Richard Vosser

Richard Vosser inquired about the implications of recent giredestrant/lidERA study results on the design of AstraZeneca's SERENA-4 trial and the commercial potential of CAMBRIA-1 in the adjuvant setting.

Answer

Susan Galbraith, EVP, Oncology R&D, explained that SERENA-4's design enriches for endocrine-sensitive patients and aims to prevent ESR1 mutations, building confidence from observed SERD activity in endocrine-sensitive settings. Dave Fredrickson, EVP, Oncology Business Unit, added that CAMBRIA-1 targets the prevalent AI and AI/CDK4/6 patient population, offering broad access and competitive timelines.

Richard Vosser inquired about the implications of the LIDEA study results on the design of the SERENA-4 trial and sought insights into the CAMBRIA-1 study.

Answer

Susan Galbraith, EVP, Oncology R&D, AstraZeneca, explained that SERDs show activity in endocrine-sensitive ESR wild-type patients, underpinning confidence in SERENA-4's design to enrich for this population. She highlighted CAMBRIA-1 and CAMBRIA-2 as two adjuvant studies covering a broad patient population, including combinations with abemaciclib. Dave Fredrickson, EVP, Oncology Business Unit, AstraZeneca, added that CAMBRIA-1 targets the prevalent 2-5 year population, offering the broadest program for both prevalent and incident patient pools.

Richard Vosser asked about the read-across from the Dato-DXd data at ESMO, particularly its better tolerability, to other Dato-DXd trials and ADC programs. He also sought more color on the strong Imfinzi sales, its rollouts in bladder and lung cancer, and its future growth runway.

Answer

EVP of Oncology R&D Susan Galbraith attributed Dato-DXd's tolerability to its linker stability, which drives a differentiated profile and increases confidence in early-stage studies and combinations. EVP of Oncology Business Unit Dave Fredrickson highlighted Imfinzi's growth drivers as Adriatic, AEGEAN, and NIAGARA, with sustained trajectory expected from new indications and upcoming regulatory approvals for MATTERHORN and POTOMAC.

Richard Vosser asked about the read across from Dato-DXd's better tolerability data at ESMO to other Dato-DXd trials and ADC programs. He also requested more color on Imfinzi's strong sales, its rollouts, and its runway of growth.

Answer

EVP of Oncology R&D Susan Galbraith attributed Dato-DXd's tolerability to linker stability, driving higher response rates and OS, increasing confidence in early-stage breast cancer and lung cancer studies. EVP of Oncology Business Unit Dave Fredrickson highlighted Imfinzi's growth drivers (ADRIATIC, AEGEAN, NIAGARA), first-mover advantage, and upcoming regulatory approvals for MATTERHORN and POTOMAC.

Richard Vosser asked about international operations, specifically the anticipated 5% impact from Loss of Exclusivity (LOE) and potential delays in generic competition. He also questioned the competitive landscape with Mounjaro's strong performance in international markets, the rollout strategy for injectable Wegovy, and expected growth from the 7.2mg dose.

Answer

CEO Mike Doustdar acknowledged potential delays in generic competition, which could offer some upside. However, he noted that Mounjaro's strong U.S. preference is spilling over into international markets via social media. Novo Nordisk is adjusting to this competition but hopes the launch of the 7.2mg injectable Wegovy in the U.S. will eventually create a positive spillover effect globally, emphasizing the importance of demonstrating superior weight loss and cardiovascular benefits at higher doses.

Richard Vosser asked about international operations, specifically the 5% LOE impact and potential delays from competitors like Sandoz, Mounjaro's large numbers in IO, the rollout of injectable Wegovy, and expected growth from the 7.2mg dose in other markets.

Answer

CEO Mike Doustdar acknowledged potential delays in LOE competition, which could offer upside to targets. He noted that Mounjaro's strong U.S. preference share is spilling over to international markets via social media, impacting Wegovy's preference. Doustdar expressed hope that the U.S. launch of the 7.2mg Wegovy dose would eventually benefit international markets, aiming to change the current preference share where competitors dominate.

Richard Vosser asked about formulary access for both injectable and oral Wegovy in the commercial channel, considering potential employer incentives to reduce access due to lower-priced cash options. He also inquired if the strong oral launch and lower prices were impacting compounder volumes or if Novo Nordisk was taking share from compounders.

