Sachin Jain

Sachin Jain questioned the mid-term price elasticity for Wegovy pill, asking if $150 is a price floor and if the company would consider lowering prices for higher-dose oral ($299) or injectable ($349) versions given strong demand at lower prices. He also asked CFO Karsten Munk Knudsen about the drivers for flat margins despite aggressive top-line guidance, seeking details on cost savings.

Answer

CEO Mike Doustdar explained that price is crucial for volume, citing the Wegovy pill's launch at $149, which generated 15 times more first-month prescriptions than injectable Wegovy and twice that of Zepbound, demonstrating a better business case. He views the short-term price reduction as an investment for medium-term volume increases. CFO Karsten Munk Knudsen attributed flat margins to discretionary items like restructuring costs (a net benefit compared to 2025) and super-disciplined resourcing, with budget cuts across many departments while prioritizing R&D investments.

Sachin Jain posed a midterm question on price elasticity, asking if the $150 price point for Oral Wegovy is a floor and if higher doses (oral $299, injectable $349) might see price reductions. He also questioned the flat margin guidance despite aggressive top-line growth, seeking details on cost savings and moving parts.

Answer

CEO Mike Doustdar explained that price is crucial for volume, citing the Oral Wegovy launch's success at $149 as evidence of unlocking significant market demand, making it a better business case despite the lower price. CFO Karsten Munk Knudsen attributed the flat margin guidance to discretionary items like restructuring costs in 2025 (offset by Akero running costs in 2026) and super-disciplined resourcing, with budget cuts across many departments while prioritizing R&D investments.

Sachin Jain inquired about the shift in 2026 guidance from Q3 expectations to the current -5% to -13% range, asking what new volume and price components, particularly related to the cash channel, contributed to this change. He also asked what factors would lead to the bottom end of the guidance, specifically concerning oral assumptions and injectable switch.

Answer

Karsten Munk Knudsen (CFO, Novo Nordisk) clarified that no 2026 guidance was given in Q3, and the current guidance is based on Q4 2025 run rates and new market intel, including nuances on international operations' pricing/reimbursement, strong Wegovy pill uptake in the first month, and the response to lower injectable Wegovy initiation prices. He highlighted the dynamic nature of the obesity market, competitive dynamics, gross-to-net forecasts, and channel dynamics as key variables impacting the range.

Sachin Jain sought clarification on the shift in Novo Nordisk's 2026 guidance from Q3 expectations to the current -5% to -13% range, asking about the volume and price components, new pricing factors like the cash channel, and what would lead to the bottom end of the guidance range, particularly concerning oral assumptions and injectable switch.

Answer

CFO Karsten Munk Knudsen clarified that the guidance is based on the latest market trends, including the Q4 2025 run rate and new market intelligence. Key changes since Q3 include more nuanced international operations run rate and U.S. intel on Wegovy pill uptake and Wegovy injectable cash business response to lower initiation prices. He highlighted the dynamic nature of the obesity market, with variables like competitive dynamics, gross-to-nets, and channel dynamics impacting pricing and volume, contributing to the range of the guidance.

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.

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.

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 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 asked about remibrutinib, specifically regarding FDA conversations on avoiding liver monitoring in MS given no Hy's Law, and the efficacy targets for relapse rate progression, noting the lack of phase II data.

Answer

Vasant Narasimhan, CEO of Novartis, explained that remibrutinib already has an approved label without liver safety discussion for CSU, indicating its structural design avoids off-target toxicities. He noted FDA requested limited liver monitoring out of caution due to competitor findings, but Novartis plans to advocate for the current label given no liver signals in their study. For efficacy, he acknowledged the lack of phase II data but expressed confidence in strong target saturation and a compelling profile if the class is effective, based on PK/PD and established market presence.

Sachin Jain asked about remibrutinib's liver monitoring requirements in MS, FDA conversations regarding the label, and efficacy targets for relapse rate progression, especially given the lack of phase 2 data.

Answer

Vasant Narasimhan, CEO of Novartis, explained that remibrutinib already has an approved label without liver safety discussion for CSU, indicating no off-target toxicities. He noted that the FDA requested limited liver monitoring out of caution, which is less extensive than for competitors, and Novartis plans to advocate for the current label in MS given no liver signals. He also expressed confidence in strong target saturation and a compelling efficacy profile for remibrutinib in RRMS, despite the absence of phase 2 data.

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 asked about the number of physicians who have completed Blenrep's REMS certification process and the expected cadence for the year. He also inquired about the mid-year HIV event, specifically if financials through the loss of exclusivity (LOE) would be disclosed, the anticipated rate of decline relative to consensus, and if Q6M would be included in the midterm guide upon Phase III initiation. Additionally, he asked Luke Miels about potential official cost savings programs for simplification and specific R&D acceleration programs targeting earlier readouts or filings.

