Filed by Bowne Pure Compliance
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
(Mark one)
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þ |
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QUARTERLY REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
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 |
For the transition period from to
Commission File Number 0-16132
CELGENE CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware
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22-2711928 |
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(State or other jurisdiction of incorporation
or organization)
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(I.R.S. Employer Identification
Number) |
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86 Morris Avenue, Summit, NJ
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07901 |
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(Address of principal executive offices)
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(Zip Code) |
(908) 673-9000
(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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or
a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule
12b-2 of the Exchange Act. (check one):
Large accelerated þ Accelerated o Non-accelerated o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
At May 3, 2007, 379,896,053 shares of Common Stock par value $.01 per share, were outstanding.
CELGENE CORPORATION
FORM 10-Q TABLE OF CONTENTS
2
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(Dollars in thousands, except per share amounts)
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Three-Month Period Ended |
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March 31, |
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2007 |
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2006 |
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Revenue: |
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Net product sales |
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$ |
269,796 |
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$ |
160,243 |
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Collaborative agreements and other revenue |
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4,804 |
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3,893 |
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Royalty revenue |
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18,815 |
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17,705 |
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Total revenue |
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293,415 |
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181,841 |
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Expenses: |
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Cost of goods sold |
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22,055 |
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30,144 |
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Research and development |
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79,575 |
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54,524 |
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Selling, general and administrative |
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107,421 |
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66,897 |
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Total expenses |
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209,051 |
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151,565 |
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Operating income |
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84,364 |
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30,276 |
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Other income and expense: |
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Interest and investment income, net |
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24,774 |
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4,651 |
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Equity in losses of affiliated companies |
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1,283 |
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3,091 |
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Interest expense |
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2,688 |
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2,365 |
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Other income, net |
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931 |
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1,595 |
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Income before income taxes |
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106,098 |
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31,066 |
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Income tax provision |
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48,689 |
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15,042 |
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Net income |
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$ |
57,409 |
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$ |
16,024 |
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Net income per common share: |
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Basic |
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$ |
0.15 |
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$ |
0.05 |
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Diluted |
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$ |
0.14 |
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$ |
0.04 |
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Weighted average shares: |
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Basic |
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377,599 |
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343,966 |
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Diluted |
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429,306 |
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400,699 |
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See accompanying Notes to Consolidated Financial Statements
3
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Dollars in thousands, except per share amounts)
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March 31, 2007 |
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December 31, 2006 |
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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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$ |
1,018,623 |
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$ |
1,439,415 |
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Marketable securities available for sale |
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1,096,495 |
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542,805 |
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Accounts receivable, net of allowances of $10,023 and $6,625 at March 31, 2007
and December 31, 2006, respectively |
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129,650 |
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127,777 |
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Inventory |
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30,216 |
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25,371 |
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Deferred income taxes |
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87,022 |
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87,979 |
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Other current assets |
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80,569 |
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87,657 |
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Total current assets |
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2,442,575 |
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2,311,004 |
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Property, plant and equipment, net |
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154,172 |
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146,645 |
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Investment in affiliated companies |
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15,096 |
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16,379 |
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Intangible assets, net |
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98,819 |
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100,509 |
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Goodwill |
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38,707 |
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38,494 |
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Other assets |
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136,250 |
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122,760 |
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Total assets |
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$ |
2,885,619 |
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$ |
2,735,791 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
25,126 |
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$ |
24,410 |
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Accrued expenses |
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88,832 |
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112,992 |
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Income taxes payable |
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862 |
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84,859 |
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Current portion of deferred revenue |
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7,722 |
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7,647 |
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Other current liabilities |
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11,466 |
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9,795 |
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Total current liabilities |
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134,008 |
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239,703 |
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Long-term convertible notes |
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399,883 |
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399,889 |
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Deferred revenue, net of current portion |
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62,451 |
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63,027 |
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Other non-current liabilities |
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170,212 |
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56,995 |
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Total liabilities |
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766,554 |
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759,614 |
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Commitments and Contingencies |
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Stockholders equity: |
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Preferred stock, $.01 par value per share, 5,000,000 shares
authorized; none outstanding at March 31, 2007 and December 31, 2006, respectively |
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Common stock, $.01 par value per share, 575,000,000 shares authorized; issued
383,403,209 and 380,092,309 shares at March 31, 2007 and December 31, 2006, respectively |
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3,834 |
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3,801 |
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Common stock in treasury, at cost; 3,938,012 and 4,057,553 shares at March 31, 2007 and
December 31, 2006, respectively |
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(144,025 |
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(148,097 |
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Additional paid-in capital |
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2,288,335 |
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2,209,889 |
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Accumulated deficit |
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(44,363 |
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(101,773 |
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Accumulated other comprehensive income |
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15,284 |
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12,357 |
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Total stockholders equity |
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2,119,065 |
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1,976,177 |
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Total liabilities and stockholders equity |
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$ |
2,885,619 |
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$ |
2,735,791 |
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See accompanying Notes to Consolidated Financial Statements
4
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Dollars in thousands)
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Three-Month Period Ended |
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March 31, |
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2007 |
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2006 |
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Cash flows from operating activities: |
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Net income |
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$ |
57,409 |
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$ |
16,024 |
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Adjustments to reconcile income from continuing operations
to net cash provided by operating activities: |
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Depreciation and amortization of long-term assets |
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6,913 |
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5,592 |
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Provision for accounts receivable allowances |
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3,445 |
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309 |
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Realized loss on marketable securities available for sale |
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64 |
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3,346 |
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Unrealized loss (gain) on value of EntreMed warrants |
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62 |
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(107 |
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Equity in losses of affiliated companies |
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1,283 |
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3,091 |
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Non-cash stock-based compensation expense |
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9,573 |
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14,889 |
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Amortization of discount on marketable securities available for sale, net |
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(1,381 |
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(337 |
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Amortization of debt issuance cost |
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611 |
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611 |
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Deferred income taxes |
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(9,571 |
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(8,501 |
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Shares issued for employee benefit plans |
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1,287 |
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1,366 |
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Other |
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(67 |
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584 |
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Change in current assets and liabilities: |
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Increase in accounts receivable |
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(5,058 |
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(12,828 |
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(Increase) decrease in inventory |
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(4,790 |
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3,770 |
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Decrease (Increase) in other operating assets |
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8,616 |
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(2,956 |
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Decrease in accounts payable and accrued expenses |
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(15,134 |
) |
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(9,416 |
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Increase in income tax payable |
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37,330 |
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1,647 |
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Decrease in deferred revenue |
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(795 |
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(1,381 |
) |
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Net cash provided by operating activities |
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89,797 |
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15,703 |
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Cash flows from investing activities: |
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Capital expenditures |
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(10,754 |
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(9,447 |
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Proceeds from sales and maturities of marketable securities available for sale |
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706,204 |
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235,067 |
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Purchases of marketable securities available for sale |
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(1,256,255 |
) |
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(214,821 |
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Investment in affiliated companies |
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(2,000 |
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Purchase of long-term investments |
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(1,406 |
) |
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Net cash (used in) provided by investing activities |
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(562,211 |
) |
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8,799 |
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Cash flows from financing activities: |
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Net proceeds from exercise of common stock options and warrants |
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31,302 |
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23,101 |
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Excess tax benefit from share-based compensation arrangements |
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19,525 |
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21,586 |
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Net cash provided by financing activities |
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50,827 |
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44,687 |
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Effect of currency rate changes on cash and cash equivalents |
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795 |
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1,963 |
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Net (decrease) increase in cash and cash equivalents |
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(420,792 |
) |
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71,152 |
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Cash and cash equivalents at beginning of period |
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1,439,415 |
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123,316 |
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Cash and cash equivalents at end of period |
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$ |
1,018,623 |
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$ |
194,468 |
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See accompanying Notes to Consolidated Financial Statements
5
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(Unaudited)
(Dollars in thousands)
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Three-Month Period Ended |
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March 31, |
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2007 |
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2006 |
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Supplemental schedule of non-cash investing and financing activity: |
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Change in net unrealized loss (gain) on marketable
securities available for sale |
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$ |
2,259 |
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$ |
(2,911 |
) |
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Matured shares tendered in connection with stock option exercises |
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$ |
(963 |
) |
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$ |
(376 |
) |
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Conversion of convertible notes |
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$ |
6 |
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$ |
9 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
1,750 |
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$ |
1,750 |
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Income taxes paid |
|
$ |
|
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|
$ |
296 |
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|
|
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|
See accompanying Notes to Consolidated Financial Statements
6
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
1. Nature of Business and Summary of Significant Accounting Policies
Nature of Business and Basis of Presentation: Celgene Corporation and its subsidiaries
(collectively Celgene or the Company) is a global biopharmaceutical company primarily engaged
in the discovery, development and commercialization of innovative therapies designed to treat
cancer and immune-inflammatory diseases through regulation of cellular, genomic and proteomic
targets. The Companys commercial stage programs include pharmaceutical sales of
REVLIMID®, THALOMID®, ALKERAN® and sales of FOCALINTM
to Novartis Pharma AG, or Novartis; a licensing agreement with Novartis which entitles us to
royalties on FOCALIN XRTM and the entire RITALIN® family of drugs; a
licensing and product supply agreement with Pharmion Corporation for its sales of thalidomide; and
sales of tissue and cellular products and services through its Cellular Therapeutics subsidiary.
