Novartis (NOVN) Investor Update summary

Strategic Focus and Portfolio Development

• Transitioning to a pure-play medicines company with deep expertise in renal disease and transplantation, aiming to transform the kidney disease landscape and delay or prevent dialysis and transplant in glomerular disorders.

• Building a comprehensive renal pipeline through internal innovation (iptacopan) and external acquisitions (Chinook: atrasentan, zigakibart), targeting diseases like IgAN, C3G, LN, IC-MPGN, aHUS, AAV, FSGS, and Alport’s.

• Fabhalta approved as first-in-class oral Factor B inhibitor for IgA nephropathy, serving as a blueprint for future launches and ongoing studies to assess long-term kidney function impact.

• Commercial strategy focuses on a multi-product, multi-indication approach, leveraging integrated go-to-market and payer strategies to maximize synergies and market reach.

• Commitment to innovation, patient access, and portfolio synergies to drive transformative impact in renal diseases.

Market Opportunity and Commercialization

• IgA nephropathy identified as the ideal entry point, with 185,000 prevalent US patients and 45,000 eligible for treatment; robust commercial footprint covers over 70% of IgAN HCPs.

• Advanced analytics and AI/ML models used to identify patient locations and optimize HCP engagement, achieving 84% accuracy.

• Direct-to-consumer and multi-channel approaches enhance patient identification and engagement.

• Market access established rapidly, with 73% coverage in PNH and one-third in IgA nephropathy; strong patient support programs offer REMS validation, vaccine support, affordability, and rapid therapy initiation.

• Commercial and medical infrastructure built for IgAN will scale to support future launches in other renal indications.

Clinical Pipeline and Data Highlights

• Atrasentan demonstrated 36% reduction in UPCR at week 36 in phase 3 ALIGN, with significant proteinuria reduction and FDA review underway.

• Zigakibart showed up to 54% UPCR reduction and sustained eGFR stabilization in phase 2, with phase 3 readout expected in 2026.

• Iptacopan in C3G showed sustained proteinuria reduction and eGFR stabilization over 12 months, supporting global regulatory filings by year-end 2024.

• Advancing three clinical programs in lupus nephritis with diverse modalities, including complement inhibition, BAFF-R inhibition, and CAR-T cell therapy.

• Early research includes collaboration with Borealis for RNA-focused renal therapies, exploring siRNA and RNA modalities as next-generation interventions.