Ethical Drug Business, Consumer Healthcare Business, Takeda's Business Locations, Restructuring of Businesses.
38 We provide superb pharmaceutical productsthe ultimate goal of "Takeda-ism"to global medical professions and patients For prostate cancer, breast cancer and endometriosis For peptic ulcers A reliable partner for consumers in the age of self-medication Consumer Healthcare Drugs & Quasi-Drugs (Consumer Healthcare Business) Benza Block S Banze Block L Banza Block IP In the consumer healthcare business, Takeda sells over-the-counter (OTC) drugs as one element of its pharmaceuticals business. Takeda believes OTC drugs will become an increasingly important product category in view of the "age of self-medication" to come. In fiscal 2008, consumer healthcare business sales increased 4.1 percent to 64.4 billion. The regulatory environment changed in June 2009 with the enactment of the first amendments to Japan's Pharmaceutical Affairs Law in about 50 years. For OTC drugs, in addition to supplying quality products that are safe and effective, companies must meet stricter requirements for providing consumers with dru
FFiinnaanncciiaall RReessuullttss ffoorr 11sstt HHaallff FFYY22000088 DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2037 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/financial/index.html 2006-2010 Medium-Term Plan Growth toward a World-class Pharmaceutical Company 1. Enhancement of capability to create new drugs through in-house R&D activities ・ Thorough review of the R&D management scheme and investments focused on the global research infrastructure ・ Building a structure that will enable continued launch of new products from its in-house R&D from fiscal 2011 ・ Enhancement of the R&D pipeline to a level where the company can expect ethical drugs sales* (consolidated basis) of 2 trillion yen in fiscal 2015 *Excluding sales of products for which Takeda acts as a distributor to wholesalers 2. Formulation of a tri-polar marketing function (Japan, USA, Europe) ・ Solidifying market
17 X. Pipeline Development Activities ■ New compounds ■ Additional indications/new formulations ■ Characteristics of projects ■ Other alliance projects ■ Clinical study protocol summaries ■ Outcome studies Research Activities ■ Main joint research activities 18 Development activities ■ New Compounds Development code Drug Class (administration route) Indications Stage In-house/ In-license SYR-322 DPP-4 inhibitor (oral) Diabetes mellitus Diabetes mellitus (Fixed-dose combination with ACTOS) US Jpn EU US EU Filed (Dec 07) Filed (Sep 08) P-III Filed (Sep 08) P-III In-house TAK-390MR Proton pump inhibitor (oral) Erosive esophagitis (healing and maintenance) and non-erosive gastro-esophageal reflux disease US Jpn Filed (Dec 07) P-II In-house TAK-375 MT1/MT2 receptor agonist (oral) Insomnia Circadian rhythm sleep disorder (CRSD) EU Jpn US P-III *Re-submission of a MAA is under consideration Filed (Feb 08) P-II In-house Vectibix TM Fully
17 X. Pipeline Development Activities ■ New compounds ■ Additional indications/new formulations ■ Characteristics of projects ■ Other alliance projects ■ Clinical study protocol summaries ■ Outcome studies Research Activities ■ Main joint research activities 18 Development activities New Compounds Development code Drug Class (administration route) Indications Stage In-house/ In-license SYR-322 DPP-4 inhibitor (oral) Diabetes mellitus Diabetes mellitus (Fixed-dose combination with Actos) US Jpn EU US EU Jpn Filed (Dec 07) Filed (Sep 08) P-III Filed (Sep 08) P-III P-I In-house TAK-390MR Proton pump inhibitor (oral) Erosive esophagitis (healing and maintenance) and non-erosive gastro-esophageal reflux disease US Jpn Approved (Jan 09) P-II In-house TMX-67 Non-purine, selective xanthine oxidase inhibitor (oral) Hyperuricemia in patients with gout US Approved (Feb 09) In-license (Teijin) TAK-375 MT1/MT2 receptor agonist (oral) Insomnia J
FFiinnaanncciiaall RReessuullttss ffoorr FFYY22000088 DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2037 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/financial/index.html 2006-2010 Medium-Term Plan Growth toward a World-class Pharmaceutical Company 1. Enhancement of capability to create new drugs through in-house R&D activities ・ Thorough review of the R&D management scheme and investments focused on the global research infrastructure ・ Building a structure that will enable continued launch of new products from its in-house R&D from fiscal 2011 ・ Enhancement of the R&D pipeline to a level where the company can expect ethical drugs sales* (consolidated basis) of 2 trillion yen in fiscal 2015 *Excluding sales of products for which Takeda acts as a distributor to wholesalers 2. Formulation of a tri-polar marketing function (Japan, USA, Europe) ・ Solidifying market function in each
