Slide 1: FY2017 2Q Consolidated Financial Overview (IFRS based)
FY2017 2Q Consolidated Financial Overview (IFRS based) CHUGAI PHARMACEUTICAL CO., LTD. Executive Vice President, CFO Yoshio Itaya July 27/28, 2017
Slide 2: Forward-Looking Statements
FY2017 2Q Consolidated Financial Overview Forward-Looking Statements This presentation may include forward-looking statements pertaining to the business and prospects of Chugai Pharmaceutical Co., Ltd. (the “Company”). These statements reflect the Company’s current analysis of existing information a
Slide 3: 2Q Results Summary
FY2017 2Q Consolidated Financial Overview 2Q Results Summary Revenues: 252.8 billion yen (+5.3, +2.1% YoY) • Domestic sales excl. Tamiflu: decrease due to impact of HIP revision (-1.2, -0.7%) • Overseas sales: growth of Alecensa, but lower sales of Actemra mainly due to FX impact (-0.1, -0.2%) • R
Slide 4: IFRS and Core Results Jan-Jun
FY2017 2Q Consolidated Financial Overview IFRS and Core Results Jan-Jun IFRS results Non-core items Core results (Billion JPY) 2017 2017 Intangible assets Others (Billions of JPY) Jan - Jun Jan - Jun Non-Core items Revenues 252.8 252.8 Sales 236.8 236.8 1. Intangible assets: Amortization of intangib
Slide 5: Financial Overview Jan - Jun
FY2017 2Q Consolidated Financial Overview Year on Year (Core) Financial Overview Jan - Jun 2016 2017 (Billions of JPY) Jan - Jun Jan - Jun Growth vs. Revenues vs. Revenues (Billions of JPY) Revenues 247.5 252.8 +5.3 +2.1% Royalties and other operating income +5.6 Sales 237.2 236.8 -0.4 -0.2% Increas
Slide 6: Sales (excl. Tamiflu) Jan - Jun
FY2017 2Q Consolidated Financial Overview Year on Year Sales (excl. Tamiflu) Jan - Jun Sales by Disease Area, Sales by Products, Year on Year Comparisons Year on Year Changes (Billions of JPY) 230.0 -1.3, -0.6% 228.7 Overseas -5.4, -14.8% Actemra Alecensa +4.1, +292.9% 45.8 -0.1, -0.2% 45.7 (oversea
Slide 7: Tamiflu Sales Trends
FY2017 2Q Consolidated Financial Overview Tamiflu Sales Trends Fiscal Term Sales Season (Billions of JPY) FY2012 FY2013 FY2014 FY2015 FY2016 FY2017 (from the second half of FY to Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun the first half of the next FY) 7.
Slide 8: Operating Profit Jan - Jun
FY2017 2Q Consolidated Financial Overview Year on Year (Core) Operating Profit Jan - Jun (Billion of JPY) (Billions of JPY) 2016 2017 Growth Jan - Jun Jan - Jun Revenues 247.5 252.8 +5.3 R&D Cost of sales -124.4 -120.8 +3.6 Royalties and +0.9 -2.3 Gross profit 123.1 131.9 +8.8 other operating M&D G&
Slide 9: Financial Overview Apr - Jun
FY2017 2Q Consolidated Financial Overview Year on Year (Core) Financial Overview Apr - Jun 2016 2017 (Billions of JPY) Apr - Jun Apr - Jun Growth Increase in gross profit from sales +0.6 vs. Revenues vs. Revenues Improvement of cost of sales ratio to Revenues 127.6 127.3 -0.3 -0.2% sales Sales 121.6
Slide 10: Financial Progress Jan - Jun
FY2017 2Q Consolidated Financial Overview vs. Forecast (Core) Financial Progress Jan - Jun Forecast Actual on Feb. 1 2016 (Billions of JPY) 2017 2017 Progress Progress * Jan - Jun Jan - Dec Revenues 252.8 520.5 48.6% 50.3% Sales 236.8 490.4 48.3% 50.2% excl. Tamiflu 228.7 482.2 47.4% 50.1% Cost of s
Slide 11: Sales Progress (excl. Tamiflu) Jan - Jun
FY2017 2Q Consolidated Financial Overview vs. Forecast (Core) Sales Progress (excl. Tamiflu) Jan - Jun Forecast Forecast Actual Actual on Feb. 1 2016 on Feb. 1 2016 (Billions of JPY) (Billions of JPY) 2017 2017 2017 2017 Progress Progress * Progress Progress * Jan - Jun Jan - Dec Jan - Jun Jan - Dec
