James Quigley

James Quigley asked about the importance of REDEFINE 4 in demonstrating CagriSema's differentiation from Zepbound from a physician and marketing perspective, inquiring about Zepbound's behavior in flexible dosing scenarios and confirming if CagriSema would still launch if REDEFINE 4 shows no statistically significant difference. He also questioned launch preparations for the Wegovy Pill in ex-US markets, balancing this with US launch processes and pricing in an MFN world.

Answer

EVP of Research and Development and CSO Martin Lange explained that REDEFINE 4, an amended study, aims for non-inferiority with potential for superiority in weight loss, and an upside on gastrointestinal side effects and tolerability. He noted that CV benefits from semaglutide could further differentiate CagriSema, confirming that a launch is still considered even with non-inferiority. EVP of Product and Portfolio Strategy Ludovic Helfgott stated that the primary focus for the Wegovy Pill launch remains the US in 2026, but options are open for selected IO markets, leveraging telehealth knowledge and Rybelsus's success in those regions.

James Quigley asked about the importance of REDEFINE 4 in demonstrating differentiation for CagriSema from a physician and marketing perspective versus Zepbound, and if Novo Nordisk would still launch CagriSema if REDEFINE 4 shows no statistically significant difference. He also inquired about launch preparations for the Wegovy Pill in ex-US markets, specifically why Novo Nordisk is now considering selected IO countries versus a previous US-only focus, and how this balances with US launch processes and pricing in an MFN world.

Answer

EVP of Research and Development and CSO, Martin Holst Lange, stated that while REDEFINE 4's base case is non-inferiority with potential for superiority, even with non-inferiority on weight loss, there's upside potential on gastrointestinal side effects, tolerability, and CV benefits, which would differentiate CagriSema. EVP of Product and Portfolio Strategy, Ludovic Helfgott, confirmed that the primary focus for the Wegovy Pill launch in 2026 remains the US, but the company is opening the option to launch in selected IO markets, leveraging telehealth knowledge from the US and successful Rybelsus experience in IO markets to build quicker positions.

James Quigley of Goldman Sachs asked for Novo Nordisk's competitive view on orfagliptin's Phase III data relative to Wegovy and oral semaglutide, and how this might impact market segmentation. He also later inquired about the risk of 'healthcare tourism' with generic semaglutide from Canada potentially entering the U.S. market.

Answer

Martin Lange, EVP & Chief Scientific Officer, highlighted oral semaglutide's superior weight loss (17% vs. 12%) and better tolerability compared to orfagliptin. David Moore, EVP of US Operations, and Ludovic Helfgott, EVP of Product & Portfolio Strategy, expressed excitement for unlocking new patient segments with an oral option. Regarding Canadian generics, Mr. Moore stated there is no legal mechanism for unapproved products to enter the U.S., and Karsten Knudsen, EVP & CFO, confirmed that while erosion in Canada is expected, legal teams are prepared to defend the U.S. business from parallel trade.

James Quigley of Goldman Sachs asked about Novo Nordisk's view on competitor orfagliptin data relative to oral semaglutide and its impact on market segmentation. He also inquired about the risk of 'healthcare tourism' from Canada to the U.S. once generic semaglutide becomes available there.

Answer

Martin Lange (CSO) asserted oral semaglutide's superior efficacy (17% vs 12% weight loss) and tolerability. David Moore (EVP - US Operations) and Ludovic Helfgott (EVP - Product & Portfolio Strategy) added that oral sema will unlock new patient segments. Regarding Canadian generics, David Moore stated there is no legal mechanism for unapproved products to enter the U.S., and Karsten Knudsen (CFO) confirmed that legal teams are prepared to defend the U.S. business from inappropriate parallel trade.

Inquired about the wide range in the second-half guidance, asking for the key variables and assumptions. Also requested more detail on the impact of compounding, including the estimated drag on Wegovy and assumptions about patient switching behavior.

Answer

The guidance range reflects uncertainty around the conversion of over one million patients from compounded GLP-1s to branded products in the second half, which is a key driver for growth alongside the MASH label update and the CVS formulary win. The company is actively trying to capture these patients through expanded cash offers, improved insurance access, and targeted marketing about the safety and availability of authentic Wegovy.

James Quigley inquired about the key variables driving the wide range in the updated full-year guidance and requested more detail on the estimated market impact of compounded GLP-1s on Wegovy.

Answer

CFO Karsten Knudsen explained the guidance range hinges on the successful transition of patients from compounded to branded products in the second half of the year, driven by new cash-pay channels and the CVS formulary win. He estimated over one million patients are on compounded GLP-1s. Dave Moore, EVP of U.S. Operations, added that an estimated 70% of compounding is of semaglutide and outlined a three-part strategy to capture these patients.

James Quigley sought clarification on the Cosentyx rebate adjustment, asking which prior periods it related to (Q1/Q2 2025 or 2024) and its implications for modeling 2026.

Answer

Harry Kirsch, CFO of Novartis, clarified that the Cosentyx rebate adjustment mainly related to Q2 2025. He explained that the underlying Q3 performance already accounts for such channel mix changes, providing a good basis for future modeling. Vasant Narasimhan added that the year-to-date net impact across the entire portfolio is relatively clean, balancing Q1's upside with Q3's downside.