10 U.S.operations The restructuring of In 1977, Takeda established a 50-50 partnership with Abbott Laboratories in the U.S. for research and development of new drugs. TAP Pharmaceutical Products Inc. was established in 1985 as a joint venture with Abbott in conjunction with the launch of the prostate cancer treatment Lupron (generic name: leuprorelin acetate). Since then TAP has greatly contributed to the growth of Takeda's ethical pharmaceutical business in the U.S. market through the expanding sales of Lupron Depot (sustained release formulation of leuprorelin acetate) and the peptic ulcer treatment Prevacid (generic name: lansoprazole). In April 2008, Takeda implemented the division of TAP upon agreement with Abbott and TAP became a wholly-owned subsidiary of Takeda. In July 2008, TAP was merged into Takeda Pharmaceuticals North America, Inc. (TPNA), and subsequently TAP's development function was integrated into Takeda Global Research & Development Center Inc. (TGRD). Through this restructuring, Takeda r
SUMMARY OF FINANCIAL STATEMENTS (Consolidated) First quarter results for the fiscal year ending March 31, 2008 These financial statements have been prepared for reference only, in accordance with accounting principles and practices generally accepted in Japan. July 31, 2007 Takeda Pharmaceutical Company Limited Listed exchanges: Osaka, Tokyo, Nagoya, Fukuoka, Sapporo TSE Code : 4502 URL : http://www.takeda.co.jp/ Representative: Yasuchika Hasegawa, President Contact : Hirofumi Inoue, General Manager, Corporate Communications Department Tel : +81 3 3278-2037 1. First Quarter Consolidated Financial Results (April 1, 2007 to June 30, 2007) for the Fiscal Year Ending March 31, 2008 (1) Consolidated Operating Results Millions of yen, rounded to the nearest million (Percentages shown in columns below represent changes from the quarterly results for the same quarter in the previous year and the full-year results for the previous year, respectively.) Three months ended June 30, 2007 Three months ended June 30, 2006
FFiinnaanncciiaall RReessuullttss ffoorr FFYY22000066 DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2037 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/financial/index.html 2006-2010 Medium-Term Management Plan 〜 Growth toward a World-class Pharmaceutical Company with Japanese Origin 〜 1. Enhancement of capability to create new drugs through in-house R&D activities ・ Thorough review of the R&D management scheme and investments focused on the global research infrastructure ・ Building a structure that will enable continued launch of new products from its in-house R&D from fiscal 2011 ・ Enhancement of the R&D pipeline to a level where the company can expect sales of in-house ethical products of 2 trillion yen in fiscal 2015 2. Formulation of a tri-polar marketing function (Japan, USA, Europe) ・ Solidifying market function in each region with self-sustaining and appropriate operatio
FFiinnaanncciiaall RReessuullttss ffoorr 11sstt HHaallff FFYY22000066 DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2039 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/english/financial/index.html 2006-2010 Medium-Term Management Plan 〜 Growth toward a World-class Pharmaceutical Company with Japanese Origin 〜 1. Enhancement of capability to create new drugs through in-house R&D activities ・ Thorough review of the R&D management scheme and investments focused on the global research infrastructure ・ Building a structure that will enable continued launch of new products from its in-house R&D from fiscal 2011 ・ Enhancement of the R&D pipeline to a level where the company can expect sales of in-house ethical products of 2 trillion yen in fiscal 2015 2. Formulation of a tri-polar marketing function (Japan, USA, Europe) ・ Solidifying market function in each region with self-sustaining
