Sachin Jain

Sachin Jain of Bank of America asked about the relative timing and perceived probability of success for the Dato-DXd AVANZAR and TROPION-Lung07 trials, and questioned if AstraZeneca could adjust its tozorakimab COPD trial given competitor issues with event rates.

Answer

EVP of Biopharmaceuticals R&D, Sharon Barr, declined to comment on ongoing trial event rates for tozorakimab but reiterated confidence based on Phase 2 data and the asset's differentiated mechanism. EVP of Oncology R&D, Susan Galbraith, noted that AVANZAR completed accrual earlier but did not speculate on the relative timing of readouts, mentioning that learnings from the broader Dato-DXd program are being applied.

Sachin Jain requested a high-level perspective on the U.S. pricing environment, including potential executive orders, and asked for an appraisal of the commercial opportunity for camizestrant from the SERENA-6 trial relative to the drug's overall $5 billion+ potential.

Answer

CEO Pascal Soriot addressed U.S. pricing by emphasizing the need for a global "rebalancing" where Europe contributes more to funding innovation, while noting that net price differences are often minimal. EVP, Oncology, David Fredrickson explained that while the adjuvant setting (SERENA-4) is the largest opportunity for camizestrant, SERENA-6 is a significant and important first step, targeting a substantial patient population with an existing testing infrastructure in the U.S.

Sachin Jain from Bank of America asked about two key pipeline assets: the peak sales contribution of baxdrostat from its resistant hypertension opportunity and the scientific rationale for confidence in the SERD camizestrant in the broader first-line setting.

Answer

Ruud Dobber, EVP of BioPharmaceuticals, stated that while a specific sales split for baxdrostat hasn't been disclosed, the unmet need in resistant hypertension resonates strongly with specialists. Susan Galbraith, EVP of Oncology R&D, explained that confidence in camizestrant's first-line efficacy stems from its dual action of inhibiting and degrading the estrogen receptor, which is superior to aromatase inhibitors, and its observed activity in the overall population in SERENA-2.

Sachin Jain asked about the obesity pipeline, seeking details on why the Eccogene-partnered oral GLP-1 is considered best-in-class and about the amylin molecule's safety profile. He also asked about the importance of the non-squamous subset data for Dato-DXd.

Answer

EVP, BioPharmaceuticals R&D, Sharon Barr, highlighted the oral GLP-1's positive Phase I profile with no safety red flags. For the amylin molecule, she noted its selectivity over calcitonin is key for a better tolerability profile. EVP, Oncology R&D, Susan Galbraith, deferred comment on the Dato-DXd subset analysis until the full overall survival data is presented at a future congress.

Sachin Jain asked about Novo Nordisk's scenario planning for Wegovy Pill pricing, considering API restriction and the ability to compete on price, along with further details on its launch cadence. He also requested high-level insights into the 2026 outlook, including moving parts like gross-to-net favorability, semaglutide IO patents, and Akero R&D costs, in relation to consensus estimates.

Answer

EVP of US Operations Dave Moore expressed excitement for the Wegovy Pill, highlighting its potential to expand the market and cater to patients preferring oral medication. He stated it would be available across all channels (Medicaid, Medicare, commercial, and cash offerings) and emphasized its competitive efficacy and tolerability profile. CFO Karsten Knudsen stated that Novo Nordisk does not guide for the next year but noted that current momentum forms the foundation for future trends. He highlighted key factors for 2026: a 2 percentage point gross-to-net favorability in 2025 that won't repeat, a low single-digit negative impact from IO patent expiry, and a 3 percentage point negative impact on operating profit growth from Akero R&D costs.

Sachin Jain asked about Novo Nordisk's scenario planning for Wegovy Pill pricing, considering recent news and API restriction capabilities, and the ability to compete on price, along with any further color on its launch cadence. He also requested high-level insights into the moving parts for the 2026 outlook, including gross-to-net favorability, semaglutide IO patents, and the Akero acquisition.

Answer

EVP of US Operations, Dave Moore, expressed excitement for the Wegovy Pill, highlighting its potential to expand the market and cater to patients preferring an oral option. He stated that it would be available in all channels (Medicaid, Medicare, commercial, and cash offerings) and emphasized its competitive efficacy and tolerability profile. Chief Financial Officer, Karsten Munk Knudsen, stated that Novo Nordisk does not guide for next year but noted key factors: a ~2 percentage point gross-to-net favorability in 2025 sales growth that will not repeat, a low single-digit negative impact from loss of exclusivity in certain IO markets, the Wegovy Pill launch, and a 3% negative impact on 2026 operating profit growth from Akero's R&D costs.

Sachin Jain of Bank of America questioned the drivers of recent Wegovy prescription trends, seeking to separate the CVS formulary impact from underlying growth, and asked for commentary on the revised 2026 consensus growth expectations.

Answer

David Moore, EVP of U.S. Operations, noted the recent prescription uptick is a mix of the CVS conversion and other commercial efforts. CFO Karsten Knudsen addressed the 2026 outlook by emphasizing the large, underpenetrated market opportunity and quantified the expected headwind from loss of exclusivity in select markets as a low single-digit impact to group sales.

Pressed for more details on the compounded patient funnel, including assumptions on inventory and conversion rates. He also questioned Wegovy's competitive standing against Lilly for cash-paying patients and asked about the growth drivers for Ozempic in the second half of the year.

