UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM 10-Q
(Mark
One)
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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For
the quarterly period ended March 31, 2008
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OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For
the transition period from
to
.
Commission
File Number 0-28494
MILLENNIUM
PHARMACEUTICALS, INC.
(Exact name of
registrant as specified in its charter)
Delaware
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04-3177038
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(State or other
jurisdiction
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(I.R.S. Employer
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of incorporation
or organization)
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Identification
No.)
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40
Landsdowne Street, Cambridge, Massachusetts 02139
(Address of
principal executive offices) (zip code)
(617)
679-7000
(Registrants
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
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Accelerated
filer
o
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Non-accelerated
filer
o
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Smaller
reporting company
o
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(Do not check if
a smaller reporting company)
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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
registrants Common Stock, $0.001 par value, outstanding on May 2,
2008: 327,288,246
MILLENNIUM
PHARMACEUTICALS, INC.
FORM 10-Q
FOR
THE QUARTER ENDED MARCH 31, 2008
TABLE
OF CONTENTS
The
following Millennium trademarks are used in this Quarterly Report on Form 10-Q:
Millennium®, the Millennium M logo and
design (registered), Millennium Pharmaceuticals, VELCADE® (bortezomib) for
Injection, and INTEGRILIN® (eptifibatide) Injection. All are covered by
registrations or pending applications for registration in the U.S. Patent and
Trademark Office and many other countries. DOXIL® (doxorubicin HCl liposome
injection) is a trademark of Ortho Biotech Products, L.P, ReoPro® (abciximab)
is a trademark of Eli Lilly & Company, Aggrastat® (tirofiban) is a
trademark of Merck & Co., Inc., Thalomid® (thalidomide) and
Revlimid® (lenalidomide) are trademarks of Celgene Corporation and Angiomax®
(bivalirudin) is a trademark of The Medicines Company.
Other
trademarks used in this Quarterly Report on Form 10-Q are the property of
their respective owners.
2
PART I FINANCIAL
INFORMATION
Item 1.
Condensed Consolidated Financial Statements
Millennium
Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except per share amounts)
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March 31,
2008
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December 31,
2007
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(unaudited)
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Assets
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Current assets:
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Cash and cash
equivalents
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$
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143,973
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$
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89,163
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Marketable
securities
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787,315
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802,113
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Accounts
receivable, net of allowances of $514 in 2008 and $524 in 2007
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85,562
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126,349
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Inventory
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7,410
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6,821
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Prepaid expenses
and other current assets
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10,118
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9,624
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Total current
assets
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1,034,378
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1,034,070
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Property and
equipment, net
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144,715
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147,869
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Restricted cash
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7,584
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7,650
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Other assets
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29,646
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29,961
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Goodwill
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1,218,630
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1,217,501
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Developed
technology, net
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230,048
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238,413
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Intangible
assets, net
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60,914
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61,036
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Total assets
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$
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2,725,915
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$
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2,736,500
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Liabilities
and Stockholders Equity
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Current
liabilities:
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Accounts payable
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$
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16,562
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23,461
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Accrued expenses
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59,311
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75,370
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Current portion
of restructuring
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19,862
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22,986
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Current portion
of deferred revenue
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4,357
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9,412
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Current portion
of capital lease obligations
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1,262
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1,246
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Total current
liabilities
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101,354
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132,475
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Other long-term
liabilities
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2,333
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2,016
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Restructuring,
net of current portion
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21,359
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26,416
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Deferred
revenue, net of current portion
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14,574
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14,905
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Capital lease
obligations, net of current portion
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73,474
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73,795
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Long-term debt
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250,000
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250,000
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Commitments and
contingencies
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Stockholders
Equity:
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Preferred stock,
$0.001 par value; 5,000 shares authorized, none issued
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Common stock,
$0.001 par value; 500,000 shares authorized: 326,660 shares at March 31,
2008 and 324,605 shares at December 31, 2007 issued and outstanding
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327
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325
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Additional
paid-in capital
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4,738,195
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4,728,762
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Accumulated
other comprehensive income
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5,755
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3,888
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Accumulated
deficit
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(2,481,456
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)
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(2,496,082
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)
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Total
stockholders equity
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2,262,821
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2,236,893
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Total
liabilities and stockholders equity
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$
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2,725,915
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$
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2,736,500
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The accompanying
notes are an integral part of these condensed consolidated financial
statements.
