Simon Baker

Simon Baker inquired about the overarching principles guiding the rationalization of Sanofi's phase two portfolio and sought clarification on Dupixent's patent protection strategy and potential loss of exclusivity beyond the main patent expiry in March 2031.

Answer

Houman Ashrafian, EVP and Head of Research and Development, explained that the portfolio rationalization is guided by a dynamic capital allocation strategy, ensuring resources are spent on programs with established value. Roy Papatheodorou, General Counsel, stated that Dupixent is expected to be protected by multiple patents beyond March 2031, ranging to 2035, and the company intends to vigorously defend its strong patent portfolio.

Simon Baker asked about the overarching principles guiding the rationalization of Sanofi's phase two portfolio and sought insights into Dupixent's patent life beyond March 2031, given numerous patents expiring between late 2031 and February 2045.

Answer

Paul Hudson, CEO, and Houman Ashrafian, EVP and Head of Research and Development, explained that the phase two portfolio rationalization is guided by a dynamic capital allocation strategy, regularly reallocating resources based on value and scientific differentiation. Roy Papatheodorou, General Counsel, confirmed that Dupixent is expected to be protected by patents beyond March 2031 in the U.S., citing a strong portfolio of granted and to-be-granted patents extending to 2035, which Sanofi intends to vigorously defend.

Simon Baker asked about the magnitude of Dupixent's gross margin benefit from manufacturing improvements in Q3, the potential of rosibutinib in Graves' disease, and Sanofi's appetite for CMV vaccination given Moderna's recent failure and Sanofi's past work.

Answer

François-Xavier Roger (CFO) stated that Dupixent's C3 manufacturing impact was 'very limited' in Q3, with the overall gross margin increasing by 2.5%, driven by volume, product mix (including Ayvakit), and industrial restructuring. Houman Ashrafian (Head of R&D) highlighted Graves' disease as a promising opportunity for rosibutinib due to its autoimmune nature and the molecule's unique properties. Thomas Triomphe (Head of Vaccines) acknowledged CMV as a difficult target, noting Sanofi's past work and welcoming a vaccine despite having interrupted its own program decades ago.

Simon P. Baker asked about the magnitude of Dupixent's gross margin improvement from manufacturing efficiencies in Q3. He also inquired about the potential for rosibutinib in Graves' disease and Sanofi's current interest in CMV vaccination following recent industry news.

Answer

CFO François-Xavier Roger clarified that Dupixent's C3 manufacturing had a very limited impact on Q3 gross margin, with the overall gross margin increase driven by volume growth, product mix (Ayvakit being more significant), and industrial restructuring. Head of R&D Houman Ashrafian expressed optimism for rosibutinib in Graves' disease, citing its autoimmune nature and success in other disorders. Head of Vaccines Thomas Triomphe acknowledged the recent CMV news but stated Sanofi had discontinued its own CMV program decades ago due to efficacy concerns, despite recognizing the need for a vaccine.

Simon Baker of Rothschild & Co Redburn requested an update on the U.S. outlook for Beyfortus and asked for the rationale behind pursuing KIT inhibition for inflammatory diseases with the Blueprint asset.

Answer

EVP of Vaccines Thomas Triomphe stated that Beyfortus growth will continue through geographic expansion and it will remain dominant due to its superior half-life and real-world data. EVP & Head of R&D Houman Ashrafian explained that successfully targeting wild-type c-kit is a 'holy grail' that could unlock significant opportunities in inflammation if an adequate therapeutic index is achieved.

Simon Baker of Redburn Atlantic asked for the posterior probability from the Bayesian study for brivekimig and inquired about other internal combination candidates for the oral TNF inhibitor, such as the IRAK4 degrader.

Answer

Houman Ashrafian (EVP, Head of R&D) declined to provide the specific posterior probability for the brivekimig study but reiterated that the results were compelling. Regarding oral TNF combinations, he stated that while there are multiple rational partners, it would be unwise to disclose them at this time. CEO Paul Hudson added that the strategy involves identifying diseases where combinations can achieve new efficacy benchmarks.

