Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q1 2024 Earnings Presentation
29 slides from Kyowa Kirin's earnings presentation, May 2024
Slide 1: Results Presentation Fiscal 2024 First Quarter
Results Presentation Fiscal 2024 First Quarter
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
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: Financial Review
Financial Review © Kyowa Kirin Co., Ltd. 4
Slide 5: Summary of Q1 Results
Summary of Q1 Results ( Billion Yen / Rounded ) 2023Q1 2024Q1 FY2024 Changes Progresses Results Results Plans Revenue 93.5 105.6 +12.0 (+13%) 473.0 22% [Overseas Ratio] [63%] [68%] [70%] Gross Profit 74.6 80.0 +5.4 (+7%) 348.0 23% [Gross Profit Margin] [80%] [76%] [74%] SG&A 41.8 40.2 -1.6 (-4%) 166
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -2.4 Although Duvroq, Phozevel, and Crysvita increased, revenue in Japan region decreased by 7% due mainly to negative impact by annual NHI price-cut and shrink in G-Lasta affected by +12.0 billion yen competitive products. (incl. forex effect +7.3) ⚫ North America +6.
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2023Q1 2024Q1 2024 Item Changes Reasons Progresses Results Results Plans Crysvita 2.3 2.5 +0.2 (+7%) Market penetration (Launched in Dec 2019) 12.9 19% Poteligeo 0.4 0.4 +0.0 (+1%) 1.9 23% Nesp + Nesp-AG1 4.2 3.5 -0.8 (-18%) 14.4 24% NHI price
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2023Q1 2024Q1 2024 Item Changes Reasons Progresses Results Results Plans Crysvita 27.1 35.4 +8.2 (+30%) 175.9 20% North America 18.8 22.8 +4.0 (+21%) [North America] Market penetration [EMEA] Geographical expansion & Additional indication (
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- +0.4 billion yen ⚫ Gross Profit +5.4 (incl. forex effect +6.4) (incl. forex effect +2.1) Increased in conjunction with JPY12.0B rise in revenue. COGs have increased due to the North America Crysvita Sales royalty after Apr 27, 2023. Hence, gross profit % declined YoY. (80% →76
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Mar) +1.9 billion yen Core Operating Profit +0.4 Profit Before Tax +2.5 ⚫ Finance/Other +2.1 • Gain on disposal of fixed assets +2.4 (0 → 2.4) • Impairment losses +0.9 (-1.1 → -0.2) • Provision for loss on contracts +0.6 (-0.6 → - ) • Business restructuring expenses
Slide 11: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 11
Slide 12: 2024 Key Actions & Q1 Topics
2024 Key Actions & Q1 Topics Q1 Topics 2024 Key Actions ⚫ Strengthen evidence-based marketing activities. ⚫ Strengthen evidence-based marketing activities. ⚫ North America ⚫ North America: ・The number of patient enrollments in the treatment preparation stage and treatment Enhance disease awareness a
Slide 13: 2024 Key Actions & Q1 Topics
2024 Key Actions & Q1 Topics 2024 Key Action Q1 Topics ⚫ Deeper penetration into the existing markets as well as expansion of targets through further ⚫ NA : Sales revenue increased by 44% YoY. Patient penetration progression of evidence-based promotional activities. has increased through enhanced cu
Slide 14: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 14
Slide 15: News Flow of Main Development Pipeline Products
News Flow of Main Development Pipeline Products As of May 7, 2024 Code Events (Completed are in bold) Timeline Generic Name (Completed are in orange) Atopic Dermatitis P3（ROCKET Program） In progress KHK4083/AMG 451 rocatinlimab Asthma P2 initiation1 Q2 2024 Prurigo nodularis P3 initiation H2 2024 KH
Slide 16: News Flow in 2024
News Flow in 2024 © Kyowa Kirin Co., Ltd. 16
Slide 17: Year-to-date Key News Flow
Year-to-date Key News Flow Category Date Headline As of May 7, 2024 PP 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 bioph
Slide 18: Appendix
Appendix © Kyowa Kirin Co., Ltd. 18
Slide 19: Accounting treatment of share acquisition of Orchard Therapeutics
Accounting treatment of share acquisition of Orchard Therapeutics (Tentative) ✓ Completed the share acquisition on January 24, 2024, and started consolidation from the February 2024 ✓ Recognized intangible assets of $208M and goodwill of $282M ✓ Intangible assets will be amortized over 20 years (19
Slide 20: Strategic Investment
Strategic Investment ～For successful creation and delivery of life-changing value Licensing-in and M&A investments to strengthen the portfolio 2021-2025 Cash Allocation* ● Priority will be given to the focus disease areas ➢ bone & mineral ➢ intractable hematological diseases/hemato oncology ➢ rare d
Slide 21: Main Development Pipeline Products (After Ph2)
Main Development Pipeline Products (After Ph2) As of May 7, 2024 Planned Approval Total addressable Diseases under development*1 Development status No. of Patients*4 Year*2 market*3 Moderate and severe 2026/2027 P3 (Global) ★★★★★ 16M Atopic Dermatitis KHK4083/AMG 451 Moderate and severe Preparation
Slide 22: Main Development Pipeline Products (nonclinical ~ Ph1)
Main Development Pipeline Products (nonclinical ~ Ph1) As of May 7, 2024 Diseases under development*1 Development status Modality, technology KK4277 SLE, CLE P1 (JP, Asia) Antibody, POTELLIGENT® Advanced or metastatic solid P1 (JP: in progress, US: in KK2260 Antibody, REGULGENTTM tumors preparation)
Slide 23: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of May 7, 2024 T : Topline data D : Detailed data Code Generic Name Target Disease 2024 2025 2026 ＋ P3 IGNITE P3 HORIZON P3 SHUTTLE KHK4083/ Moderate and severe P3 ASTRO AMG 451 Atopic Dermatitis rocatinlimab P3 ORBIT P3 VOYAGER P3 ASCEND P3 OUTPOS
Slide 24: FOREX Information
FOREX Information Average FOREX Rates (yen) 2023Q1 2024Q1 Changes 2024 Plans USD 132 147 +15 140 GBP 161 187 +26 180 EUR 141 160 +19 155 Q1 YoY FOREX Impacts (billion yen) Revenue Core OP USD +4.2 +1.0 GBP +0.4 -0.5 EUR +1.6 +1.0 FY2024 FOREX Sensitivities (based on 2024 Plans, billion yen) Changes
Slide 25: 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 26: 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 27: 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
Slide 28: 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
Slide 29: Kyowa Kirin Co., Ltd. Corporate Communications Department
Kyowa Kirin Co., Ltd. Corporate Communications Department +81-3-5205-7206 / ir@kyowakirin.com