The accompanying unaudited consolidated financial statements have been prepared from the books and
records of the Company pursuant to the rules and regulations of the Securities and Exchange
Commission for reporting on Form 10-Q. Pursuant to such rules and regulations, certain information
and footnote disclosures normally included in financial statements prepared in accordance with
accounting principles generally accepted in the United States of America have been condensed or
omitted. The consolidated financial statements include the accounts of Celgene Corporation and its
subsidiaries. All inter-company transactions and balances have been eliminated. Investments in
limited partnerships and interests in which the Company has an equity interest of 50% or less and
does not otherwise have a controlling financial interest are accounted for by either the equity or
cost method. Certain reclassifications have been made to the prior periods consolidated financial
statements in order to conform to the current periods presentation. The interim consolidated
financial statements should be read in conjunction with the consolidated financial statements and
notes thereto included in the Companys Annual Report on Form 10-K for the year ended December 31,
2006.
Interim results may not be indicative of the results that may be expected for the full year. In the
opinion of management, these financial statements include all normal and recurring adjustments
considered necessary for a fair presentation of these interim statements.
Recent Accounting Principles: In June 2006, the Financial Accounting Standards Board, or FASB,
issued FASB Interpretation No. 48, or FIN, 48, Accounting for Uncertainty in Income Taxesan
interpretation of FASB Statement No. 109. FIN 48 clarifies the accounting for uncertainty in
income taxes recognized in an enterprises financial statements in accordance with Statement of
Financial Accounting Standards, or SFAS, No. 109, Accounting for Income Taxes, or SFAS 109, and
prescribes a recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN
48 also provides guidance on derecognition, classification, interest and penalties, accounting in
interim periods, disclosure, and transition. The Company adopted the provisions of FIN 48
effective January 1, 2007 and had no cumulative effect adjustment related to the adoption.
However, certain amounts have been reclassified in the consolidated balance sheet and new
disclosures have been provided to comply with the requirements of the statement. See Note 10,
Income taxes, for additional information.
On May 2, 2007, the FASB issued FASB Staff Position, or FSP, FIN 48-1, Definition of Settlement in
FASB Interpretation No. 48, or FSP FIN 48-1. FSP FIN 48-1 provides guidance on how an enterprise
should determine whether a tax position is effectively settled for the purpose of recognizing
previously unrecognized tax benefits. The Company retroactively adopted the provisions of FSP FIN
48-1 effective January 1, 2007 and has determined that it had no impact on its consolidated
financial statements.
7
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
In February 2007, the FASB issued SFAS, No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities, or SFAS 159, which provides companies with an option to report selected
financial assets and liabilities at fair value. SFAS 159s objective is to reduce both complexity
in accounting for financial instruments and the volatility in earnings caused by measuring related
assets and liabilities differently. Generally accepted accounting principles have required
different measurement attributes for different assets and liabilities that can create artificial
volatility in earnings. SFAS 159 helps to mitigate this type of accounting-induced volatility by
enabling companies to report related assets and liabilities at fair value, which would likely
reduce the need for companies to comply with detailed rules for hedge accounting. SFAS 159 also
establishes presentation and disclosure requirements designed to facilitate comparisons between
companies that choose different measurement attributes for similar types of assets and liabilities.
SFAS 159 requires companies to provide additional information that will help investors and other
users of financial statements to more easily understand the effect of a companys choice to use
fair value on its earnings. It also requires a company to display the fair value of those assets
and liabilities for which it has chosen to use fair value on the face of the balance sheet. SFAS
159 is effective for the Company beginning January 1, 2008. The Company is currently evaluating
the impact of the adoption of SFAS 159, if any, on its consolidated financial statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, or SFAS 157, which
establishes a framework for measuring fair value, and expands disclosures about fair value
measurements. Where applicable, SFAS 157 simplifies and codifies related guidance within generally
accepted accounting principles. SFAS 157 is effective for the Company beginning January 1, 2008.
The Company is currently evaluating the impact of the adoption of SFAS 157, if any, on its
consolidated financial statements.
In December 2006, the FASB issued FSP EITF Issue No. 00-19-2, Accounting for Registration Payment
Arrangements, or FSP 00-19-2, which addresses an issuers accounting for registration payment
arrangements. FSP 00-19-2 specifies that the contingent obligation to make future payments or
otherwise transfer consideration under a registration payment arrangement, whether issued as a
separate agreement or included as a provision of a financial instrument or other agreement, should
be separately recognized and measured in accordance with SFAS No. 5, Accounting for
Contingencies. FSP 00-19-2 was issued in December 2006 and is effective immediately for
registration payment arrangements and the financial instruments subject to those arrangements that
were entered into or modified subsequent to the issuance of FSP 00-19-2. For registration payments
arrangements and financial instruments subject to those arrangements that were entered into prior
to the issuance of FSP 00-19-2, it is effective for financial statements issued for fiscal years
beginning after December 15, 2006. The Company has adopted the provisions of FSP 00-19-2 effective
January 1, 2007 and has determined that the adoption had no impact on its consolidated financial
statements. See Note 7, Long-Term Debt, for additional information.
In February 2006, the FASB issued SFAS No. 155, Accounting for Certain Hybrid Financial
Instruments an amendment of FASB Statements No. 133 and 140, or SFAS 155, which permits a fair
value re-measurement for any hybrid financial instrument that contains an embedded derivative that
would otherwise require bifurcation. The Company has adopted the provisions of SFAS 155 effective
January 1, 2007 and has determined that it had no impact on its consolidated financial statements.
2. Earnings Per Share (EPS)
Basic earnings per share is computed by dividing net income by the weighted-average number of
common shares outstanding during the period. Diluted earnings per share is computed by dividing net
income adjusted to add back the after-tax amount of interest recognized in the period associated
with any convertible debt issuance that may be dilutive by the weighted-average number of common
shares outstanding during the period increased to include all additional common shares that would
have been outstanding assuming potentially dilutive common shares had been issued and any proceeds
thereof used to repurchase common stock at the average market price during the period. The proceeds used to repurchase common
stock are assumed to be the sum of the amount to be paid to the Company upon exercise of options,
the amount of compensation cost attributed to future services and not yet recognized and, if
applicable, the amount of excess income tax benefit that would be credited to paid-in capital upon
exercise.
8
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Net income |
|
$ |
57,409 |
|
|
$ |
16,024 |
|
Interest expense on convertible debt, net of tax |
|
|
1,393 |
|
|
|
1,393 |
|
|
|
|
|
|
|
|
Net income for diluted computation |
|
$ |
58,802 |
|
|
$ |
17,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
377,599 |
|
|
|
343,966 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
Options, warrants and other incentives |
|
|
18,693 |
|
|
|
23,711 |
|
Convertible debt |
|
|
33,014 |
|
|
|
33,022 |
|
|
|
|
|
|
|
|
Diluted |
|
|
429,306 |
|
|
|
400,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income Per Share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.15 |
|
|
$ |
0.05 |
|
Diluted |
|
$ |
0.14 |
|
|
$ |
0.04 |
|
|
|
|
|
|
|
|
The total number of potential common shares excluded from the diluted earnings per share
computation because their inclusion would have been anti-dilutive was 2,681,971 and 832,473 shares
as of March 31, 2007 and 2006, respectively.
9
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
3. Comprehensive Income
The components of comprehensive income, which represents the change in equity from non-owner
sources, consists of net income (losses), changes in currency translation adjustments and the after
tax effects of changes in net unrealized gains (losses) on marketable securities classified as
available for sale
A summary of comprehensive income for the three-month periods ended March 31, 2007 and 2006
follows:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Net income |
|
$ |
57,409 |
|
|
$ |
16,024 |
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Unrealized gains (losses) on marketable
securities available for sale, net of tax |
|
|
1,306 |
|
|
|
(4,569 |
) |
Less: reclassification adjustment for
losses included in net income |
|
|
64 |
|
|
|
3,345 |
|
|
|
|
|
|
|
|
Total unrealized gains (losses) on marketable
securities available for sale, net of tax |
|
|
1,370 |
|
|
|
(1,224 |
) |
Currency translation adjustments |
|
|
1,557 |
|
|
|
(478 |
) |
|
|
|
|
|
|
|
Total other comprehensive income (loss) |
|
|
2,927 |
|
|
|
(1,702 |
) |
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
60,336 |
|
|
$ |
14,322 |
|
|
|
|
|
|
|
|
4. Cash, Cash Equivalents and Marketable Securities Available-for-Sale
Money market funds of $992.4 million and $1,400.9 million at March 31, 2007 and December 31, 2006,
respectively, are recorded at cost, which approximates fair value and are included in cash and cash
equivalents.