An analyst on behalf of Simon Baker asked about Sanofi's appetite for radiopharma and inquired about any changes in approach that would explain the better-than-expected performance in the older, broader product portfolio.

Answer

Houman Ashrafian, EVP and Head of R&D, stated that while they are watchful of the radioligand therapy space, they remain focused on their core therapeutic areas and have no current programs. Olivier Charmeil, EVP and Head of General Medicines GBU, attributed the strong performance of the legacy portfolio to a multi-year strategy of simplification, including reducing the number of product families, optimizing the geographic footprint, and reallocating resources to growth drivers.

Simon Baker asked about the typicality and factors influencing the $7.6 million deferred revenue balance, seeking clarity for modeling. He also inquired about underlying sequential trends in the cost of goods sold (COGS) line, asking if it's too early to see gross margin improvement and the expected timeframe for such improvement.

Answer

CEO Dr. Christian Itin explained that deferred revenue reflects the lag between product shipment to centers and actual patient infusion, influenced by scheduling and patient condition. He stated that COGS are noisy during launch, but volume increases and operational efficiencies (reducing time and material costs per batch) are expected to drive improvements in the COGS ratio as sales grow next year. CFO Rob Dolski added that Q3's gross margin difference was mainly due to deferred revenue recognition and that more data points are needed for a smoother trend.

Simon Baker of Rothschild & Co Redburn asked how the reimbursement process for cell therapies differs from traditional drugs, affecting the launch sequence in Europe. He also asked for perspective on the UK's new framework for point-of-care manufacturing.

Answer

CEO Christian Itin provided a detailed explanation of the challenges in European reimbursement for cell therapies, citing a major disconnect between regulators who approve drugs based on single-arm trials and market access bodies whose methodologies require randomized controlled data. This systemic issue, where the models cannot quantify the benefit of curative therapies, complicates pricing and launch sequencing, making the traditional Germany-first approach less certain.

Simon Baker of Redburn Atlantic asked for the expected timeline of a decision by NICE in the U.K. for AUCATZYL. He also requested details on the duration of patient exposure and follow-up that will be presented in the interim analysis of the Carlyle SLE study.

Answer

Executive Christian Itin explained that the NICE assessment and regulatory approval in the U.K. are two ongoing parallel processes, and he would provide updates after clearing the regulatory hurdle. For the Carlyle study data, he specified that at the April R&D event, one patient will have over six months of follow-up, two will have over three months, and three will have between one and three months of follow-up.

Simon Baker asked for an update on AstraZeneca's confidence in Sonivodotin (Claudin 18.2 ADC) ahead of its gastric phase III data in H1 2026, and for thoughts on the broader scope of Claudin 18 beyond gastric cancer.

Answer

EVP of Oncology R&D Susan Galbraith expressed encouragement from Sonivodotin's response rate data in late-line patients. She discussed investigating it in earlier lines and combinations (with IO therapy), noting Claudin 18.2's high expression in gastric cancer (>50% patients) and also in pancreatic cancer, where they are exploring different payloads.

Simon Baker requested an update on confidence in Sonivodotin as the gastric phase III data approaches in H1 2026, and thoughts on the broader scope of Claudin 18 beyond gastric cancer.

Answer

EVP of Oncology R&D Susan Galbraith expressed encouragement for Sonivodotin, a Claudin 18.2 ADC, citing encouraging response rates in late-line patients and its potential in earlier-line settings and combinations with IO therapy. She noted Claudin 18.2's expression in over 50% of gastric cancer patients and its presence in pancreatic cancer, where AstraZeneca is also exploring its data.

Simon Baker asked for quantification of the financially motivated patient discontinuation rates prior to the Part D redesign and questioned if the removal of two neuroscience assets from the pipeline signaled a strategic exit from the therapeutic area.

Answer

EVP, Oncology, David Fredrickson declined to give specific percentages but noted a significant reduction in free goods utilization, with future growth driven by new indications. EVP, BioPharmaceuticals R&D, Sharon Barr confirmed the company has closed its neuroscience group, calling it a strategic prioritization to focus resources on core areas like weight management, respiratory, and immunology.

