Stephen Barker

Stephen Barker from Jefferies inquired about two accounting matters: a COGS adjustment related to inventory valuation and an R&D expense reclassification. He also sought clarification on the Entyvio gross-to-net true-up adjustment.

Answer

Milano Furuta, an executive at Takeda, explained the COGS impact was a one-time recognition of accumulated FX on inventory, with a new process to prevent recurrence. He confirmed the R&D cost was a one-off accrual for post-trial access to discontinued drugs. Regarding Entyvio, he clarified the $50 million adjustment corrected past U.S. government pricing miscalculations over 10 quarters.

Questioned the rationale for ending the JR-141 partnership for Hunter syndrome and the strategic thinking behind the new AC Immune deal for Alzheimer's, particularly regarding the company's confidence in the amyloid thesis.

Answer

The JR-141 partnership termination was part of a broader pipeline prioritization to focus resources on the emerging late-stage pipeline. The AC Immune deal reflects a belief that an active immunotherapy (vaccine) could offer a safer and more effective treatment for Alzheimer's by enabling earlier intervention, differentiating it from current passive antibodies. Takeda's existing Hunter syndrome treatment, ELAPRASE, continues to perform well.

Stephen Barker of Jefferies asked for the rationale behind ending the partnership with JCR for the Hunter syndrome candidate JR-141. He also questioned the decision to pursue an Alzheimer's vaccine with AC Immune, given the regulatory challenges and general questions surrounding the amyloid thesis.

Answer

Andrew Plump, President of R&D, stated that the JCR partnership termination was part of a broader pipeline prioritization to support emerging late-stage assets. Regarding the AC Immune deal, he expressed confidence in the amyloid beta clearing approach, suggesting a vaccine could offer a safer profile and allow for earlier intervention, potentially increasing efficacy. Julie Kim, President, U.S. Business Unit, added that Takeda's existing Hunter syndrome treatment, ELAPRASE, continues to serve patient needs well.

Stephen Barker of Jefferies questioned the rationale for ending the Hunter syndrome partnership with JCR Pharmaceuticals and sought commentary on the decision to pursue an Alzheimer's vaccine with AC Immune, given perceived challenges with the amyloid hypothesis.

Answer

R&D President Andy Plump stated the JCR partnership termination was part of a broader pipeline prioritization. Regarding the AC Immune deal, he expressed confidence in the amyloid beta target, suggesting a vaccine could offer a safer profile and be used earlier in treatment to potentially increase efficacy. Executive Julie Kim added that Takeda's existing treatment, ELAPRASE, continues to serve Hunter syndrome patients well.

Stephen Barker from Jefferies questioned the significant year-over-year decline in Q1 SG&A and R&D spending relative to the full-year forecast. He also asked for more detail on the potential indications for the next-generation orexin agonist, such as sleep apnea or obesity.

Answer

CFO Milano Furuta attributed the SG&A decline primarily to foreign exchange effects and noted R&D spending is set to ramp up for new trials, with Q1 benefiting from efficiency programs and tight cost management. R&D President Andrew Plump confirmed the company is exploring a breadth of indications for orexin agonists, including respiration and metabolism, based on scientific literature, but stated it is too early to specify targets like obesity.

Questioned the geographic sales mix and implied pricing for Qdenga, and asked for details on the company's path to restoring its core operating profit margin to the low-to-mid 30s, specifically where the cost improvements would come from.

Answer

For Qdenga, the revenue mix will increasingly shift towards emerging/endemic countries as national immunization programs are adopted, and an average price of around $20 per dose is a reasonable assumption. The return to a low-to-mid 30s margin will be driven by a combination of revenue growth from high-margin products, productivity gains from technology and AI, and overall cost control, with more details to be provided in May.

Stephen Barker from Jefferies inquired about the current patient trend for Xocova in Japan, the potential demand impact from upcoming patient out-of-pocket payments, and the outlook for the COVID vaccine's approval timeline and potential government purchases.

Answer

Toshinobu Iwasaki, Senior Executive Officer, estimated 70,000-100,000 current patients and noted the company is advocating for continued public funding to maintain treatment rates. Regarding the vaccine, he stated the approval timeline is uncertain but not distant, and discussions on government purchase volume and price will commence post-approval.