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 June 30, 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
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(I.R.S. Employer Identification |
or organization)
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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):
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Large accelerated þ
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Accelerated o
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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 July 31, 2007, 382,729,979 shares of Common Stock, par value $.01 per share, were
outstanding.
CELGENE CORPORATION
FORM 10-Q TABLE OF CONTENTS
2
PART 1 FINANCIAL INFORMATION
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(Dollars in thousands, except per share amounts)
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Three-Month Periods Ended |
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Six-Month Periods Ended |
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June 30, |
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June 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenue: |
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Net product sales |
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$ |
318,945 |
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$ |
176,401 |
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$ |
588,741 |
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$ |
336,644 |
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Collaborative agreements and other revenue |
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5,100 |
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4,323 |
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9,904 |
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8,216 |
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Royalty revenue |
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23,862 |
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16,515 |
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42,677 |
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34,220 |
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Total revenue |
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347,907 |
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197,239 |
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641,322 |
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379,080 |
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Expenses: |
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Cost of goods sold |
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28,701 |
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26,799 |
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50,756 |
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56,943 |
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Research and development |
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89,934 |
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57,018 |
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169,509 |
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111,542 |
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Selling, general and administrative |
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113,986 |
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83,036 |
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221,407 |
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149,903 |
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Total expenses |
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232,621 |
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166,853 |
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441,672 |
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318,388 |
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Operating income |
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115,286 |
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30,386 |
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199,650 |
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60,692 |
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Other income and expense: |
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Interest and investment income, net |
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26,376 |
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8,198 |
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51,150 |
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12,849 |
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Equity in losses of affiliated companies |
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949 |
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1,375 |
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2,232 |
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4,466 |
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Interest expense |
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2,611 |
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2,361 |
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5,299 |
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4,725 |
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Other income (expense), net |
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(5,008 |
) |
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1,495 |
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(4,077 |
) |
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3,059 |
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Income before income taxes |
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133,094 |
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36,343 |
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239,192 |
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67,409 |
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Income tax provision |
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78,224 |
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26,735 |
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126,913 |
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41,777 |
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Net income |
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$ |
54,870 |
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$ |
9,608 |
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$ |
112,279 |
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$ |
25,632 |
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Net income per common share: |
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Basic |
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$ |
0.14 |
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$ |
0.03 |
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$ |
0.30 |
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$ |
0.07 |
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Diluted |
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$ |
0.13 |
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$ |
0.03 |
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$ |
0.27 |
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$ |
0.07 |
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Weighted average shares: |
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Basic |
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381,086 |
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347,696 |
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379,350 |
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345,841 |
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Diluted |
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431,377 |
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370,360 |
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430,346 |
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369,108 |
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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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June 30, 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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$ |
967,916 |
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$ |
1,439,415 |
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Marketable securities available for sale |
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1,353,896 |
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542,805 |
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Accounts receivable, net of allowances of $5,947 and $6,625 at June 30, 2007
and December 31, 2006, respectively |
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145,654 |
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127,777 |
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Inventory |
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48,161 |
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25,371 |
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Deferred income taxes |
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87,438 |
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87,979 |
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Other current assets |
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92,334 |
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87,657 |
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Total current assets |
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2,695,399 |
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2,311,004 |
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Property, plant and equipment, net |
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164,804 |
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146,645 |
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Investment in affiliated companies |
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15,368 |
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16,379 |
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Intangible assets, net |
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|
98,295 |
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|
100,509 |
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Goodwill |
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39,441 |
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38,494 |
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Other assets |
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135,303 |
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122,760 |
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Total assets |
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$ |
3,148,610 |
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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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$ |
38,006 |
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$ |
24,410 |
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Accrued expenses |
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127,244 |
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|
112,992 |
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Income taxes payable |
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|
919 |
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|
84,859 |
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Convertible notes |
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|
399,880 |
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Current portion of deferred revenue |
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7,606 |
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7,647 |
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Other current liabilities |
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34,321 |
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9,795 |
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Total current liabilities |
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607,976 |
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239,703 |
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Convertible notes |
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399,889 |
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Deferred revenue, net of current portion |
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62,601 |
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63,027 |
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Non-current income taxes payable |
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133,681 |
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Other non-current liabilities |
