Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Q3 2024 Earnings Presentation

42 slides from Kyowa Kirin's earnings presentation, 2024

  1. Slide 1: Results Presentation Fiscal 2024 Third Quarter

    Results Presentation Fiscal 2024 Third Quarter

  2. Slide 2: Agenda

    Agenda Financial Review Managing Executive Officer, Chief Financial Officer (CFO) Motohiko Kawaguchi Commercial Update Managing Executive Officer, Chief Strategy Officer (CSO) Yasuo Fujii R&D Update Senior Managing Executive officer, Chief Medical Officer (CMO) Takeyoshi Yamashita, Ph.D. News Flow i

  3. Slide 3: Forward-looking statements disclaimer

    This document contains certain forward-looking statements relating to such items as the company’s (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the present time and upon reasona

  4. Slide 4: Financial Review

    Financial Review © Kyowa Kirin Co., Ltd. 4

  5. Slide 5: Summary of Q3 Results

    Summary of Q3 Results ( Billion Yen / Rounded ) 2023Q3 2024Q3 FY2024 Progress Changes Results Results Rev. Plans to goal Revenue 306.1 362.8 +56.7 (+19%) 492.0 74% [Overseas Ratio] [64%] [72%] [71%] Gross Profit 229.1 268.8 +39.7 (+17%) 364.0 74% [Gross Profit Margin] [75%] [74%] [74%] SG&A 119.3 12

  6. Slide 6: YoY Analysis -Revenue-

    YoY Analysis -Revenue- ⚫ Japan -8.9 Although Phozevel, Duvroq and Crysvita increased, revenue in Japan region decreased by 8% due mainly to negative impact by annual NHI price-cut and shrink in G-Lasta affected by +56.7 billion yen competitive products. (incl. forex effect +23.3) ⚫ North America +27

  7. Slide 7: Revenue of Major Items (Japan)

    Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2023Q3 2024Q3 2024 Progress Item Changes Reasons Results Results Rev. Plans* to goal Crysvita 7.4 8.2 +0.8 (+11%) Market penetration (Launched in Dec 2019) 12.9 63% Poteligeo 1.4 1.4 -0.1 (-4%) 1.9 72% Nesp + Nesp-AG1 12.7 10.4 -2.2 (-17%) 14.

  8. Slide 8: Revenue of Major Items (ex-Japan)

    Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2023Q3 2024Q3 2024 Progress Item Changes Reasons Results Results Rev. Plans to goal Crysvita 95.7 126.7 +31.0 (+32%) 187.8 67% North America 70.2 87.2 +17.1 (+24%) Market penetration EMEA 24.5 37.1 +12.7 (+52%) APAC 1.1 2.3 +1.2 (+117%) Pot

  9. Slide 9: YoY Analysis -Core OP-

    YoY Analysis -Core OP- +13.5 billion yen ⚫ Gross Profit +39.7 (incl. forex effect +20.3) (incl. forex effect +8.4) Increased in conjunction with JPY 56.7B rise in revenue. COGs have increased due to the North America Crysvita Sales royalty after Apr 27, 2023. Hence, gross profit % declined YoY. (75%

  10. Slide 10: YoY Analysis -Profit-

    YoY Analysis -Profit- Profit (Jan-Sep) +2.3 billion yen Core Operating Profit +13.5 Profit Before Tax +7.2 ⚫ Finance/Other -6.3 • EMEA established medicines portfolio: Gain on sales of 51% shares plus gain on valuation of remaining 49% shares -14.8 (14.8 → 0) • Gain on Equity transfer for KKCN (Chin

  11. Slide 11: Commercial Update

    Commercial Update © Kyowa Kirin Co., Ltd. 11

  12. Slide 12: 2024 Key Actions & Q3 Topics (Crysvita)

    2024 Key Actions & Q3 Topics Q3 Topics 2024 Key Actions ⚫ Strengthen evidence-based marketing activities. ⚫ Strengthen evidence-based marketing activities. ⚫ North America ⚫ North America: ・Although sales revenue decreased from the previous quarter due to the inventory adjustment, Enhance disease aw

