03 200903-1q qualitative information · of quarterly financial statements: (simplified accounting...

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Summary of 1st Quarter Financial Results for year ended March 31, 2009 (Unaudited) July 30, 2008 Company name: Mitsubishi Tanabe Pharma Corporation Stock exchange listings (Section): Tokyo, Osaka (First Sections) Securities code number: 4508 URL: http://www.mt-pharma.co.jp/ Headquarters: 3-2-10, Dosho-mach, Chuo-ku, Osaka 541-8505 Representative: Name: Natsuki Hayama Title: President and Representative Director For further information, please contact: Name: Yoshihisa Sasou Title: General Manager, Corporate Communications Department Telephone: (06) 6205-5211 Planned date of filing of quarterly securities report: August 12, 2008 Note; 1st Quarter of fiscal 2008 : Amounts less than \ 1 million have been rounded. 1st Quarter of fiscal 2007 : Amounts less than \ 1 million have been truncated. 1. Results for 1st Quarter (April 1, 2008 to June 30, 2008 (1) Consolidated Business Results Net sales Operating income Ordinary income Yen million % change Yen million % change Yen million % change 1st Quarter of Fiscal 2008 108,249 - 25,389 - 25,940 - 1st Quarter of Fiscal 2007 48,357 6.5 10,486 6.0 11,395 3.7 Net income Net income per share Net income per share (diluted) Yen million % change Yen Yen 1st Quarter of Fiscal 2008 14,648 - 26.10 - 1st Quarter of Fiscal 2007 7,033 1.0 28.72 - (Note) Percentage changes in the above list show change in comparison with the previous 1st quarter. (2) Consolidated Financial Position Total assets Net assets Equity ratio Net assets per share Yen million Yen million % Yen 30-Jun-08 809,560 674,402 81.6 1,176.56 31-Mar-08 807,261 667,808 80.9 1,163.96 (Note) Shareholders' equity \660,297 million (\653,229 million in fiscal 2007) 2. Dividends Dividends per share (Record date) 2nd Quarter Year-end For the year Yen Yen Yen Fiscal 2007 - 13.00 20.68 Fiscal 2008 14.00 14.00 28.00 (projected) (Note) 1. Revision to dividend forecast in the quarter under review: No 2. In the fiscal year ended March 31, 2008, dividends were paid to the shareholder as of September 20, rather than as shareholders of the end of the period. For further information, please see the notes on page 3.

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Page 1: 03 200903-1Q Qualitative Information · of quarterly financial statements: (Simplified accounting methods) 1. Inventory valuation method In regard to write-downs of inventory, the

Summary of 1st Quarter Financial Results for year ended March 31, 2009(Unaudited)

July 30, 2008Company name: Mitsubishi Tanabe Pharma CorporationStock exchange listings (Section): Tokyo, Osaka (First Sections)Securities code number: 4508URL: http://www.mt-pharma.co.jp/Headquarters: 3-2-10, Dosho-mach, Chuo-ku, Osaka 541-8505Representative: Name: Natsuki Hayama

Title: President and Representative DirectorFor further information, please contact: Name: Yoshihisa Sasou

Title: General Manager, Corporate Communications DepartmentTelephone: (06) 6205-5211

Planned date of filing of quarterly securities report: August 12, 2008

Note; 1st Quarter of fiscal 2008 : Amounts less than \ 1 million have been rounded. 1st Quarter of fiscal 2007 : Amounts less than \ 1 million have been truncated.

1. Results for 1st Quarter (April 1, 2008 to June 30, 2008 )(1) Consolidated Business Results

Net sales Operating income Ordinary incomeYen million % change Yen million % change Yen million % change

1st Quarter of Fiscal 2008 108,249 - 25,389 - 25,940 -1st Quarter of Fiscal 2007 48,357 6.5 10,486 6.0 11,395 3.7

Net income Net incomeper share

Net incomeper share(diluted)

Yen million % change Yen Yen1st Quarter of Fiscal 2008 14,648 - 26.10 -1st Quarter of Fiscal 2007 7,033 1.0 28.72 -

(Note) Percentage changes in the above list show change in comparison with the previous 1st quarter.

(2) Consolidated Financial Position

Total assets Net assets Equity ratio Net assets per share

Yen million Yen million % Yen30-Jun-08 809,560 674,402 81.6 1,176.5631-Mar-08 807,261 667,808 80.9 1,163.96(Note) Shareholders' equity  \660,297 million  (\653,229 million in fiscal 2007)

2. DividendsDividends per share

(Record date) 2nd Quarter Year-end For the yearYen Yen Yen

Fiscal 2007 - 13.00 20.68Fiscal 2008 14.00 14.00 28.00(projected)(Note) 1. Revision to dividend forecast in the quarter under review: No 2. In the fiscal year ended March 31, 2008, dividends were paid to the shareholder as of September 20, rather than as shareholders of the end of the period. For further information, please see the notes on page 3.

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3. Forecasts for Fiscal 2008 (April 1, 2008 to March 31, 2009)Net sales Operating income Ordinary income

Yen million % change Yen million % change Yen million % change1st half 206,000 - 33,500 - 34,000 -Full year 425,000 34.6 75,000 38.8 76,000 39.7

Net income Net incomeper share

Yen million % change Yen1st half 15,000 - 26.73Full year 39,000 77.3 69.49(Note) Revision to consolidated results forecast in the quarter under review: No

4. Other(1) Significant change involving subsidiaries during the period (changes in designated subsidiaries accompanying changes in the scope of consolidation) [Yes/No]: No

(2) Application of simplified accounting methods or of special accounting methods in the preparation of quarterlyfinancial statements: YesNote: For details, please see page 5, Quantitative Information / Financial Statements, etc., 4. Other.

(3) Changes in accounting principles, procedures, method of presentation associated with the preparation of the quarterly consolidated financial statements (Items noted in the Changes in the Basis of Presenting Quarterly Consolidated Financial Statements section)1. Change accompanying revision of accounting standards: Yes2. Other changes: NoNote: For details, please see page 6, Quantitative Information / Financial Statements, etc., 4. Other.

(4) Number of shares issued (common stock)1. Number of shares issued at the end of the period (including treasury stock) 1st Quarter of fiscal 2008 561,417,916 shares Fiscal 2007 561,417,916 shares

2. Number of shares of treasury stock at the end of the period 1st Quarter of fiscal 2008 209,957 shares Fiscal 2007 202,957 shares

3. Average number of shares of during the period (quarter) 1st Quarter of fiscal 2008 561,212,034 shares 1st Quarter of fiscal 2007 244,926,372 shares

(Notes)From the current fiscal year, the Company has adopted ASBJ Statement No. 12, “Accounting Standard forQuarterly Financial Statements”, and ASBJ Guidance No. 14, “Implementation Guidance for Accounting Standards for Quarterly Financial Statements”. In addition, the Company prepares quarterly financial statements according to “Rules for Quarterly Financial Reporting.”

