Peter Verdult

Peter Verdult asked for an update on Novartis's basket of cell therapy programs in autoimmune diseases, inquiring about which ones are expected to readout next year, specific indications, and the company's overall enthusiasm for these programs.

Answer

Vasant Narasimhan, CEO of Novartis, expressed continued enthusiasm, highlighting a significant internal effort on YTB, currently in pivotal studies for four indications, with follow-on programs in four additional indications. He mentioned trispecific and bispecific monoclonals also being explored. The first readouts are expected in SLE lupus nephritis, building on previously presented 'spectacular results,' and other programs are advancing rapidly, with some potentially reading out next year depending on enrollment.

Peter Verdult followed up on Novartis's basket of cell therapy programs in autoimmune diseases, asking about specific indications with readouts next year and the company's overall enthusiasm level for these programs.

Answer

Vasant Narasimhan, CEO of Novartis, expressed continued enthusiasm for the cell therapy programs, highlighting a significant internal effort on YTB with pivotal studies in four indications and follow-on programs in four additional indications. He noted that the first readouts are expected in SLE lupus nephritis, building on previously presented 'spectacular results,' and mentioned that other programs might also have readouts next year depending on enrollment, with some having FDA alignment for single-arm filings.

Peter Verdult asked for clarification on the market's reaction to the ianalumab abstract, specifically if the full data presentation would improve appreciation, and requested details on the 12 domains of the SDI index most important to patients and physicians.

Answer

CEO Vasant Narasimhan emphasized that Novartis's focus is on delivering a compelling proposition to patients and physicians, and that detailed data presented on Thursday would clarify their conviction. He highlighted that individual patient benefit, symptomatic improvements (fatigue, salivary flow), and reduction in steroid use are key for patients and physicians, rather than the aggregate SDI score.

Peter Verdult asked for clarification on the market's reaction to the ianalumab abstract and whether the full data presentation would improve its appreciation, specifically inquiring about the 12 domains of the SDI index and their importance to patients and physicians.

Answer

Vasant Narasimhan, CEO of Novartis, expressed confidence that detailed data presented on Thursday would clarify the company's conviction. He emphasized that individual patient benefit, symptomatic improvements (fatigue, salivary flow, daily living), and reduction in steroid use are more crucial to patients and physicians than the aggregate SDI score, especially in a highly variable disease with no approved drug.

Peter Verdult of Citigroup asked for a big-picture view on the Inflation Reduction Act (IRA), inquiring about the initial price negotiation process and whether there's increased confidence that oligonucleotides like pelacarsen could get the 13-year exclusivity period of biologics.

Answer

CEO Vasant Narasimhan characterized the IRA process as 'government price setting,' not negotiation, and reiterated that the policy is bad for innovation long-term. While Novartis has factored the IRA into its guidance, he expressed hope for legislative fixes. He noted a bipartisan bill is being discussed to extend exclusivity for genetically targeted therapies like oligonucleotides from 9 to 13 years, and the company continues to advocate for this change.

Peter Verdult of BNP Paribas requested an update on discussions with the US administration, including CMS and HHS, regarding the implementation of drug pricing frameworks and potential future policies.

Answer

CEO Vasant Narasimhan described the ongoing dialogues as productive and focused on finding solutions that encourage innovation while lowering patient costs, potentially by reducing the role of intermediaries. He emphasized the administration's goal of maintaining US leadership in biopharmaceutical innovation and Novartis's efforts to educate policymakers on the value the industry provides.

Peter Verdult asked about the commercial opportunity for ianalumab in Sjögren's syndrome, inquiring if its potential could be similar to or larger than Cosentyx in hidradenitis suppurativa (HS), given the positive physician feedback.

Answer

CEO Vasant Narasimhan confirmed that ianalumab has the potential to be a multi-billion dollar medicine in Sjögren's alone due to the high unmet need. However, he emphasized that it remains a high-risk study because of the disease's heterogeneity and the challenging ESSDAI primary endpoint, making positive patient-reported outcomes crucial for success.