The amortized cost, gross unrealized holding gains, gross unrealized holding losses and estimated
fair value of available-for-sale securities by major security type and class of security at March
31, 2007 and December 31, 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
March 31, 2007 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations |
|
$ |
159,955 |
|
|
$ |
513 |
|
|
$ |
(345 |
) |
|
$ |
160,123 |
|
U.S. treasury securities |
|
|
103,966 |
|
|
|
9 |
|
|
|
(276 |
) |
|
|
103,699 |
|
Government-sponsored agency securities |
|
|
755,988 |
|
|
|
360 |
|
|
|
(3,096 |
) |
|
|
753,252 |
|
Corporate debt securities |
|
|
13,464 |
|
|
|
21 |
|
|
|
(544 |
) |
|
|
12,941 |
|
Other asset-backed securities |
|
|
13,940 |
|
|
|
1,705 |
|
|
|
(157 |
) |
|
|
15,488 |
|
Marketable equity securities |
|
|
20,212 |
|
|
|
30,780 |
|
|
|
|
|
|
|
50,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,067,525 |
|
|
$ |
33,388 |
|
|
$ |
(4,418 |
) |
|
$ |
1,096,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
December 31, 2006 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations |
|
$ |
62,137 |
|
|
$ |
281 |
|
|
$ |
(426 |
) |
|
$ |
61,992 |
|
U.S. treasury securities |
|
|
53,260 |
|
|
|
|
|
|
|
(497 |
) |
|
|
52,763 |
|
Government-sponsored agency securities |
|
|
349,756 |
|
|
|
70 |
|
|
|
(3,771 |
) |
|
|
346,055 |
|
Corporate debt securities |
|
|
13,477 |
|
|
|
17 |
|
|
|
(470 |
) |
|
|
13,024 |
|
Other asset-backed securities |
|
|
17,315 |
|
|
|
1,731 |
|
|
|
|
|
|
|
19,046 |
|
Marketable equity securities |
|
|
20,212 |
|
|
|
29,713 |
|
|
|
|
|
|
|
49,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
516,157 |
|
|
$ |
31,812 |
|
|
$ |
(5,164 |
) |
|
$ |
542,805 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Government-sponsored agency securities include fixed rate asset-backed securities issued by
the Federal National Mortgage Association and the Federal Home Loan Bank. Other asset-backed
securities are securities backed by collateral other than mortgage obligations. Unrealized losses
for mortgage-backed obligations, U.S. treasury securities and government-sponsored agency
securities were primarily due to increases in interest rates. Unrealized losses for corporate debt
and other asset-backed securities were due to increases in interest rates as well as widening
credit spreads. The Company has sufficient liquidity and the intent to hold these securities until
the market value recovers. Moreover, the Company does not believe it is probable that it will be
unable to collect all amounts due according to the contractual terms of the individual
investments.
Duration of debt securities classified as available-for-sale at March 31, 2007 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
|
|
|
|
|
|
|
Duration of one year or less |
|
$ |
266,364 |
|
|
$ |
266,368 |
|
Duration of one through three years |
|
|
587,173 |
|
|
|
586,353 |
|
Duration of three through five years |
|
|
181,103 |
|
|
|
180,081 |
|
Duration of five through seven years |
|
|
12,673 |
|
|
|
12,701 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,047,313 |
|
|
$ |
1,045,503 |
|
|
|
|
|
|
|
|
5. Inventory
A summary of inventories by major category at March 31, 2007 and December 31, 2006 follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
10,575 |
|
|
$ |
10,133 |
|
Work in process |
|
|
7,497 |
|
|
|
4,715 |
|
Finished goods |
|
|
12,144 |
|
|
|
10,523 |
|
|
|
|
|
|
|
|
Total |
|
$ |
30,216 |
|
|
$ |
25,371 |
|
|
|
|
|
|
|
|
11
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
6. Investment in Affiliated Companies
A summary of the Companys equity investment in affiliated companies follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
Investment in Affiliated Companies |
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Investment in EntreMed, Inc. equity |
|
$ |
1,701 |
|
|
$ |
2,609 |
|
Excess of investment over share of EntreMed equity (1) |
|
|
12,615 |
|
|
|
12,690 |
|
|
|
|
|
|
|
|
Investment in EntreMed |
|
$ |
14,316 |
|
|
$ |
15,299 |
|
Investment in Burrill Life Sciences, LLP |
|
|
780 |
|
|
|
1,080 |
|
|
|
|
|
|
|
|
Investment in affiliated companies |
|
$ |
15,096 |
|
|
$ |
16,379 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
March 31, |
|
Equity in Losses of Affiliated Companies |
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Celgenes share of EntreMed, Inc. losses (2) (3) |
|
$ |
908 |
|
|
$ |
3,007 |
|
Amortization of intangibles |
|
|
75 |
|
|
|
84 |
|
|
|
|
|
|
|
|
Equity in losses of EntreMed |
|
$ |
983 |
|
|
$ |
3,091 |
|
Celgene share of losses in Burrill Life Sciences |
|
|
300 |
|
|
|
|
|
|
|
|
|
|
|
|
Equity in losses of affiliated companies |
|
$ |
1,283 |
|
|
$ |
3,091 |
|
|
|
|
|
|
|
|
(1) |
|
Consists of intangible assets and goodwill of $226 and $12,389 at March 31,
2007 and $301 and $12,389 at December 31, 2006. |
(2) |
|
The Company records its interest and share of losses in EntreMed Inc.
based on its common stock ownership, which was 12.3% and 10.75% at March 31, 2007 and 2006,
respectively. |
(3) |
|
March 31, 2006 includes $2,430 related to the Companys share of
EntreMeds in-process research and development write-down related to its acquisition of
Miikana Therapeutics Inc. on January 10, 2006. |
The fair value of the Companys common stock investment in EntreMed Inc. at March 31, 2007 was
$15.5 million.
7. Long-Term Debt
Convertible Debt: In June 2003, the Company issued an aggregate principal amount of $400.0 million
of unsecured convertible notes due June 2008. The notes have a five-year term and a coupon rate of
1.75% payable semi-annually on June 1 and December 1. Each $1,000 principal amount of convertible
notes is convertible into 82.5592 shares of common stock as adjusted, or a conversion rate of
$12.1125 per share, which represented a 50% premium to the closing price on May 28, 2003 of the
Companys common stock of $8.075 per share, after adjusting prices for the two-for-one stock splits
affected on February 17, 2006 and October 22, 2004. The debt issuance costs related to these
convertible notes, which totaled approximately $12.2 million, are classified under other assets on
the consolidated balance sheet and are being amortized over five years, assuming no conversion.
Under the terms of the purchase agreement, the noteholders can convert the outstanding notes at any
time into 33,014,025 shares of common stock at the conversion price. In addition, the noteholders
have the right to require the Company to redeem the notes in cash at a price equal to 100% of the
principal amount to be redeemed, plus accrued interest, prior to maturity in the event of a change
of control and certain other transactions defined as a fundamental change in the indenture
governing the notes. Subsequent to the June 2003 issuance date, an immaterial amount of principal
has been converted into common stock.
At March 31, 2007 and December 31, 2006, the fair value of the Companys convertible notes
outstanding exceeded the carrying value by approximately $1.319 billion and $1.507 billion,
respectively.
12
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
Under the Registration Rights Agreement for the 1.75% Convertible Notes due June 2008, or the
Registration Rights Agreement, the Company could be subject to liquidated damages if the
effectiveness of the registration statement covering the convertible debt is not maintained at any
time prior to the earlier of: (i) two years after the conversion of the last convertible note into
common stock or (ii) June 2010. The Company believes the likelihood of occurrence of such event is
remote and, as such, we have not recorded a liability at March 31, 2007. In the unlikely event
that it becomes probable that we would have to pay liquidated damages under the Registration Rights
Agreement, we have estimated the maximum potential liquidated damages as of March 31, 2007 to be
approximately $2.0 million per year. Such damages (a) would accrue only with respect to the shares
of the Companys common stock (underlying the Notes) that were not already sold by the holder
(using the registration statement or pursuant to SEC Rule 144) and that were not eligible for sale
without a registration statement, (b) would accrue only over the period during which the
registration statement was not effective and (c) would be settled in cash in accordance with the
terms of the Registration Rights Agreement.
8. Goodwill and Intangible Assets
Intangible Assets: A summary of intangible assets by category follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
March 31, 2007 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Penn T supply agreements |
|
$ |
108,999 |
|
|
$ |
(14,587 |
) |
|
$ |
94,412 |
|
|
|
12.9 |
|
License |
|
|
4,410 |
|
|
|
(387 |
) |
|
|
4,023 |
|
|
|
13.8 |
|
Technology |
|
|
122 |
|
|
|
(15 |
) |
|
|
107 |
|
|
|
12.0 |
|
Acquired workforce |
|
|
297 |
|
|
|
(20 |
) |
|
|
277 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
113,828 |
|
|
$ |
(15,009 |
) |
|
$ |
98,819 |
|
|
|
12.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
December 31, 2006 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Penn T supply agreements |
|
$ |
108,462 |
|
|
$ |
(12,296 |
) |
|
$ |
96,166 |
|
|
|
12.9 |
|
License |
|
|
4,250 |
|
|
|
(307 |
) |
|
|
3,943 |
|
|
|
13.8 |
|
Technology |
|
|
122 |
|
|
|
(12 |
) |
|
|
110 |
|
|
|
12.0 |
|
Acquired workforce |
|
|
295 |
|
|
|
(5 |
) |
|
|
290 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
113,129 |
|
|
$ |
(12,620 |
) |
|
$ |
100,509 |
|
|
|
12.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The $0.7 million increase in gross carrying value of intangible assets from December 31, 2006
to March 31, 2007 was principally due to the impact of foreign currency translation.
Amortization of acquired intangible assets was approximately $2.3 million and $2.2 million for the
three-month periods ended March 31, 2007 and 2006, respectively. Assuming no changes in the gross
carrying amount of intangible assets, the amortization of intangible assets for the next five
fiscal years is estimated to be approximately $9.3 million per year.