3
Millennium
Pharmaceuticals, Inc.
Condensed Consolidated Statements of
Operations
(unaudited)
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Three Months Ended March 31,
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(in thousands, except per share amounts)
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2008
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2007
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Revenues:
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Net product
sales
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$
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83,470
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$
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58,640
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Revenue under
strategic alliances
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15,523
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15,714
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Royalties
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40,459
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36,370
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Total revenues
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139,452
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110,724
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Costs and
expenses:
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Cost of sales
(excludes amortization of acquired intangible assets)
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10,160
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5,358
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Research and
development (Note 1)
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71,406
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69,206
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Selling, general
and administrative (Note 1)
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49,795
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41,548
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Restructuring
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(2,870
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)
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5,611
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Amortization of
intangibles
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8,487
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8,487
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Total costs and
expenses
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136,978
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130,210
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Income (loss)
from operations
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2,474
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(19,486
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)
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Other income
(expense):
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Investment
income, net
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14,553
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15,495
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Interest expense
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(2,401
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)
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(2,787
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)
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Net income
(loss)
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$
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14,626
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$
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(6,778
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)
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Amounts
per common share:
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Earnings (loss)
per share, basic and diluted
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$
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0.05
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$
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(0.02
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)
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Weighted average
shares, basic
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321,608
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316,072
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Weighted average
shares, diluted
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326,694
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316,072
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Note 1: Stock-based
compensation expense is allocated in the condensed consolidated statements of
operations expense lines as follows:
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Three Months Ended March 31,
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(in thousands)
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2008
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2007
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Research and
development
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$
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1,361
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$
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2,055
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Selling, general
and administrative
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4,162
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3,347
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The accompanying
notes are an integral part of these condensed consolidated financial
statements.
4
Millennium
Pharmaceuticals, Inc
Condensed Consolidated Statements of
Cash Flows
(unaudited)
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Three Months Ended
March 31,
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(in thousands)
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2008
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2007
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Cash
Flows from Operating Activities:
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Net income
(loss)
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$
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14,626
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$
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(6,778
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)
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Adjustments to
reconcile net income (loss) to net cash provided by operating activities:
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Depreciation and
amortization
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12,634
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17,083
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Realized gain on
sale of restructured assets
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(211
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)
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Amortization of
deferred financing costs
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402
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448
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Realized gain on
securities, net
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(3,315
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)
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(5,092
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)
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401K stock match
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167
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1,650
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Stock-based
compensation expense
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5,523
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5,402
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Changes in
operating assets and liabilities:
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Accounts
receivable
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40,787
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24,203
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Inventory
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(589
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)
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1,508
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Prepaid expenses
and other current assets
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(494
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)
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576
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Restricted cash
and other assets
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66
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(3,509
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)
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Accounts payable
and accrued expenses
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(30,863
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)
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(20,534
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)
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Deferred revenue
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(5,386
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)
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(838
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)
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Other long-term
liabilities
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317
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34
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|
Net cash
provided by operating activities
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33,664
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14,153
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Cash
Flows from Investing Activities:
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Investments in
marketable securities
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(177,153
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)
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(190,474
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)
