Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q2 2024 Earnings Presentation
40 slides from Kyowa Kirin's earnings presentation, August 2024
Slide 1: Results Presentation Fiscal 2024 Second Quarter
Results Presentation Fiscal 2024 Second Quarter
Slide 2: Agenda
Agenda Financial Review Commercial Update R&D Update News Flow in 2024 Q&A President and Chief Executive Officer (CEO) Masashi Miyamoto, Ph.D. Senior Managing Executive officer, Chief Medical Officer (CMO) Takeyoshi Yamashita, Ph.D. Managing Executive Officer, Chief Financial Officer (CFO) Motohiko
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
Rev. Plan FX Rates (full-year) USD 140 → 151 / USD GBP 180 → 191 / GBP Summary of Q2 Results EUR 155 → 163 / EUR ( Billion Yen / Rounded ) 2023Q2 2024Q2 FY2024 Progress Changes Results Results Rev. Plans to goal 473.0→ Revenue 199.2 233.0 +33.8 (+17%) 492.0 47% [Overseas Ratio] [63%] [71%] [71%] 348
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- ⚫ Japan -5.7 Although Phozevel, Duvroq and Crysvita increased, revenue in Japan region decreased by 8% due mainly to negative impact by annual NHI price-cut and shrink in G-Lasta affected by +33.8 billion yen competitive products. (incl. forex effect +18.6) ⚫ North America +19
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion Yen / Rounded ) 2023Q2 2024Q2 2024 Progress Item Changes Reasons Results Results Rev. Plans* to goal Crysvita 4.8 5.4 +0.5 (+11) Market penetration (Launched in Dec 2019) 12.9 42% Poteligeo 0.9 1.0 +0.0 (+4%) 1.9 50% Nesp + Nesp-AG1 8.4 6.9 -1.4 (-17%) 14.4 4
Slide 8: Revenue of Major Items (ex-Japan)
Revenue of Major Items (ex-Japan) ( Billion Yen / Rounded ) 2023Q2 2024Q2 2024 Progress Item Changes Reasons Results Results Rev. Plans to goal 175.9→ Crysvita 61.9 85.5 +23.6 (+38%) 187.8 46% North America 46.0 58.7 +12.7 (+27%) [North America] Market penetration [EMEA] Geographical expansion & Add
Slide 9: YoY Analysis -Core OP-
YoY Analysis -Core OP- +6.7 billion yen ⚫ Gross Profit +21.3 (incl. forex effect +16.2) (incl. forex effect +6.3) Increased in conjunction with JPY 33.8B rise in revenue. COGs have increased due to the North America Crysvita Sales royalty after Apr 27, 2023. Hence, gross profit % declined YoY. (76%
Slide 10: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Jun) +16.1 billion yen Core Operating Profit +6.7 Profit Before Tax +20.5 ⚫ Finance/Other +13.8 • Impairment losses +9.1 (-9.4 → -0.3) • Gain on disposal of fixed assets +2.4 (0 → 2.4) © Kyowa Kirin Co., Ltd. 10
Slide 11: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 11
Slide 12: 2024 Key Actions & Q2 Topics (Crysvita)
2024 Key Actions & Q2 Topics Q2 Topics 2024 Key Actions ⚫ Strengthen evidence-based marketing activities. ⚫ Strengthen evidence-based marketing activities. ⚫ North America ⚫ North America: ・Seasonal factors have dissipated, and solid growth continues.(generally in line with plans) Enhance disease aw
Slide 13: 2024 Key Actions & Q2 Topics (Poteligeo)
2024 Key Actions & Q2 Topics 2024 Key Action Q2 Topics ⚫ Deeper penetration into the existing markets as well as expansion of targets through ⚫ NA : Sales revenue increased 50% YoY due to: further progression of evidence-based promotional activities. • Expand evidence-based promotional activities to
Slide 14: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 14
Slide 15: News Flow of Main Development Pipeline Products
News Flow of Main Development Pipeline Products As of Aug 1, 2024 Code Timeline Generic Name Events (Completed are in bold) (Completed are in orange) Atopic Dermatitis P3（ROCKET Program） In progress KHK4083/AMG 451 rocatinlimab Asthma P2 initiation May 2024 Prurigo nodularis P3 initiation July 2024
