• U.S. District Court for the District of Delaware ruled the Entresto (sacubitril / valsartan) ‘combination patent’ to be invalid
• Novartis will appeal to the U.S. Court of Appeals for the Federal Circuit to reverse the District Court’s ruling
• No generic Entresto product has received FDA approval as of today
• Pending a final appeal decision and other ongoing litigation involving multiple patents, any launch once generics receive FDA approval would be ‘at risk’
• Novartis maintains confidence in short and mid-term growth, maintains 2023 guidance and mid-term outlook

The company will continue to defend vigorously its intellectual property rights relating to Entresto, including the combination patent as well as multiple patents covering additional innovations. Currently no generic Entresto products have tentative or final FDA approval. If approved, any commercial launch of a generic Entresto product prior to the final outcome of Novartis appeal, or ongoing infringement litigations involving other patents, may be at risk of later litigation developments.

Novartis maintains its confidence in the growth and profitability outlook for both the short and mid-term, based on the future growth potential of other key brands including Kisqali, Pluvicto, Leqvio, Kesimpta, Scemblix and iptacopan.

Despite the potential for earlier-than-expected entry of generic Entresto products in the U.S., Novartis maintains its full-year 2023 group guidance¹ to investors:

• Group Sales expected to grow mid-single digit (in cc)
• Group Core OpInc expected to grow high-single digit (in cc)

The company also maintains its mid-term outlook of +4% sales growth (in cc) 2022-2027 CAGR, with 40% Core OpInc margin for Novartis ex-Sandoz.

Novartis new focused strategy remains on track to deliver growth, driven by key in-market and launch brands, and a strong pipeline of high value innovative medicines.