Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — FY2021 Earnings Presentation
35 slides from Kyowa Kirin's earnings presentation, February 2022
Slide 1: Results Presentation Fiscal 2021
Results Presentation Fiscal 2021
Slide 2: Agenda
Agenda Medium Term Business Plan Review ‐ Progress in FY2021 Medium Term Business Plan Review ‐ Outlook for FY2022 Shareholders Return Commercial Update R&D Update President and Chief Executive Officer Masashi Miyamoto, Ph.D. Q&A President and Chief Executive Officer Masashi Miyamoto, Ph.D. Executiv
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: Medium Term Business Plan Review: Progress in FY2021
Medium Term Business Plan Review Progress in FY2021 © Kyowa Kirin Co., Ltd. 4
Slide 5: 2021 Review
2021 Review Provide pharmaceuticals for unmet medical needs Address patient‐centric healthcare needs Maximize the value of G3B Patient advocacy Evolved OKK matrix structure to reinforce global product axis Launched regional and cross‐functional collaboration on patient advocacy activities
Slide 6: Summary of FY2021 Results
Summary of FY2021 Results ( Billion Yen / Rounded ) 2020 2021 Changes 2021 Achieved Results Results Plans Revenue 318.4 352.2 +33.9 (+11%) 351.0 100% [Overseas Ratio] [48%] [54%] [54%] Gross Profit 237.9 264.4 +26.5 (+11%) 270.0 98% [Gross Profit Margin] [75%] [75%] [77%] SG&A 126.6 145.6 +19.0 (+15
Slide 7: FY2020 vs FY2021 -Revenue-
FY2020 vs FY2021 ‐Revenue‐ Japan ‐3.1 Decrease of Nesp‐AG & Nouriast (Competitors) etc. and negative impact by NHI price‐cut in 2020/2021 were offset by increase of Crysvita, Haruropi, Duvroq (New products) and G‐ +33.9 billion yen Lasta (Market’s recovery & penetration), etc. However, co‐promotio
Slide 8: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2020 2021 Changes 2021 Achieved Item Results Results Reasons Plans Nesp + Nesp‐AG*1 29.5 26.3 ‐3.3 (‐11%) 23.2 113% Biosimilars’ penetration Nesp 4.4 4.0 ‐0.4 (‐9%) & NHI price‐cut 3.8 105% Nesp‐AG 25.2 22.3 ‐2.9 (‐11%) 19.4 115% Duvroq 0.6 2.
Slide 9: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex‐Japan) ( Billion Yen / Rounded ) 2020 2021 Changes 2021 Achieved Item Reasons Results Results Plans Crysvita 54.4 78.3 +23.9 (+44%) [North America] Market penetration 77.2 101% North America 42.4 57.7 +15.3 (+36%) & Additional indication (TIO) [EMEA] Geographical expansion
Slide 10: FY2020 vs FY2021 -Core OP-
FY2020 vs FY2021 ‐Core OP‐ +5.7 billion yen Gross Profit +26.5 (incl. forex effect +7.6) Increased in conjunction with 33.9B yen rise in revenue. Margin is almost same (incl. forex effect +2.5) level as FY2020 (74.7%→75.1%, +0.4%) due to forex impact related to elimination of intercompany profits
Slide 11: FY2020 vs FY2021 -Profit-
FY2020 vs FY 2021 ‐Profit‐ Profit (Jan‐Dec) +5.3 billion yen • Provision for compensation losses [3.4→ ‐] +3.4 • Business restructuring expenses [2.0→0.1] +1.9 • Impairment losses [2.9(KHK2375 IPR&D 2.6)→5.3(Haruropi sales rights 4.2)] ‐2.4 • Foreign exchange gain/losses [gain 0.5→losses 0.5] ‐1.0 C
Slide 12: Medium Term Business Plan Review: Outlook for FY2022
