Chugai Pharmaceutical Co., Ltd. · TSE:4519
Chugai Pharmaceutical — FY2011 Earnings Presentation
42 slides from Chugai Pharmaceutical's earnings presentation, Feb 1, 2012
Slide 1: Aiming to Become a Top Japanese Pharmaceutical Company - 2011 Results & 2012 Outlook
Aiming to Become a Top Japanese Pharmaceutical Company - 2011 Results & 2012 Outlook - CHUGAI PHARMACEUTICAL CO.,, LTD. President and CEO Osamu Nagayama February 1/2, 2012
Slide 2: Forward Looking Statements
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Forward Looking Statements Forward-Looking This presentation may include forward-looking statements pertaining to the business and prospects of Chugai Pharmaceutical Co., Ltd. (the “Company”). These statemen
Slide 3: Overview of 2011
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Overview of 2011 Impact p of the Great East Japan p Earthquake q Production Activities Loss on disaster (Extraordinary Loss): 4.7billion yen Utsunomiya Ut i PlPlantt and d some off our contract t t man
Slide 4: 2011 Full Year Results
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - 2011 Full Year Results Decline in both Revenues and Operating p g income due to the Great East Japan Earthquake （billi （billions off yen） ） 2010 2011 Y Y YoY vs. plan l Revenues 379.5 373.5 -1.6% -5.5% Domes
Slide 5: R&D Update: 2011 Approvals and New Development Projects
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - R&D Update: 2011 Approvals and New Development Projects Prosperous p progress p g ～ strong g contribution from 2012～ Approved Projects New Development Projects MIRCERA Renal Anemia XELODA HERCEPTIN ACTEMRA R
Slide 6: 2012 Forecast
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - 2012 Forecast Strong sales & profit growth from new products launches and additional indications to absorb NHI price cut impact （billions of yen） 2011 2012 Plan YoY Revenues 373.5 418.5 +12.0% Sales 363.6 40
Slide 7: Sunrise 2012 Assumptions
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Sunrise 2012 Assumptions Deviation from the original assumptions for (bil JPY) (bil.JPY) Revenue Operating Income Sunrise 2012, announced in 2008 460.0 Big gap between the current situation and assumptions m
Slide 8: Enhancement of Sales Force
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Enhancement of Sales Force To achieve the goals of Sunrise 2012 by contributing to standardized healthcare quality and to eliminate care disparities in Japan Oncology Unit Establish a new organization g to c
Slide 9: Avastin
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Avastin 22.0% sales increase, absorbing NHI price cut (bil JPY) (bil. CRC: Enhance the solid position as standard t d d ththerapy NSCLC: Appeal efficacy and 68 8 68.8 safety with new clinical data 56.4
Slide 10: Epogin/Mircera
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Epogin/Mircera Regain the position as market leader in ESA market ～ 2012 target market share : 60% ～ (bil. JPY) Mircera Epogin Appeal monthly dosage features 29.6 Generate publications and medical 5.9 pr
Slide 11: Alfarol/Edirol
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Alfarol/Edirol Appeal “Grade A” recommendation in Osteoporosis Treatment G Guideline 2011 (1 ( St & only Vitamin D3 to obtain Grade G A)) (bil. JPY) Edirol Alfarol 7.8 Expand awareness of competitive 1.3 a
Slide 12: Actemra
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Actemra ＜Growth Drivers＞ ADACTA Study Data Readout 1st line approval in US (expected in 2012) Approval for subcutaneous formulation SC Filing (Japan, US, EU; expected in 2013) SC Filing NHI Price Overseas
Slide 13: Promotion of PHC Based Projects
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Promotion of PHC Based Projects Development based on PHC with the strength of Roche Group Chugai development pipeline(PHC) Roche Project As of February 1, 2012 pertuzumab T-DM1 GA101 (BC) (BC) (NHL) Tarceva
Slide 14: Utilizing Innovative Antibody Engineering Technology
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Utilizing Innovative Antibody Engineering Technology Chugai g Pharmabodyy Research Pte. Ltd. ＜Purpose for Establishment＞ Generate novel therapeutic antibodies by focusing on utilization of recycling and sw
Slide 15: Introduction of Recycling Antibody and Sweeping Antibody
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Introduction of Recycling Antibody and Sweeping Antibody Recycling y g Antibodyy Sweeping p g Antibodyy Further engineering of recycling antibody technology “Sweeping antibody” generated by further engineeri
Slide 16: Chugai-Roche Basic Agreements
Aiming to Become a Top Japanese Pharmaceutical Company - Review of 2011 and Plans for 2012 - Chugai Roche Basic Agreements Chugai-Roche Ownership Arrangements Period Upper Threshold Oct.1, 2002 – Sept. 30, 2007 50.1% 59 9% 59.9% Oct.1, 2007 – Sept. 30, 2012 ownership increased from 50.1% to 59.9%
Slide 17: FY2011 Consolidated Financial Overview
FY2011 Consolidated Financial Overview CHUGAI PHARMACEUTICAL CO., CO LTD LTD. Senior Vice President and CFO Yoshio Itaya February 1, 2012
Slide 18: Summary
FY2011 Consolidated Financial Overview Summary Revenues R and d profits fit ddeclined li d due d tto negative ti sales l growth th • Revenues: 373.5 billion JPY (-1.6%), Operating Income: 62.4 billion JPY (-5.7%) • Tamiflu sales: significantly declined as stockpiling sales close out • Sales excl.
