Novartis (NOVN) Investor update summary

Remibrutinib profile

• Selective, covalent irreversible BTK inhibitor with CNS penetration, near-complete BTK occupancy and a short half-life; designed to modulate peripheral B cells and CNS microglia without chronic B-cell depletion.

• Approved for CSU in the US, EU, Japan and China; US approval also covers symptomatic dermographism, a CIndU subtype.

• Safety experience cited across 4,500+ trial participants in 40 studies, at doses up to 600 mg, and 10,000+ commercial CSU patients, with no liver safety signal reported in those programs.

REMODEL efficacy in relapsing MS

• Two randomized Phase III trials comparing remibrutinib 100 mg BID with teriflunomide met the primary ARR endpoint; ARR fell 35.2% in REMODEL-1 (0.073 vs. 0.112) and 31.2% in REMODEL-2 (0.080 vs. 0.116).

• New or enlarging T2 lesion rates fell 65.3% and 70.3%; Gd+ T1 lesions per scan fell 66.3% and 66.2% across the trials.

• Six-month confirmed disability progression risk fell 30% (HR 0.7; 95% CI 0.51–0.98; P=0.038); more than 92% remained progression-free through 24 months.

• NEDA-3 was achieved by 55.0% vs. 32.1% (OR 2.81); six-month PIRA risk fell 28.3% (HR 0.7; P=0.055).

Safety and regulatory outlook

• Pooled AE-related discontinuations were 3.1% with remibrutinib vs. 5.8% with teriflunomide; infections were balanced, with no opportunistic infections. Two deaths in the remibrutinib arm were assessed as unrelated to treatment.

• Newly occurring ALT >3×ULN was 2.0% vs. 7.4%; no Hy’s Law cases occurred, and liver enzyme elevations were lower than with teriflunomide.

• Bleeding events were predominantly minor and transient, with no related serious events; infection rates showed no material difference.

• Global filings were underway; US filing was expected by year-end 2026 using a priority review voucher, with separate NDAs planned for immunology and MS. Leadership did not expect liver monitoring in the MS label, subject to regulatory discussions.