James Gordon

James Gordon inquired about the efficacy bar for the Phase 3 myositis trial (Q3 readout), specifically if the goal is to exceed competitors like Janssen's VELA trial or achieve similar efficacy with better tolerability. He also sought clarification on the 2026 OpEx guidance, assuming a similar growth pace as 2025 but with more R&D investment.

Answer

Karen Massey, Chief Operating Officer, stated that for myositis, argenx is looking for a statistically significant benefit, emphasizing the high unmet need in IMNM where any benefit is clinically meaningful. Luc Truyen, Chief Medical Officer, noted that the Phase 3 builds on robust Phase 2 data, and while direct comparisons are difficult, positive data is always beneficial for patients. Karl Gubitz, Chief Financial Officer, confirmed that combined R&D and SG&A expenses are expected to grow at a similar rate as 2025 (around 30% over 2024's $2.7 billion), with the majority of growth allocated to R&D to support the pipeline.

James Gordon asked about the efficacy bar for the phase III myositis trial in Q3, specifically if it aims for superiority over Provance/Brekpo or similar efficacy with better tolerability, and sought clarification on the 2026 OpEx guide.

Answer

Karen Massey, COO, stated that for myositis, argenx is looking for a statistically significant benefit, noting the high unmet need in IMNM. Luc Truyen, CMO, explained the phase III program is based on robust phase II data, aiming for meaningful benefit across subsets, and acknowledged the difficulty of direct comparisons. Karl Gubitz, CFO, indicated that combined R&D and SG&A expenses are expected to grow at a similar rate as 2025 (around 30%), with most growth in R&D.

James Gordon from JPMorgan Chase & Co. asked about the CIDP launch dynamics, questioning if Vyvgart use is expanding into IVIG-naive patients beyond the initial target population, and also inquired about the future outlook for gross margin given cost reduction efforts and royalty payments.

Answer

CFO Karl Gubitz projected the gross margin to remain around 11%, as reduced manufacturing costs from scaling up are expected to be offset by increasing royalty payments to Halozyme as the subcutaneous formulation's share grows. COO Karen Massey added that 85-90% of CIDP patients are still IVIG switches, consistent with the initial strategy, and that expanding to earlier lines of treatment will depend on securing payer access over time.

James Gordon asked about the variance in VYVGART's list price across the U.S., EU, and Japan in light of most-favored nation concerns, the pricing of the pre-filled syringe (PFS) outside the U.S., and the expected impact of the Part D shift on net price for the remainder of the year.

Answer

Chief Financial Officer Karl Gubitz stated that argenx maintains disciplined pricing, keeping list prices within a narrow band across priority markets, and confirmed that PFS pricing has been set. He noted that gross-to-net will increase as the product mix shifts to the pharmacy benefit. Chief Operating Officer Karen Massey added that investors should focus on the consistent long-term growth trajectory rather than quarterly fluctuations.

James Gordon questioned whether open-label extension (OLE) data supporting intermittent dosing would be included in the CIDP label and asked about potential pricing mechanisms, such as price caps, to manage costs.

Answer

CEO Tim Van Hauwermeiren suggested the label would likely reflect the weekly dosing from the pivotal trial, but OLE data would be crucial for payer conversations. COO Karen Massey added that the pricing approach will mirror gMG, utilizing value-based arrangements with payers to ensure broad access, rather than a simple price cap.

James Gordon asked about Genmab's expectations for the OS benefit in the EPKINLY first-line DLBCL trial, the efficacy bar relative to Polivy, and thoughts on the JUPITER frontline trial.

Answer

CEO Jan van de Winkel and CMO Tahamtan Ahmadi responded. Ahmadi clarified that the primary endpoint for the EPKINLY first-line DLBCL trial is PFS, and Genmab anticipates transformative results based on robust Phase II data and the high CR rates seen with EPKINLY+R² in second-line follicular lymphoma. He expects the compound-by-compound results to exceed currently reported positive Phase III data sets. Regarding OS, he noted it's a lagging endpoint in DLBCL and a discussion for after the data readout. He did not specifically comment on JUPITER.

James Gordon asked about the expected overall survival (OS) benefit for Epkinly in first-line DLBCL, considering other agents like Polivy have struggled with OS, and what efficacy bar Epkinly needs to meet or exceed relative to Polivy and the JUPITER frontline trial.

Answer

CMO Tahamtan Ahmadi clarified that the primary endpoint for the Epkinly first-line DLBCL trial is progression-free survival (PFS). He expressed anticipation that Epkinly in combination with R-CHOP will be transformative, based on robust Phase 2 data sets and particularly strong complete response (CR) rates. Ahmadi stated that they expect the compound-by-compound results to exceed currently reported positive Phase 3 data sets. Regarding OS, he noted it's a lagging endpoint influenced by PFS and suggested further discussion once the data set is available.

