Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q2 2020 Earnings Presentation
33 slides from Kyowa Kirin's earnings presentation, 2020
Slide 1: Results Presentation Fiscal 2020 Second Quarter
Results Presentation Fiscal 2020 Second Quarter
Slide 2: Agenda
Agenda Q2 Financial Review & FY2020 Revised Plan R&D Review Business Topics President and Chief Executive Officer Masashi Miyamoto, Ph.D Q&A President and Chief Executive Officer Masashi Miyamoto, Ph.D Executive Officer, Head of Finance Motohiko Kawaguchi Executive Officer, Head of R&D Yoshifumi Tor
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: Q2 Financial Review & FY2020 Revised Plan
Q2 Financial Review & FY2020 Revised Plan © Kyowa Kirin Co., Ltd. 4
Slide 5: Summary of Q2 Results
Summary of Q2 Results ( Billion Yen / Rounded ) 2019Q2 2020Q2 2020 Changes Progress Results Results New Plan 327.0→ 48%→ Revenue 151.4 157.8 +6.4 (+4%) 313.0 50% [Overseas Ratio] [37%] [46%] [53%] 250.0→ 47%→ Gross Profit 112.8 116.9 +4.1 (+4%) 236.0 50% [Gross Profit margin] [74%] [74%] [75%] 65.0→
Slide 6: YoY Analysis - Revenue
YoY Analysis ‐Revenue‐ Japan ‐8.3 • Romiplate (Additional indication), G‐Lasta and Rituximab BS made +6.4 billion yen strong growth, however they could not cover the impact such as the shrink of Nesp (Shift to Nesp‐AG) and Patanol/Allelock (Lower (incl. forex effect ‐1.8) pollen and COVID‐19*) and
Slide 7: Revenue of Major Items (Japan)
Revenue of Major Items (Japan) ( Billion yen / Rounded ) 2019Q2 2020Q2 Changes Reason 2020 Progress Item Results Results New Plan Nesp + Nesp‐AG* 25.6 14.6 ‐11.0 (‐43%) 34.7→ 28.9 50% Nesp‐AG launched in Aug 2019 Nesp 25.6 2.2 ‐23.4 (‐91%) and Biosimilars’ penetration 4.0→ 4.6 48% Nesp‐AG ー 12.4 +12
Slide 8: Revenue of Major Items (Overseas)
Revenue of Major Items (Overseas) ( Billion yen / Rounded ) 2019Q2 2020Q2 Changes Reason 2020 Progress Item Results Results New Plan Crysvita*1 13.4 24.7 +11.4 (+85%) Steady market penetration 56.6→ 51.1 48% North America 9.9 19.1 +9.3 (+95%) EMEA 3.5 5.6 +2.0 (+58%) COVID‐19 (Treatment Poteligeo 5.
Slide 9: YoY Analysis - Core OP
YoY Analysis ‐Core OP‐ +2.3 billion yen Gross Profit +4.1 (incl. forex effect ‐1.5) (incl. forex effect ‐0.8) • Increased in conjunction with the rise in revenue. (¥Bn) SG&A ‐2.9 (incl. forex effect +0.7) • Increased selling and launch readiness expenses in the EU/US, including Crysvita’s profit
Slide 10: YoY Analysis - Profit
YoY Analysis ‐Profit‐ Profit (Jan‐Jun) ‐20.3 billion yen (¥Bn) • KHB shares sold in Apr 2019 (Gain on sale of KHB shares 29.7) • Business restructuring expenses (5.1→2.1) +3.0 • Impairment losses (4.8→2.7) +2.1 • Foreign exchange gain/loss +0.8 Core Operating Profit +2.3 Profit from Continued Operat
Slide 11: Summary of FY2020 Revised Plan
Summary of FY2020 Revised Plan ( Billion Yen / Rounded ) 2019 2020 2020 Changes Results Original Plan New Plan Revenue 305.8 327.0 313.0 ‐14.0 (‐4%) [Overseas Ratio] [39%] [47%] [47%] Gross Profit 226.2 250.0 236.0 ‐14.0 (‐6%) [Gross Profit margin] [74%] [76%] [75%] Core OP 59.4 65.0 60.0 ‐5.0 (‐8%)
Slide 12: FY2020 Original Plan vs Revised Plan
FY2020 Original Plan vs Revised Plan Profit (Jan‐Dec) ‐5.0 billion yen Revenue ‐14.0 (Nesp‐AG ‐6.3, • Increase of the deferred tax asset Crysvita ‐5.5, Poteligeo ‐4.3 etc.) due to the change in the assumed • One‐time gain expected tax rate in UK (17%→19%) (¥Bn) ±0 • SG&A +8.0 • Impairment losses ‐2.
