Avelumab

Primary results from the Phase II ARACOG (AFT-47) head-to-head trial evaluating NUBEQA ® (darolutamide) versus enzalutamide in men with metastatic and non-metastatic castration-resistant prostate cancer (CRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) will be presented Bayer will also present data from across its oncology portfolio, including XOFIGO ® (radium-223 dichloride), HYRNUO ® (sevabertinib), VITRAKVI ® (larotrectinib), and STIVARGA ® (regorafenib) WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that new data from studies across their oncology portfolio will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from May 29–June 2. In total, 16 abstracts will be presented spanning multiple cancer types, including prostate cancers, breast cancer, lung cancers, salivary gland cancer, renal cell carcinoma and colorectal cancers, further supporting Bayer’s commitment to the research of treatments for cancers and encouraging scientific exchange. Primary results from the Phase II ARACOG (AFT-47) head-to-head trial evaluating NUBEQA® (darolutamide) versus enzalutamide in men with metastatic and non-metastatic castration-resistant prostate cancer (CRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) will be presented as an oral abstract and are additionally featured in the ASCO 2026 Annual Meeting Press Program. Data from a subgroup post-hoc analysis of the investigational Phase III ARANOTE trial investigating prostate-specific antigen outcomes of NUBEQA plus androgen deprivation therapy (ADT) in patients with metastatic castration-resistant prostate cancer (mCSPC) will also be presented. NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1 Presentations will also highlight data from two trials investigating the safety and efficacy of XOFIGO® (radium-223 dichloride). Results from the Phase II RADICAL IR-US (Alliance A031801) randomized trial evaluating XOFIGO plus cabozantinib in patients with renal cell carcinoma (RCC) with bone metastases (BM) will be presented as an oral abstract session. Data from the Phase II ETCTN 10302 trial investigating XOFIGO in combination with paclitaxel in patients with metastatic breast cancer will be presented as a poster session. XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.2 XOFIGO is not approved in this investigational indication in combination with enzalutamide. Details on selected abstracts from Bayer at the 2026 ASCO Annual Meeting follow: NUBEQA (darolutamide) Cognitive effects of darolutamide vs enzalutamide: Results of ARACOG (AFT-47), a randomized clinical trial from the Alliance for Clinical Trials in Oncology Abstract: 5005; May 30, 4:24 p.m.–4:36 p.m. CDT Abstract: 5005; May 30, 4:24 p.m.–4:36 p.m. CDT Prostate-specific antigen outcomes of darolutamide and androgen deprivation therapy in patient subgroups by age, comorbidities, and concomitant medications: ARANOTE post hoc analyses Abstract: 5103; May 31, 9:00 a.m.–12:00 p.m. CDT Abstract: 5103; May 31, 9:00 a.m.–12:00 p.m. CDT XOFIGO (radium-223 dichloride) A phase 2 randomized trial of radium-223 dichloride and cabozantinib in patients (pts) with renal cell carcinoma (RCC) with bone metastases (BM): RADICAL (Alliance A031801) Abstract: 4500; May 29, 2:45 p.m.–2:57 p.m. CDT Abstract: 4500; May 29, 2:45 p.m.–2:57 p.m. CDT ETCTN 10302: A randomized phase II trial of radium-223 dichloride in combination with paclitaxel in patients with bone metastatic breast cancer Abstract: 3096; May 30, 1:30 p.m.–4:30 p.m. CDT Abstract: 3096; May 30, 1:30 p.m.–4:30 p.m. CDT HYRNUO® (sevabertinib) SOHO-01: Updated safety and efficacy of sevabertinib in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) Abstract: 8622; May 31, 9:00 a.m.–12:00 p.m. CDT Abstract: 8622; May 31, 9:00 a.m.–12:00 p.m. CDT VITRAKVI® (larotrectinib) Efficacy and safety of larotrectinib in patients with non-primary central nervous system TRK fusion cancer: An updated analysis Abstract: 3145; May 30, 1:30 p.m.–4:30 p.m. CDT Abstract: 3145; May 30, 1:30 p.m.–4:30 p.m. CDT Precision oncology in practice: Real-world multicenter experience with larotrectinib in pediatric extracranial NTRK fusion–positive tumors Abstract: 10036; June 1, 1:30 p.m.–4:30 p.m. CDT Abstract: 10036; June 1, 1:30 p.m.–4:30 p.m. CDT STIVARGA® (regorafenib) Evaluation of the combination of regorafenib + avelumab in patients with HPV-associated cancer: The phase II REGOMUNE study Abstract: 2517; May 30, 8:42 a.m.-8:48 a.m. CDT Abstract: 2517; May 30, 8:42 a.m.-8:48 a.m. CDT About NUBEQA® (darolutamide)1 NUBEQA® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. NUBEQA was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic castration-sensitive prostate cancer (mCSPC) Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo. In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure – Seizure occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%). In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%). In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%). Drug Interactions Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers. Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed. Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA. Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA. For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information. Please see the full Prescribing Information. About XOFIGO® (radium-223 dichloride) Injection2 XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Important Safety Information for XOFIGO® (radium-223 dichloride) Injection Warnings and Precautions: Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the XOFIGO arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with XOFIGO bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the XOFIGO arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of XOFIGO-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with XOFIGO and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with XOFIGO. