Slide 1: Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook - CHUGAI PHARMACEUTICAL CO., LTD. President, COO Tatsuro Kosaka January 28/29, 2015
Slide 2: Forward-Looking Statements
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- 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 curre
Slide 3: 2014 Results
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- 2014 Results Revenues: 8.8% YoY increase led by steady growth of new products Core Operating Profit: Target achievement rate 108.9%, with a minimal YoY decline 2013 2014 2014年 achiev. billion JPY Jan -Dec Jan - Dec Growth
Slide 4: Overview of 2014
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- Overview of 2014 Revenues: 461.1 billion yen (YoY +8.8%) Product launch: 2 new products, Kadcyla, Alecensa Approval: new formulation of RoActemra (SC, EU) Filing: 2 projects, Zelboraf, Xeloda Clinical developmen
Slide 5: Mid-term Business Plan ACCEL 15
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- Mid-term Business Plan “ACCEL 15” <Strategic Policies> 1. Increase of Marketing Productivity 2. Acceleration of Global Development 3. Continuous Generation of Innovative Realization of Projects 4. Further Strengthening of
Slide 6: Progress of ACCEL 15 in 2014
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- Progress of ACCEL 15 in 2014 Increase of Marketing Productivity Acceleration of Global Development Fast penetration of new products Started P3 multinational study of HER2 franchise Alecensa (NSCLC) Alecensa Prog
Slide 7: Sales Performance up to 2014
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- Sales Performance up to 2014 Sustainable sales growth driven by steady growth of mainstay products and fast penetration of new products 【billion JPY】 ＜Sales excluding Tamiflu＞ 423.8 390.2 347.1 74.3 338.7 336.2 61.1 Overs
Slide 8: R&D Performance up to 2014
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- R&D Performance up to 2014 Seamless development and launch of innovative drugs Number of new project Number of ongoing multinational studies Number of filings Number of approvals 3 10 12 4 8 2 4 6 11 15 3 12 7 4 4 8 7 7 7
Slide 9: A Top Pharmaceutical Company: FY2014 Achievement of Quantitative Target
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- A Top Pharmaceutical Company FY2014 Achievement of Quantitative Target Target: Gain a position among the top 3 major Japanese pharmaceutical companies 2014 2013 Domestic sales share △ Ranked 4th 5th Consolidated operating
Slide 10: 2015 Outlook
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- 2015 Outlook Increase in revenues and profit led by mainstay and new products 2014 2015 billion JPY Jan - Dec Jan - Dec Growth forecast Revenues 461.1 486.5 +25.4 +5.5% Sales 436.9 460.8 +23.9 +5.5% Royalties and other 24
Slide 11: Focus for 2015
Aiming to Become a Top Pharmaceutical Company - 2014 Results and 2015 Outlook- Realizing the High Level Achievement of ACCEL 15 Focus for 2015 Market creation by Enhancement of development providing solutions capabilities to obtain utilizing all-Chugai Early PoC/PoC with resources Increase of Accele
Slide 12: FY2014 Consolidated Financial Overview (IFRS based)
FY2014 Consolidated Financial Overview (IFRS based) CHUGAI PHARMACEUTICAL CO., LTD. Executive Vice President, CFO Yoshio Itaya January 28/29, 2015
Slide 13: Full Year Results Summary
FY2014 Consolidated Financial Overview Full Year Results Summary Revenues: 461.1 billion JPY (+37.4, +8.8% YoY) • Domestic sales excl. Tamiflu (+20.3, +6.2%): increase due to steady growth of mainstay products and new products • Overseas sales (+13.2, +21.6%): increase due to yen depreciation and
Slide 14: IFRS and Core Results Jan – Dec
FY2014 Consolidated Financial Overview IFRS and Core Results Jan – Dec IFRS results Non-core items Core results (Billion JPY) (Billion JPY) 2014 Intangible assets Other 2014 and Business eliminated Non-Core items Jan - Dec combinations items Jan - Dec 1. Intangible/Business combinations Revenues 461
Slide 15: Financial Overview Jan – Dec
FY2014 Consolidated Financial Overview Year on Year (Core) Financial Overview Jan – Dec 2013 2014 (Billion JPY) (Billion JPY) Jan - Dec Jan - Dec Growth vs. Revenues vs. Revenues Revenues 423.7 461.1 +37.4 +8.8% Royalties and other operating income +1.8 Sales 401.3 436.9 +35.6 +8.9% Actemra-related
Slide 16: Sales (excl. Tamiflu) Jan – Dec
FY2014 Consolidated Financial Overview Year on Year Sales (excl. Tamiflu) Jan – Dec Sales (excl. Tamiflu) (Billion JPY) 423.8 (+33.6, +8.6%) Actemra Epogin (overseas) -3.9 390.2 (6.6) (55.7) +12.5 Overseas 74.3 Neutrogin Avastin -2.2 +13.2, +21.6% (5.9) (82.3) +6.9 61.1 Perjeta Others -2.2 Sigmart 2
Slide 17: Tamiflu Sales Performance
FY2014 Consolidated Financial Overview Tamiflu Sales Performance Fiscal Term Sales (Billion JPY) FY2009.12 FY2010.12 FY2011.12 FY2012.12 FY2013.12 FY2014.12 Cases per Seasonal sentinel* Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Sales (millions) 2
Slide 18: Operating Profit Jan – Dec
FY2014 Consolidated Financial Overview Year on Year (Core) Operating Profit Jan – Dec (Billion JPY) 2013 2014 (Billion JPY) Growth M&D R&D Jan - Dec Jan - Dec Royalties and other Revenues 423.7 461.1 +37.4 operating income +1.8 -0.2 Cost of sales -186.1 -217.0 -30.9 Gross profit 237.6 244.2 +6.6 -6.