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57,125 |
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|
56,995 |
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Total liabilities |
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861,383 |
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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 June 30, 2007 and December 31, 2006, respectively |
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Common stock, $.01 par value per share, 575,000,000 shares authorized; issued
386,541,154 and 380,092,309 shares at June 30, 2007 and December 31, 2006, respectively |
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|
3,865 |
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|
3,801 |
|
Common stock in treasury, at cost; 4,018,811 and 4,057,553 shares at June 30, 2007 and
December 31, 2006, respectively |
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(149,073 |
) |
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|
(148,097 |
) |
Additional paid-in capital |
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2,402,934 |
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2,209,889 |
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Retained earnings (deficit) |
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|
10,506 |
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|
(101,773 |
) |
Accumulated other comprehensive income |
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|
18,995 |
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|
12,357 |
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Total stockholders equity |
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2,287,227 |
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|
1,976,177 |
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Total liabilities and stockholders equity |
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$ |
3,148,610 |
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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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Six-Month Periods Ended |
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June 30, |
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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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$ |
112,279 |
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$ |
25,632 |
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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 |
|
|
14,985 |
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|
12,101 |
|
Provision for accounts receivable allowances |
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|
4,735 |
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|
819 |
|
Realized loss on marketable securities available for sale |
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|
1,446 |
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|
3,704 |
|
Unrealized loss on value of EntreMed warrants |
|
|
59 |
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|
270 |
|
Equity in losses of affiliated companies |
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|
2,232 |
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|
4,466 |
|
Non-cash stock-based compensation expense |
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|
26,554 |
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|
|
35,607 |
|
Amortization of discount on marketable securities available for sale, net |
|
|
(2,120 |
) |
|
|
(1,461 |
) |
Amortization of debt issuance cost |
|
|
1,221 |
|
|
|
1,221 |
|
Deferred income taxes |
|
|
(13,329 |
) |
|
|
(15,287 |
) |
Shares issued for employee benefit plans |
|
|
2,940 |
|
|
|
6,518 |
|
Other |
|
|
(807 |
) |
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|
1,012 |
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|
|
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Change in current assets and liabilities: |
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Increase in accounts receivable |
|
|
(22,058 |
) |
|
|
(8,162 |
) |
Increase in inventory |
|
|
(22,032 |
) |
|
|
(13,824 |
) |
Increase in other operating assets |
|
|
(7,280 |
) |
|
|
(46,717 |
) |
Increase (decrease) in accounts payable and accrued expenses |
|
|
33,552 |
|
|
|
(63,034 |
) |
Increase in income tax payable |
|
|
62,980 |
|
|
|
26,443 |
|
Decrease in deferred revenue |
|
|
(3,239 |
) |
|
|
(1,156 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
192,118 |
|
|
|
(31,848 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Capital expenditures |
|
|
(26,168 |
) |
|
|
(17,371 |
) |
Proceeds from sales and maturities of marketable securities available
for sale |
|
|
1,294,803 |
|
|
|
299,019 |
|
Purchases of marketable securities available for sale |
|
|
(2,083,978 |
) |
|
|
(339,175 |
) |
Investment in affiliated companies |
|
|
(1,221 |
) |
|
|
(2,000 |
) |
Purchase of long-term investments |
|
|
(1,406 |
) |
|
|
(625 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(817,970 |
) |
|
|
(60,152 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Net proceeds from exercise of common stock options and warrants |
|
|
74,434 |
|
|
|
45,932 |
|
Excess tax benefit from share-based compensation arrangements |
|
|
77,263 |
|
|
|
40,294 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
151,697 |
|
|
|
86,226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of currency rate changes on cash and cash equivalents |
|
|
2,656 |
|
|
|
3,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(471,499 |
) |
|
|
(2,398 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
1,439,415 |
|
|
|
123,316 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
967,916 |
|
|
$ |
120,918 |
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
5
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(Unaudited)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
Six-Month Periods Ended |
|
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing activity: |
|
|
|
|
|
|
|
|
Change in net unrealized loss (gain) on marketable
securities available for sale |
|
$ |
(187 |
) |
|
$ |
(5,687 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matured shares tendered in connection with stock option exercises |
|
$ |
(6,011 |
) |
|
$ |
(84,394 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes |
|
$ |
9 |
|
|
$ |
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
3,500 |
|
|
$ |
3,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
|
|
|
$ |
23,576 |
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
6
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 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 the Company
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 in
licensed territories; 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 U.S. generally accepted accounting principles for interim
information and 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 complete annual financial statements 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 consolidated financial 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. 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.
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
7
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
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 was 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 payment 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, Convertible 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.
In June 2007, the FASB ratified Emerging Issues Task Force, or EITF, Issue No. 07-3, Accounting
for Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities, or EITF 07-3, which provides that non-refundable advance payments for
future research and development activities should be deferred and capitalized until the related
goods are delivered or the related services are performed. EITF 07-3 is effective for the Company
beginning January 1, 2008. The Company is currently evaluating the impact of the adoption of EITF
07-3 on its consolidated financial statements.
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. 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.
8
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Six-Month Periods Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
54,870 |
|
|
$ |
9,608 |
|
|
$ |
112,279 |
|
|
$ |
25,632 |
|
Interest expense on convertible debt, net of tax |
|
|
1,393 |
|
|
|
|
|
|
|
2,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income for diluted computation |
|
$ |
56,263 |
|
|
$ |
9,608 |
|
|
$ |
115,064 |
|
|
$ |
25,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
381,086 |
|
|
|
347,696 |
|
|
|
379,350 |
|
|
|
345,841 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options, warrants and other incentives |
|
|
17,277 |
|
|
|
22,664 |
|
|
|
17,982 |
|
|
|
23,267 |
|
Convertible debt |
|
|
33,014 |
|
|
|
|
|
|
|
33,014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
431,377 |
|
|
|
370,360 |
|
|
|
430,346 |
|
|
|
369,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income Per Share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.14 |
|
|
$ |
0.03 |
|
|
$ |
0.30 |
|
|
$ |
0.07 |
|
Diluted |
|
$ |
0.13 |
|
|
$ |
0.03 |
|
|
$ |
0.27 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total number of potential common shares excluded from the diluted earnings per share
computation because their inclusion would have been anti-dilutive was 3,421,890 and 35,718,208
shares for the three-month periods ended June 30, 2007 and 2006, respectively. The total number of
potential common shares excluded for the six-month periods ended June 30, 2007 and 2006 was
4,166,847 and 35,803,816 shares, respectively.
9
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
The components of comprehensive income, which represents the change in equity from non-owner
sources, consists of net income, 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 and six-month periods ended June 30, 2007 and 2006
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Six-Month Periods Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income |
|
$ |
54,870 |
|
|
$ |
9,608 |
|
|
$ |
112,279 |
|
|
$ |
25,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized losses on marketable securities
available for sale, net of tax |
|
|
(2,009 |
) |
|
|
(1,769 |
) |
|
|
(703 |
) |
|
|
(6,339 |
) |
Less: reclassification adjustment for losses
included in net income |
|
|
1,382 |
|
|
|
321 |
|
|
|
1,446 |
|
|
|
3,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total unrealized gains (losses) on
marketable securities available for sale,
net of tax |
|
|
(627 |
) |
|
|
(1,448 |
) |
|
|
743 |
|
|
|
(2,672 |
) |
Currency translation adjustments |
|
|
4,337 |
|
|
|
(4,554 |
) |
|
|
5,895 |
|
|
|
(5,032 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive income (loss) |
|
|
3,710 |
|
|
|
(6,002 |
) |
|
|
6,638 |
|
|
|
(7,704 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
58,580 |
|
|
$ |
3,606 |
|
|
$ |
118,917 |
|
|
$ |
17,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
4. |
|
Cash, Cash Equivalents and Marketable Securities Available-for-Sale |
Money market funds of $946.7 million and $1.401 billion at June 30, 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 June
30, 2007 and December 31, 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
June 30, 2007 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations |
|
$ |
219,568 |
|
|
$ |
229 |
|
|
$ |
(1,669 |
) |
|
$ |
218,128 |
|
U.S. treasury securities |
|
|
92,537 |
|
|
|
12 |
|
|
|
(406 |
) |
|
|
92,143 |
|
Government-sponsored agency securities |
|
|
968,397 |
|
|
|
208 |
|
|
|
(7,988 |
) |
|
|
960,617 |
|
Corporate debt securities |
|
|
13,452 |
|
|
|
18 |
|
|
|
(587 |
) |
|
|
12,883 |
|
Other asset-backed securities |
|
|
11,822 |
|
|
|
2,152 |
|
|
|
|
|
|
|
13,974 |
|
Marketable equity securities |
|
|
20,213 |
|
|
|
35,938 |
|
|
|
|
|
|
|
56,151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,325,989 |
|
|
$ |
38,557 |
|
|
$ |
(10,650 |
) |
|
$ |
1,353,896 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations include fixed rate asset-backed securities issued by the Federal
National Mortgage Association, the Federal Home Loan Bank, the Federal Home Loan Mortgage
Corporation, and the Government National Mortgage Association. Government-sponsored agency
securities include general unsecured obligations of the issuing agency. 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
were due to increases in interest rates as well as widening credit spreads. The Company has
sufficient liquidity and intends to hold these securities with unrealized losses until the market
value recovers. Moreover, the Company believes it is probable that it will collect all amounts due
according to the contractual terms of the individual investments.
