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- **Pipeline Success**: Three Phase III assets (oveporexton, rusfertide, zasocitinib) exceed expectations, positioning Takeda for 2027 launches to offset ENTYVIO biosimilar risk.
- **Financial Resilience**: Q3 revenue (-3.3% YoY) and core OP (-3.4% YoY) reflect VYVANSE generic erosion, but 6.7% growth in launch products (ENTYVIO Pen, TAKHZYRO) signals recovery.
- **Strategic Adjustments**: Organizational restructuring and AI adoption aim to accelerate launches, while progressive dividend policy supports shareholder returns.
- **Key Risks**: ENTYVIO IRA price cuts (2028) and TAKHZYRO competitor pressure highlight need for disciplined cost management and pipeline diversification.

**【CEO Summary】**
- Takeda reported strong fundamentals in Q3 FY25, with disciplined cost management and operational efficiency. CEO Christophe Weber highlighted three key pipeline assets: oveporexton (narcolepsy), rusfertide (polycythemia vera), and zasocitinib (psoriasis), all with Phase III data exceeding expectations. These launches are expected to offset the long-term impact of ENTYVIO biosimilar entry (2030+). Weber emphasized the company's ability to maintain growth while preparing for future launches.

**【CFO Financial Commentary】**
- Q3 FY25 revenue: JPY 3.4 trillion (-3.3% YoY, -2.8% at CER). Core operating profit (OP): JPY 971.6 billion (-3.4% YoY). Adjusted free cash flow: JPY 125.9 billion, despite a USD 1.2 billion upfront payment to Innovent Biologics.
- Growth and launch products (50% of revenue) grew 6.7% YoY (CER), driven by ENTYVIO Pen (+7.4%), TAKHZYRO (+2.4%), and QDENGA (+22.1%). ENTYVIO Pen achieved 80% U.S. PBM coverage.
- VYVANSE generic erosion impact is tapering, with core OP limited to a 3.4% YoY decline due to OpEx savings and R&D cost control.

**【R&D Pipeline Update】**
- **Oveporexton**: FDA NDA submitted; Phase III showed statistically significant improvement in narcolepsy symptoms (85% of patients reached normative ESS scores). Expected launch in 2027.
- **Rusfertide**: FDA NDA submitted; Phase III demonstrated durable hematocrit control in polycythemia vera. Expected launch in 2027.
- **Zasocitinib**: Phase III psoriasis data showed 50% PASI 90 at week 16. Regulatory filings underway for 2027 launch. Head-to-head vs. deucravacitinib study fully enrolled.
- **Mezagitamab**: Proof-of-concept data in IgA nephropathy showed durable kidney function preservation. Phase III planned for 2026.
- **TAK-928/TAK-921**: Innovent-partnered oncology assets show early promise in lung and colorectal cancer (TAK-928) and gastric/pancreatic cancer (TAK-921). Global data generation underway.

**【Organizational Changes】**
- CEO transition to Julie Kim (effective June 2026) includes organizational restructuring to accelerate launches. New U.S.-focused commercial teams and streamlined R&D processes will enhance execution speed. AI adoption in operations aims to reduce costs and improve efficiency.

**【Q&A Highlights】**
- **ENTYVIO IRA Impact**: CMS selected ENTYVIO for 2028 Medicare price negotiations. Takeda anticipates a significant price cut but remains confident in achieving peak sales of JPY 75-90 billion. ENTYVIO Pen's 80% U.S. coverage and 50-50 IV/Pen split target supports long-term stability.
- **Dividend Policy**: Progressive dividend policy remains, with decisions based on core EPS, cash flow, and debt reduction. FY26 guidance to be announced in May.
- **Pipeline Investment**: R&D expenses will rise due to Innovent partnerships and late-stage pipeline advancement. Launch costs for three new products (2026-2027) are deemed critical for future growth.
- **TAKHZYRO Competitors**: DAWNZERA and other entrants impact new patient starts, but TAKHZYRO's real-world efficacy (attack-free periods >1 year) maintains leadership in hereditary angioedema.