Peter Verdult asked for details on the REDEFINE 4 trial design for CagriSema, specifically if flexible dosing was allowed as in REDEFINE 1, and any major differences between the trials. He also questioned the spirit of the 2026 guidance, asking if it reflected genuine concerns about cannibalization and competition or a conservative approach to prevent further downgrades.

Answer

EVP and Chief Scientific Officer, Martin Holst Lange, confirmed that REDEFINE 4 compares CagriSema and tirzepatide for weight loss, with dosing similar to REDEFINE 1. He noted that while trial duration was optimized in REDEFINE 4, the full weight loss potential of CagriSema is expected from REDEFINE 11, which incorporates all learnings on flexible titration. CEO Maziar Doustdar explained that the guidance reflects the volatile and dynamic obesity market, based on macro trends, Q4 run rates, and new data like the Wegovy pill's first four weeks, with assumptions for future events like LOE and Medicare access, providing a midpoint with a four-point range on each side.

Peter Verdult asked Martin Holst Lange for details on the REDEFINE 4 trial design for CagriSema, specifically if flexible dosing was allowed as in REDEFINE 1, and any major differences to be aware of. He also asked Mike Doustdar if the 2026 guidance reflected genuine concerns about cannibalization and competition or if it was a conservative start to prevent further downgrades.

Answer

Martin Holst Lange (EVP and Chief Scientific Officer, Novo Nordisk) confirmed that REDEFINE 4 compares CagriSema and tirzepatide for weight loss, testing for non-inferiority then superiority, with dosing similar to REDEFINE 1. He noted that REDEFINE 11 incorporates learnings on longer treatment duration and flexible titration to optimize weight loss potential. Maziar Doustdar (CEO, Novo Nordisk) stated that the guidance reflects the dynamic obesity market, based on Q4 2025 run rates and new data like the Wegovy pill uptake. He acknowledged the LOE in international operations and the gradual ramp-up of Medicare coverage as factors, providing a range due to inherent market volatility.

Peter Verdult asked if the pursuit of Medcera signals waning confidence in Novo Nordisk's internal pipeline, seeking clarification on the clinical differentiation of Medcera's assets (MET 97, MET 233) compared to CagriSema and amycretin, beyond just monthly dosing. He also asked for confirmation regarding reports of FTC contact concerning the Medcera acquisition.

Answer

President and CEO, Novo Nordisk, Mike Doustdar, expressed excitement for the internal pipeline but stated that no pipeline is broad enough for the ambition to treat hundreds of millions, highlighting Medcera's differentiated and complementary assets. EVP of Research and Development and CSO, Martin Holst Lange, added that Medcera's pipeline offers differentiation and complementarity across efficacy, safety, tolerability, scalability, and dosing frequency, crucial for serving diverse obesity patient needs. Chief Financial Officer, Karsten Munk Knudsen, stated that the company could not comment on FTC details due to ongoing processes but affirmed confidence in the deal's compliance with all laws and regulations.

Peter Verdult asked if the pursuit of Medcera signals waning confidence in Novo Nordisk's internal pipeline, seeking clarification on the clinical differentiation of Medcera's assets (MET 97, MET 233) from CagriSema and amycretin beyond just monthly dosing. He also requested confirmation regarding contact from the FTC concerning the Medcera acquisition.

Answer

President and CEO Mike Doustdar expressed excitement for Novo Nordisk's internal pipeline but stated that no pipeline is broad enough for the ambition to treat hundreds of millions of people, emphasizing Medcera's differentiated and complementary assets. EVP of Research and Development and CSO Martin Lange added that Medcera's pipeline offers differentiation and complementarity across efficacy, safety, tolerability, scalability, and dosing frequency, crucial for serving diverse obesity patient needs. CFO Karsten Knudsen declined to provide details on the FTC process, stating the company is confident the deal complies with all regulations.

