Hiroyuki Matsubara

Hiroyuki Matsubara asked about the slowdown in Takhzyro's CER growth, specifically if it's due to competitor Donzera and Medicare Part D redesign, and its impact on prescription rates. Matsubara also sought Takeda's midterm strategy to increase operating profit given anticipated R&D and launch spending for new products like Oveporexton and Zasocitinib.

Answer

CEO-elect Julie Kim confirmed that Takhzyro's slower growth is due to market maturation, impact from new competitive entrants on new starts, and higher-than-anticipated impact from Medicare Part D redesign in the U.S. She emphasized Takhzyro's superior long-term efficacy based on real-world evidence. CFO Milano Furuta explained that new products typically contribute to profit in their second or third year post-launch, with Oveporexton expected to have fast uptake, rusfertide moderate, and zasocitinib slower due to market competition. He also mentioned that the completion of Vyvanse intangible asset amortization would positively impact reported operating profit.

Hiroyuki Matsubara (Nomura Securities) asked about the slowing growth rate of Takhzyro on a CER basis since Q2, inquiring if it was impacted by competitor Dawnzera and its effect on prescription rates for existing and new patients. He also sought Takeda's mid-term outlook for operating profit, considering increased R&D spending for new launches like oveporexton and zasocitinib, and other pipeline assets.

Answer

Julie Kim (CEO-elect) acknowledged that the HAE market is maturing, with high diagnosis and prophylaxis penetration. She confirmed an impact on new starts from recent competitive entrants and noted a higher-than-anticipated impact from Medicare Part D redesign in the U.S. Kim emphasized Takhzyro's superior long-term efficacy and real-world attack-free data. Milano Furuta (CFO) explained that new products typically contribute to profit in their second or third year post-launch. He anticipated fast uptake for oveporexton, a more competitive market for zasocitinib requiring monitoring, and rusfertide falling in between. Furuta projected overall profit enhancement from these and five other pipeline assets launching in the next 5-6 years, also noting a positive contribution from the completion of Vyvanse intangible asset amortization.

Asked about the competitive landscape for Takhzyro, including patient switching dynamics with Orladeyo and threats from new therapies, and also inquired about the potential of the next-generation Orexin agonist (TAK-360) and its differentiation from TAK-861.

Answer

For Takhzyro, patients are switching back from Orladeyo due to Takhzyro's superior efficacy, and while new competitors show similar efficacy, Takhzyro benefits from its long-term data and market leadership. The next-generation Orexin agonist, TAK-360, is a novel structure, and its positioning will depend on the forthcoming data from TAK-861, with more details to be shared at a future R&D event.