Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — FY2022 Earnings Presentation
44 slides from Kyowa Kirin's earnings presentation, February 2023
Slide 1: Results Presentation Fiscal 2022
Results Presentation Fiscal 2022
Slide 2: Agenda
Agenda 2021-2025 Medium Term Business Plan - FY2022 Review, FY2023 Plans, Financial KPI progress - Shareholders Return Commercial Update R&D Update Q&A President and Chief Executive Officer Masashi Miyamoto, Ph.D. Managing Executive Officer, Head of Finance Motohiko Kawaguchi Executive Officer, Vice
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
Slide 4: 2021-2025 Medium Term Business Plan - FY2022 Review
2021-2025 Medium Term Business Plan - FY2022 Review - © Kyowa Kirin Co., Ltd. 4
Slide 5: Qualitative Review for FY2022
Qualitative Review for FY2022 Provide pharmaceuticals for unmet medical needs Address patient-centric healthcare needs ◼ Maximize the value of G3B ◼ Patient Advocacy ✓ Crysvita：Revenue reached 127.1 billion yen in five years after launch; ✓ Established the Kyowa Kirin Group Policy for Access to Medi
Slide 6: Quantitative Summary of FY22 Results
Quantitative Summary of FY22 Results ( Billion Yen / Rounded ) FY2021 FY2022 FY2022 Changes Achieved Results Results Revised Plans Revenue 352.2 398.4 +46.1 (+13%) 400.0 100% [Overseas Ratio] [54%] [61%] [62%] Gross Profit 264.4 311.5 +47.1 (+18%) 312.0 100% [Gross Profit Margin] [75%] [78%] [78%] S
Slide 7: FY21 vs FY22 -Revenue-
FY21 vs FY22 -Revenue- ⚫ Japan -8.2 Although Duvroq, Romiplate, Crysvita, and G-Lasta increased, revenue in Japan region decreased by 5% due mainly to negative impact by NHI price-cut in April 2021 & April 2022, +46.1 billion yen and shrink in Patanol, which was affected by generic products entered
Slide 8: FY21 vs FY22 -Revenue of Major Items in Japan-
FY21 vs FY22 -Revenue of Major Items in Japan- ( Billion Yen / Rounded ) FY2021 FY2022 FY2022 Item Changes Reasons Achieved Results Results Rev. Plans Nesp + Nesp-AG1 26.3 21.1 -5.2 (-35%) 20.7 102% NHI price-cut & Nesp 4.0 3.4 -0.5 (-14%) 3.3 104% Biosimilars’ penetration Nesp-AG 22.3 17.6 -4.7 (-2
Slide 9: FY21 vs FY22 -Revenue of Major Items outside Japan-
FY21 vs FY22 -Revenue of Major Items outside Japan- ( Billion Yen / Rounded ) FY2021 FY2022 FY2022 Item Changes Reasons Achieved Results Results Rev. Plans Crysvita 78.3 118.2 +39.9 (+51%) 116.2 102% North America 57.7 87.0 +29.3 (+51%) [North America] Market penetration [EMEA] Geographical expansio
Slide 10: FY21 vs FY22 -Core OP-
FY21 vs FY22 -Core OP- +21.0 billion yen ⚫ Gross Profit +47.1 (incl. forex effect +27.5) Increased in conjunction with the 46.1 rise in revenue. Margin improved by 3% (75% (incl. forex effect +11.0) →78%) due mainly to increased proportion of profitable “Global 3 brands” and tech- licensing revenue.
Slide 11: FY21 vs FY22 -Profit-
FY21 vs FY22 -Profit- Profit (Jan-Dec) +1.2 billion yen • Impairment losses -12.7 +47.1 -25.8 [FY21] 5.3 (incl. Haruropi sales rights 4.2) 100 [FY22] 18.0 (incl. ME-401 IPR&D 14.3, irofotase alfa IPR&D 3.2) • Business restructuring expenses -2.3 • Foreign exchange gain/losses +3.1 80 -0.3 -13.5 60 -
Slide 12: 2021-2025 Medium Term Business Plan - FY2023 Plans
2021-2025 Medium Term Business Plan - FY2023 Plans - © Kyowa Kirin Co., Ltd. 12
Slide 13: Qualitative Plans for 2023
Qualitative Plans for 2023 Provide pharmaceuticals for unmet medical needs Address patient-centric healthcare needs ◼ Maximize the value of G3B ◼ Patient advocacy ✓ Initiate own sales of Crysvita in North America ✓ Standardize patient advocacy activities in the global development process ✓ Further g
Slide 14: Strategic Investment
Strategic Investment ～For successful creation and delivery of life-changing value Licensing-in and M&A investments to strengthen the portfolio ● Development pipeline with synergies with Crysvita 2021-2025 Cash Allocation* and Poteligeo ◆Bone, Mineral ◆Hematologic oncology ● Implementing the strength
Slide 15: Quantitative Summary of FY23 Plans