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue XOFIGO in patients who experience life-threatening complications despite supportive care for bone marrow failure Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of XOFIGO. Prior to first administering XOFIGO, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue XOFIGO if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with XOFIGO have not been established. Outside of a clinical trial, concomitant use of XOFIGO in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, XOFIGO should be discontinued Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: XOFIGO is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of XOFIGO in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received XOFIGO in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of XOFIGO and agents other than gonadotropin-releasing hormone analogues have not been established Embryo-Fetal Toxicity: The safety and efficacy of XOFIGO have not been established in females. XOFIGO can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with XOFIGO Administration and Radiation Protection: XOFIGO should be received, used, and administered only by authorized persons in designated clinical settings. The administration of XOFIGO is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations Fluid Status: Dehydration occurred in 3% of patients on XOFIGO and 1% of patients on placebo. XOFIGO increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on XOFIGO Secondary Malignant Neoplasms: XOFIGO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, XOFIGO may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the XOFIGO arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the XOFIGO group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with XOFIGO will tolerate subsequent cytotoxic chemotherapy Adverse Reactions: The most common adverse reactions (≥10%) in the XOFIGO arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of XOFIGO-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the XOFIGO arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%). Please see the full Prescribing Information for XOFIGO (radium Ra 223 dichloride). About HYRNUO (sevabertinib)3 HYRNUO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. IMPORTANT SAFETY INFORMATION Warnings & Precautions Diarrhea HYRNUO can cause severe diarrhea that can lead to dehydration and electrolyte imbalances. In the pooled safety population, diarrhea was reported in 86% of patients who received HYRNUO including Grade 3 in 15%. The median time to first onset of any grade diarrhea was four days. Dosage interruptions occurred in 15% of patients, and dose reductions occurred in 12% of patients. At the first sign of diarrhea or increased bowel movement frequency, instruct patients to start an antidiarrheal treatment (e.g., loperamide), and to increase their fluid and electrolyte intake. Interrupt, reduce the dose or permanently discontinue HYRNUO based on severity. Hepatotoxicity HYRNUO can cause severe hepatotoxicity characterized by elevations of liver function tests. In the pooled safety population, based on adverse reaction data, hepatotoxicity occurred in 24% of patients treated with HYRNUO including 3% Grade 3. Based on laboratory data, 35% of patients treated with HYRNUO experienced increased alanine aminotransferase (ALT), including 2.3% Grade 3. Increased aspartate aminotransferase (AST) occurred in 35% of patients treated with HYRNUO, including 2.3% Grade 3. Increased bilirubin occurred in 12% of patients treated with HYRNUO. The median time to first onset of AST or ALT elevation was 1.4 (range 0.2 to 14.5) months. HYRNUO was interrupted for an adverse reaction of hepatotoxicity in 4.1% of patients, the dose was reduced in 4.1% and permanently discontinued in 0.4%. Monitor liver function tests including ALT, AST, and total bilirubin at baseline prior to the first administration of HYRNUO, every 2 weeks for the first month and then monthly thereafter as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Interrupt, reduce the dose or permanently discontinue HYRNUO based on the severity of the adverse reaction. Interstitial Lung Disease/Pneumonitis HYRNUO can cause severe interstitial lung disease (ILD)/pneumonitis. In the pooled safety population, ILD/pneumonitis occurred in two patients (0.7%) treated with HYRNUO, including 0.4% Grade 3. One patient required interruption of HYRNUO. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Discontinue HYRNUO upon confirmation of ILD/pneumonitis. Ocular Toxicity HYRNUO can cause ocular toxicity. In the pooled safety population, ocular toxicity occurred in 14% of patients treated with HYRNUO, including 11% Grade 1, 2.6% Grade 2 and 0.4% Grade 3 (one case of corneal epithelial microcysts with temporary unilateral blindness). Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Interrupt, reduce the dose or permanently discontinue HYRNUO based on severity. Pancreatic Enzyme Elevation HYRNUO can cause elevations of amylase and lipase levels. In the pooled safety population, based on laboratory data, increased amylase occurred in 32% of patients treated with HYRNUO, including 3.2% Grade 3 or 4. Increased lipase elevation occurred in 40% of patients treated with HYRNUO, including 10% Grade 3 or 4. Two patients (0.7%) required interruption of HYRNUO due to increased lipase and three (1.1%) required interruption of HYRNUO due to increased amylase. The median time to onset of increased amylase/lipase was 1.4 months (range: 0.2 to 17 months). Monitor amylase and lipase regularly during treatment with HYRNUO. Interrupt, reduce the dose or permanently discontinue HYRNUO based on severity. Embryo-fetal toxicity Based on findings from animal studies and its mechanism of action, HYRNUO can cause fetal harm when administered to a pregnant woman. In embryo-fetal development studies, oral administration of sevabertinib to pregnant rats during the period of organogenesis resulted in alterations to growth at maternal exposures ≥0.18 times the human exposure based on area under the curve (AUC) at the clinical dose of 20 mg twice daily. Animal studies with disrupted or depleted HER2/EGFR and in vitro assays have demonstrated that inhibition of HER2 and/or EGFR results in structural abnormalities, alteration to growth, and embryo-fetal and infant mortality. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with HYRNUO and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with HYRNUO and for 1 week after the last dose. Adverse Reactions In SOHO-01 (Groups D and E), serious adverse reactions occurred in 31% of patients who received HYRNUO. Serious adverse reactions in ≥2% of patients were diarrhea (6%), pneumonia (3.7%), dyspnea (2.2%), and pleural effusion (2.2%). The most common adverse reactions (>20%) in patients who received HYRNUO were diarrhea (87%), rash (66%), paronychia (33%), stomatitis (29%), and nausea (21%). The most common Grade 3 and 4 laboratory abnormalities (≥2%) were potassium decreased (13%), lipase increased (12%), lymphocyte count decreased (6%), sodium decreased (4.4%), amylase increased (3.8%), aspartate aminotransferase (AST) increased (3%), and alanine aminotransferase (ALT) increased (3%). Laboratory abnormalities in <20% of patients who received HYRNUO include blood bilirubin increased (14%; all were Grades 1 or 2). Clinically relevant adverse reactions in <10% of patients who received HYRNUO included edema (8%), cardiac arrhythmia (6%; includes arrhythmia, atrioventricular block complete, electrocardiogram QT prolonged, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachycardia, tachycardia) and alopecia (3.7%). Drug Interactions Effects of Other Drugs on HYRNUO - Sevabertinib is a CYP3A substrate. Concomitant use with a strong or moderate CYP3A inhibitor may increase sevabertinib plasma concentrations, which may increase the risk of HYRNUO adverse reactions. Monitor patients for increased HYRNUO-associated adverse reactions with moderate CYP3A inhibitors. Avoid concomitant use of HYRNUO with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce HYRNUO dose. Concomitant use with a strong or moderate CYP3A inducer may decrease sevabertinib plasma concentrations, which may decrease the effectiveness of HYRNUO. Avoid concomitant use of HYRNUO with strong or moderate CYP3A inducers. Effects of HYRNUO on Other Drugs – Sevabertinib is a weak to moderate CYP3A inhibitor. Sevabertinib increases exposure of CYP3A substrates, which may increase the risk of adverse reactions related to these substrates. Avoid concomitant use of HYRNUO with CYP3A substrates where minimal increases in the concentration may lead to serious adverse reactions unless otherwise recommended in the Prescribing Information of the CYP3A substrate. Sevabertinib is a P-gp inhibitor. Sevabertinib increases exposure of P-gp substrates, which may increase the risk of adverse reactions related to these substrates. Refer to the Prescribing Information for P-gp substrates where minimal increases in the concentration may lead to serious adverse reactions. Sevabertinib is an inhibitor of CYP1A1 in vitro. Sevabertinib may increase exposure of CYP1A1 substrates, which may increase the risk of adverse reactions related to these substrates. Refer to the Prescribing Information of CYP1A1 substrates. Please see full Prescribing Information. About VITRAKVI® (larotrectinib)4 VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. IMPORTANT SAFETY INFORMATION Warnings and Precautions Central Nervous System Effects: Central nervous system (CNS) adverse reactions occurred in patients receiving VITRAKVI, including dizziness, cognitive impairment, mood disorders, and sleep disturbances. In patients who received VITRAKVI, all grades CNS effects including cognitive impairment, mood disorders, dizziness and sleep disorders were observed in 40.3% with Grades 3-4 in 3.8% of patients. Cognitive impairment occurred in 11% of patients. The median time to onset of cognitive impairment was 6 months (range: 2 days to 56 months). Cognitive impairment occurring in ≥ 1% of patients included memory impairment (4.1%), disturbance in attention (3.6%), confusional state (2.3%), cognitive disorder (1.6%), delirium (1.4%), and hallucination (1.1%). Grade 3 cognitive adverse reactions occurred in 1.8% of patients and Grade 4 cognitive adverse reactions in 0.2% of patients. Among the 49 patients with cognitive impairment, 6% required a dose modification and 18% required dose interruption. Mood disorders occurred in 14% of patients. The median time to onset of mood disorders was 3.3 months (range: 1 day to 65 months). Mood disorders occurring in ≥1% of patients included anxiety (5%), agitation (3.2%), depression (3.2%), irritability (2.3%), and restlessness (1.1%). Grade 3 mood disorders occurred in 0.9% of patients. Among the 63 patients who experienced mood disorders, no patient required a dose modification, and 1.6% required dose interruption. Dizziness occurred in 22% of patients, and Grade 3 dizziness occurred in 0.9% of patients. Among the 96 patients who experienced dizziness, 6% of patients required a dose modification and 5% required dose interruption. Sleep disturbances occurred in 12% of patients. Sleep disturbances included insomnia (9%), somnolence (3.4%), and sleep disorder (0.5%). Grade 3 sleep disturbances occurred in 0.2% of patients. Among the 54 patients who experienced sleep disturbances, no patient required a dose modification and 3.7% required dose interruption. Advise patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed. Skeletal Fractures: Skeletal fractures can occur in patients taking