Takeda Pharmaceutical Company Limited (TAK) Q3 2026 Earnings Call Transcript

- **VYVANSE Impact Waning**: FY25 H1 LOE peak, FY26 growth acceleration with 3 new launches.
- **ENTYVIO Growth Revised**: FY25 growth 6% (vs. 9%) due to competition, but Pen QoQ +20% in U.S.
- **FX Headwinds**: Euro volatility reduces FY25 core OP by ~JPY 10 billion.
- **Innovent Deal Potential**: 3 assets targeting $40+ billion lung/CRC market; Phase III data expected Q4 FY25.
- **R&D Efficiency**: 90%+ R&D programs enabled by AI by FY26; JPY 27.4 billion H1 restructuring savings.

**【CEO Summary Section】**
- FY25 H1 revenue: JPY 2.2 trillion (-6.9% YoY, -3.9% at CER) due to VYVANSE LOE impact (JPY 100 billion loss). Core OP: JPY 639.2 billion (-11.2% YoY, -8.8% at CER). ENTYVIO launch products grew 5.3% at CER, with ENTYVIO Pen QoQ +20% in U.S. FY26 outlook: VYVANSE LOE impact waning, 3 new launches (rusfertide, oveporexton, zasocitinib), and Innovent Biologics partnership to drive growth.

**【CFO Financial Commentary】**
- FY25 H1: Core EPS JPY 279 (-40% YoY), reported EPS JPY 72 (impacted by JPY 58.2 billion cell therapy impairment). FX headwinds: Euro strength vs. BRL (QDENGA) and JPY appreciation. FY25 guidance: Core OP and EPS now expected to decline low single digits (vs. prior flat guidance). FY25 AFG: JPY 525.4 billion free cash flow, JPY 200 dividend per share.

**【R&D & Pipeline Updates】**
- **Oveporexton**: Phase III data shows statistically significant improvement across 14 endpoints for NT1. U.S. filing planned for FY25. Next-gen orexin agonist (TAK-360) in Phase II for NT2/idiopathic hypersomnia.
- **Mezagitamab**: 96-week IgA nephropathy data shows stable renal function 18 months post-treatment. Phase III VERIFY study enrolling well.
- **Innovent Biologics Deal**: 3 assets acquired:
  - IBI363 (PD-1/IL-2 alpha bias bispecific) for NSCLC/CRC
  - IBI343 (Claudin 18.2 ADC) for gastric/pancreatic cancer
  - Option for IBI3001 (EGFR/B7H3 ADC)
- **Nabla Bio Partnership**: AI-driven drug discovery to accelerate pipeline (e.g., 90%+ of R&D programs enabled by in silico tech by FY26).

**【Q&A Highlights】**
- **Innovent Deal Costs**: 60-40 cost split for IBI363, with Takeda leading global dev/commercialization. R&D spending offset by efficiency programs (e.g., JPY 27.4 billion H1 restructuring savings).
- **FX Mitigation**: Long-term manufacturing footprint rebalancing; FY25 euro volatility impact estimated at JPY 10 billion.
- **ENTYVIO Pen Penetration**: U.S. Pen share 9%, targeting acceleration via PBM contract expansion (2/3 PBMs signed). FY25 ENTYVIO growth revised to 6% (vs. prior 9%) due to competition and Medicare Part D redesign.
- **Innovent Data Reliability**: Global Phase II IBI363 data (U.S./Australia) expected Q4 FY25; China data correlation validated via Takeda radiologist review.
- **Dividend Sustainability**: Progressive policy based on core EPS, free cash flow, and debt reduction. FY26 dividend proposal to be announced in May FY26.


Takeda Pharmaceutical Company Limited (TAK) Q2 2026 Earnings Call Transcript

- **VYVANSE Impact Waning**: Q1 revenue decline (8.4% YoY) driven by generics, but FY2025 last year of significant impact.
- **Oveporexton Breakthrough**: Phase III results show transformative benefits for narcolepsy type 1, with US filing planned Q4.
- **Strong Cash Flow Management**: JPY190.1B adjusted FCF; debt refinanced at favorable terms to reduce maturity profile.
- **Pipeline Momentum**: 5 late-stage programs on track for FY2025-2029 filings, including oveporexton, rusfertide, and zasocitinib.
- **US Strategy Shift**: Exploring DTC model for select products; maintaining manufacturing/R&D presence despite geopolitical risks.