13
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
Goodwill: At March 31, 2007, the Companys goodwill related to the acquisition of Penn T on
October 21, 2004. The change in the carrying value of goodwill is summarized as follows:
|
|
|
|
|
Balance, December 31, 2006 |
|
$ |
38,494 |
|
Foreign currency translation |
|
|
213 |
|
|
|
|
|
Balance, March 31, 2007 |
|
$ |
38,707 |
|
|
|
|
|
9. Share-Based Compensation
There have been no significant changes to the share based compensation plans during the three
months ended March 31, 2007, except for an amendment to the 1995 Non-Employee Directors Incentive
Plan, effective June 12, 2007. The Non-Employee Directors Incentive Plan was amended to increase
the number of options to purchase common stock granted to each new Non-Employee Director, from
20,000 to 25,000 and to increase the quarterly grants of options from 3,750 (15,000 annually) to
4,625 (18,500 annually).
The following table summarizes the components of share-based compensation expense in the
consolidated statements of operations for the three-month periods ended March 31, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Cost of good sold |
|
$ |
387 |
|
|
$ |
458 |
|
Research and development |
|
|
2,602 |
|
|
|
3,948 |
|
Selling, general and administrative |
|
|
6,584 |
|
|
|
10,378 |
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
9,573 |
|
|
$ |
14,784 |
|
|
|
|
|
|
|
|
As of March 31, 2007, there was $74.8 million of unrecognized compensation cost related to stock
options granted under our various stock based plans. These costs will be recognized over an
expected remaining weighted-average period of 1.6 years. The total fair value of shares vested
during the three-month periods ended March 31, 2007 and 2006 was $4.3 million and $21.5 million,
respectively.
The weighted-average grant-date fair value of the stock options granted during the three-month
periods ended March 31, 2007 and 2006 was $22.09 per share and $15.08 per share, respectively.
There have been no significant changes to the assumptions used to estimate the fair value of
options granted during the three-month period ended March 31, 2007.
14
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
Stock option transactions for the quarter ended March 31, 2007 under all plans are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
|
|
|
|
Price |
|
|
Contractual |
|
|
Value |
|
|
|
Options |
|
|
Per Option |
|
|
Term (years) |
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2006 |
|
|
37,111,688 |
|
|
$ |
18.18 |
|
|
|
6.0 |
|
|
$ |
959,600 |
|
Changes during the year: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,458,634 |
|
|
|
54.83 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(3,309,996 |
) |
|
|
9.91 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(236,098 |
) |
|
|
19.09 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(1,500 |
) |
|
|
4.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2007 |
|
|
35,022,728 |
|
|
$ |
20.49 |
|
|
|
6.0 |
|
|
$ |
1,125,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest at March 31, 2007 |
|
|
34,062,990 |
|
|
$ |
20.22 |
|
|
|
5.9 |
|
|
$ |
1,103,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at March 31, 2007 |
|
|
25,077,610 |
|
|
$ |
18.06 |
|
|
|
5.2 |
|
|
$ |
862,894 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total intrinsic value of stock options exercised during the three-month periods ended
March 31, 2007 and 2006 was $146.4 million and $121.2 million, respectively. The Company primarily
utilizes newly issued shares to satisfy the exercise of stock options.
10. Income Taxes
The Company periodically evaluates the likelihood of the realization of deferred tax assets, and
reduces the carrying amount of those deferred tax assets by a valuation allowance to the extent it
believes a portion will not be realized. The Company considers many factors when assessing the
likelihood of future realization of its deferred tax assets, including recent cumulative earnings
experience by taxing jurisdiction, expectations of future taxable income, the carryforward periods
available to it for tax reporting purposes, and other relevant factors. Significant judgment is
required in making this assessment.
The Company adopted the provisions of FIN 48 and FSP FIN 48-1 effective January 1, 2007. FIN 48
clarifies the accounting for uncertainty in income taxes recognized in an enterprises financial
statements in accordance with SFAS 109 and prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, disclosure, and transition.
The Company had no cumulative effect adjustment related to the adoption. However, certain amounts
have been reclassified in the consolidated balance sheet in order to comply with the requirements
of the statement.
The Company has provided a liability for unrecognized tax benefits related to various federal,
state, and foreign income tax matters as of March 31, 2007 of $107.6 million, which is recorded in
other non-current liabilities. The liability at January 1, 2007 was $85.2 million. Additions of
$22.4 million for unrecognized tax positions relating to current year activities were recorded in
the quarter ended March 31, 2007. If recognized, these amounts would impact the Companys
effective tax rate. Additionally, the Company has $3.7 million of unrecognized tax benefits related
to certain deferred tax assets. There are no unrecognized tax benefits as of March 31, 2007, for
which it is reasonably possible that there will be a significant change within the next twelve
months. The liability for unrecognized tax benefits is expected to increase in the next twelve
months relating to operations occurring in that period.
15
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
The Companys tax returns have been audited by the Internal Revenue Service through the year 2003.
The Company is also subject to audits by various state and foreign taxing authorities, which are
not material to the Companys tax positions as of March 31, 2007.
As of March 31, 2007, the Company has accrued $3.3 million of interest and penalties related to
uncertain tax positions. The Company accounts for interest and penalties related to uncertain tax
positions as part of its provision for federal and state income taxes.
The Company recorded a discrete deferred tax benefit of approximately $7.5 million during the
three months ended March 31, 2007, as a result of a research and experimentation tax credit study
covering prior years. In addition, the Company generated research and experimentation tax credits
of $19.1 million related to stock option compensation for which no deferred tax benefit was
recorded at March 31, 2007. Under SFAS 123R, excess tax benefits related to stock option
compensation are recognized in the period in which such benefits are realized through the reduction
of income taxes payable. These tax benefits will be recorded as an increase in additional paid-in
capital when realized.
At March 31, 2006, the Company recorded a tax benefit of approximately $6.1 million primarily
related to the resolution of certain tax positions taken on the Companys income tax returns in tax
years 2000-2002 with the completion of an audit for that period.
11. Agreements
In November 2001, the Company licensed to Pharmion Corporation exclusive rights relating to the
development and commercial use of its intellectual property covering thalidomide and S.T.E.P.S®. Under the terms of the
agreement, the Company receives a royalty of 8% of Pharmions net thalidomide sales in countries
where Pharmion has received regulatory approval and a S.T.E.P.S.® license fee of 8% in
all other licensed territories. In December 2004, following the Companys acquisition of Penn T
Limited, the Company entered into an amended thalidomide supply agreement with Pharmion whereby, in
exchange for a reduction in Pharmions purchase price of thalidomide to 15.5% of its net sales of
thalidomide, the Company received a one-time payment of 39.6 million British pounds sterling, or
U.S. dollar equivalency of $77.0 million. Under the December 2004 agreement, as amended, the
Company also received a one-time payment of $3.0 million in return for granting license rights to
Pharmion to develop and market thalidomide in additional territories and eliminating certain of its
license termination rights. Under a separate letter agreement simultaneously entered into by the
parties, Pharmion has also agreed to provide the Company with an aggregate $8.0 million over a
three-year period commencing on January 1, 2005 and ending on December 31, 2007 to support the two
companies existing thalidomide research and development efforts.
Pursuant to EITF 00-21, the Company has determined that the agreements constitute a single unit of
accounting and pursuant to SAB No. 104, the Company has recorded the payments received as deferred
revenue and is amortizing such payments on a straight-line basis over an estimated useful life of
13 years, which is the estimated term of the supply agreement. The remaining payments to be
received under the thalidomide research and development letter agreement is approximately $2.0
million at March 31, 2007 and will be recorded as deferred revenue as such payments are received
and amortized over the remaining useful life of the supply agreement.
16
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
In April 2000, the Company entered into a development and license agreement with Novartis in which
the Company granted to Novartis an exclusive worldwide license (excluding Canada) to further
develop and market FOCALINTM and FOCALIN XRTM, the extended
release drug formulation (d-methylphenidate, or d- MPH). We have retained the exclusive commercial
rights to FOCALINTM IR and FOCALIN XRTM for oncology-related disorders. The
Company also granted Novartis rights to all of its related
intellectual property and patents,
including new formulations of the currently marketed RITALIN®. Under the agreement, the
Company has received upfront and regulatory achievement milestone payments totaling $55.0 million
through March 31, 2007 and is entitled to additional payments upon attainment of certain other
milestone events. The Company also sells FOCALINTM to Novartis and receives royalties
on all of Novartis sales of FOCALIN XRTM and RITALIN® family of Attention
Deficit Hyper-activity Disorder related products. The research portion of the agreement terminated
in June 2003.
In March 2003, the Company entered into a supply and distribution agreement with GlaxoSmithKline,
or GSK, to distribute, promote and sell ALKERAN® (melphalan), a therapy approved by the
FDA for the palliative treatment of multiple myeloma and carcinoma of the ovary. Under the terms of
the agreement, the Company purchases ALKERAN® tablets and ALKERAN® for
infusion from GSK and distributes the products in the United States under the Celgene label. The
agreement requires the Company to purchase certain minimum quantities each year under a take-or-pay
arrangement. The agreement has been extended through March 31, 2009. On March 31, 2007, the
remaining minimum purchase requirements under the agreement totaled $61.5 million, consisting of
the following:
|
|
|
|
|
§ April 1, 2007 December 31, 2007 |
|
$ |
23,212 |
|
§ January 1, 2008 December 31, 2008 |
|
|
30,525 |
|
§ January 1, 2009 March 31, 2009 |
|
|
7,725 |
|
|
|
|
|
|
|
$ |
61,462 |
|
|
|
|
|
17
PART 1 FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Cautionary Statements for Forward-Looking Information
Certain statements contained or incorporated by reference in this Quarterly Report are
forward-looking statements concerning our business, results of operations, economic performance and
financial condition based on our current expectations. These forward-looking statements are not
guarantees of future performance and involve risks and uncertainties that could cause actual
results to differ materially from those implied by such forward-looking statements. Given these
risks and uncertainties, you are cautioned not to place undue reliance on any forward-looking
statements.
