TAKEDA PHARMACEUTICAL CO LTD earnings calls

MIMRYLO launch and zaso UC dose

Q (Hidemaru Yamaguchi · Citi): He asked two things: early launch impressions or numbers for MIMRYLO, and which zaso dose showed benefit and what is needed before Phase III.

A: Management said MIMRYLO launch is early but reception from doctors and patients is enthusiastic; they have no quantitative measures yet. For zaso in UC, they were pleased with efficacy at the middle dose but want to see Crohn's data and analyze dose behavior before deciding on Phase III.

MIMRYLO uptake and Phase III plan

Q (Teresa Bitetti): Clarify MIMRYLO launch uptake/reimbursement progress and what you need to decide on Phase III for zaso UC and Crohn's.

A: Teresa said the MIMRYLO launch is going well, with strong interest from HCPs and patients and focus on education and access, but it's too early for numbers. Andy said UC data were encouraging at the middle dose, but because there is no clear dose response they will wait for Crohn's data and further mechanistic analysis before deciding on Phase III.

Dose choice for Phase III

Q (Hidemaru Yamaguchi · Citi): Can you proceed with 50 mg given 75 mg did not show benefit, or do you need more dose analysis?

A: Management said the data suggest a path forward in IBD but they will not decide Phase III dosing until they have Crohn's data and consider the two data sets together. They also noted potential for combination use and that zasocitinib might work as monotherapy or in combinations.

"We really want to look at the Crohn's disease data and the 2 data sets together." — Andrew Plump (PRESIDENT)

UC dose comparison and NT1 timing

Q (Shinichiro Muraoka · Morgan Stanley): Does the 30%/20% remission in the deck match your data and dose response? And will NT1 (ORZEYFUL) data be press released Jan–Mar then presented?

A: Management said dose dependency for zaso is still being analyzed and that they pivoted to release UC data earlier because UC and Crohn's readouts are staggered; they plan to review both. For NT1 timing, Julie later noted launches in Japan and China started October 15 and initial targeting is diagnosed patients on treatment.

Which zaso dose showed efficacy and MIMRYLO coverage

Q (Stephen Barker · Jefferies): Which zaso dose showed indications of efficacy? And what percent of lives are covered for MIMRYLO and path to broader coverage?

A: Andy clarified the mid (50 mg) dose showed encouraging efficacy while the higher dose did not show dose response; they will analyze mechanistically and await Crohn's data. Teresa said it's early for MIMRYLO but scripts are being written with prior auth, payers are engaged, and Medicare usually comes first then commercial.

Meaning of low-dose result and robustness

Q (Stephen Barker · Jefferies): Given high dose missed, is the low-dose result meaningful or possibly chance?

A: Management said concern is expected when dose response is absent, but they feel the result is robust because of the magnitude, consistency across clinical and endoscopic endpoints, and mechanistic hypotheses that higher doses could alter immune effects; ultimately Crohn's data will be definitive.

"We see consistency of data across both the clinical endpoints and the objective endoscopic endpoints." — Andrew Plump (PRESIDENT)

MIMRYLO patient mix and coverage progress

Q (Teresa Bitetti · Jefferies): What is payer access for MIMRYLO and mix of low-risk phlebotomy vs high-risk patients?

A: Teresa said MIMRYLO has NCCN Category 1 for low and high risk, payers are engaged, Medicare expected to come first then commercial, and scripts are going through with prior auth. She added high-risk patients are defined by age 65+ or prior thrombotic event and population likely skews somewhat toward high risk but is rather evenly distributed.

zaso vs Entyvio and ORZEYFUL uptake

Q (Matsubara · Nomura): How does zaso compare to ENTYVIO and any safety signals like TB? And initial physician feedback for ORZEYFUL in Japan/China?

A: Andy noted they are still analyzing dose dependency for zaso and earlier said UC efficacy at the middle dose was on par with other oral agents; no new safety concerns were raised in UC versus psoriasis dose experience. Julie said ORZEYFUL launched Oct 15 in Japan and China two weeks prior and initial response is pleasing, targeting diagnosed patients on treatment first while working on diagnosis.

U.S. ORZEYFUL launch readiness and Japan/China feedback

Q (Rhonda Pacheco): How prepared is the U.S. launch for ORZEYFUL and what feedback from HCPs in Japan/China so far?

A: Rhonda said the U.S. commercial, access, and patient support teams are ready, with education, payer engagement, specialty distribution, and diagnosis tools underway; feedback from HCPs has been overwhelmingly positive. Julie added that Japan and China launches began Oct 15 and initial response is positive, focusing first on already diagnosed and treated patients.

Why more confidence in Crohn's and TAK-360 trial change

Q (Michael Nedelcovych · TD Cowen): Why is there greater confidence for zasocitinib in Crohn's than UC and could you pursue pivotal trials only in Crohn's? Also why start TAK-360 Phase II in both NT1 and NT2 now?

A: Andy explained mechanistic rationale suggests higher likelihood of success in Crohn's and they will consider Crohn's data together with UC before deciding on pivotal plans; delay between readouts explains staggered timing. On TAK-360, management elsewhere had said commercial rationale for two products but transcript did not include a detailed TAK-360 explanation in this exchange.

(No substantive question)

Q (Tony Ren · Macquarie): Analyst checked connection ('Can you hear me?').

A: No management content in this exchange beyond call facilitation; no clinical or commercial answer was given here.

Claudin 18.2 differentiation and ORZEYFUL pricing

Q (Tony Ren · Macquarie): How will your Claudin 18.2 ADC differentiate versus competitors and what is ORZEYFUL launch pricing strategy ex-U.S.?

A: Teresa said they feel confident TAK-921 differentiates on safety due to Fc-silenced linker and low GI toxicity and that efficacy in a very sick population supports competitive positioning and moving to frontline studies. Julie said China sales are currently private market pending NRDL submission next summer and Japan pricing is about $100,000 annualized in U.S. dollars.

ORZEYFUL NRDL timing and Japan price

Q (Teresa Bitetti · Macquarie): Clarify NRDL timing in China and pricing in Japan for ORZEYFUL.

A: Julie explained China will require NRDL submission next summer with hoped-for listing in January of '28, and Japan pricing equates to roughly about $100,000 annualized in U.S. dollars.

"For Japan, we have received pricing in Japan, as you may be aware, and the equivalent in U.S. dollars is roughly about $100,000 on an annualized basis." — Julie Kim (CEO)

Capital Markets Day and product performance outlook

Q (Seiji Wakao · JPMorgan): Will you finalize Phase III plan for zaso by Capital Markets Day, and can you explain Q2 performance drivers for ENTYVIO and PDT and outlook for H2?

A: Andy said development strategy for zaso will be clarified at Capital Markets Day in December and they remain cautious about dose-response uncertainty but encouraged by 50 mg signal. Rhonda said ENTYVIO is performing in line with expectations, with sustained demand growth and pen uptake supporting growth. Ramy said IG demand grew mid-single digits with SCIG up 17% while IVIG declined due to phasing and market dynamics; they expect IVIG to accelerate in H2 and China albumin to return to growth as policies settle.

Closing remarks and Capital Markets Day reminder

Q (Rhonda Pacheco): No new question — closing and reminder about Capital Markets Day.

A: Julie closed by saying they made notable progress in H1, will continue disciplined execution to bring medicines to patients and support access, and they will share more details on growth strategy at Capital Markets Day on December 11.

"We look forward to connecting today's progress with our longer-term ambition at our Capital Markets Day on December 11." — Julie Kim (CEO)