Quantitative Summary of FY23 Plans ( Billion Yen / Rounded ) FY2021 FY2022 FY2023 Changes Results Results Plans Revenue 352.2 398.4 426.0 +27.6 (+7%) [Overseas Ratio] [54%] [61%] [64%] Gross Profit 264.4 311.5 326.0 +14.5 (+5%) [Gross Profit Margin] [75%] [78%] [77%] SG&A 145.6 166.2 162.0 -4.2 (-3%
Slide 16: FY22 vs FY23 -Revenue of Major Items in Japan-
FY22 vs FY23 -Revenue of Major Items in Japan- ( Billion Yen / Rounded ) FY2021 FY2022 FY2023 Item Changes Reasons Results Results Plans Nesp + Nesp-AG1 26.3 21.1 16.6 -4.5 (-21%) NHI price-cut & Nesp 4.0 3.4 2.8 -0.6 (-18%) Biosimilars’ penetration Nesp-AG 22.3 17.6 13.8 -3.8 (-22%) Duvroq 2.6 6.6
Slide 17: FY22 vs FY23 -Revenue of Major Items outside Japan-
FY22 vs FY23 -Revenue of Major Items outside Japan- ( Billion Yen / Rounded ) FY2021 FY2022 FY2023 Item Changes Reasons Results Results Plans Crysvita 78.3 118.2 138.0 +19.8 (+17%) North America 57.7 87.0 [North America] Market penetration [EMEA] Geographical expansion EMEA 20.6 31.0 & Additional in
Slide 18: FY2022 vs FY2023 -Core OP-
FY2022 vs FY2023 -Core OP- ⚫ Gross Profit +14.5 While gross profit will grow with the 27.6 rise in revenue (Japan-3.1, North America +19.9, EMEA-0.8, APAC+4.4, Other+7.3), COGs will also increase due to the Crysvita-related +1.3 billion yen scheme change from ‘Profit-sharing (SG&A)’ to ‘Sales royalt
Slide 19: P/L Impact on North American Crysvita Business
P/L Impact on North American Crysvita Business Based on the Collaboration and License Agreement in 2013, Kyowa Kirin takes over the field activities in North America from Ultragenyx, starting from April 27, 2023 (6th year from launch). FY2022 FY2023 FY2023 FY2024 FY2024 JAN 1 – APR 26 APR 27 – DEC 3
Slide 20: FY2022 vs FY2023 -Profit-
FY2022 vs FY2023 -Profit- Revenue +27.6 • Japan -3.1 (NHI price-cut) • North America +19.9 (Growth of G3B) • EMEA -0.8 (Growth of G3B and Exclusion of Established Medicine business) • APAC +4.4 (Growth of G3B & existing products) Profit (Jan-Dec) +22.4 billion yen • Other +7.3 (Growth of Fasenra and
Slide 21: 2021-2025 Medium Term Business Plan - Financial KPI Progress
2021-2025 Medium Term Business Plan - Financial KPI Progress - © Kyowa Kirin Co., Ltd. 21
Slide 22: Progresses of Financial KPIs (Numerical Guidance)
2021-2025 Medium Term Business Plan Progresses of Financial KPIs (Numerical Guidance) © Kyowa Kirin Co., Ltd. 22
Slide 23: Shareholders Return
Shareholders Return © Kyowa Kirin Co., Ltd. 23
Slide 24: Shareholders Return
Shareholders Return ✓ FY22 dividend is 51 yen, and FY23 to be 54 yen (plan) ✓ Plans 7-year consecutive rises since FY17 ✓ FY21-23 weighted average payout ratio is 40.5% (plan) (Mid-term guidance for payout ratio “Targeting sustained dividend hikes with 40%”) Dividend (yen) Payout Return on Year ¥54
Slide 25: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 25
Slide 26: 2022 Review & 2023 Key Actions (Crysvita)
2022 Review & 2023 Key Actions 2022 Review 2023 Key Actions ⚫ Sales revenue reached JPY 127.1 bn. ⚫ North America: ⚫ North America: Start own sales (Establish and start own operation of the direct sales force). Amended the contract with Ultragenyx for smooth transition. ⚫ EMEA: Disease awareness act
Slide 27: 2022 Review & 2023 Key Actions
2022 Review & 2023 Key Actions 2022 Review Sales Revenue 29.6 Launched Countries ⚫ North America/EMEA: (Billion Yen) / Regions 2.0 Increase product perception and sustain growth by evidence-led 24.2 promotional activities focused on patients with blood tumor. 24 2.0 ⚫ EMEA: Launched countries/region
Slide 28: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 28
Slide 29: Upcoming Events: Main Development Pipeline Products
Upcoming Events: Main Development Pipeline Products Month Completed Code Event (Completed is in bold) Generic Name Time Expected KHK4083/AMG 451 Atopic Dermatitis P3 Initiation Dec. 2022 rocatinlimab KHK4951 nAMD P1 LPO Aug. 2022 tivozanib P2 Initiation H2 2023 ME-401 iB-NHL (mono, 3L+) P2 topline d
Slide 30: Rocatinlimab Phase 3 Program
