UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

(Mark One)

   x

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

 

 

 

For the quarterly period ended March 31, 2008

 

 

 

 

 

OR

 

 

 

   o

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                       to                       .

 

Commission File Number 0-28494

 

MILLENNIUM PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

04-3177038

(State or other jurisdiction

 

(I.R.S. Employer

of incorporation or organization)

 

Identification No.)

 

40 Landsdowne Street, Cambridge, Massachusetts 02139

(Address of principal executive offices) (zip code)

 

(617)  679-7000

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes    x      No    o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer x

 

Accelerated filer  o

 

 

 

Non-accelerated filer o

 

Smaller reporting company  o

(Do not check if a smaller reporting company)

 

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes   o     No   x

 

Number of shares of the registrant’s Common Stock, $0.001 par value, outstanding on May 2, 2008:   327,288,246

 

 



 

MILLENNIUM PHARMACEUTICALS, INC.

 

FORM 10-Q

 

FOR THE QUARTER ENDED MARCH 31, 2008

 

TABLE OF CONTENTS

 

PART I

 

FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Condensed Consolidated Financial Statements

 

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of March 31, 2008 and December 31, 2007

 

3

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the three months ended March 31, 2008 and 2007

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2008 and 2007

 

5

 

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements

 

6

 

 

 

 

 

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

16

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

28

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

28

 

 

 

 

 

PART II

 

OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

29

 

 

 

 

 

Item 1A.

 

Risk Factors That May Affect Results

 

30

 

 

 

 

 

Item 6.

 

Exhibits

 

44

 

 

 

 

 

 

 

Signatures

 

45

 

 

 

 

 

 

 

Exhibit Index

 

46

 

The following Millennium trademarks are used in this Quarterly Report on Form 10-Q: Millennium®, the Millennium “M” logo and design (registered), Millennium Pharmaceuticals™, VELCADE® (bortezomib) for Injection, and INTEGRILIN® (eptifibatide) Injection. All are covered by registrations or pending applications for registration in the U.S. Patent and Trademark Office and many other countries. DOXIL® (doxorubicin HCl liposome injection) is a trademark of Ortho Biotech Products, L.P, ReoPro® (abciximab) is a trademark of Eli Lilly & Company, Aggrastat® (tirofiban) is a trademark of Merck & Co., Inc., Thalomid® (thalidomide) and Revlimid® (lenalidomide) are trademarks of Celgene Corporation and Angiomax® (bivalirudin) is a trademark of The Medicines Company.   Other trademarks used in this Quarterly Report on Form 10-Q are the property of their respective owners.

 

2



 

PART I   FINANCIAL INFORMATION

 

Item 1.   Condensed Consolidated Financial Statements

 

Millennium Pharmaceuticals, Inc.

 

Condensed Consolidated Balance Sheets

 

(in thousands, except per share amounts)

 

March 31,
2008

 

December 31,
2007

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

143,973

 

$

89,163

 

Marketable securities

 

787,315

 

802,113

 

Accounts receivable, net of allowances of $514 in 2008 and $524 in 2007

 

85,562

 

126,349

 

Inventory

 

7,410

 

6,821

 

Prepaid expenses and other current assets

 

10,118

 

9,624

 

Total current assets

 

1,034,378

 

1,034,070

 

Property and equipment, net

 

144,715

 

147,869

 

Restricted cash

 

7,584

 

7,650

 

Other assets

 

29,646

 

29,961

 

Goodwill

 

1,218,630

 

1,217,501

 

Developed technology, net

 

230,048

 

238,413

 

Intangible assets, net

 

60,914

 

61,036

 

Total assets

 

$

2,725,915

 

$

2,736,500

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

16,562

 

23,461

 

Accrued expenses

 

59,311

 

75,370

 

Current portion of restructuring

 

19,862

 

22,986

 

Current portion of deferred revenue

 

4,357

 

9,412

 

Current portion of capital lease obligations

 

1,262

 

1,246

 

Total current liabilities

 

101,354

 

132,475

 

Other long-term liabilities

 

2,333

 

2,016

 

Restructuring, net of current portion

 

21,359

 

26,416

 

Deferred revenue, net of current portion

 

14,574

 

14,905

 

Capital lease obligations, net of current portion

 

73,474

 

73,795

 

Long-term debt

 

250,000

 

250,000

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000 shares authorized, none issued

 

 

 

Common stock, $0.001 par value; 500,000 shares authorized: 326,660 shares at March 31, 2008 and 324,605 shares at December 31, 2007 issued and outstanding

 

327

 

325

 

Additional paid-in capital

 

4,738,195

 

4,728,762

 

Accumulated other comprehensive income

 

5,755

 

3,888

 

Accumulated deficit

 

(2,481,456

)

(2,496,082

)

Total stockholders’ equity

 

2,262,821

 

2,236,893

 

Total liabilities and stockholders’ equity

 

$

2,725,915

 

$

2,736,500

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3



 

Millennium Pharmaceuticals, Inc.

 

Condensed Consolidated Statements of Operations

 

(unaudited)

 

 

 

Three Months Ended March 31,

 

(in thousands, except per share amounts)

 

2008

 

2007

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

Net product sales

 

$

83,470

 

$

58,640

 

Revenue under strategic alliances

 

15,523

 

15,714

 

Royalties

 

40,459

 

36,370

 

Total revenues

 

139,452

 

110,724

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

Cost of sales (excludes amortization of acquired intangible assets)

 

10,160

 

5,358

 

Research and development (Note 1)

 

71,406

 

69,206

 

Selling, general and administrative (Note 1)

 

49,795

 

41,548

 

Restructuring

 

(2,870

)

5,611

 

Amortization of intangibles

 

8,487

 

8,487

 

Total costs and expenses

 

136,978

 

130,210

 

 

 

 

 

 

 

Income (loss) from operations

 

2,474

 

(19,486

)

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

Investment income, net

 

14,553

 

15,495

 

Interest expense

 

(2,401

)

(2,787

)

Net income (loss)

 

$

14,626

 

$

(6,778

)

 

 

 

 

 

 

Amounts per common share:

 

 

 

 

 

 

 

 

 

 

 

Earnings (loss) per share, basic and diluted

 

$

0.05

 

$

(0.02

)

 

 

 

 

 

 

Weighted average shares, basic

 

321,608

 

316,072

 

Weighted average shares, diluted

 

326,694

 

316,072

 

 

Note 1:  Stock-based compensation expense is allocated in the condensed consolidated statements of operations expense lines as follows:

 

 

 

Three Months Ended March 31,

 

(in thousands)

 

2008

 

2007

 

 

 

 

 

 

 

Research and development

 

$

1,361

 

$

2,055

 

Selling, general and administrative

 

4,162

 

3,347

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4



 

Millennium Pharmaceuticals, Inc

 

Condensed Consolidated Statements of Cash Flows

 

(unaudited)

 

 

 

Three Months Ended 
March 31,

 

(in thousands)

 

2008

 

2007

 

 

 

 

 

 

 

Cash Flows from Operating Activities:

 

 

 

 

 

Net income (loss)

 

$

14,626

 

$

(6,778

)

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

12,634

 

17,083

 

Realized gain on sale of restructured assets

 

(211

)

 

Amortization of deferred financing costs

 

402

 

448

 

Realized gain on securities, net

 

(3,315

)

(5,092

)

401K stock match

 

167

 

1,650

 

Stock-based compensation expense

 

5,523

 

5,402

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

40,787

 

24,203

 

Inventory

 

(589

)

1,508

 

Prepaid expenses and other current assets

 

(494

)

576

 

Restricted cash and other assets

 

66

 

(3,509

)

Accounts payable and accrued expenses

 

(30,863

)

(20,534

)

Deferred revenue

 

(5,386

)

(838

)

Other long-term liabilities

 

317

 

34

 

Net cash provided by operating activities

 

33,664

 

14,153

 

 

 

 

 

 

 

Cash Flows from Investing Activities:

 

 

 

 

 

Investments in marketable securities

 

(177,153

)

(190,474

)

Proceeds from sales and maturities of marketable securities

 

195,811

 

117,991

 

Purchases of property and equipment

 

(1,354

)

(1,100

)

Other investing activities

 

400

 

1,269

 

Net cash provided by (used in) investing activities

 

17,704

 

(72,314

)

 

 

 

 

 

 

Cash Flows from Financing Activities:

 

 

 

 

 

Net proceeds from employee stock purchases

 

3,747

 

8,351

 

Repayment of principal of long-term debt obligations

 

 

(99,571

)

Principal payments on capital leases

 

(305

)

(291

)

Net cash provided by (used in) financing activities

 

3,442

 

(91,511

)

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

 

54,810

 

(149,672

)

Effects of exchange rate changes on cash and cash equivalents

 

 

1

 

Cash and cash equivalents, beginning of period

 

89,163

 

212,273

 

Cash and cash equivalents, end of period

 

$

143,973

 

$

62,602

 

 

 

 

 

 

 

Supplemental Cash Flow Information:

 

 

 

 

 

Cash paid for interest

 

$

610

 

$

3,323

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

5



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

 

1.   Basis of Presentation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the accompanying condensed consolidated financial statements have been included. Interim results for the three months ended March 31, 2008 are not necessarily indicative of the results that may be expected for the year ending December 31, 2008. For further information, refer to the consolidated financial statements and accompanying footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission (“SEC”) on February 29, 2008.

 

The information presented in the condensed consolidated financial statements and related footnotes at March 31, 2008, and for the three months ended March 31, 2008 and 2007, is unaudited and the condensed consolidated balance sheet amounts and related footnotes at December 31, 2007, have been derived from audited financial statements.

 

2.   Summary of Significant Accounting Policies

 

Cash Equivalents, Marketable Securities and Other Investments

 

Cash equivalents principally consist of money market funds and corporate bonds with maturities of three months or less at the date of purchase. Marketable securities primarily consist of investment-grade corporate bonds, asset-backed debt securities and U.S. government agency debt securities. Other investments represent ownership in private companies in which the Company holds less than a 20 percent ownership position and does not otherwise exercise significant influence. The Company carries such investments at cost unless significant influence can be exercised over the investee, in which case such securities are recorded using the equity method. The Company monitors these investments in private companies on a quarterly basis and determines whether any impairment in their value would require a charge to the statement of operations, based on the implied value from any recent rounds of financing completed by the investee, market prices of comparable public companies and general market conditions.  These other investments are included in other long-term assets at March 31, 2008 and December 31, 2007.

 

Management determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. Marketable securities at March 31, 2008 and December 31, 2007 are classified as “available-for-sale.” Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in a separate component of stockholders’ equity. The cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in investment income. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities and other investments are included in investment income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in investment income.

 

During the three months ended March 31, 2008, the Company recorded realized gains on marketable securities and other investments of $3.7 million and realized losses on marketable securities of $0.4 million.  During the three months ended March 31, 2007, the Company recorded realized gains on marketable securities and other investments of $6.0 million and realized losses on marketable securities of $0.9 million.

 

Realized gains on marketable securities for the three months ended March 31, 2008 included a realized gain of approximately $1.2 million related to the Company’s share of proceeds from a class action proceeding against WorldCom, Inc.  The Company had previously recorded realized losses equal to the carrying value of its investment in WorldCom, Inc., as the decline in value was determined to be other-than-temporary at that time.

 

Realized gains on marketable securities for the three months ended March 31, 2007 included a realized gain of approximately $3.5 million related to the sale of the Company’s investment in SGX Pharmaceuticals, Inc. and a realized gain of approximately $2.3 million related to the Company’s share of proceeds from a class action proceeding against WorldCom, Inc.

 

Segment Information

 

Statement of Financial Accounting Standards (“SFAS”) No. 131, “Disclosures about Segments of an Enterprise and Related Information” (“SFAS No. 131”), establishes standards for the way that public business enterprises report information about operating

 

6



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

segments in their financial statements. SFAS No. 131 also establishes standards for related disclosures about products and services, geographic areas, and major customers.

 

The Company operates in one business segment, which focuses on the research, development and commercialization of therapeutic products. All of the Company’s product sales are currently related to sales of VELCADE ® (bortezomib) for Injection. The remainder of the Company’s total revenue is related to its strategic alliances and royalties.

 

Revenues from Ortho Biotech Products, L.P. (“OBL”), a member of the Johnson & Johnson Family of Companies, accounted for approximately 19 percent and 15 percent of consolidated revenues for the three months ended March 31, 2008 and 2007, respectively.

 

Revenues from Schering-Plough Ltd. and Schering Corporation (collectively “SGP”) accounted for approximately 16 percent and 25 percent of consolidated revenues for the three months ended March 31, 2008 and 2007, respectively.

 

There were no other significant customers under strategic alliances and royalties for the three months ended March 31, 2008 and 2007.

 

Information Concerning Market and Source of Supply Concentration

 

The Company relies on third party contract manufacturers for the manufacturing of the active ingredient, formulation, fill/finish and packaging of VELCADE for both commercial purposes and for ongoing clinical trials. The Company has established long term supply relationships for the production of commercial supplies of VELCADE. The Company works with one manufacturer under a long term supply agreement to complete fill/finish for VELCADE. The Company is currently qualifying a second fill/finish supplier in order to mitigate its risk of VELCADE supply interruption.

 

The Company distributes VELCADE in the United States through a sole-source open access distribution model where the Company sells directly to an independent third party who in turn distributes to the wholesaler base. In April 2006, the Company’s distributor added a second distribution site to its network in order to improve access to the product for physicians in the western United States.

 

INTEGRILIN has received regulatory approvals in the United States, the countries of the European Union and a number of other countries for various indications. The Company and SGP co-promoted INTEGRILIN in the United States and shared any profits and losses through August 31, 2005. In September 2005, SGP acquired the exclusive development and commercialization rights to INTEGRILIN in the United States from the Company. In the European Union, GlaxoSmithKline plc (“GSK”) exclusively markets INTEGRILIN. The Company continues to manage the supply chain for INTEGRILIN at the expense of SGP for products sold in the SGP territories, and at the expense of GSK in the GSK territory.

 

The Company relies on third party contract manufacturers for the clinical and commercial production of INTEGRILIN. The Company has three approved manufacturers, two of which currently provide the Company with eptifibatide, the active pharmaceutical ingredient (“API”) necessary to make INTEGRILIN, for both clinical trials and commercial supply. Solvay, S.A., one of the current manufacturers, owns the process technology used by it and one other manufacturer for the production of the API. In June 2006, the Company received FDA approval of its own alternative process technology utilized by the second manufacturer for the production of eptifibatide. The European Medicines Agency approved the alternate process technology for eptifibatide in June 2007. The Company has two manufacturers that currently perform fill/finish services for INTEGRILIN and two packaging suppliers for INTEGRILIN for the United States. The FDA or other regulatory agencies must approve the processes or the facilities that may be used for the manufacture of the Company’s marketed products.

 

Inventory

 

Inventory consists of currently marketed products, including VELCADE and INTEGRILIN. Inventories are stated at the lower of cost (first in, first out) or market. Inventories are reviewed periodically for slow-moving or obsolete status based on sales activity, both projected and historical.

 

VELCADE inventories primarily relate to raw materials used in production, work in process and finished goods inventory on hand. INTEGRILIN inventories include raw materials used in production and work in process to supply GSK and limited amounts of work in process to supply SGP.

 

7



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

Inventory consists of the following (in thousands):

 

 

 

March 31, 2008

 

December 31, 2007

 

Raw materials

 

$

3,909

 

$

4,270

 

Work in process

 

2,794

 

1,385

 

Finished goods

 

707

 

1,166

 

 

 

$

7,410

 

$

6,821

 

 

Goodwill and Intangible Assets

 

Intangible assets consist of specifically identified intangible assets. Goodwill is the excess of any purchase price over the estimated fair market value of net tangible assets acquired not allocated to specific intangible assets.

 

Intangible assets consist of the following (in thousands):

 

 

 

March 31, 2008

 

December 31, 2007

 

 

 

Gross Carrying
Amount

 

Accumulated
Amortization

 

Gross Carrying
Amount

 

Accumulated
Amortization

 

Developed technology

 

$

435,000

 

$

(204,952

)

$

435,000

 

$

(196,587

)

Core technology

 

$

18,712

 

$

(18,712

)

$

18,712

 

$

(18,712

)

Other

 

17,060

 

(15,146

)

17,060

 

(15,024

)

Total amortizable intangible assets, excluding developed technology

 

35,772

 

(33,858

)

35,772

 

(33,736

)

Total indefinite-lived trademark

 

59,000

 

 

59,000

 

 

Total intangible assets, excluding developed technology

 

$

94,772

 

$

(33,858

)

$

94,772

 

$

(33,736

)

 

Amortization of intangibles is computed using the straight-line method over the useful lives of the respective assets as follows:

 

Developed technology

 

13 years

 

Core technology

 

4 years

 

Other

 

2 to 12 years

 

 

Amortization expense was approximately $8.5 million in each of the three months ended March 31, 2008 and 2007.  The Company expects to incur amortization expense of approximately $34.0 million for each of the next five years.

 

As required by SFAS No. 142, “Goodwill and Other Intangible Assets,” goodwill and indefinite lived intangible assets are not amortized, but are reviewed annually for impairment, or more frequently if impairment indicators arise. Separable intangible assets that are not deemed to have an indefinite life are amortized over their useful lives and reviewed for impairment when events or changes in circumstances suggest that the assets may not be recoverable. The Company tests for goodwill impairment annually, on October 1, and whenever events or changes in circumstances suggest that the carrying amount may not be recoverable.