**【CEO Opening Remarks】**
- FY2025 Q1 revenue decline (8.4% YoY) driven by VYVANSE generic erosion, expected to moderate in future quarters.
- FY2025 outlook unchanged; FY2025 will be last year of significant VYVANSE impact.
- Pipeline progress: oveporexton Phase III studies met all endpoints for narcolepsy type 1, with potential to become new standard of care.

**【CFO Financial Commentary】**
- Q1 revenue: JPY1.1 trillion (down 8.4% YoY, 3.7% at CR), core OP JPY321.8 billion (-15.8% YoY, -11.9% FCR).
- Launched products (50% of revenue) grew 5% CR, including Entyvio (+4.9%), TAKHZYRO, and Fruzaqla expansion.
- VYVANSE decline (3.7% CR) due to US generic supply recovery and Canada/GER/BRAZIL LOEs; FX headwinds from JPY appreciation.
- Strong cash flow (adjusted FCF JPY190.1 billion); debt refinanced with USD2.4B bonds at favorable terms.

**【R&D Pipeline Update】**
- Oveporexton Phase III results: statistically significant improvements across all NT1 symptoms (EDS, cataplexy, cognition), with >95% patients enrolling in LTE.
- Next-gen orexin agonist (TAK-360) in Phase II for NT2/idiopathic hypersomnia; new molecule to enter clinic FY2025.
- Rusfertide (polycythemia vera) Phase III data highlighted as "practice-changing" at ASCO; 52-week update planned H2 FY2025.
- Zasocitinib Phase III head-to-head vs deucravacitinib for psoriasis; trial powered for superiority.

**【Q&A Highlights】**
- **Product Recovery**: ENTYVIO growth expected to accelerate with expanded pen access; QDENGA supply ramping up.
- **Orexin Franchise**: TAK-861 positioned as best-in-class; next-gen molecules targeting broader orexin-related indications (e.g., sleep-wake disorders, metabolism).
- **US Investment Strategy**: Maintain manufacturing/R&D presence despite tariffs; DTC model being evaluated for select products.
- **R&D Spending**: Q1 R&D savings (efficiency programs) reinvested in pipeline; FY2025 R&D guidance remains on track.
- **Tariff Mitigation**: <10% of US revenue exposed to tariffs; contingency plans in place.


Takeda Pharmaceutical Company Limited (TAK) Q1 FY2025 Earnings Call Transcript

- **Revenue resilience**: 2.8% CER growth offset by VYVANSE generic impact, with 14.7% Growth Product portfolio expansion.
- **Margin improvement**: Core operating profit margin up 60bps to 25.4%, driven by JPY 150B OpEx savings.
- **Pipeline breakthrough**: Rusfertide Phase III data shows 73% phlebotomy-free patients, oveporexton narcolepsy trials on track for 2025 readout.
- **FY25 Outlook**: Flat revenue, profit, and EPS, with final VYVANSE impact and JPY 130B Medicare/340B rebate headwind.
- **Tariff mitigation**: 8-10% U.S. revenue exposure, 70% CMOs U.S.-based, limiting tariff risk.
- **Dividend growth**: JPY 200/share increase, reflecting 40% payout ratio and strong cash flow.

**【CEO Summary Section】**
- Fiscal 2024 revenue grew 2.8% at CER, driven by 14.7% growth in the Growth and Launch Product portfolio (now 48% of total revenue). VYVANSE loss of exclusivity reduced core EPS slightly due to higher tax expenses.
- Core operating profit margin improved to 25.4% (up 60bps vs. prior year), driven by OpEx savings from a multiyear efficiency program.
- Late-stage pipeline momentum: 6 Phase III programs, including rusfertide (polycythemia vera) with Phase III data showing 73% of patients requiring 0 phlebotomies vs. 22% on placebo.
- FY25 outlook: Broadly flat revenue, core operating profit, and core EPS at CER, with final year of VYVANSE generic impact.

**【CFO Financial Commentary】**
- FY24 core revenue: JPY 4.58T (7.5% YoY), core operating profit: JPY 1.16T (10.2% YoY at actual FX). Free cash flow: JPY 769B, supporting JPY 100B buyback and dividend increase to JPY 200/share.
- Efficiency program delivered JPY 150B OpEx savings in FY24, with restructuring costs of JPY 128.1B (below forecast of JPY 140B).
- FY25 guidance: Core revenue flat (VYVANSE decline offset by Growth Products), core OP and EPS flat, free cash flow JPY 750-850B.