Rocatinlimab Phase 3 PROGRAM W0 W24 Dose 1 Q4W* Dose 2 Q4W* Adult, mono Placebo Q4W* • Another study will be conducted to Dose 1 Q4W* evaluate the safety and efficacy of long- Adult, mono Placebo Q4W* term administration in adults and Dose 1 Q4W* adolescents Dose 2 Q4W* • Interim analysis from long
Slide 31: Main Development Pipeline Products
Main Development Pipeline Products Planned Approval Total addressable Diseases under development*1 Development status No. of Patients*4 Year*2 market*3 KHK4083/ Moderate and severe AMG 451 2026/2027 Ph3 (Global) ★★★★★ 16M Atopic Dermatitis rocatinlimab KHK4951 Neovascular (wet) age-related Preparing
Slide 32: News Flow in 2022
News Flow in 2022 © Kyowa Kirin Co., Ltd. 32
Slide 33: Year-to-date Key News Flow ①
Year-to-date Key News Flow ① AS of February 7, 2023 Category Date Headline ESG Jan 11 Introduction of renewable energy “Aqua Premium” for Fuji Research Park and CMC R&D Center LCM Jan 31 NDA submission of Topical Ophthalmic Mitomycin C agent (Japan) LCM Feb 25 Approval for partial change of approved
Slide 34: Year-to-date Key News Flow ②
Year-to-date Key News Flow ② AS of February 7, 2023 Category Date Headline R&D Jun 5 New clinical data on Zandelisib (American Society of Clinical Oncology Annual Meeting 2022) R&D Jun 10 Clinical data on Zandelisib (European Hematology Association 2022 Hybrid Congress) LCM Jun 27 Positive CHMP opin
Slide 35: Year-to-date Key News Flow ③
Year-to-date Key News Flow ③ AS of February 7, 2023 Category Date Headline LCM Oct 17 Application for partial change of approved indication of Lumicef for Palmoplantar Pustulosis (Japan) R&D Oct 20 Data from Phase 3 clinical study of Tenapanor Hydrochloride (KHK7791) for hemodialysis patients on dia
Slide 36: Year-to-date Key News Flow ④
Year-to-date Key News Flow ④ AS of February 7, 2023 Category Date Headline R&D Dec 6 Discontinuation of Zandelisib joint development with MEI Pharma outside of Japan, and impairment losses recorded LCM Dec 6 Launch of “G-Lasta Subcutaneous Injection 3.6 mg BodyPod” (Japan) R&D Dec 13 Lancet publicat
Slide 37: Appendix
Appendix © Kyowa Kirin Co., Ltd. 37
Slide 38: FOREX Information
FOREX Information Average FOREX Rates (yen) FY2021 FY2022 Changes FY2023 Plans USD 109 130 +21 130 GBP 150 161 +11 160 EUR 130 137 +7 135 FY22 FOREX Impacts (vs FY21, billion yen) Revenue Core OP USD +22.1 +8.2 GBP +4.6 +1.2 FY23 FOREX Sensitivities (vs FY23 Plan, billion yen) Changes Revenue Core O
Slide 39: Crysvita - Collaboration with Ultragenyx
Crysvita ‐ Collaboration with Ultragenyx ‐ Economic Terms • Kyowa Kirin books sales • 50/50 profit share for 5 years from the U.S. launch US & Canada ⁃ Supply price: 35% of net sales through 2022, 30% thereafter (No impact on the sales royalties stated below) • After 5 years (April 27, 2023-), Kyowa
Slide 40: 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 •
Slide 41: Main Development Pipeline Products: Future Plans
Main Development Pipeline Products: Future Plans As of 2023, February 7th T : Topline data Code Target Disease 2022 2023 2024 ＋ Generic Name P3 IGNITE KHK4083/ P3 HORIZON AMG 451 Atopic dermatitis P3 “ROCKET PROGRAM” SHUTTLE rocatinlimab P3 ASTRO P3 ORBIT KHK4951 Neovascular age-related P1 tivozanib
Slide 42: Estimated Patient Numbers
Estimated Patient Numbers Disease Country/ Incidence Prevalence* Reference Region ATL JP 1,150 / y Survey and countermeasures to HTLV-1 infection and related diseases in Japan. 2009 summary research report (Yamaguchi, 2010) PTCL JP 2,000 Ministry of Health, Labour and Welfare: 2017 Patient survey (i
Slide 43: List of Acronyms
List of Acronyms AD Atopic Dermatitis ADPKD Autosomal Dominant Polycystic Kidney Disease AG Authorized Generic AP, APAC Asia-Pacific AS Alport Syndrome ATL Adult T-Cell Leukemia/Lymphoma BS Biosimilar CKD Chronic Kidney Disease CLL Chronic Lymphocytic Leukemia DKD Diabetic Kidney Disease EMEA Europe
Slide 44: Kyowa Kirin Co., Ltd. Corporate Communications Dept., IR Group
Kyowa Kirin Co., Ltd. Corporate Communications Dept., IR Group +81-3-5205-7206 / ir@kyowakirin.com