All these estimates are forward-looking statements based on a number of assumptions and beliefs in light of the information currently available to management and are subject to risks and uncertainties.Actual financial results may differ materially depending on a number of factors, including economic conditionsand currency exchange rate fluctuations.

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(Notes)

(Dividends per share)

Dividends per share

(Record date) 20-Sep. Yen

Fiscal 2007 7.68

On October 1, 2007, the Company merged with Mitsubishi Pharma Corporation. Because the merger was completed as a reverse acquisition under the accounting standards for business combinations, the results for the full fiscal year ended March 31, 2008 were calculated as the sum of the consolidated results of the former Mitsubishi Pharma Corporation for the first half of the fiscal year and the consolidated results of Mitsubishi Tanabe Pharma Corporation for the second half of the fiscal year.

As a result, for dividends per share in the fiscal year ended March 31, 2008, the dividend to the shareholder on the record date of September 20, 2007 are distributed from the retained earnings of the former Mitsubishi Pharma Corporation, and the year-end dividends are the ones from the retained earnings of the Company, respectively.

The former Tanabe Seiyaku Co., Ltd. paid an interim dividend of ¥13 per share, for total dividends of ¥3,183 million.

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[Qualitative Information Financial Statements etc.] 1. Qualitative information about consolidated results of operations

In the first quarter ended June 30, 2008, consolidated net sales totaled ¥108.2 billion. Sales of

pharmaceuticals were ¥100.6 billion.

Domestic sales of ethical drugs totaled ¥87.9 billion. Including such factors as the NHI drug price

revisions implemented in April 2008, the operating environment was challenging. In this setting, significant sales growth was achieved by Remicade, an anti-TNFαmonoclonal antibody, and Mearubik,

a measles and rubella combined vaccine. Favorable growth was posted by such products as Talion, a

treatment for allergic disorders, and Anplag, an oral anti-platelet. Moreover, in April 2008 the

Company established Tanabe Seiyaku Hanbai Co., Ltd., which has made a full-fledged start in the

promotion and sales of generic drugs.

In overseas sales of ethical drugs, solid results were registered by such products as Herbesser, a

calcium antagonist. Overseas sales of ethical drugs were ¥6.5 billion.

In the other business segment, overseas sales of bulk pharmaceutical intermediates were favorable,

and the segment recorded sales of ¥7.6 billion.

The rate of overseas sales to the net sales was 8.4%.

As a result of the strong net sales, gross profit was ¥68.6 billion. SG&A expenses totaled ¥43.2

billion, including merger-related goodwill amortization of ¥2.5 billion. However, R&D expenses (¥16.2

billion, 15.0% of net sales) and labor costs were held to low levels. As a result, operating income was

¥25.3 billion, and ordinary income was ¥25.9 billion.

Impairment loss of ¥0.6 billion associated with the closure of the 2nd Nabari Training Center (Mie

Prefecture) was recorded as special loss, and net income for the quarter under review was ¥14.6

billion.

2. Qualitative information about consolidated financial position (1) Assets, liabilities, and net assets

Total assets at the end of the first quarter were ¥809.5 billion, an increase of ¥2.2 billion from the

end of the previous fiscal year. Major increases included short-term loans receivable and investment in

securities, while cash and time deposits declined due to such factors as the purchases of investments

in securities, and the payment of income taxes and year-end dividends.

Total liabilities at the end of the quarter were ¥135.1 billion, a decline of ¥4.2 billion from the end of

the previous fiscal year. Major declines included income taxes payable and reserve for bonuses.

Net assets were ¥674.4 billion, an increase of ¥6.5 billion from the end of the previous fiscal year. As

a result, the equity ratio was 81.6%, compared with 80.9% at the end of the previous fiscal year.

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(2) Cash flows

(Cash flows from operating activities)

Income before income taxes and minority interests was ¥25.2 billion, but due to an increase in notes

and accounts receivable-trade and the payment of income taxes, net cash provided by operating

activities was ¥5.5 billion.

(Cash flows from investing activities)

In investing activities, due to such factors as purchases of marketable securities and purchases of

investment in securities, net cash used in investing activities totaled ¥59.9 billion.

(Cash flows from financing activities)

Due to such items as dividends paid, net cash used in financing activities was ¥8.6 billion.

As a result, the balance of cash and cash equivalents at the end of the period under review was

¥95.6 billion, a decrease of ¥64.4 billion from the end of the previous fiscal year.

3. Qualitative information about consolidated results forecasts There are no revisions to the consolidated results forecasts for the interim period and for the fiscal

year that were announced on May 7, 2008.

The results forecast for the full fiscal year is based on information available at the present point in

time and reflects the effects of cost synergies and restructuring expenses.

4. Other (1) Significant changes involving subsidiaries during the period (changes in designated subsidiaries

accompanying changes in the scope of consolidation)

Not applicable.

(2) Application of simplified accounting methods or of special accounting methods in the preparation

of quarterly financial statements:

(Simplified accounting methods)

1. Inventory valuation method

In regard to write-downs of inventory, the carrying amount of items for which the profitability

has clearly declined is reduced to the estimated net selling value.

2. Method of calculation of income taxes, deferred tax assets, and deferred tax liabilities.

The calculation of income tax payments, deferred tax assets, and deferred tax liabilities is based

on the sum of important adjustment and tax credit items.

In regard to judgments about the recoverability of deferred tax assets, in the event that there

are no marked changes in the management environment, etc., since the end of the previous fiscal

year and there are no marked changes in the occurrence of temporary differences, the judgments

utilize a method based on the future results forecasts used in the previous consolidated

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settlement of accounts and on tax planning. In the event that there are marked changes in the

management environment, etc., since the end of the previous fiscal year or there are marked

changes in the occurrence of temporary differences, the judgements utilize the a method based on

the future results forecasts used in the previous consolidated settlement of accounts and on tax

planning as well as the influence of the marked changes.

(3) Changes in accounting principles, procedures, method of presentation associated with the

preparation of the quarterly consolidated financial statements

1. From the current fiscal year, the Company has adopted ASBJ Statement No. 12, “Accounting

Standard for Quarterly Financial Statements”, and ASBJ Guidance No. 14, “Implementation

Guidance for Accounting Standards for Quarterly Financial Statements”. In addition, the

Company prepares quarterly financial statements according to “Rules for Quarterly Financial

Reporting.”

2. Changes in inventory valuation standard and inventory valuation method

Previously, merchandise and finished goods were principally handled by the lower of cost or

market method using weighted average cost, and raw materials and others were principally

handled by the cost method using weighted average cost. From the quarter under review,

accompanying the adoption of “Accounting Standard for Measurement of Inventories” (ASBJ

Statement No. 9, July 5, 2006), the Company has principally changed to the cost method using

weighted average cost (method of reducing book value in accordance with declines in profitability).

This change will not have a significant effect on results.