James Quigley followed up on ianalumab, asking why statistical significance in the Neptune trial was only achieved in the last two blocks of data, and how Novartis plans to address the lack of statistical significance in secondary endpoints like fatigue and salivary flow when discussing data with physicians.

Answer

CEO Vasant Narasimhan clarified that the primary endpoint for ianalumab was met at 48 weeks in both studies, and the nominal significance at earlier time points was just an indication. He explained that while secondary endpoints might not reach statistical significance due to hierarchical testing, Novartis will present detailed post-hoc analyses, biopsy data, and quality of life metrics on Thursday to demonstrate patient benefits, focusing on symptom improvement rather than SDI scores for physicians and patients.

James Quigley of Goldman Sachs asked about Pluvicto's potential in earlier prostate cancer lines, addressing physician concerns about side effects, and how the next-generation actinium-based PSMA therapy fits into the treatment paradigm.

Answer

CEO Vasant Narasimhan responded that Novartis has not received feedback on the specific side effects mentioned, emphasizing Pluvicto's favorable safety profile. He positioned the actinium-based therapy for use in patients who have progressed on Pluvicto, with the potential for earlier use in the future pending further safety and efficacy data.

James Quigley asked about pelacarsen's competitiveness in light of competitor data showing longer dosing intervals and inquired about the political appetite in Europe for addressing the innovation imbalance between the EU and the U.S.

Answer

CEO Vasant Narasimhan stated that the immediate focus is on delivering the Phase III HORIZON trial to establish pelacarsen as a first-in-class therapy, while also developing longer-acting options for life cycle management. Regarding Europe, he noted that while advocacy is ongoing to rethink how innovation is valued, it is unclear if the European Commission will prioritize it over regulatory streamlining.

James Quigley requested a breakdown of the 2025 guidance into volume, generic impact, and pricing. He also asked what second-half growth would be without the generic impact and if the guided H2 rate is a sensible exit rate for the long-term.

Answer

CFO Harry Kirsch responded that Novartis expects continued strong volume growth, slightly more pricing pressure than in 2024 (1-2% negative), and a key impact from generics based on analog models. He stated that if the three major generic entries did not happen, the second half of the year would look like the first half, but affirmed that the generic entry assumption is a careful part of their model.

James Quigley from Goldman Sachs asked about the competitive dynamics for Pluvicto in the U.S., specifically what is needed to increase share in centers with lower adoption and the progress of expanding into community centers.

Answer

CEO Vasant Narasimhan explained that while established RLT sites have high Pluvicto adoption (up to 90%), about one-third of sites, mostly in the community, require more education to refer patients earlier instead of cycling through chemotherapy. To drive growth, Novartis has expanded its field force, is launching a DTC campaign, and is working to build confidence and referral pathways from community oncology.

James Quigley asked for clarification on Dupixent's BOI and gross margin, specifically if his estimated 72% operating margin for Q3 is accurate for calculating payaway, and how operating leverage and margin peaking should be considered. He also inquired about Altuvio's market penetration and share in the factor VIII market and its potential ceiling.

Answer

CFO François-Xavier Roger stated that Sanofi does not disclose product-specific margins, including for Dupixent, but confirmed that Dupixent's margin has improved over time due to scale efficiencies. Head of General Medicines Brian Foard did not provide specific market share data for Altuvio but reiterated that it takes most business from the factor marketplace and some from non-factors like Hemlibra, with progress continuing.

James Quigley followed up on the Regeneron payaway, asking for a ballpark figure for Dupixent's BOI margin (62% last year, 72% Q3 this year) and gross margin (92-93%), and how to think about operating leverage and when the margin might peak. He also asked for a follow-up on Altuvio's market penetration and share in the factor VIII market, and why it might not reach 100% given the data.

Answer

François-Xavier Roger (CFO) stated that Sanofi does not disclose product-specific margins, but confirmed Dupixent's margin has improved over time due to scale efficiencies. Brian Foard (Head of General Medicines) reiterated that Altuvio takes most business from the factor marketplace, including 10% from Hemlibra, and is the number one switched asset, but did not share exact end market share projections.

James Quigley of Goldman Sachs asked about the Phase III plans for amlitelimab in asthma, specifically regarding the study population and timeline. He also requested more detail on the drivers of the strong Q1 gross margin improvement and its expected progression.

Answer

Houman Ashrafian (EVP, Head of R&D) stated that Sanofi is consulting with KOLs to define the Phase III protocol for amlitelimab but will ensure the population with high unmet need is 'overrepresented.' CFO François-Xavier Roger attributed about two-thirds of the gross margin improvement to favorable product mix and manufacturing efficiencies, with further, though not significant, improvement expected through 2025.

Asked for the key factors driving the slow recovery in BPS equipment orders and for an idea of when equipment might become less of a drag on growth.

Answer

The slow equipment recovery is due to a mix of factors, including some remaining industry overcapacity. However, utilization is increasing, and the project funnel is building, especially with CDMOs and for new capability additions. The company did not give a specific timeline but pointed to these positive underlying trends.

Sought clarification on milestone recognition, headwinds affecting H2 guidance, and the expected timing and cadence of revenue catch-up in Q3 and Q4.

Answer

The Sandoz payment was an upfront fee, not a milestone; current milestones are primarily from BMS. The main headwind for H2 growth is in the API manufacturing business due to a business development gap following the cyberattack. Major payments from BMS and Sandoz are already factored into guidance, and further milestones are not guided for as they depend on partner execution.