Luisa Hector

Luisa Hector asked about the increased capital allocation to vaccines in 2025, its opportunity cost versus the drug pipeline, and sought more details on the Dynavax acquisition, including its valuation, primary US opportunity, and the potential for its shingles candidate as a booster.

Answer

Thomas Triomphe, EVP of Vaccines, explained that capital allocation is based on strategic fit, capabilities, and long-term business perspective, not per tier, emphasizing the strong fundamentals of the vaccination business. He detailed the Dynavax acquisition's rationale, highlighting Heplisav-B's differentiated 2-dose regimen in the US and the shingles candidate's potential for similar efficacy with better tolerability.

Luisa Hector questioned whether the EUR 3 billion deployed in vaccines business development and M&A in 2025 represents a significant step up in capital allocation to vaccines, and asked about the opportunity cost versus building the drug pipeline. She also sought more color on the Dynavax acquisition, including its valuation, U.S. market focus, and the potential for its shingles candidate.

Answer

Paul Hudson, CEO, and Thomas Kudsk Larsen, Head of Investor Relations, clarified that capital allocation is not viewed per tier but based on strategic fit, capabilities, and long-term business perspective. They emphasized the strong fundamentals of the vaccination business and the fit of 2025 acquisitions. For Dynavax, the rationale includes strengthening the older adult portfolio with Heplisav-B's differentiated 2-dose regimen in the U.S. and the potential for a shingles candidate with improved tolerability.

Luisa Hector inquired about updates on Sanofi's conversations with the U.S. administration regarding policy, the complexity of shared assets like Dupixent, and whether current silence indicates a bottleneck or concern.

Answer

Paul Hudson (CEO) stated that Sanofi has had ongoing dialogue with the U.S. government and other administrations since before receiving the letter in July, focusing on communicating the value Sanofi brings.

Luisa Hector from Berenberg inquired about Sanofi's R&D transformation, seeking an update on confidence levels regarding the pipeline targets set during the December 2023 R&D Day, including the goal for 12 blockbuster assets.

Answer

EVP & Head of R&D Houman Ashrafian affirmed that Sanofi is now an R&D-driven company and remains committed to its key pipeline molecules. CEO Paul Hudson added that while not every effort has succeeded, the team remains optimistic about the 'Big 12' assets but stressed the need for patience and diligence, as confidence will be built on successful Phase 3 data.

Luisa Hector of Berenberg inquired about Sanofi's broader respiratory franchise strategy beyond Dupixent, including assets like amlitelimab and lunsekimig. She also requested more details on the Dupixent launch in COPD, particularly regarding reimbursement status and sales phasing for 2025.

Answer

CEO Paul Hudson and Houman Ashrafian (EVP, Head of R&D) outlined a strategy of developing multiple mechanisms to address different patient segments in the large, underpenetrated asthma market. Brian Foard (EVP, Head of Global Hub, US General Medicines) provided an update on the Dupixent COPD launch, highlighting a record-setting pace for Medicare and commercial coverage (90% and 88%, respectively) and the most rapid respiratory initiation to date. He stated that 2025 is expected to be the inflection year for the indication.

Luisa Hector of Berenberg inquired about the rationale and timing for the EUR 5 billion share buyback, plans for M&A, and the competitive positioning of the PCV21 vaccine.

Answer

CFO François-Xavier Roger explained the buyback aims to mitigate Opella dilution and reflects shareholder feedback, starting mid-next week. He noted a disciplined M&A approach focused on core therapeutic areas. Executive Thomas Triomphe highlighted that PCV21 will be the first pediatric vaccine with over 20 valencies to enter a national immunization schedule, positioning it competitively.

Luisa Hector asked about Dupixent's potential expansion, questioning if Study C in chronic spontaneous urticaria (CSU) would be sufficient for approval and when the Phase II induction data for ulcerative colitis (UC) would be available.

Answer

Brian Foard, EVP and Head of Global Hub, Specialty Care GBU, confirmed they need a positive trial readout to file for CSU and noted the launch in Japan has gone well. Houman Ashrafian, EVP and Head of R&D, added that for the UC program (TL1A), results are anticipated in Q4 of this year after the study was accelerated, and he highlighted the molecule's unique potency and binding profile.

Luisa Hector asked if the $80 billion 2030 ambition is now conservative given the unprecedented success rate, and what the mix of this success means for profitability. She also inquired about any changes in launch timings or the mix of ex-U.S. contribution in light of the U.S. deal.

Answer

CEO Pascal Soriot maintained that $80 billion remains an ambitious goal, acknowledging the high success rate but emphasizing the inherent risks of the business. He noted that while specialty care products drive higher profitability, investments in R&D for new technologies and commercial expansion across biopharma and rare disease will continue. CFO Aradhana Sarin added that all moving parts are being considered for future profitability.

Luisa Hector asked if the $80 billion 2030 ambition is now conservative given the unprecedented success rate, requesting comments on the mix and implications for profitability. She also asked if there are any changes in launch timings or the mix of ex-U.S. contribution (sticking at 50%) in light of the U.S. deal.