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5. CONSOLIDATED FINANCIAL STATEMENTS

(1) CONSOLIDATED BALANCE SHEETS (Millions of yen)

Year

Accounts

As of As of June 30, 2008 March 31, 2008

Amount Amount Assets  Current assets

Cash and time deposits 31,291 79,655Notes and accounts receivable-trade 137,557 125,280Marketable securities 47,642 55,634Merchandise and finished goods 56,008 51,652Work in process 3,649 4,017Raw materials and supplies 17,689 17,804Short-term loans receivable 50,708 30,924Deferred tax assets 10,014 12,664Other 3,300 4,419Allowance for doubtful receivables (52) (23)Total current assets 357,806 382,026

  Fixed assetsProperty, plant and equipment Buildings and structures, net 49,599 51,320 Machinery, equipment and vehicles, net 22,690 23,698 Tools, furniture and fixtures, net 5,767 5,991 Land 54,920 55,124 Construction in progress 5,291 3,377 Total property, plant and equipment 138,267 139,510Intangible fixed assets Goodwill 143,037 145,550 Other 3,341 3,506 Total intangible fixed assets 146,378 149,056Investments and other assets Investment in securities 119,777 88,000 Long-term loans receivable 185 183 Long-term prepaid expenses 1,239 1,003 Deferred tax assets 2,512 4,037 Prepaid pension expenses 34,415 33,988 Long-term deposits 5,405 5,740 Other 3,608 3,751 Allowance for doubtful receivables (32) (33) Total investments and other assets 167,109 136,669Total fixed assets 451,754 425,235

  Total assets 809,560 807,261

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(Millions of yen)

Year

Accounts

As of As of June 30, 2008 March 31, 2008

Amount Amount  Liabilities  Current liabilities

Notes and accounts payable-trade 35,742 27,139Short-term loans payable 5,700 6,741Current maturities of long-term loans payable 962 1,240Accounts payable-other 17,391 18,206Income taxes payable 8,169 15,271Reserve for employees' bonuses 6,782 13,593Reserve for directors' bonuses 3 11Reserve for sales returns 166 195Reserve for sales rebates 10 4Reserve for loss on shutdown of plants 824 830Other 10,395 6,219Total current liabilities 86,144 89,449

  Long-term liabilitiesLong-term loans payable 170 170Deferred tax liabilities 12,496 12,802Accrued retirement benefits for employees 17,084 16,928Accrued retirement benefits for directors andcorporate auditors 22 43Reserve for health management allowances forHIV compensation 1,688 1,758Reserve for health management allowances forSMON compensation 4,973 5,093Reserve for HCV litigation 11,200 11,200Other 1,381 2,010Total long-term liabilities 49,014 50,004Total liabilities 135,158 139,453

  Net assets Shareholders' equity

Common stock 50,000 50,000Capital surplus 451,184 451,184Retained earnings 160,685 153,332Treasury stock (218) (209)Total shareholders' equity 661,651 654,307

 Valuation and translation adjustmentsUnrealized holding gains on securities 3,115 1,511Deferred gains or losses on hedges (238) (841)Foreign currency translation adjustment (4,231) (1,748)Total valuation and translation adjustments (1,354) (1,078)

 Minority interests 14,105 14,579 Total net assets 674,402 667,808

  Total liabilities and net assets 809,560 807,261

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(2) CONSOLIDATED STATEMENTS OF INCOME(Millions of yen)

Year

Accounts

April 1, 2008 -June 30, 2008

Amount

 Net sales 108,249 Cost of sales 39,576 Gross profit 68,673 Selling, general and administrative expenses

Advertising expenses 694Sales promotion expenses 2,321Salaries and allowances 6,904Provision for bonuses 3,506Provision for directors' bonuses 2Retirement benefit expenses 95Provision for directors' retirement benefits 4Depreciation and amortization 508Research and development expenses 16,283Amortization of goodwill 2,513Other 10,454Total selling, general and administrative expenses 43,284

 Operating income 25,389 Non-operating income

Interest income 476Dividends income 462Foreign exchange gain 46Equity in earnings of affiliates 49Other 126Total non-operating income 1,159

 Non-operating expensesInterest expenses 24Donations 173Loss on disposal of property, plant and equipment 148Other 263Total non-operating expenses 608

 Ordinary income 25,940 Extraordinary income

Gain on sales of property, plant and equipment 16Gain on transfer of business 40Total extraordinary income 56

 Extraordinary lossImpairment loss 639Loss on valuation of investment in securities 96Other 6Total extraordinary losses 741

 Income before income taxes and minority interests 25,255 Income taxes-current 8,065 Income taxes-deferred 2,365 Minority interests (177) Net income 14,648

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(3) CONSOLIDATED STATEMENTS OF CASH FLOWS(Millions of yen)

YearAccounts

April 1, 2008 -June 30, 2008

Cash flows from operating activities:Income before income taxes and minority interests 25,255Depreciation and amortization 3,433Impairment loss 639Amortization of goodwill 2,513Increase (decrease) in accrued retirement benefits for employees 188Decrease (increase) in prepaid pension expenses (427)Increase (decrease) in allowance for doubtful receivables 28Interest and dividends income (938)Interest expenses 24Loss (gain) on sales and disposal of fixed assets 100Loss (gain) on valuation of investment in securities 96Equity in (earnings) losses of affiliates (19)Decrease (increase) in notes and accounts receivable-trade (12,696)Decrease (increase) in inventories (4,132)Increase (decrease) in notes and accounts payable-trade 8,923Increase (decrease) in accounts payable-other (1,612)Other, net (2,978)Subtotal 18,397Interest and dividends income received 1,046Interest expenses paid (25)Proceeds from subsidy 1,027Income taxes paid (14,873)Net cash provided by (used in) operating activities 5,572

Cash flows from investing activities:Purchase of marketable securities (42,002)Proceeds from sales and redemption of marketable securities 14,500Increase in time deposits (513)Decrease in time deposits 26Purchase of property, plant and equipment (2,362)Proceeds from sales of property, plant and equipment 21Purchase of intangible fixed assets (153)Purchase of investment in securities (30,082)Proceeds from sales and redemption of investment in securities 500Other, net 121Net cash provided by (used in) investing activities (59,944)

Cash flows from financing activities:Increase (decrease) in short-term loans payable, net (1,039)Repayment of long-term loans payable (278)Purchase of treasury stock (9)Cash dividends paid (7,296)Other, net (51)Net cash provided by (used in) financing activities (8,673)

Effect of exchange rate change on cash and cash equivalents (1,421) Net increase (decrease) in cash and cash equivalents (64,466) Cash and cash equivalents at beginning of period 160,096 Cash and cash equivalents at end of period 95,630

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From the current fiscal year, the Company has adopted ASBJ Statement No. 12, “Accounting Standard

for Quarterly Financial Statements”, and ASBJ Guidance No. 14, “Implementation Guidance for

Accounting Standards for Quarterly Financial Statements”. In addition, the Company prepares quarterly

financial statements according to “Rules for Quarterly Financial Reporting.”

(4) Note regarding going concern assumption Not applicable.