 

On October 1, 2007, the Company performed its annual goodwill impairment test and determined that no impairment existed on that date. The Company continually monitors business and market conditions to assess whether an impairment indicator exists. If the Company were to determine that an impairment indicator exists, it would be required to perform an impairment test, which might result in a material impairment charge to the statement of operations.

 

Goodwill as of March 31, 2008 consists of the excess purchase price over the estimated fair value of net tangible and intangible assets. The carrying value may be adjusted as a result of the continued settlement of contingent consideration arising from acquisitions. Accordingly, goodwill increased by $1.1 million and $0.8 million for the three months ended March 31, 2008 and 2007, respectively.

 

8



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

Fair Value Measurements

 

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements” (“SFAS No. 157”). The Company adopted SFAS No. 157 as of January 1, 2008 and the adoption did not have a material impact on the consolidated financial statements or results of operations of the Company.

 

SFAS No. 157 defines fair value, establishes a framework for measuring fair value, establishes a three-level valuation hierarchy for disclosure of fair value measurement and enhances disclosure requirements for fair value measurements.  SFAS No. 157 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumption, SFAS No. 157 established a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

·                   Level 1 – Observable inputs such as quoted prices in active markets;

·                   Level 2 – Inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and

·                   Level 3 – Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

 

The Company’s third-party investment custodian provides a report which classifies the Company’s holdings within its portfolio under the above valuation hierarchy assumptions.  The Company reviews any estimates and judgments applied by the custodian in determining the appropriate investment classifications.

 

The Company’s marketable securities were valued at March 31, 2008 by its third-party investment custodian using information provided by pricing services. Because the Company’s investment portfolio includes many fixed income securities that do not always trade on a daily basis, the pricing service applied other available information as applicable through processes such as benchmark yields, benchmarking of like securities, sector groupings and matrix pricing to prepare evaluations. In addition, model processes were used to assess interest rate impact and develop prepayment scenarios. These models take into consideration relevant credit information, perceived market movements, sector news and economic events. The inputs into these models may include benchmark yields, reported trades, broker-dealer quotes, issuer spreads and other relevant data.

 

Assets measured at fair value at March 31, 2008 are as follows:

 

 

 

 

 

Fair Value Measurements at Reporting Date Using

 

 

 

 

 

Quoted Prices in
Active Markets for
Identical Assets

 

Significant Other
Observable
Inputs

 

Significant
Unobservable
Inputs

 

Description

 

March 31, 2008

 

(Level 1)

 

(Level 2)

 

(Level 3)

 

Corporate bonds

 

$

509,853

 

$

 

$

509,853

 

$

 

Asset-backed securities

 

158,067

 

 

158,067

 

 

U.S. government securities

 

119,395

 

119,395

 

 

 

Total

 

$

787,315

 

$

119,395

 

$

667,920

 

$

 

 

Revenue Recognition

 

The Company recognizes revenue from the sale of its products, strategic alliances and royalties. The Company’s revenue arrangements with multiple elements are divided into separate units of accounting if specified criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration received is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

 

Net product sales

 

The Company records product sales of VELCADE when delivery has occurred, title has transferred, collection is reasonably assured and the Company has no further obligations. Allowances are recorded as a reduction to product sales for discounts, product

 

9



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

returns and governmental and contractual adjustments at the time of sale. Costs incurred by the Company for shipping and handling are recorded in cost of sales.

 

Revenue under strategic alliances

 

The Company recognizes revenue under strategic alliances from nonrefundable license payments, milestone payments, reimbursement of research and development costs and reimbursement of manufacturing-related costs. Nonrefundable upfront fees for which no further performance obligations exist are recognized as revenue on the earlier of when payments are received or collection is assured.

 

Nonrefundable upfront licensing fees and guaranteed, time-based payments that require continuing involvement in the form of research and development, manufacturing or other commercialization efforts by the Company are recognized as revenue:

 

·                   ratably over the development period if development risk is significant;

 

·                   ratably over the manufacturing period or estimated product useful life if development risk has been substantially eliminated; or

 

·                   based upon the level of research services performed during the period of the research contract.

 

Milestone payments are recognized as revenue when the performance obligations, as defined in the contract, are achieved. Performance obligations typically consist of significant milestones in the development life cycle of the related technology or product candidate, such as initiation of clinical trials, filing for approval with regulatory agencies and approvals by regulatory agencies.

 

Reimbursements of research and development costs are recognized as revenue as the related costs are incurred.

 

Royalties

 

Royalties are recognized as revenue when earned. Royalties may include:

 

·                   royalties earned on sales of INTEGRILIN in the United States and other territories around the world, as provided by SGP;

 

·                   royalties, or distribution fees, earned on international sales of VELCADE, as provided by OBL;

 

·                   royalties earned on sales of INTEGRILIN in Europe, as provided by GSK; and

 

·                   other royalties.

 

Advertising and Promotional Expenses

 

Advertising and promotional expenses are expensed as incurred. During the three months ended March 31, 2008 and 2007, advertising and promotional expenses were $7.3 million and $6.7 million, respectively.

 

Earnings (Loss) Per Common Share

 

Basic earnings (loss) per common share is computed using the weighted-average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted earnings (loss) per share is based upon the weighted average number of common shares outstanding during the period, plus additional weighted average common equivalent shares outstanding during the period when the effect is not anti-dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options and warrants (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method), the assumed conversion of convertible notes and the vesting of unvested restricted shares of common stock. Common equivalent shares from options, warrants, unvested restricted shares and the assumed conversion of convertible notes that were not included in the calculation of diluted shares because the effect would have been anti-dilutive were 25.4 million and 36.6 million at March 31, 2008 and 2007, respectively.

 

10



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

Basic and diluted earnings (loss) per common share were determined as follows (in thousands, except per share amounts):

 

 

 

Three Months Ended March 31,

 

 

 

2008

 

2007

 

Basic

 

 

 

 

 

Net income (loss)

 

$

14,626

 

$

(6,778

)

Weighted average shares outstanding

 

321,608

 

316,072

 

Basic earnings (loss) per share

 

$

0.05

 

$

(0.02

)

Diluted

 

 

 

 

 

Net income (loss)

 

$

14,626

 

$

(6,778

)

Weighted average shares outstanding

 

321,608

 

316,072

 

Effect of dilutive options and restricted stock

 

5,086

 

 

Weighted average shares assuming dilution

 

326,694

 

316,072

 

Diluted earnings (loss) per share

 

$

0.05

 

$

(0.02

)

 

Comprehensive Income (Loss)

 

Comprehensive income (loss) comprises net income (loss), changes in unrealized gains and losses on marketable securities and cumulative foreign currency translation adjustments. The following table displays comprehensive income (loss) (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2008

 

2007

 

Net income (loss)

 

$

14,626

 

$

(6,778

)

Unrealized gain (loss) on marketable securities

 

1,865

 

(615

)

Cumulative translation adjustments

 

2

 

4

 

Comprehensive income (loss)

 

$

16,493

 

$

(7,389

)

 

The components of accumulated other comprehensive income were as follows (in thousands):

 

 

 

March 31, 2008

 

December 31, 2007

 

Unrealized gain on marketable securities

 

$

6,757

 

$

4,892

 

Cumulative translation adjustments

 

(1,002

)

(1,004

)

Accumulated other comprehensive income

 

$

5,755

 

$

3,888

 

 

Stock-Based Compensation Expense

 

SFAS No. 123 (revised 2004), “Share Based Payment” (“SFAS 123R”), requires the recognition of the fair value of stock-based compensation in the Company’s statements of operations. Stock-based compensation expense primarily relates to stock options, restricted stock and stock issued under the Company’s employee stock purchase plans.  The Company recognized stock-based compensation expense of $5.5 million and $5.4 million during the three months ended March 31, 2008 and 2007, respectively.

 

Accounting Pronouncements

 

In December 2007, the FASB issued EITF Issue 07-1, “Accounting for Collaborative Arrangements” (“EITF 07-1”). EITF 07-1 requires collaborators to present the results of activities for which they act as the principal on a gross basis and report any payments received from (made to) other collaborators based on other applicable GAAP or, in the absence of other applicable GAAP, based on analogy to authoritative accounting literature or a reasonable, rational, and consistently applied accounting policy election. Further, EITF 07-1 clarified the determination of whether transactions within a collaborative arrangement are part of a vendor-customer (or analogous) relationship subject to EITF 01-9, “Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products).” EITF 07-1 will be effective for the Company beginning on January 1, 2009. The Company is currently evaluating the effect EITF 07-1 will have on its consolidated financial position and results of operations.

 

11



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

3.   Restructuring

 

2006 Resource Alignment

 

In October 2006, the Company announced a program to further align resources with its current corporate priorities of advancing VELCADE and accelerating the clinical and preclinical pipeline by lowering investment in discovery and supporting areas. As part of its program, the Company reduced in-house research and development technologies and headcount in areas where the work could be outsourced.

 

The Company recorded net restructuring credits of approximately $0.1 million during the three months ended March 31, 2008, under the 2006 restructuring program, primarily related to a gain on the sale of previously impaired assets offset by the net present value adjustment for facilities charged to restructuring in prior years and employee termination benefits as a result of headcount reductions.  The Company recorded restructuring charges of approximately $5.0 million during the three months ended March 31, 2007, under the 2006 restructuring program, primarily for facilities-related costs associated with vacated buildings and employee termination benefits as a result of headcount reductions.

 

The following table displays the restructuring activity and liability balances (in thousands):

 

 

 

Balance at

 

 

 

 

 

Balance at

 

 

 

December 31,

 

Net Charges/

 

 

 

March 31,

 

 

 

2007

 

(Credits)

 

Payments

 

2008

 

Termination benefits

 

$

639

 

$

47

 

$

(222

)

$

464

 

Facilities

 

9,480

 

113

 

(830

)

8,763

 

Asset impairment

 

 

(211

)

211

 

 

Total

 

$

10,119

 

$

(51

)

$

(841

)

$

9,227

 

 

  2005 Strategic Refinement

 

In October 2005, the Company announced its 2005 restructuring plan in support of a refined business strategy focused on advancing key growth assets, including VELCADE, advancing the Company’s clinical pipeline and building a leading oncology-focused discovery organization. In connection with the strategic refinement, the Company substantially reduced its effort in inflammation discovery and reduced overall headcount, including eliminating positions in INTEGRILIN sales and marketing, inflammation discovery and various other business support groups.

 

The Company recorded restructuring charges of approximately $0.1 million and $0.2 million during the three months ended March 31, 2008 and 2007, respectively, under the 2005 restructuring plan, primarily related to the net present value adjustment for facilities charged to restructuring in prior years.

 

The following table displays the restructuring activity and liability balances (in thousands):

 

 

 

Balance at

 

 

 

 

 

Balance at

 

 

 

December 31,

 

Net Charges/

 

 

 

March 31,

 

 

 

2007

 

(Credits)

 

Payments

 

2008

 

Facilities

 

$

6,232

 

$

102

 

$

(223

)

$

6,111

 

 

2003 Restructuring Plan

 

In December 2002 and June 2003, the Company realigned its resources to become a commercially-focused biopharmaceutical company. The Company discontinued specified discovery research efforts, reduced overall headcount, primarily in its discovery group, and consolidated its research and development facilities.

 

The Company recorded net restructuring credits of approximately $2.9 million during the three months ended March 31, 2008, under the Company’s 2003 restructuring plan, primarily related to the earlier than anticipated sublease of one of its facilities and the sublease extension of another facility, both charged to restructuring in prior years.  The Company recorded restructuring charges of approximately $0.4 million during the three months ended March 31, 2007, under the Company’s 2003 restructuring plan, primarily related to the net present value adjustment for facilities charged to restructuring in prior years.

 

12



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

The following table displays the restructuring activity and liability balances (in thousands):

 

 

 

Balance at

 

 

 

 

 

Balance at

 

 

 

December 31,

 

Net Charges/

 

 

 

March 31,

 

 

 

2007

 

(Credits)

 

Payments

 

2008

 

Facilities

 

$

33,051

 

$

(2,921

)

$

(4,247

)

$

25,883

 

 

  The Company accounts for its restructuring charges in accordance with SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities” (“SFAS No. 146”). SFAS No. 146 requires that a liability for a cost associated with an exit or disposal activity be recognized and measured initially at its fair value in the period in which the liability is incurred, except for one-time termination benefits that meet specified requirements. Costs of termination benefits relate to severance packages, out-placement services and career counseling for employees affected by the restructuring.

 

In accordance with SFAS No. 146, the Company’s facilities related expenses and liabilities in all restructuring plans include estimates of the remaining rental obligations, net of estimated sublease income, for facilities the Company no longer occupies. The Company reviews its estimates and assumptions on a regular basis, until the outcome is finalized, and makes whatever modifications are necessary, based on the Company’s best judgment, to reflect any changed circumstances.

 

In connection with its 2006 decision to abandon certain facilities in 2007 under the 2006 restructuring program, the Company shortened the useful lives of the leasehold improvements at these facilities in accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets.” During the three months ended March 31, 2008 and 2007, the Company recorded additional depreciation expense of approximately $0.1 million and $2.8 million, respectively, in research and development expense related to its decision.

 

The projected timing of payments of the remaining restructuring liabilities under all of the Company’s restructuring initiatives at March 31, 2008 is approximately $19.9 million due through March 31, 2009 and $21.3 million thereafter through 2014. The actual amount and timing of the payment of the remaining accrued liability is dependent upon the ultimate terms of any potential subleases or lease restructuring.

 

4.  Convertible Debt

 

The Company had the following convertible notes outstanding at March 31, 2008 and December 31, 2007:

 

 

 

March 31, 2008

 

December 31, 2007

 

2.25% convertible senior notes due November 15, 2011

 

$

250,000

 

$

250,000

 

 

The Company’s 2.25% convertible senior notes due November 15, 2011 (the “2.25%” notes) are convertible into the Company’s common stock based upon a conversion rate of 64.6465 shares of common stock per $1,000 principal amount of the 2.25% notes, which was equal to the initial conversion price of approximately $15.47 per share of stock, subject to adjustment. The 2.25% notes are convertible only in the following circumstances: (1) if the closing price of the common stock exceeds 120% of the conversion price within a specified period, (2) if specified distributions to holders of the common stock are made or specified corporate transactions occur, (3) if the average trading price per $1,000 principal amount is less than 98% of the product of the closing price of common stock and the then applicable conversion rate within a specified period or (4) during the last three months prior to the maturity date of the notes, unless previously repurchased by the Company under certain circumstances. The 2.25% notes are subordinated in right of payment to all existing and future secured debt of the Company.

 

Under the terms of the 2.25% notes, the Company is required to make semi-annual interest payments on the outstanding principal balance on May 15 and November 15 of each year. All required interest payments to date have been made.

 

5.  Stock Plans

 

SFAS 123R requires the recognition of the fair value of stock-based compensation in the Company’s statements of operations. Stock-based compensation expense primarily relates to stock options, restricted stock and stock issued under the Company’s employee stock purchase plans.

 

13



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

The following table summarizes the weighted-average assumptions the Company used in its fair value calculations at the date of grant:

 

 

 

Stock Options

 

Stock Purchase Plan

 

 

 

Three Months Ended March 31,

 

Three Months Ended March 31,

 

 

 

2008

 

2007

 

2008

 

2007

 

Expected life

 

4.5

 

4.4

 

0.5

 

0.5

 

Risk-free interest

 

2.58

%

4.73

%

3.50

%

4.82

%

Volatility

 

40

%

40

%

35

%

40

%

 

The Company has never declared cash dividends on any of its capital stock and does not expect to do so in the foreseeable future.

 

The following table presents the combined option activity of the Company’s stock plans for the three months ended March 31, 2008:

 

 

 

 

 

 

 

Weighted-

 

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

Shares of

 

Weighted-

 

Remaining

 

 

 

 

 

Common Stock

 

Average

 

Contractual

 

Aggregate

 

 

 

Attributable to

 

Exercise Price

 

Term

 

Intrinsic Value

 

 

 

Options

 

of Options

 

(in years)

 

(in thousands)

 

Outstanding at January 1, 2008

 

19,904,277

 

$

16.32

 

 

 

 

 

Granted

 

2,569,505

 

13.93

 

 

 

 

 

Exercised

 

(397,296

)

9.43

 

 

 

 

 

Forfeited or expired

 

(272,481

)

30.69

 

 

 

 

 

Outstanding at March 31, 2008

 

21,804,005

 

$

15.98

 

6.08

 

$

68,608

 

Vested or expected to vest at March 31, 2008

 

21,037,972

 

$

16.11

 

5.96

 

$

66,402

 

Exercisable at March 31, 2008

 

16,505,532

 

$

17.20

 

5.12

 

$

51,274

 

 

As of March 31, 2008, the total remaining unrecognized compensation cost related to nonvested stock option awards amounted to approximately $14.5 million, including estimated forfeitures, which will be recognized over the weighed-average remaining requisite service period of approximately one and one half years.

 

A summary of the status of nonvested shares of restricted stock and restricted stock units as of March 31, 2008, and changes during the three months then ended, is presented below:

 

 

 

Shares

 

Weighted-Average
Grant Date Fair Value

 

Nonvested at January 1, 2008

 

3,079,541

 

$

10.70

 

Granted

 

1,708,974

 

13.91

 

Vested

 

(940,072

)

10.71

 

Forfeited

 

(57,881

)

11.93

 

Nonvested at March 31, 2008

 

3,790,562

 

$

12.15

 

 

As of March 31, 2008 the total remaining unrecognized compensation cost related to nonvested restricted stock awards and restricted stock units amounted to approximately $23.2 million, including estimated forfeitures, which will be recognized over the weighted-average remaining requisite service period of approximately one and one half years.

