NOVARTIS AG Q4 FY25 earnings call NVS

Novartis demonstrated strong R&D execution in 2025, meeting most milestones and trial starts. The company is on track for seven pivotal readouts in 2026, which are expected to strengthen the mid-term outlook and support the guided mid-single-digit sales growth into the 2030s. Key readouts include pelacarsen for CVRR, Ianalumab in Sjogren's disease, and Del-zota DMD, assuming the closure of the Avidity deal. Additional readouts for Ianalumab in hematology and Del-desiran DM1 are also anticipated.

Following the 96-week data from the Phase III MANIFEST program, pelabresib has a path forward for registration. The data showed deep and durable responses and a comparable safety profile to ruxolitinib in myelofibrosis, including sustained improvements in symptom scores and anemia. An agreement with the EU allows filing in 2026 based on this data. In the U.S., China, and Japan, a new Phase III study will commence, focusing on patients with high TSS50 at baseline to achieve regulatory approval.

The renal portfolio, including Vanrafia and Fabhalta, contributed 50% of the NBRx market growth in IgAN. Fabhalta is approved in C3G in 45 countries, and Vanrafia has been submitted in the EU. The company expects full data sets for Fabhalta eGFR in IgAN and Vanrafia eGFR in H1 2026. The zigakibart Phase III protocol was amended to align UPCR readout with interim eGFR readout in H1 2027, aiming for a full approval with both proteinuria and eGFR benefit, positioning it as a fourth renal agent.

Rhapsido's U.S. launch is showing encouraging early results with strong demand from allergists and dermatologists, and over 2,000 HCP starts in its sampling program. Access is identified as the gating factor, with steady sales pickup expected in H2 2026 as access improves. The brand has significant long-term sales potential across multiple indications, including CSU, CIndU, HS, and food allergy, with positive food allergy data to be presented in Q1 2026, leading to a broad Phase III program.

Novartis continues its nearly 100-year commitment to global health, particularly in malaria. The company presented positive data for KLU156 (ganaplacide plus lumefantrine), a novel malaria medicine, showing 99.2% cure rates and the potential to block transmission. This represents the first new malaria medicine in 25 years, reinforcing Novartis' mission in global health and its long-standing efforts in neglected tropical diseases.

Novartis maintains a balanced, shareholder-friendly capital allocation strategy. In 2025, over $10 billion was invested in R&D, an 8% increase year-over-year, alongside four acquisitions and ten licensing deals. The company completed a $15 billion share buyback program and launched a new $10 billion program, with $7.7 billion remaining. A 6% dividend increase to CHF 3.70 per share was proposed, marking the 29th consecutive increase in Swiss francs.