Introduction
Celgene Corporation and its subsidiaries (collectively we or our) is a global integrated
biopharmaceutical company primarily engaged in the discovery, development and commercialization of
innovative therapies designed to treat cancer and immune-inflammatory related diseases. Our lead
products are: REVLIMID® (lenalidomide), which was approved by the U.S. Food and Drug
Administration, or FDA, in December 2005 for treatment of patients with transfusion-dependent
anemia due to low- or intermediate-1-risk myelodysplastic syndromes, or MDS, associated with a
deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in
June 2006 for treatment in combination with dexamethasone for multiple myeloma patients who have
received at least one prior therapy; and, THALOMID® (thalidomide), which gained FDA
approval in May 2006 for treatment in combination with dexamethasone of newly diagnosed multiple
myeloma patients and which is also approved in erythema nodosum leprosum, an inflammatory
complication of leprosy. Over the past several years, our total revenues have increased led by
REVLIMID® and THALOMID® which has enabled us to make substantial investments
in research and development and thus, advance our broad portfolio of drug candidates in our product
pipeline, including our IMiDs® compounds, which are a class of compounds proprietary to
us with certain immunomodulatory and other biologically important properties. We believe that the
commercial potential of REVLIMID® and THALOMID®, the depth of our product
pipeline, near-term regulatory activities and clinical data reported both at major medical
conferences and in peer-reviewed publications provide the catalysts for our future growth.
Factors Affecting Future Results
Future operating results will depend on many factors, including demand for our products, regulatory
approvals of our products and product candidates, the timing and market acceptance of new products
launched by us or competing companies, the timing of research and development milestones,
challenges to our intellectual property and our ability to control costs. See also Risk Factors
contained in Part I, Item 1A of our 2006 Annual Report on Form 10-K. Some of the more salient
factors that we are focused on include: the ability of REVLIMID® to successfully
penetrate relevant markets, our ability to advance regulatory and clinical programs and competitive
risks.
The ability of REVLIMID® to successfully penetrate relevant markets: Our REVLIMID®
launch strategy has included among other things: registering physicians in the
RevAssist® program, which is a proprietary risk-management distribution program
tailored specifically to help ensure the safe use of REVLIMID®; partnering with
contracted pharmacies to ensure, to the maximum extent possible, safe and rapid distribution of
REVLIMID®. While these initiatives appear to have resulted in a highly visible and
successful product launch, we remain focused on ensuring REVLIMID®s continued market
penetration in both multiple myeloma and MDS. We do not have long-term data on the use of the
product and cannot predict whether REVLIMID® will gain widespread acceptance, which
18
will mostly depend on
the acceptance of regulators, physicians, patients, payors and opinion leaders. The success of
REVLIMIDÒ will also depend, in part, on prescription drug coverage by government
health agencies, commercial and employer health plans, and other third-party payors. As an oral
cancer agent, REVLIMIDÒ qualifies as a Medicare, Part D drug. Each Part D plan
will review REVLIMIDÒ for addition to their formulary. As with all new products
introduced into the market, there may be some lag time before being added to each plans formulary,
which may impact our commercial performance.
The ability to advance regulatory and clinical programs: Obtaining international regulatory
approvals beginning with Europe is a key component of our continued growth strategy. Two
REVLIMID® Marketing Authorization Applications, or MAAs, are being evaluated by the
European Medicines Agency, or EMEA. One seeks approval to market REVLIMID® for the
treatment of previously treated multiple myeloma patients and the other for the treatment of
transfusion dependent anemia in patients who have MDS with the 5q chromosomal deletion.
Swissmedic, the Swiss Agency for Therapeutic Products, also is evaluating two REVLIMID®
MAAs for the treatment of previously treated multiple myeloma patients and for the treatment of
transfusion dependent anemia in patients who have MDS with the 5q chromosomal deletion,
respectively. Additionally, the Therapeutic Goods Administration in Australia is evaluating an MAA
for the treatment of previously treated multiple myeloma patients.
In March 2007, the EMEAs Committee for Medicinal Products for Human Use recommended
REVLIMID® for approval in combination with dexamethasone as a treatment for patients
with multiple myeloma who have received at least one prior therapy. If REVLIMID® is
approved, the period of time it takes to obtain pricing and reimbursement approvals in each
European Union member state could delay our international growth. In April 2007, we announced that
the Eastern Cooperative Oncology Group, or ECOG, has reported that its Data Monitoring Committees,
or DMC, review of preliminary results from a large, randomized clinical trial for patients with
newly diagnosed multiple myeloma has found that the use of a low-dose of dexamethasone in
combination with lenalidomide suggests survival advantage for patients when compared to the higher,
standard-dose of dexamethasone that is used in combination with lenalidomide to treat the disease.
The regulatory utility of these findings are unclear at this time.
A major objective of our on-going clinical programs is to broaden our knowledge about the full
potential of REVLIMID®, our other proprietary IMiDs® compounds, and other
pipeline products and to continue to evaluate them in a broad range of hematological malignancies,
other cancers and other diseases. Our near-term focus is on evaluating REVLIMID® as a
treatment of chronic lymphocytic leukemia and aggressive non-Hodgkins lymphomas.
Competitive Risks: While competition could limit REVLIMID® and THALOMID®
sales, we do not believe that competing products would eliminate their use entirely. With respect
to our THALOMID® franchise, a generic competitor has filed an abbreviated new drug
application (ANDA) for approval to market generic thalidomide in the United States. The matter is
currently in litigation pertaining to our U.S. patents covering our S.T.E.P.S.®
, or System for Thalidomide
Education and Prescribing Safety, program for the safe distribution and
appropriate use of thalidomide. We also have exclusive rights to several issued patents covering
the use of THALOMID® in oncology and other therapeutic areas.
19
Results of Operations -
Three-Month Period Ended March 31, 2007 and 2006
Total Revenue: Total revenue and related percentages for the three-month periods ended March 31,
2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
% Change |
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
146,233 |
|
|
$ |
32,443 |
|
|
|
350.7 |
% |
THALOMID® |
|
|
106,034 |
|
|
|
107,211 |
|
|
|
(1.1 |
)% |
ALKERAN® |
|
|
15,964 |
|
|
|
18,295 |
|
|
|
(12.7 |
)% |
FOCALINTM |
|
|
1,491 |
|
|
|
2,101 |
|
|
|
(29.0 |
)% |
Other |
|
|
74 |
|
|
|
193 |
|
|
|
(61.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
$ |
269,796 |
|
|
$ |
160,243 |
|
|
|
68.4 |
% |
Collaborative agreements
and other revenue |
|
|
4,804 |
|
|
|
3,893 |
|
|
|
23.4 |
% |
Royalty revenue |
|
|
18,815 |
|
|
|
17,705 |
|
|
|
6.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
293,415 |
|
|
$ |
181,841 |
|
|
|
61.4 |
% |
|
|
|
|
|
|
|
|
|
|
Net Product Sales:
REVLIMID® net sales increased in the three-month period ended March 31, 2007 compared to
the prior year quarter primarily due to the FDAs approval in June 2006 for treatment in
combination with dexamethasone of patients with multiple myeloma who have received at least one
prior therapy. REVLIMID® achieved significant increases in market share across all
lines of therapy for multiple myeloma. Contributing to the increase in sales was the
impact of our European Named Patient Program, or NPP, which offers European patients in need access
to REVLIMID® on a compassionate use basis.
Net sales of THALOMID® were down slightly for the three-month period ended March 31,
2007 compared to the prior year quarter due to the impact of lower sales volumes, which were offset
by price increases, as we continue to move towards a cost of therapy pricing structure as opposed
to a price per milligram basis. Sales volumes decreased due to continued average daily dose
declines. Partially offsetting the decrease in THALOMID® sales were favorable gross to
net sales adjustments, as discussed below.
ALKERANâ
net sales were $2.3 million lower in the three-month period ended March
31, 2007 compared to the prior year quarter as unit sales of both tablet and injectable doses
declined. This decline was partially offset by higher pricing for the injectable form and lower
gross to net sales accruals for sales returns.
Sales of FOCALINTM, which is sold exclusively to Novartis and is dependent on the timing
of orders from Novartis for their commercial distribution, decreased by $0.6 million in the
three-month period ended March 31, 2007 compared to the prior year quarter partly due to patient
migration to FOCALIN XRTM, which is sold by Novartis and for which we receive a royalty.
Gross to Net Sales Accruals: We record gross to net sales accruals for sales returns, discounts,
Medicaid rebates and distributor charge-backs and service fees. Allowances for sales returns are
based on the actual returns history for consumed lots and the trend experience for lots where
product is still being returned.
20
Discounts accruals are based on payment terms extended to customers. Medicaid rebate accruals are
based on historical payment data and estimates of future Medicaid beneficiary utilization.
Distributor charge-back accruals are based on the differentials between product acquisition prices
paid by wholesalers and lower government contract pricing paid by eligible customers covered under
federally qualified programs. Distributor services accruals are based on contractual fees to be
paid to the wholesale distributor for services provided.
