Martin Lange
Analyst · Peter Verdult from BNP Paribas
Thank you, Karsten. The first quarter was eventful with numerous readouts and regulatory milestones. Within obesity, we obtained FDA approval for high-dose semaglutide at 7.2 milligram in the U.S. We have also initiated the 2 pivotal Phase III trials in the zenagamtide development program, AMAZE, plus Phase III trials investigating zenagamtide in people with obesity and sleep apnea, in people with obesity and knee osteoarthritis, and to investigate weight loss maintenance. Within diabetes, we completed the pivotal Phase III trial REIMAGINE 1 for CagriSema in people with type 2 diabetes inadequately controlled by diet and exercise. CagriSema demonstrated a superior HbA1c reduction of up to 1.8 percentage points and a superior weight loss of up to 13.8% at 40 weeks. Detailed results from REIMAGINE 1, 2 and 3 will be presented at the American Diabetes Association Conference in 2026. A weekly insulin received FDA approval as the first and only once-weekly long-acting basal insulin for people living with type 2 diabetes, with launch expected in the FlexTouch device in the U.S. in H2 2026. Recently, we announced top line results from the Phase III HIBISCUS study evaluating Etavopivat in sickle cell disease in addition to standard of care. Sickle cell disease affects approximately 8 million individuals worldwide — treatment options remain limited and the unmet need is significant. Etavopivat is a novel once-daily oral small molecule designed to improve red blood cell health via pyruvate kinase-R activation. HIBISCUS was a randomized, double-blinded 52-week trial investigating Etavopivat versus placebo in 385 people aged 12 years or older. The co-primary endpoints were annualized VOC rate reduction and hemoglobin response. Etavopivat successfully met both co-primary endpoints, making it the first of its class to do so — substantially reducing VOC events and improving hemoglobin response. In the trial, Etavopivat demonstrated a superior reduction in annualized VOC rates by 27% compared to placebo. Time to first VOC event was delayed by around 4 months compared to placebo. For the hemoglobin endpoint, Etavopivat demonstrated a superior increase in the proportion of people achieving a hemoglobin response greater than 1 gram per deciliter at week 24 — 48.7% compared to 7.2% with placebo. As an exploratory analysis, Etavopivat also significantly reduced the risk of blood transfusion. The top line safety profile was in line with previous Etavopivat trials. Based on HIBISCUS results, Novo Nordisk plans to submit the first regulatory approval of Etavopivat in Q4 2026. Earlier this year, Novo Nordisk and United Laboratories announced top line results for UBT251, a long-acting synthetic peptide triple agonist targeting GLP-1, GIP and glucagon receptors, in 2 Chinese Phase II trials — one in obesity and one in diabetes. In the obesity Phase II trial, the highest mean weight loss observed was 19.7% after 24 weeks. In the type 2 diabetes trial, the largest mean A1c reduction was 2.16 percentage points at 24 weeks and the highest mean weight loss observed was 9.8%. Safety and tolerability appeared consistent with tri-agonist-based therapies. Novo Nordisk has initiated a global Phase Ib/IIa trial in obesity with results expected in 2027, and expects to start a global Phase II trial with UBT251 in type 2 diabetes in Q2 2026. Looking ahead for the rest of 2026 — within obesity, we still expect a decision in the U.S. for CagriSema at the end of 2026 with a potential launch in 2027 around the same time of the REDEFINE 11 top line results. We expect to initiate a Phase IIIb trial with CagriSema high dose in Q2 2026. We also expect to initiate the AMAZE 9 trial for oral zenagamtide in Q3 and a Phase III trial with cagrilintide high dose in Q4 2026. In the U.S., we anticipate the decision regarding Wegovy FlexTouch resubmitted in Q1. In the EU, we expect a decision on Wegovy pill and the single-dose device for injectable Wegovy 7.2 milligram. Within obesity-related comorbidities, we expect Phase III results for efruxifermin in the SYNCHRONY real-world trial in MASH. Within diabetes, we have initiated the Phase II trial for our GLP-1/GIP/amylin tri-agonist and expect to initiate the zenagamtide Phase III program AMBITION in Q4 2026. Within diabetes-associated comorbidities, the first readout of Ziltivekimab from the ZEUS Phase III trial is anticipated in Q3 2026. Lastly, we are awaiting regulatory decisions in the U.S. and EU for denecimig, previously known as Mim8, for people living with hemophilia A. Over to you, Michael.