Answer

CEO Pascal Soriot stated that $80 billion remains an ambitious goal, acknowledging excitement from readouts but emphasizing business risks. He aims to overachieve if possible and discussed continued R&D investment (low 20s) in new technologies and commercial investment beyond oncology. He noted specialty care products drive higher profitability, but weight loss/metabolic conditions require more investment, without committing to specific profitability targets beyond past statements.

Luisa Hector of Berenberg asked a big-picture question about whether the mix of the 2030 revenue ambition has shifted given the diversification but continued strength in oncology, and if the company has the right number of therapy areas for sustained growth.

Answer

CEO Pascal Soriot affirmed the company's balanced portfolio, noting that Biopharmaceuticals is nearly as large as Oncology and provides a crucial foundation in emerging markets. He expressed confidence in the current therapy areas—Oncology, Biopharmaceuticals (CVRM and R&I), and Rare Disease—as they address the world's biggest causes of mortality. He believes the pipeline, particularly in CVRM with assets like an oral PCSK9 and Baxdrostat, will drive significant future growth, ensuring the company has enough focus areas to grow beyond 2030.

Luisa Hector asked if AstraZeneca's perspective on the obesity market has evolved and requested an update on the status of investigations in China and the company's market share performance there.

Answer

EVP, BioPharma, Ruud Dobber expressed high excitement for their differentiated obesity strategy, focusing on an oral GLP-1 fit for combinations and targeting a broad patient population, including in emerging markets. EVP, Europe & Canada, Iskra Reic reported that the China investigations have been concluded by authorities and referred to the prosecutor, with no illegal gain found for the company. She confirmed strong Q1 performance, with underlying business growth of 9% and market share gains for key products like Enhertu and Breztri.

Luisa Hector from Berenberg asked for confirmation on market share stability for key drugs in China, quantification of the 2025 Medicare Part D redesign impact, and details on the components of the anticipated $3 billion in deal-related payments.

Answer

Iskra Reic, Head of International, stated that key market shares like Tagrisso's remain stable in China, with some temporary dynamics for Farxiga due to hospital budget caps. David Fredrickson, EVP of Oncology, noted the Part D impact is manageable and offset by growth opportunities. CFO Aradhana Sarin explained the $3 billion in payments are mostly success-based milestones for various programs, including those with Daiichi Sankyo and CinCor.

Luisa Hector asked for the scientific hypothesis behind two new Phase II trial starts: the Fusion-acquired radioconjugate in prostate cancer and the in-house anti-folate ADC in ovarian cancer.

Answer

EVP, Oncology R&D, Susan Galbraith, explained the folate receptor alpha ADC is a proprietary asset that shows preclinical activity at lower target expression levels, suggesting differentiation. For the Fusion asset, FPI-2265, she noted it's an alpha-emitting radioconjugate targeting the validated PSMA target. Alpha emitters offer a different mechanism than beta emitters and have shown activity in patients post-Pluvicto, with the Phase II trial being potentially registrational.

Luisa Hector asked about the next steps for AbbVie's CAR-T and oral peptide platforms in immunology, and the ultimate achievable market penetration for advanced therapies in mature indications, considering the role of combinations and new technologies.

Answer

EVP, Research and Development, and CSO Roopal Thakkar detailed the in-situ CAR-T's benefits (off-the-shelf, transient expression, no lymphodepletion) and plans to start dosing in RA and lupus next year. He also discussed the oral peptide platform's focus on potency and extended half-life for candidates like oral IL-23 and TL-1A. EVP and CCO Jeff Stewart highlighted varying biopenetration rates across immunology indications, emphasizing significant headroom and unmet need that new technologies and line-of-therapy expansion will address.

Luisa Hector asked about the next steps for AbbVie's CAR-T and oral peptide platforms in immunology and the ultimately achievable market penetration for advanced therapies in mature indications, considering combinations and new technologies.

Answer

Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, detailed Capstan's in-situ CAR-T platform, highlighting its off-the-shelf, transient expression, B-cell depletion without lymphodepletion, and plans to test in RA and lupus next year. For oral peptides (Nimble acquisition), the focus is on potent, long-half-life molecules like oral IL-23 and TL1A. He also discussed that higher efficacy from combinations is crucial for refractory IBD patients. Jeff Stewart, Executive Vice President, Chief Commercial Officer, added that biopenetration rates vary significantly, indicating substantial headroom for advanced therapies, with new technologies and line-of-therapy expansion driving growth.

Luisa Hector of Berenberg requested more detail on the channel mix pressure affecting VRAYLAR in Q3 and the rationale for extending the collaboration with Gedeon Richter.

Answer

CFO Scott Reents explained the VRAYLAR guidance adjustment was due to a slight, cumulative channel mix shift that created a modest negative price impact. CSO Roopal Thakkar stated the expanded Gedeon Richter partnership builds on a strong relationship to develop more assets in psychiatry, a key strategic area for AbbVie.