During the six-month period ended June 30, 2007, the Company determined that its other
asset-backed securities had sustained an other-than-temporary impairment due to a reduction in
their future estimated cash flows and, as a result, the Company recognized an impairment loss of
$1.2 million, which was recorded in interest and investment income, net.
11
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
Duration of debt securities classified as available-for-sale at June 30, 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
Duration of one year or less |
|
$ |
211,774 |
|
|
$ |
211,456 |
|
Duration of one through three years |
|
|
773,129 |
|
|
|
768,905 |
|
Duration of three through five years |
|
|
290,108 |
|
|
|
286,242 |
|
Duration of five years or more |
|
|
30,765 |
|
|
|
31,142 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,305,776 |
|
|
$ |
1,297,745 |
|
|
|
|
|
|
|
|
A summary of inventories by major category at June 30, 2007 and December 31, 2006 follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials |
|
$ |
10,564 |
|
|
$ |
10,133 |
|
Work in process |
|
|
12,763 |
|
|
|
4,715 |
|
Finished goods |
|
|
24,834 |
|
|
|
10,523 |
|
|
|
|
|
|
|
|
Total |
|
$ |
48,161 |
|
|
$ |
25,371 |
|
|
|
|
|
|
|
|
12
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 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:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
Investment in Affiliated Companies |
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Investment in EntreMed, Inc. equity |
|
$ |
717 |
|
|
$ |
2,609 |
|
Excess of investment over share of EntreMed equity (1) |
|
|
12,540 |
|
|
|
12,690 |
|
|
|
|
|
|
|
|
Investment in EntreMed |
|
$ |
13,257 |
|
|
$ |
15,299 |
|
Investment in Burrill Life Sciences, LLP |
|
|
2,111 |
|
|
|
1,080 |
|
|
|
|
|
|
|
|
Investment in affiliated companies |
|
$ |
15,368 |
|
|
$ |
16,379 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Six-Month Periods Ended |
|
|
|
June 30, |
|
|
June 30, |
|
Equity in Losses of Affiliated Companies |
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Celgenes share of affiliated companies (2) (3) |
|
$ |
874 |
|
|
$ |
1,309 |
|
|
$ |
2,081 |
|
|
$ |
4,316 |
|
Amortization of intangibles |
|
|
75 |
|
|
|
66 |
|
|
|
151 |
|
|
|
150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in losses of affiliated companies |
|
$ |
949 |
|
|
$ |
1,375 |
|
|
$ |
2,232 |
|
|
$ |
4,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Consists of intangible assets and goodwill of $151 and $12,389, respectively, at June 30, 2007 and $301 and $12,389,
respectively, 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 June 30, 2007 and 2006, respectively. |
|
(3) |
|
The six-month period ended June 30, 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 June 30, 2007 was
$15.9 million.
Convertible Notes: 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
price 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 33,013,778 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.
13
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
In June 2007, the Companys convertible notes, with a book value of $399.9 million, became current
and were reclassified from long-term convertible notes to current convertible notes, due to their
maturity in June 2008. Based on the current price of our common stock, the Company expects
noteholders to convert the notes into shares of common stock and does not expect such conversion to
have a material impact on our financial condition, liquidity or capital resources.
At June 30, 2007 and December 31, 2006, the fair value of the Companys convertible notes
outstanding exceeded the carrying value by approximately $1.893 billion and $1.507 billion,
respectively.
Under the Registration Rights Agreement for the notes, 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, the Company has not
recorded a liability at June 30, 2007. In the unlikely event that it becomes probable that the
Company would have to pay liquidated damages under the Registration Rights Agreement, the Company
has estimated the maximum potential liquidated damages as of June 30, 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, subsequent to its initial effectiveness, and (c) would be settled in
cash in accordance with the terms of the Registration Rights Agreement.
8. |
|
Intangible Assets and Goodwill |
Intangible Assets: A summary of intangible assets by category follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
June 30, 2007 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Penn T supply agreements |
|
$ |
111,131 |
|
|
$ |
(17,146 |
) |
|
$ |
93,985 |
|
|
|
12.9 |
|
License |
|
|
4,412 |
|
|
|
(467 |
) |
|
|
3,945 |
|
|
|
13.8 |
|
Technology |
|
|
122 |
|
|
|
(18 |
) |
|
|
104 |
|
|
|
12.0 |
|
Acquired workforce |
|
|
295 |
|
|
|
(34 |
) |
|
|
261 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
115,960 |
|
|
$ |
(17,665 |
) |
|
$ |
98,295 |
|
|
|
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 $2.8 million increase in gross carrying value of intangible assets from December 31, 2006
to June 30, 2007 was principally due to the impact of foreign currency translation.
14
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
Amortization of acquired intangible assets was approximately $2.3 million and $2.2 million for the
three-month periods ended June 30, 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.
Goodwill: At June 30, 2007, the Companys goodwill related to the acquisition of Penn T Limited 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 |
|
|
947 |
|
|
|
|
|
Balance, June 30, 2007 |
|
$ |
39,441 |
|
|
|
|
|
9. |
|
Share-Based Compensation |
There have been no significant changes to the share-based compensation plans during the six months
ended June 30, 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 and six-month periods ended June 30, 2007 and
2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
Six-Month Periods Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of good sold |
|
$ |
405 |
|
|
$ |
461 |
|
|
$ |
793 |
|
|
$ |
919 |
|
Research and development |
|
|
3,343 |
|
|
|
3,401 |
|
|
|
5,945 |
|
|
|
7,349 |
|
Selling, general and administrative |
|
|
8,427 |
|
|
|
16,855 |
|
|
|
15,010 |
|
|
|
27,232 |
|
Other income and expense, net |
|
|
4,806 |
|
|
|
|
|
|
|
4,806 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
16,981 |
|
|
$ |
20,717 |
|
|
$ |
26,554 |
|
|
$ |
35,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2007, there was $107.7 million of unrecognized compensation costs related to
stock options granted under our various stock-based plans. These costs will be recognized over an
expected remaining weighted-average period of 1.8 years.