(5) Segment Information 1. Segment information by business segment

April 1, 2008 - June 30, 2008 (Millions of yen) Pharma-

ceuticals Other

businesses Total

Elimination

Consolidated

Net sales

1. Sales to third parties

100,626 7,623 108,249

( - ) 108,249

2. Intra-group sales or transfers

- 1,236 1,236

(1,236) -Total 100,626 8,859 109,485 (1,236) 108,249Operating income 24,586 767 25,353 36 25,389

(Notes)

1. The business segments are classified into “Pharmaceuticals” and “Other businesses” on the basis of the kind and character of products and merchandise.

2. The principal products in each of the business segment are as follows: Business segment Principal products

Pharma- ceuticals Ethical drugs, over-the-counter drugs

Other businesses Fine chemicals, real-estate leasing, information services, advertising, etc.

2. Segment information by geographical area

Since net sales outside Japan of all segments constituted less than 10% of the consolidated totals for the

first quarter of the fiscal year ended March 31, 2009, the disclosure of geographical segment information

has been omitted.

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3. Overseas sales

April 1, 2008 - June 30, 2008 (Millions of yen)

Overseas sales Consolidated net sales Rate of overseas sales to consolidated net sales

9,076 108,249 8.4%

(Notes)

1. Overseas sales include export sales of the Company and its domestic subsidiaries and sales of its foreign

consolidated subsidiaries other than exports to Japan.

2. Since overseas sales of each segment constituted less than 10% of the consolidated totals for the period, the

disclosure of overseas sales by region has been omitted.

(6) Note regarding substantial change in shareholders' equity Not applicable.

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【Reference】

(1) CONSOLIDATED STATEMENTS OF INCOME FOR PREVIOUS 1ST QUARTER

Amount %Net sales 48,357 100.0 Cost of sales 19,299 39.9

Gross profit after reversal adjustment 29,057 60.1 Selling, general and administrative expenses 18,570 38.4 [Including research and development expenses] [6,365] [13.2] Operating income 10,486 21.7 Non-operating income 1,126 2.3

Interest income 158 Dividend income 353 Rent 9 Foreign exchange gains 414 Other 189

Non-operating expenses 217 0.4 Interest expenses 3 Donations 91 Losses on disposal of property, plant and equipment 49 Losses on disposal of inventories 28 Equity in earnings of affiliates 13 Other 31

Ordinary income 11,395 23.6 Special Gains 7 0.0

Gains on sale of property, plant and equipment 4 Other 3

Special Losses 64 0.2 Merger-related expenses 60

Write-down of investment securities 3 Income before income taxes 11,338 23.4 Income taxes:

Current 4,251 8.8 Minority interests (53) (0.1) Net income 7,033 14.5

Jun.30, 2007Year

Accounts

Apr.1, 2007 -(Millions of yen)

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(2) CONSOLIDATED STATEMENTS OF CASH FLOWS FOR PREVIOUS 1ST QUARTER

Apr.1, 2007 -Jun.30, 2007

Cash flows from operating activities:Net income before income taxes 11,338 Depreciation 1,441 Increase (decrease) in accrued employees' retirement benefits (49)(Increase) decrease in prepaid pension expenses 9 Increase (decrease) in allowance for doubtful receivables 4 Interest and dividend income (512)Interest expense 3 Gains on sale of property, plant and equipment 25 Write-down of investment securities 3 Equity in earnings of affiliates 13 (Increase) decrease in notes and accounts receivable (5,761)(Increase) decrease in inventories (5,336)Increase (decrease) in notes and accounts payable 7,560 Increase (decrease) in accrued payable 283 Other, net (2,137) Subtotal 6,887 Interest and dividend received 477 Interest paid (3)Income taxes paid (9,497)

Net cash provided by (used in) operating activities (2,136) Cash flows from investing activities:

Purchases of marketable securities (5,557)Proceeds from sale of marketable securities 6,798 Investments in time deposits (324)Maturation of time deposits 314 Purchases of property, plant and equipment (741)Proceeds from sale of property, plant and equipment 14 Purchases of intangible fixed assets (18)Purchases of investment securities (5,990)Proceeds from sale of investment securities 593 Other, net (2)

Net cash provided by (used in) investing activities (4,913) Cash flows from financing activities:

Net repayment of short-term bank loans (11)Payments for purchases of treasury stock (15)Dividends paid (2,940)Other, net 1

Net cash provided by (used in) financing activities (2,967) Effect of exchange rate changes on cash and cash equivalents 132 Increase in cash and cash equivalents (9,884) Cash and cash equivalents at beginning of the period 46,121 Cash and cash equivalents at end of the period 36,237

YearAccounts

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(3) Segment Information For Previous 1st Quarter

1. Segment information by business segment

April 1, 2007 - June 30, 2007 (Millions of yen) Pharmaceuticals Other

businesses Total

Elimination

Consolidated

Net sales

(1) Sales to third parties 45,244 3,112 48,357

( - ) 48,357

(2) Intra-group sales or transfers - - -

( - ) -

Total 45,244 3,112 48,357 ( - ) 48,357

Operating expenses 34,549 3,320 37,870 ( - ) 37,870

Operating income 10,694 (208) 10,486 ( - ) 10,486

(Notes) 1. The business segments are classified into “Pharmaceuticals” and “Other businesses” on the basis of the

kind and character of products and merchandise. 2. The principal products in each of the business segment are as follows:

Business segment Principal products

Pharmaceuticals Ethical drugs, over-the-counter drugs

Other businesses Fine chemicals, food additives, information services, advertising, etc.

3. Accompanying revision of the tax law, from this first quarter under review, depreciation and amortization expense for tangible fixed assets acquired on or after April 1, 2007 is recorded in the manner stipulated by the revised tax law. As a result, operating expenses for pharmaceutical segment increased ¥101 million compared to previous fiscal years’.

2. Overseas sales

April 1, 2007 - June 30, 2007 (Millions of yen)

Overseas sales Consolidated net sales Rate of overseas sales to consolidated net sales

4,441 48,357 9.2%

(Notes) 1. Overseas sales include export sales of the Company and its domestic subsidiaries and sales of its foreign

consolidated subsidiaries other than exports to Japan.

