Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q3 2023 Earnings Presentation
35 slides from Kyowa Kirin's earnings presentation, November 2023
Slide 1: Results Presentation Fiscal 2023 Third Quarter
Results Presentation Fiscal 2023 Third Quarter
Slide 2: Agenda
Agenda Financial Review Managing Executive Officer, CFO 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, CSO Head of Str
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 ) 2022Q3 2023Q3 2023 Changes Progresses Results Results Revised Plans Revenue 283.8 306.1 +22.3 (+8%) 426.0 72% [Overseas Ratio] [61%] [64%] [64%] Gross Profit 219.6 229.1 +9.4 (+4%) 326.0 70% [Gross Profit Margin] [77%] [75%] [77%] SG&A 117.3 119.3 +2.0
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -2.3 Although Duvroq, Romiplate, and Crysvita increased, revenue in Japan region decreased by 2% due mainly to negative impact by annual NHI price-cut and shrink in Nesp-AG affected by +22.3 billion yen competitive products. (incl. forex effect +13.9) ⚫ North America +
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2022Q3 2023Q3 2023 Item Changes Reasons Progresses Results Results Plans Nesp + Nesp-AG1 15.7 12.7 -3.1 (-20%) 16.6 76% NHI price-cut & Nesp 2.5 2.3 -0.2 (-8%) 2.8 82% Biosimilars’ penetration Nesp-AG 13.2 10.3 -2.9 (-22%) 13.8 75% Duvroq 4.4
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2022Q3 2023Q3 2023 Item Changes Reasons Progresses Results Results Plans Crysvita 78.7 95.7 +17.0 (+22%) 138.0 69% North America 57.4 70.2 +12.8 (+22%) [North America] Market penetration [EMEA] Geographical expansion & Additional indication
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- ⚫ Gross Profit +9.4 (incl. forex effect +12.0) +0.0 billion yen Increased in conjunction with JPY22.3B rise in revenue. COGs have increased due to the (incl. forex effect +4.2) North America Crysvita Sales royalty after Apr 27, 2023. Hence, gross profit % declined YoY. (77% →7
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Sep) +4.3 billion yen • EMEA established medicines portfolio: Gain on sales of 51% shares plus gain on valuation of remaining 49% shares +14.8 • Impairment losses -6.2 [FY22: irofotase alfa IPR&D -3.2] [FY23: RTA 402 IPR&D -8.3, Expiration of research collaboration
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 & Q3 Topics (Crysvita)
2023 Key Actions & Q3 Topics Q3 Topics 2023 Key Actions ⚫ North America: ⚫ North America: ・The number of patient enrollments in the treatment preparation stage and treatment Start own sales (Establish and start own operation of the direct sales force). patients continued to increase steadily, throug
Slide 13: 2023 Key Actions & Q3 Topics (Poteligeo)
2023 Key Actions & Q3 Topics 2023 Key Actions Sales Revenue (Billion Yen) ⚫ Strengthen promotional activities utilizing evidences including efficacy in blood involvement. 8.0 ⚫ Raise awareness of importance of blood testing among early-stage patients 7.0 6.0 Q3 Topics 5.0 5.7 North ⚫ North America:
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 As of November 1, 2023 Code Events (Completed are in bold) Timeline Generic Name (Completed are in orange) KHK4083/AMG 451 Atopic Dermatitis P3 (ROCKET PROGRAM) In Progress rocatinlimab Asthma P2 To be initiated nAMD P1 data presentation Oct. 2023
Slide 16: KW-3357 Preeclampsia Ph3 data
KW-3357 Preeclampsia Ph3 data Screening Treatment / Observational period Follow-up period KW-3357 Administration Pregnancy Termination 3-Day and 28-Day Follow-up Exam & Observation Enrollment & Randomization Placebo Administration Pregnancy 3-Day and 28-Day Follow-up Exam & Observation Termination U
Slide 17: Overview of KK2260 and KK2269
Overview of KK2260 and KK2269 Antigen A Binding Domain ◼ Both are Kyowa Kirin's proprietary bispecific antibodies with REGULGENTTM technology ◼ The phase 1 studies information for both products have been disclosed on jRCT* * Trial ID KK2260: jRCT2031230372, KK2269: jRCT2031230419 KK2260 KK2269 Count