The weighted-average grant-date fair value of the stock options granted during the three-month
periods ended June 30, 2007 and 2006 was $23.46 per share and $16.80 per share, respectively. The
weighted-average grant-date fair value of the stock options granted during the six-month periods
ended June 30, 2007 and 2006 was $22.83 per share and $16.58 per share, respectively. There have
been no significant changes to the assumptions used to estimate the fair value of options granted
during the three and six-month periods ended June 30, 2007, as compared to December 31, 2006.
15
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
Stock option transactions for the six months ended June 30, 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 period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
3,150,632 |
|
|
|
57.04 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(6,447,694 |
) |
|
|
12.09 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(513,188 |
) |
|
|
23.86 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(1,500 |
) |
|
|
4.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2007 |
|
|
33,299,938 |
|
|
$ |
22.95 |
|
|
|
6.0 |
|
|
$ |
1,148,246 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest at June 30, 2007 |
|
|
32,150,615 |
|
|
$ |
22.49 |
|
|
|
5.9 |
|
|
$ |
1,123,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at June 30, 2007 |
|
|
23,488,620 |
|
|
$ |
18.89 |
|
|
|
5.1 |
|
|
$ |
903,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total fair value of shares vested during the six-month periods ended June 30, 2007 and
2006 was $18.0 million and $38.6 million, respectively. The total intrinsic value of stock options
exercised during the six-month periods ended June 30, 2007 and 2006 was $297.5 million and $310.8
million, respectively. The Company primarily utilizes newly issued shares to satisfy the exercise
of stock options.
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.
The Companys tax returns have been audited by the Internal Revenue Service, or IRS, through the
year 2003. Tax returns for the years 2004 and 2005 are currently under examination by the IRS.
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 June 30, 2007.
16
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2007
(THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS, UNLESS OTHERWISE INDICATED)
The Company regularly reevaluates its tax positions and the associated interest and penalties, if
applicable, resulting from audits of federal, state and foreign income tax filings, as well as
changes in tax law that would reduce the technical merits of the position to below more likely than
not. The Company believes that its accruals for tax liabilities are adequate for all open years.
Many factors are considered in making these evaluations, including past history, recent
interpretations of tax law, and the specifics of each matter. Because tax regulations are subject
to interpretation and tax litigation is inherently uncertain, these evaluations can involve a
series of complex judgments about future events and can rely heavily on estimates and assumptions.
These evaluations are based on estimates and assumptions that have been deemed reasonable by
management. However, if managements estimates are not representative of actual outcomes, the
Companys results of operations could be materially impacted.
Unrecognized tax benefits, represented by liabilities on the balance sheet and all subject to
audit, arise when the estimated benefit recorded in the financial statements differs from the
amounts taken or expected to be taken in a tax return because of the uncertainties described above.
Included with the associated liability is gross accrued interest of approximately $3.0 million, as
of January 1, 2007, upon adoption of FIN 48. The liability for unrecognized tax benefits was $85.2
million at January 1, 2007. These unrecognized tax benefits relate primarily to issues common
among multinational corporations. Virtually all of these unrecognized tax benefits, if recognized,
would impact the effective income tax rate. The Company accounts for interest and penalties
related to uncertain tax positions as part of its provision for federal and state income taxes.
Changes to the amount of unrecognized tax benefits from January 1, 2007 relate primarily to current
year activities. There are no unrecognized tax benefits as of June 30, 2007 for which it is
reasonably possible that there will be a significant change in 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.
During the six-month period ended June 30, 2007, the Company recorded a deferred tax benefit of
approximately $7.0 million, 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 $18.1
million during the six months ended June 30, 2007 related to stock option compensation for which no
deferred tax benefit was recorded. 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.
In the first quarter of 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 audits for that period.
17
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Forward-Looking Information
Certain statements contained or incorporated by reference in this Quarterly Report on Form 10-Q 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.
Executive Summary
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
primary commercial stage products are REVLIMID® (lenalidomide) and THALOMID®
(thalidomide). We also record sales from ALKERAN®, which we obtain through a
supply and distribution agreement with GlaxoSmithKline, or GSK, and FOCALINTM, which we
sell exclusively to Novartis. Our international operations are in the early stages of development
and we expect them to provide a more significant contribution to future financial results as our
products obtain additional regulatory approval for sale in foreign markets. Other sources of
revenue include royalties which we primarily receive from Novartis Pharma AG, or Novartis, on its
sales of the entire family of RITALIN® drugs and FOCALIN XRTM, in addition to
revenues from collaborative agreements and licensing fees.
For the quarter ended June 30, 2007, we reported revenue of $347.9 million, net income of $54.9
million and diluted earnings per share of $0.13, representing increases of 76.4%, 471.1% and
333.3%, respectively, over the prior year quarter ended June 30, 2006. This increase reflects the
expanded use of REVLIMID® and higher investment income, partly offset by increased
operating expenses required to support our on-going expansion. On a year-to-date basis, revenues,
net income and diluted per share earnings were $641.3 million, $112.3 million and $0.27,
representing increases of 69.2%, 338.0% and 285.7%, respectively.
Our future growth and operating results will depend on the continued acceptance of our currently
marketed products, regulatory approvals of both new products and the expanded use of existing
products, depth of our product pipeline and ability to commercialize these products, competition to
our marketed products and challenges to our intellectual property. We continue to expand our
international infrastructure in anticipation of international regulatory approvals and
commercialization of our products. See also Risk Factors contained in Part I, Item 1A of our
Annual Report on Form 10-K for fiscal year 2006.
In June 2007, REVLIMID® was granted full marketing authorization by the European
Medicines Agency, or EMEA, for use in combination with dexamethasone as a treatment for patients
with multiple myeloma who have received at least one prior therapy. We are currently working with
local regulatory authorities to determine next steps for pricing, reimbursement and distribution
for all European Union member states. A Marketing Authorization Application, or MAA, seeking
approval to market REVLIMID® for treatment of transfusion-dependent anemia due to
low-or-intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic
abnormality with or without additional cytogenetic abnormalities is currently being evaluated by
the EMEAs Committee for Medicinal Products for Human Use, or CHMP.