Slide 13: R&D Review
R&D Review © Kyowa Kirin Co., Ltd. 13
Slide 14: Key Development Updates in 20Q2
Key Development Updates in 20Q2 • Approval of KRN23 for the treatment of XLH in Hong Kong (April) • Presentation of updated phase 1b study data on ME‐401 for the treatment of follicular lymphoma and other B‐cell malignancies at ASCO (May) • Presentation of phase 2 study data on KHK7791 for the treat
Slide 15: ME-401: Results of a Phase 1b study in B-cell malignancies
ME‐401: Results of a Phase 1b study in B‐cell malignancies ASCO 2020 ClinicalTrials.gov Identifier: NCT02914938 Treatment: ME‐401 monotherapy or in combination with rituximab on IS Daily No therapy Daily dosing x2 cycles x1 week x3 weeks Cycles 1 and 2 Intermittent Schedule on Cycles ≥3 Overall
Slide 16: ME-401: Phase 2 TIDAL study in r/r FL patients
ME‐401: Phase 2 TIDAL study in r/r FL patients ClinicalTrials.gov Identifier: NCT03768505 Subjects: Patients with r/r FL after failure of at least two prior systemic therapies including chemotherapy and an anti‐CD20 antibody Treatment: ME‐401 on intermittent schedule as monotherapy Daily No ther
Slide 17: KHK7791: Phase 2 (PB switching) study design
KHK7791: Phase 2 (PB switching) study design ClinicalTrials.gov Identifier: NCT03831607 Open‐label, single‐arm, phosphate binder switch study for subjects with hyperphosphatemia undergoing hemodialysis Screening Pre‐enrollment Enrollment Phosphate binder (PB) 92 subjects 83 subjects 67 subjects +
Slide 18: KHK7791: Phase 2 (PB switching) study results
KHK7791: Phase 2 (PB switching) study results Primary endpoint Achievement ratio P value [95%CI] 30% decrease 71.6% (48/67) <0.001 [59.3, 82.0] CI confidence interval. Mean change Mean change in s‐P over time in total PB tablets over time Start of KHK7791 (mg/dL) Start of KHK7791 administratio
Slide 19: Key Development Updates after June
Key Development Updates after June • Receipt of a positive opinion by the Committee for Medicinal Products for Human Use on the marketing authorization application for KRN23 for adult XLH in Europe (July) © Kyowa Kirin Co., Ltd. 19
Slide 20: Business Topics
Business Topics © Kyowa Kirin Co., Ltd. 20
Slide 21: Impact of COVID-19 and Countermeasures
Impact of COVID‐19 and Countermeasures Supply Chains • March to April: Disrupted logistics mainly in the EU, but no problems now • No delays in the import and supply of raw materials • Logistics costs are rising Region Status • Japan (sales) ⁃ In principle, working from home ⁃ Product recall, PV act
Slide 22: Our Supporting Activities Related to COVID-19
Our Supporting Activities Related to COVID‐19 China Zhong Nanshan Medical Foundation Donation March Japan National Institution of Infectious Diseases Provided March API ‐ April EMEA Supported local medical systems and patients Donation April Counties (e.g. The Red Cross in Spain） EMEA Supported heal
Slide 23: Business topics