Slide 19: Financial Overview Jan - Dec
Year on Year FY2011 Consolidated Financial Overview Financial Overview Jan - Dec (Billion JPY) (Billion JPY) 2010 As % of 2011 As % of Growth Sales excl. Tamiflu Jan-Dec Revenues Jan-Dec Revenues % Domestic -9.1 Revenues 379.5 373.5 -6.0 -1.6 Overseas +6.6 Sales 375.6 363.6 -12.0 12.0 -3.2 3.2 S
Slide 20: Sales (excl. Tamiflu) Jan - Dec
Year on Year FY2011 Consolidated Financial Overview Sales (excl (excl. Tamiflu) Jan - Dec Sales (excl. Tamiflu) (Billion JPY) 3 9 (-2.5, 354.9 ( 2 -0.7%) 0 %) 357.4 33 0 33.0 Epogin E i Actemra A t Overseas 39.6 (28.8) (overseas) -11.2 +7.8 +6.6, +20.0% (20.5) 37.4 33.8 Others Pegasys 25.8 -3.6, -9.
Slide 21: Tamiflu Sales Performance
FY2011 Consolidated Financial Overview Tamiflu Sales Performance Fiscal Term Sales (Billion JPY) FY2005.12 FY2006.12 FY2007.12 FY2008.12 FY2009.12 FY2010.12 FY2011.12 FY2012.12 C a se s p e r Seasonal se n ti n e l * Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan
Slide 22: Operating Income Jan - Dec
Year on Year FY2011 Consolidated Financial Overview Operating Income Jan - Dec (Billion JPY) (Billion JPY) 2010 2011 Gro th Growth Jan-Dec Jan-Dec (%) Revenues 379.5 373.5 -6.0 -1.6 Other operating Cost of Sales 162.4 157.5 -4.9 -3.0 revenues Gross profit Increase in SG&A Gross Profit 217.1 216.0 -1
Slide 23: Financial Overview Oct - Dec
Year on Year FY2011 Consolidated Financial Overview Financial Overview Oct - Dec (Billion JPY) 2010 2011 (Billion JPY) As % of As % of Growth Oct-Dec Revenues Oct-Dec Revenues % Sales excl. Tamiflu -6.3 Revenues 103.4 97.5 -5.9 Mircera +3.1 -5.7 Sales 102.3 96.2 -6.1 Actemra (domestic) +0.7 -6.0 e
Slide 24: Financial Overview Jan - Dec vs. Forecast
vs. Forecast FY2011 Consolidated Financial Overview Financial Overview Jan - Dec A ctua l F oreca s t on J ul . 21 (Billion JPY) 2011 2011 A chi ev . Actual Forecast on Jul. 21 J a n-Dec J a n-D ec Var ian c e ( %) (Billion JPY) 2011 2011 Sales e xcl. Tamiflu 354.9 374.3 -19.4 94.8 Achiev. 141.9 150
Slide 25: Impact of the Earthquake and Tax Reform
vs. Forecast FY2011 Consolidated Financial Overview Impact of the Earthquake and Tax Reform The Great East Japan Earthquake Loss on disaster (Extraordinary Loss): 4.7 billion JPY • Loss on buildings g and equipment q p was less than expected p as: i. insurance for buildings and equipment recorded,
Slide 26: Impact from Foreign Exchange
vs. Forecast FY2011 Consolidated Financial Overview Impact from Foreign Exchange FX impacts Jan Jan-Jun Jun FX impacts Jul Jul-Dec Dec FX rate t to t the th JPY 1CHF 1EUR (Billion JPY) (vs. forecast on Apr 21) (vs. forecast on Jul 21) Assumption Jan – Dec 85.00 110.00 as of Apr 21* +1.0 -0.5 Actual
Slide 27: Balance Sheet Items (Assets)
Year on Year FY2011 Consolidated Financial Overview Balance Sheet Items (Assets) (Billion JPY) Cash and deposits +31.0 Cash and deposits Marketable securities Inventories Marketable securities +1.3 -2 5 -2.5 +0 1 +0.1 Others Accounts -5.1 +0.6 Accounts receivable -2.5 receivable +32.2 Property
Slide 28: Balance Sheet Items (Liabilities)
Year on Year FY2011 Consolidated Financial Overview Balance Sheet Items (Liabilities) (Billion JPY) Others Accounts payable -2 1 -2.1 Income +3.0 taxes Income taxes payable +10.5 payable +4.4 Accounts Accrued payables Accrued expenses Accrued payables +2.0 payable +10.5 Accrued expenses +2.5
Slide 29: Cash Flow Statement Jan - Dec
Actual 2011 FY2011 Consolidated Financial Overview Cash Flow Statement Jan - Dec (Billion JPY) Cash flow from operating activities +69.6 Investing In esting Income before taxes and minority interests +57.1 Operating activities activities Financing Depreciation and amortization +15.9 -15.1 +4.7 act
Slide 30: 2012 Forecast Jan - Dec
2012 Forecast FY2011 Consolidated Financial Overview 2012 Forecast Jan - Dec Actual Forecast (Billion JPY) Growth (Billion JPY) 2011 2012 Jan-Dec As % of Jan-Dec As % of % Sales excl. Tamiflu +39.2 Revenues Revenues Revenues 373 5 373.5 418 5 418.5 +45 0 +45.0 +12.0 12.0 Sales of Tamiflu +0.9 Sa