VITRAKVI. Among 444 patients who received VITRAKVI across clinical trials, fractures occurred in 7% of patients; 6% of 290 adult patients and 10% of 154 pediatric patients. Median time to first fracture was 13 months (range 27 days to 73 months) in patients followed per fracture. The most common fractures were of the rib (1.4%), fibula, foot or wrist (0.7% each). Most fractures were associated with minimal or moderate trauma. Some fractures were associated with radiologic abnormalities suggestive of local tumor involvement. VITRAKVI treatment was interrupted due to fracture in 1.4% patients. Promptly evaluate patients with signs or symptoms of potential fracture (e.g., pain, changes in mobility, deformity). There are no data on the effects of VITRAKVI on healing of known fractures or risk of future fractures. Hepatotoxicity: Hepatotoxicity including drug induced liver injury (DILI) has occurred in patients taking VITRAKVI. In patients who received VITRAKVI (n=444), increased AST of any grade occurred in 62% of patients and increased ALT of any grade occurred in 61%. Grade 3-4 increased AST or ALT occurred in 7% and 8% of patients, respectively. The median time to onset of increased AST was 1.9 months (range: 4 days to 3.8 years). The median time to onset of increased ALT was 1.9 months (range: 1 day to 4.9 years). Increased AST and ALT leading to dose modifications occurred in 1.6% and 3.2% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 4 (0.9%) patients. There have been reports from clinical studies and postmarketing cases of Grade ≥ 2 increases in ALT and/or AST with increases in bilirubin ≥ 2 x ULN. Obtain liver function tests (ALT, AST, ALP and bilirubin) before initiation of VITRAKVI and monitor every 2 weeks during the first 2 months of treatment, then monthly thereafter, or more frequently following the occurrence of Grade 2 or greater AST or ALT elevation. Temporarily withhold, reduce the dose, or permanently discontinue VITRAKVI based on severity. Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the last dose of VITRAKVI. Adverse Reactions The most common adverse reactions (≥20%), including laboratory abnormalities, were: increased AST (62%), increased ALT (61%), anemia (45%), hypoalbuminemia (44%), musculoskeletal pain (41%), increased alkaline phosphatase (40%), leukopenia (37%), lymphopenia (35%), neutropenia (34%), hypocalcemia (32%), fatigue (31%), vomiting (30%), cough (29%), constipation (27%), pyrexia (26%), diarrhea (26%), nausea (25%), abdominal pain (24%), dizziness (22%), and rash (21%). Drug Interactions Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John’s wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs. For coadministration with moderate CYP3A4 inhibitors, monitor for adverse reactions more frequently and reduce the dosage based on severity. For coadministration with moderate CYP3A4 inducers, modify dose as recommended. Use in Specific Populations Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the last dose. For important risk and use information about VITRAKVI, please see the full Prescribing Information. About STIVARGA® (regorafenib)5 STIVARGA is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. STIVARGA is indicated for the treatment of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. STIVARGA is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. IMPORTANT SAFETY INFORMATION WARNING: HEPATOTOXICITY Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence. Hepatotoxicity: Severe drug-induced liver injury with fatal outcome occurred in STIVARGA-treated patients in clinical trials. In most cases, liver dysfunction occurred within the first 2 months of therapy and was characterized by a hepatocellular pattern of injury. Additionally, hyperammonemic encephalopathy, including fatal cases, has been reported in the postmarketing setting in patients treated with STIVARGA. The risk of hyperammonemic encephalopathy appears increased in patients with liver dysfunction, liver metastases, or primary liver cancer. In the metastatic CRC study, fatal hepatic failure occurred in 1.6% of patients in the regorafenib arm and in 0.4% of patients in the placebo arm. In the GIST study, fatal hepatic failure occurred in 0.8% of patients in the regorafenib arm. In the HCC study, there was no increase in the incidence of fatal hepatic failure as compared to placebo. Liver Function Monitoring: Obtain liver function tests (ALT, AST, and bilirubin) before initiation of STIVARGA and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the ULN or baseline. For patients who develop unexplained lethargy or changes in mental status, measure ammonia level and initiate appropriate clinical management. Temporarily hold and then reduce or permanently discontinue STIVARGA depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis. If hyperammonemic encephalopathy is confirmed, withhold and consider permanent discontinuation of STIVARGA. Infections: STIVARGA caused an increased risk of infections. The overall incidence of infection (Grades 1-5) was higher (32% vs 17%) in 1142 STIVARGA-treated patients as compared to the control arm in randomized, placebo-controlled trials. The incidence of Grade 3 or greater infections in STIVARGA-treated patients was 9%. The most common infections were urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%), and pneumonia (2.6%). Fatal outcomes caused by infection occurred more often in patients treated with STIVARGA (1.0%) as compared to patients receiving placebo (0.3%); the most common fatal infections were respiratory (0.6% vs 0.2%). Withhold STIVARGA for Grade 3 or 4 infections, or worsening infection of any Grade. Resume STIVARGA at the same dose following resolution of infection. Hemorrhage: STIVARGA caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 18.2% in 1142 patients treated with STIVARGA vs 9.5% with placebo in