18
This application remains under
review, but based on the length of time to complete an analysis to compare the trial results
with historical data sets from patient registries, we have recently become pessimistic about
achieving approval in 2007, but are targeting to complete this analysis by the end of 2007 for
consideration by the CHMP in early 2008. This strategy will likely require the withdrawl of the
application and resubmission after analysis of the existing data is completed. In addition, we
have completed enrollment of a double blinded placebo controlled European phase III trial, MDS-004,
examining REVLIMID® safety and efficacy in the deletion 5q MDS patient population.
Other international regulatory initiatives include MAAs currently being evaluated by Swissmedic,
the Swiss Agency for Therapeutic Products, the Therapeutic Goods Administration in Australia and
Health Canada. In April 2007, the Eastern Cooperative Oncology Group, or ECOG, 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 found that the use of a low-dose
of dexamethasone in combination with REVLIMID® suggests survival advantage for patients
when compared to the higher, standard-dose of dexamethasone that is used in combination with
REVLIMID® to treat the disease. These same results on survival advantage with lower
risk for infections, blood clots or other serious side effects were also presented at the June 2007
annual American Society of Clinical Oncology, or ASCO, medical conference. The regulatory utility
of these findings are unclear at this time.
Over the past several years, we have made substantial investments in research and development in
support of our existing products, proprietary IMiDs® compounds, and other pipeline
products as we continue to evaluate them in a broad range of hematological malignancies, other
cancers and other diseases. REVLIMID® is currently being evaluated as a treatment for
non-Hodgkins lymphomas, or NHL, and chronic lymphocytic leukemia, or CLL. In May 2007, we
announced plans to advance the development of leading oral anti-inflammatory candidates across a
broad range of inflammatory diseases. Our oral TNF synthesis inhibitor and anti-inflammatory
agent, CC-10004 (apremilast), has demonstrated favorable activity and side effect profiles in
placebo controlled proof-of-mechanism trial in moderate to severe psoriasis. We also received
acceptance of our Investigational New Drug, or IND, application to evaluate CC-4047 (pomalidomide)
in a proof-of-principle study in sickle cell anemia. We are also evaluating CC-4047 for treatment
in other diseases including myelofibrosis, myeloma and other solid tumor cancers.
19
Results of Operations
Three-Month Periods Ended June 30, 2007 and 2006
Total Revenue: Total revenue and related percentages for the three-month periods ended June 30,
2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
Percent |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
180,963 |
|
|
$ |
63,020 |
|
|
$ |
117,943 |
|
|
|
187.2 |
% |
THALOMID® |
|
|
117,708 |
|
|
|
107,193 |
|
|
|
10,515 |
|
|
|
9.8 |
% |
ALKERAN® |
|
|
18,738 |
|
|
|
4,452 |
|
|
|
14,286 |
|
|
|
320.9 |
% |
FOCALINTM |
|
|
1,461 |
|
|
|
1,666 |
|
|
|
(205 |
) |
|
|
-12.3 |
% |
Other |
|
|
75 |
|
|
|
70 |
|
|
|
5 |
|
|
|
7.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
|
318,945 |
|
|
|
176,401 |
|
|
|
142,544 |
|
|
|
80.8 |
% |
Collaborative agreements
and other revenue |
|
|
5,100 |
|
|
|
4,323 |
|
|
|
777 |
|
|
|
18.0 |
% |
Royalty revenue |
|
|
23,862 |
|
|
|
16,515 |
|
|
|
7,347 |
|
|
|
44.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
347,907 |
|
|
$ |
197,239 |
|
|
$ |
150,668 |
|
|
|
76.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Product Sales: In December 2005, REVLIMID® was approved by the U.S. Food and
Drug Administration, or FDA, for use in the treatment of patients with transfusion-dependent anemia
due to low-or-intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q
cytogenetic abnormality with or without additional cytogenetic abnormalities and in June 2006 for
treatment in combination with dexamethasone of patients with multiple myeloma who have received at
least one prior therapy. The increase in REVLIMID® net sales for the three-month period
ended June 30, 2007 compared to the three-month period ended June 30, 2006 reflects the products
expanded use resulting from the FDAs June 2006 approval in multiple myeloma. The establishment of
our European Named Patient Program, or NPP, which offers European patients in need of treatment
access to REVLIMID® on a compassionate use basis also contributed to the increase in
sales. On June 19, 2007, REVLIMID® was granted full marketing authorization by the EMEA
for use in combination with dexamethasone as a treatment for patients with multiple myeloma who
have received at least one prior therapy. We are now working with local regulatory authorities to
determine next steps for pricing, reimbursement and distribution for all EU member states. A small
amount of sales resulting from this approval are included in the quarter ended June 30, 2007.
THALOMID® was approved by the FDA in May 2006 in combination with dexamethasone for the
treatment of newly diagnosed multiple myeloma and in July 1998 for the acute treatment of cutaneous
manifestations of moderate to severe erythema nodosum leprosum, or ENL, and as maintenance therapy
for prevention and suppression of the cutaneous manifestation of ENL recurrence. Barr
Laboratories, Inc., a generic drug manufacturer filed an ANDA with a Paragraph IV certification
seeking authorization from the FDA to market a generic version of 50mg, 100mg and 200mg
THALOMID® in the United States for the acute treatment of cutaneous manifestations of
moderate to severe ENL. On January 18, 2007, we filed an infringement action in the Unitied States
District Court of New Jersey against Barr. By bringing suit, we are entitled up to a maximum
30-month injunction, from the date of the court filing, against the applicants marketing of
generic THALOMID®. For additional information see Part I,
20
Item 1A Risk Factors and
Item 3 Legal Proceedings contained in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2006. THALOMID® recorded a sales increase for the three-month period
ended June 30, 2007 compared to the three-month period ended June 30, 2006 due to price increases
which were partially offset by lower sales volumes resulting from average daily dose declines, as
we continue to move towards a cost of therapy pricing structure as opposed to a price per milligram
basis. Further offsetting the increase in THALOMID® net sales were higher gross to net
sales deductions partly due to the anticipated increase in use of REVLIMID®.
ALKERAN®, which is licensed from GlaxoSmithKline and sold under the Celgene label, is
approved by the FDA for the palliative treatment of multiple myeloma and carcinoma of the ovary.
Net sales were higher in the three-month period ended June 30, 2007 compared to the three-month
period ended June 30, 2006 due to higher unit sales for both tablet and injectable forms, higher
pricing for the injectable form and a decrease in gross to net sales deductions. Sales volumes for
the three-month period ended June 30, 2006 were lower than normal primarily due to supply
disruptions, which lead to inconsistent supplies of ALKERAN® IV and consequently
inconsistent end-market buying patterns.
