Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q3 2022 Earnings Presentation
33 slides from Kyowa Kirin's earnings presentation, November 2022
Slide 1: Results Presentation Fiscal 2022 Third Quarter
Results Presentation Fiscal 2022 Third 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 2022 Managing Executive Officer, Head of Strategy Ta
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 Q3 Results
Summary of Q3 Results ( Billion Yen / Rounded ) 2021Q3 2022Q3 2022 Changes Progresses Results Results Revised Plans Revenue 254.0 283.8 +29.8 (+12%) 400.0 71% [Overseas Ratio] [53%] [61%] [62%] Gross Profit 189.9 219.6 +29.8 (+16%) 312.0 70% [Gross Profit Margin] [75%] [77%] [78%] SG&A 104.1 117.3 +
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -5.6 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 +29.8 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 ) 2021Q3 2022Q3 2022 Item Changes Reasons Progresses Results Results Rev. Plans Nesp + Nesp-AG1 19.6 15.7 -3.9 (-20%) 20.7 76% NHI price-cut & Nesp 2.9 2.5 -0.4 (-14%) 3.3 76% Biosimilars’ penetration Nesp-AG 16.7 13.2 -3.5 (-21%) 17.4 76% Duvro
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2021Q3 2022Q3 2022 Item Changes Reasons Progresses Results Results Rev. Plans Crysvita 55.1 78.7 +23.7 (+43%) 116.2 68% [North America] Market penetration North America 40.3 57.4 +17.1 (+42%) [EMEA] Geographical expansion & Additional indic
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- +14.0 billion yen ⚫ Gross Profit +29.8 (incl. forex effect +16.6) Increased in conjunction with JPY29.8B rise in revenue. Margin improved by 2% (incl. forex effect +6.7) (75%→77%) because there was a big negative impact related to elimination of intercompany profits on invento
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Sep) +16.3 billion yen +29.8 -17.1 • Foreign exchange gain/losses +4.1 • Impairment losses +1.7 60 4.9 (incl. Haruropi sales rights 4.2) → 3.2 (irofotase alfa IPR&D) +4.5 -2.2 +1.3 40 49.2 20 32.9 Core Operating Profit +14.0 Profit Before Tax +18.5 0 Jan-Sep Gross S
Slide 11: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 11
Slide 12: Crysvita 2022 Key Actions & Q3 Topics
Crysvita 2022 Key Actions & Q3 Topics 2022 Key Actions ⚫ North America: Initiate full-scale preparation for transfer of commercialization (Billion Yen) planned in spring 2023. ⚫ EMEA: Continue to focus on geographical & indication expansion. TIO review completed. 35.0 Q3 Topics ⚫ North America: Amen
Slide 13: Crysvita - Agreement for Transition Scheme Change
Crysvita ‐ Agreement for Transition Scheme Change ‐ 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, 3
Slide 14: Poteligeo 2022 Key Actions & Q3 Topics
Poteligeo 2022 Key Actions & Q3 Topics (Billion Yen) 2022 Key Actions ⚫ EMEA: Continue to talk with payers to ensure reimbursement and patient access to product. ⚫ US/EMEA: Work with HCPs to gather and share evidence such as clinical data 7.0 in association of blood tumor burden to help understand b
Slide 15: Nourianz 2022 Key Actions & Q3 Topics
Nourianz (Billion Yen) 2022 Key Actions & Q3 Topics 2022 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. Q3 Topics 4.0 ⚫ North America: In challenging
Slide 16: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 16
Slide 17: Upcoming Events: Next-generation Strategic Products
Upcoming Events: Next-generation Strategic Products : Completed events from Aug 5, 2022, to Nov 4, 2022. Month Code Event Time Expected Generic Name Completed KHK4083/AMG 451 End of 2022 Atopic dermatitis P3 restart rocatinlimab - Beginning of 2023 ME-401 iB-NHL (mono, 3L+) P2 topline data (JP) H2 2
Slide 18: Tenapanor: Phase 3 Study – Study Design
Tenapanor: Phase 3 Study (Combination therapy with PBs) – Study Design ASN 2022 ClinicalTrials.gov Identifier: NCT04766398 ◼ A study of tenapanor combination with PBs for Japanese hemodialysis patients with hyperphosphatemia who have poor phosphorus control with existing PBs ◼ Subjects: Hyperphospha
Slide 19: Tenapanor: Phase 3 Study – Results
Tenapanor: Phase 3 Study (combination therapy with PBs) – Results ASN 2022 ClinicalTrials.gov Identifier: NCT04766398 ◼ Primary endpoint ◼ Mean serum phosphorus levels over time ◼ Adverse effects Placebo Tenapanor (n=85) (n=84) TEAEs ➢ Addition of Tenapanor to patients who have poor phosphorus Total
Slide 20: What Kyowa Kirin expects from KHK7791
What Kyowa Kirin expects from KHK7791 KHK7791 (tenapanor), a phosphorus absorption inhibitor with a new MOA different from conventional PBs, which inhibits phosphorus absorption from gastrointestinal tracts by inhibiting NHE3 (Na+/H+ exchange transporter 3) * This picture is for illustration purpose
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 November 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
Slide 23: Year-to-date Key News Flow ②
Year-to-date Key News Flow ② AS of November 4, 2022 Category Date Headline R&D Jun 5 New clinical data on Zandelisib (American Society of Clinical Oncology Annual Meeting 2022) R&D Jun 10 Clinical data on Zandelisib (European Hematology Association 2022 Hybrid Congress) LCM Jun 27 Positive CHMP opin
Slide 24: Year-to-date Key News Flow ③
Year-to-date Key News Flow ③ AS of November 4, 2022 Category Date Headline LCM Oct 17 Application for partial change of approved indication of Lumicef for Palmoplantar Pustulosis (Japan) R&D Oct 20 Data from Phase 3 clinical study of Tenapanor Hydrochloride (KHK7791) for hemodialysis patients on dia
Slide 25: Appendix
Appendix © Kyowa Kirin Co., Ltd. 25
Slide 26: 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 27: FOREX Information
FOREX Information Average FOREX Rates (yen) 2021Q3 2022Q3 Changes 2022 Rev. Plans USD/JPY 108 126 +18 128 GBP/JPY 149 160 +11 162 Q3 YoY FOREX Impacts (billion yen) Revenue Core OP USD/JPY +12.8 +4.6 GBP/JPY +3.4 +0.9 FY2022 FOREX Sensitivities (billion yen) Changes Revenue Core OP USD/JPY +1 yen +1
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 • After 5 years (April 27 2023~), Kyowa Kirin pays tiered sales royalties in mid-high 20% range to Ultragenyx • Supply price: 35% of net sales through
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: Development Plan of Next-generation Strategic Products
Development Plan of Next-generation Strategic Products T : Topline data D : Detailed data As of Nov 4, 2022 Code Target Disease 2022 2023 2024 ＋ Generic Name KHK4083/AMG Atopic dermatitis P3 ROCKET 451 rocatinlimab FL (mono, 3L+) P2 D** TIDAL MZL (mono, 3L+) P2 ME-401 zandelisib FL/MZL (combo, 2L+)
Slide 31: 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 32: 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 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