Capacity Expansion and Supply
Q: How much capacity will the Catalent facilities add by 2026?
A: Adding three Catalent facilities will significantly increase our fill-finish capacity by 2026. Currently, we have around five filling sites; incorporating these facilities represents a meaningful step-up. For single-dose syringes—used mainly for Wegovy in the U.S.—we have limited in-house capacity. This expansion brings important production platforms under full control, enhancing speed and scale to meet growing demand.

Market Evolution and Competition
Q: How will the obesity market evolve with new products and competitors?
A: With over 800 million people living with obesity and less than 1 million being treated annually, there's ample room for growth. We anticipate different market segments, focusing on high-efficacy treatments like Wegovy, which addresses weight loss and cardiovascular risks—31% of deaths are from cardiovascular issues. While new competitors may enter, we see market expansion rather than cannibalization, addressing varied patient needs.

Wegovy Pricing and Net Price Evolution
Q: How is the net price evolution for Wegovy in the U.S.?
A: The net price evolution for Wegovy in the U.S. is as expected. We're focusing on volume opportunities and are pleased with market access—over 50 million people with obesity are covered. We'll work with payers to maintain or improve coverage. Despite competitive dynamics, there are no pricing surprises, and we see significant volume growth potential, currently serving less than 1 million patients.

Sales & Distribution (S&D) Phasing
Q: What is causing the increase in S&D spend through the year?
A: Our S&D phasing is slightly backloaded, with first-quarter S&D at 20% of sales and full-year expectation around 22%. This aligns with commercial strategies linked to supply availability and R&D readouts. For example, following SELECT, we'll increase promotion based on the updated label, incurring additional spending. While supply impacts planning, promotional activities drive S&D expenses throughout the year.

Clinical Trial Design for Next-Gen Products
Q: Will future trials use placebo or active comparators like semaglutide?
A: Trial design depends on regulatory considerations and existing standards. In areas with a gold standard like semaglutide, future trials may compare against it rather than placebo. For CagriSema, demonstrating parity or superiority to semaglutide requires appropriate trial sizing and endpoints. If no gold standard exists, placebo comparisons remain appropriate.

Medicare Part D Redesign Impact
Q: How will the Part D redesign affect net pricing for Ozempic and Rybelsus in 2025?
A: It's early to determine the full impact as formularies are still being negotiated. Initially, we thought the redesign would be positive due to the elimination of the donut hole, but now we believe it's broadly neutral. The redesign changes exposure in catastrophic coverage and other areas. The effect on plan sponsors and cost-sharing remains to be seen, and competitive dynamics are unchanged.

Once-Monthly GLP-1/GIP Data Timing
Q: When will Phase I data for once-monthly GLP-1/GIP be available, and is dosing convenience important?
A: The ongoing study for once-monthly GLP-1/GIP is expected to read out around the turn of the year. While dosing convenience is a factor, current market dynamics prioritize efficacy over convenience. Our pipeline focuses on differentiated efficacy first, with convenience being secondary.

Lean Mass Loss and Muscle Sparing
Q: Is lean mass loss a concern with weight loss treatments like semaglutide?
A: Physicians don't currently see lean mass loss as a significant concern. Typically, 25% to 45% of weight loss comes from lean body mass, depending on the speed of loss. Semaglutide's proportional lean mass loss (~35%-40%) is within the normal, healthy range. SELECT data show improvements in cardiovascular morbidity and all-cause mortality, indicating a healthy weight loss. We're comfortable with patient outcomes focusing on overall health benefits.

Applying Once-Monthly Technology to Other Assets
Q: Can once-monthly dosing be applied to other pipeline assets like amycretin or CagriSema?
A: We are exploring several modalities for prolonged action in the preclinical space. While current clinical assets attract attention, their application to other compounds depends on efficacy and scalability. The ongoing once-monthly GLP-1/GIP study helps us evaluate this technology's potential for broader use.

Confidence in Drug’s Brain Penetration
Q: How confident are you that your drug won't have psychiatric side effects due to brain penetration?
A: We're confident that our drug's brain penetration is substantially less than previous drugs in this class. Historical issues were linked to high exposure levels. Based on preclinical and clinical data, we're not concerned but are cautious. We'll conduct a large-scale Phase II study specifically to rule out any new psychiatric risks.

Wegovy Formulations and U.S. Strategy
Q: Have you revised plans for Wegovy's single-use pen or considered direct distribution models?
A: We continuously evaluate how to optimize our U.S. portfolio. Currently, we're focused on the single-dose device but are exploring ways to make dosing more efficient and require less capacity. This includes optimizing presentation formats and potentially releasing smaller products to increase scalability across our value chain.

NASH Trial Expectations
Q: For semaglutide in NASH, is NASH resolution without fibrosis improvement enough for approval?
A: Regulatory approval requires improvement in both steatosis and fibrosis. Our Phase II study showed significant reduction in steatosis and a promising numerical reduction in fibrosis, though it wasn't powered for fibrosis endpoints. The FDA indicated that if similar results in Phase III (ESSENCE) are statistically significant—with fibrosis improvement over 10%—it would be acceptable for approval.