 

6. Subsequent Event

 

On April 10, 2008, the Company entered into an Agreement and Plan of Merger with Takeda Pharmaceutical Company Limited, a corporation organized under the laws of Japan, or TPC, Takeda America Holdings, Inc., a New York corporation and wholly-owned subsidiary of TPC, or Parent, and Mahogany Acquisition Corp., a Delaware corporation and a wholly-owned subsidiary of Parent, or Merger Sub.  Pursuant to the merger agreement, upon the terms and subject to the conditions thereof, Merger Sub commenced a tender offer on April 11, 2008 to acquire all of the outstanding shares of the Company’s common stock at a purchase price of $25.00 per share, net to the holder in cash, subject to any required withholding of taxes, upon the terms and subject to the conditions set forth in the Offer to Purchase, dated April 11, 2008, and the related Letter of Transmittal, each as amended or supplemented from time to time.

 

                The initial offering period for the tender offer expired at 12:00 midnight, New York City time, at the end of Thursday, May 8, 2008.  According to the depositary for the tender offer, as of the expiration of the initial offering period, 300,871,367 shares of the Company’s common stock had been tendered, representing approximately 91.9% of the Company’s outstanding shares of common stock (of which 26,917,513 shares, or approximately 8.2% of the Company’s outstanding shares, were tendered under guaranteed delivery procedures).  Merger Sub has accepted for payment all shares of the Company’s common stock that were validly tendered and not withdrawn during the initial offering period, and payment for such shares has been or will be made promptly, in accordance with the terms of the tender offer.  The Company has been advised that shares validly tendered in satisfaction of guaranteed delivery procedures will also be accepted for payment and promptly paid for.  Pursuant to the merger agreement, promptly upon acceptance for payment of, and payment for, the tendered shares of the Company’s common stock in the tender offer, Merger Sub has the right to designate a number of individuals to the Company’s board of directors.

 

 

 

14



 

Millennium Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements (continued)

 

                Merger Sub has commenced a subsequent offering period to acquire all of the remaining untendered shares.  This subsequent offering period will expire at 12:00 midnight, New York City time, at the end of May 13, 2008, unless extended. During this subsequent offering period, holders of shares of the Company’s common stock who did not previously tender their shares in the offer may do so and Merger Sub will promptly purchase any shares properly tendered as such shares are tendered for the same consideration, without interest, paid in the tender offer. Procedures for tendering shares during the subsequent offer period are the same as during the initial offering period with two exceptions: (1) shares cannot be delivered by using the guaranteed delivery procedure, and (2) pursuant to applicable law, shares tendered during the subsequent offer period may not be withdrawn. Merger Sub reserves the right to further extend the subsequent offering period in accordance with applicable law and the terms of the merger agreement.

 

After expiration of the subsequent offering period, TPC intends to complete its acquisition of the Company on or about May 14, 2008, by means of a merger under Delaware law. As a result of its purchase of shares in the tender offer, Merger Sub has sufficient voting power to approve the merger without the affirmative vote of any other stockholder of the Company. As a result of such merger, the Company will become an indirect wholly-owned subsidiary of TPC, and each share of the Company’s outstanding common stock will be cancelled and (except for shares held by the Company, TPC, wholly-owned subsidiaries of Takeda or the Company, or by holders who properly exercise their appraisal rights under Delaware law) will be converted into the right to receive the same consideration, without interest, received by holders who tendered shares in the tender offer.  Following the effective time of the merger, the Company’s common stock will cease to be traded on Nasdaq.

 

In the Offer to Purchase, Parent and Merger Sub stated that they would need approximately $8.8 billion to purchase all of the Company’s outstanding shares of common stock pursuant to the tender offer, to cash out certain employee options, restricted stock and restricted stock units, to fund amounts that may become payable under the Company’s outstanding convertible notes, and to consummate the merger, plus related fees and expenses. Parent and Merger Sub also stated in the Offer to Purchase that, to the extent necessary, TPC would provide them with sufficient funds through cash on hand to purchase all shares properly tendered in the tender offer and would provide funding for the merger. The tender offer was not conditioned upon Parent’s, Merger Sub’s or TPC’s ability to finance the purchase of shares pursuant to the tender offer.  Pursuant to the merger agreement, TPC has unconditionally guaranteed the full and complete performance by Parent and Merger Sub of their respective obligations under the merger agreement.

 

On April 10, 2008, a purported shareholder class action lawsuit was filed by a single plaintiff against the Company and each of its directors, as well as Parent and Merger Sub, in Superior Court for Middlesex County, Massachusetts.  The action, captioned Eleanor Turberg v. Millennium Pharmaceuticals, Inc. et al. (Case No. 08-1466, Superior Court, Middlesex County, MA), is brought by Eleanor Turberg, who claims to be an individual Millennium stockholder, on her own behalf, and seeks certification as a class action on behalf of all Millennium stockholders except the defendants and any person, firm, trust, corporation or other entity related to or affiliated with any defendants.  The complaint alleges, among other things, that the defendants breached fiduciary duties of loyalty, due care, independence, good faith and fair dealing, and/or aided and abetted the breach of fiduciary duties, owed to our stockholders in connection with the transactions contemplated by the Merger Agreement.  The complaint seeks, among other things, an order:

 

·                   enjoining the defendants from proceeding with the proposed acquisition of shares of our common stock by Takeda,

 

·                   rescinding, to the extent already implemented, the proposed acquisition of shares of our common stock by Takeda,

 

·                   awarding the plaintiff and the purported class damages and

 

·                   awarding plaintiff the costs and disbursements of the action, including reasonable attorneys’ and experts’ fees.

 

On May 5, 2008, the court heard the plaintiff’s motion for a preliminary injunction enjoining the acceptance of tendered shares by Takeda.  Following the hearing, the court denied the plaintiff’s motion.

 

15



 

Item 2.         Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Our management’s discussion and analysis of our financial condition and results of our operations contains forward-looking statements, including statements about our growth and future operating results, discovery and development of products, strategic alliances and intellectual property. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We often use the words “expect,” “anticipate,” “intend,” “plan,” “believe,” “may,” “will” and similar expressions to help identify forward-looking statements.

 

Actual results may differ from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, those factors discussed in this annual report under the heading “Risk Factors.”

 

Overview

 

We are an innovation-driven biopharmaceutical company focused on discovering, developing and commercializing medicines to improve the lives of patients with cancer, inflammatory bowel diseases and other inflammatory diseases. We currently commercialize VELCADE, the global market leader for the treatment of patients with multiple myeloma who have received at least one prior therapy and the United States market leader for the treatment of mantle cell lymphoma, or MCL, patients who have received at least one prior therapy. We are also awaiting a decision from the Food and Drug Administration, or FDA, with respect to our supplementary new drug application, or sNDA, to market VELCADE for patients with newly diagnosed multiple myeloma. We have a development pipeline of clinical and preclinical product candidates in our therapeutic focus areas of cancer and inflammatory diseases and we have an oncology-focused drug discovery organization. Strategic business relationships are a key component of our business to maximize the global potential of our products and product candidates.

 

In January 2007, we began, with Ortho Biotech Inc., or OBI, to jointly promote VELCADE for a two year time period in the United States. We believe this collaboration, with the well-established OBI oncology sales force, is helping us to realize the full potential of VELCADE in the U.S. market. In May 2007, the FDA granted marketing approval to OBI for the combination therapy of VELCADE/DOXIL ® (pegylated liposomal doxorubicin) in multiple myeloma patients who have received at least one prior therapy.

 

Our business strategy is to build a portfolio of new medicines based on our understanding of genomics and protein homeostasis, which is a set of particular molecular pathways that affect the establishment and progression of diseases. These molecular pathways include the related effects of proteins on cellular performance, reproduction and death. We plan to develop and commercialize many of our products on our own, but expect to seek development and commercial collaborators when favorable terms are available or when we otherwise believe that doing so would be advantageous to us.

 

In the near term, we expect to focus our commercial activities in cancer where we plan to build on our commercial and regulatory experience with VELCADE. We also are working to obtain approval to market VELCADE in the United States and, through Ortho Biotech Products, L.P., or OBL, a member of The Johnson & Johnson Family of Companies and an affiliate of OBI, outside of the United States for the treatment of multiple myeloma in newly diagnosed, or front-line, patients and for the treatment of additional types of cancers. We believe, if approved, these additional uses of VELCADE will lead to a significant expansion of our cancer business.

 

In the area of inflammatory disease, we are advancing novel product candidates in clinical development as potential treatments for serious and widely prevalent conditions. For example, MLN0002 is a highly selective gut-targeted immune therapy being studied in inflammatory bowel diseases. We expect to initiate pivotal trials with MLN0002 in patients with moderate to severe ulcerative colitis and Crohn’s disease in late 2008 or early 2009. If we successfully complete these trials and are successful in obtaining FDA approval, we believe MLN0002 could be available to patients as early as 2012.  In the long term, we expect to bring new products to market on a regular basis from our pipeline of discovery and development-stage programs. We also expect to continue to evaluate opportunities to in-license and acquire molecules from other companies in order to supplement our pipeline.

 

On April 10, 2008, we entered into an Agreement and Plan of Merger with Takeda America Holdings, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, and Mahogany Acquisition Corp., a wholly-owned subsidiary of Takeda America Holdings, Inc., which we refer to as Merger Sub.  We refer to Takeda America Holdings, Inc., Takeda Pharmaceutical Company Limited and Merger Sub collectively as Takeda and we refer to the Agreement and Plan of Merger as the Merger Agreement.  Pursuant to the Merger Agreement, Merger Sub has completed a cash tender offer for all of our outstanding common stock at a purchase price of $25.00 per share.

 

The tender offer expired at midnight at the end of May 8, 2008, after which Merger Sub accepted and paid for all shares validly tendered and not withdrawn at the time, representing approximately 83.7% of our outstanding common stock (excluding 26,917,513 shares, or approximately 8.2% of our outstanding shares, tendered under guaranteed delivery procedures), and announced a three business day subsequent offering period.   We expect that the subsequent offering period will be followed by the merger of Merger Sub into Millennium on or shortly after May 14, 2008 under the short-form merger procedures provided by Delaware law.

 

 

16



 

VELCADE® (bortezomib) for Injection

 

In May 2003, the FDA granted us approval to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on their most recent therapy, commonly referred to as third-line and beyond. In March 2005, the FDA granted us approval for the treatment of patients with multiple myeloma who have received at least one prior therapy, commonly referred to as relapsed, or second-line multiple myeloma.

 

In late 2007, we announced positive results from the large, randomized, Phase III VISTA trial in patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation. In this trial, the therapy of VELCADE, melphalan and prednisone demonstrated a highly statistically significant improvement, compared with melphalan and prednisone alone across all efficacy endpoints. In December 2007, we filed a sNDA, for use of VELCADE in patients with newly diagnosed multiple myeloma. The filing was granted priority review by the FDA. The FDA decision date is scheduled to occur by June 20, 2008.

 

Outside of the United States, VELCADE is approved by the European Commission as a monotherapy for multiple myeloma patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. Regulatory authorities in a number of other countries, including countries within Latin America, South-East Asia and Japan have also approved VELCADE. The product is now approved in more than 85 countries. In December 2007, OBL submitted a variation to its Marketing Authorization to the European Medicines Evaluation Agency, or EMEA, for use of VELCADE for the treatment of newly diagnosed multiple myeloma. We expect the EMEA’s decision on the submission by the end of 2008.

 

In December 2006, the FDA granted approval of VELCADE for the treatment of patients with MCL who have received at least one prior therapy, commonly referred to as relapsed, or second-line MCL.

 

Our Alliances

 

Ortho Biotech Collaborations

 

In June 2003, we entered into an agreement with OBL to collaborate on the commercialization of VELCADE and with Johnson & Johnson Pharmaceutical Research & Development, L.L.C., or JJPRD, for the continued clinical development of VELCADE. OBL and its affiliate, Janssen-Cilag, are commercializing VELCADE outside of the United States, and Janssen Pharmaceutical K.K. is responsible for Japan. We receive distribution fees from OBL and its affiliates from sales of VELCADE outside of the United States. We record these distribution fees as royalties. We manage the supply chain for VELCADE at the expense of OBL for products sold in the OBL territories. We retain a limited option to co-promote VELCADE with OBL at a future date in specified European countries.

 

We are engaged with JJPRD in an extensive global program for further clinical development of VELCADE with the purpose of maximizing the commercial potential of VELCADE. This program is investigating the potential of VELCADE to treat multiple forms of tumors, including continued clinical development of VELCADE for multiple myeloma and non-Hodgkin’s lymphoma, or NHL. JJPRD is currently responsible for 45% of the joint development costs. We are responsible for the remaining 55% of the joint development costs. We are eligible to receive payments from JJPRD or OBL for achieving clinical development milestones, regulatory milestones outside of the United States or agreed-upon sales levels of VELCADE outside of the United States.

 

In October 2006, we entered into a two-year agreement with OBI to jointly promote VELCADE in the U.S. Under the terms of the agreement, in the first quarter of 2007, OBI began jointly promoting VELCADE with us to U.S.-based physicians. Under this agreement, we pay the cost of a portion of the OBI sales effort dedicated to VELCADE and a commission if sales associated with the increased effort exceed specified targets. Both parties are able to terminate the agreement under certain circumstances and subject to fees. We continue to be responsible for commercialization, manufacturing and distribution of VELCADE in the U.S.

 

INTEGRILIN® (eptifibatide) Injection

 

Through August 31, 2005, we co-promoted INTEGRILIN in the United States in collaboration with Schering-Plough Ltd. and Schering Corporation, together referred to as SGP, and shared profits and losses. Since September 1, 2005, SGP has marketed INTEGRILIN in the United States and specified other areas outside of the European Union. GlaxoSmithKline plc, or GSK, markets INTEGRILIN in the European Union under a license from us.

 

SGP Collaboration

 

In April 1995, COR Therapeutics, Inc., or COR, entered into a collaboration agreement with SGP to jointly develop and commercialize INTEGRILIN on a worldwide basis. We acquired COR in February 2002. Under our original collaboration agreement with SGP, we generally shared any profits or losses from INTEGRILIN sales in the United States included in co-promotion revenue

 

17



 

with SGP and we granted SGP an exclusive license to market INTEGRILIN outside the United States and the European Union in exchange for royalty obligations.

 

On September 1, 2005, SGP obtained the exclusive U.S. development and commercialization rights for INTEGRILIN products from us and paid us a nonrefundable upfront payment of approximately $35.5 million. In addition, we are entitled to receive royalties on net product sales of INTEGRILIN in the United States from SGP for so long as SGP is engaged in the commercialization and sale of an INTEGRILIN product in the United States, with the potential of receiving royalties beyond the 2014 patent expiration date. Minimum royalty payments for 2006 and 2007 were approximately $85.4 million. There are no guaranteed minimum royalty payments for 2008 or future years. We also receive royalties on net product sales by SGP in SGP’s territory outside of the United States. SGP’s obligation to pay us royalties in other countries expires on a country by country basis upon the later of fifteen years from the first commercial use of an INTEGRILIN product in such country and the expiration of the last to expire patent covering such INTEGRILIN product. We continue to manage the supply chain for INTEGRILIN at the expense of SGP for products sold in the SGP territories including the U.S. We receive payments as a result of managing the supply chain and record those payments as strategic alliance revenue.

 

GSK License Agreement

 

In June 2004, we reacquired the rights to market INTEGRILIN in Europe from SGP and concurrently entered into a license agreement granting GSK exclusive marketing rights to INTEGRILIN in Europe. In January 2005, the transition of the INTEGRILIN marketing authorizations for the European Union from SGP to GSK was completed, and GSK began selling INTEGRILIN in the countries of the European Union. GSK also markets INTEGRILIN in other European countries where it has received approval of the transfer from SGP to GSK of the relevant marketing authorizations. Under the terms of the agreement, we have received license fees and are entitled to future royalties from GSK on INTEGRILIN sales in Europe subject to the achievement of specified objectives. We manage the supply chain for INTEGRILIN at the expense of GSK for products sold in the GSK territories. We receive payments as a result of managing the supply chain and record those payments as strategic alliance revenue.

 

sanofi-aventis Small Molecule Inflammatory Disease Collaboration

 

In June 2000, we entered into a broad agreement in the field of inflammatory disease with Aventis, now sanofi-aventis, which includes joint discovery, development and commercialization of small molecule drugs for the treatment of specified inflammatory diseases. This agreement covers certain of our development programs in the inflammatory disease area and provides us with potential access to sanofi-aventis’ large promotional infrastructure in connection with the commercialization of jointly developed products. The discovery phase of this collaboration has concluded. One development program, MLN6095, continues under the agreement.

 

As provided in the original agreement, in North America, we have agreed to share the responsibility for and cost of developing, manufacturing and marketing products arising from the alliance. Outside of North America, sanofi-aventis is responsible for and bears the cost of developing, manufacturing and marketing products arising from the alliance. sanofi-aventis is required to pay us a royalty on product sales outside of North America.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, inventory, intangible assets, goodwill, restructuring and stock-based compensation expense. We base our estimates on historical experience and on various other factors that we believe are appropriate under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

18



 

While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements included in this report, we believe the following accounting policies are most critical to aid in fully understanding and evaluating our reported financial results.