Slide 12: Impact from Foreign Exchange
FY2017 2Q Consolidated Financial Overview vs. Forecast (Core) Impact from Foreign Exchange FX impact Jan – Jun 2017 [Reference] (Billions of JPY) Historical exchange rate to the JPY (FX impact vs. Assumption) JPY Forecast rate 2017 EUR 2017 CHF 2016 EUR 2016 CHF 135 +0.0 130 Revenues 1EUR: 122JPY Sa
Slide 13: Balance Sheet Items
FY2017 2Q Consolidated Financial Overview vs. 2016 Year End Balance Sheet Items < Assets, Liabilities, and Net Assets > 2016 2017 ●Decrease in net working capital -11.5 (Billions of JPY) Change Dec Jun Decrease in trade accounts receivable -11.8 Trade accounts receivable 140.7 128.9 - 11.8 Inventori
Slide 14: Net Cash
FY2017 2Q Consolidated Financial Overview vs. 2016 Year End Net Cash (Billions of JPY) ●Operating profit after adjustments +56.9 Total investment Decrease in net working +11.6 Operating profit +47.1 -24.7 capital, etc. Depreciation and amortization, etc. +9.8 Others ●Decrease in net working capital,
Slide 15: Free Cash Flow Jan - Jun
FY2017 2Q Consolidated Financial Overview Year on Year Free Cash Flow Jan - Jun 2016 2017 ●Operating profit after adjustment +3.6 (Billions of JPY) Change Jan-Jun Jan-Jun ●Total increase (‐) / decrease in net working +30.1 Operating profit - IFRS basis 43.5 47.1 +3.6 capital, etc. Depreciation and i
Slide 16: Overview of Development Pipeline
Overview of Development Pipeline CHUGAI PHARMACEUTICAL CO., LTD. Senior Vice President Head of Project & Lifecycle Management Unit Yasushi Ito July 27/28, 2017
Slide 17: Projects under Development (1)
Overview of Development Pipeline Projects under Development (1) (as of Jul. 27, 2017) Phase I Phase II Phase III Filed CKI27 RG1273 / Perjeta RG7446 / RG7446 / (Japan / overseas) - breast cancer atezolizumab atezolizumab - solid tumors (adjuvant) - NSCLC (adjuvant) - NSCLC - gastric cancer - SCLC RG
Slide 18: Projects under Development (2)
Overview of Development Pipeline Projects under Development (2) (as of Jul. 27, 2017) Phase I Phase II Phase III Filed EOS789 Renal (Japan / overseas) - Hyperphosphatemia RG7845 MRA / Actemra MRA / Actemra - rheumatoid arthritis★ - systemic sclerosis - large-vessel vasculitis Autoimmune SA237 / RG61
Slide 19: Development Status (1)
Overview of Development Pipeline Development Status (1) In- Actemra® house Giant-cell arteritis Approved in May 2017 (US) Recommendation for approval granted in July 2017 (EU) In- ACE910 / emicizumab house Hemophilia A (inhibitor) Filed for marketing approval in June (US/EU), July (Japan) 2017 In- R
Slide 20: Development Status (2)
Overview of Development Pipeline Development Status (2) In- Suvenyl® house Knee osteoarthritis / Shoulder periarthritis Started Phase 3 study in July 2017 (China) In- RG7845 (BTK inhibitor) licensed Rheumatoid arthritis Started Phase 1 study in June 2017 In- RG7421 / cobimetinib (MEK inhibitor) lice
Slide 21: Other Progress
Overview of Development Pipeline Other Progress In- Actemra® house Rheumatoid arthritis, weekly dosing Approved in June 2017 In- ACE910 / emicizumab house License agreement with JW Pharmaceutical to grant exclusive marketing right in South Korea in May 2017 In- CIM331 / nemolizumab house Atopic derm
Slide 22: MoA of RG7845 (BTK inhibitor)
Overview of Development Pipeline MoA of RG7845 (BTK inhibitor) • BTK is a non-receptor tyrosine kinase which plays an important role in the pathogenesis of autoimmune diseases: proliferation of B cells and differentiation into antibody- producing cells, cytokine production of myeloid cells etc. • BT