randomized, placebo-controlled trials. The incidence of Grade 3 or greater hemorrhage in patients treated with STIVARGA was 3.0%. The incidence of fatal hemorrhagic events was 0.7%, involving the central nervous system or the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue STIVARGA in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin. Gastrointestinal Perforation or Fistula: Gastrointestinal perforation occurred in 0.6% of 4518 patients treated with STIVARGA across all clinical trials of STIVARGA administered as a single agent; this included 8 fatal events. Gastrointestinal fistula occurred in 0.8% of patients treated with STIVARGA and in 0.2% of patients in the placebo arm across randomized, placebo-controlled trials. Permanently discontinue STIVARGA in patients who develop gastrointestinal perforation or fistula. Dermatological Toxicity: In randomized, placebo-controlled trials, adverse skin reactions occurred in 71.9% of patients in the regorafenib arm and in 25.5% of patients in the placebo arm, including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia syndrome (PPES) and severe rash, requiring dose modification. In the randomized, placebo-controlled trials, the overall incidence of HFSR was higher in 1142 STIVARGA-treated patients (53% vs 8%) than in the placebo-treated patients. Most cases of HFSR in STIVARGA-treated patients appeared during the first cycle of treatment. The incidences of Grade 3 HFSR (16% vs <1%), Grade 3 rash (3% vs <1%), serious adverse reactions of erythema multiforme (<0.1% vs 0%), and Stevens-Johnson syndrome (<0.1% vs 0%) were higher in STIVARGA-treated patients. Across all trials, a higher incidence of HFSR was observed in Asian patients treated with STIVARGA (all grades: 72%; Grade 3: 18%). Toxic epidermal necrolysis occurred in 0.02% of 4518 STIVARGA-treated patients across all clinical trials of STIVARGA administered as a single agent. Withhold STIVARGA, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity. Hypertension: Hypertensive crisis occurred in 0.2% in STIVARGA-treated patients and in none of the patients in placebo arm across all randomized, placebo-controlled trials. STIVARGA caused an increased incidence of hypertension (30% vs 8% in metastatic CRC, 59% vs 27% in GIST, and 31% vs 6% in HCC). The onset of hypertension occurred during the first cycle of treatment in most patients who developed hypertension (67% in randomized, placebo-controlled trials). Do not initiate STIVARGA until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold STIVARGA for severe or uncontrolled hypertension. Cardiac Ischemia and Infarction: STIVARGA increased the incidence of myocardial ischemia and infarction (0.9% with STIVARGA vs 0.2% with placebo) in randomized placebo-controlled trials. Withhold STIVARGA in patients who develop new or acute onset cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristics finding on MRI, occurred in one of 4800 STIVARGA-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, severe headache, visual disturbances, confusion, or altered mental function. Discontinue STIVARGA in patients who develop RPLS. Wound Healing Complications: Impaired wound healing complications can occur in patients who receive drugs that inhibit the VEGF signaling pathway. Therefore, STIVARGA has the potential to adversely affect wound healing. Withhold STIVARGA for at least 2 weeks prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of STIVARGA after resolution of wound healing complications has not been established. Embryo-Fetal Toxicity: STIVARGA can cause fetal harm when administered to a pregnant woman. There are no available data on STIVARGA use in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with STIVARGA and for 2 months after the final dose. Nursing Mothers: Because of the potential for serious adverse reactions in breastfed infants from STIVARGA, do not breastfeed during treatment with STIVARGA and for 2 weeks after the final dose. Most Frequently Observed Adverse Drug Reactions in mCRC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), pain (59% vs 48%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%). Most Frequently Observed Adverse Drug Reactions in GIST (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 12%), pain (60% vs 55%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%). Most Frequently Observed Adverse Drug Reactions in HCC (≥30%): The most frequently observed adverse drug reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in HCC, respectively, were: pain (55% vs 44%), HFSR/PPE (51% vs 7%), asthenia/fatigue (42% vs 33%), diarrhea (41% vs 15%), hypertension (31% vs 6%), infection (31% vs 18%), decreased appetite and food intake (31% vs 15%). For important risk and use information, please see the full Prescribing Information including the Boxed Warning. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes seven marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com. ©2026 Bayer BAYER, the Bayer Cross, NUBEQA, HYRNUO, VITRAKVI, STIVARGA, and XOFIGO are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Solid first-quarter performance driven by Process Solutions and Semiconductor Materials Strong foreign exchange effects remain a headwind Group net sales of € 5.1 billion (organic growth +2.9%) EBITDA pre of € 1.5 billion (organic growth +5.3%) Company upgrades full-year 2026 guidance Building from a position of strength, the Group sharpens its strategic direction to create mid- to long-term value and growth – and confirms its mid-term guidance Merck KGaA, Darmstadt, Germany, a leading science and technology company, delivered a solid start to fiscal 2026. In the first quarter, the Group generated moderate organic sales growth and sustained profitability. This was driven by Process Solutions and Semiconductor Materials, while strong foreign exchange effects continued to weigh