Medium Term Business Plan Review Outlook for FY2022 © Kyowa Kirin Co., Ltd. 12
Slide 13: 2022 Goals
2022 Goals Provide pharmaceuticals for unmet medical needs Address patient‐centric healthcare needs Maximize the value of G3B Patient advocacy For the further market penetration; Promote patient advocacy activities Steadily implement the Crysvita transition plan in North America and increase
Slide 14: Summary of FY2022 Plans
Summary of FY2022 Plans ( Billion Yen / Rounded ) 2020 2021 2022 Changes Results Results Plans Revenue 318.4 352.2 380.0 +27.8 (+8%) [Overseas Ratio] [48%] [54%] [59%] Gross Profit 237.9 264.4 298.0 +33.6 (+13%) [Gross Profit Margin] [75%] [75%] [78%] SG&A 126.6 145.6 164.0 +18.4 (+13%) [S&G Ratio]
Slide 15: FY2022 Plans of Major Items (Japan)
FY2022 Plans of Major Items (Japan) ( Billion Yen / Rounded ) 2020 2021 2022 Changes Item Results Results Plans Reasons Nesp + Nesp‐AG*1 29.5 26.3 19.5 ‐6.8 (‐26%) Penetration of biosimilars/HIF‐PHIs Nesp 4.4 4.0 3.1 ‐0.9 (‐23%) & NHI price‐cut Nesp‐AG 25.2 22.3 16.4 ‐5.8 (‐26%) Duvroq 0.6 2.6 5.5 +
Slide 16: FY2022 Plans of Major Items (ex-Japan)
FY2022 Plans of Major Items (ex‐Japan) ( Billion Yen / Rounded ) 2020 2021 2022 Changes Item Results Results Plans Reasons Crysvita 54.4 78.3 105.2 +26.9 (+34%) Market penetration & Geographical expansion North America 42.4 57.7 EMEA 12.0 20.6 Asia / Oceania － 0.0 Poteligeo 11.5 15.3 22.5 +7.3 (+48%
Slide 17: FY2021 vs FY2022 -Core OP-
FY2021 vs FY2022 ‐Core OP‐ Gross Profit +33.6 Due mainly to 27.8B yen rise in revenue (Japan‐7.9, North America+22.1, EMEA+6.4, Asia/Oceania‐1.8, Other+8.9) and absence of FY2021’s negative factor on COGS. Margin is expected to improve by 3.4% (75.1%→78.4%). Core OP +1.3 billion yen SG&A ‐18.4 D
Slide 18: Shareholders Return
Shareholders Return © Kyowa Kirin Co., Ltd. 18
Slide 19: FY2021 dividend is 46 yen, and FY2022 to be 48 yen (plan)
Shareholders Return FY2021 dividend is 46 yen, and FY2022 to be 48 yen (plan) Plans 6‐year consecutive rises since FY2017 Dividend (yen) Payout Return on Year *1 Interim Year‐end Ratio Equity 2016 12.50 12.50 25.00 44.9% 5.3% 2017 12.50 14.50 27.00 34.4% 7.2% 2018 15.00 20.00 35.00 35.2% 8.6% *2
Slide 20: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 20
Slide 21: Crysvita: 2021 Review & 2022 Key Actions
(Billion Yen) 120 10.0 100 2021 Review & 2022 Key Actions 80 7.2 2021 Japan Steady progress in patient discovery and expansion of markets and 60 indications. 3.8 57.7 105.2 North Achieved the plan with strong growth in Japan, North America, and EMEA. 40 America 2022 0.1 42.4 North America︓Begi
Slide 22: 2021 Review & 2022 Key Actions
（Billion Yen） 2021 Review & 2022 Key Actions 30 2021 North America: In addition to mitigating COVID‐19 impacts, achieved 25 the target through campaign focused on patients with blood burden. 1.9 EMEA: Below the target due to tough price negotiation for 20 reimbursement under COVID‐19. Japan 2.0
Slide 23: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 23
Slide 24: Upcoming Events: Next-generation Strategic Products