Slide 16: Rocatinlimab is a Potential T-cell Rebalancing Therapy
Rocatinlimab is a Potential T-cell Rebalancing Therapy • T-cell imbalance is a root cause of inflammatory disease • Rocatinlimab is the potential first and only T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting OX40 receptor • Rocatinlimab is a T-cell rebalancing t
Slide 17: Rocatinlimab – Progress of the ROCKET Program
Rocatinlimab – Progress of the ROCKET Program • Composed of eight studies enrolling adult and adolescent patients • To date, over 3,100 patients have been enrolled in the ROCKET Program with five studies having completed enrollment 1. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT053984
Slide 18: News Flow in 2024
News Flow in 2024 © Kyowa Kirin Co., Ltd. 18
Slide 19: Year-to-date Key News Flow
Year-to-date Key News Flow As of Aug 1, 2024 Category Date Headline SP Jan 5 Out-licensed the exclusive and worldwide rights to Boehringer Ingelheim of developing first-in-class treatment for fibro-inflammatory diseases. SI Jan 24 Completion of share acquisition of Orchard Therapeutics plc, UK bioph
Slide 20: Year-to-date Key News Flow
Year-to-date Key News Flow As of Aug 1, 2024 Category Date Headline ESG May 14 Announced the Publication of a Patient-focused Global Consensus Statement for Improving Diagnosis and Care in Cutaneous T-Cell Lymphoma ( Kyowa Kirin, Inc. ) LCM May 17 Approval for Partial Change of Approved Indication o
Slide 21: Efforts toward the expansion of newborn screening (NBS) for MLD
Efforts toward the expansion of newborn screening (NBS) for MLD https://ir.orchard-tx.com/news-releases/news-release-details/orchard-therapeutics-celebrates-global-progress-toward-advancing Nomination to add MLD to the RUSP1 submitted by Norway has adopted MLD into its national NBS multi-disciplinar
Slide 22: Establishing New Biologics Manufacturing Plant in North Carolina
Establishing New Biologics Manufacturing Plant in North Carolina ✓ Investing up to $530M in construction with two-bioreactor facility ✓ Scheduled to commence construction in H2 2024 and complete in 2027 ✓ Planning to manufacture innovative biologic therapies, including next-generation antibodies, fo
Slide 23: Restructuring of APAC business
Restructuring of APAC business ✓ APAC business will be restructured in accordance with Story For Vision 2030 ✓ China business: Divest all the equity to WinHealth ✓ Established medicines portfolio (excl. China): Grant commercial license to DKSH ✓ Global products (Crysvita and Poteligeo): Grant commer
Slide 24: P/L Impact on Restructuring of APAC business
P/L Impact on Restructuring of APAC business Country / region Until September 2024 October 2024 onwards Divest CN Sales to Partner (Established medicines portfolio) Partnering CN/HK/MO/ Revenue (Established medicines portfolio & Global MY/SG/TH Sales to market Sales to Partner products） /KR/TW Conti
Slide 25: Transition of the Research Organization toward Vision 2030
Transition of the Research Organization aiming to realize Vision toward 2030 ✓ Implement the transition to research functions in line with the 'Story for Vision 2030' and aim to further strengthen our drug discovery capabilities. 1) Shifting focus disease areas: bone & mineral, intractable hematolog
Slide 26: Appendix
Appendix © Kyowa Kirin Co., Ltd. 26
Slide 27: Our Vision toward 2030
Our Vision toward 2030 Provide pharmaceuticals for unmet medical needs We are focused on developing medicines for diseases where there is a Our Vision toward 2030 clear patient need for new options. We make full use of multiple therapeutic modalities, including biotechnology Kyowa Kirin will realize
Slide 28: Story for Vision 2030