Business topics June Commercial launch of “Poteligeo” in Europe June Approval of “Duvroq” in Japan for Patients with Renal Anemia June Approval of “Adalimumab (Genetical Recombination) [Adalimumab Biosimilar 1]” in Japan July U.S. FDA Approval of “Hulio” (adalimumab‐fkjp) July Positive CHMP Opinion
Slide 24: Product portfolio in Nephrology area (as of July 2020)
Product portfolio in Nephrology area (as of July 2020) Renal function Progress of CKD Stage Non dialysis stage (CKD stage 1‐5) ESRD/Dialysis Stage Hyper Coniel (1991) Coversyl (1998) tension Co‐morbidity/ Diabetes Onglyza (2013) Cause of disease KW‐3357 RTA 402 Espo (1990) Nesp (2007) Darbepoetin al
Slide 25: Appendix
Appendix © Kyowa Kirin Co., Ltd. 25
Slide 26: FOREX Information
FOREX Information Average FOREX Rate (Yen) 2019Q2 2020Q2 2020 Currency Changes Results Results New Plan USD/JPY 110 109 ‐1 108 GBP/JPY 143 138 ‐5 135 2020Q2 FOREX Impact (YoY) (Billion yen) Currency Revenue Core OP USD/JPY ‐0.2 ‐0.1 GBP/JPY ‐1.1 ‐0.4 FY2020 Currency Fluctuation Sensitivity (New) (Bi
Slide 27: Key progress in development (2020 Q2)
Key progress in development (2020 Q2) Note: Listed events were completed between January 1st, 2020 and June 30th, 2020. Generic name Month Code Indication Country/region Event Istradefylline Jan. KW‐6002 Parkinson’s disease EU Accepted MAA Pegfilgrastim Feb. KRN125 Chemotherapy induced febrile neutr
Slide 28: Submission plan of major pipeline
Submission plan of major pipeline As of June 30th, 2020 Generic name Code Indication Country/region 2020 H1 2020 H2 2021 Brodalumab KHK4827 Psoriasis CN + Brodalumab KHK4827 Psoriasis AS + Brodalumab KHK4827 Axial spondyloarthritis JP + Brodalumab Axial spondyloarthritis KHK4827 Psoriatic arthritis
Slide 29: Development plan of major pipeline
Development plan of major pipeline As of June 30th, 2020 Generic name Code Indication Country/region 2020 2021 2022~ Bardoxolone methyl Diabetic Kidney disease RTA 402 JP Phase 3 Bleselumab1 Recurrence of FSGS in de ASKP1240 novo kidney transplant US Phase 2 Phase 3 Entinostat Breast cancer KHK2375
Slide 30: Estimated annual incidence/prevalence
Estimated annual incidence/prevalence Disease Country Estimated # of Incidence (i) Source /Region or Prevalence (p) ATL Japan i: 1,150 per year i: Survey and countermeasures to HTLV‐1 infection and related diseases in Japan. 2009 summary p: 2,000 research report (Yamaguchi, 2010) p: Ministry of Heal
Slide 31: Crysvita - Collaboration with Ultragenyx
Crysvita ‐ Collaboration with Ultragenyx ‐ Kyowa Kirin Group Ultragenyx Books sales For first 5 years, splits profits in half U.S.A For first 5 years, splits profits in half After 5 years, receives mid to high 20% range sales /Canada After 5 years, pays mid to high 20% range sales royalty
Slide 32: List of acronyms
List of acronyms AA Aplastic Anemia AD Atopic Dermatitis ATL Adult T‐Cell Leukemia/Lymphoma BS Biosimilar CKD Chronic Kidney Disease CTCL Cutaneous T‐Cell Lymphoma DKD Diabetic Kidney Disease ENS Epidermal Nevus Syndrome FL Follicular Lymphoma FSGS Focal Segmental Glomerulosclerosis HAM HTLV‐1 Assoc
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