  13. Slide 13: 2024 Key Actions & Q3 Topics (Poteligeo)

    2024 Key Actions & Q3 Topics Q3 Topics 2024 Key Action ⚫ NA : Sales revenue increased 44% year-on-year YTD due to: ⚫ Deeper penetration into the existing markets as well as expansion of targets through • Continue to expand evidence-based promotional activities to focus not only on cases with further

  14. Slide 14: R&D Update

    R&D Update © Kyowa Kirin Co., Ltd. 14

  15. Slide 15: News Flow of Main Development Pipeline Products

    News Flow of Main Development Pipeline Products As of Oct. 31, 2024 Code Timeline Generic Name Events (Completed are in bold) (Completed are in orange) P3 (ROCKET Program) In progress Atopic Dermatitis KHK4083/AMG 451 HORIZON Topline Data Sep 2024 rocatinlimab Asthma P2 In progress Prurigo nodularis

  16. Slide 16: News Flow in 2024

    News Flow in 2024 © Kyowa Kirin Co., Ltd. 16

  17. Slide 17: Year-to-date Key News Flow

    Year-to-date Key News Flow As of Oct 31, 2024 Category Date Headline SP Jan 5 Out-licensed the exclusive and worldwide rights to Boehringer Ingelheim of developing first-in-class treatment for fibro-inflammatory diseases. SI Jan 24 Completion of share acquisition of Orchard Therapeutics plc, UK biop

  18. Slide 18: Year-to-date Key News Flow

    Year-to-date Key News Flow As of Oct 31, 2024 Category Date Headline ESG May 14 Announced the Publication of a Patient-focused Global Consensus Statement for Improving Diagnosis and Care in Cutaneous T-Cell Lymphoma ( Kyowa Kirin, Inc. ) LCM May 17 Approval for Partial Change of Approved Indication

  19. Slide 19: Year-to-date Key News Flow

    Year-to-date Key News Flow As of Oct 31, 2024 Category Date Headline MKT Sep 19 Presented new research on the real-world experiences of people living with XLH and the impact of Crysvita treatment at American Society for Bone and Mineral Research (ASBMR) 2024 annual meeting R&D Sep 25 Announced Top-l

  20. Slide 20: Changes of Representative Director

    Changes of Representative Director Kyowa Kirin agreed on changes of its Representative Directors. The changes will be formally approved at the Ordinary General Meeting of Shareholders and the Board of Directors meeting to be held on March 2025. ~Reason for change (Abstracts)~ Kyowa Kirin will step i

  21. Slide 21: P/L Impact on EMEA established medicines portfolio (updated Q3 2024)

    P/L Impact on EMEA established medicines portfolio (updated Q3 2024) Before After 2024 2025 2026 Aug 2023 Aug 2023 unrealized 49% of the transfer value £ 66.4M(JPY13.1B) Tostran until Oct 3 brands 1 brand Product sales IP transfer IP transfer Established portfolio Revenue 13 brands Sales Royalties &

  22. Slide 22: P/L Impact on Restructuring of APAC business

    P/L Impact on Restructuring of APAC business Country / region Until September 2024 October 2024 onwards Divest CN Sales to Partner (Established medicines portfolio) Partnering CN/HK/MO/ Revenue (Established medicines portfolio & Global MY/SG/TH Sales to market Sales to Partner products） /KR/TW In ad

  23. Slide 23: Appendix

    Appendix © Kyowa Kirin Co., Ltd. 23

  24. Slide 24: Our Vision toward 2030

    Our Vision toward 2030 Provide pharmaceuticals for unmet medical needs We are focused on developing medicines for diseases where there is a Our Vision toward 2030 clear patient need for new options. We make full use of multiple therapeutic modalities, including biotechnology Kyowa Kirin will realize