on reported figures. “Our first-quarter performance underlines the strength of the company’s diversified portfolio and its clear focus on complementary science and technology businesses,” said Kai Beckmann, Chairman of the Executive Board and Group CEO of Merck KGaA, Darmstadt, Germany, since May 1. “Based on our performance in the first quarter and our current market conditions, we upgrade our full-year 2026 financial guidance. At the same time, we sharpen the strategic direction of the company for the long-term. As markets, technologies and customer needs evolve, we will adapt our operating model and move towards a stronger focus on integrated workflow solutions for customers, expanding our offerings for customers and patients and bundling capabilities across our businesses.” First-quarter results In the first quarter of 2026, reported Group net sales reached € 5.1 billion (Q1 2025: € 5.3 billion). Despite organic growth of 2.9% compared with the year-earlier quarter, strong foreign exchange effects had an impact of –5.5%, resulting in a 2.8% decline in reported net sales. EBITDA pre grew by 5.3% organically and amounted to € 1.5 billion (Q1 2025: € 1.5 billion), with foreign exchange effects of –5.7%. This corresponds to an improved EBITDA pre margin of 29.8% (Q1 2025: 29.1%), supported by one-time effects in the Electronics business sector. Earnings per share pre came in at € 2.11, in line with the year-earlier quarter (Q1 2025: € 2.12). The development reflects disciplined cost management and differing contributions from all three business sectors, offset by negative foreign exchange effects. Group performance shaped by solid demand In the first quarter of 2026, Merck KGaA, Darmstadt, Germany, recorded solid demand across its portfolio. Despite ongoing macroeconomic uncertainty and geopolitical tensions, this development reflects resilience in the company’s attractive growth markets. Demand trends varied across regions and applications, underscoring the value of the Group’s diversified business model and global footprint. Foreign exchange effects significantly weighed on reported sales and earnings at Group level, driven primarily by the development of the U.S. dollar against the euro as well as foreign exchange effects in key Asian markets. These effects are in line with the assumptions underlying the company’s guidance for the year. Life Science benefits from growth across the business with innovation at its core Life Science delivered a strong start to 2026, with organic growth across the business led by Process Solutions. The performance reflected the business sector’s breadth across research, development, manufacturing, and regulated applications, as well as a sharpened focus on operational effectiveness. Effective January 1, 2026, a new go-to-market model aligned the organization more closely with customer needs and purchasing journeys through three distinct business units: Process Solutions, Discovery Solutions and Advanced Solutions. Net sales of Life Science grew by 2.2% to € 2.3 billion. Strong organic growth of 8.3% overcame foreign exchange effects of –6.0%. EBITDA pre was € 649 million, an increase of 4.2% year-on-year. Organic growth of 7.4% and portfolio effects of 1.6% surpassed foreign exchange effects of –4.8%. Process Solutions, which offers solutions for every step of pharmaceutical manufacturing, remained the growth driver in the first quarter. Net sales grew organically by 16.2% and surpassed the threshold of € 1 billion. Growth was supported by strong momentum in downstream processing and single-use solutions, alongside limited safety stock building in response to regional developments as well as contributions from new customer projects. Order intake remained strong across the portfolio. On March 31, 2026, Life Science also closed the acquisition of JSR Life Sciences’ chromatography business. These technologies help improve productivity and support scalable biologics manufacturing. Discovery Solutions, with its digital-first portfolio of biology and chemistry products for research and early-stage workflows, grew organically by 1.6%. Due to foreign exchange effects, net sales declined to € 692 million. The business unit’s performance was supported by continued demand from academic, biotech and pharmaceutical customers in a gradually improving research spending environment. Advanced Solutions saw organic growth of 4.0%. However, foreign exchange effects and a small portfolio effect led to an overall decline of 2.7% to € 563 million. The business unit delivers tailored products and services that help customers address unique needs in high-touch and regulated environments. Performance was supported by demand for key solutions across the portfolio in quality-critical end markets such as diagnostics, testing and regulated manufacturing. Life Science continued to increase its investment in R&D, expanding its portfolio with solutions for improved performance across research and biopharmaceutical manufacturing. Recent launches include the digitally enabled Milli-Q® CLX 8Series systems, which enable clinical labs to target 99.9% uptime of high-quality purified water. The FemtoQuest™ system enhances capabilities for ultrasensitive biomarker detection with up to 1,000 times greater sensitivity than traditional methods. Furthermore, Millipore Express® Ace supports more efficient and sustainable sterilizing-grade filtration, underlining the company’s commitment to bringing greener alternatives to the market. These innovations help customers improve efficiency and performance across crucial research and manufacturing workflows. Healthcare delivers stable performance amid portfolio dynamics Sales in Healthcare were supported by treatments addressing rare diseases and cardiovascular, metabolic and endocrine diseases, while pricing and lifecycle effects continued to impact