 

Revenue

 

We recognize revenue from the sale of our products, our strategic alliances, as well as royalties and distribution fees based on net sales of licensed products. We divide our revenue arrangements with multiple elements into separate units of accounting if specified criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. We allocate the consideration we receive among the separate units based on their respective fair values, and we apply the applicable revenue recognition criteria to each of the separate units. We classify advance payments received in excess of amounts earned as deferred revenue until earned.

 

Net product sales

 

We recognize revenue from the sale of VELCADE in the United States when delivery has occurred and title has transferred. During the fourth quarter of 2004, we began distributing VELCADE through a sole-source open access distribution model in which we sell directly to an independent third party who in turn distributes to the wholesaler base. In April 2006, our sole-source distributor added a second distribution site to its network in order to improve access to the product for physicians in the western United States. Under our agreement with our sole-source distributor, inventory levels are contractually limited to no more than three weeks. VELCADE product inventory levels held by the sole-source distributor have historically been below this limit at the end of each quarter. We expect future inventory levels to be within our desired range of one to two weeks of inventory in the distribution channel.

 

We record allowances as a reduction to product sales for discounts, product returns and governmental and contractual adjustments at the time of sale. Calculating these gross-to-net sales adjustments involves estimates and judgments based primarily on sales or invoice data and historical experience.

 

An analysis of the amount of, and change in, these allowances is as follows (in thousands):

 

 

 

Discounts

 

Returns

 

Governmental and
contractual adjustments

 

Total

 

Balance at December 31, 2007

 

$

819

 

$

3,453

 

$

3,238

 

$

7,510

 

Current provisions relating to sales in current period

 

1,828

 

851

 

5,258

 

7,937

 

Payments/credits relating to sales in current period

 

(638

)

(4

)

(2,646

)

(3,288

)

Payments/credits relating to sales in prior period

 

(988

)

(301

)

(2,382

)

(3,671

)

Balance at March 31, 2008

 

$

1,021

 

$

3,999

 

$

3,468

 

$

8,488

 

 

Discounts

 

We offer a 2% prompt payment discount to our sole-source distributor as an incentive to remit payment in accordance with the stated terms of the invoice. Because our customer typically takes advantage of the prompt payment discount, we accrue 100% of the prompt payment discount, based on the gross amount of each invoice, at the time of sale. We adjust the accrual quarterly to reflect actual experience. Historically, these adjustments have not been material.

 

Returns

 

We estimate VELCADE product returns based on historical return patterns. Under our current methodology, we track actual returns by individual production lots. Returns on closed lots (i.e., lots no longer eligible for credits under our returned goods policy) are analyzed to determine historical returns experience. Returns on open lots (i.e., lots still eligible for credits under our returned goods policy) are monitored and compared with historical return trends and rates. Historical rates of return are adjusted for known or expected changes in the marketplace.

 

We consider several factors in our estimation process, including our internal sales forecasts and inventory levels in the distribution channel. We have experienced, and expect, that wholesalers will not stock significant inventory due to the product’s cost, expense to store and just-in-time distribution model and as a result, returns have been, and we expect will continue to be low. When considering the level of inventory in the distribution channel, we determine whether an adjustment to the sales return reserve is appropriate. For example, if levels of inventory in the distribution channel increase and we believe sales returns will be larger than expected, we adjust the sales return reserve, taking into account historical experience, our returned goods policy and the shelf life of our product, which ranges from 18 to 24 months.

 

19



 

We have reduced and may, from time to time in the future, reduce our product returns estimate. Doing so results in increased product revenue at the time the return estimate is reduced. For example, since the launch of VELCADE in 2003, we have estimated our returns based upon historical trends in the pharmaceutical industry for similar products and our historical return patterns as they became available. In 2006, we reduced our return estimate based on lower than previously anticipated returns as our first commercial lots reached expiration during the second half of 2005. These adjustments to our estimates were not material to product sales in any quarter or on an annual basis for 2006. We did not make any adjustments to our return estimate during the three months ended March 31, 2008.

 

If circumstances change or conditions become more competitive in the market for therapeutic products that address the approved indications for VELCADE, we may take actions to increase our product return estimates. Doing so would result in an incremental reduction of product sales at the time the return estimate is changed. For example, an increase in our returns as a percentage of gross sales for the three months ended March 31, 2008 of 0.50% would have resulted in a $0.5 million decrease in net product sales.

 

Governmental and contractual adjustments

 

Governmental and contractual adjustment reserves relate to chargebacks and rebates. Chargeback reserves represent our estimated obligations resulting from the difference between the wholesaler price and the lower pricing as mandated by statute to eligible federally funded healthcare providers, and in rare instances, lower contractual pricing to certain other classes of trade. We determine our chargeback estimates based on our historical chargeback data. Chargebacks are generally invoiced and paid monthly in arrears, so that our accrual consists of an estimate of the amount to be expected for the current month’s product sales for which actual adjustments have not been billed, plus an accrual based upon the amount of inventory in the distribution channel. Rebate reserves relate to our reimbursement arrangements with state Medicaid programs. We determine our rebate estimates based on our historical experience regarding rebates, outstanding claims and payments under state Medicaid programs. Rebate amounts generally are invoiced and paid quarterly in arrears, so that our accrual consists of an estimate of the rebates that will be paid on the current quarter’s product sales, plus an accrual for unprocessed and unpaid rebates from prior periods. Governmental and contractual adjustment reserve accruals are recorded in the same period the related revenue is recognized resulting in a reduction to product revenue and the establishment of a liability. We adjust the accrual rate quarterly to reflect actual experience, taking into consideration price increases, as well as current and expected product sales to federally and state funded healthcare providers. Historically, these adjustments have not been material.

 

Revenue under strategic alliances

 

We recognize nonrefundable upfront licensing fees and guaranteed, time-based payments that, in either case, require continuing involvement in the form of research and development, manufacturing or other commercialization efforts by us as strategic alliance revenue:

 

·                            ratably over the development period if development risk is significant;

 

·                            ratably over the manufacturing period or estimated product useful life if development risk has been substantially eliminated; or

 

·                            based upon the level of research services performed during the period of the research contract.

 

When the period of deferral cannot be specifically identified from the contract, management estimates the period based upon other critical factors contained within the contract. We continually review these estimates, which could result in a change in the deferral period and might impact the timing and the amount of revenue recognized.

 

Milestone payments are recognized as strategic alliance revenue when the substantive performance obligations, as defined in the contract, are achieved. Performance obligations typically consist of significant milestones in the development life cycle of the related product candidate, such as initiation of clinical trials, filing for approval with regulatory agencies and approvals by regulatory agencies. Reimbursements of research and development costs are recognized as strategic alliance revenue as the related costs are incurred.

 

Royalties

 

We are entitled to receive royalty payments under license agreements with a number of third parties that sell products based on technology we have developed or to which we have rights. These license agreements provide for the payment of royalties to us based on sales of the licensed product and we record royalty revenues based on estimates of sales from interim data provided by licensees.

 

20



 

Under certain of our license agreements, the royalty structure is tiered based upon annual sales and resets at the beginning of each annual period. For all of our royalty arrangements, we perform an analysis of historical royalties we have been paid, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual royalty revenues and estimated royalty revenues are adjusted for in the period which they become known, typically the following quarter. These adjustments have not been, and we do not expect them to be, significant. To the extent we do not have sufficient ability to accurately estimate royalty revenue, we record royalties on a cash basis

 

Inventory

 

Inventory consists of currently marketed products. VELCADE inventories primarily represent raw materials used in production, work in process and finished goods inventory on hand, valued at cost. INTEGRILIN inventories include raw materials used in production and work in process, valued at cost, to supply GSK and limited amounts of work in process, valued at cost, to supply SGP. We review inventories periodically for slow-moving or obsolete status based on sales activity, both projected and historical. Our current sales projections provide for full utilization of the inventory balance. If product sales levels differ from projections or a launch of a new product is delayed, inventory may not be fully utilized and could be subject to impairment, at which point we would adjust inventory to its net realizable value.

 

Intangible Assets

 

We have acquired significant intangible assets that we value and record. Those assets that do not yet have regulatory approval and for which there are no alternative uses are expensed as acquired in-process research and development, and those that are specifically identified and have alternative future uses are capitalized. We use a discounted cash flow model to value intangible assets at acquisition. The discounted cash flow model requires assumptions about the timing and amount of future cash inflows and outflows, risk, the cost of capital, and terminal values. Each of these factors can significantly affect the value of the intangible asset. We review intangible assets for impairment using an undiscounted net cash flows approach when impairment indicators arise. If the undiscounted cash flows of an intangible asset are less than the carrying value of an intangible asset, we would write down the intangible asset to the discounted cash flow value. Where we cannot identify cash flows for an individual asset, our review is applied at the lowest group level for which cash flows are identifiable.

 

Goodwill

 

On October 1, 2007, we performed our annual goodwill impairment test and determined that no impairment existed on that date. We continually monitor business and market conditions to assess whether an impairment indicator exists. If we were to determine that an impairment indicator exists, we would be required to perform an impairment test, which could result in a material impairment charge to our statement of operations.

 

Restructuring

 

In accordance with Statement of Financial Accounting Standard, or SFAS, No. 146, “Accounting for Costs Associated with Exit or Disposal Activities,” our facilities related expenses and liabilities under all of our restructuring plans included estimates of the remaining rental obligations, net of estimated sublease income, for facilities we no longer occupy. We review our estimates and assumptions on a regular basis until the outcome is finalized, and make whatever modifications we believe necessary, based on our best judgment, to reflect any changed circumstances. It is possible that such estimates could change in the future resulting in additional adjustments, and the effect of any such adjustments could be material.

 

Stock-Based Compensation Expense

 

SFAS No. 123 (revised 2004), “Share Based Payment,” or SFAS 123R, requires the recognition of the fair value of stock-based compensation expense in our operations, and accordingly the SFAS 123R fair value method has had and will continue to have a significant impact on our results of operations, although it will have no impact on our overall financial position. Option valuation models require the input of highly subjective assumptions, including stock price volatility and expected term of an option. In determining our volatility, we have considered implied volatilities of currently traded options to provide an estimate of volatility based upon current trading activity in addition to our historical volatility. After considering other such factors as our stage of development, the length of time we have been public and the impact of having a marketed product, we believe a blended volatility rate based upon historical performance, as well as the implied volatilities of currently traded options, best reflects the expected volatility of our stock going forward. Changes in market price directly affect volatility and could cause stock-based compensation expense to vary significantly in future reporting periods.

 

21



 

We use historical data to estimate option exercise and employee termination behavior, adjusted for known trends, to arrive at the estimated expected life of an option. We update these assumptions on a quarterly basis to reflect recent historical data. Additionally, we are required to estimate forfeiture rates to approximate the number of shares that will vest in a period to which the fair value is applied. We will continually monitor employee exercise behavior and may further adjust the estimated term and forfeiture rates in future periods. Increasing the estimated life would result in an increase in the fair value to be recognized over the requisite service period, generally the vesting period. Estimated forfeitures will be adjusted to actual forfeitures upon the vest date of the cancelled options as a cumulative adjustment on a quarterly basis. Doing so could cause future expenses to vary at each reporting period.

 

In March 2006, we revised our annual merit compensation program to include the availability of both stock options and restricted stock to certain employees. In March 2007, we extended the choice of stock options or restricted stock to all employees through the annual merit compensation program. Additionally, in March 2007, we implemented performance based vesting for a portion of executive officer restricted stock awards. A significant portion of the annual equity awards to all executive officers will vest only upon achievement of predefined performance objectives. In May 2007, we issued restricted stock units to members of the Board of Directors as partial compensation for their board member service. For the three months ended March 31, 2008 and 2007, we recognized total stock-based compensation expense under SFAS 123R of $5.5 million and $5.4 million, respectively. As of March 31, 2008, the total remaining unrecognized compensation cost related to nonvested stock option awards amounted to approximately $14.5 million, including estimated forfeitures, which will be recognized over the weighted-average remaining requisite service periods of approximately one and one half years. As of March 31, 2008, the total remaining unrecognized compensation cost related to nonvested restricted stock awards and restricted stock units amounted to approximately $23.2 million, including estimated forfeitures, which will be recognized over the weighted-average remaining requisite service periods of approximately one and one half years.

 

Accounting Pronouncements

 

In December 2007, the FASB issued EITF Issue 07-1, “Accounting for Collaborative Arrangements,” or EITF 07-1. EITF 07-1 requires collaborators to present the results of activities for which they act as the principal on a gross basis and report any payments received from (made to) other collaborators based on other applicable GAAP or, in the absence of other applicable GAAP, based on analogy to authoritative accounting literature or a reasonable, rational, and consistently applied accounting policy election. Further, EITF 07-1 clarified the determination of whether transactions within a collaborative arrangement are part of a vendor-customer (or analogous) relationship subject to EITF 01-9, “Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products).” EITF 07-1 will be effective for us beginning on January 1, 2009. We are currently evaluating the effect of EITF 07-1 on our consolidated financial statements.

 

Subsequent Event

 

On April 10, 2008, we entered into an Agreement and Plan of Merger with Takeda Pharmaceutical Company Limited, a corporation organized under the laws of Japan, or TPC, Takeda America Holdings, Inc., a New York corporation and wholly-owned subsidiary of TPC, or Parent, and Mahogany Acquisition Corp., a Delaware corporation and a wholly-owned subsidiary of Parent, or Merger Sub.  Pursuant to the merger agreement, upon the terms and subject to the conditions thereof, Merger Sub commenced a tender offer on April 11, 2008 to acquire all of the outstanding shares of our common stock at a purchase price of $25.00 per share, net to the holder in cash, subject to any required withholding of taxes, upon the terms and subject to the conditions set forth in the Offer to Purchase, dated April 11, 2008, and the related Letter of Transmittal, each as amended or supplemented from time to time.

 

The initial offering period for the tender offer expired at 12:00 midnight, New York City time, at the end of Thursday, May 8, 2008.  According to the depositary for the tender offer, as of the expiration of the initial offering period, 300,871,367 shares of our common stock had been tendered, representing approximately 91.9% of our outstanding shares of common stock (of which 26,917,513 shares, or approximately 8.2% of our outstanding shares, were tendered under guaranteed delivery procedures).  Merger Sub has accepted for payment all shares of our common stock that were validly tendered and not withdrawn during the initial offering period, and payment for such shares has been or will be made promptly, in accordance with the terms of the tender offer.  We have been advised that shares validly tendered in satisfaction of guaranteed delivery procedures will also be accepted for payment and promptly paid for.  Pursuant to the merger agreement, promptly upon acceptance for payment of, and payment for, the tendered shares of our common stock in the tender offer, Merger Sub has the right to designate a number of individuals to our board of directors.

 

Merger Sub has commenced a subsequent offering period to acquire all of the remaining untendered shares.  This subsequent offering period will expire at 12:00 midnight, New York City time, at the end of May 13, 2008, unless extended. During this subsequent offering period, holders of shares of our common stock who did not previously tender their shares in the offer may do so and Merger Sub will promptly purchase any shares properly tendered as such shares are tendered for the same consideration, without interest, paid in the tender offer. Procedures for tendering shares during the subsequent offer period are the same as during the initial offering period with two exceptions: (1) shares cannot be delivered by using the guaranteed delivery procedure, and (2) pursuant to applicable law, shares tendered during the subsequent offer period may not be withdrawn. Merger Sub reserves the right to further extend the subsequent offering period in accordance with applicable law and the terms of the merger agreement.

 

After expiration of the subsequent offering period, TPC intends to complete its acquisition of Millennium on or about May 14, 2008, by means of a merger under Delaware law. As a result of its purchase of shares in the tender offer, Merger Sub has sufficient voting power to approve the merger without the affirmative vote of any other Millennium stockholder. As a result of such merger, we will become an indirect wholly-owned subsidiary of TPC, and each share of our outstanding common stock will be cancelled and (except for shares held by us, TPC, wholly-owned subsidiaries of Takeda or us, or by holders who properly exercise their appraisal rights under Delaware law) will be converted into the right to receive the same consideration, without interest, received by holders who tendered shares in the tender offer.  Following the effective time of the merger, our common stock will cease to be traded on Nasdaq.

 

In the Offer to Purchase, Parent and Merger Sub stated that they would need approximately $8.8 billion to purchase all of our outstanding shares of common stock pursuant to the tender offer, to cash out certain employee options, restricted stock and restricted stock units, to fund amounts that may become payable under our outstanding convertible notes, and to consummate the merger, plus related fees and expenses. Parent and Merger Sub also stated in the Offer to Purchase that, to the extent necessary, TPC would provide them with sufficient funds through cash on hand to purchase all shares properly tendered in the tender offer and would provide funding for the merger. The tender offer was not conditioned upon Parent’s, Merger Sub’s or TPC’s ability to finance the purchase of shares pursuant to the tender offer.  Pursuant to the merger agreement, TPC has unconditionally guaranteed the full and complete performance by Parent and Merger Sub of their respective obligations under the merger agreement.