Slide 23: Results of Clinical Trials (1)
Overview of Development Pipeline Results of Clinical Trials (1) In- RG7446 / atezolizumab licensed Locally advanced or metastatic urothelial carcinoma Primary endpoint not achieved in global Phase 3 study (IMvigor211) • Statistically significant improvement in overall survival compared to chemothera
Slide 24: Results of Clinical Trials (2)
Overview of Development Pipeline Results of Clinical Trials (2) In- Alecensa ® house ALK+ NSCLC Japanese Phase 3 study (J-ALEX) • May 2017: efficacy and safety data published in The Lancet Online Global Phase 3 study (ALEX) • June 2017: efficacy and safety data presented at the 2017 annual meeting o
Slide 25: Alecensa / alectinib ALEX Study
Overview of Development Pipeline Alecensa ® / alectinib ALEX Study • Results from alectinib arm compared with crizotinib arm demonstrated: – a 53% reduction in the risk of disease progression or death (primary endpoint) – a 12-month cumulative incidence rate of CNS progression of 9.4% vs. 41.4% in c
Slide 26: ACE910 / Emicizumab HAVEN 1 Study
Overview of Development Pipeline ACE910 / Emicizumab HAVEN 1 Study • Study was conducted in adult or adolescent (>12 years of age) hemophilia A patients with inhibitors • A 87% reduction in treated bleeds was observed compared with No prophylaxis group (primary endpoint) • A 79% reduction in treated
Slide 27: ACE910 / Emicizumab HAVEN 2 Study
Overview of Development Pipeline ACE910 / Emicizumab HAVEN 2 Study • Interim analysis was conducted in 19 children (<12 years of age) with hemophilia A with inhibitors (median observation period: 12 weeks) • Only one of 19 children receiving emicizumab reported a treated bleed • An intra-patient com
Slide 28: Foundation Medicine, Inc., FMI
Foundation Medicine, Inc., FMI • Founded 2010 in Cambridge, MA, USA. • In 2015, Roche made an equity investment and owns approx 59.6% of the common stock as of Dec 2016. Development of Future Pharma & FMI portfolios Opportunities Collaboration with Roche Pharma portfolios using existing FMI Essentia
Slide 29: Chugai's Contribution to PHC
Chugai’s Contribution to PHC Human Deeper TCGA Evolving Clinical understanding Targeted Tx Genome Comprehensive technology decision disease approach Project diagnosis incl. NGS support biology 1990~ Now Future Single patient, CGP precisely comprehensive profile, individualised treatment connects opt
Slide 30: Projected Submissions (Post PoC NMEs and Products)
Overview of Development Pipeline Projected Submissions (Post PoC NMEs and Products) NME line extension Filed in-house in-licensed ACTEMRA atezolizumab *Atopic dermatitis is under development by licensees (MRA) (RG7446) [Galderma (overseas) and Maruho (Japan)] Giant Cell Arteritis NSCLC (EU) nemolizu
Slide 31: Updates on the Development Requests for Unapproved Drugs/Indications
Overview of Development Pipeline Updates on the Development Requests for Unapproved Drugs/Indications Review Committee of Development Requests for Unapproved Drugs/Indication • 1st round requests: all approved (ten indications, including additional dosages and administrations, of eight products) • 2
Slide 32: Contacts: Corporate Communications Dept.
Contacts: Corporate Communications Dept. Media Relations Group Tel: +81 (0)3-3273-0881 Fax: +81 (0)3-3281-6607 e-mail: pr@chugai-pharm.co.jp Koki Harada, Hiroshi Araki, Sachiyo Yoshimura, Chisato Miyoshi, Yayoi Yamada Investor Relations Group Tel: +81 (0)3-3273-0554 Fax: +81 (0)3-3281-6607 e-mail: i