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    James Quigley • Goldman Sachs

    James Quigley's questions to Novo Nordisk A/S (NVO) leadership

    James Quigley's questions to Novo Nordisk A/S (NVO) leadership • Q2 2025

    Question

    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.

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    James Quigley's questions to Novo Nordisk A/S (NVO) leadership • Q2 2025

    Question

    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.

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    James Quigley's questions to Novo Nordisk A/S (NVO) leadership • Q1 2025

    Question

    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.

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    James Quigley's questions to Novartis AG (NVS) leadership

    James Quigley's questions to Novartis AG (NVS) leadership • Q2 2025

    Question

    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.

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    James Quigley's questions to Novartis AG (NVS) leadership • Q1 2025

    Question

    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.

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    James Quigley's questions to Novartis AG (NVS) leadership • Q4 2024

    Question

    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.

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    James Quigley's questions to Novartis AG (NVS) leadership • Q2 2024

    Question

    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.

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    James Quigley's questions to Sanofi SA (SNY) leadership

    James Quigley's questions to Sanofi SA (SNY) leadership • Q1 2025

    Question

    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.

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