Gross to net sales accruals and the balance in the related allowance accounts for the three-month
periods ended March 31, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
|
|
returns and |
|
|
|
|
|
|
Medicaid |
|
|
chargebacks |
|
|
|
|
2007 |
|
allowances |
|
|
Discounts |
|
|
rebates |
|
|
and services |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
$ |
9,480 |
|
|
$ |
2,296 |
|
|
$ |
7,468 |
|
|
$ |
10,633 |
|
|
$ |
29,877 |
|
Allowances for sales during 2007 |
|
|
7,961 |
|
|
|
5,679 |
|
|
|
5,976 |
|
|
|
15,204 |
|
|
|
34,820 |
|
Allowances for sales during prior
periods |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Credits issued for prior year sales |
|
|
(7,127 |
) |
|
|
(2,104 |
) |
|
|
(5,708 |
) |
|
|
(8,525 |
) |
|
|
(23,464 |
) |
Credits issued for sales during 2007 |
|
|
(907 |
) |
|
|
(3,621 |
) |
|
|
|
|
|
|
(8,888 |
) |
|
|
(13,416 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2007 |
|
$ |
9,407 |
|
|
$ |
2,250 |
|
|
$ |
7,736 |
|
|
$ |
8,424 |
|
|
$ |
27,817 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
|
|
returns and |
|
|
|
|
|
|
Medicaid |
|
|
chargebacks |
|
|
|
|
2006 |
|
allowances |
|
|
Discounts |
|
|
rebates |
|
|
and services |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
$ |
5,017 |
|
|
$ |
1,447 |
|
|
$ |
20,960 |
|
|
$ |
6,778 |
|
|
$ |
34,202 |
|
Allowances for sales during 2006 |
|
|
9,088 |
|
|
|
4,160 |
|
|
|
11,712 |
|
|
|
13,881 |
|
|
|
38,841 |
|
Allowances for sales during prior
periods |
|
|
7,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,543 |
|
Credits issued for prior year sales |
|
|
(11,172 |
) |
|
|
(1,394 |
) |
|
|
(8,529 |
) |
|
|
(6,314 |
) |
|
|
(27,409 |
) |
Credits issued for sales during 2006 |
|
|
(2,138 |
) |
|
|
(2,426 |
) |
|
|
|
|
|
|
(7,002 |
) |
|
|
(11,566 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
$ |
8,338 |
|
|
$ |
1,787 |
|
|
$ |
24,143 |
|
|
$ |
7,343 |
|
|
$ |
41,611 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales returns and allowances decreased in the three-month period ended March 31, 2007 compared to
the three-month period ended March 31, 2006 primarily due to incremental THALOMIDâ reserves
in 2006. Discounts increased in the current year quarter primarily from increased sales of
REVLIMIDâ.
Medicaid rebate allowances decreased in the current year quarter due to the favorable impact of the
new Medicare, Part D legislation, which became effective January 1, 2006. As a result of the new
legislation many patients who had been eligible to receive THALOMIDâ through
Medicaid coverage are now covered under Medicare, Part D. The prior year quarters ending balance
included $11.8 million in accrued 2005 rebates, which were paid in the second quarter of 2006.
Distributor charge-backs increased in the current year quarter primarily due to
THALOMIDâ price increases, which increased the differential between annual
contract pricing available to federally funded healthcare providers and our wholesale acquisition
cost, in addition to increased REVLIMIDâ sales, which were partly offset by more
favorable contract pricing of ALKERANâ injectables beginning in 2007.
Other Revenues:
Revenues from collaborative agreements and other sources totaled $4.8 million and $3.9 million for
the three-month periods ended March 31, 2007 and 2006, respectively. The $0.9 million increase in
the current year quarter was primarily due to license fees generated from our
S.T.E.P.S. â program.
21
Royalty revenue totaled $18.8 million for the three-month period ended March 31, 2007 and included
amounts received from Novartis on sales of their entire family of Ritalin® drugs and
FOCALIN XRTM of $7.0 million and $11.3 million, respectively. Royalty revenue for the
three-month period ended March 31, 2006 totaled $17.7 million and included amounts related to
Ritalin® and FOCALIN XRTM of $10.4 million and $6.9 million, respectively.
Cost of Goods Sold: Cost of goods sold and related percentages for the three-month periods ended
March 31, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
March 31, |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
$ |
22,055 |
|
|
$ |
30,144 |
|
|
|
|
|
|
|
|
|
|
(Decrease) Increase from prior year |
|
$ |
(8,089 |
) |
|
$ |
17,540 |
|
|
|
|
|
|
|
|
|
|
Percentage (decrease) increase from prior year |
|
|
(26.8 |
%) |
|
|
139.2 |
% |
|
|
|
|
|
|
|
|
|
Percentage of net product sales |
|
|
8.2 |
% |
|
|
18.8 |
% |
Cost of goods sold and cost of goods sold as a percentage of net product sales for the three-month
period ended March 31, 2007 decreased compared to the three-month period ended March 31, 2006
primarily due to lower ALKERANâ costs resulting from lower sales volumes and lower
unit costs related to ALKERANâ for injection. Partially offsetting the decrease in
cost of goods sold were higher REVLIMID royalties payable resulting from an increase in the
products sales. The increase in REVLIMID sales benefited cost of goods sold as a percentage of
net product sales, since the product carries a lower cost relative to our other products.
Research and Development: Research and development expenses and related percentages for the
three-month periods ended March 31, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
March 31, |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
79,575 |
|
|
$ |
54,524 |
|
|
|
|
|
|
|
|
|
|
Increase from prior year |
|
$ |
25,051 |
|
|
$ |
14,487 |
|
|
|
|
|
|
|
|
|
|
Percentage increase from prior year |
|
|
45.9 |
% |
|
|
36.2 |
% |
|
|
|
|
|
|
|
|
|
Percentage of total revenue |
|
|
27.1 |
% |
|
|
30.0 |
% |
Research and development expenses increased by $25.1 million for the three-month period ended March
31, 2007 compared to the prior year quarter primarily due to higher clinical development expenses,
which among other things support multiple programs evaluating REVLIMIDâ and other
IMiDsâ across a broad range of cancers, including chronic lymphocytic leukemia and
non-Hodgkins lymphoma and higher expenses to support ongoing research of other compounds as well
as our kinase and ligase inhibitor programs and placental-derived stem cell program. We have
received approval of our Investigational New Drug, or IND, application to evaluate CC-4047
(pomalidomide) in a proof-of-principle study in sickle cell anemia.
22
For the three-month period ended March 31, 2007, research and development expenses consisted of
$32.7 million spent on human pharmaceutical clinical programs; $33.3 million spent on other
pharmaceutical programs, including toxicology, analytical research and development, drug discovery,
quality and regulatory affairs; $10.0 million spent on biopharmaceutical discovery and development
programs; and $3.5 million spent on placental stem cell and biomaterials programs. These
expenditures support ongoing clinical progress in multiple proprietary development programs for
REVLIMIDâ and THALOMIDâ in addition to supporting
other compounds and the placental stem cell program. For the three-month period ended March 31,
2006, expenses consisted of $19.7 million spent on human pharmaceutical clinical programs; $22.7
million spent on other pharmaceutical programs, including toxicology, analytical research and
development, drug discovery, quality and regulatory affairs; $9.5 million spent on
biopharmaceutical discovery and development programs; and $2.6 million spent on placental stem cell
and biomaterials programs.
Selling, General and Administrative: Selling, general and administrative expenses and related
percentages for the three-month periods ended March 31, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
March 31, |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
$ |
107,421 |
|
|
$ |
66,897 |
|
|
|
|
|
|
|
|
|
|
Increase from prior year |
|
$ |
40,524 |
|
|
$ |
29,091 |
|
|
|
|
|
|
|
|
|
|
Percentage increase from prior year |
|
|
60.6 |
% |
|
|
76.9 |
% |
|
|
|
|
|
|
|
|
|
Percentage of total revenue |
|
|
36.6 |
% |
|
|
36.8 |
% |
Selling, general and administrative expenses for the three-month period ended March 31, 2007
increased by $40.5 million compared to the prior year quarter primarily due to an increase in
donations to non-profit agencies that assist patients with the co-payments of
REVLIMIDâ;
higher marketing and sales costs related to product launch preparation activities
in Europe, and continued international expansion throughout Europe, Japan, Australia and Canada; higher allowances for doubtful accounts; plus an increase in
general administrative expenses primarily related to higher personnel, professional and other
outside service costs due to continued growth of the Company.
Interest and Investment Income, Net: Interest and investment income, net was $24.8 million for
the three-month period ended March 31, 2007, representing an increase of $20.1 million over the
$4.7 million recorded for the three-month period ended March 31, 2006. The increase was due to
higher average cash, cash equivalents and marketable securities balances resulting from the
November 2006 issuance of an additional 20,000,000 shares of our common stock, which generated net
proceeds of $1.006 billion. In addition, the three-month period ended March 31, 2006 included an
other-than-temporary impairment loss on marketable securities available for sale of $3.3 million.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $1.3 million and $3.1 million for the three-month periods ended March 31, 2007 and 2006,
respectively. The decrease was due to lower EntreMed equity losses of $2.1 million, partially
offset by $0.3 million in equity losses recorded in the current year period related to our
investment in Burrill Life Sciences Capital Fund III.