James Gordon inquired about the duration of the Oral Wegovy opportunity, specifically its patent expiry in Europe (2031) and the U.S. (2032), and the potential for longer IP. He also asked about Novo Nordisk's M&A strategy, balancing large obesity deals with diversification, given the high cost of assets in the obesity space.

Answer

CFO Karsten Munk Knudsen clarified that while the compound LOE is the same, the tablet formulation of Oral Wegovy (starting with 1.5mg) yields longer IP into the late 2030s, which is crucial given the formulation's importance. CEO Mike Doustdar viewed obesity as a diversified therapy area with multiple segments and price points, citing examples like Semaglutide becoming a low-priced standard of care post-LOE and high-value assets like efruxifermin for MASH F4, which competes with liver transplants, justifying different pricing strategies. He stressed the importance of scaling and portfolio breadth.

James Gordon asked about the duration of the Oral Wegovy opportunity, specifically regarding its European (2031) and U.S. (2032) patent expiry dates and potential for longer IP. He also questioned the M&A strategy, asking how Novo Nordisk balances large obesity deals with diversification, given the high cost of obesity assets and potential bidding wars.

Answer

CFO Karsten Munk Knudsen clarified that while the compound LOE is the same for oral and injectable, the tablet formulation of Wegovy pill offers longer IP into the late 2030s, emphasizing the importance of formulation. CEO Mike Doustdar explained that obesity is a diversified therapy area with multiple diseases and segments, allowing for different products and price points. He cited examples like low-priced Semaglutide post-LOE for high volume and high-priced Efruxifermin for MASH F4, competing with liver transplants, to illustrate segmentation and value-based pricing.

James Gordon asked about the win conditions for Pelacarsen, specifically if a statistically significant benefit below the original 20-25% relative reduction target would still be commercially viable, given a potentially lower event rate.

Answer

Vasant Narasimhan, CEO of Novartis, confirmed that the study is powered for 20% (70 mg/dL) and 25% (90 mg/dL) relative reductions, but acknowledged that a win with a lower relative reduction, potentially in the mid-teens CVR, is possible. He stated that the commercial approach for such an outcome would need to be evaluated based on the data, but emphasized that no protocol or study design changes have occurred.

James Gordon asked about Pelacarsen, specifically what a 'win' now looks like given a potentially lower event rate, whether the original efficacy targets (20% broader, 25% narrow) are still the minimum, and if a statistically significant but lower benefit would still yield strong commercial prospects.

Answer

Vasant Narasimhan, CEO of Novartis, confirmed the study is powered for 20% and 25% relative reductions in the respective patient groups. He stated that a win is possible with a lower relative reduction, potentially in the mid-teens, and that the commercial approach for such a scenario would be evaluated based on the data. He reiterated that there have been no changes to the protocol or study design.

James Gordon from Barclays inquired about GSK's R&D and commercial strategy for its respiratory portfolio, specifically how Nucala, Extensa, IL-33, and TSLP will be segmented given overlapping products and competition. He also asked about the timeline for six-monthly HIV treatment and PrEP phase III trials, the commercial implications of four-month and six-month dosing on the total addressable market (TAM), and whether the reiterated GBP 40 billion+ revenue target includes recent acquisitions and business development.

Answer

Luke Miels (Chief Commercial Officer) directed Tony Wood (Chief Scientific Officer) to address the respiratory strategy, Deborah Waterhouse (CEO, ViiV Healthcare) for HIV, and Julie Brown (CFO) for the revenue target. Tony Wood explained GSK's approach to COPD, segmenting by high EO, intermediate T2, and low T2 populations, and highlighted ongoing studies for Extensa, TSLPs, and IL-33. Luke Miels added that GSK aims to focus on long-acting options and is shifting Nucala reps to Extensa. Deborah Waterhouse confirmed the Q6M treatment regimen selection mid-year, with Phase 2B starting this year for a 2028-2030 launch, and Phase 1 for Q6M PrEP starting this year. She detailed the TAM expansion for Q4M and Q6M, projecting significant market share capture. Julie Brown clarified that the GBP 40 billion+ target includes IDRx (Efimostirmen and Hengrui license) but not the recently announced RAPT acquisition.