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Reference (Simple Sum Basis)

1. Profit and Loss (Millions of yen)

FY2007/Q1 Simple sum FY2008/ Q1 Increase(Decrease) %Change

Forecasts for 1st half ofFY2008

(Apr.-Sep., 2008)

Achieved% (Apr.-Jun., 2007) (Apr.-Jun., 2008)

Net Sales 104,913 100.0 108,249 100.0 3,336 3.2 206,000 100.0 52.5

[Domestic] [96,737] [92.2] [99,173] [91.6] [2,436] [2.5] [184,500] [89.6] [53.8]

[Overseas] [8,176] [7.8] [9,076] [8.4] [900] [11.0] [21,500] [10.4] [42.2]

Pharmaceuticals 97,461 92.9 100,626 93.0 3,165 3.2 191,200 92.8 52.6

[Domestic] [90,850] [86.6] [93,683] [86.6] [2,833] [3.1] [174,100] [84.5] [53.8]

[Overseas] [6,611] [6.3] [6,943] [6.4] [332] [5.0] [17,100] [8.3] [40.6]

Other Businesses 7,451 7.1 7,623 7.0 172 2.3 14,800 7.2 51.5

[Domestic] [5,886] [5.6] [5,490] [5.1] [(396)] [(6.7)] [10,400] [5.0] [52.8]

[Overseas] [1,565] [1.5] [2,133] [1.9] [568] [36.3] [4,400] [2.1] [48.5]Cost of Sales 38,849 37.0 39,576 36.6 727 1.9 74,500 36.2 53.1

SG & A expenses 44,278 42.2 43,284 40.0 (994) (2.2) 98,000 47.6 44.2

R&D expenses 17,775 16.9 16,283 15.0 (1,492) (8.4) 39,500 19.2 41.2

Labor costs 13,473 12.8 12,551 11.6 (922) (6.8) 25,000 12.1 50.2

Amortization of goodwill 21 0.0 2,513 2.3 2,492 - 5,000 2.4 50.3

Sales promotion expenses 2,688 2.6 2,321 2.2 (367) (13.7) 7,400 3.6 31.4

Other 10,321 9.8 9,616 8.9 (705) (6.8) 21,100 10.2 45.6

Operating Income 21,784 20.8 25,389 23.5 3,605 16.5 33,500 16.3 75.8

Non-operating income 1,558 1,159 (399)

Interest income 353 476 123

Dividends income 438 462 24

Foreign exchange gain 465 46 (419)

Other 300 175 (125)

Non-operating Expenses 639 608 (31)

Interest expenses 23 24 1

Donations 229 173 (56)Loss on disposalof property, plantand equipment 94 148 54

Other 292 263 (29)

Ordinary income 22,703 21.6 25,940 24.0 3,237 14.3 34,000 16.5 76.3

Extraordinary income 87 56 (31) - - Gain on sales of property, plant andequipment 42 16 (26)

Gain on transfer of business - 40 40

Other 45 - (45)

Extraordinary loss 178 741 563 6,500 0.0 11.4

Merger-related expenses 90 - (90)Additional retirementallowance 82 - (82)

Impairment loss - 639 639Loss on valuation ofinvestment in securities 3 96 93

Other 2 6 4Net income 12,927 12.3 14,648 13.5 1,721 13.3 15,000 7.3 97.7Total Labor Costs 24,134 23.0 23,069 21.3 (1,065) (4.4) 46,200 22.4 49.9

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2. Sales of Main Products (Billions of yen)

FY2007/Q1 Simple sum(Apr.-Jun., 2007)

FY2008/Q1(Apr.-Jun., 2008)

Increase(Decrease) %

Forecasts for 1st half ofFY2008

(Apr.-Sep., 2008)%

Ethical drugs 96.1 99.4 3.3 3.4 188.6 52.7

Ethical drugs domestic sales 86.5 88.0 1.4 1.7 163.5 53.8

Remicade 6.3 8.9 2.6 41.2 16.7 53.0

Radicut 7.2 7.3 0.1 1.2 14.4 50.9

Anplag 4.5 4.9 0.4 8.8 9.8 49.9

Urso 4.2 4.3 0.1 1.9 8.9 48.0

Ceredist 4.1 4.3 0.3 6.4 7.7 56.2

Tanatril 3.4 3.4 0.0 (1.2) 6.4 53.4

Herbesser 3.6 3.3 (0.3) (9.1) 6.1 54.2

Depas 2.9 3.1 0.2 6.2 6.1 50.9

Venoglobulin-IH 3.2 2.9 (0.3) (8.5) 6.0 48.8

Maintate 2.8 2.7 (0.1) (1.9) 5.0 54.1

Sermion 2.7 2.3 (0.5) (16.6) 4.4 51.7

Liple 2.3 2.3 0.0 1.3 4.3 53.7

Talion 1.6 2.1 0.4 24.7 3.8 53.5

Omeprazon 1.6 1.6 0.0 (1.3) 3.1 49.7

Theodur 1.6 1.5 (0.1) (9.2) 2.2 65.5

Neuart 1.4 1.4 0.0 2.0 2.7 52.9

Gastrom 1.5 1.3 (0.2) (15.4) 2.5 50.5

Fulcaliq 1.4 1.2 (0.2) (14.8) 2.5 46.7

Novastan 0.7 0.8 0.0 5.7 1.4 54.9

Vaccine 4.0 5.4 1.4 34.8 6.5 84.1

[Influenza] [(0.1)] [0.0] [0.1] [-] [0.6] [(2.1)]

[Mearubik] [3.1] [4.6] [1.5] [46.6] [4.7] [96.8]

Generic Drugs*1 1.0 1.0 0.0 4.0 2.3 43.3

Ethical drugs overseas sales 5.8 6.6 0.8 13.5 12.6 52.1

Herbesser 1.1 1.5 0.4 34.3 3.0 48.6Argatroban(Novastan) 0.8 1.0 0.2 25.3 2.1 47.7

Tanatril 0.4 0.7 0.2 53.8 0.9 70.5

Vaccine 0.7 0.5 (0.2) (24.6) 0.7 73.6

Contracted manufacturing products*2 3.5 3.7 0.2 6.4 7.0 53.1

Licensing Fee, etc. 0.3 1.1 0.8 281.3 5.6 20.4

OTC prodcuts 1.4 1.3 (0.1) (8.6) 2.6 48.8

Pharmaceuticals 97.5 100.6 3.2 3.2 191.2 52.6

Other businesses 7.5 7.6 0.2 2.3 14.8 51.5

Total 104.9 108.2 3.3 3.2 206.0 52.5

*1: Sold by Tanabe Seiyaku Hanbai Co., Ltd*2: Active pharmaceutical ingredients, etc. ordered by other companies.

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3. Quarterly Trend for FY2007 and FY2008 (P/L) (Millions of yen)

FY2007 FY2008

Q1Apr. to Jun.

Q2Jul. to Sep.

Q3Oct. to Dec.

Q4Jan. to Mar. Total Q1

Apr. to Jun.Forecasts for

1st halfForecasts for

full year

Net sales 104,913 102,819 115,747 85,948 409,427 108,249 206,000 425,00025.6% 25.1% 28.3% 21.0% 100.0% 25.5% 48.5% 100.0%

[Domestic] [96,737] [92,096] [106,964] [76,347] [372,144] [99,173] [184,500] [383,000][26.0%] [24.7%] [28.7%] [20.6%] [100.0%] [25.9%] [48.2%] [100.0%]

[Overseas] [8,176] [10,723] [8,783] [9,601] [37,283] [9,076] [21,500] [42,000][21.9%] [28.8%] [23.5%] [25.8%] [100.0%] [21.6%] [51.2%] [100.0%]

Pharmaceuticals 97,461 95,242 108,388 78,412 379,503 100,626 191,200 395,60025.7% 25.1% 28.6% 20.6% 100.0% 25.4% 48.3% 100.0%