 

 

22



 

Results of Operations

 

 

 

 

 

 

 

Increase/

 

 

 

 

 

 

 

(Decrease)

 

 

 

Three Months Ended
March 31,

 

Percentage
Change

 

(in thousands, except per share amounts)

 

2008

 

2007

 

2008/2007

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

Net product sales

 

$

83,470

 

$

58,640

 

42

%

Revenue under strategic alliances

 

15,523

 

15,714

 

(1

)

Royalties

 

40,459

 

36,370

 

11

 

Total revenues

 

139,452

 

110,724

 

26

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales (excludes amortization of acquired intangible assets)

 

10,160

 

5,358

 

90

 

Research and development (Note 1)

 

71,406

 

69,206

 

3

 

Selling, general and administrative (Note 1)

 

49,795

 

41,548

 

20

 

Restructuring

 

(2,870

)

5,611

 

(151

)

Amortization of intangibles

 

8,487

 

8,487

 

 

Total costs and expenses

 

136,978

 

130,210

 

5

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

2,474

 

(19,486

)

113

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

Investment income, net

 

14,553

 

15,495

 

(6

)

Interest expense

 

(2,401

)

(2,787

)

(14

)

Net income (loss)

 

$

14,626

 

$

(6,778

)

316

%

 

 

 

 

 

 

 

 

Amounts per common share:

 

 

 

 

 

 

 

Earnings (loss) per share, basic and diluted

 

$

0.05

 

$

(0.02

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares, basic

 

321,608

 

316,072

 

 

 

Weighted average shares, diluted

 

326,694

 

316,072

 

 

 

 

Note 1:  Stock-based compensation expense is allocated in the condensed consolidated statements of operations expense lines as follows:

 

 

 

Three Months Ended
March 31,

 

(in thousands)

 

2008

 

2007

 

 

 

 

 

 

 

Research and development

 

$

1,361

 

$

2,055

 

Selling, general and administrative

 

4,162

 

3,347

 

 

  Revenues

 

Total revenues increased 26% to $139.5 million during the three months ended March 31, 2008, or the 2008 Three Month Period, compared to the three months ended March 31, 2007, or the 2007 Three Month Period.  The increase was primarily related to higher net product sales and additional royalty revenue earned on sales of VELCADE outside the United States.

 

Net product sales of VELCADE increased 42% to $83.5 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The increase was primarily attributable to growth in product demand and to a lesser extent, price increases during the period.    Reserves as a percentage of gross product sales for discounts, product returns and governmental and contractual adjustments were 9% in the 2008 Three Month Period and 7% in the 2007 Three Month Period.  The increase in reserves was primarily related to increased governmental and contractual adjustments.  Net product sales of VELCADE represented approximately 60% and 53% of our total revenues in the 2008 and 2007 Three Month Periods, respectively.

 

Revenue under strategic alliances decreased 1% to $15.5 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The decrease was primarily attributable to lower reimbursement of research and development costs offset by higher nonrefundable license payments.  We expect revenue under strategic alliances to fluctuate in future periods depending on the level of

 

23



 

revenues earned for ongoing development efforts, the level of milestones achieved and the number of alliances we may enter into in the future with other biopharmaceutical companies.

 

Royalty revenue increased 11% to $40.5 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The increase was primarily a result of increased sales of VELCADE outside the United States.

 

Cost of Sales

 

Cost of sales increased 90% to $10.2 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The increase was primarily related to costs associated with managing the INTEGRILN supply chain on behalf of SGP and GSK and manufacturing-related expenses associated with increased sales of VELCADE.

 

Research and Development

 

Research and development expenses increased 3% to $71.4 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The increase was primarily a result of higher expenses associated with manufacturing and clinical development activity, including expenses related to MLN0002.  Partially offsetting this increase was a decrease in stock-based compensation expense as a result of forfeitures in excess of our original estimates related to certain cliff-based awards held by employees whose employment was terminated in connection with restructuring initiatives and normal attrition.

 

In addition to our ongoing clinical trials of VELCADE, we have a significant pipeline of product candidates in clinical and late preclinical development. In March 2008, we announced the expansion of our inflammatory bowel disease program through the advancement of MLN3126 from discovery to our development pipeline.  MLN3126 is a selective antagonist of CCR9, a chemokine receptor know to be important in the migration of inflammatory cells into the gastrointestinal tract.  The following chart summarizes the applicable disease indication and the clinical or preclinical trial status of our pipeline of drug candidates.

 

Product Description

 

Disease Indication

 

Current Trial Status

Cancer

 

 

 

 

MLN0518 is a small molecule inhibitor of the class III receptor tyrosine kinase (RTKs), FLT-3, c-KIT, and PDGF-R

 

Acute myeloid leukemia
Glioma(1)
Prostate cancer(1)

 

phase I/II
phase I/II
phase I/II

MLN8054/MLN8237 are small molecule inhibitors of Aurora A Kinase

 

Advanced malignancies

 

phase I

MLN4924 is a small molecule inhibitor of Nedd8—activating enzyme (NAE)

 

Advanced malignancies

 

phase I

MLN2238 is a second generation proteasome small molecule inhibitor

 

Advanced malignancies

 

preclinical

Inflammatory Bowel Diseases

 

 

 

 

MLN0002 is a humanized monoclonal antibody directed against the alpha4beta7 integrin

 

Ulcerative colitis
Crohn’s disease

 

phase II(2)

MLN3126 is a small molecule CCR9 inhibitor

 

Crohn’s disease

 

preclinical

Other Inflammatory Diseases

 

 

 

 

MLN1202 is a humanized monoclonal antibody directed against CCR2

 

Atherosclerosis
Multiple sclerosis

 

phase IIa-completed

MLN3897/3701 are small molecule CCR1 inhibitors(3)

 

Chronic inflammatory diseases

 

phase I/II

MLN6094 is a small molecule CrTh2 receptor antagonist(4)

 

Asthma

 

preclinical

 


(1)

 

Trials are conducted through Cancer Therapy Evaluation Program, a division of the National Cancer Institute.

 

 

 

(2)

 

Clinical trials resumed in May 2007 with a new, commercially scalable cell line; prior phase II data established proof-of-concept for this mechanism in ulcerative colitis.

 

 

 

(3)

 

In November 2007, we announced that the results from a phase II trial of MLN3897 did not achieve the pre-established criteria for moving this product candidate forward in rheumatoid arthritis. We are contemplating further development of this program in oncology indications.

 

 

 

(4)

 

In development through our sanofi-aventis small molecule inflamatory disease collaboration.

 

Completion of clinical trials may take several years or more and the length of time can vary substantially according to the type, complexity, novelty and intended use of a product candidate. The types of costs incurred during a clinical trial vary depending upon the type of product candidate and the nature of the study.

 

24



 

We estimate that clinical trials in our areas of focus are typically completed over the following timelines:

 

Clinical Phase

 

Objective

 

Estimated Completion Period

phase I

 

Establish safety in humans, study how the drug works, metabolizes and interacts with other drugs

 

1–2 years

phase II

 

Evaluate efficacy, optimal dosages and expanded evidence of safety

 

2–3 years

phase III

 

Confirm efficacy and safety of the product

 

2–3 years

 

U pon successful completion of phase III clinical trials of a product candidate, we intend to submit the results to the FDA to support regulatory approval. However, we cannot be certain that any of our product candidates will prove to be safe or effective, will receive regulatory approvals, or will be successfully commercialized. Our clinical trials might prove that our product candidates may not be effective in treating the disease or have undesirable or unintended side effects, toxicities or other characteristics that require us to cease further development of the product candidate. The cost to take a product candidate through clinical trials is dependent upon, among other things, the disease indications, the timing, the size and dosing schedule of each clinical trial, the number of patients enrolled in each trial and the speed at which patients are enrolled and treated. We could incur increased product development costs if we experience delays in clinical trial enrollment, delays in the evaluation of clinical trial results or delays in regulatory approvals.

 

Some products that are likely to result from our research and development projects are based on new technologies and new therapeutic approaches that have not been extensively tested in humans. The regulatory requirements governing these types of products may be more rigorous than for conventional products. As a result, it is difficult to estimate the nature and length of the efforts to complete such products as we may experience a longer regulatory process in connection with any products that we develop based upon these new technologies or therapeutic approaches. In addition, ultimate approval for commercial manufacturing and marketing of our products is dependent on the FDA or applicable approval body in the country for which approval is being sought, adding further uncertainty to estimated costs and completion dates. Significant delays could allow our competitors to bring products to market before we do and impair our ability to commercialize our product candidates.

 

Due to the variability in the length of time necessary to develop a product, the uncertainties related to the estimated cost of the projects and ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the ultimate cost to bring our product candidates to market are not available.

 

We budget and monitor our research and development costs by type or category, rather than by project on a comprehensive or fully allocated basis. Significant categories of costs include personnel, clinical, third party research and development services and laboratory supplies. In addition, a significant portion of our research and development expenses is not tracked by project as it benefits multiple projects or our technology platform. Consequently, fully loaded research and development cost summaries by project are not available.

 

Given the uncertainties related to development, we are currently unable to reliably estimate when, if ever, our product candidates will generate revenue and cash flows. We do not expect to receive net cash inflows from any of our major research and development projects until a product candidate becomes a profitable commercial product.

 

Selling, General and Administrative

 

Selling, general and administrative expenses increased 20% to $49.8 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The increase was primarily attributable to higher expense associated with the long-term investment in our VELCADE brand, including continuing medical education, marketing materials, and higher commission expense payable to our sales force with increased product sales.

 

Restructuring

 

During the 2008 Three Month Period, we recorded a total of $2.9 million of net restructuring credits under all of our restructuring initiatives. We recorded net restructuring credits of approximately $0.1 million under the 2006 restructuring program primarily related to a gain on the sale of previously impaired assets offset by the net present value adjustment for facilities charged to restructuring in prior years and employee termination benefits as a result of headcount reductions.  We recorded restructuring charges in the 2008 Three Month Period of approximately $0.1 million under the 2005 restructuring plan, primarily related to the net present value adjustment for facilities charged to restructuring in prior years.  We also recorded net restructuring credits of approximately $2.9 million in the 2008 Three Month Period under the 2003 restructuring plan primarily related to the earlier than anticipated sublease of one of our facilities and the sublease extension of another facility, both charged to restructuring in prior years.

 

During the 2007 Three Month Period, we recorded a total of $5.6 million of restructuring charges under all of our restructuring initiatives. We recorded restructuring charges of approximately $5.0 million under the 2006 restructuring program primarily for

 

25



 

facilities-related costs associated with vacated buildings and employee termination benefits as a result of headcount reductions.  We also recorded restructuring charges in the 2007 Three Month Period of approximately $0.2 million and $0.4 million under the 2005 and 2003 restructuring plans, respectively, primarily related to the net present value adjustment for facilities charged to restructuring in prior years.

 

We estimate that of the remaining restructuring liabilities under all restructuring initiatives at March 31, 2008, we will pay approximately $19.9 million through March 31, 2009 and $21.3 million thereafter through 2014.

 

In connection with the 2006 decision to abandon certain facilities in 2007 under the 2006 restructuring program, we shortened the useful lives of the leasehold improvements at these facilities in accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets.”  During the 2008 and 2007 Three Month Periods, we recorded additional amortization expense of approximately $0.1 million and $2.8 million, respectively, in research and development expense related to our decision.

 

Amortization of Intangibles

 

Amortization of intangible assets was $8.5 million in both the 2008 and 2007 Three Month Periods. Amortization primarily related to specifically identified intangible assets from the COR acquisition. We will continue to amortize the specifically identified intangible assets from our COR acquisition through 2015. We expect to incur amortization expense of approximately $34.0 million for each of the next five years.

 

Investment Income

 

Investment income decreased 6% to $14.6 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The decrease was primarily attributable to lower realized gains offset by higher interest income as a result of higher average balance of invested funds.  Realized gains in the 2007 Three Month Period included a $3.5 million gain on sale of our investment in SGX Pharmaceuticals, Inc. common stock and a $2.3 million gain related to our share of additional proceeds from a the class action proceeding against WorldCom, Inc.

 

Interest Expense

 

Interest expense decreased 14% to $2.4 million in the 2008 Three Month Period compared to the 2007 Three Month Period.  The decrease was primarily related to a decrease in interest on our convertible notes as a result of lower average balances of indebtedness during the period due to the repayment of our $83.3 million principal balance and our $16.2 million principal balance convertible notes during the 2007 Three Month Period.

 

Liquidity and Capital Resources

 

We require cash to fund our operating expenses, to make capital expenditures, acquisitions and investments and to pay debt service, including principal and interest and capital lease payments. We have and may in the future lose money in these investments and our ability to liquidate these investments is in some cases very limited. We may also owe our partners milestone payments and royalties. We also have committed to fund development costs incurred by some of our collaborators.

 

We have funded our cash requirements primarily through the following:

 

·          product sales of VELCADE;

 

·          payments from our strategic collaborators, including equity investments, license fees, milestone payments and research funding;

 

·          royalty payments related to the sales of our products; and

 

·          equity and debt financings in the public markets.

 

In the future, we expect to continue to fund our cash requirements from some or all of these sources as well as from sales of other products, subject to receiving regulatory approval. We are entitled to additional committed research and development funding under some of our strategic alliances. We believe the key factors that could affect our internal and external sources of cash are:

 

·          revenues from sales of VELCADE, INTEGRILIN and other products and services for which we may obtain marketing approval in the future or which are sold by companies that may owe us royalty, milestone, distribution or other payments on account of such products;

 

·          the success of our clinical and preclinical development programs;

 

·          our ability to enter into additional strategic collaborations and to maintain existing collaborations as well as the success of

 

26



 

     such collaborations; and

 

·          the receptivity of the capital markets to financings by biopharmaceutical companies generally and to financings by us specifically.

 

As of March 31, 2008, we had $931.3 million in cash, cash equivalents and marketable securities. This excludes $7.6 million of interest-bearing marketable securities classified as restricted cash on our balance sheet as of March 31, 2008, which primarily serve as collateral for letters of credit securing leased facilities.

 

Our significant capital resources and sources and uses of cash are as follows:

 

 

(in thousands)

 

March 31, 2008

 

December 31, 2007

 

Cash, cash equivalents and marketable securities

 

$

931,288

 

$

891,276

 

Working capital

 

933,024

 

901,595

 

 

 

 

Three Months Ended March 31,

 

 

 

2008

 

2007

 

Cash provided by (used in):

 

 

 

 

 

Operating activities

 

$

33,664

 

$

14,153

 

Investing activities

 

17,704

 

(72,314

)

Financing activities

 

3,442

 

(91,511

)

Capital expenditures (included in investing activities above)

 

(1,354

)

(1,100

)

 

Cash Flows

 

Operating activities provided cash of $33.7 million in the 2008 Three Month Period.  The principal source of funds was the collection of accounts receivable, net income and adjustments for non-cash charges offset by the payment of expenses.  Cash flows from operations can vary significantly due to various factors including changes in accounts receivable, as well as changes in accounts payable and accrued expenses. The average collection period of our accounts receivable can vary and is dependent on various factors, including the type of revenue and the payment terms related to those revenues.

 

Investing activities provided cash of $17.7 million in the 2008 Three Month Period. The principal source of funds was proceeds from the sale of marketable securities.  In February 2008, we received proceeds of approximately $1.2 million related to our share of proceeds from a class action proceeding against WorldCom, Inc.

 

Financing activities provided cash of $3.4 million in the 2008 Three Month Period. The principal source of funds was from the purchase of common stock by our employees.  We also used $0.3 million in financing activities to make principal payments on our capital leases.

 

We believe that our existing cash and cash equivalents and the anticipated cash receipts from our product sales, current strategic alliances and royalties will be sufficient to support our expected operations, fund our debt service and capital lease obligations and fund our capital commitments for at least the next several years.

 

Contractual Obligations

 

There have been no additional significant changes to our contractual obligations and commercial commitments included in our Form 10-K as of December 31, 2007.

 

As of March 31, 2008, we did not have any financing arrangements that were not reflected in our balance sheet.

 

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Item 3.       Quantitative and Qualitative Disclosures About Market Risk

 

We manage our fixed income investment portfolio in accordance with our Policy for Securities Investments, or Investment Policy, that has been approved by our Board of Directors. The primary objectives of our Investment Policy are to preserve principal, maintain a high degree of liquidity to meet operating needs, and obtain competitive returns subject to prevailing market conditions. Investments are made primarily in investment-grade corporate bonds with effective maturities of three years or less, asset-backed debt securities and U.S. government agency debt securities. These investments are subject to risk of default, changes in credit rating and changes in market value. These investments are also subject to interest rate risk and will decrease in value if market interest rates increase. A hypothetical 100 basis point increase in interest rates would result in an approximate $13.9 million decrease in the fair value of our investments as of March 31, 2008. However, due to the conservative nature of our investments and relatively short effective maturities of debt instruments, interest rate risk is mitigated. Our Investment Policy specifies credit quality standards for our investments and limits the amount of exposure from any single issue, issuer or type of investment. We do not own derivative financial instruments in our investment portfolio as of March 31, 2008.

 

We receive distribution fees from OBL based on worldwide product sales of VELCADE outside of the U.S. and we make payments for certain inventory purchases and clinical trials outside of the U.S.  As a result, our financial position, results of operations and cash flows can be affected by fluctuations in foreign currency exchange rates, primarily the EURO.  Movement in foreign currency exchange rates could cause royalty revenue or research and development expense to vary significantly in future reporting periods.  We currently do not engage in any hedging strategies with respect to such foreign currency exposures.

 

The estimated fair value of our 2.25% notes as of March 31, 2008 was $297.1 million based on quoted market values. The interest rates on our convertible notes and capital lease obligations are fixed and therefore not subject to interest rate risk.

 

As of March 31, 2008 we did not have any financing arrangements that were not reflected in our balance sheet.