Interest Expense: Interest expense was $2.7 and $2.4 million for the three-month periods ended
March 31, 2007 and 2006, respectively. The $0.3 million increase related to the note payable to
Siegfried in connection with our December 2006 purchase of an active pharmaceutical ingredient, or
API, manufacturing facility in Zofingen, Switzerland.
23
Other Income, Net: Other income, net was $0.9 million and $1.6 million for the three-month periods
ended March 31, 2007 and 2006, respectively. The decrease was primarily due to a decrease in
foreign exchange gains.
Income Tax Provision: The income tax provision for the three-month period ended March 31, 2007 was
$48.7 million and reflects an effective tax rate of 53%, net of a discrete deferred tax benefit of
approximately $7.5 million primarily related to the recognition of research and experimentation tax
credits, resulting from a study covering prior years, conducted in the first quarter. The
effective tax rate also reflects the tax expense impacted by certain expenses incurred in taxing
jurisdictions outside the United States for which we do not presently receive a tax benefit and
nondeductible expenses which include share-based compensation expense related to incentive stock
options. The income tax provision for the three-month period ended March 31, 2006 was $15.0
million and reflects an effective tax rate of 68%, adjusted for tax benefits of approximately $6.1
million primarily related to the resolution of certain tax positions taken on our income tax
returns for the tax years 2000 through 2002. The decrease in the effective tax rate was primarily
due to higher earnings in the current year period.
Net Income: Net income and per common share amounts for the three-month periods ended March 31,
2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
March 31, |
|
(In thousands $, except per share amounts) |
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Net income |
|
$ |
57,409 |
|
|
$ |
16,024 |
|
|
|
|
|
|
|
|
|
|
Per common share amounts: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.15 |
|
|
$ |
0.05 |
|
Diluted (1) |
|
$ |
0.14 |
|
|
$ |
0.04 |
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
377,599 |
|
|
|
343,966 |
|
Diluted |
|
|
429,306 |
|
|
|
400,699 |
|
|
|
|
(1) |
|
In computing diluted earnings per share, the numerator has been adjusted to add
back the after-tax amount of interest expense recognized in the year on our convertible debt. See
Note 2 to our unaudited consolidated financial statements. |
Net income increased by $41.4 million primarily due to higher REVLIMIDâ sales
and higher investment income partly offset by increased operating expenses required to support the
Companys on-going expansion.
24
Liquidity and Capital Resources
Cash flows from operating, investing and financing activities for the three-month periods ended
March 31, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
March 31, |
|
|
Increase / |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
89,797 |
|
|
$ |
15,703 |
|
|
$ |
74,094 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
$ |
(562,211 |
) |
|
$ |
8,799 |
|
|
$ |
(571,010 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
$ |
50,827 |
|
|
$ |
44,687 |
|
|
$ |
6,140 |
|
Operating Activities: Net cash provided by operating activities increased in the three-month
period ended March 31, 2007, as compared to three-month period ended March 31, 2006, primarily due
to higher earnings, an income tax refund of $12.0 million in the current year period and an
increase in income taxes payable, partially offset by higher working capital levels. See working
capital discussion below.
Investing Activities: Net cash used in investing activities in the three-month period ended March
31, 2007 included $550.1 million for net purchases of available-for-sale marketable securities,
$10.8 million for capital expenditures and $1.4 million for the purchase of long-term investments.
Our ongoing construction of a drug product manufacturing facility at our Neuchatel, Switzerland
site and expansion and renovation of our headquarters in Summit, New Jersey were the primary areas
of capital spending during the three-month period ended March 31, 2007. For the full year 2007, we
expect capital spending to be in the range of $50 to $60 million. Net cash provided by investing
activities in the three-month period ended March 31, 2006 included $20.2 million from net sales of
marketable securities available for sale, partially offset by $9.4 million for capital expenditures
and $2.0 million for an additional investment in EntreMed, Inc.
Financing Activities: Net cash provided by financing activities in the three-month period ended
March 31, 2007 included $31.3 million from the exercise of employee stock options and $19.5 million
from excess tax benefits recognized upon exercise of such options, as compared to $23.1 million
from the exercise of employee stock options and $21.6 million from excess tax benefits recognized
upon exercise of such options in the three-month period ended March 31, 2006. Statement of
Financial Accounting Standards, or SFAS, No. 123R, Share-Based Payments requires excess tax
benefits (i.e., the tax benefit recognized upon exercise of stock options in excess of the benefit
recognized from recognizing compensation cost for those options) to be classified as financing cash
flows in the Consolidated Statement of Cash Flows.
25
Working Capital and Cash, Cash Equivalents and Marketable Securities: Working capital and cash,
cash equivalents and marketable securities at March 31, 2007 and 2006, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
Increase / |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
2,115,118 |
|
|
$ |
1,982,220 |
|
|
$ |
132,898 |
|
Other current assets and current liabilities, net (1) |
|
|
114,149 |
|
|
|
8,749 |
|
|
|
105,400 |
|
|
|
|
|
|
|
|
|
|
|
Working capital (2) |
|
$ |
2,229,267 |
|
|
$ |
1,990,969 |
|
|
$ |
238,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes accounts receivable, net of allowances, inventory, other current assets, accounts payable, accrued
expenses, income taxes payable and other current liabilities. |
|
(2) |
|
In accordance with FASB Interpretation No., or FIN, 48, we reclassed $85.2 million of current income taxes payable to
other non-current liabilities in the three-month period ended March 31, 2007. Excluding this reclass, our working
capital increased $153.1 million during the quarter. |
Accounts receivable, net: Accounts receivable, net as of March 31, 2007 increased $1.9
million from December 31, 2006 as a result of higher net sales. Our days of sales outstanding, or
DSO, as of March 31, 2007 remained relatively flat compared to December 31, 2006. Allowance for
doubtful accounts
increased $3.4 million primarily due to disputed credits associated with a certain large retail
pharmacy chain.
Inventory: Inventory as of March 31, 2007 increased $4.8 million from December 31, 2006 to support
our sales growth.
Other Current Assets: Other current assets as of March 31, 2007 decreased $7.1 million from
December 31, 2006 primarily due to a $12.0 million income tax refund, and a decrease in the amounts
due from Novartis on the FOCALINTM and Ritalin® family of drugs, partially
offset by an increase in marketable securities interest receivables.
Accounts Payable, Accrued Expenses and Other Current Liabilities: Accounts payable, accrued
expenses and other current liabilities as of March 31, 2007 decreased $21.8 million from December
31, 2006 primarily due to the payout of certain year-end accruals such as management incentives and
savings plan match.
Income Taxes Payable: Income taxes payable as of March 31, 2007 decreased $84.0 million from
December 31, 2006 primarily due to the reclassification of $85.2 million of certain income tax
liabilities to non-current liabilities in accordance with FIN 48.
Cash, Cash Equivalents and Marketable Securities: We invest our excess cash primarily in money
market funds and in highly liquid debt instruments of U.S. municipalities, corporations,
government-sponsored agencies and the U.S. Treasury. All investments with maturities of three
months or less from the date of purchase are classified as cash equivalents and all highly liquid
investments with maturities of greater than three months from the date of purchase are classified
as marketable securities. We determine the appropriate classification of our investments in
marketable debt and equity securities at the time of purchase. The increase in cash, cash
equivalents and marketable securities from December 31, 2006 to March 31, 2007 was primarily due to
$79.0 million of free cash flows (operating cash flows less capital expenditures) plus $50.8
million of net cash provided by financing activities.
We expect to make substantial additional expenditures to further develop and commercialize our
products. We expect increased research and product development costs, clinical trial costs,
expenses associated with the regulatory approval process, international expansion costs and
commercialization of product costs and capital investments. However, existing cash, cash
equivalents and marketable securities available for sale, combined with cash received from expected
net product sales and revenues from various research, collaboration and royalty agreements, are
expected to provide sufficient capital resources to fund our operations for the foreseeable future.
26
Convertible
Debt: Our convertible debt is convertible at any time into
33,014,025 shares of common stock at a conversion price of $12.1125
per share. The dilution effect of our convertible debt is included in
our diluted earning per share calculation. Based on the current price
of our common stock, we would expect noteholders to convert the notes
into shares of common stock and do not expect such conversion to have
a material impact on our financial condition, liquidity or capital
resources.
Contractual Obligations
The following table sets forth our contractual obligations as of March 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due By Period |
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
|
|
|
(In millions $) |
|
1 Year |
|
|
1-3 Years |
|
|
3-5 Years |
|
|
5 Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible note obligations |
|
$ |
|
|
|
$ |
399.9 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
399.9 |
|
Operating leases |
|
|
6.6 |
|
|
|
11.1 |
|
|
|
9.8 |
|
|
|
5.0 |
|
|
|
32.5 |
|
ALKERAN® supply agreements |
|
|
23.2 |
|
|
|
38.3 |
|
|
|
|
|
|
|
|
|
|
|
61.5 |
|
Manufacturing facility note payable |
|
|
3.4 |
|
|
|
6.7 |
|
|
|
6.7 |
|
|
|
16.5 |
|
|
|
33.3 |
|
Other contract commitments |
|
|
22.5 |
|
|
|
6.1 |
|
|
|
|
|
|
|
|
|
|
|
28.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
55.7 |
|
|
$ |
462.1 |
|
|
$ |
16.5 |
|
|
$ |
21.5 |
|
|
$ |
555.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We have provided a liability for unrecognized tax benefits related to various federal, state, and
foreign income tax matters of $107.6 million, at March 31, 2007, which is included in other non-current liabilities. These amounts are not included in
the table above as the timing of their settlement was not reasonably estimable at March 31, 2007.