Answer

The company acknowledged that data on compounding is poor, which is why the expected impact is guided for H2. They believe Wegovy's strong brand and the fact that most compounding is of semaglutide will help capture patients. For Ozempic, growth will be driven by leveraging its broad label through new marketing campaigns and focusing on improving patient adherence, with a potential small uplift from converting the mid-single-digit percentage of diabetes patients also using compounded drugs.

Sachin Jain pressed for more detail on assumptions for converting patients from compounded semaglutide, including inventory levels and competitive dynamics for cash-pay patients. He also asked what will drive Ozempic's growth in the second half of the year.

Answer

CFO Karsten Knudsen acknowledged that data on compounding is imprecise and patient inventory could delay the transition to branded products until H2. Dave Moore, EVP of U.S. Operations, highlighted Wegovy's brand strength for capturing patients. For Ozempic, he pointed to continued market growth, a new 'Ozempic era' commercial campaign leveraging its broad label, and efforts to improve patient retention.

Sachin Jain asked about the phasing of S&D expenses throughout the year and sought clarification on the clinical trial endpoints for semaglutide in NASH, specifically regarding the fibrosis improvement hurdle.

Answer

Karsten Knudsen, Group's CFO, confirmed that S&D spending is back-loaded, linked to commercial strategies around supply and R&D readouts like SELECT. Martin Lange, Head of R&D, clarified that for NASH, the Phase II trial showed a numerical, not statistical, improvement in fibrosis. The FDA indicated a similar numerical result in the larger, properly powered Phase III study would be sufficient for regulatory purposes.

Sachin Jain inquired about the regulatory status of Poly-SPMS, specifically regarding the FDA's questions and the delayed PDUFA date. He also sought clarification on Sanofi's 2026 profitable growth outlook, asking if it implies EBIT and EPS growth exceeding sales growth.

Answer

Head of R&D Houman Ashrafian confirmed ongoing conversations with the FDA regarding Poly-SPMS data submissions, with a PDUFA date set for December 28. CFO François-Xavier Roger affirmed that profitable growth for 2026 means gross margin, BOI, and EPS are expected to grow faster than sales, a trend observed consistently in 2025 and projected for future years.

Sachin Jain asked for an update on the Poly-SPMS regulatory debate and confidence in resolving FDA questions, and sought clarification on whether 'profitable growth for 2026' implies EBIT and EPS growth exceeding sales growth.

Answer

Houman Ashrafian (Head of R&D) confirmed the FDA requested an extension for Poly-SPMS, data sets have been submitted, and the PDUFA date is December 28th. François-Xavier Roger (CFO) clarified that profitable growth means all P&L items, including gross margin, BOI, and EPS, are expected to grow faster than sales, a trend observed in 2025 and targeted for 2026 and beyond.

Sachin Jain of Bank of America sought clarification on amlitelemab's longer-dosing potential, expectations for tolebrutinib's REMS program, and whether Business Operating Income (BOI) margin is expected to grow in addition to absolute BOI.

Answer

EVP & Head of R&D Houman Ashrafian clarified that while Q4W dosing is differentiated, Q12W potential is supported by prior data. He declined to comment on the REMS. CFO François Roger confirmed absolute BOI growth but did not commit to margin expansion, citing the need to absorb the end of the Regeneron R&D reimbursement.

Sachin Jain asked about launch expectations for Depamokumab (DEPI), including market expansion and potential cannibalization of Nucala, and questioned the sustainability of ex-US Shingrix growth trends.

Answer

CCO Luke Miels expressed high excitement for Depamokumab, citing strong market research and a strategy to target competitors first to minimize internal disruption. For Shingrix, he explained that ex-US growth is robust, driven by varying funding levels in key markets like Japan and France, and reiterated confidence in the remaining international opportunity. CEO Dame Emma Walmsley declined to comment on a follow-up Blenrep question.

Sachin Jain of Bank of America inquired about Novartis's confidence in the Phase III Sjogren's syndrome data for inalumab, asking if both studies must be positive for filing. He also asked about US drug pricing policy, questioning if Novartis's proposed solutions involve price cuts and the potential timeline for resolution.

Answer

CEO Vasant Narasimhan stated that while Sjogren's is a challenging indication, they have strong Phase II data and the filing path will depend on the results from both studies, which will be reviewed together. On US policy, he clarified the focus is on reducing patient out-of-pocket costs rather than list price cuts, and noted that a timeline for resolution is difficult to predict due to the complexity of the required policy changes.

Sachin Jain of Bank of America inquired about the impact of the FDA's recent acceptance of MRD negativity as an endpoint in first-line myeloma on development strategies and on Johnson & Johnson's upcoming decision for HexaBody-CD38 (GEN3014). He also asked if the upcoming ASCO data for acasunlimab (GEN1046) would include overall survival (OS) data and if there were any delays in finalizing the Phase III trial design with regulators.

Answer

Chief Medical Officer Tahamtan Ahmadi stated that the MRD negativity endpoint is a positive development that facilitates novel mechanism development, a view he noted J&J also shares. Regarding acasunlimab, Dr. Ahmadi confirmed that health authority interactions are complete and the pivotal trial is on track to start by year-end. While not detailing the ASCO abstract, he stressed that OS is the most critical data point for their decision-making process.