Story for Vision 2030 Strategies for creating and delivering life-changing value Disease Science Value Global deployment of delivery on products developed by Focus disease areas: bone & mineral, intractable taking full advantage of our own hematological diseases/hemato oncology, and rare diseases th
Slide 29: 2021-2025 Medium Term Business Plan - Revision of Financial KPI
2021-2025 Medium Term Business Plan - Revision of Financial KPI - ◼ Record high in Core operating profit for FY2023. Achieved KPIs such as “ROE of 10%” and “CAGR of 10% or higher” ◼ Due to the restructuring of our business model to adapt to environmental changes, the continuous achievement timing of
Slide 30: Accounting treatment of share acquisition of Orchard Therapeutics
Accounting treatment of share acquisition of Orchard Therapeutics (Finalized) ✓ Completed the share acquisition on January 24, 2024, and started consolidation from the February 2024 ✓ Recognized intangible assets of $208M (JPY 30.8B) and goodwill of $230M (JPY 34.1B) ✓ Intangible assets will be amor
Slide 31: Main Development Pipeline Products (After Ph2)
Main Development Pipeline Products (After Ph2) As of Aug 1, 2024 Planned Approval Total addressable Diseases under development*1 Development status No. of Patients*4 Year*2 market*3 Moderate to severe 2026/2027 P3 (Global) ★★★★★ 16M Atopic Dermatitis KHK4083/AMG 451 Moderate to severe TBD P2 (Global
Slide 32: Main Development Pipeline Products (nonclinical ~ Ph1)
Main Development Pipeline Products (nonclinical ~ Ph1) As of Aug 1, 2024 Diseases under development*1 Development status Modality, technology KK4277 SLE, CLE P1 (JP, Asia) Antibody, POTELLIGENT® Advanced or metastatic solid P1 (JP: in progress, US: in KK2260 Antibody, REGULGENTTM tumors preparation)
Slide 33: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of Aug 1, 2024 T : Topline data D : Detailed data Code Generic Name Target Disease 2024 2025 2026 ＋ P3 IGNITE P3 HORIZON P3 SHUTTLE KHK4083/ Moderate to severe P3 ASTRO atopic dermatitis AMG 451 P3 ORBIT rocatinlimab P3 VOYAGER P3 ASCEND P3 OUTPOST
Slide 34: Rocatinlimab: Phase 2b data
Rocatinlimab: Phase 2b data1 The Least-squares (LS) mean percent change in Eczema Area and Severity Index (EASI) score Week 16 Week 24 Week 36 Week 56 Rocatinlimab 150 mg Q4W, % -62.2 -68.3 -78.7 -75.0 Rocatinlimab 600 mg Q4W, % -59.5 -73.4 -82.3 -79.5 Rocatinlimab 300 mg Q2W, % -73.6 -81.6 -88.1 -8
Slide 35: Libmeldy (OTL-200, atidarsagene autotemcel)
Libmeldy® (OTL-200, atidarsagene autotemcel) ◼ MLD (Metachromatic Leukodystrophy) ⚫ Fatal genetic CNS disorder ⚫ Rapid and irreversible loss of motor and cognitive function ⚫ In its most severe form, most children pass away within five years of symptom onset1 Ref.) Orchard Therapeutics plc, Q2 2023
Slide 36: FOREX Information
FOREX Information Average FOREX Rates (yen) 2023Q2 2024Q2 Changes 2024 Rev. Plans USD 134 151 +17 151 GBP 164 191 +27 191 EUR 144 163 +19 163 Q1 YoY FOREX Impacts (billion yen) Revenue Core OP USD +11.8 +3.9 GBP +1.1 -0.6 EUR +3.2 +1.8 FY2024 FOREX Sensitivities (based on 2024 Plans, billion yen) Ch
Slide 37: 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 38: 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 39: List of Acronyms
List of Acronyms AD Atopic Dermatitis AG Authorized Generic APAC Asia-Pacific AML Acute Myeloid Leukemia BS Biosimilar CTCL cutaneous T cell lymphoma DME Diabetic Macular Edema EMEA Europe, the Middle East and Africa JP Japan LCM Lifecycle Management MDS Myelodysplastic syndromes MF Mycosis fungoide
Slide 40: Kyowa Kirin Co., Ltd. Corporate Communications Department
Kyowa Kirin Co., Ltd. Corporate Communications Department +81-3-5205-7206 / ir@kyowakirin.com