Steve Barker

Steve Barker questioned the robust Q3 Entyvio sales growth, asking if Takeda expects to exceed its 6% full-year guidance and what factors are driving this performance. He also inquired about the anticipated impact of Entyvio's inclusion in IRA price negotiations on future price cuts and the $7.5-$9 billion peak sales guidance.

Answer

CEO Christophe Weber attributed Entyvio's Q3 performance to improved U.S. coverage for Entyvio Pen, now at 80% with major PBMs, and expressed hope for continued pen progress. He noted the aim for a 50/50 split between IV and pen, projecting stable market share growth at market pace. CEO-elect Julie Kim stated that Entyvio's IRA selection was anticipated, and while the final price is unknown, previous cohorts saw higher price cuts. She indicated that the peak revenue guidance would be updated after pricing is determined.

Steve Barker (Jefferies) questioned the robustness of Entyvio's Q3 sales (17% YOY reported, 7.4% CER) and whether Takeda could exceed its 6% full-year guidance, which implies a Q4 decline. He also asked about the sustainability of Q3's strong performance. Additionally, Barker inquired about the potential impact of Entyvio's selection for the third cycle of IRA price negotiations, including the expected price cut size and its effect on the $7.5 billion-$9 billion peak sales guidance.

Answer

Christophe Weber (CEO) expressed satisfaction with Entyvio's Q3 performance, attributing it partly to improved U.S. coverage for the Entyvio Pen, now at 80% with all three major PBMs. He aims for a 50/50 split between IV and pen formulations long-term, projecting stable market share and growth at market pace. Julie Kim (CEO-elect) stated that Entyvio's IRA selection was anticipated. She noted that the final price would be determined by year-end, observing that the second cohort of IRA-selected drugs experienced higher price cuts than the first. Kim indicated that peak revenue guidance would be updated once the pricing situation for Entyvio is clear.

Questioned the discrepancy between the substantial Q1 drop in SG&A and R&D spending versus the full-year guidance. Also asked for more detail on the potential new indications for the next-generation orexin agonist, specifically its application in areas like Alzheimer's, sleep apnea, and obesity.

Answer

The company explained the Q1 spending drop was due to FX impact on SG&A and the timing of R&D trial ramp-ups, combined with efficiency savings, but reiterated the full-year guidance is unchanged. For orexin, they confirmed they are exploring a broad range of indications including respiration and metabolism but are not yet specifying diseases like obesity, pending further data.