Slide 18: News Flow in 2023
News Flow in 2023 © Kyowa Kirin Co., Ltd. 18
Slide 19: Year-to-date Key News Flow
Year-to-date Key News Flow Category Date Headline As of November 1, 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 s
Slide 20: Year-to-date Key News Flow
Year-to-date Key News Flow Category Date Headline As of November 1, 2023 LCM Aug 23 Approval for partial change of LUMICEF® for Palmoplantar Pustulosis (Japan) LCM Aug 30 Approval for Calcimimetics Agent ORKEDIA® TABLETS 4mg (Japan) LCM Sep25 Approval for Partial Change of Romiplate® for Aplastic An
Slide 21: Acquire shares of Orchard Therapeutics: Strategic Rationale
Acquire shares of Orchard Therapeutics ~Strategic Rationale~ Our purpose of the acquisition: ◼ To enrich our pipeline to address the UMNs** for which there is still no cure ◼ To obtain capabilities in Cell Gene Therapy R&D * to address the future UMNs ** Unmet medical needs • Strengthen the business
Slide 22: Acquire shares of Orchard Therapeutics: Transaction Summary
Acquire shares of Orchard Therapeutics ~Transaction Summary~ Items Summary ◼ Orchard Therapeutics plc (London) Target — Listed on NASDAQ ◼ $16.00 per ADS / approx. $387.4 million (approx. JPY 57.3 billion) — Orchard shareholders will hold additional contingent value rights (CVR) of $1.00 per ADS. Pu
Slide 23: Acquire shares of Orchard Therapeutics: Expected Synergy
Acquire shares of Orchard Therapeutics ~Expected Synergy~ Further Development as a Global Specialty Pharmaceutical Company ◼ To be a Japan-based Global Specialty Pharmaceutical Company providing life-changing value to high unmet medical needs in concert with our existing business through Crysvita an
Slide 24: P/L Impact on EMEA established medicines portfolio
P/L Impact on EMEA established medicines portfolio Before 2023 2023 2024 2025 2023 Q2 Q3 Q4 Until the end of July Product sales (for Tostran, until Oct 12) From August Established portfolio Revenue 13 brands Sales Royalties & license fees Tostran IP transfer Disposal contingency （ADVANZ PHARMA） proc
Slide 25: Appendix
Appendix © Kyowa Kirin Co., Ltd. 25
Slide 26: 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 27: 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 28: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of November 1, 2023 T : Topline data D : Detailed data Code Target Disease 2023 2024 2025 ＋ Generic Name P3 IGNITE P3 HORIZON P3 SHUTTLE KHK4083/ Atopic dermatitis P3 ASTRO AMG 451 rocatinlimab P3 ORBIT P3 VOYAGER P3 ASCEND Neovascular age-related
Slide 29: Main Development Pipeline Products
Main Development Pipeline Products As of November 1, 2023 Planned Approval Total addressable Diseases under development*1 Development status No. of Patients*4 Year*2 market*3 KHK4083/ Moderate and severe AMG 451 2026/2027 Ph3 (Global) ★★★★★ 16M atopic dermatitis rocatinlimab KHK4083/ Moderate and se
Slide 30: FOREX Information
FOREX Information Average FOREX Rates (yen) 2022Q3 2023Q3 Changes 2023 Plans USD 126 137 +11 130 GBP 160 170 +10 160 EUR 135 148 +13 135 Q3 YoY FOREX Impacts (billion yen) Revenue Core OP USD +9.2 +2.8 GBP +0.6 -0.3 EUR +2.7 +1.3 FY2023 FOREX Sensitivities (based on 2023 Plans, billion yen) Changes
Slide 31: 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 32: 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 33: 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 34: List of Acronyms
List of Acronyms AD Atopic Dermatitis ADPKD Autosomal Dominant Polycystic Kidney Disease AG Authorized Generic AP, APAC Asia-Pacific ATL Adult T-Cell Leukemia/Lymphoma BS Biosimilar DME Diabetic Macular Edema EMEA Europe, the Middle East and Africa JP Japan LCM Lifecycle Management NA North America
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