Jay Olson

Management cited KOL and patient-advocacy feedback and sized the severe frequent-bleeder pool at almost 10,000 people, conditioned on Phase 3 execution.

Steven outlined first-line PDAC study with both gem/nab and mFOLFIRINOX, time-to-event primary endpoint. Bill emphasized these are largest white spaces in cancer. Potential for adjuvant/neoadjuvant studies and colorectal expansion.

Bill cited complex risk-benefit and prioritization of higher PTRS programs. Pablo confirmed 989 pivotal ET trial start first half 2026, MF second half 2026. BET termination does not reduce MPN ambition.

Bill prioritized MPNs as #1 given asymmetric advantage with 989, 617, bispecific, and discovery programs. I&I has credible path with povo franchise. Oncology programs must meet high bar of defensibility.

Pablo said ASCO provides incremental update with more follow-up. Pivotal trials in platinum-resistant ovarian cancer moving forward, companion diagnostic advancing well, bev combo Phase 1 underway.

Herve confirmed XR commercialization expected 2026, giving ~2.5 year window before first generic in 2029. BET combo decision depends on first-line data and broader MPN portfolio evolution.

Gordon said Amgen applies Repatha's clinical and commercial experience across Olpasiran and MariTide, developing each for multiple indications as a durable cardiovascular franchise.

Bradner emphasized Repatha is the only PCSK9 to demonstrate primary prevention benefit, hitting both dual primary endpoints. Gordon called it a landmark trial and a call to action for primary care physicians. AmgenNow pricing at $239/month highlighted.

Bradner confirmed FORTITUDE-101 positive for overall survival and FORTITUDE-102 readout window adjusted to H2 2025 or H1 2026. Regulatory strategy integrates both data sets.

Bradner described FORTITUDE-101 (doublet) readout expected in Q2 and FORTITUDE-102 (triplet with nivolumab) in H2 2025. Gordon noted 1M+ new cases globally and ~7,000 initial U.S. addressable patients.

Bradner highlighted that VESALIUS-CV's 12,000+ patient data set would yield insights beyond LDL-C into broader cardiovascular outcomes. Gordon noted significant synergies applying LDL-lowering expertise to Lp(a) lowering with olpasiran.

Priya noted fluid biomarkers return within 6 months of stopping therapy, reinforcing maintenance value. Real-world data shows patients want to stay on therapy. Subcu maintenance already simplifies ongoing treatment. Subcu initiation (PDUFA May 2026) could be major inflection for patient journey. Interchangeability relevant for presymptomatic population in AHEAD 3-45.

Robin declined to give specific product margin but expects improvement as manufacturing processes enhance. Chris noted margin expansion will come from revenue growing into existing OpEx level rather than OpEx expanding. Significant ongoing R&D investment (AHEAD 3-45, subcu formulations) and commercial market-creation costs.

Priya highlighted subcu safety advantage (fewer infusion reactions), efficacy bioequivalence. Human factors study showed patients could self-administer with training. Alisha noted IV maintenance already welcomed by community; physicians will offer all options and let patients choose. Rural patients expected to prefer subcu. Subcu initiation filing also being prepared.