James Gordon asked about GSK's R&D and commercial strategy for its respiratory portfolio, including Nucala, Extensa, IL-33, and TSLP, considering overlapping products and competition. He also inquired about the timeline for six-monthly HIV treatment and PrEP phase III trials, the commercial implications of four-month and six-month regimens on the total addressable market (TAM), and a clarification on whether the reiterated GBP 40 billion+ revenue target includes recent acquisitions.

Answer

Tony Wood, Chief Scientific Officer, detailed the respiratory strategy, segmenting COPD by patient population for Nucala, Extensa, TSLP, and IL-33, and mentioning ongoing studies and new mechanisms. Luke Miels, Chief Commercial Officer, emphasized a focus on long-acting treatments and the successful Nucala COPD launch. Deborah Waterhouse, CEO of ViiV Healthcare, confirmed the Q6M treatment regimen selection mid-year, outlining the Q6M treatment phase IIb and Q6M PrEP pathways, and projected significant TAM expansion with longer-acting options. Julie Brown, CFO, clarified that the GBP 40 billion+ revenue target includes IDRx and Hengrui but not the recently announced Rapt acquisition.

James Gordon inquired about GSK's confidence in securing a US approval for Blenrep this year, its importance for maintaining margins through the 2028 HIV patent expiry, and the key differentiators of the new Hengrui-partnered PDE3/4 inhibitor.

Answer

CEO Dame Emma Walmsley reiterated high confidence in Blenrep's data and the ongoing constructive dialogue with the FDA but respected the process's confidentiality. Chief Scientific Officer Tony Wood detailed that the Hengrui PDE3/4 inhibitor has higher potency than competitors, enabling a DPI formulation. CCO Luke Miels added this provides a synergistic delivery approach for a broader patient population.

James Gordon asked about the launch expectations for Nucala COPD and Blenrep, including gating factors and precedents, and inquired about the potential impact of U.S. tariffs and GSK's mitigation strategies.

Answer

Chief Commercial Officer Luke Miels detailed the launch strategies, highlighting Nucala's competitive profile and Blenrep's cautious, staged rollout focused on managing side effects. CSO Tony Wood added specifics on Blenrep's safety data. CEO Emma Walmsley addressed tariffs, stating GSK is well-prepared with resilient supply chains, a favorable product mix, and productivity levers to mitigate potential impacts, reaffirming the company's outlook.

James Gordon of JPMorgan Chase & Co. asked about the potential ceiling for GSK's leverage following the buyback and if large-scale M&A is still an option. He also questioned the confidence in camlipixant, given a competitor's P2X3 drug previously failed.

Answer

CEO Emma Walmsley reaffirmed that investing in growth, including disciplined, bolt-on BD, remains the top priority. CFO Julie Brown added that GSK will maintain a strong investment-grade rating without a hard leverage ceiling. On camlipixant, Chief Scientific Officer Tony Wood and CCO Luke Miels highlighted its superior therapeutic index, with significantly lower taste-related side effects compared to the competitor's drug, which they believe provides a superior asset and a better-designed trial for a large unmet need.

James Gordon of JPMorgan Chase & Co. asked for clarification on the significant downgrade to the 2024 vaccines guidance, questioning the relative impact of Arexvy versus Shingrix. He also sought an update on the data and timeline for establishing an Arexvy revaccination interval.

Answer

Julie Brown, Chief Financial Officer, clarified that the guidance change was primarily driven by the revised expectations for RSV following the ACIP decision, compounded by a very strong comparative period in H2 2023 due to launch stocking. Tony Wood, Chief Scientific Officer, stated that a decision on Arexvy revaccination will depend on the full data package, including efficacy and immunogenicity trends over three seasons, and that it is premature to speculate before this data is available.

James Gordon inquired about Sanofi's reported EUR 14-15 billion business development firepower, asking if it would primarily focus on immunology assets to complement Dupixent or if the company plans to diversify into other areas, and whether it would involve one large deal or multiple acquisitions. He also asked for an update on EFTO Alpha's regulatory plans, including FDA discussions and the potential to file on existing data.

Answer

François-Xavier Roger, CFO, clarified that the EUR 15 billion represents the upper limit to maintain the company's credit rating, and BD focus remains on strengthening existing therapeutic areas or white spaces with scientific differentiation and financial return. Houman Ashrafian, EVP and Head of Research and Development, stated that Sanofi will imminently engage with the FDA to discuss EFTO Alpha's trajectory and requirements for a replication study.

James Gordon asked about Sanofi's attributed EUR 14-15 billion BD firepower for the year, questioning if it would primarily focus on immunology to complement Dupixent or diversify into other areas, and whether it would be used for one large deal. He also sought an update on EFTO Alpha's regulatory plans, including FDA discussions and potential filing on existing data.