Luisa Hector asked a policy question regarding the lack of subsequent deals with the administration, inquiring if there might be a bandwidth issue. She also asked about potential Direct-to-Consumer (DTC) offerings, specifically for Eliquis and Sotyktu, their impact on volumes, and the company's confidence in Eliquis guidance for 2026 and 2027, including any potential tightening of ranges.

Answer

CEO Chris Boerner stated that the policy environment remains dynamic, with frequent and constructive discussions with the administration on issues like MFN and tariffs. He emphasized agreement on the need for U.S. price equalization and ex-U.S. price increases while preserving innovation. Chief Commercialization Officer Adam Lenkowsky discussed the Eliquis Direct to Patient program, offering a discounted rate, and announced Sotyktu would also be available via DTC at a significant discount starting January 2024, as part of a commitment to patient access. He noted that Part D redesign for Eliquis is leading to a more even distribution of sales, with positives and negatives roughly offsetting.

Luisa Hector posed a policy question regarding the lack of subsequent IRA deals and potential bandwidth issues, and asked about the impact of potential Direct-to-Consumer (DTC) offerings for Eliquis on volumes. She also sought clarification on the confidence and potential for tightening the 2026 and 2027 Eliquis guidance, given the observed impact of Part D redesign and DTC changes.

Answer

Chris Boerner, Board Chair and CEO, described the policy environment as dynamic, with frequent and constructive engagement with the administration on issues like MFN, tariffs, and price equalization, while aiming to preserve innovation. Adam Lenkowsky, Chief Commercialization Officer, detailed the Direct to Patient program for Eliquis, offering a discounted rate, and announced a similar platform for Sotyktu with an 80% discount, emphasizing commitment to patient access. He noted that Part D redesign for Eliquis is leading to a more even distribution of sales, with positives and negatives roughly offsetting.

Luisa Hector of Berenberg asked for quantification of any inventory stocking impacts and for more detail on the rationale for externalizing certain immunology assets through the new company formed with Bain Capital.

Answer

EVP & CFO David Elkins clarified that the strong quarterly performance was driven by underlying demand with very little inventory stocking. CEO Chris Boerner explained the Bain Capital deal allows BMY to advance promising assets that did not meet internal funding priorities while retaining future value through royalties, milestones, and a 20% equity stake.

Luisa Hector questioned how the disappointing readout from the Cobenfy ARISE trial in adjunctive schizophrenia impacts the company's confidence in the upcoming Alzheimer's disease psychosis trial.

Answer

Chief Medical Officer Samit Hirawat stated that the ARISE data has no impact on their confidence in the Alzheimer's program. He explained that the diseases are different, and the Alzheimer's trials are based on prior positive data for xanomeline and feature a distinct study design with a longer treatment duration. He also confirmed plans for seven new Phase III trials for Cobenfy.

Luisa Hector of Berenberg asked for quantification of the 2025 impact from Medicare Part D redesign and requested an update on the filing plans for cendakimab.

Answer

Chief Commercialization Officer Adam Lenkowsky stated that the Part D redesign impact is expected to be roughly net neutral across the portfolio for the year. He noted Eliquis will see favorability, altering its quarterly sales cadence, while other products like Revlimid will face increased gross-to-net pressure. He also announced that the company has decided not to commercialize cendakimab to prioritize investments in opportunities with higher potential returns.

Luisa Hector requested more color on the access and pricing outlook for SOTYKTU into next year and asked about the desired profile from the upcoming psoriatic arthritis trial.

Answer

Chief Commercialization Officer Adam Lenkowsky acknowledged SOTYKTU's slower-than-desired performance but noted access has doubled to ~50% with zero step-edits, which involves significant rebating that will take quarters to be offset by volume. Head of Global Drug Development Samit Hirawat stated the psoriatic arthritis data is expected by year-end and, if positive, would strengthen the drug's profile and lead to a 2025 filing.

Luisa Hector from Berenberg asked for commentary on recent personnel changes at the FDA and HHS and the potential impact on the outlook for vaccines.

Answer

Dr. Dean Li, President of Research Labs, responded that for programs with imminent PDUFA dates, dialogue with the FDA remains active and on track. He confirmed no shifts in timelines for near-term filings but stated they cannot comment on the mid- to long-term impact of personnel transitions.

Luisa Hector requested more details on the oral PCSK9 inhibitor program, asking about the targeted cholesterol lowering levels, the timing of data release for the three trials, and potential future combination strategies with assets like the oral GLP-1.

Answer

Dr. Dean Li, President of Merck Research Labs, explained that the goal for the oral PCSK9 inhibitor, enlicitide, is to achieve a profile similar to injectable PCSK9 antibodies. He anticipates data from three Phase III trials reading out in 2025, with a potential presentation at a major conference late in the year. He confirmed the asset is a platform for combinations, with more details to follow after the Phase III data is available.