Astellas Pharma Inc. · TSE:4503

Astellas Pharma — Corporate Update (November 2023)

22 slides from Astellas Pharma's corporate update, Nov 6, 2023

  1. Slide 1: Investor Call: IZERVAY GATHER2 2-Year Data Presented at AAO 2023

    INVESTOR CALL: IZERVAY™ (AVACINCAPTAD PEGOL INTRAVITREAL SOLUTION) GATHER2 2-YEAR DATA PRESENTED AT AAO 2023 November 6, 2023 (JST)

  2. Slide 2: Cautionary Statement Regarding Forward-Looking Information

    CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING 2 INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These sta

  3. Slide 3: 注意事項

    注意事項 3 本資料には、医薬品に関する情報が含まれています。それらの医薬品は、すべての国で発売されてい るとは限らず、また、国によって商標、効能・効果、用法・用量等が異なる可能性もあります。ここ に記載されている内容は、株主や投資家の皆さまのための情報開示を目的としており、開発品を含む いかなる医療用医薬品の宣伝広告、医学的アドバイスを意図するものではありません。

  4. Slide 4: Dhaval Desai

    4 DHAVAL DESAI SENIOR VICE PRESIDENT AND CHIEF DEVELOPMENT OFFICER, IVERIC BIO, AN ASTELLAS COMPANY

  5. Slide 5: Today's Presentation Contents

    5 TODAY’S PRESENTATION CONTENTS 1 AAO Update and GATHER2 Summary and Background Dhaval Desai 2 GATHER2 2-Year Data Erin Henry 3 Lifecycle Management Update Dhaval Desai 4 Q&A

  6. Slide 6: AAO Update and GATHER2 Summary and Background

    6 AAO UPDATE AND GATHER2 SUMMARY AND BACKGROUND

  7. Slide 7: AAO Update

    AAO UPDATE HCB ive: ey y astellas

  8. Slide 8: Summary of GATHER2: 2-Year Data

    8 SUMMARY OF GATHER2: 2-YEAR DATA Both monthly (EM) and every other month (EOM) IZERVAY reduced GA growth vs sham Treatment effect more than doubled over 2 years compared to 1 year for IZERVAY IZERVAY was well tolerated: over 2 years, there was 1 case of non-serious IOI, 1 case of culture- positive

  9. Slide 9: IZERVAY Is Designed to Be a Specific Inhibitor of Complement C5

    9 IZERVAY IS DESIGNED TO BE A SPECIFIC INHIBITOR OF COMPLEMENT C5 Classical pathway Alternative pathway Lectin pathway C3 convertase C3 C3a C3b + C5 convertase IZERVAY Avacincaptad C5 pegol Anti-C5 pegylated RNA aptamer Inflammasome Relatively small physical size & Membrane attack complex Inhibition

  10. Slide 10: IZERVAY Achieved the 12-Month Prespecified Primary Objective in 2 Pivotal Phase 3 Studies

    IZERVAY ACHIEVED THE 12-MONTH PRESPECIFIED PRIMARY OBJECTIVE 10 IN 2 PIVOTAL PHASE 3 STUDIES1,2 IZERVAY 2 mg (N=67) Sham (N=110) IZERVAY 2 mg (N=225) Sham (N=222) 2.25 2.25 2.121 Mean GA Growth (Slope) From Mean GA Growth (Slope) From 2.00 2.00 1.889 1.75 1.75 1.745 Baseline (mm2) Baseline (mm2) 1.5

  11. Slide 11: GATHER2 Is a 2-Year, Phase 3, Sham-Controlled Study

    GATHER2 IS A 2-YEAR, PHASE 3, INTERNATIONAL, MULTICENTER, 11 PROSPECTIVE, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY (NCT04435366) Year 1 Year 2 Months Months IZERVAY 2 mg (N=225) Re-randomized IZERVAY 2 mg EM (n=96) 1:1 N=448a Randomized 1:1 IZERVAY 2 mg EOM (n=93) Sham (N=222) Primary Analys

  12. Slide 12: GATHER2 2-Year Data

    12 GATHER2 2-YEAR DATA ERIN HENRY VICE PRESIDENT, PRODUCT STRATEGY AND INNOVATION, IVERIC BIO, AN ASTELLAS COMPANY

  13. Slide 13: IZERVAY Reduced GA Growth When Dosed EM and EOM vs Sham

    13 IZERVAY REDUCED GA GROWTH WHEN DOSED EM AND EOM VS SHAM IZERVAY 2 mg EM (n=96) IZERVAY 2 mg EOM (n=93) Sham (n=203) Mean GA Growth (Slope) From Baseline 5.5 5.180 mm2 Re-randomized 5.0 p=0.0165 4.5 4.456 mm2 p=0.0015a 4.204 mm2 (observed; mm2) 4.0 3.5 3.0 Monthly IZERVAY 2 mg months 0-12 2.5 2.0