 

Item 4.         Controls and Procedures

 

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2008. In designing and evaluating our disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applied its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our chief executive officer and chief financial officer concluded that as of March 31, 2008, our disclosure controls and procedures were (1) designed to ensure that material information relating to us is made known to our chief executive officer and chief financial officer by others, particularly during the period in which this report was prepared and (2) effective, in that they provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

 

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended March 31, 2008 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II OTHER INFORMATION

 

Item 1.  LEGAL PROCEEDINGS

 

On April 10, 2008, a purported shareholder class action lawsuit was filed by a single plaintiff against us and each of our directors, as well as Takeda America Holdings, Inc. and Mahogony Acquisition Corp., in Superior Court for Middlesex County, Massachusetts.  The action, captioned Eleanor Turberg v. Millennium Pharmaceuticals, Inc. et al. (Case No. 08-1466, Superior Court, Middlesex County, MA), is brought by Eleanor Turberg, who claims to be an individual Millennium stockholder, on her own behalf, and seeks certification as a class action on behalf of all Millennium stockholders except the defendants and any person, firm, trust, corporation or other entity related to or affiliated with any defendants.  The complaint alleges, among other things, that the defendants breached fiduciary duties of loyalty, due care, independence, good faith and fair dealing, and/or aided and abetted the breach of fiduciary duties, owed to our stockholders in connection with the transactions contemplated by the Merger Agreement.  The complaint seeks, among other things, an order:

 

·                   enjoining the defendants from proceeding with the proposed acquisition of shares of our common stock by Takeda,

 

·                   rescinding, to the extent already implemented, the proposed acquisition of shares of our common stock by Takeda,

 

·                   awarding the plaintiff and the purported class damages and

 

·                   awarding plaintiff the costs and disbursements of the action, including reasonable attorneys’ and experts’ fees.

 

On May 5, 2008, the court heard the plaintiff’s motion for a preliminary injunction enjoining the acceptance of tendered shares by Takeda.  Following the hearing, the court denied the plaintiff’s motion.

 

We intend to vigorously defend against these claims; however, the outcome of all litigation is uncertain and we may not be successful in defending against these claims.  Regardless of the outcome of this lawsuit, it could delay or prevent our acquisition by Takeda, divert the attention of our management and employees from our day-to-day business and otherwise adversely affect us financially.

 

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Item 1A.  RISK FACTORS

 

This Quarterly Report on Form 10-Q contains forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. In addition, we, or others on our behalf, may make forward-looking statements in press releases or written statements, or in our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “will,” “assume” or “continue,” and variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and involve important risks, uncertainties and assumptions that are difficult to predict. We describe some of the risks, uncertainties and assumptions that could affect our business, including our financial condition and results of operations, in this “Risk Factors” section. We have based our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made.

 

We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecast by our forward-looking statements. Reference is made in particular to forward-looking statements about our acquisition by Takeda, growth and future financial and operating results, discovery and development of products, strategic alliances, regulatory approvals, competitive strengths, intellectual property, litigation, mergers and acquisitions, market acceptance or continued acceptance of our products, accounting estimates, financing activities, ongoing contractual obligations and sales efforts. We do not intend to update or revise any forward-looking statements, whether as a result of new information, future events, changes in assumptions or otherwise.

 

Risks Related to Our Acquisition

 

If our acquisition by Takeda is not completed as expected, our stock price, business and results of operations may suffer.

 

On April 10, 2008, we entered into an Agreement and Plan of Merger with Takeda America Holdings, Inc., which we refer to as Parent, and Mahogany Acquisition Corp., a wholly-owned subsidiary of Parent, which we refer to as Merger Sub.  We refer to the Agreement and Plan of Merger as the Merger Agreement, which we have previously filed with the U.S. Securities and Exchange Commission.  Pursuant to the Merger Agreement, Merger Sub has completed a tender offer for all of our outstanding common stock at a purchase price of $25.00 per share.  The tender offer expired at midnight at the end of May 8, 2008, after which Merger Sub accepted and paid for all shares validly tendered and not withdrawn at the time, representing approximately 83.7% of our outstanding common stock (excluding 26,917,513 shares, or approximately 8.2% of our outstanding shares, tendered under guaranteed delivery procedures), and announced a three business day subsequent offering period.   We expect that the subsequent offering period will be followed by the merger of Merger Sub into Millennium on or shortly after May 14, 2008 under the short-form merger procedures provided by Delaware law.

 

It is possible, however, that the required conditions to the short-form merger or the merger generally under the Merger Agreement may not be satisfied.  The merger might be delayed if Takeda cannot use the short-form merger procedure and is required to obtain stockholder approval, or it could be prevented if a court or other governmental authority were to block the merger or make it illegal.  If the merger is delayed or otherwise not consummated within the contemplated time periods or at all, we could suffer a number of consequences that may adversely affect our business, results of operations and stock price, including:

 

·       activities related to the merger and related uncertainties may lead to a loss of revenue and market position that we may not be able to regain if the proposed transaction does not occur;

 

·       the market price of our common stock could decline following an announcement that the proposed transaction had been abandoned or delayed;

 

·       because Takeda would own a substantial majority of our common stock, there may not be an active trading market for our remaining shares of common stock and we may not be able to sustain our Nasdaq listing;

 

·       we would remain liable for our costs related to the proposed transaction, including substantial legal, accounting and investment banking expenses; and

 

·       we may not be able to take advantage of alternative business opportunities or effectively respond to competitive pressures.

 

A lawsuit has been filed against us and the members of our Board of Directors arising out of our acquisition by Takeda, which may delay or prevent the proposed transaction.

 

On April 10, 2008, a purported shareholder class action lawsuit was filed by a single plaintiff against us and each of our directors, as well as Parent and Merger Sub, in Superior Court for Middlesex County, Massachusetts.  The action, captioned Eleanor Turberg v. Millennium Pharmaceuticals, Inc. et al. (Case No. 08-1466, Superior Court, Middlesex County, MA), is brought by Eleanor Turberg, who claims to be an individual Millennium stockholder, on her own behalf, and seeks certification as a class action on behalf of all Millennium stockholders except the defendants and any person, firm, trust, corporation or other entity related to or affiliated with any defendants.  The complaint alleges, among other things, that the defendants breached fiduciary duties of loyalty, due care, independence, good faith and fair dealing, and/or aided and abetted the breach of fiduciary duties, owed to our stockholders in connection with the transactions contemplated by the Merger Agreement.  The complaint seeks, among other things, an order (a) enjoining the defendants from proceeding with the proposed acquisition of shares of our common stock by Takeda, (b) rescinding, to the extent already implemented, the proposed acquisition of shares of our common stock by Takeda, (c) awarding the plaintiff and the purported class damages and (d) awarding plaintiff the costs and disbursements of the action, including reasonable attorneys’ and experts’ fees.  On May 5, 2008, the court denied the plaintiff’s motion for a preliminary injunction against Merger Sub accepting shares tendered in the tender offer, and on May 9, 2008, Merger Sub accepted the shares tendered in the tender offer.  We intend to vigorously defend against these claims; however, the outcome of all litigation is uncertain and we may not be successful in defending against these claims.  Regardless of the outcome of this lawsuit, it could delay or prevent our acquisition by Takeda, divert the attention of our management and employees from our day-to-day business and otherwise adversely affect us financially.

 

Regulatory Risks

 

Our business will be harmed if we do not obtain approval to market VELCADE for additional therapeutic uses.

 

An important part of our strategy to grow our business is to market VELCADE for additional indications. To do so, we will need to successfully conduct clinical trials in accordance with good clinical practices and then apply for and obtain the appropriate regulatory approvals. If we are unsuccessful in our clinical trials, or we experience a delay in obtaining or are unable to obtain authorizations for expanded uses of VELCADE, our revenues will not grow as expected and our business and operating results will be harmed. For example, in December 2007 we submitted a sNDA to the FDA, and OBL submitted a variation to their Marketing Authorization to the EMEA, to market VELCADE for patients with newly diagnosed multiple myeloma. If these submissions are not approved by the regulatory agencies, sales of VELCADE could be materially lower than anticipated. Future sales of VELCADE could also be materially lower than expected if the results from our phase III clinical trial in patients with relapsed follicular or marginal zone NHL do not justify a label expansion into this indication.

 

We may not be able to obtain approval in additional countries to market VELCADE.

 

VELCADE is currently approved for marketing in the United States and a total of 85 countries including the countries of the European Union. If OBL is not able to obtain approval to market VELCADE in additional countries, OBL will lose the opportunity to sell in those countries and we may not be able to earn potential milestone payments under our agreement with OBL or collect potential distribution fees on sales of VELCADE by OBL in those countries.

 

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We may not be able to obtain marketing approval for products resulting from our development efforts.

 

The products that we are developing require research and development, extensive preclinical studies and clinical trials and regulatory approval, including the submission of user fees, prior to any commercial sales. This process is expensive and lengthy, and can often take a number of years. In some cases, the length of time that it takes for us to achieve various regulatory approval milestones affects the payments that we are eligible to receive under our strategic alliance agreements.

 

We may need to successfully address a number of technological challenges in order to complete development of our products. Moreover, these products may not be effective in treating any disease or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude completing development, obtaining regulatory approval or prevent or limit commercial use. For example, in November 2007, we announced that the results from a phase II trial of MLN3897 did not achieve the pre-established criteria for moving this product candidate forward in rheumatoid arthritis.

 

Failure to gain approval for the products we are developing could have a material adverse impact on our business.

 

If we fail to comply with regulatory requirements, or if we experience unanticipated problems with our approved products, our products could be subject to restrictions or withdrawal from the market.

 

Any product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, adverse event reporting and promotional activities for such product, is subject to continual review and periodic inspections by the FDA and other regulatory authorities. Later discovery of previously unknown problems or safety issues with our products or manufacturing processes, or failure to comply with regulatory requirements, may result in restrictions on such products or manufacturing processes, withdrawal of the products from the market, warning letters, product recalls or seizures, the imposition of total or partial suspension of production or distribution, fines, civil or criminal penalties or a refusal by the FDA and other regulatory authorities to approve pending applications for marketing approval of new drugs or supplements to approved applications. As with any recently approved therapeutic product, we expect that our knowledge of the safety profile for VELCADE will expand after wider usage, and the possibility exists of patients receiving VELCADE treatment experiencing unexpected or more frequently than expected serious adverse events, which could have a material adverse effect on our business.

 

We are a party to collaborations that transfer responsibility for specified regulatory requirements, such as filing and maintenance of marketing authorizations and safety reporting, to our collaborators. If our collaborators do not fulfill these regulatory obligations, products, including VELCADE and INTEGRILIN, could be withdrawn from the market, which would have a material adverse effect on our business. Additionally, the FDA requires that we, along with our collaborators and third party manufacturers, may not employ, in any capacity, persons who have been debarred under the FDA’s Application Integrity Policy. Employment of such a debarred person (even if inadvertently) may result in delays in the FDA’s review or approval of our products, or the rejection of data developed with the involvement of such person(s).

 

Additionally, because VELCADE and other products we may develop could be used in combination with therapies we do not control, our sales of VELCADE and other future products could be adversely affected if those combined therapies became subject to increased safety concerns, were withdrawn from the market or otherwise lost favor among practitioners.

 

Recently enacted legislation may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to produce, market and distribute products after approval.

 

On September 27, 2007, the President signed the Food and Drug Administration Amendments Act of 2007, or the FDAAA, into law. The FDAAA grants a variety of new powers to the FDA, many of which are aimed at improving the safety of drug products before and after approval. Under the FDAAA, companies that violate the new law are subject to substantial civil monetary penalties. While we expect the FDAAA to have a substantial effect on the pharmaceutical industry, the extent of that effect is not yet known. As the FDA issues regulations, guidance and interpretations relating to the new legislation, the impact on the industry, as well as our business, will become clearer. The new requirements and other changes that the FDAAA imposes may make it more difficult, and likely more costly, to obtain approval of new pharmaceutical products and to produce, market and distribute products after approval.

 

Some of our products may be based on new technologies, which may affect our ability or the time we require to obtain necessary regulatory approvals.

 

Products that result from our research and development programs may be based on new technologies, such as proteasome inhibition, Nedd 8—activating enzyme inhibition, IKK beta inhibition and other new therapeutic approaches that have not been extensively tested in humans. The regulatory requirements governing these types of products may be more rigorous than for

 

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conventional products. As a result, we may experience a longer development or regulatory process in connection with any products that we develop based on these new technologies or new therapeutic approaches.

 

Risks Relating to Our Business, Strategy and Industry

 

Our revenues over the next several years will be materially dependent on the commercial success of VELCADE and INTEGRILIN.

 

VELCADE was approved by the FDA in May 2003 and commercially launched in the United States shortly after that date. Marketing of VELCADE outside the United States commenced in April 2004. INTEGRILIN has been on the market in the United States since June 1998. Marketing of INTEGRILIN outside the United States commenced in mid-1999.

 

Our business plan contemplates obtaining marketing authorization to sell VELCADE in many countries for the treatment of all patients with multiple myeloma and both in the United States and abroad for other indications. We will be adversely affected if VELCADE does not receive such approvals, or if such approvals are subject to limitations on the indicated uses for which we may market the product.

 

We will not achieve our business plan, and we may be forced to scale back our operations and research and development programs, if we do not obtain regulatory approval to sell VELCADE in additional countries or for additional therapeutic uses or the sales of VELCADE or INTEGRILIN do not meet our expectations.

 

We face substantial competition, and others may discover, develop or commercialize products before or more successfully than we do.

 

The fields of biotechnology and pharmaceuticals are highly competitive. Many of our competitors are substantially larger than we are, and these competitors have substantially greater capital resources, research and development staffs and facilities than we have. Furthermore, many of our competitors are more experienced than we are in drug research, discovery, development and commercialization, obtaining regulatory approvals and product manufacturing and marketing. As a result, our competitors may discover, develop and commercialize pharmaceutical products before or in a shorter timeframe than we do. In addition, our competitors may discover, develop and commercialize products that make the products that we or our collaborators have developed, or are seeking to develop and commercialize, non-competitive or obsolete.

 

With respect to VELCADE, we face competition from Celgene Corporation’s Thalomid and Revlimid. In May 2006, the FDA approved the use of Thalomid for the treatment of newly diagnosed multiple myeloma. Revlimid was approved by the FDA in December 2005 for the treatment of a subset of patients with myelodysplastic syndromes and in June 2006 for multiple myeloma patients who have received at least one prior therapy. We also face competition for VELCADE from traditional chemotherapy treatments and other potentially competitive therapies for VELCADE, including other proteasome inhibitors, some of which are in late-stage clinical development for the treatment of multiple myeloma. In addition, multiple myeloma therapies in development may reduce the number of patients available for VELCADE treatment through enrollment of these patients in clinical trials of potentially competing products.

 

Due to the incidence and severity of cardiovascular diseases, the market for therapeutic products that address these diseases is large, and we expect the already intense competition in this field to increase. The most significant competitors for SGP and GSK in marketing INTEGRILIN are major pharmaceutical companies and biotechnology companies. The two products that compete directly with INTEGRILIN in the GP IIb-IIIa inhibitor market segment are ReoPro ® (abciximab), which is produced by Johnson & Johnson and sold by Johnson & Johnson and Eli Lilly and Company, and Aggrastat ® (tirofiban HCl), which is produced and sold by Merck & Co., Inc. outside of the United States and by Medicure Inc. in the United States.

 

Sales of INTEGRILIN could also be negatively affected in the future by other competitive factors, including:

 

·                   expanded use of heparin replacement therapies, such as Angiomax ® (bivalirudin), which is produced and sold by The Medicines Company;

 

·                   changing treatment practices for PCI and ACS based on new technologies, including the use of drug-coated stents;

 

·                   increased use of another class of anti-platelet drugs known as ADP inhibitors in patients whose symptoms make them potential candidates for treatment with INTEGRILIN; and

 

·                   the introduction of new therapeutics to treat cardiovascular diseases.

 

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Sales of INTEGRILIN and possibly VELCADE in particular reporting periods may be affected by fluctuations in inventory, allowances and buying patterns.

 

We distribute VELCADE in the U.S. through a sole-source distribution model, where we sell directly to a third party who in turn distributes to the wholesaler base. Our VELCADE product inventory levels may fluctuate from time to time depending on the consistency of the distribution logistics of this arrangement and the buying patterns of these wholesalers.

 

Additionally, we make provisions at the time of sale of VELCADE for discounts, product returns and governmental and contractual adjustments based on historical experience updated for changes in facts and circumstances, as appropriate. To the extent these allowances are incorrect, we may need to adjust our estimates, which could have a material impact on the timing and actual amount of revenue we are able to recognize from these sales. Also, pricing decisions may cause fluctuations in our quarterly results. For example, purchasers of VELCADE may increase purchase orders in anticipation of a price increase and reduce order levels following the price increase.

 

A significant portion of INTEGRILIN domestic pharmaceutical sales is made by SGP to major drug wholesalers. These sales are affected by fluctuations in the buying patterns of these wholesalers and the corresponding changes in inventory levels maintained by them. Inventory levels held by these wholesalers may fluctuate significantly from quarter to quarter. If these wholesalers build inventory levels excessively in any quarter, sales to the wholesalers in future quarters may unexpectedly decrease notwithstanding steady prescriber demand. Because SGP commercializes INTEGRILIN and manages product distribution, we have limited insight into or control over factors affecting changes in distributor inventory levels. If SGP does not appropriately manage this distribution, SGP may not realize sales goals for the product which would reduce the royalty revenue we recognize and thus adversely affect our business.

 

Because many of our research and development projects are based on new technologies and new therapeutic approaches that have not been extensively tested in humans, it is possible that our discovery process will not result in commercial products.

 

The process of discovering drugs based upon genomics and other new technologies is evolving rapidly. Our effort to develop new therapeutics is focused on the discovery of novel targets and pathways. Many novel targets and pathways that appear viable in preclinical models do not result in intended biologic outcomes due to pathway redundancy in humans. As a result, we anticipate that many of these targets and pathways will not result in the successful development of marketable therapeutics. Rapid technological development by us or others may result in compounds, products or processes becoming obsolete before we recover our development expenses. Further, manufacturing costs or products based on these new technologies may make products uneconomical to commercialize.