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Proceeds from
sales and maturities of marketable securities
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195,811
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117,991
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Purchases of
property and equipment
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(1,354
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)
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(1,100
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)
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Other investing
activities
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400
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1,269
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Net cash
provided by (used in) investing activities
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17,704
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(72,314
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)
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Cash
Flows from Financing Activities:
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|
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Net proceeds
from employee stock purchases
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3,747
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8,351
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|
Repayment of
principal of long-term debt obligations
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|
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(99,571
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)
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Principal
payments on capital leases
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(305
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)
|
(291
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)
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Net cash
provided by (used in) financing activities
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3,442
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(91,511
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)
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Increase
(decrease) in cash and cash equivalents
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54,810
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(149,672
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)
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Effects of
exchange rate changes on cash and cash equivalents
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1
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|
Cash and cash
equivalents, beginning of period
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89,163
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|
212,273
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Cash and cash
equivalents, end of period
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$
|
143,973
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$
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62,602
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|
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Supplemental
Cash Flow Information:
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|
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Cash paid for
interest
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$
|
610
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$
|
3,323
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|
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
Companys 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 Companys 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 Companys
investment in SGX Pharmaceuticals, Inc. and a realized gain of
approximately $2.3 million related to the Companys 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 Companys product sales are currently related to sales of
VELCADE
®
(bortezomib) for Injection. The remainder of the Companys
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 Companys 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 Companys 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 Companys third-party
investment custodian provides a report which classifies the Companys 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 Companys marketable
securities were valued at March 31, 2008 by its third-party investment
custodian using information provided by pricing services. Because the Companys
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 Companys 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 Companys statements of
operations. Stock-based compensation expense primarily relates to stock
options, restricted stock and stock issued under the Companys 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
Vendors 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 Companys
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 Companys 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 Companys 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 Companys
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 Companys 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 Companys 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 Companys 2.25%
convertible senior notes due November 15, 2011 (the 2.25% notes) are
convertible into the Companys 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 Companys statements of operations. Stock-based
compensation expense primarily relates to stock options, restricted stock and
stock issued under the Companys 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 Companys 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 Companys 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 Companys common stock had been tendered, representing approximately
91.9% of the Companys outstanding shares of common stock (of which 26,917,513
shares, or approximately 8.2% of the Companys outstanding shares, were
tendered under guaranteed delivery procedures).
Merger Sub has accepted for payment all shares of the Companys 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 Companys common stock in the tender offer,
Merger Sub has the right to designate a number of individuals to the Companys
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 Companys 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 Companys 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 Companys 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 Companys 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
Companys 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 Parents, Merger Subs or TPCs 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 plaintiffs motion for a preliminary injunction
enjoining the acceptance of tendered shares by Takeda. Following the
hearing, the court denied the plaintiffs motion.
15
Item
2. Managements Discussion and
Analysis of Financial Condition and Results of Operations
Our managements 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 Crohns 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
EMEAs 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-Hodgkins
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 SGPs
territory outside of the United States. SGPs 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 managements 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 products 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 months 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 quarters 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 Vendors 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 Parents, Merger Subs or TPCs
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
Nedd8activating 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
Crohns disease
|
|
phase II(2)
|
MLN3126 is a small molecule CCR9 inhibitor
|
|
Crohns 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
|
|
12 years
|
phase II
|
|
Evaluate
efficacy, optimal dosages and expanded evidence of safety
|
|
23 years
|
phase III
|
|
Confirm efficacy
and safety of the product
|
|
23 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.
27
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 SECs 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.
28
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 plaintiffs motion for a preliminary injunction enjoining the
acceptance of tendered shares by Takeda. Following the hearing, the court
denied the plaintiffs 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.
29
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 managements 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 managements 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
plaintiffs 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.
30
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 FDAs Application Integrity Policy. Employment of such a
debarred person (even if inadvertently) may result in delays in the FDAs
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
8activating 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
31
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 Corporations 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.
32
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;
33
·
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:
34
·
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
managements 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.
35
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
36
·
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.
37
·
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 SGPs 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.
38
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 Ariads 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 Ariads 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, Ariads 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.
39
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 products 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.
40
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 FDAs 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
41
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
42
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.
43
Item
6. Exhibits
(a)
|
|
Exhibits
|
|
|
|
|
|
The exhibits listed in
the Exhibit Index are included in this report.
|
44
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)
|
45
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
|
46
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