X. Pipeline Development Activities ■ New compounds ■ Additional indications/new formulations ■ Characteristics of projects ■ Other alliance projects ■ Clinical study protocol summaries ■ Outcome studies Research Activities ■ Main joint research activities 18 19 Development activities ■ New Compounds Development code Drug Class (administration route) Indications Stage In-house / In-license Jpn P-III U.S. P-III In-house EU P-III Insomnia Jpn P-III EU Filed (Mar 07) Alzheimer's sleep / wake disturbance U.S. P-II Circadian rhythm sleep disorder (CRSD) U.S. P-II U.S. P-III EU P-III In-house Jpn P-II U.S. P-III Jpn P-I U.S. P-III EU P-III Jpn P-II U.S. P-II EU P-II U.S. P-II EU P-II Jpn P-I U.S. P-II EU P-II Jpn P-I / II Hypercholesterolemia In-license. (Sucampo) P-III conducted by Sucampo Constipation-predominant Irritable Bowel Syndrome U.S. P-III Severe sepsis In-house Chronic kidney disease (CKD) / cancer-related anemia In-houseHypertension TAK-536 < azilsartan > AF37702 < - > Synthetic,
18 X. Pipeline Development Activities ■ New compounds ■ Additional indications / new formulations ■ Characteristics of projects ■ Other alliance projects ■ Clinical study protocol summaries ■ Outcome studies Research Activities ■ Main joint research activities ■ Recent fruits of Takeda research ■ Notes Indications or formulations Brand name (country/region) Progress in stage Non-erosive reflux disease Takepron (Jpn) Filed→Approved (Jun 06) Combination drug of Actos / SU Duetact TM (U.S.) Filed→Approved (Jul 06) Combination drug of Actos / TAK-536 < Not decided yet > (U.S.) P-III Fixed combination with diuretic Blopress,Amias, Kenzen (EU) P-III Chronic kidney disease (CKD) / cancer-related anemia Hematide TM (U.S. , EU/ Jpn ) P-II / P-I Hypertension < Not decided yet > (U.S.,EU) P-II Gastric cancer, non-small cell lung cancer (NSLC), colorectal cancer < Not decided yet > (Jpn) P-II Secondary eradication of Helicobactor pylori Takepron (Jpn) Filed (Aug 06) Combination drug of Actos and metformin Com
IX. Pipeline Development Activities ■ New compounds ■ Additional indications / new formulations ■ Characteristics of projects ■ Other alliance projects ■ Clinical study protocol summaries ■ Outcome studies Research Activities ■ Main joint research activities ■ Recent fruits of Takeda research ■ Notes 【Progress in stage (Oct 2005 - Mar 2006)】Indications or formulations Brand name (country/region) Progress in stage Reduction of the risk of macrovascular events in patients with type 2 diabetes mellitus and pre-existing macrovascular disease Actos (EU) P-III→Filed (Dec 05) Diabetes mellitus < Not decided yet > (U.S., EU) P-II→P-III Obesity < Not decided yet > (Jpn) P-I→P-II Erosive esophagitis and non-erosive gastroesophageal reflux disease < Not decided yet > (Jpn) P-I Chronic idiopathic constipation < AMITIZA TM (U.S.) Filed→ Approval (Jan 06) Combination drug of Actos / Metformin XT < ACTOplus met TM XR> (U.S.) Filed (Mar 06) Paget's disease < Benet > (Jpn) P-II→P-III Alzheimer's sleep / wake
FFiinnaanncciiaall RReessuullttss ffoorr FFYY22000055 DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2039 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/financial/index.html [Takeda-ism] We, the members of the Takeda Group, pledge to act with integrity at all times, especially when facing difficulties or challenges. "Integrity" refers to our compliance with the highest ethical standards, our fairness and honesty in conducting every activity, and our perseverance in pursuing the ideal forms for our operations and management. Through the demonstration of these qualities, we show our commitment to building trust and confidence in all the people around us, and our determination to continue to expand the business. These empower our progress in our global endeavors to fulfill our mission to "strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products." 2
IX. Pipeline Development Activities ■ New compounds ■ Additional indications / new formulations ■ Characteristics of projects ■ Other alliance projects ■ Clinical study protocol summaries ■ Outcome studies Research Activities ■ Main joint research activities ■ Recent fruits of Takeda research 【Progress in stage (Apr - Sep 2005)】 Indications or formulations Brand name (country/region) Progress in stage TAK-375 Insomnia Rozerem (U.S.) Filed→Approved (Jul 05) Combination drug of Actos / SU (U.S.) Filed (Jun 05) (EU) Filed (Jul 05) 6-month depot (Germany) Filed (Jun 05) Constipation IBS (U.S.) P-II→P-III Severe sepsis (Jpn, U.S., EU) P-I→P-III Concomitant therapy with metformin ( Jpn) P-III Diabetes mellitus (U.S.) P-II Hyperlipidemia (Jpn) P-I TAP-144-SR Premenopausal breast cancer Leuplin SR injection kit 11.25 (Jpn) Filed→Approved (Aug 05) AD-4833MET Combination d