In April 2000, we licensed to Novartis the worldwide rights (excluding Canada) to
FOCALINTM and FOCALIN XRTM, which are approved for the treatment of attention
deficit hyperactivity disorder, or ADHD. We retained the rights to these products for the treatment
of oncology-related disorders. We sell FOCALINTM exclusively to Novartis and also
supply them with FOCALIN XRTM, for which we receive a
royalty. Sales of FOCALINTM decreased in the three-month period ended June 30, 2007
compared to the three-month period ended June 30, 2006 due to patient migration to FOCALIN
XRTM.
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources totaled $5.1 million and $4.3 million for the three-month periods ended June 30, 2007 and
2006, respectively. The $0.8 million increase in the three-month period ended June 30, 2007 was
primarily due to license fees generated from our S.T.E.P.S.® program and umbilical
cord blood enrollment, collection and storage fees generated through our LifeBank USASM
business.
Royalty Revenue: Royalty revenue increased by $7.3 million for the three-month period ended June
30, 2007 compared to the three-month period ended June 30, 2006 primarily due to amounts received
from Novartis on their sales of Ritalin® and FOCALIN XRTM.
Gross to Net Sales Accruals: We record accruals for sales returns, discounts, Medicaid rebates and
distributor charge-backs and service fees. Allowances for sales returns are based on among other
things: actual returns history for consumed lots, returns trend experience for lots where product
is still being returned, levels of inventory in the distribution channel and the introduction of
competing products. Discount 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 June
30, 2007 and 2006 were as follows:
21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
|
|
Return |
|
|
|
|
|
|
Medicaid |
|
|
Charge-backs |
|
|
|
|
2007 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
And Services |
|
|
Total |
|
Balance at March 31, 2007 |
|
$ |
9,407 |
|
|
$ |
2,250 |
|
|
$ |
7,736 |
|
|
$ |
8,424 |
|
|
$ |
27,817 |
|
Allowances for sales during 2007 |
|
|
9,662 |
|
|
|
6,717 |
|
|
|
8,256 |
|
|
|
18,016 |
|
|
|
42,651 |
|
Allowances for sales during prior periods |
|
|
1,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,027 |
|
Credits issued for prior year sales |
|
|
(3,380 |
) |
|
|
(79 |
) |
|
|
(1,323 |
) |
|
|
(646 |
) |
|
|
(5,428 |
) |
Credits issued for sales during 2007 |
|
|
(1,772 |
) |
|
|
(6,271 |
) |
|
|
(5,502 |
) |
|
|
(16,736 |
) |
|
|
(30,281 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
$ |
14,944 |
|
|
$ |
2,617 |
|
|
$ |
9,167 |
|
|
$ |
9,058 |
|
|
$ |
35,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
|
|
Return |
|
|
|
|
|
|
Medicaid |
|
|
Charge-backs |
|
|
|
|
2006 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
And Services |
|
|
Total |
|
Balance at March 31, 2006 |
|
$ |
8,338 |
|
|
$ |
1,787 |
|
|
$ |
24,143 |
|
|
$ |
7,343 |
|
|
$ |
41,611 |
|
Allowances for sales during 2006 |
|
|
8,370 |
|
|
|
4,327 |
|
|
|
115 |
|
|
|
13,072 |
|
|
|
25,884 |
|
Allowances for sales during prior periods |
|
|
15,436 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,436 |
|
Credits issued for prior year sales |
|
|
(13,849 |
) |
|
|
(85 |
) |
|
|
(11,732 |
) |
|
|
|
|
|
|
(25,666 |
) |
Credits issued for sales during 2006 |
|
|
(6,658 |
) |
|
|
(4,277 |
) |
|
|
(5,301 |
) |
|
|
(12,786 |
) |
|
|
(29,022 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
$ |
11,637 |
|
|
$ |
1,752 |
|
|
$ |
7,225 |
|
|
$ |
7,629 |
|
|
$ |
28,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales return allowances decreased in the three-month period ended June 30, 2007 compared to
the three-month period ended June 30, 2006. The decrease was due to higher
THALOMID® and ALKERAN® IV
returns in 2006, partially offset by higher allowances in the three-month period ended June 30,
2007. The higher allowances in the three-month period ended June 30, 2007 were the result of
planned THALOMID® inventory centralization and rationalization at several major
pharmacy chains as well as the expected impact on THALOMID® returns resulting from
the anticipated increase in use of REVLIMID® in newly diagnosed multiple myeloma
as a result of recent clinical data. The higher THALOMID® credits issued for
returns during the three-month period ended June 30, 2006 were for one large retail pharmacy chain.
The returns from this customer were the result of efforts to more aggressively manage inventory at
its pharmacies as well as our previous trade carton configuration, which included up to ten sleeves
of THALOMID® capsules with each order and S.T.E.P.S.® related
restrictions, which limited the chains ability to transfer inventories between its locations. As
a result of the higher returns activity, we recorded additional allowances during the three-month
period ended June 30, 2006 for all estimated THALOMID® pharmacy inventories and
implemented other measures, including the introduction of single sleeve units beginning on June 7,
2006 (rather than requiring full carton purchases), which was designed to allow customers to more
effectively manage their inventories since they can now order smaller quantities and limit our
product returns exposure. Discounts increased in the current year quarter primarily from increased
sales of REVLIMID® .
Medicaid rebate allowances increased in the three-month period ended June 30, 2007 compared to the
three-month period ended June 30, 2006 primarily due to an increase in THALOMID®
accruals. Our Medicaid rebate accruals are based on the Medicaid Unit Rebate Amount formula
established by the Center for Medicaid and Medicare Services using the estimated Medicaid dispense
quantities. We base the estimated Medicaid dispense quantities on the previous quarter actual
Medicaid dispenses, which individual states typically begin reporting to us approximately 45 days
after the close of each quarter. The three-month period ended June 30, 2006 included a $5.9
million favorable adjustment to the accrual resulting from sufficient data being obtained regarding
actual first quarter 2006 Medicaid dispenses to allow us to adjust the Medicaid rebate accrual to
reflect the impact of the new Medicare, Part D legislation and resulting shift in patient
population.
22
Distributor charge-backs increased in the three-month period ended June 30, 2007 compared to the
three-month period ended June 30, 2006 primarily due to REVLIMID® ,
THALOMID® and ALKERAN® IV price increases, which increased the
differential between annual contract pricing available to federally funded healthcare providers and
our wholesale acquisition cost.