Simon Baker of Redburn Atlantic asked for an update on the potential scope for the TIGIT target (rilvegostomig) beyond non-small cell lung cancer and for highlights of growth drivers in emerging markets excluding China.

Answer

Susan Galbraith, EVP of Oncology R&D, noted that beyond lung cancer, rilvegostomig is being studied in biliary tract cancer and has potential in other indications like gastric and HCC, with good combination capability with ADCs. Iskra Reic, Head of International, explained that strong double-digit growth is seen across all emerging market regions (LatAm, Asia, MEA) and is expected to continue, driven by later-cycle launches of key brands like Breztri and Enhertu.

Simon Baker asked about the rebate adjustment, specifically if any drugs other than Cosentyx were called out, and if any drug benefited from the rebate adjustment in Q3.

Answer

CFO Harry Kirsch clarified that the prior period rebate adjustment amounted to roughly $180 million, impacting Q3 by about 1.5-2 percentage points. He stated that Cosentyx was a big piece of this, and another significant portion was Entresto, mainly due to patients entering the catastrophic phase of Medicare Part D redesign. He also mentioned smaller elements related to 2024 inflation penalty parts.

Simon Baker asked why the placebo response in the ianalumab Sjogren's trial (Neptune 1) plateaued at week 48 but then reversed.

Answer

Vasant Narasimhan, CEO of Novartis, explained that Sjogren's disease is highly variable, leading to some variability in placebo response. He noted that both studies were adequately controlled and well-designed, and that the Q month data showed better results than Q3 month data, indicating an expected dose response. He deferred further detailed comments until the full data presentation.

Simon Baker from Rothschild & Co Redburn asked for details on the price-volume dynamics for Cosentyx and why competitive pressures are considered temporary. He also inquired about efforts to reform drug pricing clawbacks in the UK.

Answer

CFO Harry Kirsch attributed some price pressure on Cosentyx to the Medicare Part D redesign. CEO Vasant Narasimhan added that new competitive entries typically cause a temporary market disruption before stabilizing. Regarding the UK, he confirmed active engagement with the government to reform the VPAG system to better support a vibrant biopharmaceutical sector.

Simon Baker asked about Novartis's exposure to potential U.S. tariffs, the company's decision not to highlight this risk, and for feedback on its letter to the Financial Times regarding EU innovation. He also requested more detail on the 2% positive gross-to-net impact, specifically which products were most affected.

Answer

CEO Vasant Narasimhan stated that guidance fully accounts for potential tariffs and that the company is increasing its U.S. manufacturing footprint to mitigate risks. He also advocated for the EU to better reward innovation. CFO Harry Kirsch explained the gross-to-net favorability was broad-based across many brands due to lower Medicaid utilization and favorable channel mix, not distorting any single product's growth rate.

Simon Baker asked for commentary on the resilience of Novartis's gross margin in 2025, considering the potential loss of exclusivity for Entresto and the company's historical strength in managing patent expiries.

Answer

CFO Harry Kirsch stated that he expects further margin improvement to come primarily from SG&A leverage, with SG&A growing significantly below sales. He acknowledged that the gross margin will face some pressure from product mix shifts (e.g., higher royalties on newer molecules), but this will be more than offset by SG&A efficiencies and ongoing manufacturing productivity programs.

Simon Baker of Rothschild & Co Redburn asked for a timeframe on resolving the U.S. drug compounding issue and whether an ITC complaint has been filed. He also questioned why the de-emphasis of Rybelsus should not be seen as a precedent for the oral obesity launch.

Answer

David Moore (EVP - US Operations) reported active dialogue with the FDA to stop fake API from China but could not provide a specific date. Karsten Knudsen (CFO) confirmed all legal options are on the table. On the Rybelsus comparison, David Moore explained the market dynamics are different, as obesity patients are moving from injectables to a novel oral option. Martin Lange (CSO) added that oral semaglutide for obesity was designed to match injectable efficacy, unlike Rybelsus in diabetes.

Simon Baker of Rothschild & Co Redburn asked for a timeframe on resolving the drug compounding issue and inquired about specific legal actions. He later questioned why the commercial deemphasis of Rybelsus should not be seen as a precedent for the oral obesity drug launch.

