Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q1 2023 Earnings Presentation
33 slides from Kyowa Kirin's earnings presentation, May 2023
Slide 1: Results Presentation Fiscal 2023 First Quarter
Results Presentation Fiscal 2023 First Quarter
Slide 2: Agenda
Agenda Financial Review Managing Executive Officer, Head of Finance Motohiko Kawaguchi Commercial Update Executive Officer, Head of Global Product Strategy Tomohiro Sudo R&D Update Executive Officer, Head of R&D Yoshifumi Torii, Ph.D. News Flow in 2023 Managing Executive Officer, Head of Strategy Ya
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 ) 2022Q1 2023Q1 2023 Changes Progresses Results Results Revised Plans Revenue 87.8 93.5 +5.8 (+7%) 426.0 22% [Overseas Ratio] [58%] [63%] [64%] Gross Profit 65.6 74.6 +9.0 (+14%) 326.0 23% [Gross Profit Margin] [75%] [80%] [77%] SG&A 36.1 41.8 +5.7 (+16%
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -1.4 Although Duvroq, Romiplate, and Crysvita increased, revenue in Japan region decreased by 4% due mainly to negative impact by NHI price-cut in April 2022 and shrink in Nesp-AG and +5.8 billion yen Allelock affected by competitive products. (incl. forex effect +5.6)
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2022Q1 2023Q1 2023 Item Changes Reasons Progresses Results Results Plans Nesp + Nesp-AG1 5.2 4.2 -1.0 (-20%) 16.6 25% NHI price-cut & Nesp 0.8 0.8 -0.1 (-9%) 2.8 27% Biosimilars’ penetration Nesp-AG 4.4 3.5 -1.0 (-22%) 13.8 25% Duvroq 1.1 1.8
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2022Q1 2023Q1 2023 Item Changes Reasons Progresses Results Results Plans Crysvita 22.2 27.1 +4.9 (+22%) 138.0 20% North America 15.8 18.8 +3.0 (+19%) [North America] Market penetration [EMEA] Geographical expansion EMEA 6.3 8.0 +1.7 (+27%)
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- ⚫ Gross Profit +9.0 (incl. forex effect +5.2) -0.4 billion yen Increased in conjunction with JPY5.8B rise in revenue. Margin improved by 5% (75%→80%) due mainly to increased proportion of profitable “Global 3 brands” and tech- (incl. forex effect +1.6) licensing revenue. ⚫ SG&
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Mar) -3.3 billion yen • Impairment losses+1.1 [Expiration of research collaboration with Ardelyx] • Provision for loss on contracts -0.6 • Business restructuring expenses -0.5 • Foreign exchange gain -0.9 Core Operating Profit -0.4 Profit Before Tax -3.1 © Kyowa Kir
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 & Q1 Topics (Crysvita)
2023 Key Actions & Q1 Topics Q1 Topics 2023 Key Actions ⚫ North America: ⚫ North America: ・Establishment of own operation of the direct sales force progressed as planned. Start own sales (Establish and start own operation of the direct sales force). ・The number of patient enrollments in the treatmen
Slide 13: 2023 Key Actions & Q1 Topics (Poteligeo)
2023 Key Actions & Q1 Topics Sales Revenue (Billion Yen) 7.0 2023 Key Actions 6.0 ⚫ Strengthen promotional activities utilizing evidences including blood tumor data. 5.0 ⚫ Raise awareness of importance of blood testing among early-stage patients 4.6 4.0 4.8 4.4 4.3 North America Q1 Topics 3.0 3.5 3.
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 Code Events (Completed are in bold) Timeline Generic Name (Completed are in orange) KHK4083/AMG 451 Atopic Dermatitis P3 Initiation Dec. 2022 rocatinlimab KHK4951 nAMD P1 LPO Aug. 2022 tivozanib P2 Initiation H2 2023 ME-401 Disclosed Discontinuatio
Slide 16: RTA 402 Ph3 study results
RTA 402 Ph3 study results Post-treatment Screening period Treatment period observation period RTA 402 5 mg 10 mg 15mg Off-drug Enrollment/Randomization Placebo Off-drug ≤ 4 weeks 3 - 4 years 16 weeks after termination of study treatment Time to onset of a ≥ 30% decrease in eGFR from Primary Endpoint
Slide 17: News Flow in 2023
News Flow in 2023 © Kyowa Kirin Co., Ltd. 17
Slide 18: Year-to-date Key News Flow
Year-to-date Key News Flow Category Date Headline As of May 10, 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 study
Slide 19: Appendix
Appendix © Kyowa Kirin Co., Ltd. 19
Slide 20: Least-squares mean percent change in EASI score
Least-squares mean percent change in 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 -85.4 Rocatinlimab 600 mg Q2W, % -61.4 -72.2 -81.1 -85.1 Placebo/rocatinl
Slide 21: Durability of EASI-75 response after treatment discontinuation
Durability of EASI-75 response after treatment discontinuation (Full Analysis Set) Probability of not having relapse (defined as loss of EASI-75 response) during the off-drug follow-up period is shown for patients who achieved EASI-75 response at Week 36 (last dose of rocatinlimab, Week 34). Patient
Slide 22: Biomarker levels over time: Serum TARC (CCL17)
Biomarker levels over time: Serum TARC (CCL17) (Safety Analysis Set) Q2W, every 2 weeks; Q4W, every 4 weeks; TARC, thymus and activation-regulated chemokine Data presented from safety analysis set, which included patients who received at least 1 dose of investigational product; 273 of the 274 random
Slide 23: Transcriptome Deconvolution Analysis: Differential Cell Contribution
Transcriptome Deconvolution Analysis (Microarray Analysis): Differential Cell Contribution ▪ Significant decreases in keratinocytes, key immune cells (Th2/Th17 cells), and neutrophils were observed Differential cell contribution analysis between AD lesion and non-lesion samples at baseline, and betw
Slide 24: 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 25: 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 26: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of 2023, May 10 Code Target Disease 2023 2024 2025 ＋ Generic Name P3 IGNITE P3 HORIZON ROCKET PROGRAM KHK4083/ P3 SHUTTLE AMG 451 Atopic dermatitis P3 ASTRO rocatinlimab P3 ORBIT P3 KHK4951 Neovascular age-related P2 tivozanib macular degeneration
Slide 27: 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 28: FOREX Information
FOREX Information Average FOREX Rates (yen) 2022Q1 2023Q1 Changes 2023 Plans USD 114 132 +18 130 GBP 154 161 +7 160 EUR 129 141 +12 135 Q1 YoY FOREX Impacts (billion yen) Revenue Core OP USD +4.3 +1.1 GBP +0.2 -0.1 EUR +0.5 +0.3 FY2023 FOREX Sensitivities (based on 2023 Plans, billion yen) Changes R
Slide 29: 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 30: 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 31: 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 32: 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 33: 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