患者。HIF会调控铁元素的动员和促红细胞生成素（EPO）的产生，以此刺激血红细胞的生成，从而改善氧气运输。在两项INNO2VATE研究中，与darbepoetin α（一种血红细胞刺激剂）相比，vadadustat治疗使患者的血红蛋白（Hb）水平较基线变化达到非劣效性标准。2.Syndax公司白血病新药获优先审评。Syndax 公司潜在“first-in-class”menin抑制剂revumenib的上市申请获FDA受理，用于治疗携带KMT2A重排（KMT2Ar）的复发/难治性急性白血病患者，同时FDA也授予其优先审评资格。在关键AUGMENT-101研究中，revumenib在携带KMT2Ar的急性白血病人群中达到23%（p=0.0036）的完全缓解（CR）率或带部分血液学恢复的完全缓解（CRh）率。此前，该新药这一适应症已被FDA授予突破性疗法认定。3.Novocure公司肿瘤电场疗法肺癌Ⅲ期临床积极。Novocure公司肿瘤治疗电场（TTFields）治疗非小细胞肺癌（NSCLC）的Ⅲ期临床METIS达到了主要终点。TTFields旨在通过多种机制施加物理外力，以抑制肿瘤细胞有丝分裂，进而抑制其生长。数据显示，与支持性护理相比，TTFields联合标准治疗显著延长了患者无颅内进展的时间（21.9个月vs11.3个月，P=0.016）；关键性次要终点的初步分析未显示出统计学意义。此外，再鼎医药拥有TTFields的中国权益。4.迷幻色胺抑郁症Ⅱ期临床积极。Beckley Psytech公司基于短效迷幻色胺5-MeO-DMT开发的创新配方BPL-003，在治疗耐药性抑郁症（TRD）的Ⅱa期研究中获积极结果。BPL-003（10mg）单剂量鼻腔给药第二天后，有55%的患者的MADRS评分降低超过50%；第4周时，实现MADRS评分小于10分的临床缓解率达到55%，且疗效维持至第12周。BPL-003总体耐受性良好，药物的急性效应平均在不到两小时内消退。5.罕见遗传性眼病基因疗法早期临床积极。Opus Genetics公司基因疗法OPGx-LCA5治疗LCA5型Leber先天性黑朦（LCA）患者的Ⅰ/Ⅱ期临床试验结果积极。OPGx-LCA5旨在使用腺相关病毒8（AAV8）载体将功能性LCA5基因精确递送到外层视网膜。首批患者给药90天期间，患者视网膜已显示出明显的生物活性迹象；且OPGx-LCA5耐受性良好。该公司计划将OPGx-LCA5推进到下一个最高剂量，并扩大研究人群，纳入13岁或以上的受试者。6.Synthekine公司新型CAR-T获批IND。Synthekine公司CD19 CAR-T产品 SYNCAR-001获FDA批准开展新药研究，联合正交的IL-2配体STK-009，评估联合用药治疗非肾性系统性红斑狼疮（SLE）和狼疮性肾炎（LN）患者的疗效。SYNCAR-001+STK-009是一种基于Synthekine专有正交配体—受体信号平台的细胞因子诱导细胞治疗方案，也是一种双组分疗法。通过利用Synthekine的正交IL-2技术，STK-009有望驱动SYNCAR-001细胞的植入和受控的细胞增殖，而无需进行淋巴清除。7.艾伯维购进FIC自免病小分子。艾伯维与自免病药物公司Landos Biopharma签订最终协议，将以超过2亿美元的总交易金额收购Landos，并获得该公司拟开发用于治疗溃疡性结肠炎（UC）的临床期主打项目NX-13。NX-13是一款潜在“first-in-class”口服NLRX1激动剂，旨在减少活性氧和氧化应激，并同时减少促炎信号，具有抗炎作用并促进上皮修复的潜力。此项交易预计将于2024年第二季度完成。医药热点1. 翁建平任安徽医科大学校长。日前，安徽省委决定，任命翁建平同志为安徽医科大学校长；郑兰荣接替翁建平，任蚌埠医科大学党委副书记、校长。翁建平是中国著名的内分泌专家。翁建平于2020年担任蚌埠医学院院长，2023年12月，蚌埠医学院更名蚌埠医科大学，翁建平出任校长。目前，翁建平还担任中国科学技术大学临床医学院执行院长。2.国家规范助产服务资源调整。3月27日，国家卫健委发布关于加强助产服务管理的通知，强化助产服务规划布局。通知强调，各级妇幼保健机构、二级以上公立综合医院、承担危重孕产妇救治中心任务的公立医疗机构、地广人稀地区的公立基层医疗卫生机构原则上应保障产科持续服务。其他公立医疗机构拟关停产科要广泛征求建档孕产妇意见，书面征求当地街道办事处(乡镇政府)和县级卫生健康行政部门意见，切实保障群众看病就医权益。3.北京3月30日起执行国采政策。据北京市医保局官网3月27日消息，自3月30日起，北京市全面执行第九批国家组织药品集中带量采购中选结果及医保支付标准等相关政策，采购周期至2027年12月31日。第九批国家组织药品集中带量采购涵盖感染、肿瘤、心脑血管疾病、胃肠道疾病、精神疾病等常见病和慢性病用药，以及急抢救药、短缺药等重点药品。本次集采共计41种药品，中选药品价格平均降幅58%。评审动态  1. CDE新药受理情况（03月28日) 2. FDA新药获批情况（北美03月27日）股市资讯上个交易日 A 股医药板块 +0.52%涨幅前三     跌幅前三明德生物+10.02%  新 产 业 -9.71%莱茵生物 +9.25%  绿康生化-8.97%凯因科技 +6.65%  *ST太安-5.11%【泰恩康】全资子公司山东华铂凯盛生物科技有限公司于近日收到国家药品监督管理局签发的富马酸卢帕他定片境内生产药品注册上市许可申请《受理通知书》。【莱美药业】公司参股公司四川康德赛医疗科技有限公司的一款自主研发用于治疗失代偿期肝硬化的巨噬细胞CUD005注射液获得药物临床试验默示许可并取得由国家药品监督管理局核准签发的《药物临床试验批准通知书》。 【百奥泰】2023年营业收入7.05亿元，同比增长54.86%，归母净利润-3.95亿元，同比下降17.87%。 - The End -戳“阅读原文”，了解更多医药研发及股市资讯。