Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q2 2022 Earnings Presentation
31 slides from Kyowa Kirin's earnings presentation, August 2022
Slide 1: Results Presentation Fiscal 2022 Second Quarter
Results Presentation Fiscal 2022 Second Quarter
Slide 2: Agenda
Agenda Financial Review Commercial Update R&D Update News Flow in 2022 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 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 Q2 Results
Summary of Q2 Results ( Billion Yen / Rounded ) 2021Q2 2022Q2 2022 Changes Progresses Results Results Revised Plans 380.0→ Revenue 165.0 185.3 +20.2 (+12%) 400.0 46% [Overseas Ratio] [52%] [59%] [62%] 298.0→ Gross Profit 123.8 141.9 +18.1 (+15%) 312.0 45% [Gross Profit Margin] [75%] [77%] [78%] 164.
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -3.9 Although Duvroq, Romiplate, G-Lasta, and Crysvita increased, revenue in Japan region decreased by 5% due mainly to negative impact by NHI price-cut in April 2021 & April 2022 +20.2 billion yen and shrink in Patanol for which generic products entered the market las
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2021Q2 2022Q2 2022 Item Changes Reasons Progresses Results Results Rev. Plans Nesp + Nesp-AG1 12.9 10.5 -2.4 (-19%) 19.5→ 20.7 51% NHI price-cut & Nesp 1.9 1.6 -0.3 (-14%) Biosimilars’ penetration 3.1→ 3.3 50% Nesp-AG 11.0 8.8 -2.2 (-20%) 16.4
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2021Q2 2022Q2 2022 Item Changes Reasons Progresses Results Results Rev. Plans Crysvita 35.4 49.4 +14.0 (+40%) 105.2→ 116.2 43% [North America] Market penetration North America 25.7 35.9 +10.1 (+39%) [EMEA] Geographical expansion & Additiona
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- +9.0 billion yen ⚫ Gross Profit +18.1 (incl. forex effect +9.1) Increased in conjunction with JPY20.2B rise in revenue. Margin improved by 1.6% (incl. forex effect +3.7) (75.0%→76.6%) because there was a big negative impact related to elimination of intercompany profits on inv
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Jun) +9.9 billion yen +18.1 -10.6 • Foreign exchange gain/losses +4.0 40.0 +3.4 -2.4 +1.5 30.0 20.0 35.0 25.1 10.0 Core Operating Profit +9.0 Profit Before Tax +12.4 0.0 Jan-Jun Gross SG&A Equity Finance Income Jan-Jun 2021 Profit /R&D Method /Other Taxes 2022 © Kyo
Slide 11: Summary of FY2022 Revised Plan
Summary of FY2022 Revised Plan ( Billion Yen / Rounded ) 2022 Full Year 2022H1 2022H2 2022 Full Year Changes Original Plans Results Revised Plans Revised Plans Revenue 380.0 185.3 214.7 400.0 +20.0 (+5%) [Overseas Ratio] [59%] [59%] [65%] [62%] Gross Profit 298.0 141.9 170.1 312.0 +14.0 (+5%) [Gross
Slide 12: FY2022 Original Plan vs Revised Plan
FY2022 Original Plan vs Revised Plan Profit (Jan-Dec) +10.0 billion yen • Foreign exchange gain/losses, etc. • Due to increase in pre-tax profit • Sales Revenue +20.0 70.0 (Japan -0.6, North America +11.6, +14.0 -5.0 EMEA +3.7, APAC +4.0, Other +1.3) +3.0 -3.0 • COGs -6.0 +1.0 60.0 • SG&A -8.0 • R&D
Slide 13: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 13
Slide 14: Crysvita 2022 Key Actions & Q2 Topics
Crysvita 2022 Key Actions & Q2 Topics Key Actions ⚫ North America: Initiate full-scale preparation for transfer of commercialization planned in spring 2023. (Billion Yen) ⚫ EMEA: Continue to focus on geographical & indication expansion. TIO review to be completed. 35.0 Q2 Topics ⚫ North America: Re-
Slide 15: Poteligeo 2022 Key Actions & Q2 Topics
Poteligeo 2022 Key Actions & Q2 Topics Key Actions ⚫ EMEA: Continue to talk with payers to ensure reimbursement and patient (Billion Yen) access to product. ⚫ US/EMEA: Work with Healthcare professionals to gather and share evidence such as clinical data in association of blood tumor burden to help u
Slide 16: Nourianz 2022 Key Actions & Q2 Topics
Nourianz (Billion Yen) 2022 Key Actions & Q2 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. Q2 Topics 4.0 ⚫ North America: Behind the original
Slide 17: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 17
Slide 18: Upcoming Events: Next-generation Strategic Products
Upcoming Events: Next-generation Strategic Products : Completed events from May 11, 2022, to Aug 4, 2022 Code Event Time Expected Month Completed Generic Name KHK4083/AMG 451 Atopic dermatitis P3 FPI (enrollment paused) Mid-2022 Jun-2022 rocatinlimab Parkinson’s disease P3 FPI Discontinued KW-6356 P
Slide 19: Update: Rocatinlimab Ph3 ROCKET Program Amendment
Update: Rocatinlimab (KHK4083/AMG 451) Ph3 ROCKET Program Amendment ◼ The ROCKET Phase 3 program was initiated in June 2022. ◼ However, following additional discussions with regulators and our partner, we are amending the studies to improve patient convenience and investigate a range of doses. ◼ No
Slide 20: Update: Other pipelines whose development plans have changed
Update: Other pipelines whose development plans have changed ◼ KW-6356: Development discontinuation ⚫ Based on communication with the regulatory authorities, we concluded that it would be difficult to achieve its target product profile which we had aimed for. ⚫ We decided to discontinue KW-6356's de
Slide 21: News Flow in 2022
News Flow in 2022 © Kyowa Kirin Co., Ltd. 21
Slide 22: Year-to-date Key News Flow ①
Year-to-date Key News Flow ① AS of August 4, 2022 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 In
Slide 23: Year-to-date Key News Flow ②
Year-to-date Key News Flow ② AS of August 4, 2022 Category Date Headline R&D Jun 5 New Clinical Data on Zandelisib (American Society of Clinical Oncology Annual Meeting) R&D Jun 10 Clinical Data on Zandelisib (European Hematology Association 2022 Hybrid Congress) LCM Jun 27 Positive CHMP Opinion for
Slide 24: Appendix
Appendix © Kyowa Kirin Co., Ltd. 24
Slide 25: FOREX Information
FOREX Information Average FOREX Rates (yen) 2021Q2 2022Q2 Changes 2022 Rev. Plans USD/JPY 107 120 +13 128 GBP/JPY 147 158 +11 162 Q2 YoY FOREX Impacts (billion yen) Revenue Core OP USD/JPY +6.3 +2.4 GBP/JPY +2.1 +0.5 FY2022 FOREX Sensitivities (billion yen) Changes Revenue Core OP USD/JPY +1 yen +1.
Slide 26: 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 27: 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 28: Development Plan of Next-generation Strategic Products
Development Plan of Next-generation Strategic Products T : Topline data D : Detailed data As of Aug 4, 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 Discontinued FL (mono, 3L+) P2 D** TIDAL MZL (mo
Slide 29: 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 30: 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 31: 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