Operating Costs and Expenses: Operating costs, expenses and related percentages for the
three-month periods ended June 30, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
Percent |
|
|
|
2007 |
|
|
2006 |
|
|
Increase |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
$ |
28,701 |
|
|
$ |
26,799 |
|
|
$ |
1,902 |
|
|
|
7.1 |
% |
Percent of net product sales |
|
|
9.0 |
% |
|
|
15.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
89,934 |
|
|
$ |
57,018 |
|
|
$ |
32,916 |
|
|
|
57.7 |
% |
Percent of total revenue |
|
|
25.9 |
% |
|
|
28.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
113,986 |
|
|
$ |
83,036 |
|
|
$ |
30,950 |
|
|
|
37.3 |
% |
Percent of total revenue |
|
|
32.8 |
% |
|
|
42.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Goods Sold: Cost of goods sold increased for the three-month period ended June 30,
2007 compared to the three-month period ended June 30, 2006 primarily due to higher costs and
royalties related to higher unit sales of REVLIMID® . The increase in REVLIMID® sales had a
favorable impact on cost of goods sold as a percent of net product sales, since the product carries
a lower cost relative to our other products.
Research and Development: Research and development expenses increased by $32.9 million for the
three-month period ended June 30, 2007 compared to the three-month period ended June 30, 2006
primarily due to higher clinical development expenses in support of multiple programs, including
REVLIMID® and other IMiDs® across a broad range of cancers,
including NHL and CLL. Tumor lysis syndrome has been observed in approximately 3% of CLL patients
treated with REVLIMID® . As a result of these findings, we are delaying the
enrollment of new patients into our CLL-001 study, where a higher dose of
REVLIMID® was used, and we now intend to amend the protocol to incorporate a dose
escalation regimen to the targeted dose. Expenses to support ongoing research of other compounds,
such as the IMiD® CC-4047 (pomalidomide), as well as our kinase and ligase
inhibitor programs and placental-derived stem cell program, also increased.
For the three-month period ended June 30, 2007, research and development expenses consisted of
$36.8 million spent on human pharmaceutical clinical programs; $38.5 million spent on other
pharmaceutical programs, including toxicology, analytical research and development, drug discovery,
quality and regulatory affairs; $11.2 million spent on biopharmaceutical discovery and development
programs; and $3.4 million spent on placental stem cell and biomaterials programs. For the
three-month period ended June 30, 2006, expenses consisted of $22.0 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;
$9.4 million spent on biopharmaceutical discovery and development programs; and $2.9 million spent
on placental stem cell and biomaterials programs.
23
Selling, General and Administrative: Selling, general and administrative expenses increased by
$31.0 million for the three-month period ended June 30, 2007 compared to the three-month period
ended June 30, 2006 primarily due to an increase in donations to non-profit agencies that assist
patients with the co-payments of REVLIMID® ; higher marketing and sales costs
related to REVLIMID® product launch preparation activities in Europe, and
continued international expansion throughout Europe, Japan, Australia and Canada; plus an increase
in general administrative expenses primarily related to higher personnel, professional and other
outside service costs due to our continued growth.
Interest and Investment Income, Net: Interest and investment income, net was $26.4 million for the
three-month period ended June 30, 2007, representing an increase of $18.2 million over the $8.2
million recorded for the three-month period ended June 30, 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 periods ended June 30, 2007 and 2006 included
other-than-temporary impairment losses on marketable securities available for sale of $1.2 million
and $0.3 million, respectively.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $0.9 million and $1.4 million for the three-month periods ended June 30, 2007 and 2006,
respectively. The decrease in losses was primarily due to reduced losses related to our investment
in EntreMed.
Interest Expense: Interest expense was $2.6 million and $2.4 million for the three-month periods
ended June 30, 2007 and 2006, respectively. The $0.2 million increase related to the note payable
to Siegfried Ltd. and Siegfried Dienste AG (together Siegfried) in connection with our December
2006 purchase of an active pharmaceutical ingredient, or API, manufacturing facility in Zofingen,
Switzerland.
Other Income (Expense), Net: Other income (expense), net was a net expense of $5.0 million for the
three-month period ended June 30, 2007 and net income of $1.5 million for the three-month period
ended June 30, 2006. The decrease for the three-month period ended June 30, 2007 was due
to a decrease in foreign exchange gains and termination benefit resulting from the modification of certain outstanding stock options of a terminated employee.
Income Tax Provision: The income tax provision for the three-month period ended June 30, 2007 was
$78.2 million and reflects an effective tax rate of 58.8%. The effective tax rate reflects the tax
expense impact of 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 June 30, 2006 was $26.7 million, reflecting an effective tax rate of
71%. The decrease in the effective tax rate was primarily due to higher earnings in the
three-month period ended June 30, 2007.
24
Results of Operations
Six-Month Periods Ended June 30, 2007 and 2006
Total Revenue: Total revenue and related percentages for the six-month periods ended June 30, 2007
and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six-Month Period Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
Percent |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
327,196 |
|
|
$ |
95,463 |
|
|
$ |
231,733 |
|
|
|
242.7 |
% |
THALOMID® |
|
|
223,742 |
|
|
|
214,404 |
|
|
|
9,338 |
|
|
|
4.4 |
% |
ALKERAN® |
|
|
34,702 |
|
|
|
22,747 |
|
|
|
11,955 |
|
|
|
52.6 |
% |
FOCALINTM |
|
|
2,952 |
|
|
|
3,767 |
|
|
|
(815 |
) |
|
|
-21.6 |
% |
Other |
|
|
149 |
|
|
|
263 |
|
|
|
(114 |
) |
|
|
-43.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
|
588,741 |
|
|
|
336,644 |
|
|
|
252,097 |
|
|
|
74.9 |
% |
Collaborative agreements
and other revenue |
|
|
9,904 |
|
|
|
8,216 |
|
|
|
1,688 |
|
|
|
20.5 |
% |
Royalty revenue |
|
|
42,677 |
|
|
|
34,220 |
|
|
|
8,457 |
|
|
|
24.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
641,322 |
|
|
$ |
379,080 |
|
|
$ |
262,242 |
|
|
|
69.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Product Sales: REVLIMID® net sales increased in the six-month period ended
June 30, 2007 compared to the six-month period ended June 30, 2006 primarily due to the products
expanded use resulting from the FDAs June 2006 approval in multiple myeloma. The establishment of
our NPP, which offers European patients in need of treatment access to REVLIMID® on a
compassionate use basis also contributed to the increase in sales.