 

If our clinical trials are unsuccessful, or if they experience significant delays, our ability to commercialize products will be impaired.

 

We must provide the FDA and foreign regulatory authorities with preclinical and clinical data demonstrating that our products are safe and effective before they can be approved for commercial sale. Clinical development, including preclinical testing, is a long, expensive and uncertain process. It may take us several years to complete our testing, and failure can occur at any stage of testing. Interim results of preclinical or clinical studies do not necessarily predict their final results, and acceptable results in early studies might not be seen in later studies. Any preclinical or clinical test may fail to produce results satisfactory to the FDA or other regulatory authorities. Preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval. Negative or inconclusive results from a preclinical study or clinical trial, adverse medical events during a clinical trial or safety issues resulting from products of the same class of drug could cause pending regulatory action to be delayed, a preclinical study or clinical trial to be repeated or prolonged or a program to be terminated, even if other studies or trials relating to the program are successful.

 

We may not complete our planned preclinical or clinical trials on schedule or at all. We may not be able to confirm the safety and efficacy of our potential drugs in long-term clinical trials, which may result in a delay or failure to commercialize our products. We may have difficulty obtaining a sufficient number of appropriate patients or clinical support to conduct our clinical trials as planned. A number of additional events could delay the completion of our clinical trials, including:

 

·                   conditions imposed on us by the FDA or foreign regulatory authorities regarding the scope or design of our clinical trials, requirements for additional trials or trial data or restrictions on the distribution of products;

 

·                   slower enrollment in our clinical trials than we anticipate;

 

·                   lower retention rates for patients in our clinical trials than we anticipate;

 

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·                   insufficient supply or deficient quality of our product candidates or other materials necessary to conduct our clinical trials; or

 

·                   the failure of our third party contractors to comply with regulatory requirements or otherwise meet their contractual obligations to us in a timely manner, or at all.

 

In addition, institutional review boards or regulators, including the FDA, or our collaborators may hold, suspend or terminate our clinical trials for various reasons, including noncompliance with regulatory requirements or if, in their opinion, the participating subjects are being exposed to unacceptable health risks. As a result, we may have to expend substantial additional funds to obtain access to resources or delay or modify our plans significantly. Our product development costs will increase if we experience delays in testing or approvals. Significant clinical trial delays could allow our competitors to bring products to market before we do and impair our ability to commercialize our products or potential products.

 

If third parties on which we rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our product candidates.

 

We depend on independent clinical investigators and, in some cases, contract research organizations and other third party service providers to conduct the clinical trials of our product candidates and expect to continue to do so. We rely heavily on these parties for successful execution of our clinical trials, but we do not control many aspects of their activities. Nonetheless, we are responsible for confirming that each of our clinical trials is conducted in accordance with the general investigational plan and protocol. Our reliance on these third parties that we do not control does not relieve us of our responsibility to comply with the regulations and standards of the FDA relating to good clinical practices. Third parties may not complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or the applicable trial plans and protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates or result in enforcement action against us.

 

Because many of the products that we are developing are based on new technologies and therapeutic approaches, the market may not be receptive to these products upon their introduction.

 

The commercial success of any of our products for which we may obtain marketing approval from the FDA or other regulatory authorities will depend upon their acceptance by the medical community and third party payors and consumers as clinically useful, cost-effective and safe. Many of the products that we are developing are based upon new technologies or therapeutic approaches. As a result, it may be more difficult for us to achieve market acceptance of our products, particularly the first products that we introduce to the market based on new technologies and therapeutic approaches. Our efforts to educate the medical community on these potentially unique approaches may require greater resources than would be typically required for products based on conventional technologies or therapeutic approaches. The safety, efficacy, convenience and cost-effectiveness of our products as compared to competitive products will also affect market acceptance.

 

Because of the high demand for talented personnel within our industry, we could experience difficulties in recruiting or retaining employees necessary for our success and growth.

 

Because competition for talented employees within our industry is fierce, we may not be successful in hiring, retaining or promptly replacing key management, sales, marketing and technical personnel. Any failure to expeditiously fill our needs for key personnel could reduce our operational capacity and productivity and have a material adverse effect on our business.

 

Our strategy of generating growth through license arrangements and acquisitions may not be successful.

 

An important element of our business strategy is to acquire additional therapeutic agents through license arrangements or acquisitions of other companies.  Although we regularly review and engage in discussions with third parties with respect to such transactions, we may be unable to license or acquire other suitable products or product candidates from third parties for a number of reasons. In particular, the licensing and acquisition of pharmaceutical and biological products, including through the acquisition of other companies, is a competitive area. A number of other companies are also pursuing strategies to license or acquire products within our therapeutic focus areas of cancer and inflammation. These other companies may have a competitive advantage over us due to their size, cash resources and greater drug research, discovery and development and commercialization capabilities.

 

Other factors that may prevent us from licensing or otherwise acquiring suitable products and product candidates include the following:

 

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·                   we may be unable to license or acquire the relevant technology on terms that would allow us to make an appropriate return on the product;

 

·                   companies that perceive us to be their competitor may be unwilling to assign or license their product rights to us; or

 

·                   we may be unable to identify suitable products or product candidates within our areas of focus.

 

In addition, we expect competition for licensing and acquisition candidates in the biotechnology and pharmaceutical fields to increase, which may mean fewer suitable opportunities for us as well as higher prices. If we are unable to successfully obtain rights to suitable products and product candidates, our business, financial condition and prospects for growth could suffer.

 

If we fail to successfully manage any acquisitions, our ability to develop our product candidates and expand our product candidate pipeline may be harmed.

 

Following any future acquisitions that we may make, our failure to adequately address the financial, operational or legal risks of these transactions could harm our business. Financial aspects of these transactions that could alter our financial position, reported operating results or stock price include:

 

·                   use of cash resources;

 

·                   higher than anticipated acquisition costs and expenses;

 

·                   potentially dilutive issuances of equity securities;

 

·                   the incurrence of debt and contingent liabilities;

 

·                   impairment losses or restructuring charges;

 

·                   large write-offs and difficulties in assessing the relative percentages of in-process research and development expense that can be immediately written off as compared to the amount that must be amortized over the appropriate life of the asset; and

 

·                   amortization expenses related to other intangible assets.

 

Operational risks that could harm our existing operations or prevent realization of anticipated benefits from these transactions include:

 

·                   challenges associated with managing an increasingly diversified business;

 

·                   disruption of our ongoing business;

 

·                   difficulty and expense in assimilating the operations, products, technology, information systems or personnel of acquired companies;

 

·                   diversion of management’s time and attention from other business concerns;

 

·                   inability to maintain uniform standards, controls, procedures and policies, including the requirements of Sarbanes-Oxley;

 

·                   difficulty of confirming compliance with all applicable laws and regulations;

 

·                   the assumption of known and unknown liabilities of acquired companies, including intellectual property claims; and

 

·                   subsequent loss of key personnel.

 

If we are unable to successfully manage our acquisitions, our ability to develop new products and continue to expand our product pipeline may be limited.

 

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Risks Relating to Our Financial Results and Need for Financing

 

We have incurred substantial losses and cannot be certain when we will achieve ongoing profitability.

 

We recorded net income of $14.6 million for the three months ended March 31, 2008 and net income of $14.9 million for the year ended December 31, 2007.  However, we incurred net losses of $6.8 million for the three months ended March 31, 2007, $44.0 million for the year ended December 31, 2006 and $198.2 million for the year ended December 31, 2005. It is possible that we will incur operating losses in future periods which may be significant. As of March 31, 2008, we had an accumulated deficit of $2.5 billion.

 

We expect to continue to incur significant expenses in connection with our research and development programs and commercialization activities. As a result, we will need to generate significant revenues to continue to operate profitably. Our ability to generate future profits would be adversely affected if our acquired intangible assets, primarily resulting from our acquisition of COR, and goodwill became impaired as a result of reduced market capitalization, reduced VELCADE revenues, product failures or withdrawals.

 

We cannot be certain if and to what extent we will achieve ongoing profitability because of the significant uncertainties with respect to our ability to successfully develop products and generate revenues from the sale of approved products and from existing and potential future strategic alliances.

 

We may need additional financing, which may be difficult to obtain. Our failure to obtain necessary financing or doing so on unattractive terms could adversely affect our business and operations.

 

We will require substantial funds to conduct research and development, including preclinical testing and clinical trials of our potential products. We will also require substantial funds to meet our obligations to our collaborators, manufacture and market products that are approved for commercial sale, including VELCADE, and meet our debt service obligations. We may also require additional financing to execute on product in-licensing or acquisition opportunities. Additional financing may not be available when we need it or may not be available on favorable terms.

 

If we are unable to obtain adequate funding on a timely basis, we may have to delay or curtail our research and development programs, our product commercialization activities or our in-licensing or acquisition activities. We could be required to seek funds through arrangements with collaborators or others that may require us to relinquish rights to specified technologies, product candidates or products which we would otherwise pursue on our own.

 

Our indebtedness and debt service obligations may adversely affect our cash flow and otherwise negatively affect our operations.

 

At March  31, 2008, we had approximately $250.0 million of convertible debt outstanding and $74.7 million of capital lease obligations. As a result of the announcement of our acquisition by Takeda, holders of our convertible debt may elect to convert such debt into shares of our common stock or, following the merger, into the equivalent cash merger consideration, until the end of a repurchase period that will be specified in our notice to the noteholders.  We may incur additional indebtedness in the future, including long term debt, credit lines and property and equipment financings to finance capital expenditures. We intend to satisfy our current and future debt service obligations from cash generated by our operations, our existing cash and investments and funds from external sources. We may not have sufficient funds and we may be unable to arrange for additional financing to satisfy our principal or interest payment obligations when those obligations become due. Funds from external sources may not be available on acceptable terms, or at all.

 

Our indebtedness could have significant additional negative consequences, including:

 

·                   increasing our vulnerability to general adverse economic and industry conditions;

 

·                   limiting our ability to obtain additional financing;

 

·                   requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including capital expenditures and research and development;

 

·                   limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

 

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·                   placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.

 

If we do not achieve the anticipated benefits of our restructuring efforts, or if the costs of our restructuring efforts exceed anticipated levels, our business could be harmed.

 

We recorded net restructuring credits of $2.9 million for the three months ended March 31, 2008 and restructuring charges of $5.6 million for the three months ended March 31, 2007, $12.9 million for the year ended December 31, 2007, $20.4 million for the year ended December 31, 2006 and $77.1 million for the year ended December 31, 2005. Costs associated with our restructuring efforts have included reducing our in-house research and development technologies and headcount in areas in which we believe the work can now be outsourced cost effectively. As a result of these efforts, we expect to recognize other cost savings. We may not achieve our estimated expense reductions or recognize other cost savings anticipated from restructurings because such savings are difficult to predict and speculative in nature.

 

A portion of our revenues and expenses is subject to exchange rate fluctuations in the normal course of business, which could adversely affect our reported results of operations.

 

We receive distribution fees from OBL based on worldwide sales of VELCADE outside of the U.S. and we make payments for certain inventory purchases and clinical trials outside of the U.S. As a result, our financial position, results of operations and cash flows can be affected by fluctuations in foreign currency exchange rates, primarily the euro. Movement in foreign currency exchange rates could cause royalty revenue or clinical trial costs to vary significantly in the future and may affect period-to-period comparisons of our operating results. Historically, we have not hedged our exposure to these fluctuations in exchange rates.

 

Risks Relating to Collaborators

 

We depend significantly on our collaborators to work with us to commercialize and develop products including VELCADE and INTEGRILIN.

 

Outside of the United States, we commercialize VELCADE through an alliance with OBL. We began jointly promoting VELCADE in the United States in the first quarter of 2007 under a two-year agreement with OBI. On September 1, 2005, we transferred exclusive U.S. commercialization and development rights of INTEGRILIN to SGP and SGP is solely responsible for the commercialization and development of INTEGRILIN outside of Europe. GSK is responsible for marketing and selling INTEGRILIN in Europe. We conduct substantial discovery and development activities through strategic alliances, including with OBL for the ongoing development of VELCADE.

 

We expect to enter into additional alliances in the future, especially in connection with product development and commercialization. The success of our alliances depends heavily on the efforts and activities of our collaborators.

 

Each of our collaborators has significant discretion in determining the efforts and resources that it will apply to the alliance and the degree to which it shares financial and product sales and inventory information. Our existing and any future alliances may not be scientifically or commercially successful.

 

The risks that we face in connection with these existing and any future alliances include the following:

 

·                   All of our strategic alliance agreements are for fixed terms and are subject to termination under various circumstances, including, in many cases, such as in our collaboration and our joint promotion agreement with OBL and OBI, without cause.

 

·                   Our collaborators may change the focus of their development and commercialization efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their development and commercialization priorities following mergers and consolidations, which have been common in recent years in these industries. The likelihood of some of our products, including VELCADE and INTEGRILIN, to reach their potential could be limited if our collaborators decrease or fail to increase marketing or spending efforts related to such products.

 

·                   We expect to rely on our collaborators to manufacture many products covered by our alliances.

 

·                   In our strategic alliance agreements, we generally agree not to conduct specified types of research and development in the field that is the subject of the alliance. These agreements may have the effect of limiting the areas of research and development that we may pursue, either alone or in collaboration with third parties.

 

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·                   Our collaborators may develop and commercialize, either alone or with others, products that are similar to or competitive with the products that are the subject of the alliance with us.

 

·                   Our collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to expose us to potential litigation.

 

We are substantially dependent on SGP for future revenues related to INTEGRILIN.

 

Under the terms of our revised agreement with SGP effective as of September 1, 2005, SGP began paying us royalties based on net product sales of INTEGRILIN. Under the agreement, beginning in 2008, SGP no longer has minimum royalty obligations to us. As a result, if SGP’s INTEGRILIN sales are less than expected, we will receive less royalty revenue than we expect, which could have a material adverse effect on our financial results and our ability to fund other parts of our business.

 

We may not be successful in establishing additional strategic alliances, which could adversely affect our ability to develop and commercialize products.

 

An important element of our business strategy is entering into strategic alliances for the development and commercialization of selected products. In some instances, if we are unsuccessful in reaching an agreement with a suitable collaborator, we may fail to meet all of our business objectives for the applicable product or program. We face significant competition in seeking appropriate collaborators. Moreover, these alliance arrangements are complex to negotiate and time-consuming to document. We may not be successful in our efforts to establish additional strategic alliances or other alternative arrangements. The terms of any additional strategic alliances or other arrangements that we establish may not be favorable to us. We may incur significant infrastructure, research and development and other expenses as we try to maximize the value of assets subject to these arrangements. Moreover, such strategic alliances or other arrangements may not be successful.

 

Risks Relating to Intellectual Property

 

If we are unable to obtain patent protection for our discoveries, the value of our technology and products will be adversely affected. If we infringe patent or other intellectual property rights of third parties, we may not be able to develop and commercialize our products or the cost of doing so may increase.

 

Our patent positions, and those of other pharmaceutical and biotechnology companies, are generally uncertain and involve complex legal, scientific and factual questions. Our ability to develop and commercialize products depends in significant part on our ability to:

 

·                   obtain and maintain patents;

 

·                   obtain licenses to the proprietary rights of others on commercially reasonable terms;

 

·                   operate without infringing upon the proprietary rights of others;

 

·                   prevent others from infringing on our proprietary rights; and

 

·                   protect trade secrets.

 

There is significant uncertainty about the validity and permissible scope of patents in our industry, which may make it difficult for us to obtain patent protection for our discoveries.

 

The validity and permissible scope of patent claims in the pharmaceutical and biotechnology fields, including, for example, the genomics field, involve important unresolved legal principles and are the subject of public policy debate in the United States and abroad. We have filed patent applications in the U.S. and abroad seeking patent protection on our current products and our potential products and processes emanating from our research and development, and we have similarly obtained rights to various patents and patent applications from various third parties under licensing arrangements. There is significant uncertainty both in the United States and abroad regarding the duration and enforceability of patent protection available for pharmaceutical and biopharmaceutical products and processes. The ultimate scope of patent protection to be afforded such inventions will be dependent upon the decisions rendered by patent offices, courts and legislators in the U.S. and abroad. Thus, there is no assurance that our pending patent applications, or those of third parties that we have licensed, will ultimately be granted as patents or that those patents that have issued or will be issued in the future will withstand challenge in court or patent offices in the U.S. or abroad.

 

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Third parties may own or control patents or patent applications and require us to seek licenses, which could increase our development and commercialization costs, or prevent us from developing or marketing our products.

 

We may not have rights under some patents or patent applications related to some of our existing and proposed products or processes. Third parties may own or control these patents and patent applications in the United States and abroad. Therefore, in some cases, such as those described below, in order to develop, manufacture, sell or import some of our existing and proposed products or processes, we or our collaborators may choose to seek, or be required to seek, licenses under third party patents issued in the United States and abroad, or those that might issue from United States and foreign patent applications. In such event, we would be required to pay license fees or royalties or both to the licensor. If licenses are not available to us on acceptable terms, we or our collaborators may not be able to develop, manufacture, sell or import these products or processes and we could be liable to the holders of those licenses for infringement damages.

 

Our MLN0002 and MLN1202 product candidates are humanized monoclonal antibodies. We are aware of third party patents and patent applications that relate to humanized or modified antibodies, products useful for making humanized or modified antibodies and processes for making and using recombinant antibodies.

