Slide 1: Conference on Q3 FY2024 Financial Results
Conference on Q3 FY2024 (April 1, 2024 to December 31, 2024) Financial Results Toru Kimura, President and CEO Sumitomo Pharma Co., Ltd. January 31, 2025
Slide 2: Disclaimer Regarding Forward-looking Statements
Disclaimer Regarding Forward-looking Statements This material contains forecasts, projections, goals, plans, and other forward-looking statements regarding the Group’s financial results and other data. Such forward-looking statements are based on the Company’s assumptions, estimates, outlook, and ot
Slide 3: Agenda
Agenda Financial Results for Q3 FY2024 Financial Forecasts for FY2024 Research and Development Q&A © Sumitomo Pharma Co., Ltd. All Rights Reserved. 2
Slide 4: Financial Results for Q3 FY2024
Financial Results for Q3 FY2024 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 3
Slide 5: Financial Highlights for Q3 FY2024
Financial Results for Q3 FY2024 Financial Highlights for Q3 FY2024 Revenue growth and cost-reduction efforts led to a significant improvement, turning to core operating profit to profitability Revenue Increased by 24.7% YoY: Increased by sales expansion of ORGOVYX® and GEMTESA® in the U.S. Cos
Slide 6: Financial Results for Q3 FY2024 (Core Basis)
Financial Results for Q3 FY2024 Revised full-year forecasts Financial Results for Q3 FY2024 (Core Basis) （See P.11） Billions of JPY Q3YTD Q3YTD Change FY2024 Revenue increased primarily FY2023 FY2024 May 14 Progress owing to sales expansion of three Results Results Value FX impact % forecasts % ke
Slide 7: Revenue of Major Products in North America
Financial Results for Q3 FY2024 Revenue of Major Products in North America Q3YTD Q3YTD Q3YTD Q3YTD Change FY2024 Revenue growth of three key FY2023 FY2024 Change FY2023 FY2024 FX JPY-basis products in total exceeded the Results Results Results Results Value % May 14 forecasts impact Progress % pla
Slide 8: Revenue of Major Products in Japan & Asia
Financial Results for Q3 FY2024 Revenue of Major Products in Japan & Asia Billions of JPY Q3YTD Q3YTD Change FY2024 FY2023 FY2024 May 14 Progress Results Results Value ％ forecasts % Japan Japan Equa®/EquMet® 24.6 20.9 (3.7) (14.9) 26.3 79.6 LATUDA® 9.0 10.2 1.2 13.7 13.0 78.7 Sales of LATUDA®, TWY
Slide 9: Segment Information (Core Basis)
Financial Results for Q3 FY2024 Segment Information (Core Basis) Billions of JPY North Japan Asia Total Japan America Despite cost reduction in SG&A expenses, the Revenue 78.5 179.4 35.3 293.2 decline in gross profit from lower sales had a greater Cost of sales 40.3 64.9 8.3 113.5 impact, decreasi
Slide 10: Financial Forecasts for FY2024
Financial Forecasts for FY2024 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 9
Slide 11: Financial Highlights for Revised Forecasts
Financial Forecasts for FY2024 Financial Highlights for Revised Forecasts Core operating profit revised up to 30 billion yen due to increased sales of three key products and the effects of cost management Revenue ORGOVYX® sales in the U.S. exceeded initial expectations, and the effects of one-ti
Slide 12: Financial Forecasts for FY2024 (Core Basis)
Financial Forecasts for FY2024 Financial Forecasts for FY2024 (Core Basis) FX rates: Billions of JPY FY2024 Previous forecasts : FY2024 FY2024 Change from Previous 1US$ = ¥145.00, 1RMB = ¥20.00 May 14 Revised forecasts Revised forecasts : Forecasts Forecasts Value FX impact 1US$ = ¥152.00, 1RMB = ¥2
Slide 13: Revenue of Major Products in North America
Financial Forecasts for FY2024 Revenue of Major Products in North America FY2024 FY2024 FY2024 FY2024 Change May 14 Revised Change May 14 Revised Forecasts Forecasts Forecasts Forecasts Value FX impact % North America Millions of USD Billions of JPY ORGOVYX® 400 516 116 57.9 78.5 20.6 3.6 35.6 Sal