  25. Slide 25: Story for Vision 2030

    Story for Vision 2030 Strategies for creating and delivering life-changing value Disease Science Value Global deployment of delivery on products developed by Focus disease areas: bone & mineral, intractable taking full advantage of our own hematological diseases/hemato oncology, and rare diseases th

  26. Slide 26: 2021-2025 Medium Term Business Plan - Revision of Financial KPI

    2021-2025 Medium Term Business Plan - Revision of Financial KPI - ◼ Record high in Core operating profit for FY2023. Achieved KPIs such as “ROE of 10%” and “CAGR of 10% or higher” ◼ Due to the restructuring of our business model to adapt to environmental changes, the continuous achievement timing of

  27. Slide 27: Accounting treatment of share acquisition of Orchard Therapeutics (Finalized)

    Accounting treatment of share acquisition of Orchard Therapeutics (Finalized) ✓ Completed the share acquisition on January 24, 2024, and started consolidation from the February 2024 ✓ Recognized intangible assets of $208M (JPY 30.8B) and goodwill of $230M (JPY 34.1B) ✓ Intangible assets will be amor

  28. Slide 28: Main Development Pipeline Products (After Ph2)

    Main Development Pipeline Products (After Ph2) As of Oct. 31, 2024 Planned Approval Total addressable Diseases under development*1 Development status No. of Patients*4 Year*2 market*3 Moderate to severe 2026/2027 P3 (Global) ★★★★★ 16M Atopic Dermatitis KHK4083/AMG 451 Prurigo nodularis TBD P3 (Globa

  29. Slide 29: Main Development Pipeline Products (nonclinical ~ Ph1)

    Main Development Pipeline Products (nonclinical ~ Ph1) As of Oct. 31, 2024 Diseases under development*1 Development status Modality, technology KK4277 SLE, CLE P1 (JP) Antibody, POTELLIGENT® Advanced or metastatic solid P1 (JP: in progress, US: in KK2260 Antibody, REGULGENTTM tumors preparation) Adv

  30. Slide 30: Main Development Pipeline Products: Future plans

    Main Development Pipeline Products: Future plans As of Oct. 31, 2024 Code Generic Name Target Disease 2024 2025 2026 ＋ P3 IGNITE P3 HORIZON P3 SHUTTLE Moderate to severe P3 ASTRO KHK4083/ atopic dermatitis P3 ORBIT AMG 451 P3 VOYAGER rocatinlimab P3 ASCEND P3 OUTPOST Prurigo nodularis P3 Moderate to

  31. Slide 31: ROCKET HORIZON Study design

    ROCKET HORIZON Study design Monotherapy Treatment (24 Weeks) 20210146 N = 543 Rocatinlimab Dose 1 Q4W Long-term Randomization + loading dose at W2 Maintenance Trial Screening N = 726 (3:1) N = 183 Placebo Q4W + loading dose at W2 Safety Follow-Up Week 0 Week 2 Week 24 (Baseline) (Loading Dose) (Prim

  32. Slide 32: ROCKET HORIZON: Summary of Results

    ROCKET HORIZON: Summary of Results ◼ Co-primary endpoints were achieved ⚫ vIGA-ADTM 0/11 with a ≥ 2-point reduction from baseline: Ex-US rocatinlimab 19.3% vs. Placebo 6.6% (12.8% difference, p<0.001) ⚫ EASI-752： Ex-US For US rocatinlimab 32.8% vs. Placebo 13.7% (19.1% difference, p<0.001) ⚫ rIGA 0/

  33. Slide 33: Critical Role of OX40 Signaling in T-Cell Driven Inflammation and AD Pathogenesis

    Critical Role of OX40 Signaling in Orchestrating T-Cell Driven Inflammation and AD Pathogenesis Langerhans cells are activated From 2023 AAD annual Meeting 2023 upon encounter with antigens 17-21 March 2023 that penetrate skin and express OX40L1-3 • Inflammation • Epidermal dysfunction Following TCR