Answer

EVP, U.S. Operations, Dave Moore stated that injectable Wegovy access remains relatively stable, with ongoing discussions, though some states like California have dropped Medicaid coverage for anti-obesity medications. For the Wegovy pill, he noted positive progress in the first month with coverage from CVS, Prime, Optum, and Anthem. Regarding compounding, he reported the market as relatively stable, with no immediate change observed, but acknowledged the potential for switching from compounders as more data becomes available from the 170,000+ people on the Wegovy pill, mostly self-pay.

Richard Vosser asked about formulary access for injectable Wegovy in the commercial channel for 2026, considering potential employer incentives to reduce access due to lower-priced cash channel options. He also inquired if the lower prices of the oral Wegovy were impacting compounder volumes or if Novo Nordisk was gaining share from compounders with the oral launch.

Answer

Dave Moore (EVP, Novo Nordisk) stated that injectable Wegovy access remains relatively stable, though some states dropped Medicaid coverage for AOMs, which Novo Nordisk hopes to re-engage with due to lower prices. For the Wegovy pill, commercial access is progressing, with CVS, Prime, Optum, and Anthem already covering it. He noted no immediate change in compounder volumes, but expects some switching from compounding as more data becomes available, given the strong self-pay uptake of the Wegovy pill.

Richard Vosser from JPMorgan Chase & Co. asked about the evolution of patient 'stay time' on therapy across different channels and products. He also inquired about what Novo hopes to learn from the Phase 2 diabetes data for amicretin to inform its Phase 3 trial design.

Answer

Ludovic Helfgott (EVP - Product & Portfolio Strategy) noted stay time varies, with initiatives aimed at extending it by highlighting long-term benefits. For amicretin, Martin Lange (CSO) explained the Phase 2 data will help determine the optimal dose for diabetes, specifically whether it needs to be different from the obesity dose to balance glycemic control and weight loss.

Richard Vosser of JPMorgan Chase & Co. asked about the evolution of patient 'stay time' on therapy globally and how it might differ across channels like oral. He also inquired what Novo Nordisk hopes to learn from the Phase II diabetes data for amicretin to inform Phase III design.

Answer

Ludovic Helfgott, EVP of Product & Portfolio Strategy, noted stay time is currently ~7 months for Wegovy and several years for Ozempic, but expects patterns to vary, making a single average less meaningful. Regarding amicretin, Martin Lange, EVP & Chief Scientific Officer, explained the Phase II data is crucial to understand the dose-response for glycemic control vs. weight loss and to determine if differentiated doses for diabetes and obesity are needed.

Richard Vosser from JPMorgan Chase & Co. asked about the pricing outlook for Wegovy and Ozempic for the second half of 2025 and into 2026, and the potential impact of the SURPASS-CVOT trial results on competitive dynamics.

Answer

CFO Karsten Knudsen indicated Wegovy price erosion would be more skewed to H2 2025 due to channel mix and access investments. EVP Martin Lange noted that SURPASS-CVOT data showed non-inferiority to dulaglutide, reinforcing that semaglutide's 26% CV risk reduction remains unsurpassed in the incretin class. EVP Ludovic Helfgott added this validates that not all GLP-1s are the same.

Richard Vosser asked about the apparent conflict in partnering with telehealth companies that also offer compounded drugs and questioned the competitive landscape for Ozempic in International Operations (IO) against Mounjaro.

Answer

Dave Moore, EVP of U.S. Operations, clarified that Novo Nordisk does not support unlawful compounding and that telehealth partnerships are designed to provide patients access to authentic Wegovy. Maziar Doustdar, EVP of International Operations, stated that Novo Nordisk maintains a stable 64% volume market share for injectable GLP-1s in IO and is accelerating Wegovy launches as supply constraints ease.

Richard Vosser asked about the anticipated impact of the Medicare Part D redesign in 2025 on the net pricing for Ozempic and Rybelsus.

Answer

Karsten Knudsen, Group's CFO, indicated that the situation remains uncertain as formulary negotiations are ongoing. He noted that the company's view on the redesign's financial impact has shifted from positive to 'broadly neutral.' The final effect on Novo Nordisk will depend on how plan sponsors react, but he stated the underlying competitive dynamics are unchanged.

Richard Vosser asked about the expected ramp-up of Itvisma in both US and ex-US markets, inquiring if there are warehoused patients and how to anticipate the launch trajectory.

Answer

Vasant Narasimhan, CEO of Novartis, indicated that gene therapies like Itvisma typically see a fast ramp-up as they address the prevalent patient pool, then transition to a more steady state over 2-3 years. He confirmed the presence of warehoused patients and strong access in many markets, which should allow for a relatively quick peak and maximization of the medicine.