Upcoming Events: Next‐generation Strategic Products Underlined: Completed events from Jan 1 to Nov 1, 2021 : Completed events from Nov 2, 2021, to Feb 7, 2022 Code H1 2021 H2 2021 H1 2022 H2 2022 Generic name KHK4083/ Atopic dermatitis Atopic dermatitis Atopic dermatitis AMG 451 P2b topline data P2b
Slide 25: Update 1: Zandelisib Global Ph2 TIDAL Study Topline Data
Update 1: Zandelisib Global Ph2 TIDAL Study Topline Data Cycles 1 and 2 Intermittent Dosing on Cycles ≥3 Phase 2 study (TIDAL) in patients with r/r FL Daily dosing Daily No therapy Zandelisib 8 wks 1 wk 3 wks Overall Response Rate Discontinuation Rate (ORR) 70.3% Due to Any Drug Related 9.9% 95% Cl
Slide 26: Update 2: Bardoxolone Methyl (RTA 402)
Update 2: Bardoxolone Methyl (RTA 402) • Regulatory review for Alport syndrome will continue after Q1 2022 in Japan FDA Cardiovascular and Renal Drugs Advisory Committee voted no on bardoxolone methyl's efficacy and risk‐benefit for Alport syndrome in the US. Kyowa Kirin is addressing the PMDA’s r
Slide 27: Update 3: Next-generation Strategic Products
Update 3: Next‐generation Strategic Products As of Feb 7, 2022 Country / region*1 Approval Total addressable No. of Indication*2 year*3 market*4 patients*5 ★★★ KHK4083/ NA/EU/JP Atopic dermatitis 2025/2026 16,000K AMG 451 KW‐6356 NA/EU/JP Parkinson’s disease 2026 ★★★ 3,500K ★★★ Follicular lymphoma M
Slide 28: Appendix
Appendix © Kyowa Kirin Co., Ltd. 28
Slide 29: FOREX Information
FOREX Information FY2021 Average FOREX Rate (Yen) Currency 2020 2021 Change 2022 Results Results Plans USD/JPY 107 109 +2 110 GBP/JPY 137 150 +13 150 FY2021 FOREX Impacts (YoY) (Billion yen) Currency Revenue Core OP USD/JPY +2.0 +0.6 GBP/JPY +5.0 +1.0 FY2022 FOREX Sensitivity (Billion yen) Currency
Slide 30: Crysvita - Collaboration with Ultragenyx
Crysvita ‐ Collaboration with Ultragenyx ‐ Territories Economic terms • Kyowa Kirin books sales • 50/50 profit share for 5 years from the U.S. launch U.S. & Canada • After 5 years, Kyowa Kirin pays tiered sales royalties in mid‐high 20% range to Ultragenyx • Supply price: 35% of net sales through 20
Slide 31: KHK4083/AMG 451 - Collaboration with Amgen
KHK4083/AMG 451 ‐ Collaboration with Amgen ‐ US Europe and Asia (ex. JP) JP • Amgen leads development • Amgen leads development Development • Share development cost • Share development cost • Kyowa Kirin leads development • Amgen commercializes • Amgen commercializes Commercialization and books sale
Slide 32: Development Plan of Next-generation Strategic Products
Development Plan of Next‐generation Strategic Products T : Topline data D : Detailed data As of Feb 7, 2022 Code Target disease 2021 2022 2023 2024 ＋ generic name KHK4083/ P2b T D Atopic dermatitis AMG 451 P3 P2b D KW‐6356 Parkinson’s disease P3 FL (mono, 3L+) P2 T D** MZL (mono, 3L+) P2 ME‐401 FL/M
Slide 33: Estimated Patient Numbers
Estimated Patient Numbers Country/ Disease 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 34: 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 DKD Diabetic Kidney Disease FL Follicular Lymphoma iB‐NHL Indolent B‐cell Non‐Hodgkin Lymphoma
Slide 35: 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