Brian Abrahams

Alaimo gave availability timing, the Part D versus medical exception access path, exception grant rates and the IV drop-off rationale.

Priya noted BIIB080 targets intracellular and extracellular tau via ASO approach, differentiating from failed antibody approaches. Phase 2 will test whether tau reduction translates to clinical benefit on cognition. Multiple dosing regimens and frequencies being tested. Alternative delivery options in preclinical including Alcyone device. Data expected mid-2026.

Chris emphasized building capabilities in transplant nephrology, nephrology, and rheumatology. Attracting top talent who are betting their careers on these products. Drew parallel to Sanofi's DUPIXENT launch in new therapeutic areas. Mostly investing in market research and congress presence now. Robin added: reallocating legacy business resources toward growth products.

Alisha reported positive feedback from payers, HCPs, and patients. Non-formulary exemption process underway with first patients successfully navigating it. Analog grant rates from other therapeutic areas are high. Full Medicare Part D formulary access expected by 2027. Subcu expected to enable longer therapy duration.

Alisha detailed rapid adoption: testing nearly tripled in past year, Alzheimer's Association issued first practice guidelines. Currently used mainly for triage (ruling out AD), not yet replacing PET/CSF for confirmation. Key hurdles: CMS reimbursement clarity for therapy based on blood test alone, real-world evidence. PCPs also adopting but only for fraction of patients.

Chris acknowledged EU reimbursement will take time, going market-by-market with Eisai. Noted the deep EMA examination should help in reimbursement discussions.

Chris described multiple approaches including AI-powered patient identification, genetic testing, and omnichannel marketing. Noted reimbursement not an issue in U.S.; Europe adding countries progressively.

Perettie said FDA interactions continue as normal course of business with no major changes, and the earlier line filing plans to use a dual primary endpoint of MRD and PFS.

Dietmar explained PURPOSE-365 is a PK-based study demonstrating target coverage, peak and trough levels for effective prevention. Intramuscular injection as differentiation. Johanna added market research shows frequency is most important attribute; 12-month dosing would broaden addressable population. Dan confirmed potential availability as early as 2028.

Johanna described prescription-to-injection timeline compressed from 4-6 weeks to under half that as access improves. Key logistics: specialty pharmacy approval, drug delivery to office, patient scheduling alignment. Buy-and-bill eliminates one step. Conversion rates improving monthly.

Johanna described high awareness at provider and community level. Targeted 30-day and 90-day launch plans. Buy-and-bill clinics prioritized first with specialty pharmacy as alternative.

Johanna described strong week-over-week growth driven by second-line naive PBC patients. Payer access in line with expectations for rare disease with no major barriers.

Pablo confirmed broad dose range covering all Phase III needs. Won't slow ET or second-line MF studies. Bridging strategy for back-end integration. Goal to incorporate subcu in first-line MF study.

Pablo confirmed broad dose range testing covering all potential Phase III doses. Won't slow ET or second-line MF studies; will use bridging strategy. Goal is to incorporate subcu in first-line MF study with timeline permitting.

Bill broke down Opzelura as 60% AD (growing 20%) and 40% vitiligo (growing 10%). Pediatric is incremental growth driver. International went from $60M to $120M. Sees double-digit CAGR in both US and international.

Herve outlined clear second-line MF strategy, accelerating program. For first-line combo with Jakafi, needs more safety/efficacy data. Encouraged by hemoglobin improvement shown at ASH.

McCourt acknowledged large unmet need in mild AD. Schleifer added that early bias against biologics in milder disease was unfounded given DUPIXENT safety profile.

Yancopoulos said the Phase II in Afib is a run-in to the Phase III pivotal program. Emphasized benefit-risk ratio as the key metric, with bleeding risk reduction potentially more important than anticoagulation effect. Two antibodies enable customized treatment. Sees opportunities beyond SPAF as the major future opportunity.

Yancopoulos noted the two studies were similar at 6 months before one diverged. Cited pandemic timing as a major confounding factor with exacerbation rates dropping as people avoided going outside. Discussing possibility of an additional Phase III. Development continues in nasal polyps Phase III.

McCourt highlighted EYLEA HD's blockbuster status and upcoming label catalysts but acknowledged expected additional competitive pressure on EYLEA. Declined to provide specific directional guidance.

Reshma: exploring bringing Type O (VX-017) out first or close behind zimislecel; no timeline yet, plans in H2.

Duncan highlighted Povi's trifecta of differentiated efficacy, favorable tolerability, and patient-centric dosing. Noted 8x patient preference for monthly vs weekly dosing from market research.

Reshma highlighted the key difference is RAINIER is placebo-controlled vs RUBY-3. Cited ASN expert estimate of 0-5% placebo proteinuria improvement. Could not share RAINIER baseline characteristics yet. Confirmed 240mg dose not studied further as it matched 80mg efficacy.