Slide 14: ORGOVYX
Financial Forecasts for FY2024 ORGOVYX® Plan for 3Q Actual for 3Q YoY Influence of volume and Volume grew more than expected across all segments due to YTD FY2024 YTD FY2024 comparison price against actual improved affordability and strong tactical execution $379M Volume $68M Price was higher th
Slide 15: MYFEMBREE
Financial Forecasts for FY2024 MYFEMBREE® Plan for 3Q Actual for 3Q YoY Influence of volume and Volume grew less than expected due to the lower-than- YTD FY2024 YTD FY2024 comparison price against actual expected market growth of oral GnRH antagonists and market Volume ($21M) share in EM*2 $66M Ap
Slide 16: MYFEMBREE | Shift to independent sales and development
Financial Forecasts for FY2024 MYFEMBREE®| Shift to independent sales and development Co-promotion / co-development agreement with Pfizer for MYFEMBREE® was concluded at the end of December 2024 Since January 2025, SMPA started sales and marketing activities in the US individually Future plan an
Slide 17: GEMTESA
Financial Forecasts for FY2024 GEMTESA® Plan for 3Q Actual for 3Q YoY Influence of volume and Volume was almost on track to expectation YTD FY2024 YTD FY2024 comparison price against actual Price was higher than expected due to the lower-than- $283M Volume ($6M) anticipated Medicare and coverage
Slide 18: GEMTESA
Financial Forecasts for FY2024 GEMTESA® Despite the launch of the Generic mirabegron in April, GEMTESA® ‘s TRx and NBRx continues to grow TRx in β-3 Market GE Launch NBRx in β-3 Market GE Launch 700 90 K K 80 600 70 500 60 400 50 300 40 30 200 20 100 10 04 06 08 10 12 02 04 06 08 10 12 02 04 06 08
Slide 19: Segment Information (Core Basis)
Financial Forecasts for FY2024 Segment Information (Core Basis) Billions of JPY Japan North America Asia Total Japan Revenue 99.8 235.4 45.8 381.0 Profit expected to increase due to reduction in FY2024 Revised Cost of sales 51.8 85.4 10.3 147.5 SG&A expenses Forecasts Gross profit 48.0 150.0 35.5
Slide 20: Agreement on Co-Promotion of XEPLION and XEPLION TRI
Financial Forecasts for FY2024 Agreement on Co-Promotion of Long-Acting Antipsychotic Medications "XEPLION®" and "XEPLION TRI®" with Janssen Pharma in Japan By acquiring the option of injectable formulations and expanding the range of information provided, we aim to enhance our presence in the fie
Slide 21: Research and Development
Research and Development © Sumitomo Pharma Co., Ltd. All Rights Reserved. 20
Slide 22: Development Pipeline (as of January 31, 2025)
Research and Development Development Pipeline (as of January 31, 2025) Revisions since the announcement in October 2024 are shown in red Area Generic name/Product code Mechanism of action, etc. Proposed indication Region Development stage Serotonin 5-HT2A receptor antagonist and serotonin 5-HT1A DSP
Slide 23: Major Topics in Clinical Development
Research and Development Major Topics in Clinical Development Psychiatry & Neurology (Regenerative medicine/cell therapy) Allogeneic iPS cell-derived dopaminergic neural progenitor cells (Japan) • Parkinson’s disease Preparing for NDA submission in FY2025 based on the data from the investigator-
Slide 24: Allogeneic iPSC-retinal sheet (DSP-3077) for retinitis pigmentosa
Research and Development Psychiatry & Neurology (Regenerative medicine/cell therapy): Allogeneic iPSC-retinal sheet (DSP-3077) transplantation for retinitis pigmentosa Self-organizing culture Processing Test Allogeneic iPSCs Retinal organoid Retinal sheet 3D-retina DSP-3077 Photoreceptors / nuclei /