Peter Verdult of BNP Paribas asked about price segmentation in the oral GLP-1 market, questioning if it would be a lower-priced segment than injectables. He also asked when the company's significant CapEx spending is expected to normalize.

Answer

David Moore (EVP - US Operations) stated they are not in a hurry to lower prices, emphasizing oral semaglutide is 'Wegovy in a pill' and the focus is on balancing value and access. On spending, Karsten Knudsen (CFO) responded that the company is 'very close to the peak' for CapEx and that absolute levels should decline after this year or next.

Peter Verdult of BNP Paribas questioned if Novo Nordisk anticipates price segmentation in the oral GLP-1 market, suggesting it might be a lower-priced segment. He later asked for more detail on when the company's high CapEx spending might begin to normalize.

Answer

David Moore, EVP of US Operations, responded that the company is not in a hurry to lower prices and is focused on balancing value and access. Ludovic Helfgott, EVP of Product & Portfolio Strategy, added the focus is on lifetime patient value, not a single price point. On capital expenditures, Karsten Knudsen, EVP & CFO, stated that the company is 'very close to the peak' and that absolute CapEx levels should decline thereafter.

Peter Verdult from BNP Paribas asked for details on the Q2 inventory destocking in China and the growth outlook, as well as the strategic changes the incoming CEO plans to implement, particularly in R&D and commercial strategy.

Answer

Incoming CEO Maziar Doustdar explained the China slowdown was due to a one-time inventory adjustment against a prior-year build-up, not a loss of market share, expressing high confidence in future growth. On strategy, he reiterated a sharpened focus on execution in diabetes and obesity and reallocating capital to fund growth.

Questioned the disconnect between management's focus on commercial execution and recent prescription trends, asking if factors beyond compounding, like competitor performance, were at play. He also asked for the company's thoughts on recent data for a competitor's oral drug, orforglipron.

Answer

The company attributed the difficulty in assessing script trends to the large, unmeasured compounding market, which they estimate is similar in size to their own GLP-1 business. They expressed confidence in their strategy, citing the CVS formulary win as proof of Wegovy's brand strength. Regarding oral competition, they believe their oral semaglutide has a significant advantage due to its established safety profile and manufacturing readiness for a full U.S. launch.

Peter Verdult questioned the perceived disconnect between management's focus on commercial execution and recent prescription trends, asking if it was solely due to compounders or if a competitor was outperforming. He also asked for thoughts on competitor orforglipron data.

Answer

CEO Lars Fruergaard Jørgensen attributed the difficulty in assessing script trends to the significant, unmeasured compounding market and expressed confidence in their second-half strategy. He highlighted the CVS formulary decision as a testament to Wegovy's value. Regarding competition, he emphasized Novo's head start with oral semaglutide, its extensive safety data, and its readiness for a full U.S. launch.

Peter Verdult inquired about the vaccines outlook, specifically the exposure to recent US pediatric vaccination schedule changes, Beyfortus's US versus ex-US dynamics, and the net outlook for flu given receding mRNA threats and rising competitor preventative assets. He also asked if business development activity is set to accelerate significantly.

Answer

Thomas Triomphe, EVP of Vaccines, addressed potential confusion from US childhood immunization changes but noted continued insurance coverage and HCP adherence to previous schedules. He reiterated Beyfortus's 2025 performance and deferred specific 2026 guidance. For flu, he highlighted strong Q4 performance and differentiated products, expressing no concern about mRNA threats for 2026-2027. François-Xavier Roger, CFO, stated that while Sanofi has strong balance sheet flexibility, capital allocation for BD/M&A will remain disciplined, focusing on strategic fit, scientific differentiation, and financial return, primarily targeting phase one/two assets to complement the pipeline.