[Domestic] [90,850] [87,787] [101,572] [71,144] [351,353] [93,683] [174,100] [362,800][25.9%] [25.0%] [28.9%] [20.2%] [100.0%] [25.8%] [48.0%] [100.0%]

[Overseas] [6,611] [7,455] [6,816] [7,268] [28,150] [6,943] [17,100] [32,800][23.5%] [26.5%] [24.2%] [25.8%] [100.0%] [21.2%] [52.1%] [100.0%]

Other businesses 7,451 7,576 7,359 7,536 29,923 7,623 14,800 29,40024.9% 25.3% 24.6% 25.2% 100.0% 25.9% 50.3% 100.0%

[Domestic] [5,886] [4,308] [5,392] [5,203] [20,790] [5,490] [10,400] [20,200][28.3%] [20.7%] [25.9%] [25.0%] [100.0%] [27.2%] [51.5%] [100.0%]

[Overseas] [1,565] [3,268] [1,967] [2,333] [9,133] [2,133] [4,400] [9,200][17.1%] [35.8%] [21.5%] [25.5%] [100.0%] [23.2%] [47.8%] [100.0%]

Cost of sales 38,849 36,906 42,603 32,177 150,535 39,576 74,500 159,000% of net sales 37.0% 35.9% 36.8% 37.4% 36.8% 36.6% 36.2% 37.4%

SG & A expenses 44,278 47,962 43,356 50,826 186,423 43,284 98,000 191,00023.8% 25.7% 23.3% 27.2% 100.0% 22.7% 51.3% 100.0%

R&D expenses 17,775 18,863 16,170 19,526 72,335 16,283 39,500 77,50024.6% 26.1% 22.4% 26.9% 100.0% 21.0% 51.0% 100.0%

Labor Costs 13,473 13,719 12,681 13,148 53,021 12,551 25,000 48,40025.4% 25.9% 23.9% 24.8% 100.0% 25.9% 51.7% 100.0%

Amortization ofgood will 21 21 2,580 2,514 5,136 2,513 5,000 10,000

0.4% 0.4% 50.2% 49.0% 100.0% 25.1% 50.0% 100.0%

Sales promationexpenses 2,688 4,433 2,468 3,673 13,262 2,321 7,400 14,400

20.3% 33.4% 18.6% 27.7% 100.0% 16.1% 51.4% 100.0%

Other 10,321 10,926 9,457 11,965 42,669 9,616 21,100 40,70024.2% 25.6% 22.2% 28.0% 100.0% 23.6% 51.8% 100.0%

Operating income 21,784 17,950 29,788 2,945 72,468 25,389 33,500 75,00030.1% 24.8% 41.1% 4.0% 100.0% 33.9% 44.7% 100.0%

Ordinary income 22,703 17,505 30,674 2,758 73,640 25,940 34,000 76,00030.8% 23.8% 41.7% 3.7% 100.0% 34.1% 44.7% 100.0%

Net income 12,927 7,429 17,224 (5,649) 31,932 14,648 15,000 39,00040.5% 23.3% 53.9% △ 17.7% 100.0% 37.6% 38.5% 100.0%

The each figure (excluding Cost of Sales) in the lower displays the progress rate.

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4. Quarterly Trend for FY2007 and FY2008 (Sales of Main Products) (Billions of yen)FY2007 FY2008

Q1Apr. to Jun.

Q2Jul. to Sep.

Q3Oct. to Dec.

Q4Jan. to Mar.

TotalQ1

Apr. to Jun.Forecasts for

1st halfForecasts for

full year

Ethical drugs 96.1 93.5 106.9 77.2 373.7 99.4 188.6 389.9 25.7% 25.0% 28.6% 20.7% 100.0% 25.5% 48.4% 100.0%

 Ethical drugs domestic sales 86.5 80.7 98.0 66.7 331.9 88.0 163.5 339.1 26.1% 24.3% 29.5% 20.1% 100.0% 25.9% 48.2% 100.0%

  Remicade 6.3 7.2 8.7 6.3 28.6 8.9 16.7 35.7 22.0% 25.3% 30.6% 22.1% 100.0% 24.8% 46.8% 100.0%

  Radicut 7.2 7.4 8.0 5.3 27.9 7.3 14.4 29.3 25.9% 26.4% 28.8% 18.9% 100.0% 25.0% 49.1% 100.0%

  Anplag 4.5 4.7 4.8 3.6 17.6 4.9 9.8 20.2 25.6% 26.5% 27.3% 20.6% 100.0% 24.2% 48.5% 100.0%

  Urso 4.2 4.2 4.7 3.5 16.6 4.3 8.9 18.0 25.2% 25.3% 28.3% 21.2% 100.0% 23.7% 49.3% 100.0%

  Ceredist 4.1 3.8 4.4 3.0 15.2 4.3 7.7 15.3 26.8% 24.8% 28.8% 19.6% 100.0% 28.3% 50.3% 100.0%

  Tanatril 3.4 3.0 3.7 2.3 12.4 3.4 6.4 12.6 27.8% 24.0% 29.9% 18.3% 100.0% 27.0% 50.6% 100.0%

  Herbesser 3.6 3.1 3.8 2.5 13.0 3.3 6.1 12.0 27.8% 23.8% 29.4% 19.0% 100.0% 27.3% 50.4% 100.0%

  Depas 2.9 2.9 3.2 2.5 11.5 3.1 6.1 12.3 25.5% 25.3% 27.6% 21.6% 100.0% 25.4% 49.9% 100.0%

  Venoglobulin-IH 3.2 3.1 3.4 2.1 11.8 2.9 6.0 12.2 26.9% 26.3% 28.7% 18.1% 100.0% 23.9% 48.9% 100.0%

  Maintate 2.8 2.5 3.0 2.0 10.2 2.7 5.0 10.1 27.2% 24.1% 29.2% 19.5% 100.0% 26.8% 49.6% 100.0%

  Sermion 2.7 2.3 2.7 1.7 9.5 2.3 4.4 8.6 28.7% 24.6% 28.8% 17.9% 100.0% 26.6% 51.5% 100.0%

  Liple 2.3 2.3 2.4 1.9 8.9 2.3 4.3 8.7 25.6% 25.7% 27.4% 21.3% 100.0% 26.6% 49.5% 100.0%

  Talion 1.6 1.5 2.0 3.2 8.3 2.1 3.8 10.8 19.9% 17.6% 24.4% 38.1% 100.0% 19.0% 35.6% 100.0%

  Omeprazon 1.6 1.7 1.7 1.2 6.2 1.6 3.1 6.4 25.4% 27.1% 27.6% 19.9% 100.0% 24.1% 48.5% 100.0%

  Theodur 1.6 1.4 1.9 1.1 6.0 1.5 2.2 4.4 26.9% 23.5% 31.6% 18.0% 100.0% 33.0% 50.4% 100.0%

  Neuart 1.4 1.5 1.8 1.1 5.8 1.4 2.7 5.5 24.4% 25.6% 31.1% 18.9% 100.0% 26.0% 49.2% 100.0%

