Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q1 2022 Earnings Presentation
27 slides from Kyowa Kirin's earnings presentation, May 2022
Slide 1: Results Presentation Fiscal 2022 First Quarter
Results Presentation Fiscal 2022 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, Strategy Division Tomohiro Sudo R&D Update Executive Officer, Head of R&D Yoshifumi Torii, Ph.D. News Flow in 2022 Managing Executive Officer,
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 ) 2021Q1 2022Q1 2022 Changes Progresses Results Results Plans Revenue 81.1 87.8 +6.6 (+8%) 380.0 23% [Overseas Ratio] [50%] [58%] [59%] Gross Profit 58.7 65.6 +6.9 (+12%) 298.0 22% [Gross Profit Margin] [72%] [75%] [78%] SG&A 31.7 36.1 +4.4 (+14%) 164.0
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -3.8 Although new products such as Duvroq and Crysvita increased, revenue in Japan decreased by JPY3.8B due mainly to negative impact by NHI price-cut in April 2021 and shrink in +6.6 billion yen Patanol for which generic products entered the market last December. (inc
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2021Q1 2022Q1 2022 Item Changes Reasons Progresses Results Results Plans Nesp + Nesp-AG*1 6.5 5.2 -1.2 (-19%) 19.5 27% NHI price-cut & Nesp 1.0 0.8 -0.1 (-13%) Biosimilars’ penetration 3.1 27% Nesp-AG 5.5 4.4 -1.1 (-20%) 16.4 27% Duvroq 0.2 1.
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2021Q1 2022Q1 2022 Item Changes Reasons Progresses Results Results Plans Crysvita 16.3 22.2 +6.0 (+37%) 105.2 21% [North America] Market penetration North America 11.7 15.8 +4.1 (+35%) [EMEA] Geographical expansion +1.8 (+40%) & Additional
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- +1.8 billion yen ⚫ Gross Profit +6.9 (incl. forex effect +3.3) Increased in conjunction with JPY6.6B rise in revenue. Margin improved by 2.4% (incl. forex effect +1.2) (72.4%→74.7%) because there was a big negative impact related to elimination of intercompany profits on inven
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Mar) +3.1 billion yen 30 • Foreign exchange gain/losses +1.4 +6.9 -5.8 20 +0.7 +0.6 +0.8 10 16.0 12.9 Core Operating Profit +1.8 Profit Before Tax +2.6 0 Jan-Mar Gross Profit SG&A Equity Finance Income Jan-Mar 2021 /R&D Method /Other Taxes 2022 © Kyowa Kirin Co., Lt
Slide 11: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 11
Slide 12: Crysvita 2022 Key Actions & 2022 Q1 Topics
Crysvita 2022 Key Actions & 2022 Q1 Topics Key Actions ⚫ North America：Initiate full-scale preparations for transfer of commercializa- tion in spring 2023. (Billion Yen) ⚫ EMEA：Continue to focus on geographical & indication expansion. TIO review to be completed. Q1 Topics 30.0 ⚫ North America：Negati
Slide 13: Poteligeo 2022 Key Actions & 2022 Q1 Topics
Poteligeo 2022 Key Actions & 2022 Q1 Topics (Billion Yen) Key Actions ⚫ EMEA: Continue to talk with payers to ensure reimbursement and patient access to product. ⚫ US/EMEA: Work with Healthcare professionals to gather and share evidence 6.0 such as clinical data in association of blood tumor burden
Slide 14: Nourianz 2022 Key Actions & 2022 Q1 Topics
Nourianz (Billion Yen) 2022 Key Actions & 2022 Q1 Topics Key Actions 6.0 ⚫ North America: Focus on approaching potential prescribers and get their deeper understanding of the features of Nourianz such as safety, convenience, 5.0 and novel mode of action. Q1 Topics 4.0 ⚫ North America: Increase in pa
Slide 15: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 15
Slide 16: Upcoming Events: Next-generation Strategic Products
Upcoming Events: Next-generation Strategic Products Code Event Time Expected Month Completed Generic Name KHK4083/AMG 451 Atopic dermatitis P3 FPI Mid-2022 rocatinlimab Parkinson’s disease P3 FPI H2 2022 KW-6356 Parkinson’s disease P2b detailed data H2 2022 CLL (combo, 2L+) P2 FPI H1 2022 ME-401 FL
Slide 17: Update: Zandelisib US development plan
Update: Zandelisib US development plan ◼ External Environment ⚫ Several PI3K inhibitors have received accelerated approvals from the FDA based on data from single-arm studies in blood cancers. ⚫ Around the end of 2021, several companies made a decision to withdraw their PI3K inhibitor indications/ap
Slide 18: News Flow in 2022
News Flow in 2022 © Kyowa Kirin Co., Ltd. 18
Slide 19: Year-to-date Key News Flow
Year-to-date Key News Flow AS of May 10, 2022 Category Pub date Region Headline ESG Jan 11 Japan Introduction of Renewable Energy “Aqua Premium” for its Fuji Research Park and CMC R&D Center LCM Jan 31 Japan NDA submission of Topical Ophthalmic Mitomycin C Agent ESG Feb 3 Global Formulation of Globa
Slide 20: Appendix
Appendix © Kyowa Kirin Co., Ltd. 20
Slide 21: FOREX Information
FOREX Information Average FOREX Rates (yen) 2021Q1 2022Q1 Changes 2022 Plans USD/JPY 105 114 +9 110 GBP/JPY 143 154 +11 150 Q1 YoY FOREX Impacts (billion yen) Revenue Core OP USD/JPY +2.0 +0.6 GBP/JPY +1.0 +0.2 FY2022 FOREX Sensitivities (billion yen) Changes Revenue Core OP USD/JPY +1 yen +1.1 +0.3
Slide 22: 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 • After 5 years, Kyowa Kirin pays tiered sales royalties in mid-high 20% range to Ultragenyx • Supply price: 35% of net sales through 2022, 30% therea
Slide 23: 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 24: Development Plan of Next-generation Strategic Products
Development Plan of Next-generation Strategic Products T : Topline data D : Detailed data As of May 10, 2022 Code Target Disease 2022 2023 2024 ＋ Generic Name KHK4083/ AMG 451 Atopic dermatitis P3 ROCKET rocatinlimab P2b D KW-6356 Parkinson’s disease P3 FL (mono, 3L+) P2 D** TIDAL MZL (mono, 3L+) P2
Slide 25: 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 26: List of Acronyms
List of Acronyms AD Atopic Dermatitis ADPKD Autosomal Dominant Polycystic Kidney Disease AG Authorized Generic AS Alport Syndrome ATL Adult T-Cell Leukemia/Lymphoma BS Biosimilar CKD Chronic Kidney Disease CLL Chronic Lymphocytic Leukemia DKD Diabetic Kidney Disease FL Follicular Lymphoma iB-NHL Ind
Slide 27: 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