Answer

David Moore, EVP of US Operations, stated there's no meaningful change yet in compounding and confirmed productive dialogue with the FDA. Karsten Knudsen, EVP & CFO, added all legal options are on the table. On the Rybelsus comparison, Mr. Moore explained the market dynamics are different, as an oral option in obesity is a new, attractive alternative to injectables. Martin Lange, EVP & CSO, added that oral semaglutide for obesity was designed to match the efficacy of the injectable version, unlike Rybelsus.

Simon Baker asked for Novo Nordisk's perspective on how the obesity market is expected to evolve by 2030, considering both its own product pipeline and the efforts of competitors.

Answer

Camilla Sylvest, Group Commercial Strategy Head, highlighted the vast, underserved patient population, suggesting ample room for market growth. She anticipates future market segmentation, with Novo Nordisk focusing on the high-efficacy segment, leveraging Wegovy's cardiovascular label. She believes new entrants will likely expand the overall market rather than simply create a zero-sum competition.

Simon Baker asked for clarification on the Camlopixant trial reporting timeline and questioned the impact of a potential Blenrep approval delay on GSK's 2028 and 2031 financial outlooks and its M&A strategy.

Answer

CEO Dame Emma Walmsley affirmed there is no change to Blenrep's expected ramp or the company's long-term financial outlooks, highlighting continued confidence and ongoing business development. Chief Scientific Officer Tony Wood clarified that both Camlopixant studies (CALM-1 and CALM-2) will be formally disclosed together in mid-2026, in line with the CALM-2 schedule.

Simon Baker asked about HIV PrEP market dynamics and potential clinical trial impacts from USAID funding changes. He also inquired about the upcoming camlipixant study and what would constitute a good result.

Answer

ViiV Chairman David Redfern stated there has been no direct impact on GSK/ViiV trials from USAID changes and noted strong Apretude uptake in an underdeveloped PrEP market. CSO Tony Wood discussed camlipixant, highlighting its design for a clinically significant effect and its superior selectivity profile demonstrated in the Phase II SOOTHE study, which showed a 34% reduction in cough frequency.

Simon Baker of Redburn Atlantic asked about the potential biological mechanism that could explain the observed association between Shingrix vaccination and a reduced incidence of dementia.

Answer

Tony Wood, Chief Scientific Officer, responded that the mechanism is not well understood and is an area of early scientific exploration. He mentioned several hypotheses being investigated, including potential vascular effects or the suppression of underlying viral reactivation and subsequent inflammation, but emphasized that the science is still developing.

Simon Baker asked about the Medicare Part D redesign, specifically when Gilead might start seeing a positive benefit from improved patient adherence due to lower out-of-pocket costs.

Answer

Chief Commercial Officer Johanna Mercier stated that Gilead does not expect a material volume increase from the Part D reform. She explained that numerous safety net programs already exist for HIV, and abandonment rates for key products like Biktarvy are already incredibly low. While the situation is being monitored, any potential benefit would likely appear late in the year and is not currently factored into their forecasts.

Simon Baker sought clarification on whether the 50% spend on respiratory trials referred to total trial spend or total R&D spend, and asked about the regulatory process for the COVID-flu combo, including potential impacts on the approval timeline.

Answer

CFO Jamey Mock clarified the 50% figure refers to trial expense, not total R&D. President Stephen Hoge explained that based on initial regulatory feedback, the flu efficacy data will likely be required for the combo vaccine's approval, and while a delay or unfavorable result could impact the timeline, it's possible to proceed without substantial delays if the data is submitted promptly.

Simon Baker sought clarification on whether previous comments about trial design for BNT327 pertained to triple-negative breast cancer or non-small cell lung cancer, and requested more details on the upcoming first-line NSCLC study.

Answer

Chief Medical Officer Dr. Özlem Türeci deferred the detailed answer, referring the question to the company's upcoming Innovation Day. She stated that more details on study designs, benchmarks, and pivotal trial plans for BNT327 would be disclosed at that event next week.