Answer

Luke Miels, Chief Commercial Officer, confirmed ongoing efforts to save money and dynamically move resources to high-payoff assets, highlighting B7-H3/Risres, B7-H4/MoRes, FGF21, and long-acting TSLP as key acceleration areas. Deborah Waterhouse, CEO of ViiV Healthcare, stated that the HIV story, including financials, would be detailed mid-year, with Q6M included in the long-range forecast after Phase II. She described a glide path for dolutegravir LOE, with newer regimens like Cabenuva and Apretude driving growth, and Q4M/Q6M expected to power future growth despite a dip in 2029-2030. Nina Mojas, Head of Global Product Strategy, briefly mentioned that hundreds of physicians have completed Blenrep REMS certification, with more to come.

Sachin Jain from Bank of America asked Nina Mojas for more details on Blenrep, specifically the number of physicians certified through the REMS process and the expected cadence. He then asked Deborah Waterhouse about the mid-year HIV event, inquiring if financials through the loss of exclusivity (LOE) would be disclosed, the expected rate of business decline relative to consensus, and if Q6M would be included in the midterm guide upon Phase III start. Finally, he asked Luke Miels about simplification (official cost savings program) and R&D acceleration (specific programs for earlier readouts/filing).

Answer

Luke Miels (Chief Commercial Officer) stated that GSK continuously seeks cost savings and dynamically shifts resources to high-payoff assets, highlighting B7-H3 (Risres), B7-H4 (MoRes), FGF21, and long-acting TSLP as key acceleration areas. Deborah Waterhouse (CEO, ViiV Healthcare) confirmed that Q6M would be included in the long-range forecast once it enters Phase II (mid-year). She outlined the HIV portfolio's evolution, noting the decline of Triumeq and Tivicay, the continued growth of Cabenuva Q2M and Apretude, and the future contributions of Q4M and Q6M, projecting a dip in 2029-2030 due to dolutegravir LOE but strong growth in the 2030s. Nina Mojas (Head of Global Product Strategy) stated that 'hundreds' of physicians have completed Blenrep REMS certification, emphasizing it's just the start.

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 asked for clarification on the press release's mention of 'midterm profitable growth for 5 years' and Paul Hudson's recent conference comments implying 'team's EPS', seeking insight into the intent behind this signaling. He also inquired about further TL1A phase two data expected in 2026 to profile the asset ahead of phase three data.

Answer

Paul Hudson, CEO, and François-Xavier Roger, CFO, explained that the 'profitable growth' comment was to confirm expectations for attractive growth and profitability over the next 6-8 years, addressing prior questions about consistent profitable growth. They clarified it was not a defensive move but a confirmation of the medium-term outlook. Houman Ashrafian, EVP and Head of Research and Development, confirmed that maintenance data for TL1A would be available at some point in the first half of the year.

Sachin Jain inquired about the intent behind the press release statement on 'midterm profitable growth for 5 years' and its signaling to investors. He also asked if further TL1A phase two data would be available in 2026 to profile the asset ahead of phase three.

Answer

François-Xavier Roger, CFO, explained that the 'profitable growth' statement confirms an attractive growth outlook for the next 6-8 years, addressing past questions about consistent profitable growth. He also confirmed that maintenance data for TL1A would be available in the first half of the year.

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 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 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 inquired about AstraZeneca's obesity portfolio (oral and amylin), asking about the target competitive profile given the rapidly changing landscape. He also asked about the fastest route to market for the BCMA CAR-T (AZD0120) and its differentiation on safety and administration.

Answer

EVP of Biopharmaceuticals R&D Sharon Barr discussed AZD5004, AZD6234, and AZD-9550, aiming for competitive molecules and market segmentation, noting recent data supports amylin receptor agonists. EVP of Oncology R&D Susan Galbraith highlighted AZD0120's impressive response rates, MRD negativity, attractive safety profile (no Grade 3 CRS/ICANS), and plans for phase III trials next year in multiple myeloma.

Sachin Jain inquired about AstraZeneca's obesity portfolio, specifically the oral and amylin programs, and their target competitive profile given recent competitor data. He also asked about the fastest route to market for the CD19 BCMA dual CAR-T (AZD0120) and its differentiation on safety and administration.

Answer

EVP of Biopharmaceuticals R&D Sharon Barr detailed the progress of AZD-5004, AZD-6234 (amylin peptide), and AZD-9550 (dual GLP-1 glucagon receptor agonist) in phase II, aiming for competitive profiles and market segmentation. EVP of Oncology R&D Susan Galbraith discussed the impressive response rates and safety profile of AZD0120, noting its potential for phase III trials next year in multiple myeloma settings.

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 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.