 

With respect to VELCADE, in June 2002, Ariad Pharmaceuticals, Inc., or Ariad, sent to us and approximately 50 other parties a letter offering a sublicense for the use of United States Patent No. 6,410,516, which is exclusively licensed to Ariad. If this patent is valid and Ariad successfully sues us for infringement, we would require a license from Ariad in order to manufacture and market VELCADE. In 2002, Ariad filed a lawsuit in the United States District Court for the District of Massachusetts against Eli Lilly and Company, or Lilly, alleging infringement of certain claims of Ariad’s patent. In May 2006, the jury rendered a verdict in favor of Ariad that the claims of the patent asserted in the lawsuit are valid and infringed by Lilly. The jury determined that a reasonable royalty of 2.3% should be awarded. In July 2007, the court entered a judgment in accordance with the jury verdict in favor of Ariad against Lilly. We expect that Lilly will challenge this judgment and the validity of the patent with the U.S. Court of Appeals. In July 2007, Lilly filed a motion to stay entry of the final judgment by the court pending re-examination of the patent and Ariad filed an opposition to this motion. In April 2005, Lilly also filed a request in the United States Patent and Trademark Office to reexamine the patentability of certain claims of Ariad’s patent. In addition, we are aware that Amgen Inc. has filed a declaratory relief action seeking an invalidity ruling with respect to this patent. However, Ariad’s initial success in its claim against Lilly may increase the possibility that Ariad could sue additional parties, including us, and allege infringement of the patent.

 

The timing and ultimate outcome of the Lilly and Amgen litigations and the patent reexamination proceeding cannot be determined at this time. As a result, we cannot determine whether or when a final determination as to allowance or rejection of the patent claims will be made or the outcome of any appeal of any such decision that may follow such a ruling. Thus, at the present time, we cannot assess the probability of whether Ariad will seek to enforce the patent against other companies, including our company.

 

Very recently we received a copy of a notice sent to the National Institutes of Health, or NIH, that a third party is claiming co-inventorship and co-ownership of some of the patents covering the VELCADE drug product that are exclusively licensed to us by the NIH.  The other patents which make up the VELCADE patent estate are solely owned by us and are not subject to this claim.  It is our understanding that the NIH previously reviewed and rejected the claim of this third party.  We are early in the process of evaluating this claim of co-inventorship on these patents licensed from the NIH, and the resulting implications to us if this claim were successful.

 

We may become involved in expensive patent litigation or other proceedings, which could result in our incurring substantial costs and expenses or substantial liability for damages or require us to stop our development and commercialization efforts.

 

There has been substantial litigation and other proceedings regarding the patent and other intellectual property rights in the pharmaceutical and biotechnology industries. We may become a party to patent litigation or other proceedings regarding intellectual property rights. For example, we believe that we hold patent applications that cover genes that are also claimed in patent applications filed by others. Interference proceedings before the United States Patent and Trademark Office may be necessary to establish which party was the first to invent these genes. In addition, from time to time, we receive unsolicited letters purporting to advise us of the alleged relevance of third party patents.

 

The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the cost of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. If a patent litigation or other proceeding is resolved against us, we or our collaborators may be enjoined from developing, manufacturing, selling or importing our products or processes without a license from the other party and we may be held liable for significant damages. We may not be able to obtain any required license on commercially acceptable terms or at all.

 

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.

 

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Our patent protection for any compounds that we seek to develop may be limited to a particular method of use or indication such that, if a third party were to obtain approval of the compound for use in another indication, we could be subject to competition arising from off-label use.

 

Although we generally seek the broadest patent protection available for our proprietary compounds, we may not be able to obtain patent protection for the actual composition of any particular compound and may be limited to protecting a new method of use for the compound or otherwise restricted in our ability to prevent others from exploiting the compound. If we are unable to obtain patent protection for the actual composition of any compound that we seek to develop and commercialize and must rely on method of use patent coverage, we would likely be unable to prevent others from manufacturing or marketing that compound for any use that is not protected by our patent rights. If a third party were to receive marketing approval for the compound for another use, physicians could nevertheless prescribe it for indications that are not described in the product’s labeling or approved by the FDA or other regulatory authorities. Even if we have patent protection of the prescribed indication, as a practical matter, we would have little recourse as a result of this off-label use. In that event, our revenues from the commercialization of the compound would likely be adversely affected.

 

If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.

 

We are a party to various license agreements. In particular, we license rights to patents for the formulation of VELCADE and issued patents relating to MLN0002, MLN0518 and MLN1202. We may enter into additional licenses in the future. Our existing licenses impose, and we expect future licenses will impose, various diligence, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with these obligations, the licensor may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed patents.

 

Competition from generic pharmaceutical manufacturers could negatively affect our products sales.

 

Competition from manufacturers of generic drugs is a major challenge for us in the U.S. and is growing internationally. Upon the expiration or loss of patent protection for one of our products, or upon the “at-risk” launch (despite pending patent infringement litigation against the generic product) by a generic manufacturer of a generic version of one of our products, we could lose the major portion of sales of that product in a very short period, which could adversely affect our business.

 

Generic competitors operate without our large research and development expenses and our costs of conveying medical information about our products to the medical community. In addition, the FDA approval process exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allowing generic manufacturers to rely on the safety and efficacy data of the innovator product. Generic products, however, need only demonstrate a level of availability in the bloodstream equivalent to that of the innovator product. This means that generic competitors can market a competing version of our product after the expiration or loss of our patent and charge much less. The issued U.S. patents related to VELCADE expire in 2014 with patent term extension for VELCADE expiring in 2017 and the issued foreign patents expire in 2015 with extensions issued or pending in a number of countries. However, we may not be granted any such potential or pending extension. The issued United States patents that cover INTEGRILIN expire in 2014 and 2015 and the issued foreign patents expire between 2010 and 2014. Our patent-protected products also can face competition in the form of generic versions of branded products of competitors that lose their market exclusivity.

 

In addition, third parties could produce counterfeit products labeled as VELCADE, INTEGRILIN or other of our products in the future. Counterfeit products could reduce sales or compromise goodwill associated with our product brands.

 

Risks Relating to Product Manufacturing, Marketing and Sales

 

We depend on third parties to successfully perform certain sales, marketing and distribution functions on our behalf and we may be required to incur significant costs and devote significant efforts to augment our existing capabilities.

 

We market and sell VELCADE in the United States through our cancer-specific sales force. In the first quarter of 2007, we began jointly promoting VELCADE in the United States with OBI. Our success in selling VELCADE depends heavily on the performance of these sales forces. In areas outside the United States where VELCADE has received approval, OBL or its affiliates market VELCADE. As a result, our ability to earn revenue related to VELCADE outside of the United States depends entirely on OBL.

 

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SGP exclusively markets INTEGRILIN in areas outside of Europe, including the United States, and GSK exclusively markets INTEGRILIN in Europe. As a result, our success in receiving royalties and milestone payments from sales of INTEGRILIN depends entirely on the marketing efforts of these third parties.

 

Depending on the nature of the products for which we obtain marketing approval, we may need to rely significantly on sales, marketing and distribution arrangements with our collaborators and other third parties. For example, some types of pharmaceutical products require a large sales force and extensive marketing capabilities for effective commercialization. If in the future we elect to perform sales, marketing and distribution functions for these types of products ourselves, we would face a number of additional risks, including the need to recruit a large number of additional experienced marketing and sales personnel.

 

Because we have no commercial manufacturing capabilities, we are dependent on third party manufacturers to manufacture products for us, or we will be required to incur significant costs and devote significant efforts to establish our own manufacturing facilities and capabilities.

 

We have no commercial-scale manufacturing capabilities. In order to continue to develop products, apply for regulatory approvals and commercialize products, we will need to develop, contract for or otherwise arrange for the necessary manufacturing capabilities.

 

We currently rely substantially upon third parties to produce material for preclinical testing purposes and expect to continue to do so in the future. We also currently rely, and expect to continue to rely, upon other third parties, potentially including our collaborators, to produce materials required for clinical trials and for the commercial production of our products.

 

There are a limited number of contract manufacturers that operate under the FDA’s current Good Manufacturing Practices, or GMP, regulations capable of manufacturing our products. In addition, the FDA will inspect our contract manufacturers prior to granting approval of a new drug application, and will conduct periodic, unannounced inspections to ensure strict ongoing compliance with current GMPs and other applicable regulations. If we are unable to arrange for third party manufacturing of our products, or to do so on commercially reasonable terms, we may not be able to complete development of our products or commercialize them, or we may experience delays in doing so.

 

Reliance on third party manufacturers entails risks to which we would not be subject if we manufactured products ourselves, including reliance on the third party for regulatory compliance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control and the possibility of termination or non-renewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us. Any failure by our third party manufacturers to comply with applicable regulations, including current GMP regulations, could result in sanctions being imposed on the manufacturers or us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal of approvals, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business.

 

We may in the future elect to manufacture some of our products in our own manufacturing facilities. We would need to invest substantial additional funds and recruit qualified personnel in order to build or lease and operate any manufacturing facilities.

 

Because we have no commercial manufacturing capability for VELCADE or INTEGRILIN, we are dependent on third parties to produce product sufficient to meet market demand.

 

We are responsible for managing the supply of material for all clinical and commercial production of VELCADE, including VELCADE that OBL sells or uses in clinical trials, and INTEGRILIN, including INTEGRILIN that SGP and GSK sell or use in clinical trials.

 

We rely on third party contract manufacturers to manufacture, fill/finish and package VELCADE for both commercial purposes and for all clinical trials. We have established long-term supply relationships for the production of commercial supplies of VELCADE. We work with one manufacturer, with whom we have a long-term supply agreement, to complete fill/finish for VELCADE, and have contracted with a second manufacturer who will provide fill/finish services for VELCADE in the future. If any of our current third party manufacturers performing production and fill/finish for VELCADE are unable or unwilling to continue performing these services for us, and we are unable to find a replacement manufacturer or in the future we are otherwise unable to contract with manufacturers to produce commercial supplies of VELCADE in a cost-effective manner, we could run out of VELCADE for commercial sale and clinical trials and our business could be substantially harmed.

 

We have no manufacturing facilities for INTEGRILIN and, accordingly, rely on third party contract manufacturers for the clinical and commercial production of INTEGRILIN. We have three approved manufacturers, two of which currently provide us with

 

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eptifibatide, the active ingredient necessary to make INTEGRILIN. Solvay, one of the current manufacturers, owns the process technology used by it for the production of eptifibatide. We expect to cease receiving eptifibatide from Solvay by the end of 2008. Thereafter, Lonza will be our sole source manufacturer of eptifibatide, and we own the process technology utilized by it. We have two approved manufacturers that currently perform fill/finish services for INTEGRILIN and two packaging suppliers for INTEGRILIN for the United States. If our current manufacturers are unable to continue or decide to discontinue their manufacturing, fill/finish or packaging services and we are unable to secure alternative manufacturers, the supply of INTEGRILIN could be adversely affected which could substantially harm our business. Furthermore, if we are responsible for supply chain failures that adversely affect OBL or SGP, we could be liable to these parties for any losses they may incur.

 

In 2006, Solvay raised concerns that the new Millennium process may have been developed using information asserted to be confidential and proprietary to Solvay. We subsequently met with Solvay to demonstrate why we believe no such information was used to develop our new process. If Solvay nevertheless brings a successful claim relating to these concerns and prevails, our ability to practice our new process could be negatively affected, which could adversely affect our ability to obtain INTEGRILIN from suppliers using the new process or the cost of manufacturing eptifibatide and could in turn harm our business.

 

If we fail to obtain an adequate level of reimbursement for our products by third party payors, there may be no commercially viable markets for our products.

 

The availability and levels of reimbursement by governmental and other third party payors affect the market for any pharmaceutical product or health care service. These third party payors continually attempt to contain or reduce the costs of health care by challenging the prices charged for medical products and services. In some foreign countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. We may not be able to sell our products as successfully or as profitably as we expect if we are required to sell our products at lower than anticipated prices, reimbursement is unavailable or limited in scope or amount or product price increases we implement result in reduced demand or government challenges.

 

In particular, third party payors could lower the amount that they will reimburse hospitals or doctors to treat the conditions for which the FDA has approved VELCADE or INTEGRILIN. If they do, pricing levels or sales volumes of VELCADE or INTEGRILIN may decrease. In addition, if we fail to comply with the rules applicable to the Medicaid and Medicare programs, we could be subject to the imposition of civil or criminal penalties or exclusion from these programs.

 

In foreign markets, a number of different governmental and private entities determine the level at which hospitals will be reimbursed for administering VELCADE and INTEGRILIN to insured patients. If these levels are set, or reset, too low, it may not be possible to sell VELCADE or INTEGRILIN at a profit in these markets.

 

In both the United States, on federal and state levels, and foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system. For example, the Medicare Prescription Drug and Modernization Act of 2003 and its implementing regulations impose new requirements for the distribution and pricing of prescription drugs which may adversely affect the marketing of our products. Further proposals are also likely. The potential for adoption of additional proposals and ensuing uncertainty among prescribers could reduce sales levels and could affect the timing of product revenue, our ability to raise capital, obtain additional collaborators and market our products.

 

In addition, we believe that the increasing emphasis on managed care in the United States has and will continue to put pressure on the price and usage of our present and future products, which may adversely affect product sales. Further, when a new therapeutic product is approved, the availability of governmental or private reimbursement for that product is uncertain, as is the amount for which that product will be reimbursed. We cannot predict the availability or amount of reimbursement for our product candidates, and current reimbursement policies for VELCADE or INTEGRILIN could change at any time.

 

Other matters also could be the subject of U.S. federal or state legislative or regulatory action that could adversely affect our business, including the importation of prescription drugs that are marketed outside the U.S. and sold at lower prices as a result of drug price regulations by the governments of various foreign countries. Such legislation or regulatory action could lead to a decrease in the price we receive for any approved products, which, in turn, could impair our ability to generate revenue. Alternatively, in response to legislation such as this, we might elect not to seek approval for or market our products in foreign jurisdictions in order to minimize the risk of re-importation, which could also reduce the revenue we generate from our product sales.

 

We face a risk of product liability claims and may not be able to obtain insurance.

 

Our business exposes us to the risk of product liability claims that is inherent in the manufacturing, testing and marketing of human therapeutic products. In particular, VELCADE and INTEGRILIN are administered to patients with serious diseases who have

 

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a high incidence of mortality. Although we have product liability insurance that we believe is appropriate, this insurance is subject to deductibles, co-insurance requirements and coverage limitations and the market for such insurance is becoming more restrictive. We may not be able to obtain or maintain adequate protection against potential liabilities. If we are unable to obtain insurance at acceptable cost or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may materially and adversely affect our business and financial position. These liabilities could prevent or interfere with our product commercialization efforts.

 

We face a risk of government enforcement actions in connection with marketing activities.

 

Because we are a company operating in a highly regulated industry, for many reasons, regulatory authorities could take enforcement action against us in connection with our marketing activities, including, among other things, seizure of allegedly misbranded product, cessation of promotional activities, imposition of significant fines, injunction or criminal prosecution against us and our officers or employees, and exclusion from government health care programs.

 

Our labeling and promotional activities relating to our products are regulated by the FDA and other federal and state regulatory agencies and are subject to associated risks. If we fail to comply with FDA regulations prohibiting promotion of off-label uses and the promotion of products for which marketing approval has not been obtained, the FDA, or the Office of the Inspector General of the Department of Health and Human Services or state Attorneys General could bring an enforcement action against us that could inhibit our marketing capabilities as well as result in significant penalties.

 

In addition to FDA requirements, our marketing activities are affected by government regulations and professional standards that constrain marketing practices in the pharmaceutical industry. These include, for example, anti-kickback laws that broadly prohibit payments or other incentives for physicians to prescribe a drug or to select one drug over another; self-referral laws that prohibit transactions in which physicians direct business to suppliers from which they receive compensation or have other financial ties; and industry standards and state laws intended to prevent conflicts of interest in arrangements between health care providers and the pharmaceutical industry.

 

Guidelines and recommendations can affect the use of our products.

 

Government agencies promulgate regulations and guidelines directly applicable to us and to our products. In addition, professional societies, practice management groups, private health and science foundations and organizations involved in various diseases from time to time may also publish guidelines or recommendations to the health care and patient communities. Recommendations of government agencies or these other groups or organizations may relate to such matters as usage, dosage, route of administration and use of concomitant therapies. Recommendations or guidelines suggesting the reduced use of our products or the use of competitive or alternative products that are followed by patients and health care providers could result in decreased use of our products.

 

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Item 6.    Exhibits

 

(a)

 

Exhibits

 

 

 

 

 

The exhibits listed in the Exhibit Index are included in this report.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

MILLENNIUM PHARMACEUTICALS, INC.

 

(Registrant)

 

 

 

 

Dated: May 12, 2008

/s/ MARSHA H. FANUCCI

 

Marsha H. Fanucci

 

Senior Vice President and Chief Financial Officer

 

(principal financial and chief accounting officer)

 

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Exhibit Index

 

Exhibit
No.

 

Description

10.1

 

Form of Indemnification Agreement entered into with certain executive officers of the Company, together with a schedule of parties thereto (incorporated herein by reference to Exhibit 10.58 to our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 29, 2008)

 

 

 

31.1

 

Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended

 

 

 

31.2

 

Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended

 

 

 

32.1

 

Statement Pursuant to 18 U.S.C. §1350

 

 

 

32.2

 

Statement Pursuant to 18 U.S.C. §1350

 

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