Slide 25: Phase 1/2 Study of enzomenib (DSP-5336) for Acute Leukemia
From data presented at ASH 2024 Research and Development Oncology Area: Phase 1/2 Study of enzomenib (DSP-5336) for Acute Leukemia CR/CRh rate, the important efficacy measure, was 30.4% in the MLLr patient group (with 40.0% in the 300 mg BID group) and 47.1% in the NPM1m patient group Enzomenib
Slide 26: Phase 1/2 Study of nuvisertib (TP-3654) for Myelofibrosis
From data presented at ASH 2024 Research and Development Oncology Area: Phase 1/2 Study of nuvisertib（TP-3654）for Myelofibrosis Data Cut-Off: October 1, 2024 Improvements in important efficacy measures were observed even in patients who did not respond to JAK inhibitor and in those with poor progn
Slide 27: Appendix
Appendix ＜Contents＞ P.27 Q3FY2024 Financial Results for Q3 FY2024 (Full Basis) P.28 Q3FY2024 Financial Position and Cash Flow P.29 FY2024Forecasts Revenue of Major Products in Japan & Asia P.30 R&D Main Events/Targets for FY2024 P.31 R&D Product Launch Target P.32 R&D Regenerative Medicine/Cell Ther
Slide 28: Financial Results for Q3 FY2024 (Full Basis)
Appendix (Financial Results for Q3 FY2024) Financial Results for Q3 FY2024 (Full Basis) Billions of JPY Q3YTD Q3YTD Change FY2023 FY2024 Results Results Value ％ Revenue 235.0 293.2 58.2 24.7 Cost of sales 93.2 113.8 20.6 22.1 Gross profit 141.8 179.4 37.6 26.5 SG&A expenses 191.6 131.0 (60.5) (31.6)
Slide 29: Financial Position and Cash Flow
Appendix (Financial Results for Q3 FY2024) Financial Position and Cash Flow Billions of JPY As of March As of Dec. Ｂ/Ｓ Change 2024 2024 Assets 907.5 852.1 (55.4) Increase due to FX rate impact Goodwill / Intangible assets 395.4 403.3 7.8 Other financial assets (Non-current) 161.7 38.2 (123.5) Decrea
Slide 30: Revenue of Major Products in Japan & Asia
Appendix (Financial Forecasts for FY2024) Revenue of Major Products in Japan & Asia Billions of JPY FY2024 FY2024 Change May 14 Revised Value ％ Forecasts Forecasts Japan Japan Equa®/EquMet® 26.3 25.5 (0.8) (3.0) LATUDA® 13.0 13.2 0.2 1.5 TWYMEEG® 11.3 7.9 (3.4) (30.1) Sales of TWYMEEG® revised dow
Slide 31: Main Events / Targets for FY2024
Appendix (Research and Development) Main Events / Targets for FY2024 (as of January 31, 2025) Revision since the announcement in October 2024 are shown in red Allogeneic iPS cell-derived products (Parkinson’s disease): Submit NDA in Japan Target submission date under consideration Allogeneic i
Slide 32: Product Launch Target (as of January 31, 2025)
Appendix (Research and Development) Psychiatry & Product Launch Target (as of January 31, 2025) Neurology Oncology Others No revision since the announcement in October 2024 FY2024 FY2025 FY2026 FY2027 FY2028 Allogeneic iPS cell- derived dopaminergic Development neural progenitor cells Parkinson’s di
Slide 33: Regenerative Medicine/Cell Therapy Launched Product and Development Pipeline
Appendix (Research and Development) Regenerative Medicine/Cell Therapy Launched Product and Development Pipeline (as of January 31, 2025) Revision since the announcement in October 2024 are shown in red Brand name/Cell type JP/ Clinical Approval Approval→ Product code Indications Pre-clinical Phase
Slide 34: Product Launch Target (FrontAct)
Appendix (Research and Development) Product Launch Target (FrontAct) (as of January 31, 2025) Revisions since the announcement in October 2024 are shown in red : Non-medical device : Medical device Launched FY2024 FY2025 FY2026 FY2027 FY2028 "MELTz® " (Neurorehabilitation device for hand/fingers par
Slide 35: Sumitomo Pharma
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