Slide 19: Financial Overview Oct – Dec
FY2014 Consolidated Financial Overview Year on Year (Core) Financial Overview Oct – Dec 2013 2014 (Billion JPY) (Billion JPY) Oct - Dec Oct - Dec Growth vs. Revenues vs. Revenues Revenues 117.1 127.7 +10.6 +9.1% Increase in gross profit from sales +2.3 Sales 112.5 121.7 +9.2 +8.2% Increase in sales
Slide 20: Financial Overview Jan – Dec vs. Forecast
FY2014 Consolidated Financial Overview vs. Forecast (Core) Financial Overview Jan – Dec Actual Forecast on Jan 30 (Billion JPY) 2014 2014 Achiev*. Jan - Dec Jan - Dec +/- Revenues 461.1 451.0 +10.1 102.2% Sales 436.9 427.0 +9.9 102.3% excl. Tamiflu 423.8 418.2 +5.6 101.3% Domestic 349.5 335.7 +13.8
Slide 21: Sales (excl. Tamiflu) Jan – Dec vs. Forecast
FY2014 Consolidated Financial Overview vs. Forecast (Core) Sales (excl. Tamiflu) Jan – Dec Sales (excl. Tamiflu) 423.8 (+5.6, Achiev*.101.3%) (Billion JPY) -9.4 Actemra Perjeta +4.4 85.6% (overseas) 193.6% (9.1) 418.2 Overseas (55.7) Kadcyla -8.2, -9.9% -2.0 +2.1 74.3 Mircera (4.0) 82.5 91.9% 210.5%
Slide 22: Impact from Foreign Exchange
FY2014 Consolidated Financial Overview vs. Forecast (Core) Impact from Foreign Exchange [Reference] FX impact Jan - Dec (Billion JPY) Historical exchange rates to the JPY (CHF, EUR) (vs. Forecast on Jan. 30) JPY 2014 EUR 2014 CHF 2013 EUR 2013 CHF 150 -0.5 145 140 135 Revenues Sales -0.3 130 Royalti
Slide 23: Balance Sheet Items
FY2014 Consolidated Financial Overview vs. 2013 Year End Balance Sheet Items < Assets, Liabilities, and Net Assets > 2013 2014 Net working capital +32.3 (Billion JPY) Change Trade accounts receivable +30.2 Dec Dec Trade accounts receivable 111.1 141.3 + 30.2 Increase in sales and the advance receive
Slide 24: Net Cash
FY2014 Consolidated Financial Overview vs. 2013 Year End Net Cash (Billion JPY) Total increase in net working Operating cash flow after adjustments +96.4 capital Operating profit +75.9 -33.3 Depreciation and amortization, etc. +20.5 Total investment Operating cash Total increase in net working capit
Slide 25: Free Cash Flow Jan - Dec
FY2014 Consolidated Financial Overview Year on Year Free Cash Flow Jan - Dec 2013 2014 Operating profit, net of operating cash adjustments (Billion JPY) Jan-Dec Jan-Dec Change -0.9 Total increase (-) / decrease in net working capital etc. Operating profit - IFRS basis 78.7 75.9 -2.8 -13.6 Depreciati
Slide 26: 2015 Forecast Jan - Dec
FY2014 Consolidated Financial Overview 2015 Forecast (Core) 2015 Forecast Jan - Dec Actual Forecast Growth (Billion JPY) 2014 Jan-Dec 2015 Jan-Dec vs. Revenues vs. Revenues (%) Revenues 461.1 486.5 +25.4 +5.5% Sales 436.9 460.8 +23.9 +5.5% excl. Tamiflu 423.8 453.4 +29.6 +7.0% Domestic 349.5 360.9 +
Slide 27: Sales (excl. Tamiflu) vs. 2014 Actual
FY2014 Consolidated Financial Overview 2015 Forecast (Core) Sales (excl. Tamiflu) vs. 2014 Actual Sales (excl. Tamiflu) (Billion JPY) 453.4 （+29.6, +7.0%） Actemra 423.8 -4.9 Pegasys (Overseas) +20.0 Overseas (2.1) (75.7) +18.2, +24.5% 92.5 -2.0 Copegus Avastin +5.9 74.3 Others (1.1) (88.2) -2.1,-8.2
Slide 28: Dividend Policy
FY2014 Consolidated Financial Overview Dividend Policy Policy Aiming to ensure stable profit for all shareholders and a consolidated dividend payout ratio of 50% on average to Core EPS, taking account of strategic funding needs and earnings prospects. • Dividends for FY2014 (Plan) 48 JPY： 22 + 26 •