**【R&D Pipeline Update】**
- Rusfertide Phase III data: 73% of patients required 0 phlebotomies vs. 22% on placebo, with significant quality of life improvements.
- Oveporexton Phase III narcolepsy trials completed enrollment, data expected summer 2025. Potential peak revenue $2-3B.
- Zasocitinib Phase III psoriasis trials on track for H2 2025 readout. Head-to-head vs. deucravacitinib trial planned for 2025.

**【Q&A Highlights】**
- ENTYVIO PEN reimbursement challenges persist, but patient preference strong (1,000 new prescribers/Q). Target 50-50 split between IV and PEN by FY25.
- VYVANSE generics now at 15 in U.S., FY25 impact expected to be smoother than FY24.
- Tariff exposure limited: 8-10% of U.S. revenue from non-U.S. imports, 70% of CMOs U.S.-based.
- Dividend policy: JPY 200/share increase (vs. JPY 196 prior), payout ratio ~40%.
- Medicare Part D/340B impact: JPY 130B FY25, driven by rebate increases across portfolio.


Takeda Pharmaceutical Company Limited (TAK) Q4 2024 Earnings Call Transcript

- **CEO Transition**: Christophe Weber retiring in June 2026; Julie Kim, U.S. Business Unit leader, to succeed, aligning with 2026 product launches.
- **Financial Strength**: FY24 revenue up 4.5% CER, core margin 28.5%, with JPY 100B buyback announced.
- **Pipeline Catalysts**: 3 Phase III readouts in 2025; zasocitinib poised to redefine psoriasis treatment with 2026 launch potential.
- **ENTYVIO Resilience**: 9.4% CER growth (excluding adjustments), biosimilar risk 2030-2032, with 2032 patent expiry.
- **Strategic Focus**: U.S. market (50% revenue) and oncology expansion in Japan/Europe driving growth.

**【CEO Summary Section】**
- **CEO Retirement & Succession**: Christophe Weber announced his retirement in June 2026, with Julie Kim, President of the U.S. Business Unit, set to succeed him. The transition aligns with key product launches (e.g., elritercept) in late 2026 and Board refreshments. Julie’s 30+ years of healthcare experience and track record in leading Takeda’s U.S. business (50% of revenue) were highlighted as critical qualifications.
- **Pipeline Momentum**: Emphasized 3 Phase III readouts in 2025 (risperatide, oveporexton, zasocitinib) and the potential for 2026 launches to drive growth. The U.S. market remains a strategic focus, with 50% of revenue dependent on Julie’s leadership.

**【CFO Financial Commentary】**
- **Q3 2024 Results**: Year-to-date revenue grew 4.5% CER, driven by 14.6% growth in Growth & Launch products. Core operating profit margin expanded to 28.5% (up 1.6ppt), supported by slower-than-expected VYVANSE generic erosion and OpEx savings.
- **Guidance Update**: Raised FY24 revenue and core operating profit forecasts to JPY 4.59T and JPY 1.15T, respectively, with core EPS at JPY 507. A JPY 100B share buyback was announced, leveraging excess cash flow from performance upside.
- **Key Drivers**: ENTYVIO growth (9.4% CER excluding one-off adjustments), TAKHZYRO (16.4% CER), and oncology expansion in Japan/Europe. Vaccines (Kudanga) achieved 10M+ doses sold globally.

**【Q&A Highlights】**
- **ENTYVIO Adjustments**: Q3 included a JPY 50M gross-to-net true-up adjustment and shipment timing effects, limiting year-to-date growth to 9.4% CER. Biosimilar entry risks remain 2030-2032, with patents expiring in 2032.
- **IRA Impact**: Zasocitinib’s head-to-head trial vs. Ducravacitinib will differentiate it from Otezla (included in 2025 IRA). ENTYVIO may face IRA inclusion in 2028, but peak sales guidance (JPY 750B-950B) accounts for this risk.
- **Share Buyback**: Reflects cash flow generation beyond growth investments, aligning with capital allocation policy of balancing growth and returns.
- **Succession Strategy**: Julie will lead U.S. operations until a successor is named, ensuring continuity during the transition period.


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