Strong cash generation and upgraded cash flow outlook
Adjusted free cash flow of JPY 625.9 billion YTD (after a USD 1.2 billion upfront Innovent payment); management upgraded the adjusted free cash flow forecast despite transactional spend.
Triple Phase III success and NDA submissions
Positive Phase III readouts for oveporexton, rusfertide and zasocitinib (all met or exceeded expectations). NDA filed with FDA for oveporexton and rusfertide; zasocitinib Phase III psoriasis data showed >50% achieving PASI 90 at week 16 and ~30% PASI 100, with regulatory filing preparations underway (target launch H1 CY2027). Oveporexton: ~85% of NT1 patients in Phase III moved into normative range on ESS; rusfertide maintained hematocrit <45% through 52 weeks.
Growth-and-launch products driving revenue expansion
Products classified as growth & launch (over 50% of total revenue) grew 6.7% at constant exchange rates YTD, improving from ~5% growth in Q1/Q2, narrowing the gap versus LOE headwinds.
ENTYVIO momentum and Pen uptake
ENTYVIO revenue grew 7.4% at CER in GI; ENTYVIO Pen now on formulary with all three major PBMs and commercial coverage >80% in the U.S.; management on track for full-year ENTYVIO guidance of ~6% growth.
Other product growth pockets
QDENGA accelerated to 22.1% growth (driven primarily by Brazil); FRUZAQLA continues global rollout and expansion.
Maintained profitability guidance via cost discipline
Despite revenue pressure, core operating profit YTD was JPY 971.6 billion (down 3.4% Y/Y at actual FX and CER) and reported operating profit was JPY 422.4 billion (up 1.2% Y/Y). Management maintained full-year core OP guidance (JPY 1.15 trillion) and core EPS guidance (JPY 486) through OpEx discipline and lower R&D and SG&A versus prior year.
Strategic partnerships and pipeline expansion
Innovent partnership (USD 1.2 billion upfront) added two oncology assets (TAK-928 and TAK-921); shared 60/40 investment structure and rapid data transfer to support global development—strengthening late-stage pipeline breadth.
Orderly leadership transition and organizational changes
Planned CEO handover to Julie Kim with organizational restructuring effective April 1 to accelerate commercial readiness for multiple upcoming launches and focus U.S. commercial efforts.