mature franchises. The business sector delivered net sales of € 2.1 billion and EBITDA pre of € 718 million in the first quarter of 2026. Overall, net sales declined organically by 3.4%. Positive portfolio effects added 4.4 percentage points, while foreign exchange effects had an impact of –4.0%. EBITDA pre was down 9.7% year-on-year, due mainly to foreign exchange effects of –8.5% and follow-on costs associated with the acquisition of SpringWorks Therapeutics Inc., USA, in 2025. The Rare Diseases franchise contributed significantly to the results, reflected as a portfolio effect of 4.4%. Net sales mainly include Ogsiveo®, which treats progressing desmoid tumors, and Gomekli®, approved for neurofibromatosis type 1. Following approval in China for the treatment of tenosynovial giant cell tumor (TGCT), pimicotinib has had an encouraging start and recorded its first sales in the first quarter of 2026. The Cardiovascular, Metabolism & Endocrinology franchise grew by 1.2% organically against a tough comparative base in the year-earlier quarter. Main drivers were the diabetes medicine Glucophage® with organic growth of 6.3% and the thyroid medicine Euthyrox®, which grew by 5.8% organically. In the Fertility franchise, Pergoveris®, indicated for the stimulation of follicular development in women, grew organically by 19.5% across all regions. This was more than offset by the organic decline of Gonal-f®, a follicle-stimulating hormone treatment, amid remaining net price effects in the United States. Net sales of the Oncology franchise declined organically by 4.9% compared with the year-earlier quarter. Erbitux®, a treatment for metastatic colorectal cancer and for cancer of the head and neck, saw an organic decline of 3.3% due to competition from non-comparable biologics in China. Bavencio®, which is used to treat locally advanced or metastatic urothelial carcinoma, declined organically by 13.5% amid increasing competition. In the Neurology & Immunology (N&I) franchise, Mavenclad®, indicated for relapsing forms of multiple sclerosis, saw an organic decline of 6.8% due to weaker demand in North America following the loss of market exclusivity in the United States. By contrast, organic sales continued to grow in Europe, the Middle East and Africa, and Latin America. Healthcare continues to focus on strengthening its position in rare diseases, advancing its pipeline through both internal and external innovation, and building its portfolio for sustainable profitable growth. Recent progress includes the first patient dosed in the Phase III program, ELOWEN‑1 (NCT07332481) and ELOWEN‑2 (NCT07355218), evaluating enpatoran in people living with lupus who experience active skin manifestations. In addition, ongoing regulatory filings include pimicotinib in the United States and Europe; and the company is filing Pergoveris® for review under the U.S. FDA Commissioner's National Priority Voucher (CNPV) program. Electronics supported by structural semiconductor trends Electronics recorded continued solid performance in the first quarter of 2026, with net sales of € 817 million and EBITDA pre of € 282 million. Demand was supported by advanced semiconductor applications, including materials used in artificial intelligence and high‑performance computing. Net sales grew organically by 4.2%. Due to portfolio effects of –10.6% and foreign exchange effects of –7.5%, reported net sales were lower year-on-year. EBITDA pre increased by 30.1% organically. This strong growth was driven by one-time effects from a reimbursement reflecting the recovery of costs incurred in connection with a non-quality-related supplier mislabeling dispute as well as the sale of OLED patents to Universal Display Corporation, USA. Foreign exchange effects had an impact of –‍9.2% and portfolio effects of –5.4%. Semiconductor Solutions achieved strong organic growth of 7.5%. However, net sales declined slightly to € 640 million due to foreign exchange effects of –9.1%. Semiconductor Materials grew organically in the low-teens percentage range on the back of continued demand for high-value materials for AI chip systems and advanced nodes. Advanced nodes are the latest semiconductor manufacturing processes that enable smaller feature sizes and the most powerful chips. Net sales in Delivery Systems & Services (DS&S) declined compared with the year-earlier quarter but stabilized sequentially. Net sales in Optronics were € 177 million. The Metrology & Inspection business, which provides equipment for semiconductor and optoelectronic manufacturing, grew organically in the mid-double-digit percentage range. The businesses with liquid crystals, photoresists for display applications and OLED materials declined organically due to lower demand. Merck KGaA, Darmstadt, Germany, offers one of the broadest portfolios of materials and material-related tools and equipment for the semiconductor industry. With its system know-how, the Electronics business sector is driving the convergence of optics and semiconductors to meet the demands of next-generation technologies for advanced chip systems. These tools are crucial for highly accurate wafer measurements, enabling process control and defect detection to enhance production yields and accelerate time-to-market. The company's integrated semiconductor solutions are enabling faster, smarter and more energy-efficient devices. Positioning Merck KGaA, Darmstadt, Germany, for evolving markets and future growth opportunities Against a dynamic market backdrop, Merck KGaA, Darmstadt, Germany, is sharpening its strategic direction to strengthen resilience and capture future growth opportunities. Building on its established positions across attractive markets and along the value chain, the company is continuing to align its portfolio, innovation priorities and operating model with areas of highest long-term value creation. This