Answer

Paul Hudson, CEO, and François-Xavier Roger, CFO, clarified that the EUR 15 billion represents the upper limit to maintain their credit rating, not a specific investment target. They stated that BD would predominantly strengthen existing therapeutic areas or white spaces, with a focus on phase one/two assets, while remaining disciplined. Houman Ashrafian, EVP and Head of Research and Development, confirmed that Sanofi would imminently engage with the FDA to discuss EFTO Alpha's trajectory and requirements for a replication study, following excellent data announced late last year.

James Gordon of JPMorgan Chase & Co. questioned the apparent deceleration in Immunoglobulin (IG) growth from Q1 to Q2, asking about potential one-off factors or market share loss in CIDP to competitors like Vyvgart. He also inquired if the success of a competitor's product, Sanofi's nipocalimab, would alter Grifols' medium-term guidance.

Answer

CFO Rahul Srinivasan noted that currency impacts should be factored into growth trends. President of BioPharma Roland Wandeler stated that Grifols continues to see growth in CIDP, viewing IG as the first-line standard of care, with competitors used mostly in second-line settings. CEO Nacho Abia confirmed their long-range plan already includes a risk-adjusted scenario for a competitor launch in 2027, meaning a delay would represent an upside.

James Gordon from JPMorgan inquired about the full-year free cash flow guidance, asking if it could be materially positive rather than just slightly positive, and questioned when an update on the 2025-2027 FCF target could be expected. He also sought clarity on the timeline for the Brookfield due diligence process.

Answer

CEO Nacho Abia reiterated the commitment to positive free cash flow for the year but was not ready to provide new guidance, suggesting the Capital Markets Day in October might be the occasion for an update on future years. Executive Chairman Thomas Glanzmann confirmed there is no set deadline for the Brookfield due diligence process.

James Gordon of JPMorgan Chase & Co. questioned the dependency of AstraZeneca's $80 billion 2030 revenue target on the AVANZAR trial for Datopotamab deruxtecan (Dato-DXd) and inquired about the company's strategy for VEGF bispecifics in lung cancer.

Answer

CEO Pascal Soriot stated the $80 billion target is risk-adjusted across the entire portfolio and does not depend on any single trial like AVANZAR, highlighting recent de-risking events for Baxdrostat and Geforlimab. EVP of Oncology R&D, Susan Galbraith, discussed the strategy of combining their core bispecifics, rilvagostomig and volrustomig, with their ADC portfolio and other agents to explore the VEGF mechanism in certain cancers.

James Gordon inquired about the market expansion potential for the oral PCSK9 inhibitor to reach its $5 billion+ target, plans for incremental U.S. manufacturing investments, and clarification on whether the Q1 Part D impact represents a new run-rate or if revenues could accelerate.

Answer

EVP, BioPharmaceuticals, Ruud Dobber stated that with 70% of eligible patients not at their cholesterol goal, a convenient and more affordably priced oral PCSK9 could substantially unlock the market, especially in emerging markets. CFO Aradhana Sarin noted that near-term manufacturing shifts are manageable within existing plans, with future CapEx dependent on pipeline success. EVP, Oncology, David Fredrickson clarified that while some Part D effects were a one-time Q1 event, revenue growth will continue from this new base, driven by new indications and improved adherence.

James Gordon of JPMorgan Chase & Co. inquired about AstraZeneca's performance in China, specifically the Q4 revenue decline, the 2025 outlook considering VBP impacts, and the rationale for not provisioning for a fine related to the ongoing investigation.

Answer

CEO Pascal Soriot clarified that any potential fine for the importation issue is legally defined as 1-5x the avoided duties ($0.9M) and that the Q4 sales trend was driven by typical year-end hospital budget management and a mild winter affecting respiratory products. Iskra Reic, Head of International, added that despite VBP headwinds for Farxiga and Lynparza, the rest of the portfolio is expected to grow. CFO Aradhana Sarin confirmed the China outlook is factored into the company's overall guidance.

James Gordon questioned why the guidance for collaboration revenue is no longer expected to increase, asking if AstraZeneca is now developing its PARP1 inhibitor solo and if a key Lynparza sales milestone from Merck might be delayed.

Answer

CEO Pascal Soriot explained that the timing of partnership deals is unpredictable, so assuming stable collaboration revenue is a prudent approach that highlights the core business's strength. EVP, Oncology Business Unit, David Fredrickson, noted Lynparza saw sequential growth and he is optimistic for the second half. EVP, Oncology R&D, Susan Galbraith, affirmed strong confidence in the PARP1 inhibitor, saruparib, based on its encouraging data.