  Gastrom 1.5 1.3 1.6 1.0 5.4 1.3 2.5 5.0 28.0% 24.5% 28.6% 18.9% 100.0% 25.5% 50.5% 100.0%

  Fulcaliq 1.4 1.3 1.5 0.9 5.1 1.2 2.5 4.9 27.0% 25.8% 29.0% 18.2% 100.0% 23.5% 50.3% 100.0%

Novastan 0.7 0.7 0.9 0.6 2.9 0.8 1.4 3.4 25.3% 25.4% 29.9% 19.4% 100.0% 23.4% 42.6% 100.0%

  Vaccine 4.0 2.8 6.9 3.2 16.9 5.4 6.5 16.3 23.8% 16.6% 40.7% 18.9% 100.0% 33.4% 39.7% 100.0%

  [Influenza] [(0.1)] [1.0] [5.6] [0.2] [6.6] [0.0] [0.6] [6.1][(1.3%)] [14.7%] [83.6%] [3.0%] [100.0%] [(0.2%)] [9.2%] [100.0%]

  [Mearubik] [3.1] [1.3] [0.9] [2.2] [7.6] [4.6] [4.7] [8.2][41.2%] [16.9%] [12.4%] [29.5%] [100.0%] [56.3%] [58.2%] [100.0%]

  Generic Drugs*2 1.0 0.9 1.1 0.8 3.7 1.0 2.3 5.9 26.1% 23.1% 29.8% 21.0% 100.0% 17.1% 39.6% 100.0%

 Ethical drugs overseas sales 5.8 6.0 5.9 6.0 23.6 6.6 12.6 26.3 24.4% 25.6% 24.8% 25.2% 100.0% 24.9% 47.8% 100.0%

  Herbesser 1.1 1.3 1.1 1.1 4.6 1.5 3.0 6.0 23.9% 28.7% 24.1% 23.3% 100.0% 24.3% 50.0% 100.0%

Argatroban(Novastan)

0.8 0.8 0.7 1.0 3.3 1.0 2.1 4.2 24.1% 23.6% 22.4% 29.9% 100.0% 23.4% 49.0% 100.0%

Tanatril 0.4 0.7 0.4 0.5 2.0 0.7 0.9 2.0 21.7% 33.7% 19.8% 24.8% 100.0% 33.4% 47.4% 100.0%

Vaccine 0.7 0.4 0.3 0.4 1.7 0.5 0.7 1.3 39.2% 23.7% 15.5% 21.6% 100.0% 39.7% 53.9% 100.0%

Contracted Manufacturing Products*3 3.5 5.4 2.5 3.2 14.6 3.7 7.0 17.6 23.8% 37.2% 17.2% 21.8% 100.0% 21.0% 39.5% 100.0%

Licensing Fee, etc. 0.3 1.3 0.5 1.4 3.5 1.1 5.6 6.8 8.5% 38.0% 14.1% 39.4% 100.0% 16.8% 82.3% 100.0%

OTC Drugs 1.4 1.7 1.5 1.2 5.8 1.3 2.6 5.7 23.8% 29.1% 26.2% 20.9% 100.0% 22.2% 45.6% 100.0%

Pharmaceuticals 97.5 95.2 108.4 78.4 379.5 100.6 191.2 395.6 25.7% 25.1% 28.6% 20.6% 100.0% 25.4% 48.3% 100.0%

Other Businesses 7.5 7.6 7.4 7.5 29.9 7.6 14.8 29.4 24.9% 25.3% 24.6% 25.2% 100.0% 25.9% 50.3% 100.0%

Total 104.9 102.8 115.7 85.9 409.4 108.2 206.0 425.0 25.6% 25.1% 28.3% 21.0% 100.0% 25.5% 48.5% 100.0%

*1: The each figure in the lower displays the progress rate.*2: Sold by Tanabe Seiyaku Hanbai Co., Ltd.*3: Active pharmaceutical ingredients, etc. ordered by o t her companies.

Page 20: 03 200903-1Q Qualitative Information · of quarterly financial statements: (Simplified accounting methods) 1. Inventory valuation method In regard to write-downs of inventory, the

State of New Product Development (as of July 30, 2008)

1. Pipeline in Japan

(1) New Molecular EntitiesDevelopment code

(Generic name)Category

(Indications)Stage Origin Remarks

TA-8317 Narcotic analgesicUS:Cephalon

(Fentanyl Citrate) (Breakthrough cancer pain: oral transmucosal) Phase 3

MCC-847

Leukotriene D4 antagonistUK:

AstraZeneca(Asthma) Phase 3

(Allergic Rhinitis) Phase 2

APTA-2217 PDE4 inhibitorSwitzerland:

NycomedCo-development-Nycomed, Switzerland(Roflumilast) (Asthma) Phase 2/3

(COPD) Phase 2/3

CNTO148 Anti-TNFα monoclonal antibodyUS:Centocor Co-development

-Janssen Pharma(Golimumab) (Rheumatoid arthritis) Phase 2/3

FTY720 Sphingosine-1-phosphate receptor modulatorIn-house

Co-development-Novartis Pharma-Mitsui Sugar(Fingolimod hydrochloride) (Multiple Sclerosis) Phase 2

MP-513 DPP4 InhibitorIn-house

(Type 2 Diabetes Mellitus) Phase 2

MP-424 NS3-4A protease inhibitorUS:Vertex

(Chronic hepatitis C) Phase 2 (VX-950)

MP-214 D3/D2 antagonist Hungary: Gedeon-Richter(Schizophrenia) Phase 2 (RGH-188)

MP-435 C5a antagonistIn-house

(Rheumatoid arthritis) Phase 1

TA-6666 DPP4 inhibitorIn-house

(Type 2 Diabetes Mellitus) Phase 1

TA-7284 SGLT2 inhibitorIn-house

(Diabetes mellitus) Phase 1

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(2) Additional IndicationsDevelopment code

(Generic name)Category

(Indications)Stage Origin Remarks

Neuart AnticoagulantIn-house Co-development

-CSL Behring(Freeze-dried Concentrated HumanAnthithromibin Ⅲ) (Toxemia of Pregnancy) sNDA filed

(Dec.1995)

Remicade Anti-TNFα monoclonal antibody

US:Centocor

(Infliximab〔recombinant〕)(Rheumatoid arthritis: dose escalation) sNDA filed

(Sep.2007)

(Psoriasis) sNDA filed(Feb. 2008)

(Ulcerative colitis) Phase 3

(Ankylosing spondylitis*) Phase 3

Venoglobulin-IH Human Immunoglobulin G

In-house

(Polyethylene Glycol Treated HumanNormal Immunogloblin) (IgG2 deficiency) sNDA filed

(Dec.1997)

(Polymyositis, Dermatomyositis* ) sNDA filed(May 2003)

(Hypo and gammagloblinemia: additional dose ) sNDA filed(Mar. 2008)

(Systemic Sclerosis) Phase 3

(Myasthenia Gravis) Phase 3

Modiodal Psychoneurotic agentUS:Cephalon Co-development

-Alfresa Pharma(Modafinil) (Obstructive sleep apnea) sNDA filed(May 2008)

