Tony Ren

Tony Ren asked if Takeda's estimated launch timeline of 18 months for Zasocitinib is conservative, given the potential for an earlier FDA review following a March data presentation. He also questioned if the launch of the subcutaneous Entyvio Pen has altered Takeda's thinking about the timing of Entyvio biosimilar entry.

Answer

President of R&D Andrew Plump clarified that the Zasocitinib submission timeline is determined by three factors: completed phase III studies, accrual of a 1,000-patient safety database for a full year, and the CMC package, leading to a likely submission in summer. CEO-elect Julie Kim stated that Takeda's biosimilar entry timing expectations for Entyvio have not changed, still projecting 2030-2032 due to patents and potential legal challenges. She added that IRA negotiation would also impact biosimilar pricing expectations.

Tony Ren (Macquarie) questioned the regulatory pathway for zasocitinib, asking if a launch could occur earlier than the guided 18 months, assuming an AAD presentation in March and a standard FDA review. He also asked Julie Kim if Takeda's thinking about Entyvio biosimilar entry timing had changed due to the subcutaneous pen, noting a recent conference mention of '2030 and beyond.'

Answer

Andrew Plump (President, R&D) clarified that the zasocitinib filing timeline depends on three elements: completed phase III studies, a full-year patient safety database (1,000 patients), and the CMC package. He indicated that combining these factors, submission is likely in the summer, with the FDA review timeline to be determined post-submission. Julie Kim (CEO-elect) stated that Takeda's timing expectations for Entyvio biosimilar entry have not changed, citing patents extending to 2032 but acknowledging potential legal challenges from biosimilars, hence the 2030-2032 range. She added that the IRA negotiation would also impact biosimilar pricing expectations.

Tony Ren of Macquarie Group asked for more detail on the Entyvio gross-to-net adjustment and its impact on the product's 11% CER growth guidance. He also inquired how Otezla's inclusion in IRA price negotiations affects plans for zasocitinib.

Answer

Executive Milano Furuta confirmed the adjustment was for U.S. government pricing and acknowledged it could make the 11% growth target for Entyvio challenging. CEO Christophe Weber stated that Otezla's IRA inclusion reinforces their strategy to highly differentiate zasocitinib on efficacy and safety versus existing oral treatments.

Inquired about the market impact of argenx's VYVGART on Takeda's immunoglobulin franchise in CIDP and questioned AbbVie's aggressive targeting of the frontline IBD market against ENTYVIO, also noting the absence of a market share graph in the presentation.

Answer

Takeda's expectations for its immunoglobulin franchise in CIDP are unchanged, as IG remains the gold standard of care. For ENTYVIO, the company maintains it is still the market share leader in first-line bio-naive patients. The market share graph was omitted from the presentation due to data integrity issues from a third-party claims processor following a cyber incident.

Tony Ren from Macquarie inquired about market dynamics for Takeda's immunoglobulin in CIDP following the strong launch of argenx's VYVGART. He also asked about ENTYVIO's market share in light of AbbVie's aggressive frontline strategy and why the historical market share graph was absent from the presentation.

Answer

Julie Kim, President, U.S. Business Unit, stated that expectations for Takeda's IGs in CIDP are unchanged, as they remain the gold standard. On ENTYVIO, she confirmed it is still the market share leader in first-line bio-naive and explained the share graph was temporarily removed due to a third-party cyber incident impacting claims data, but will return once resolved.

Tony Ren of Macquarie Group asked about the market dynamics for Takeda's immunoglobulin in CIDP following the strong launch of a competitor, and also questioned AbbVie's aggressive targeting of frontline IBD and the absence of the ENTYVIO market share graph in the presentation.

Answer

Executive Julie Kim stated that expectations for immunoglobulin in CIDP are unchanged as it remains the gold standard. Regarding ENTYVIO, she reiterated its market leadership in the first-line setting and explained the share graph was omitted due to a third-party cyber incident impacting claims data, with plans to restore it once the data is reliable.

Asked about the commercial expectations for the newly licensed asset rusfertide, including launch timing and peak sales. Also inquired about ENTYVIO's market dynamics, including the impact of colonoscopy procedure trends and a clarification on a slight market share decline.

Answer

For rusfertide, it is too early to provide peak sales data as the drug is still in Phase III trials, with a launch expected in a few years. For ENTYVIO, the company maintains market share leadership in first-line treatment, with the slight overall decline attributed to new competitor entries in second-line and beyond.