Slide 29: Capital Investments
FY2014 Consolidated Financial Overview Current Status/Plan for Major Capital Investments Objective - Simultaneous development and quick launch of therapeutic antibodies - Reduction of manufacturing costs for in-house products 2012 2012 2013 2013 2014 2014 2015 2016 2017 2018 2019 2020 2021 CPR (Sing
Slide 30: Overview of Development Pipeline
Overview of Development Pipeline CHUGAI PHARMACEUTICAL CO., LTD. Executive Vice President Head of Project & Lifecycle Management Unit Yutaka Tanaka January 28/29, 2015
Slide 31: Oncology Field Projects under Development
Overview of Development Pipeline Oncology Field Projects under Development (as of 28 January, 2015) Phase I Phase II Phase III Filed CKI27 / RG7304 RG435 / Avastin AF802 (RG7853) RG340 / Xeloda (Japan / overseas) - cervical cancer★ / Alecensa (overseas) - gastric cancer (adjuvant)★ - solid tumors -
Slide 32: Primary Field Projects under Development
Overview of Development Pipeline Primary Field Projects under Development (as of 28 January, 2015) Phase I Phase II Phase III Filed RG484 / Bonviva (oral) Bone & Joint - osteoporosis MRA / Actemra (overseas) MRA / Actemra - systemic sclerosis - large-vessel vasculitis MRA / Actemra (overseas) Autoim
Slide 33: Development Status
Overview of Development Pipeline Development Status In- RG7204 / Zelboraf ® licensed Unresectable melanoma with BRAF mutation Approved in December 2014 In- RG340 / Xeloda ® licensed Gastric cancer (adjuvant) [additional indication] Filed in December 2014 In- RG7446 / MPDL3280A (Engineered anti-PDL1
Slide 34: Other Progress
Overview of Development Pipeline Other Progress In- RG3502 / Kadcyla® licensed December 2014 Reported top-line results of global P3 (MARIANNE study) for 1st line therapy for breast cancer • Study met progression-free survival (PFS) non-inferiority endpoint, but did not meet PFS superiority endpoint
Slide 35: Major Data Presentations
Overview of Development Pipeline Major Data Presentations In- Alecensa ® house October 2014 Reported updates from the Japanese P1/2 study for ALK mutation positive non-small cell lung cancer at Chicago Multidisciplinary Symposium in Thoracic Oncology - 2 year survival rate of 79% (95% CI: 63-89) In-
Slide 36: Hypoparathyroidism and PCO371
Overview of Development Pipeline Hypoparathyroidism and PCO371 Parathyroid hormone (PTH) • Increases blood calcium levels through PTH1 receptors in bone and kidney Hypoparathyroidism • Caused by hypocalcemia due to underproduction of PTH, associating tetany, seizures, and other symptoms that may dis
Slide 37: 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 Ten indications (including additional dosages and administrations) of eight products from the first round requests have b
Slide 38: Projected Submissions (Post PoC NMEs and products)
Overview of Development Pipeline Projected Submissions (Post PoC NMEs and products) Seamless filings every year NME line extension MPDL3280A in-house ACE910 (RG7446) in-licensed Hemophilia A Bladder Cancer ACTEMRA GA101 / obinutuzumab lebrikizumab (MRA) (RG7159) (RG3637) Giant Cell Arteritis Indol
Slide 39: 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 Investor Relations Group Tel: +81 (0)3-3273-0554 Fax: +81 (0)3-3281-6607 e-mail: ir@chugai-pharm