Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q2 2018 Earnings Presentation
35 slides from Kyowa Kirin's earnings presentation, 2018
Slide 1: Results Presentation Fiscal 2018 Interim
Results Presentation Fiscal 2018 Interim Kyowa Hakko Kirin Co., Ltd. © Kyowa Hakko Kirin Co., Ltd.
Slide 2: Agenda
Agenda 2Q Summary Masashi Miyamoto, Ph.D Executive Director of the board, President & COO Financial Review Motohiko Kawaguchi Executive Officer, Director of Accounting Department R&D Review Masashi Miyamoto, Ph.D Executive Director of the board, President & COO Business Topics Masashi Miyamoto, Ph.D
Slide 3: Forward-looking statements
Forward‐looking statements 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 pr
Slide 4: 2Q Summary
2Q Summary © Kyowa Hakko Kirin Co., Ltd. 4
Slide 5: Summary of the Consolidated Results
Summary of the Consolidated Results 2017Q2 2018Q2 2018Q4 Progression Results Results Changes Plan Rate (published on Feb 8) ‐4.9 Revenue 177.0 172.1 335.0 51% (‐3%) Core Operating +2.0 Profit (Core OP) 30.1 32.1 51.0 63% [Margin] [17.0%] [18.7%] (+7%) [15.2%] +13.9 Profit 20.3 34.3 44.0 78% (+68%) (
Slide 6: Financial Review
Financial Review © Kyowa Hakko Kirin Co., Ltd. 6
Slide 7: Consolidated: YoY Analysis - Profit
Consolidated: YoY Analysis ‐Profit‐ Profit (Jan‐Jun) +13.9 billion yen (¥Bn) Gain on sale & valuation of Kyowa Medex shares +11.0 Gain on reversal of impairment losses +3.4 Pharmaceuticals +0.0 Pharmaceuticals ‐1.7 Bio‐Chemicals +0.7 Bio‐Chemicals ‐0.5 Upfront revenue from license‐out of FKB3
Slide 8: Summary of the Results by Segment
Summary of the Results by Segment Pharmaceuticals’ Core OP increased due to improvement in the gain/loss by the equity method despite the decrease in revenue. Bio‐Chemicals’ Core OP also increased due to improved profitability despite the decrease in revenue. 2017Q2 2018Q2 Changes 2018Q4 Progres
Slide 9: Pharmaceuticals: YoY Analysis - Revenue
Pharmaceuticals: YoY Analysis ‐Revenue‐ Domestic Drug ‐3.5 ‐3.6 billion yen • NEGATIVE･･･The main product Nesp declined due to the drug price cut. Regpara dropped due to the (incl. forex effect +1.1) presence of competing product. Long‐listed products including Allelock, Coniel, Asacol, and Depake
Slide 10: Pharmaceuticals: YoY Analysis - Core OP
Pharmaceuticals: YoY Analysis ‐Core OP‐ +1.6 billion yen Gross Profit +0.0 (incl. forex effect +0.9) • Remained at the same level as the last year as the (incl. forex effect ‐0.1) increased overseas & tech‐licensing revenue covered the lower domestic drug sales and the impact of deconsolidation of
Slide 11: Pharmaceuticals: Revenue of Major Items
Pharmaceuticals: Revenue of Major Items 2017Q2 2018Q2 2018Q4 Progression Item Results Results Changes Reason Plan Rate Nesp 26.6 25.6 -1.1 Drug price cut 52.4 49% JP (-4%) Regpara 9.4 7.8 -1.7 Market penetration 13.2 59% JP (-18%) of the competitor Market penetration Allelock 9.1 7.5 -1.7 of GE drug
Slide 12: Bio-Chemicals: YoY Analysis - Revenue
Bio‐Chemicals: YoY Analysis ‐Revenue‐ ‐1.5 billion yen (incl. forex effect +0.3) Overseas ‐0.5 (incl. forex effect +0.3) • Americas ‐0.2 (incl. forex effect ‐0.2) • Europe ‐0.0 (incl. forex effect +0.6): (¥Bn) Due to fiercer competition in certain products. • Asia & others ‐0.3 (incl. forex effect
Slide 13: Bio-Chemicals: YoY Analysis - Core OP
