Tyler Van Buren

Schleifer said Regeneron is stage-agnostic with the firepower for early or advanced deals but made no commitment to be more aggressive; Yancopoulos said internal programs usually win.

Schleifer conceded the missed timeline, attributed it to FDA leadership turnover, and confirmed more than two CMOs are now engaged as backups.

Schleifer acknowledged the question but remained noncommittal, thanking outgoing Sanofi CEO and welcoming new one while saying Regeneron is open-minded to deals.

Yancopoulos emphasized a genetics-driven, therapeutic-agnostic approach guided by Regeneron Genetics Center rather than fixed therapeutic area allocation. Criticized industry for pursuing me-too drugs against EYLEA and Dupixent rather than truly innovative new targets.

Schleifer outlined complex timeline: ideally alternate vial filler gets approved before late November PDUFA, wrapping everything up. If not, December approval of filler followed by rapid resubmission. Confirmed no outstanding review issues beyond the filler. Different filler from Libtayo adjuvant CSCC approval.

McCourt attributed EYLEA HD growth to physician appreciation for clinical efficacy, safety, and durability profile. Schleifer said Catalent issues were process/procedural not structural, Novo's CEO committed to elevating standards, and expects expeditious resolution.

Schleifer explained CRL relates to drug master file question for a third-party component, not safety/efficacy. Supplier has expeditiously responded. FDA committed to expeditious review but timeline uncertain.

Fenimore explained early dividend initiation reflects confidence in Sanofi balance paydown, adds flexibility in capital returns approach, and opens Regeneron to dividend-mandate funds.

Mercier declined to comment on how IQVIA captures the data but outlined drivers: naive and switch uptake, HCP confidence, 14% prep market growth, and over 70% persistency.

Joanna described uptake strongest in established HIV markets (SF, LA, NYC, Florida) as switch market, with growing naive prescriptions in rural South areas with high HIV incidence.

Johanna confirmed spontaneous first-line use building since ASCO June presentation. No promotion in first-line, only medical education. NCCN lists Trodelvy as only ADC recommended in first-line PD-L1 positive and negative TNBC plus second-line. First-line market approximately 10,000 women, double second-line, with 9-10 month duration of treatment versus 4-5 months in second-line.

Cindy declined to disclose filing timeline but confirmed on track for H2 2026 launch. Data cut to be shared at ASH. Continued to be impressed with safety profile, consistent with EHA presentation.

Johanna detailed 72% unaided prelaunch awareness, first script within hours, injection within days. J-code confirmed for October 1 ahead of schedule. California and Florida Medicaid on formulary August 1.

Johanna clarified Q/Q decline was inventory dynamics and tough Q4 comp. YoY 5% decline was inventory and pricing, not competitive share loss. Trodelvy maintains leadership in both TNBC and HR+/HER2-.

Johanna attributed growth to PURPOSE trial momentum and doubled-down market development efforts, expects tailwinds to carry through and potentially accelerate with lenacapavir launch.

Berman again declined event-count specifics, reiterating only that the interim is powered for the second half.

Hoge said study well powered if Phase II hazard ratio repeats. Success range from Phase II-like result to HR of 0.8, with different data patterns all potentially meaningful. Alpha reserved for subsequent analyses if interim inconclusive.

Hoge explained interim was underpowered by design; early stopping would have been an upside scenario. Final analysis is the fully powered assessment.