Peter Verdult asked for an updated outlook on vaccines, specifically regarding the impact of recent U.S. pediatric vaccination schedule changes, Beyfortus dynamics (U.S. vs. ex-U.S.), and the flu market (mRNA threats vs. competitor preventative assets). He also asked if business development activity is set to accelerate significantly given partner disappointments.

Answer

Paul Hudson, CEO, and Thomas Triomphe, EVP of Vaccines, addressed potential confusion from U.S. childhood immunization schedule changes but noted unchanged recommendations and coverage, with most HCPs adhering to previous schedules. They reiterated Beyfortus's strong 2025 performance and planned ex-U.S. expansion. For flu, they highlighted strong Q4 performance and market share gains with differentiated products, dismissing mRNA threats for 2026-2027. François-Xavier Roger, CFO, stated that Sanofi has a strong balance sheet for BD but will remain disciplined, focusing on scientific differentiation and financial returns, primarily targeting phase one/two assets to complement the pipeline and manage Dupixent's LOE.

Peter Verdult asked about the go-forward strategy for itopicumab (R33) in COPD, specifically if it involves repeating the RFI trial or focusing solely on former smokers. He also inquired about the regulatory pathway for FDO (DORA) in AATD, asking if respiratory functional endpoints would be required. Lastly, he questioned concerns about tolibrutinib (TOLI) for SPMS receiving an onerous label with weekly liver monitoring.

Answer

Head of R&D Houman Ashrafian stated that for itopicumab, a replicatory trial is anticipated, with details dependent on internal/external data and discussions with Regeneron and regulators. For FDO, he noted Sanofi's Q3/Q4 W dosing provides substantially better AAT levels than standard of care and will discuss required endpoints with regulators. For tolibrutinib SPMS, he mentioned late-stage discussions with a PDUFA date of December 28, anticipating some RAMs but no further comment on blood draw intensity. CEO Paul Hudson added that learnings from RFI 1 and 2 will inform future trials, and TOLI's initial 90-day monitoring in trials has been practical.

Peter Verdult asked Houman Ashrafian about itepekimab's go-forward strategy (repeating the RFI trial, focusing on former smokers), the regulatory pathway for FDO (efdoralprin alfa) regarding respiratory functional endpoints versus biomarker analysis, and concerns about tolibrutinib SPMS potentially receiving an onerous label requiring weekly liver monitoring and its commercial implications.

Answer

Houman Ashrafian (Head of R&D) stated that for itepekimab, a replicatory trial is anticipated, with details dependent on internal/external data and discussions with Regeneron and regulators. For FDO, he noted current standard of care targets 11 micromolar, and their Q3/Q4 W dosing is 'substantially better,' with discussions planned with regulators on levels and additional endpoints. For tolibrutinib SPMS, he mentioned late-stage discussions, anticipating some RAMs but no further disclosable comment on the intensity of blood draws, with Paul Hudson (CEO) adding confidence in their practical and responsible approach.

Peter Verdult of BNP Paribas asked about the company's view on IL-17, the latest thinking on U.S. pricing reform, and the timeline for next steps on itepecumab.

Answer

CEO Paul Hudson stated the company is focused on its own breakthrough assets in AD and reiterated concerns about patient access in Europe amid pricing discussions. EVP & Head of R&D Houman Ashrafian said that for itepecumab, the company is analyzing the mixed data with Regeneron before determining next steps with regulators.

Peter Verdult of BNP Paribas Exane asked about recent interactions with European politicians regarding innovation incentives and pressed for clarity on whether brivekimig's efficacy in HS is considered competitive with IL-17 inhibitors.

Answer

Houman Ashrafian (EVP, Head of R&D) stated that based on his experience, the early brivekimig data is 'certainly competitive' with IL-17 inhibitors like BIMZELX. CEO Paul Hudson confirmed recent conversations with EU leadership to advocate for the value of pharmaceutical innovation in Europe, acknowledging the delicate geopolitical landscape.

Peter Verdult of BNP Paribas Exane asked for confirmation on using a biomarker strategy for the TL1A asset in Phase III and questioned if Dupixent's profitability would see a significant step-up in 2025.