Bio‐Chemicals: YoY Analysis ‐Core OP‐ +0.2 billion yen (incl. forex effect +0.1) (¥Bn) Gross Profit +0.7 (incl. forex effect +0.1) • Improved profitability resulting from the lineup revamping and stable operation at the Thailand plant. SG&A ‐0.6 (incl. forex effect +0.0) • Increased advertisemen
Slide 14: R&D Review
R&D Review © Kyowa Hakko Kirin Co., Ltd. 14
Slide 15: Key development events in 2018 (1)
Key development events in 2018 (1) Generic name Country/ Indication Month Event Code region Mar. Designated under the SAKIGAKE system1 Bardoxolone methyl Diabetic kidney Japan RTA 402 disease May Initiated phase 3 study Europe Jan. Approved (BN: Fasenra) Benralizumab2 Asthma KHK4563 Japan Jan. Appro
Slide 16: Key development events in 2018 (2)
Key development events in 2018 (2) Generic name Country/ Indication Month Event Code region Evocalcet Secondary Approved Japan Mar. KHK7580 hyperparathyroidism (BN: Orkedia tablets) Chemotherapy Granisetron Approved induced nausea and Malaysia Jan. ‐ (BN: Sancuso) vomiting Mogamulizumab CTCL U.S. Ma
Slide 17: Key development update in 18Q2
Key development update in 18Q2 • Initiation of phase 3 clinical study of bardoxolone methyl (RTA 402) for the treatment of diabetic kidney disease (DKD) in Japan © Kyowa Hakko Kirin Co., Ltd. 17
Slide 18: RTA 402: Current situation regarding DKD in Japan
RTA 402: Current situation regarding DKD in Japan The number of diabetes patients in Japan is increasing1 and DKD is the leading cause in over 40% of new dialysis patients. In a recent report2 issued by the MHLW, the target number of new dialysis patients has been set as 39,344 pts (2016) → below 35
Slide 19: RTA 402: Current situation and environment
RTA 402: Current situation and environment Clinical efficacy of Update to the clinical Enhancing the healthcare RTA 402 guideline1 system2 RTA 402 showed significant Japanese Society of In order to strengthen the relation‐ ships between healthcare profes‐ improvement in GFR Nephrology proposed a new
Slide 20: RTA 402: clinical studies list
RTA 402: clinical studies list RTA 402 Development stage Dosed patients Country/ (Scheduled) trial completion date Indication (Estimated region enrollment) Phase 2 Phase 3 Chronic kidney disease Japan 2017/9 120 with diabetes1 Diabetic kidney Japan (2022/3) (700) disease2 ClinialTrials.gov identifie
Slide 21: RTA 402: Phase 2 clinical study design and status
RTA 402: Phase 2 clinical study design and status A Randomized, Double‐blind, Placebo‐controlled RTA 402 Clinical Trial in Patients with Chronic Kidney Disease and Type 2 Diabetes (TSUBAKI study) Efficacy primary endpoint: Changes in glomerular filtration rate (GFR) after 16 weeks of study drug admi
Slide 22: RTA 402: Phase 2 clinical study data
RTA 402: Phase 2 clinical study data Change in GFR assessed by inulin clearance from baseline at week 16 p=0.008 10 Placebo BARD Between 8 N=25 N=19 Groups 6 Baseline 48.13 ± 9.86 48.95 ± 9.62 ― GFR (mL/min/1.73 m2) 4 Week 16 47.71 ± 11.63 54.54 ± 12.21 ― 2 Difference ‐0.69 5.95 6.64 0 LS Mean ± 95
Slide 23: RTA 402: Phase 3 clinical study design
RTA 402: Phase 3 clinical study design A Randomized, Double‐blind, Placebo‐controlled Clinical Trial in Patients with Diabetic Kidney Disease (DKD) (AYAME study) Efficacy primary endpoint: Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD Target Disease stage: G3, G4 Target Sample size
Slide 24: Business Topics
Business Topics © Kyowa Hakko Kirin Co., Ltd. 24
