Steven Scala

Steven Scala asked about the timeline for monetizing the two potential PRVs in 2026, assuming approvals, and whether the company plans to engage potential buyers beforehand. He also sought an update on the UX701 (Wilson disease) program, specifically if the highest dose cohort data update was pushed out from the first half to later in 2026.

Answer

Howard Horn, Chief Financial Officer, stated that the company would monetize PRVs promptly, either through an option agreement or after issuance, and that they were modeling something slightly north of $100 million per PRV. Emil Kakkis, Chief Executive Officer and President, clarified that the UX701 data timeline is dependent on patient progression and ensuring at least 6-8 months of follow-up for copper effect, and is not a fundamental change but rather less specific guidance.

Steven Scala asked about the monetization timeline for the two potential PRVs in 2026, including plans to engage potential buyers. He also inquired if the UX701 (Wilson disease) data update, previously mentioned for the first half of this year, is being pushed out to later in 2026.

Answer

CFO Howard Horn stated that Ultragenyx would monetize the PRVs promptly, either through an option agreement or after issuance. CEO Emil Kakkis clarified that the UX701 data timeline is dependent on patient progression, requiring at least 6-8 months to show sufficient effect on copper in earlier cohorts. He explained that the less precise 'later this year' timeline is to allow enough time for patients at higher doses and for standard of care withdrawal, not a fundamental change.

Steven Scala inquired about a potential subtle change in messaging regarding Cosentyx in HS, asking if the market growth for HS was not meeting expectations, and if this would impact 2026 earnings.

Answer

CEO Vasant Narasimhan confirmed that Cosentyx's share in HS has stabilized after competitor entry, but acknowledged that market growth has not met original hopes. He stated that the HS market is still seen as a $3-$5 billion+ opportunity, but will take longer to develop. He declined to comment on 2026 earnings, redirecting focus to the strong Q3 performance of key growth drivers like Kisqali, Pluvicto, Scemblix, and Cosentyx.

Steven Scala asked about the breakdown of the raised long-term revenue guidance, specifically how much was attributed to currently marketed products versus higher expectations for pipeline agents.

Answer

Vasant Narasimhan, CEO of Novartis, indicated that most of the raised guidance attributed to the existing business comes from inline brands like Kisqali, Cosentyx, Pluvicto, Scemblix, and Leqvio. He also included strong launch expectations for remibrutinib and Pluvicto label expansion, noting that other pipeline assets would have limited ramp-up in the period leading up to 2029.

Steven Scala from TD Cowen asked for an update on the path forward for the COBENFI ARISE data and for clarification on the filing status of SOTYKTU in psoriatic arthritis and the confidence level in its lupus and Sjogren's programs.

Answer

EVP & Chief Medical Officer Samit Hirawat confirmed that SOTYKTU has been submitted for psoriatic arthritis. Regarding the ARISE data, he stated that analysis is ongoing and no discussions with regulators have occurred yet. He expressed confidence in the lupus and Sjogren's programs, noting they are based on positive Phase 2 data and are enrolling well.