Answer

Executive Houman Ashrafian expressed excitement about the competitive TL1A data but did not confirm a biomarker-based stratification would be obligatory, noting more details would come at the ECCO meeting. CFO François-Xavier Roger stated that overall gross margin is expected to progress in 2025, with a fair contribution from Dupixent, but emphasized that growth is not solely dependent on it.

Peter Verdult asked for the rationale behind the optimism for tolebrutinib in secondary progressive MS, given the lack of randomized Phase II data. He also prompted management for commentary on the 2025 consensus earnings outlook and the company's growth journey.

Answer

Houman Ashrafian, EVP and Head of R&D, explained that optimism for tolebrutinib is based on its differentiated profile as a potent, blood-brain barrier-penetrating kinase inhibitor that targets the disease's immunological pathophysiology. CFO François-Xavier Roger confirmed a positive outlook for 2025, supported by H1 2024 performance, and pointed to solid top-line growth, positive mix driving gross margin, flat R&D, and tight SG&A control as key drivers.

Peter Verdult inquired if consensus expectations for Baxdrostat ($2 billion) would increase post-BACS-24 data, given KOL excitement and reported blood pressure lowering. He also asked about the political environment in Europe regarding innovation and pharmaceutical pricing.

Answer

CEO Pascal Soriot expressed personal excitement for Baxdrostat due to its impact on uncontrolled hypertension and aldosterone reduction, anticipating impressive blood pressure reduction data. EVP of Biopharmaceuticals Business Unit Ruud Dobber highlighted the ongoing seven studies and the potential of Baxdrostat in combination with dapagliflozin. Pascal Soriot discussed the growing pricing disparity between the U.S. and Europe, advocating for increased European budgets for innovative pharmaceuticals to attract investment and drive economic growth.

Peter Verdult asked if expectations for Baxdrostat's asset maturity would increase post-Bax24 data, given KOL excitement and current consensus. He also inquired about the political environment in Europe regarding innovation and whether politicians are recognizing the need for increased investment.

Answer

CEO Pascal Soriot expressed excitement for Baxdrostat due to the unmet need in uncontrolled hypertension, its effect on aldosterone, and 24-hour control. EVP of Biopharmaceuticals Business Unit Ruud Dobber highlighted 7 ongoing studies and the potential for a fixed-dose combination with dapagliflozin. Pascal Soriot discussed Europe's growing price difference, low pharma healthcare cost allocation, the need for rebalancing, and the risk of losing supply chain control.

Peter Verdult of BNP Paribas asked about the impact of potential US-Europe tariffs, the competitive profile of geforlimab (C5 nanobody), and whether the company's obesity drug pricing would be materially lower than current GLP-1s.

Answer

CFO Aradhana Sarin stated that any tariff impact would be short-lived due to segregated supply chains and ongoing tech transfers. CEO Pascal Soriot confirmed the strategy for weight management involves affordable pricing for chronic use. CEO of Alexion, Marc Dunoyer, highlighted geforlimab's rapid onset and convenient administration as key differentiators that will complement the existing C5 infusion franchise.

Peter Verdult inquired about potential disruptions in interactions with the FDA and asked for expectations on the upcoming baxdrostat Phase III readout, particularly in light of recent competitor data.

Answer

EVP, Oncology R&D, Susan Galbraith and EVP, BioPharma R&D, Sharon Barr both stated they have seen no delays or disruptions in their interactions with the FDA. Regarding baxdrostat, Barr expressed confidence that the molecule has a potential best-in-class profile due to its efficacy at a low dose, longer half-life for 24-hour control, and lack of drug-drug interactions, positioning it competitively ahead of its pivotal data readout.

Peter Verdult asked for any early key performance indicator (KPI) changes for Tagrisso, Imfinzi, or Enhertu following recent ASCO data. He also sought to clarify key assumptions within the updated full-year guidance.