Slide 25: Progress in products under the alliances with partners
Progress in products under the alliances with partners Country/ Product Indication Month Event region Feb. Approved Dovobet Gel Psoriasis Japan Jun. Launched CD20 positive, B‐cell non Hodgkin’s lymphoma Rituximab BS CD20 positive, B‐cell Intravenous lymphoma under Japan Jan. Launched Infusion
Slide 26: Progress in the BS business - FUJIFILM KYOWA KIRIN BIOLOGICS
Progress in the BS business ‐FUJIFILM KYOWA KIRIN BIOLOGICS‐ FKB327 ( adalimumab, biosimilar to Humira ) Concluded an exclusive sales agreement in Europe with Mylan. Mylan who has excellent sales capabilities in Europe and is the optimum partner for maximizing the value of FKB327. Based on the
Slide 27: Appendix
Appendix © Kyowa Hakko Kirin Co., Ltd. 27
Slide 28: FOREX Information
FOREX Information Average FOREX Rate [ Yen ] 2017Q2 2018Q2 2018Q4 Currency Changes Results Results Plan USD/JPY 113 109 ‐4 110 EUR/JPY 122 132 +10 130 GBP/JPY 142 151 +9 150 2018Q2 FOREX Effect (YoY) [ Billion Yen] Segment Currency Revenue Core OP USD ‐0.2 ‐0.1 Pharmaceuticals EUR +0.0 +0.0 GBP +1.1
Slide 29: Burosumab: Collaboration with Ultragenyx (summary)
Burosumab： Collaboration with Ultragenyx (summary) KHK group Ultragenyx Splits profits in half with KHK Books sales for first 5 years U.S.A Splits profits in half with Ultragenyx for first 5 years After 5 years, receives mid to Canada After 5 years, pays mid to high 20% range sales royalty
Slide 30: Development schedule of major pipeline
Development schedule of major pipeline As of June 30 +：Estimated time of regulatory decisions Generic name Country/ Indication 2018 2019 2020~ Code region Bardoxolone methyl Diabetic kidney Japan Phase 3 RTA 402 disease Benralizumab1 U.S., Europe TBD COPD KHK4563 Japan TBD Psoriasis Asia Submission
Slide 31: Development schedule of major pipeline (cont.)
Development schedule of major pipeline (cont.) As of June 30 Country/ Code Indication 2018 2019 2020~ region Recurrence of FSGS in ASKP1240 4 de novo kidney U.S. Phase 2 transplant Ulcerative colitis U.S., Europe Phase 2 KHK4083 U.S., Europe, Atopic dermatitis Phase 2 Japan KW‐6356 Parkinson’s disea
Slide 32: Diabetes Patients under Treatment
RTA 402 for Diabetic Kidney Disease (DKD) patients Glycemic Control Diabetes Patients under Blood Pressure Control Treatment (Patient population: 7.7 million)* Protect renal function by some diabetes drugs including SGLT2 inhibitors RTA 402 Target Patients (DKD): Improve renal function by RT
Slide 33: ESG indexes
ESG indexes Included in all three ESG indexes selected by GPIF* Broad index Thematic/social (S) Kyowa Hakko Kirin is also included in several of the major socially responsible investment (SRI) indexes © Kyowa Hakko Kirin Co., Ltd. 33 * GPIF: Government Pension Investment Fund
Slide 34: List of acronyms
List of acronyms BS Biosimilar COPD Chronic Obstructive Pulmonary Disease CTCL Cutaneous T‐Cell Lymphoma CKD Chronic Kidney Disease DKD Diabetic Kidney Disease ESRD End Stage Renal Disease FSGS Focal Segmental Glomerulosclerosis ITP Idiopathic (immune) Thrombocytopenic Purpura XLH X‐linked Hypophosp
Slide 35: Kyowa Hakko Kirin Group contact
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well‐being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. Kyowa Hakko Kirin Co Ltd Corporate Communications Dept, IR Group Tel: +81‐3‐5205‐7206 © Kyowa Ha