Novo Nordisk reported a 24% sales growth and 30% operating profit growth for Q1 2024, with an increased full-year outlook.
Total sales increased by 24%, driven by both North America operations (35% growth) and international operations (11% growth).
GLP-1 diabetes treatments sales grew by 32%, insulin sales by 9%, and obesity care sales by 42%.
The company continues to dominate the diabetes market, growing faster than the total diabetes market and increasing its global diabetes value market share to 34%.
North America saw healthy prescription volume growth of the GLP-1 class by around 15% in Q1 2024.
Wegovy net prices declined in Q1 2024, with a focus on ensuring continuity of care for existing patients.
Rare disease sales decreased by 3%, with a notable decline in international operations but an increase in North America operations.
Strategic Developments and Acquisitions
Novo Nordisk is serving almost 42 million patients with diabetes and obesity treatments.
The company announced the acquisition of 3 fill-finish sites from Novo Holdings, aiming to reach more people with chronic diseases.
Acquired Cardior Pharmaceuticals, including its lead compound CDR132L for heart failure treatment, aligning with strategic aspirations in cardiovascular disease.
Research and Development Milestones
FDA approved a label expansion for Wegovy, indicating a reduction in the risk of major adverse cardiovascular events.
The FLOW Kidney Outcomes Trial demonstrated significant reduction in kidney disease progression with once-weekly Semaglutide 1.0 mg.
A Phase II trial with higher doses of once-weekly subcutaneous Semaglutide showed dose response on weight loss and a safe profile.
Upcoming R&D milestones include results from COMBINE 1, STRIDE, SOUL trials, and Phase II for monlunabant and Amycretin.
Financial Performance
Sales grew by 22% in Danish kroner and 24% at constant exchange rates in Q1 2024.
Operating profit increased by 27% in Danish kroner and 30% at constant exchange rates.
Net profit increased by 28%, and diluted earnings per share increased by 29% to DKK 5.68.
Free cash flow realized in Q1 2024 was DKK 5 billion, with capital expenditure for property, plant, and equipment at DKK 8.5 billion.
2024 Outlook
Sales growth outlook increased to between 19% and 27% at constant exchange rates.
Operating profit growth now expected to be between 22% and 30% at constant exchange rates.
Capital expenditure expected to be around DKK 45 billion, with a free cash flow expectation between DKK 57 billion and DKK 67 billion.
Question and Answer
Company Guidance Range and Uncertainty
Question
Why does the company’s 2024 guidance range span 8%, and what specific factors contribute to the persistent uncertainty?
Answer
The company attributes the broader guidance range to the high growth levels and volatility experienced in recent years, as well as the need to be cautious due to Danish regulations for listed companies.
The management team indicates that there are no major changes to the risks, either positively or negatively, and reiterates that they are on track and confident in their base plan.
High-Dose Injectable Semaglutide (Mim8) Phase II Trial and Dose Selection
Question
Did the Phase II trial of high-dose injectable Semaglutide (Mim8) find a weight loss plateau, and can you provide insights into the additional weight loss gained at 8 milligrams and 16 milligrams? Are further trials at even higher doses being considered despite the ongoing Phase III trials at 7.2 milligrams?
Answer
The company declines to comment on the specific data and weight loss observations from the trial at this time.
The focus on evaluating further development in diabetes and confidence in higher doses for obesity is based on data from the diabetes trials, and the company remains optimistic about higher doses in the obesity space.
Wegovy Supply Progression and Uptake, and Ongoing Launches
Question
Can we expect a continued gradual ramp of Wegovy starter doses throughout the year, and how is the supply situation evolving, particularly in the U.S. and China?
Answer
The company reports a significant increase in Wegovy starter dose prescriptions in the U.S., exceeding 25,000 per week, indicating confidence in the supply chain and the ability to scale.
While not providing specific guidance on new prescription growth, the company suggests that the acceleration and growth for the remainder of the year will be driven by Wegovy expansion in the U.S., TRx ramp, and continued launches in volume-capitated markets.
Mim8 Target Product Profile and Competitive Positioning
Question
Can you provide more details on the target product profile for Mim8 and how it compares to competitors, particularly in light of their new administration profiles?
Answer
The target product profile for Mim8 focuses on achieving an annual bleeding rate of zero, with an expectation of more than 50% of patients experiencing no bleeds throughout the year.
The company anticipates an attractive safety profile, a true monthly dosing profile, and a convenient, pain-free injection experience with an easy-to-use device.
Wegovy Coverage and Uptake Post-SELECT Trial
Question
Has the approval of Wegovy for obesity in the U.S. based on the SELECT trial data helped improve coverage and access, and what is the outlook for further expansion?
Answer
The company currently covers over 50 million people living with obesity in the U.S., and while there is room for growth, they are pleased with the level of access.
The label expansion based on the SELECT trial data, making Wegovy the only anti-obesity medication with proven cardiovascular benefit, has already had a positive impact, with CMS allowing for reimbursement in Medicare Part D.
The company expects a gradual uptake with a couple of million lives covered initially and anticipates further expansion and taking advantage of the SELECT data.
ESSENCE NASH Trial Outcome and Commercial Competitiveness
Question
What would be a good outcome of the ESSENCE NASH trial to give you confidence in the commercial competitiveness of the drug, and has there been an acceleration in the timeline for the readout?
Answer
The company is hoping to see results similar to those observed in the Phase II trial, which showed a significant and clinically relevant improvement in steatosis and fibrosis, as well as a good safety profile.
Positive results in the Phase III trial would indicate an attractive profile and support the FDA’s grant of breakthrough designation based on the Phase II data.
The study has been extended to include heart outcomes to address both liver-related and cardiovascular concerns.