Richard Vosser asked about the expected ramp-up of ITVISMA in the U.S. and ex-U.S. markets, inquiring if Novartis has observed warehoused patients and how to think about the launch trajectory.

Answer

Vasant Narasimhan, CEO of Novartis, explained that gene therapies typically see a fast ramp-up as they address the prevalent patient pool, then settle into a steady state. He expects ITVISMA to penetrate the majority of its relevant patient pool within the first two to three years. He confirmed the presence of warehoused patients and strong access in many markets, which should help maximize the medicine's uptake.

Richard Vosser of JPMorgan Chase & Co. questioned how the Inflation Reduction Act (IRA) and direct price negotiations could affect the long-term, mid-single-digit growth outlook for Cosentyx through 2029.

Answer

CEO Vasant Narasimhan confirmed that the potential impact of the IRA is already factored into the company's guidance. He noted that approximately 30% of Cosentyx sales are exposed to Medicare, an impact the company believes is manageable and consistent with its long-term forecast for the drug.

Richard Vosser questioned the dynamic for Scemblix, where strong prescription growth appeared to outpace revenue growth. He asked whether this was due to heavier rebating to gain first-line volume or if a revenue acceleration was expected later in the year.

Answer

CEO Vasant Narasimhan clarified that the discrepancy is likely an artifact of third-party data (IQVIA) versus the company's internal data. He stated that internal data shows TRx growth of 73%, which aligns closely with the 75% net sales growth. He attributed the difference to the product's specialty distribution channel and affirmed the focus is on accelerating first and second-line growth.

Richard Vosser noted that Kisqali's NBRx share in metastatic breast cancer has remained around 50% and asked what it would take to displace Ibrance further, questioning if the adjuvant launch provides a halo effect.

Answer

CEO Vasant Narasimhan acknowledged the share but highlighted that it began gaining last year after the positive early breast cancer (eBC) readout. He expressed hope that having a single medicine for both eBC and metastatic settings will help drive the NBRx share higher, toward a potential cap of 75-80%. However, he emphasized the main focus is maximizing the unique opportunity in node 0 and node 1 eBC patients.

Richard Vosser from JPMorgan Chase & Co. requested an update on the filing plans for pelabresib, asking what additional data is needed and what conversations are being held with regulators.

Answer

CEO Vasant Narasimhan stated that Novartis is awaiting 48-week follow-up data from the trial to get a stronger sense of pelabresib's overall profile. He mentioned that good discussions have occurred with both the FDA and EU regulators, and this upcoming data will clarify the specific requirements for filing in each region. He also noted the potential of the acquired EZH1/2 inhibitor to strengthen the prostate cancer portfolio.

Richard Vosser inquired about the rationale behind changing the primary endpoint for the empasiprubart trial in MMN to grip strength and what specific outcomes they are looking for with this new endpoint.

Answer

Luc Truyen, Chief Medical Officer, explained that the change was made in close consultation with regulatory agencies, who had a precedent for the grip strength endpoint as a meaningful outcome. He noted strong supporting data from their Phase 2 trial and expressed confidence that this switch maintains the probability of showing empasiprubart's benefit, with MMN-RODS remaining a key secondary endpoint. Tim Van Hauwermeiren, Chief Executive Officer, welcomed the harmonization with CBER and CDUSH.

Richard Vosser from JPMorgan Chase & Co. asked for the rationale behind changing the primary endpoint for the empasiprubart trial in MMN and what argenx is looking for regarding the grip strength endpoint.

Answer

Luc Truyen, Chief Medical Officer, explained that the endpoint change was made in close consultation with regulatory agencies, who had a precedent for grip strength as a meaningful outcome indicator. He noted strong accruing benefit data from Phase II on this measure, maintaining confidence in empasiprubart's potential. Tim Van Hauwermeiren, Chief Executive Officer, welcomed the harmonization with CBER and CRUSH using the same endpoint.

Richard Vosser asked for more details on Dupixent's development in COPD, including gross-to-net trends for 2026 and the launch's progress. He also inquired about the long-term safety data required by regulators for inhibrics, specifically if any particular safety signals are being scrutinized.

Answer

Head of General Medicines Brian Foard highlighted Dupixent's strong growth across foundational and new indications, with COPD being its fastest-growing respiratory indication. He noted that gross-to-net trends are monitored and captured in long-term guidance. Head of R&D Houman Ashrafian confirmed the need for long-term open-label extension safety data for inhibrics but stated no specific side effects are being looked for, with safety and tolerability in line with expectations.