Slide 31: Sales Forecast vs. 2011 Actual
2012 Forecast FY2011 Consolidated Financial Overview Sales Forecast vs vs. 2011 Actual Oncology Avastin +12 4 +12.4 Avastin： Increase penetration in NSCLC, BC Xeloda +6.8 Xeloda： Increase penetration of XELOX in CRC B Bone and d JJoint i t A t Actemra： Actemra (domestic) +0.8 Growth to be maintained
Slide 32: Growth in Revenues and Operating Income
2012 Forecast FY2011 Consolidated Financial Overview Growth in Revenues and Operating Income (Billion yen) Revenues Operating Income Other operating revenues Existing products +4.9 Other operating revenues Increase in SG&A (excl. R&D) Increase in gross profit +21.9 from sales exp. Increase in R&D ex
Slide 33: Dividend Policy
FY2011 Consolidated Financial Overview Dividend Policy Policy Aiming to ensure stable profit for all shareholders and a consolidated dividend payout ratio of over 40% on average, taking account of strategic funding needs and earnings prospects. • Dividends for FY2011 (Plan) 40JPY : 20 + 20 • Divid
Slide 34: Overview of Development Pipeline
Overview of Development Pipeline CHUGAI PHARMACEUTICAL CO., LTD. Senior Vice President Head of Lifecycle Management & Marketing Unit Yutaka Tanaka February 1/2, 2012
Slide 35: Projects under Development (as of 1 Feb. 2012)
Overview of Development Pipeline Projects under Development (as ( off 1 F Feb. b 2012) Phase I Phase II Phase III Oncology CIF/RG7167 ‐ solid tumors AF802 – NSCLC (PI/II) RG435/Avastin CKI27/RG7304 ‐ solid tumors RG435/Avastin ‐ GC GC33 ‐ liver cancer ‐ glioblastoma (relapsed) ‐ aBC MRA/Actemra ‐ PC
Slide 36: Development Status - Oncology
Overview of Development Pipeline Development Status - Oncology In- licensed Xeloda : Xelox regimen for adjuvant colon cancer Combination therapy with Oxaliplatin (Filed by Yakult) Approved in Nov. 2011 In- In licensed GA101 (RG7159) : • 1st line aggressive NHL Started P3 multinational study in Oct O
Slide 37: Development Status - Bone & Joint
Overview of Development Pipeline Development Status Status－ Bone & Joint In- house Suvenyl : Enthesopathy (Lateral epicondylitis Patellar tendinitis, epicondylitis, tendinitis Achilles tendinopathy, Plantar fasciitis) Started P3 study in Oct Oct. 2011 In- house Actemra (US) : Rheumatoid Arthritis Fi
Slide 38: Development Status - Transplant, Immunology, Infectious diseases
Overview of Development Pipeline Development p Status－ Transplant, Immunology, Infectious diseases In- licensed RG7128 (mericitabine): HCV Development suspended Prioritising the R&D portfolio 38
Slide 39: Projected Submissions (Post PoC products and NMEs)
Overview of Development Pipeline Projected Submissions (Post (P t PPoC C products d t and d NME NMEs ) Continue to make filings, every year NME line extension in-house in-licensed ACTEMRA RA (sc) SUVENYL TARCEVA (NRD101) AVASTIN NSCLC (1st line) Glioblastoma Enthesopathy pertuzumab tofogliflozin (
Slide 40: Enthesopathy
Overview of Development Pipeline Enthesopathy Cause of disease Stress Overuse Daily life (housework, job) Sports Aging A i Tendon, Bone Pathological condition Ligament (Hard Tissue) ((Soft Tissue)) Degeneration of enthesis: Enthesopathy occurs around the joints throughout the body and
Slide 41: Current Situation of the Requests Made by MHLW Unapproved Drug Committee
Overview of Development Pipeline Current Situation of the Requests Made by MHLW Unapproved Drug Committee MHLW Unapproved pp Drug g Committee Requested drug manufacturers to develop unapproved drugs with high clinical needs, including 8 cases / 10 indications for Chugai Date for request q Product
Slide 42: Contacts: Corporate Communications Dept.
Contacts: Corporate Communications Dept. Corporate Communications Group Tel: +81 (0)3-3273-0881 (0)3 3273 0881 Fax: +81 (0)3 (0)3-3281-6607 3281 6607 e-mail: [email protected] Hitoshi Aikawa, Koichi Kawahara, Kae Miyata, Hiroshi Araki Investor Relations Group Tel: T l +81 (0)3 (0)3-3273-0554 327