Alex Thompson

Alex Thompson, Managing Director at Stifel, asked about the competitive landscape in Graves' disease, specifically how Roivant plans to maintain its lead against Argenx, which is entering the area, and whether Argenx's potential for shorter or fewer studies could impact Roivant's timeline.

Answer

Matt Gline, CEO of Roivant Sciences, acknowledged that the extent of Roivant's lead would depend on Argenx's study design, but he expects a significant lead regardless. He highlighted Roivant's strong relationships with KOLs, the 26-week duration of one of their own studies, and the belief that IMVT-1402's deeper IgG suppression will matter for remission in Graves' disease.

Alex Thompson asked about the competitive landscape in Graves' disease with Argenx entering the area, and Roivant's confidence in maintaining its lead if Argenx were to run shorter studies.

Answer

CEO Matt Gline stated that the extent of Roivant's lead in Graves' will depend on Argenx's study design, but they expect a significant lead regardless. He highlighted Roivant's strong KOL relationships, existing 26-week study (2503), and the expectation that deeper IgG suppression from their drug will matter for remission in this large and exciting population.

Alex Thompson from Stifel asked about the discontinuation of empasiprubart in dermatomyositis (DM), specifically inquiring if enrollment issues were related to the IV presentation and how this compared to efgartigimod's myositis trial. He also sought an update on empasiprubart's CIDP enrollment and any potential impacts.

Answer

Luc Truyen, Chief Medical Officer, explained that the empasiprubart DM trial faced enrollment challenges in a competitive environment, leading to reprioritization despite DM remaining an important indication for argenx, as evidenced by strong enrollment in the ALKIVIA study with efgartigimod. Karen Massey, Chief Operating Officer, noted that it's too early to comment on empasiprubart's CIDP enrollment as those trials have just begun.

Alex Thompson asked about the reasons behind the discontinuation of empasiprubart in dermatomyositis (DM), specifically if enrollment issues were related to the IV presentation and how this compared to the efgartigimod myositis trial. He also questioned the enrollment status of empasiprubart in CIDP.

Answer

Luc Truyen, Chief Medical Officer, explained that the DM trial was a POC study facing a highly competitive enrollment environment, which was not helped by negative C5 readouts. He noted that robust inclusion criteria made enrollment challenging, leading to reprioritization. Karen Massey, Chief Operating Officer, added that it is too early to comment on empasiprubart's CIDP enrollment as those trials have just begun.

Alex Thompson from Stifel Institutional inquired about the evolution of Vyvgart cycles per year in Myasthenia Gravis (MG) and whether a higher gross price per patient was a key driver of the increased gross-to-net ratio.

Answer

CFO Karl Gubitz clarified that net revenue per patient for MG and CIDP remains consistent, with variables like product mix and utilization offsetting the gross-to-net impact, and confirmed no US price increases in 2025. COO Karen Massey added that while the company guides to five cycles per year for MG, the convenience of the prefilled syringe (PFS) could drive higher utilization as patients aim to maintain Minimum Symptom Expression (MSE).

Alex Thompson of Stifel asked about the chemical scaffold of the next-generation STAT6 degrader compared to KT-621 and inquired about the timing for a potential decision to split indications between the two assets.

Answer

CEO Nello Mainolfi described their chemistry platform as having a "plethora" of different scaffolds and binding moieties, providing significant IP protection. He explained that it is too early to define a strategy for splitting indications, and the company is focused on maintaining maximum optionality, especially now that its recent financing enables the initiation of multiple Phase 3 studies.

An analyst on behalf of Alex Thompson from Stifel Financial Corp. asked how many patients are currently in the open-label extension (OLE) for paltusotine and how quickly they are expected to transition to commercial drug post-launch.

Answer

CEO R. Scott Struthers noted that OLE patients are located globally. Chief Medical & Development Officer Dana Pizzuti clarified that a decision on the transition will be made after the PDUFA date and that only a small number of the total OLE patients are in the U.S. and would be eligible to switch to the commercial supply.

Alex Thompson from Stifel asked about the proportion of Yorvipath prescribers who have multiple patients on therapy and how that trend might be evolving.

Answer

President & CEO Jan Møller Mikkelsen stated that the company does not yet have sufficient data to comment on the trend of prescribers treating multiple patients.

Alex Thompson from Stifel inquired about the launch progress by partner CSL Vifor in Europe and when Travere might expect to see meaningful royalty revenue from ex-U.S. sales.

Answer

President & CEO Dr. Eric Dube deferred to CSL Vifor for specific performance commentary. CFO Chris Cline added that as CSL Vifor progresses through the country-by-country reimbursement process, revenues and subsequent royalties are expected to pick up, and the company will share more information as it becomes available.