Answer

EVP, Oncology Business Unit, David Fredrickson, highlighted the rapid NCCN guideline update for Tagrisso (LAURA) as a key positive indicator and noted strong medical interest for Imfinzi (ADRIATIC). CFO Aradhana Sarin confirmed the guidance assumes flat collaboration revenue and has factored in uncertainties around Farxiga's VBP in China and Symbicort's U.S. pricing dynamics.

Peter Verdult asked for factual confirmation on whether the Blenrep DREAMM-10 study has US trial sites. He also inquired if other assets from the Hengrui deal might enter the clinic in the next 12-18 months.

Answer

Chief Scientific Officer Tony Wood confirmed that while clinicaltrials.gov does not currently list US sites for DREAMM-10, GSK has extensive plans to increase US patient recruitment across its portfolio. Regarding the Hengrui deal, he declined to disclose specifics, but CCO Luke Miels added that some new assets will 'definitely be in the clinic next year.'

Peter Verdult of Citigroup Inc. asked about GSK's vaccine dynamics, specifically concerning Shingrix performance in China, the timeline for returning U.S. Shingrix to growth, and the outlook for U.S. RSV contracting for the upcoming season. He also inquired about the company's enthusiasm for its TIGIT mechanism given competitor data.

Answer

Luke Miels, Chief Commercial Officer, addressed the vaccine questions, expressing confidence in the long-term strategic partnership in China for Shingrix and detailing the short-term U.S. dynamics caused by wholesaler inventory and CMS rule changes. He affirmed GSK is well-positioned in RSV contracting. Tony Wood, Chief Scientific Officer, explained the differentiation of GSK's TIGIT antibody, highlighting its unique mechanism that augments immunity and depletes T-regulatory cells, with more data expected by year-end.

Peter Verdult questioned the company's credibility and the risk of another reset with an incoming CEO, asking why Q2 revenue growth wouldn't be stronger given the easy comparison from the prior year's cyber attack. He also asked if the BIOSECURE Act was translating into actual orders or just discussions.

Answer

CBO Matthias Evers stated the current reset prepares the ground for the new CEO and that H1 is a trough due to operational ramp-up times. CFO Laetitia Rouxel clarified that Q2 would see positive year-over-year top-line growth, but profitability improvements would be an H2 story. Regarding the BIOSECURE Act, Evers noted it is not yet reflected in results and is considered a future upside, with discussions currently underway.

Peter Verdult of Citi inquired about the specific 'low-hanging fruit' that gives new management confidence in accelerating free cash flow improvement this year. He also asked for clarification on the pricing premium and market share of Xembify (subcutaneous IG) and the benefits of the recent specialty pharmacy partner switch for the alpha-1 franchise.

Answer

CEO Nacho Abia responded that improving free cash flow is about instilling a company-wide mindset focused on execution, particularly around working capital and operational improvements, rather than a single magic bullet. President of Biopharma Roland Wandeler confirmed Xembify's price premium and significant growth potential from its current 5% share of IG sales. He added that the new alpha-1 partner enhances service for home infusion patients and helps onboard new patients.

Peter Verdult of Citigroup Inc. asked if the upcoming GEN1046 data would be significant enough to materially alter consensus expectations for the drug. He also requested a ballpark figure for the annualized operating cost of the newly acquired ProfoundBio, including the R&D investment needed for its lead asset, Rina-S.

Answer

Chief Medical Officer Tahamtan Ahmadi expressed excitement for the GEN1046 data, highlighting its potential to validate an IO-IO approach with strong efficacy, durability, and overall survival. Chief Financial Officer Anthony Pagano did not provide a specific annualized cost for ProfoundBio but stated that for 2024, total OpEx is expected to be at or moderately above the high end of the DKK 13.4 billion guidance range. He assured that Genmab will remain substantially profitable during the investment period and that Rina-S could be accretive by its first full year of launch.