includes the continued development of differentiated, high-growth businesses and a stronger focus on integrated solutions across customer processes. It includes the increased use of platformed capabilities and AI to enhance speed, scalability and execution across the enterprise, and a disciplined approach to external innovation through partnerships, in-licensing and selective acquisitions. Through this approach, Merck KGaA, Darmstadt, Germany, aims to further strengthen its competitive position while advancing the foundations for sustainable, profitable growth over time. At the same time, the company confirms its mid-term guidance, while the multi-year measures outlined today are expected to be implemented progressively and to strengthen the foundation for higher long-term growth while sustaining attractive margins. Kai Beckmann, Chairman of the Executive Board and Group CEO of Merck KGaA, Darmstadt, Germany, said: “Merck KGaA, Darmstadt, Germany, is operating from a position of strength, building on more than 350 years of science-driven innovation. Our unique expertise in biology, chemistry, and physics enables us to play a leading role in translating the digital world into the real world. From the laboratory to our customers and patients, we are active along the entire industrial value chain. Our strategic direction aims to increase focus across our diversified portfolio, strengthen the company’s innovation engine and enhance the scalability of its operating model. This will enable us to respond to changing market conditions, increase implementation speed, flexibility and scalability, and drive growth and sustainable value over the long term.” Guidance for 2026 Based on the Group’s performance in the first quarter and current market conditions, Merck KGaA, Darmstadt, Germany, has upgraded the target corridors for its full‑year 2026 guidance. The company now expects net sales between € 20.4 billion and € 21.4 billion and EBITDA pre between € 5.7 billion and € 6.1 billion. This adjustment primarily reflects assumptions of stronger momentum in Life Science and Healthcare's resilience in a challenging environment. The guidance assumes no sales of Mavenclad® in the United Sates from May 2026 (previous forecast: from March 2026) amid generic competition and furthermore excludes the potential commercialization of Pergoveris® in the United States. As a result, the implied organic growth corridor for Group net sales shifts to 0% to +3%. Organic EBITDA pre growth is now expected at –2% to +2%. The company anticipates foreign exchange effects to impact net sales between –3% to –1%; for EBITDA pre, the range is –5% to –2%. This translates to an EPS pre between € 7.50 and € 8.20. At the same time, the company confirms its previous mid-term guidance. Merck KGaA, Darmstadt, Germany, targets annual organic sales growth in the mid-single-digit percentage range. For the EBITDA pre margin, the company sees potential for a step-up to approximately 30%, while the multi-year measures outlined today are expected to be implemented progressively and to strengthen the foundation for higher long-term growth while sustaining attractive margins. Overview of the key figures for Q1 2026 Merck KGaA, Darmstadt, Germany Key figures € million Q1 2026 Q1 2025 Change Net sales 5,134 5,280 -2.8% Operating result (EBIT)1 937 1,006 -6.8% Margin (% of net sales)1 18.3% 19.0% EBITDA2 1,434 1,479 -3.0% Margin (% of net sales)1 27.9% 28.0% EBITDA pre1 1,530 1,535 -0.3% Margin (% of net sales)1 29.8% 29.1% Profit after income tax 669 738 -9.4% Earnings per share (€) 1.52 1.69 -10.1% Earnings per share pre (€)1 2.11 2.12 -0.5% Operating cash flow 818 556 47.2% Net financial debt1, 3 8,318 8,619 -3.5% Number of employees4 62,477 62,604 -0.2% 1 Not defined by IFRS® Accounting Standards (IFRS Accounting Standards). 2 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Figures for the reporting period ending on March 31, 2026, prior-year figures as of December 31, 2025. Life Science Net sales by business unit € million Q1 2026 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change Q1 20252 Share Process Solutions 1,011 45% 16.2% -6.1% – -10.1% 919 41% Discovery Solutions 692 30% 1.6% -5.6% – -4.0% 721 33% Advanced Solutions 563 25% 4.0% -6.2% -0.5% -2.7% 578 26% Life Science 2,266 100% 8.3% -6.0% -0.1% 2.2% 2,218 100% 1 Not defined by IFRS Accounting Standards. 2 Prior-year figures have been adjusted to reflect the transformation of the three business units. Forecast for the Group Forecast for FY 2026 € million Net sales EBITDA pre1 Free cash flow Group ~20,400 to 21,400 Organic 0% to +3% Foreign exchange effect -3% to -1% Portfolio ~0% ~5,700 to 6,100 Organic -2% to +2% Foreign exchange effect -5% to -2% Portfolio ~0% ~1,600 to 2,100 Life Science ~9,100 to 9,500 Organic +4% to +7% Foreign exchange effect -3% to -1% Portfolio ~0% ~2,600 to 2,800 Organic +4% to +8% Foreign exchange effect -4% to -1% Portfolio ~+1% n/a Healthcare ~8,100 to 8,500 Organic -6% to -3% Foreign exchange effect -3% to 0% Portfolio ~+2% ~2,600 to 2,800 Organic -12% to -8% Foreign exchange effect -5% to -2% Portfolio ~0% n/a Electronics ~3,200 to 3,400 Organic +3% to +7% Foreign exchange effect -4% to -2% Portfolio ~-7% ~900 to 1,000 Organic +21% to +27% Foreign exchange effect -4% to -1% Portfolio ~-4% n/a Corporate and Other n/a ~-450 n/a Notes to editors: The press conference for media representatives will take place at 9:30 a.m. (CEST). The respective presentation and further information for journalists, including a digital press kit, can be found here. The quarterly statement can be found here. Merck KGaA, Darmstadt, Germany, on LinkedIn. Company photos and videos can be found here. Merck KGaA, Darmstadt, Germany, stock symbols: Reuters: MRCG, Bloomberg: MRK GY, Dow Jones: MRK.DE Frankfurt Stock Exchange: ISIN: DE 000 659 9905 – WKN: 659 990