Novartis (NOVN) Investor Update summary

Strategic Focus and Portfolio Development

• Emphasis on building a comprehensive renal portfolio, leveraging internal innovation, acquisitions, and a legacy in renal transplant to address glomerular diseases and prevent progression to end-stage renal disease.

• Portfolio includes Fabhalta (iptacopan), atrasentan, zigakibart, and investigational therapies, targeting multiple mechanisms and stages of renal disease.

• Commercial strategy centers on depth and breadth in renal, with a multi-product, multi-indication approach and co-positioning of mechanisms for tailored treatment.

• Early deployment of medical and commercial teams, robust HCP engagement, advanced analytics, and AI/ML models to identify and target eligible patients.

• Patient support programs and market access strategies ensure rapid uptake, affordability, REMS validation, vaccine support, and rapid therapy initiation, leveraging experience from other rare diseases.

Product Launches and Clinical Data

• Fabhalta approved as the first oral Factor B inhibitor for IgA nephropathy, with launch serving as a blueprint for future renal indications and ongoing studies to assess long-term kidney function.

• Atrasentan demonstrated significant proteinuria reduction in phase 3 ALIGN study and is under FDA review.

• Zigakibart, an anti-APRIL antibody, showed sustained proteinuria reduction and eGFR stabilization in phase 2, with phase 3 BEYOND trial underway and 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.

• Expansion into lupus nephritis and early-stage research collaborations, including siRNA and RNA modalities, further broaden the renal pipeline.

Market Opportunity and Commercial Execution

• IgA nephropathy identified as an ideal entry point, with an estimated 185,000 prevalent US patients and 45,000 eligible for treatment.

• Combination therapy is expected to grow, with atrasentan as foundational and Fabhalta for persistent proteinuria and inflammation.

• Machine learning and DTC capabilities enable precise patient targeting and efficient HCP outreach.

• Rapid market access achieved for Fabhalta in PNH and IgA nephropathy, with strong payer coverage, $0 copay support, and scalable infrastructure for future launches.

• Both atrasentan and zigakibart are expected to become blockbusters, with iptacopan guided to $3B+ peak sales across indications.