Critical Accounting Policies
A critical accounting policy is one that is both important to the portrayal of our financial
condition and results of operation and requires managements most difficult, subjective or complex
judgments, often as a result of the need to make estimates about the effect of matters that are
inherently uncertain. Our significant accounting policies are more fully described in Note 1 of
the Notes to the Consolidated Financial Statements included in our Annual Report on Form 10-K for
the year ended December 31, 2006. Our critical accounting policies are disclosed in the
Managements Discussion and Analysis of Financial Condition and Results of Operations section of
our Annual Report on Form 10-K for the year ended December 31, 2006. The significant changes and
or expanded discussion of such critical accounting policies are contained herein:
We adopted the provisions of FIN 48 and FSP FIN 48-1 effective January 1, 2007. FIN 48 clarifies
the accounting for uncertainty in income taxes recognized in an enterprises financial statements
in accordance with SFAS No. 109, Accounting for Income Taxes, and prescribes a
recognition threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides
guidance on derecognition, classification, interest and penalties, accounting in interim periods,
disclosure, and transition. The Company had no cumulative effect adjustment related to the
adoption. However, certain amounts have been reclassified in the consolidated balance sheet in
order to comply with the requirements of the statement.
27
We have provided a liability for unrecognized tax benefits related to various federal, state, and
foreign income tax matters as of March 31, 2007 of $107.6 million, which is recorded in other
non-current liabilities. The liability at January 1, 2007 was $85.2 million. Additions of $22.4
million for tax positions relating to current year activities were recorded in the quarter ended
March 31, 2007. If recognized, these amounts would impact our effective tax rate. Additionally,
the Company has $3.7 million of unrecognized tax benefits related to certain deferred tax assets.
There are no unrecognized tax benefits as of March 31, 2007, for which it is reasonably possible
that there will be a significant change within the next twelve months. The liability for
unrecognized tax benefits is expected to increase in the next twelve months relating to operations
occurring in that period. As of March 31, 2007, we had accrued $3.3 million of interest and
penalties related to uncertain tax positions. We account for interest and penalties related to
uncertain tax positions as part of our provision for federal and state income taxes.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The following discussion provides forward-looking quantitative and qualitative information about
our potential exposure to market risk. Market risk represents the potential loss arising from
adverse changes in the value of financial instruments. The risk of loss is assessed based on the
likelihood of adverse changes in fair values, cash flows or future earnings.
We have established guidelines relative to the diversification and maturities of investments to
maintain safety and liquidity. These guidelines are reviewed periodically and may be modified
depending on market conditions. Although investments may be subject to credit risk, our investment
policy specifies
credit quality standards for our investments and limits the amount of credit exposure from any
single issue, issuer or type of investment. At March 31, 2007, our market risk sensitive
instruments consisted of marketable securities available for sale, unsecured convertible notes
issued by us and our notes payable to Siegfried.
We may periodically utilize foreign currency denominated forward contracts to hedge currency
fluctuations of transactions denominated in currencies other than the functional currency. At
March 31, 2007, we had foreign currency forward contracts outstanding to sell Swiss francs and buy
Euros for a notional amount of $20.3 million and to sell U.S. dollars and buy British pounds for a
notional amount of $12.4 million. The forward contracts expire within one year and are economic
hedges of non-functional currency receivables. As the hedges are undesignated for accounting
purposes, changes in the spot rate are re-measured through income each period. At March 31, 2007,
the gross unrealized gains on the forward contracts were approximately $0.1 million in the
aggregate.
Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably
possible near-term change in foreign currency rates. Assuming that the quarter-end exchange rates,
between the U.S. dollar and the British pound and the Swiss franc and the Euro, were to adversely
change by a hypothetical 10%, the change in the fair value of the contracts would decrease by
approximately $1.2 million and $1.8 million, respectively. However, since the contracts hedge
receivables denominated in the respective entitys functional currency, any change in the fair
value of the contract primarily would be offset by a change in the underlying value of the hedged
item.
Marketable Securities Available for Sale: At March 31, 2007, our marketable securities available
for sale consisted of U.S. treasury securities, government-sponsored agency securities,
mortgage-backed obligations, corporate debt securities, other asset-backed securities and 1,939,598
shares of Pharmion Corporation common stock. Marketable securities available for sale are carried
at fair value, held for an indefinite period of time and intended for use in meeting our ongoing
liquidity needs. Unrealized gains and losses on available-for-sale securities, which are deemed to
be temporary, are reported as a separate component of stockholders equity, net of tax. The cost
of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity.
The amortization, along with realized gains and losses, is included in interest and investment
income, net.
28
As of March 31, 2007, the principal amounts, fair values and related weighted average interest
rates of our investments in debt securities classified as marketable securities available-for-sale
were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Duration |
|
|
Less Than 1 |
|
1 to 3 |
|
3 to 5 |
|
5 to 7 |
|
|
(In thousands $) |
|
Year |
|
Years |
|
Years |
|
Years |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
$ |
266,383 |
|
|
$ |
587,635 |
|
|
$ |
191,597 |
|
|
$ |
14,400 |
|
|
$ |
1,060,015 |
|
Fair value |
|
$ |
266,368 |
|
|
$ |
586,353 |
|
|
$ |
180,081 |
|
|
$ |
12,701 |
|
|
$ |
1,045,503 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stated average interest rate |
|
|
5.3 |
% |
|
|
5.3 |
% |
|
|
4.9 |
% |
|
|
0.0 |
% |
|
|
5.1 |
% |
Pharmion Common Stock: At March 31, 2007, we held a total of 1,939,598 shares of Pharmion
Corporation common stock, which had an estimated fair value of approximately $51.0 million (based
on the closing price reported by the National Association of Securities Dealers Automated
Quotations, or NASDAQ system), and, which exceeded the cost by approximately $30.8 million. The
amount by which the fair value exceeded the cost (i.e., the unrealized gain) was included in
Accumulated Other Comprehensive Income in the Stockholders Equity section of the Consolidated
Balance Sheet. The fair
value of the Pharmion common stock investment is subject to market price volatility and any
increase or decrease in Pharmion common stocks quoted market price will have a similar percentage
increase or decrease in the fair value of our investment.
Convertible Debt: In June 2003, we issued an aggregate principal amount of $400.0 million of
unsecured convertible notes. The convertible notes have a five-year term and a coupon rate of
1.75% payable semi-annually. The convertible notes can be converted at any time into 33,014,025
shares of common stock at a stock-split adjusted conversion price of $12.1125 per share. At March
31, 2007, the fair value of the convertible notes exceeded the carrying value of $399.9 million by
approximately $1.319 billion, which we believe reflects the increase in the market price of our
common stock to $52.46 per share as of March 31, 2007. Assuming other factors are held constant,
an increase in interest rates generally results in a decrease in the fair value of fixed-rate
convertible debt, but does not impact the carrying value, and an increase in our stock price
generally results in an increase in the fair value of convertible debt, but does not impact the
carrying value.
Note Payable: At March 31, 2007, the fair value of our note payable to Siegfried approximated the
carrying value of the note of $26.3 million, due to the short period of time since we issued it.
Assuming other factors are held constant, an increase in interest rates generally will result in a
decrease in the fair value of the note. The fair value of the note will also be affected by
changes in the U.S. dollar to Swiss franc exchange rate. The note is denominated in Swiss francs.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures. As of the end of the period covered by this
quarterly report, we carried out an evaluation, under the supervision and with the participation of
the Companys management, including our Chief Executive Officer and Chief Financial Officer, of the
effectiveness of the design and operation of our disclosure controls and procedures (as defined in
the Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e)). Based upon the foregoing
evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our
disclosure controls and procedures are effective to ensure that information required to be
disclosed by the Company in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the rules and
forms of the Securities and Exchange Commission.
29
(b) Changes in Internal Control Over Financial Reporting. There have not been any changes in our
internal control over financial reporting during the fiscal quarter to which this report relates
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Our legal proceedings are described in Part I, Item 3, Legal Proceedings , of our 2006 Annual
Report on Form 10-K. There have not been any material changes as it pertains to such legal
proceedings nor have we engaged in any additional material legal proceedings.
Item 1A. Risk Factors
The risk factors included in our 2006 Annual Report on Form 10-K have not materially changed.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
10.1 |
|
Amendment to Letter Agreement between the Company and David W. Gryska. |
|
31.1 |
|
Certification by the Companys Chief Executive Officer. |
|
31.2 |
|
Certification by the Companys Chief Financial Officer. |
|
32.1 |
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
32.2 |
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
30
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.
|
|
|
|
|
|
CELGENE CORPORATION
|
|
DATE May 9, 2007 |
By: |
/s/ David W. Gryska
|
|
|
|
David W. Gryska |
|
|
|
Sr. Vice President and
Chief Financial Officer |
|
|
|
|
|
DATE May 9, 2007 |
By: |
/s/ James R. Swenson
|
|
|
|
James R. Swenson |
|
|
|
Controller |
|
31
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.1
|
|
Amendment to Letter Agreement between the Company and David W. Gryska. |
|
|
|
31.1
|
|
Certification by the Companys Chief Executive Officer. |
|
|
|
31.2
|
|
Certification by the Companys Chief Financial Officer. |
|
|
|
32.1
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
32.2
|
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
32