FFiinnaanncciiaall RReessuullttss ffoorr 11st HHaallff FFYY22000055st DATA BOOK Takeda Pharmaceutical Company Limited (TSE code 4502) Contact: Corporate Communications Dept. TEL: +81-3-3278-2039 FAX: +81-3-3278-2741 http://www.takeda.com/ Financial News http://www.takeda.com/english/financial/index.html [Takeda-ism] We, the members of the Takeda Group, pledge to act with integrity at all times, especially when facing difficulties or challenges. "Integrity" refers to our compliance with the highest ethical standards, our fairness and honesty in conducting every activity, and our perseverance in pursuing the ideal forms for our operations and management. Through the demonstration of these qualities, we show our commitment to building trust and confidence in all the people around us, and our determination to continue to expand the business. These empower our progress in our global endeavors to fulfill our mission to "strive toward better health for individuals and progress in medicine by developing superior pha
SUMMARY OF FINANCIAL RESULTS FOR FISCAL 2004: INVESTMENTS FOR TAKEDA'S FUTURE In fiscal 2004 (ended March 31, 2005), our net sales reached 1,123.0 billion, up 3.4% year on year. Our pharmaceuticals business reported net sales up 3.8% to 970.5 billion, accounting for 86.4% of total net sales (86.1% in the previous fiscal year). The remaining 13.6% of net sales (13.9% in the previous fiscal year) came from our non-pharmaceuticals businesses, which grew 0.9% year on year, coming in at 152.5 billion. The increased cost of developing new drugs is one of the factors prompting increasing numbers of global pharmaceutical companies to pursue scale merit through mergers and acquisitions, and this trend has resulted in even more intense competition in the industry. Even so, sales of Takeda's mainstay products grew, driving up revenues. Mainstay products that enjoyed higher sales in Japan included the hypertension treatment Blopress, the peptic ulcer treatment Takepron, the insulin sensitizer Actos, and the treatment fo
Takeda has until now conducted research and development, from target discovery to drug creation, at research centers in Tsukuba and Osaka in Japan. In March 2005, however, Takeda secured its first research base outside Japan with the acquisition of a U.S. bioventure. Takeda is devoted to utilizing this global research network to deliver highly innovative pharmaceuticals as quickly as possible. PROMOTING PATIENT-FOCUSED RESEARCH Takeda is taking proactive steps to strengthen its pipeline. This involves accurately understanding patient needs and focusing management resources on the Company's four core therapeutic areas: lifestyle-related diseases, cancer and urological diseases, central nervous system (CNS) diseases, and life-cycle management of drugs for digestive system diseases. Takeda further facilitates drug discovery through a product strategy system named the MPDRAP strategy*. * Enables rapid decision-making by sharing information across each of our marketing, production, development, research, alliance
To Our Shareholders: 02 A NEW START AS THE TAKEDA PHARMACEUTICAL COMPANY In fiscal 2003 we laid the groundwork for an aggressive effort to become an R&D-driven, world-class pharmaceutical company. To support this initiative, we established a global management system for our marketing, production, development, research, alliance, and intellectual property management functions, along with other strategic changes. One of those moves was the creation of a new senior management structure consisting of a chief executive officer (CEO) and a chief operating officer (COO) in June 2003 to accelerate decision-making, enhance operational agility, and increase overall transparency. Under this new structure, the chairman of the board acts as the CEO and is ultimately responsible for the performance of Takeda, including oversight of senior executives and strategic decisionmaking, while the president serves as the COO and is responsible for the Company's performance. With respect to internal control, the Auditing Department