Ben Jackson

Ben Jackson asked if Sanofi's peak sales estimates for Amlitelimab have changed following additional data, and sought insights into KOL feedback, including both positive aspects and any remaining uncertainties or 'pinch points' regarding the results.

Answer

Brian Foard, EVP and Head of Specialty Care, reiterated confidence in Amlitelimab's opportunity in the growing AD market. Houman Ashrafian, EVP and Head of Research and Development, emphasized the importance of the novel mechanism, flexible Q4/Q12 dosing, and consistent benefit-risk profile, confirming enthusiasm from KOLs despite ongoing data collection.

Ben Jackson inquired whether Sanofi's peak sales estimates for Amlitelimab have changed following additional data, and asked Houman Ashrafian to elaborate on KOL feedback, including both positive aspects and any remaining uncertainties or 'pinch points'.

Answer

Paul Hudson, CEO, and Brian Foard, EVP and Head of Specialty Care, reiterated confidence in Amlitelimab's opportunity in the growing atopic dermatitis market, emphasizing the potential for new mechanisms to accelerate market growth. Houman Ashrafian, EVP and Head of Research and Development, underscored the importance of Amlitelimab's novel T-cell modulator mechanism, its convenient Q4/Q12 dosing optionality, and its consistent benefit-risk profile. He confirmed enthusiasm from prescribers for the novel mechanism.

Ben Jackson of Jefferies asked which endpoints for amlotelimab are most important to physicians, particularly regarding itch, and if the OX40 mechanism itself could benefit itch.

Answer

EVP & Head of R&D Houman Ashrafian stated that the OX40 ligand's effect on the neuroinflammatory axis could positively impact itch. He emphasized that IGA 0/1 and EASI-75 are the key 'entry ticket' endpoints for both regulators and the clinical community in the underpenetrated atopic dermatitis market.

Benjamin Jackson from Jefferies asked if positive brivekimig results in HS suggest utility in other indications and how this impacts portfolio positioning. He also asked if the oral TNFR1 inhibitor's psoriasis data changes expectations for the upcoming rheumatoid arthritis readout and its combination strategy.

Answer

Houman Ashrafian (EVP, Head of R&D) confirmed that molecular data from the brivekimig study provides leads for other indications. For the oral TNFR1 inhibitor, he explained the psoriasis study was a 'pathfinder' to establish safety and dosing, and expectations for the RA readout remain positive. CEO Paul Hudson added that the safety profile was a key finding and that there is significant external interest in combination therapies.

Benjamin Jackson asked for color on 2025 contracting discussions for Dupixent, considering the Part D redesign and potential COPD indication. He also questioned Sanofi's confidence in Beyfortus's differentiation against a recent competitor announcement.

Answer

Brian Foard, EVP and Head of Global Hub, Specialty Care GBU, expressed confidence in payer negotiations for Dupixent due to its strong track record and confirmed the September PDUFA date does not negatively impact 2025 formulary access. Thomas Triomphe, EVP of Vaccines, highlighted Beyfortus's compelling real-world efficacy data, strong safety profile, and longer half-life as key differentiators against competitors who have yet to release data.

Ben Jackson sought more detail on the specific bottlenecks affecting the rate of VUS patient uptake in the second half of the year. Additionally, he asked about the potential pathway and timeline for a label expansion for Joenja based on the newly identified, broader clinical phenotype for APDS.

Answer

CEO Fabrice Chouraqui explained the VUS reclassification bottleneck is the time required for genetic labs to process new data, identify relevant patients, and for doctors to be informed, which will happen gradually. Chief Medical Officer Anurag Relan clarified that since the new phenotypes are considered APDS, these patients are likely covered by the existing label, potentially avoiding the need for new clinical trials for treatment access.

Ben Jackson sought more detail on the specific bottlenecks affecting the rate of VUS patient uptake for Joenja. He also asked about the potential pathway and timeline for a label expansion based on the newly discovered, broader clinical phenotype for APDS patients.

Answer

CEO Fabrice Chouraqui explained the VUS uptake bottleneck is the time required for genetic labs to process new data, identify re-classifiable patients, and for physicians to be informed. CMO Anurag Relan added that because the newly identified patients have APDS, they likely fall under the existing label, potentially not requiring new clinical trials, though further work is needed to detail the clinical features.

Ben Jackson of Jefferies pressed for more specific details on the bottlenecks affecting the rate of VUS patient uptake for Joenja. He also asked for clarification on the potential for a broader clinical phenotype for APDS, including the regulatory pathway and timeline for expanding the addressable patient population based on these new findings.

Answer

CEO Fabrice Chouraqui identified the primary bottlenecks for VUS reclassification as the time required for genetic labs to process the new data and for physicians to reconnect with these patients. CMO Anurag Relan addressed the phenotype question, explaining that the newly identified patients are still considered to have APDS, as they have the genetic abnormality and hyperactivity in the pathway. Therefore, they would likely fall under the existing Joenja label, potentially not requiring new clinical trials for this expansion.

Ben Jackson of Jefferies inquired about the breakdown of the $30 million in expected OpEx from the Abliva acquisition into recurring and non-recurring costs. He also asked about the company's potential exposure to U.S. drug tariffs and if any inventory stocking has been observed in anticipation.

Answer

CEO Fabrice Chouraqui explained that of the $30 million in Abliva-related OpEx, approximately $17 million is for R&D, with the remainder being non-recurring transaction and integration costs. He noted the company is monitoring the tariff situation, while CFO Jeroen Wakkerman confirmed no pre-emptive inventory buildup is planned.

Benjamin Jackson asked about expectations for the upcoming Capital Markets Day and whether longer-term goals would be provided. He also inquired about how Evotec is positioned to capitalize on demand for Antibody-Drug Conjugates (ADCs) and what differentiates its offering.

Answer

CBO Matthias Evers stated the Capital Markets Day will primarily be a deep dive into the Just - Evotec Biologics business, showcasing the new J.POD 2 facility in Toulouse. Regarding ADCs, Evers and COO Craig Johnstone highlighted Evotec's integrated advantage, combining small molecule chemistry with Just Biologics' continuous manufacturing platform, which is ideal for complex biologics and can be leveraged for ADC discovery and manufacturing.