Carter Gould

Yancopoulos acknowledged the miss and said Regeneron will take more shots in solid tumors, but did not address the spend or prioritization question directly.

Yancopoulos confirmed both convenience and label expansion possibilities and highlighted potential safety advantages over existing agents.

Schleifer acknowledged the implicit question about the program's future. Said they don't want to signal unconditional support that discourages others from contributing. Will reassess strategy fresh next year to determine best approach for helping patients.

Schleifer said the matching program has only been in place about a month with no useful information to share yet. Haven't heard of any major contributions through the grapevine. Watching the space very closely and hoping their contribution will stimulate others.

Schleifer took personal responsibility but defended regulatory and manufacturing teams. Attributed CRLs to FDA's increased post-COVID scrutiny of contract manufacturers, not internal failings.

Joanna clarified adherence vs persistency distinction: adherence inherently near 100% with Q6-month dosing. Persistency showing strong early trends with patients returning for second injection.

Johanna acknowledged IQVIA week-to-week volatility is real and will take a couple of quarters to stabilize. Advised combining SP intakes and buy-and-bill reports. Directionally aligned but some accounts missing from tracking.

Company representative confirmed ongoing FDA dialogue with no major shifts from prior communications. Declined to disclose specific regulatory strategy details. Continue to target 2026 launch.

Dan emphasized no disruptions seen to date. Johanna highlighted Gilead's own market development initiatives maintaining PrEP awareness. Dietmar confirmed FDA interactions on track.

Roopal confirmed the platform study anchors on SKYRIZI with a higher dose of the alpha-4 beta-7 antibody plus a TL1A arm, that co-formulation is the intended launch form, and that interim snapshots could enable a move to Phase 3 as early as the first half of 2028.

Jeff Stewart attributed the raise largely to international demand, with first full year running at $400M internationally. US Medicare ramp expected in latter part of year. 24-hour symptom control drives quality of life impact and transformational feedback from movement disorder specialists.

Rob Michael expressed support for balanced affordability policies while cautioning against reference pricing. Jeff Stewart described BoNT/E as both market stimulator and premium product opportunity via co-admin with BOTOX.

Chris declined to address enrollment specifics. Noted it's practically November so results are imminent.

Chris acknowledged sustained IP pressure from multiple fronts. BMY's IP leadership team leads industry efforts. Never take eye off the ball on IP protection.

Chris dismissed exogenous constraints, emphasizing financial strength and strategic flexibility as more important factors driving BD capacity.

Dean Li acknowledged the dosing concern directly, confirming they are considering longer intervals beyond the initial q4w focus, while emphasizing that 4-week dosing is the priority for FDA labeling.

Dean acknowledged the field will move to combinations (bispecifics, orals) and signaled Merck has a robust plan for 'being next' but declined to disclose specifics on a public call.

Dean framed OS as critical for both FDA and patients and expressed confidence in WELIREG's broad portfolio program across RCC.

Bourla confirmed discussions cover MFN, tariffs, PBM reform, 340B, and pill penalty; 340B expected to exceed $62 billion this year; wants resolution quickly.

Malik confirmed leading first-line share, good TRx momentum, but expects GTN pressure from Medicare Part D and access contracting; international grew 32% with significant expansion potential.