Richard Vosser inquired about Dupixent's development in COPD, its gross-to-net in Q3 and 2026 outlook, and the progress of the COPD launch. He also asked about efdoralprin alfa (inhibrics) data, specifically the need for long-term safety data from the open-label extension and any specific regulatory interest in its safety.

Answer

Brian Foard (Head of General Medicines) reported strong Dupixent growth from foundational indications and new launches, with COPD being its fastest respiratory indication. He noted gross-to-net is captured in sales growth and long-term guidance. Houman Ashrafian (Head of R&D) described efdoralprin alfa's preliminary data as promising and superior to standard of care, confirming interest in long-term extension for safety data, with no specific side effects being sought beyond expected safety and tolerability.

Richard Vosser of JPMorgan Chase & Co. asked about the trajectory of SG&A and R&D spending into 2026 and the resulting impact on margins. He also questioned the performance and growth outlook for Dupixent in China.

Answer

CFO François Roger explained that SG&A is growing at half the rate of sales, creating leverage, and expects absolute Business Operating Income (BOI) to increase in the coming years. He noted this will help absorb the end of the Regeneron R&D reimbursement. EVP & Head of Specialty Care Brian Foard added that Dupixent saw over 30% volume growth in China and will continue to expand as more indications gain access.

Richard Vosser of JPMorgan Chase & Co. asked about amlitelimab's efficacy in asthma compared to Dupixent, its potential read-through to atopic dermatitis, and the scientific rationale for a novel combination of an oral anti-TNF with incretins.

Answer

Houman Ashrafian (EVP, Head of R&D) clarified that Sanofi is not making direct comparisons between amlitelimab and Dupixent, as the company remains fully committed to driving Dupixent's growth. He emphasized amlitelimab's compelling data in specific patient subgroups with high unmet needs and its convenient dosing schedule. Regarding the combination therapy, he noted that a substantial body of literature supports exploring metabolic pathways, like those involving incretins, in various inflammatory diseases.

Richard Vosser of JPMorgan Chase & Co. asked about the confidence level in amlitelimab's efficacy with 12-week dosing in asthma and the implications of Dupixent's successful COPD launch on the opportunity for itepekimab.

Answer

Executive Houman Ashrafian expressed confidence that amlitelimab's efficacy will not drop off at 12 weeks, based on its pharmacodynamics. He and Executive Brian Foard explained that itepekimab targets a substantial former smoker population, complementing Dupixent and opening up the opportunity to reach over 80% of COPD patients, with a combined peak sales potential of over $5 billion.

Richard Vosser asked about the key learnings from the discontinued Novartis collaboration and whether the issue was with the DARPin technology or the targets themselves. He also requested clarification on what would constitute a good tumor-to-kidney ratio for MP0712.

Answer

CEO Patrick Amstutz explained the Novartis partnership ended due to a lack of strategic interest in the selected targets from both parties, not a failure of the DARPin technology. He noted the collaboration was a valuable learning experience in radiotherapeutics. Michael Stumpp, EVP of Projects, addressed the kidney ratio, stating that while a 2:1 ratio is ideal preclinically, the key clinical metric will be the overall therapeutic window in patients, rather than a single, specific number, due to tumor heterogeneity.

Inquired about the key learnings from the discontinued Novartis programs and what constitutes a good tumor-to-kidney ratio to look for in the upcoming MP0712 data.

Answer

The Novartis collaboration provided significant learnings on radiotherapeutic profiles and the need for rapid iteration, which wasn't possible within that collaboration's structure. The targets also failed to build scientific excitement. Regarding the tumor-to-kidney ratio for MP0712, the company aims for better than 2:1 preclinically but emphasized that in patients, the overall therapeutic window is more important than a single ratio, as it depends on many factors.

Richard Vosser asked about the key learnings from the discontinued Novartis programs and what would be considered a favorable tumor-to-kidney uptake ratio for MP0712 in the upcoming clinical studies.

Answer

CEO Patrick Amstutz explained that the Novartis collaboration provided crucial learnings on optimizing radiotherapeutics, particularly the need for rapid iteration of candidates to find the best tumor-to-kidney ratio. He clarified the partnership ended due to a mutual lack of strategic interest in the specific targets, not a technological failure. Michael Stumpp, EVP of Projects, noted that while a preclinical tumor-to-kidney ratio above 1 (ideally 2:1) is targeted, the clinical goal is to deliver a therapeutically effective dose to tumors while remaining within kidney safety limits, which will be discussed with the FDA.