Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q2 2023 Earnings Presentation
32 slides from Kyowa Kirin's earnings presentation, August 2023
Slide 1: Results Presentation Fiscal 2023 Second Quarter
Results Presentation Fiscal 2023 Second Quarter
Slide 2: Agenda
Agenda Financial Review Commercial Update R&D Update News Flow in 2023 President and Chief Executive Officer Masashi Miyamoto, Ph.D. Q&A President and Chief Executive Officer Masashi Miyamoto, Ph.D. Managing Executive Officer, Head of Finance Motohiko Kawaguchi Executive Officer, Head of R&D Yoshifu
Slide 3: Forward-looking statements
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 Q2 Results
Summary of Q2 Results ( Billion Yen / Rounded ) 2022Q2 2023Q2 2023 Changes Progresses Results Results Revised Plans Revenue 185.3 199.2 +13.9 (+8%) 426.0 47% [Overseas Ratio] [59%] [63%] [64%] Gross Profit 141.9 152.2 +10.3 (+7%) 326.0 47% [Gross Profit Margin] [77%] [76%] [77%] SG&A 76.4 82.4 +6.0
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -1.9 Although Duvroq, Romiplate, and Crysvita increased, revenue in Japan region decreased by 3% due mainly to negative impact by annual NHI price-cut and shrink in Nesp-AG and +13.9 billion yen Allelock affected by competitive products. (incl. forex effect +9.8) ⚫ Nor
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2022Q2 2023Q2 2023 Item Changes Reasons Progresses Results Results Plans Nesp + Nesp-AG1 10.5 8.4 -2.1 (-20%) 16.6 50% NHI price-cut & Nesp 1.6 1.5 -1.5 (-8%) 2.8 54% Biosimilars’ penetration Nesp-AG 8.8 6.9 -2.2 (-22%) 13.8 50% Duvroq 2.7 4.2
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2022Q2 2023Q2 2023 Item Changes Reasons Progresses Results Results Plans Crysvita 49.4 61.9 +12.5 (+25%) 138.0 45% North America 35.9 46.0 +10.2 (+28%) [North America] Market penetration [EMEA] Geographical expansion & Additional indication
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- ⚫ Gross Profit +10.3 (incl. forex effect +9.0) -2.4 billion yen Increased in conjunction with JPY13.9B rise in revenue. Margin % remains at the same level (76.6% → 76.4%) thanks to increased proportion of profitable “Global 3 brands” and (incl. forex effect +3.2) tech-licensin
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Jun) -13.4 billion yen • Impairment losses +9.4 [RTA 402 IPR&D -8.3, Expiration of research collaboration with Ardelyx -1.1] • Foreign exchange gain -2.4 (4.4 → 2.0) • Provision for loss on contracts -2.3 (closing costs: RTA 402 -1.5, ME-401 -0.9) • Business restruc
Slide 11: Commercial Update
Commercial Update Coordinated Actions to Maximize the Patient Access to G3B © Kyowa Kirin Co., Ltd. 11
Slide 12: 2023 Key Actions & Q2 Topics (Crysvita)
2023 Key Actions & Q2 Topics Q2 Topics 2023 Key Actions ⚫ North America: ⚫ North America: ・Own sales operation has made smooth start with the establishment of solid base for it. Start own sales (Establish and start own operation of the direct sales force). ・The seasonal factor has been resolved, and
Slide 13: 2023 Key Actions & Q2 Topics (Poteligeo)
2023 Key Actions & Q2 Topics Sales Revenue (Billion Yen) 2023 Key Actions 8.0 ⚫ Strengthen promotional activities utilizing evidences including blood tumor data. 7.0 ⚫ Raise awareness of importance of blood testing among early-stage patients 6.0 Q2 Topics 5.0 North 4.6 5.1 America ⚫ North America: S
Slide 14: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 14
Slide 15: Upcoming Events: Main Development Pipeline Products
Upcoming Events: Main Development Pipeline Products As of August 3, 2023 Code Events (Completed are in bold) Timeline Generic Name (Completed are in orange) KHK4083/AMG 451 Atopic Dermatitis P3 (ROCKET PROGRAM) In progress rocatinlimab Asthma P2 TBD KHK4951 nAMD P1 data presentation Q4 2023 tivozani
Slide 16: Rocatinlimab Phase 3 Program Overview
Rocatinlimab Phase 3 Program Overview ROCKET is a comprehensive phase 3 development program designed to evaluate the efficacy, safety, and tolerability of rocatinlimab (monotherapy or combination therapy) in adult and adolescent patients with moderate-to-severe AD Trial Duration 24 weeks 24 weeks 24
Slide 17: Critical Role of OX40 Signaling in 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
Slide 18: Rocatinlimab is an investigational anti-OX40 monoclonal antibody
Rocatinlimab is an investigational anti-OX40 monoclonal antibody that targets the underlying AD pathogenesis1–3 From 25th WCD Congress 3-8 July 2023 Rocatinlimab 1 2 OX40 is a co-stimulatory molecule OX40 expressed on Th2 cells, as well as other Pathogenic T cell T-cell subsets (Th1, Th17, Th22) tha
Slide 19: 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
Slide 20: News Flow in 2023
News Flow in 2023 © Kyowa Kirin Co., Ltd. 20
Slide 21: Year-to-date Key News Flow
Year-to-date Key News Flow Category Date Headline As of August 3, 2023 ESG Mar 8 Kyowa Kirin Selected for a “Health & Productivity Stock” and awarded as a “Certified Health & Productivity Management Outstanding Organization”(White 500) (Japan) R&D Mar 17 Presented New data from Phase 2b clinical stu
Slide 22: Appendix
Appendix © Kyowa Kirin Co., Ltd. 22
Slide 23: 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 24: 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 25: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of August 3, 2023 T : Topline data D : Detailed data Code Target Disease 2023 2024 2025 ＋ Generic Name P3 IGNITE P3 HORIZON P3 SHUTTLE KHK4083/ Atopic dermatitis P3 ASTRO AMG 451 rocatinlimab P3 ORBIT P3 VOYAGER P3 ASCEND KHK4951 Neovascular age-re
Slide 26: Main Development Pipeline Products
Main Development Pipeline Products Diseases under Planned Total addressable No. of Development status development*1 Approval Year*2 market*3 Patients*4 KHK4083/ Moderate and severe AMG 451 2026/2027 Ph3 (Global) ★★★★★ 16M Atopic Dermatitis rocatinlimab Neovascular (wet) age- KHK4951 Preparing for Ph
Slide 27: FOREX Information
FOREX Information Average FOREX Rates (yen) 2022Q2 2023Q2 Changes 2023 Plans USD 120 134 +14 130 GBP 158 164 +6 160 EUR 133 144 +11 135 Q2 YoY FOREX Impacts (billion yen) Revenue Core OP USD +7.0 +2.3 GBP +0.2 -0.1 EUR +1.6 +0.7 FY2023 FOREX Sensitivities (based on 2023 Plans, billion yen) Changes R
Slide 28: 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 29: 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 30: 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 31: 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 32: 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