  34. Slide 34: OX40 Signaling induces T-cell imbalance

    OX40 Signaling induces T-cell imbalance From 2023 AAD annual Meeting 2023 17-21 March 2023 (Modified) TH2 cell : Cytokines OX40L Resting T cell MHC OX40 (OX40- T cell) receptor expression TCR Naïve T cell Effector Memory T cell - Amplification of pathogenic T cell number and activity > through OX40

  35. Slide 35: Rocatinlimab Rebalances T-cells by Targeting OX40 Receptor

    Rocatinlimab Rebalances T-cells by Targeting OX40 Receptor • T-cell imbalance is a root cause of inflammatory disease • Atopic dermatitis is driven in part by the proliferation of pathogenic T-cells • Rocatinlimab has the potential to inhibit and reduce pathogenic T-cells across heterogeneous patien

  36. Slide 36: Rocatinlimab: Phase 2b data

    Rocatinlimab: Phase 2b data1 The Least-squares (LS) mean percent change in Eczema Area and Severity Index (EASI) score Week 16 Week 24 Week 36 Week 56 Rocatinlimab 150 mg Q4W, % -62.2 -68.3 -78.7 -75.0 Rocatinlimab 600 mg Q4W, % -59.5 -73.4 -82.3 -79.5 Rocatinlimab 300 mg Q2W, % -73.6 -81.6 -88.1 -8

  37. Slide 37: Libmeldy (OTL-200, atidarsagene autotemcel)

    Libmeldy® (OTL-200, atidarsagene autotemcel) ◼ MLD (Metachromatic Leukodystrophy) ⚫ Fatal genetic CNS disorder ⚫ Rapid and irreversible loss of motor and cognitive function ⚫ In its most severe form, most children pass away within five years of symptom onset1 Ref.) Orchard Therapeutics plc, Q2 2023

  38. Slide 38: FOREX Information

    FOREX Information Average FOREX Rates (yen) 2023Q3 2024Q3 Changes 2024 Rev. Plans USD 137 151 +14 151 GBP 170 193 +23 191 EUR 148 164 +16 163 Q1 YoY FOREX Impacts (billion yen) Revenue Core OP USD +14.2 +4.7 GBP +2.3 +0.2 EUR +3.8 +2.1 FY2024 FOREX Sensitivities (based on 2024 Plans, billion yen) Ch

  39. Slide 39: KHK4083/AMG 451 - Collaboration with Amgen

    KHK4083/AMG 451 ‐ Collaboration with Amgen ‐ US Europe & Asia (ex. JP) JP • Amgen leads development • Amgen leads development Development • Kyowa Kirin leads development • Share development cost • Share development cost • Amgen commercializes and • Amgen commercializes and books sales books sales •

  40. Slide 40: Estimated Patient Numbers

    Estimated Patient Numbers Disease Country/ Incidence Prevalence* Reference Region Survey and countermeasures to HTLV-1 infection and related diseases in Japan. 2009 summary research report (Yamaguchi, ATL JP 1,150 / y 2010) PTCL JP 2,000 Ministry of Health, Labour and Welfare: 2017 Patient survey (i

  41. Slide 41: List of Acronyms

    List of Acronyms AD Atopic Dermatitis AG Authorized Generic APAC Asia-Pacific AML Acute Myeloid Leukemia BS Biosimilar CTCL cutaneous T cell lymphoma DME Diabetic Macular Edema EMEA Europe, the Middle East and Africa JP Japan LCM Lifecycle Management MDS Myelodysplastic syndromes MF Mycosis fungoide

  42. Slide 42: Kyowa Kirin Co., Ltd. Corporate Communications Department

    Kyowa Kirin Co., Ltd. Corporate Communications Department +81-3-5205-7206 / ir@kyowakirin.com

Kyowa Kirin — Q3 2024 Earnings Presentation on 6ix