Valixa AntiviralSwitzerland:Roche(Valganciclovir) (Post- transplantation cytomegalovirus infection ) sNDA filed

(Jun. 2008)Ceredist Spinocerebellar degeneration remedy

In-house(Taltirelin Hydrate) (Orally disintegrating tablet: additiona

formulation)sNDA filed(Jul. 2008)

Anplag 5HT2 antagonistIn-house(Sarpogrelate Hydrochloride)

(Prevention of recurrence of cerebral infarction) Phase 3

Radicut Free radical scavengerIn-house

(Edaravone) (Amyotrophic lateral sclerosis*) Phase 3

Maintate Selective β1 antagonist Germany:Merck KGaA(Bisoprolol) (Chronic heart failure) Phase 3

Pazucross Injectable quinolone synthetic antibacterial agent

Toyama Chemical Co-development-Toyama Chemical(Pazufloxacin mesilate) (Severe or intractable case: additional dose)

(Sepsis, Pneumococcus) Phase 3

Cholebine New mode of action for diabetes treatment

In-house(Colestimide(JAN)) (Type 2 Diabetes mellitus) Phase 2

Non-absorbed phosphate binder

(Hyperphosphatemia) Phase 1

*: Orphan drug designated

Page 22: 03 200903-1Q Qualitative Information · of quarterly financial statements: (Simplified accounting methods) 1. Inventory valuation method In regard to write-downs of inventory, the

2. Pipeline Overseas

(1) New Molecular EntitiesDevelopment code

(Generic name)Category

(Indications) Region Stage Origin Region

MP-146 Uremic toxin adsorbentJapan:Kureha

(Chronic kidney disease) US, EU Phase 3

MCI-196 Non-absorbed phosphate binderIn-house

(Colestilan(INN)) (Hyperphosphatemia) US, EU Phase 3

TA-6666 DPP4 inhibitorIn-house

(Type 2 Diabetes mellitus) US Phase 2

TA-5538 NK-1 receptor antagonistIn-house

(Overactive bladder) EU Phase 2

MCC-135 Intracellular Ca Handling ModulatorIn-house

(Caldaret) (Myocardial Infarction) US, EU Phase 2

MCC-257 Neurotrophin EnhancerIn-house

(Diabetic neuropathy) US Phase 2

TA-5493 p38 inhibitorIn-house

(Rheumatoid arthritis, Psoriasis) EU Phase 1

MCI-186 Free Radical ScavengerIn-house

(Edaravone) (Acute cerebral infarction) EU Phase 1

MP-513 DPPIV inhibitorIn-house

(Type 2 Diabetes mellitus) US, EU Phase 1

GB-1057 Recombinant human serum albuminIn-house(Human serum albumin

〔recombinant〕)(Stabilizing agent) US Phase 1

TA-8995 CETP inhibitorIn-house

(Dyslipidemia) EU Phase 1

(2) Additional IndicationsDevelopment code

(Generic name)Category

(Indications) Region Stage Origin Remarks

MCI-9038(Argatroban)

Thrombin Inhibitor

In-house(Heparin-Induced Thrombocytopenia (HIT)) EU Preparing forNDA

(HIT Patients undergoing Percutaneous CoronaryIntervention(PCI)) EU Phase 3

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3. Licensing-outDevelopment code

(Generic name)Category

(Indications) Region Stage Licensee

FTY720 Sphingosine 1–phosphate receptor agonistSwitzerland:Novartis Pharma

(Fingolimod hydrochloride) (Multiple sclerosis) US, EU Phase 3

MKC-242 5-HT1A receptor agonistUS:MediciNova

(Insomnia) US Phase 2MCI-225 Norepinephrine reuptake inhibitor + 5-HT3

receptor antagonist US:Dynogen Pharmaceuticals(Diarrhea-predominant irritable bowel syndrome) US Phase 2

MKC-733 5-HT3 receptor agonist

US:Dynogen Pharmaceuticals(Constipation-predominant irritable bowelsyndrome ) US Phase 2

(Gastroesophageal reflux disease at nighttime) US Phase 1

TA-1790 PDE5 inhibitor

Avanafil (Erectile dysfunction) US Phase 2 US:Vivus

Korea Phase 2 Korea:Choongwae Pharma

TA-2005 Long-acting β2 agonistItaly:Chiesi Farmaceutici

Carmoterol (Asthma, COPD) EU Phase 2

T-0047 Cell adhesion inhibitor [α4β7/α4β1 inhibitor]UK:GlaxoSmithKline

(Firategrast) (Multiple sclerosis) EU Phase 2

MKC-231 Neurogenesis enhancerUS:BrainCells

(Depression/Anxiety) US Phase 2

TA-7284 SGLT2 inhibitor US: Johnson & JohnsonPharmaceutical Research &Development, L.L.C.(Diabetes mellitus) EU, US Phase 2

Y-39983 ROCK (rho-kinase) inhibitorJapan: Senju Pharmaceutical

(Glaucoma) Japan Phase 2

T-0128 DNA Topoisomerase I inhibitors [DDS drugcamptothecin derivative] Italy:Menarini (Malignant tumor) EU Phase 1

sTU-199 Proton pump inhibitor  France:Negma (Sidem)

(Tenatoprazole) (Gastroesophageal reflux dsease) EU Phase 1

MCC-555 PPARγ agonistUS:Perlegen Sciences

(Netoglitazone) (Type 2 Diabetes mellitus) US Phase 1

MP-412 Tyrosine kinase inhibitorUS:AVEO Pharmaceuticals

(Malignant tumor) US Phase 1

TT-138 β3 receptor agonistUS:MediciNova

(Pollakiuria, Anischuria) US Phase 1

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4. Changes Since Previous Announcement on May 7, 2008Product name

Development code(Generic name)

Category(Indications) As of May 7, 2008 As of July 30, 2008

Novastan Thrombin inhibitorsNDA Filed in Japan Approved

(Argatroban) (Heparin-Induced Thrombocytopenia (HIT)

Modiodal Psychoneurotic agentPhase 3 sNDA Filed in Japan

(Modafinil) (Obstructive sleep apnea)

Valixa AntiviralPhase 3 sNDA Filed in Japan

(Valganciclovir) (Post- transplantation cytomegalovirus infection )

Ceredist Spinocerebellar degeneration remedyNone sNDA Filed in Japan

(Taltirelin Hydrate) (Orally disintegrating tablet: additional formulation)

Pazucross Injectable quinolone synthetic antibacterial agent

(Pazufloxacin mesilate) (Severe or intractable case: additional dose) None Phase 3

(Sepsis, pneumococcus)

CNTO148 Anti-TNFα monoclonal antibodyPhase 1 Phase 2/3

(Golimumab) (Rheumatoid arthritis)

MP-214 D3/D2 antagonistPhase 1 Phase 2

(Schizophrenia)

Y-39983 ROCK (rho-kinase) inhibitorPhase 1 Phase 2

(Glaucoma)