  14. Slide 14: Treatment Effect More Than Doubled with IZERVAY Over 2 Years Compared to 1 Year

    TREATMENT EFFECT MORE THAN DOUBLED WITH IZERVAY OVER 2 YEARS 14 COMPARED TO 1 YEAR 1.4 IZERVAY 2 mg EM (n=96) IZERVAY 2 mg EOM (n=93) Difference in Mean Rate of GA Growth From Baseline Compared to Sham 1.2 1.0 (Observed; mm2) 1.04 0.8 0.81 0.6 0.4 0.41 0.2 0.31 0.0 Baseline to Months 0-12 Baseline t

  15. Slide 15: No Statistically Significant Difference in Persistent Vision Loss Between IZERVAY and Sham

    NO STATISTICALLY SIGNIFICANT DIFFERENCE IN ≥15-LETTER 15 PERSISTENT VISION LOSS BETWEEN IZERVAY AND SHAM ~ Mean change in BCVA and LL-BCVA from baseline between IZERVAY and sham was similar at two-years Hazard Ratio (CI): 0.90 (0.57, 1.42) 0.20 Log Rank P-Value: 0.6424 0.18 IZERVAY 2 mg (all treated

  16. Slide 16: Treatment Emergent Adverse Events Over 2 Years Similar and Consistent with Year 1

    TREATMENT EMERGENT ADVERSE EVENTS (TEAES) OVER 2 YEARS 16 WERE SIMILAR AND CONSISTENT WITH YEAR 11 IZERVAY Sham (N=225) (N=222) TEAEs, n (%) 208 (92.4) 184 (82.9) Ocular in study eye 144 (64.0) 107 (48.2) Non-ocular 172 (76.4) 160 (72.1) Serious TEAEs, n (%) 60 (26.7) 51 (23.0) Ocular in study eye 4

  17. Slide 17: Serious Ocular TEAEs – No New Safety Signals in Year 2

    17 SERIOUS OCULAR TEAEs – NO NEW SAFETY SIGNALS IN YEAR 2 Year 11 Year 2 Total IZERVAY 2 mg IZERVAY 2 mg IZERVAY 2 mg Sham Sham IZERVAY 2 mg Sham EM EOM (N=225) (N=222) (n=203) (N=225) (N=222) (n=96) (n=93) Serious ocular TEAEs in 2 (0.9) 2 (0.9) 2 (2.1) 0 (0.0) 0 (0.0) 4 (1.8) 2 (0.9) study eye, n

  18. Slide 18: Choroidal Neovascularization (CNV)

    18 CHOROIDAL NEOVASCULARIZATION (CNV) Year 11 Year 2 Total IZERVAY 2 mg IZERVAY 2 mg IZERVAY 2 mg Sham Sham IZERVAY 2 mg Sham EM EOM (N=225) (N=222) (n=203) (N=225) (N=222) (n=96) (n=93) CNV in study eye, n (%) 15 (6.7) 9 (4.1) 7 (7.3) 4 (4.3) 11 (5.4) 26 (11.6) 20 (9.0) Incidence of CNV in year 2 w

  19. Slide 19: Adverse Events of Special Interest

    19 ADVERSE EVENTS OF SPECIAL INTEREST Year 11 Year 2 Total IZERVAY 2 mg IZERVAY 2 mg IZERVAY 2 mg Sham Sham IZERVAY 2 mg Sham EM EOM (N=225) (N=222) (n=203) (N=225) (N=222) (n=96) (n=93) Intraocular 0 0 1 (1.0) 0 0 1 (0.4) 0 inflammation Endophthalmitis 0 0 1 (1.0)a 0 0 1 (0.4)a 0 Ischemic optic 0 0

  20. Slide 20: Summary of GATHER2: 2-Year Data

    20 SUMMARY OF GATHER2: 2-YEAR DATA Both monthly (EM) and every other month (EOM) IZERVAY reduced GA growth vs sham Treatment effect more than doubled over 2 years compared to 1 year for IZERVAY IZERVAY was well tolerated: over 2 years, there was 1 case of non-serious IOI, 1 case of culture- positive

  21. Slide 21: Lifecycle Management Update

    21 LIFECYCLE MANAGEMENT UPDATE GATHER2 LABEL EMA Ongoing open- Anticipate FDA The Marketing label study filing submission Authorization capturing long- for label update on Application for term safety data treatment duration ACP was and regimen in Q4 accepted on FY2023 17 Aug 2023 FDA, Food and Drug

  22. Slide 22: Q&A

    Wastellas Q&A ee

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