Net sales of THALOMID® were higher for the six-month period ended June 30, 2007 compared
to the six-month period ended June 30, 2006 primarily due to price increases and lower gross to net
adjustments resulting from our move towards a cost of therapy pricing structure as opposed to a
price per milligram basis. These favorable impacts were partly offset by lower sales volumes
resulting from average daily dose declines.
ALKERAN® net sales were higher in the six-month period ended June 30, 2007
compared to the six-month period ended June 30, 2006 as declines in unit sales for both tablet and
injectable forms were offset by higher pricing for the injectable form and lower gross to net
deductions.
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources totaled $9.9 million and $8.2 million for the six-month periods ended June 30, 2007 and
2006, respectively. The $1.7 million increase in the six-month period ended June 30, 2007 was
primarily due to license fees generated from our S.T.E.P.S.® program and umbilical
cord blood enrollment, collection and storage fees generated through our LifeBank USASM business.
Royalty Revenue: Royalty revenue increased by $8.5 million for the six-month period ended June 30,
2007 compared to the six-month period ended June 30, 2006 primarily due to amounts received from
Novartis on its sales of Ritalin
® and FOCALIN XR
TM.
25
Gross to Net Sales Accruals: Gross to net sales accruals and the balance in the related allowance
accounts for the six-month periods ended June 30, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
|
|
Return |
|
|
|
|
|
|
Medicaid |
|
|
Charge-backs |
|
|
|
|
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 |
|
|
17,623 |
|
|
|
12,396 |
|
|
|
14,232 |
|
|
|
33,220 |
|
|
|
77,471 |
|
Allowances for sales during prior periods |
|
|
1,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,027 |
|
Credits issued for prior year sales |
|
|
(10,507 |
) |
|
|
(2,183 |
) |
|
|
(7,031 |
) |
|
|
(6,725 |
) |
|
|
(26,446 |
) |
Credits issued for sales during 2007 |
|
|
(2,679 |
) |
|
|
(9,892 |
) |
|
|
(5,502 |
) |
|
|
(28,070 |
) |
|
|
(46,143 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
$ |
14,944 |
|
|
$ |
2,617 |
|
|
$ |
9,167 |
|
|
$ |
9,058 |
|
|
$ |
35,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
|
|
Return |
|
|
|
|
|
|
Medicaid |
|
|
Charge-backs |
|
|
|
|
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 |
|
|
17,458 |
|
|
|
8,487 |
|
|
|
11,827 |
|
|
|
26,953 |
|
|
|
64,725 |
|
Allowances for sales during prior periods |
|
|
22,979 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,979 |
|
Credits issued for prior year sales |
|
|
(25,021 |
) |
|
|
(1,479 |
) |
|
|
(20,261 |
) |
|
|
(6,314 |
) |
|
|
(53,075 |
) |
Credits issued for sales during 2006 |
|
|
(8,796 |
) |
|
|
(6,703 |
) |
|
|
(5,301 |
) |
|
|
(19,788 |
) |
|
|
(40,588 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
$ |
11,637 |
|
|
$ |
1,752 |
|
|
$ |
7,225 |
|
|
$ |
7,629 |
|
|
$ |
28,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales return allowances decreased in the six-month period ended June 30, 2007 compared to the
six-month period ended June 30, 2006. The decrease was due to higher THALOMID®
and ALKERAN® IV returns in 2006, partially offset by higher allowances in the
six-month period ended June 30, 2007. The higher allowances in the six-month period ended June 30,
2007 were the result of planned THALOMID® inventory centralization and
rationalization at several major pharmacy chains as well as the expected impact on
THALOMID® returns resulting from the anticipated increase in use of
REVLIMID® in newly diagnosed multiple myeloma as a result of recent clinical data.
The higher THALOMID® credits issued for returns during the six-month period ended
June 30, 2006 were for one large retail pharmacy chain. The returns from this customer were the
result of efforts to more aggressively manage inventory at its pharmacies as well as our previous
trade carton configuration, which included up to ten sleeves of THALOMID® capsules
with each order and S.T.E.P.S.® related restrictions, which limited the chains
ability to transfer inventories between its locations. As a result of the higher returns activity,
we recorded additional allowances during the six-month period ended June 30, 2006 for all estimated
THALOMID® pharmacy inventories and implemented other measures, including the
introduction of single sleeve units beginning on June 7, 2006 (rather than requiring full carton
purchases), which was designed to allow customers to more effectively manage their inventories
since they can now order smaller quantities and limit our product returns exposure. Discounts
increased in the current year six-month period primarily from increased sales of
REVLIMID® .
Medicaid rebate allowances increased in the six-month period ended June 30, 2007 compared to the
six-month period ended June 30, 2006 due to an increase in THALOMID® and
REVLIMID® accruals. Our Medicaid rebate accruals are based on the Medicaid Unit
Rebate Amount formula established by the Center for Medicaid and Medicare Services using the
estimated Medicaid dispense quantities. REVLIMID® dispenses increased resulting
from the introduction of the 15mg and 25mg strength tablets.
26
Distributor charge-backs increased in the six-month period ended June 30, 2007 compared to the
six-month period ended June 30, 2006 primarily due to REVLIMID® ,
THALOMID® and ALKERAN® IV price increases, which increased the
differential between annual contract pricing available to federally funded healthcare providers and
our wholesale acquisition cost.
Operating Costs and Expenses: Operating costs, expenses and related percentages for the six-month
periods ended June 30, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six-Month Period Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
Percent |
|
|
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
$ |
50,756 |
|
|
$ |
56,943 |
|
|
$ |
(6,187 |
) |
|
|
-10.9 |
% |
Percent of net product sales |
|
|
8.6 |
% |
|
|
16.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
169,509 |
|
|
$ |
111,542 |
|
|
$ |
57,967 |
|
|
|
52.0 |
% |
Percent of total revenue |
|
|
26.4 |
% |
|
|
29.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
221,407 |
|
|
$ |
149,903 |
|
|
$ |
71,504 |
|
|
|
47.7 |
% |
Percent of total revenue |
|
|
34.5 |
% |
|
|
39.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Goods Sold: Cost of goods sold and cost of goods sold as a percent of net product
sales decreased for the six-month period ended June 30, 2007 compared to the six-month period ended
June 30, 2006 primarily due to lower ALKERAN® costs resulting from lower sales
volumes and unit costs related to ALKERAN® for injection, which was partly offset
by higher REVLIMID® royalties due to a higher sales level. The increase in
REVLIMID® sales favorably impacted cost of goods sold as a percentage of net
product sales due to the products lower cost relative to our other products.
Research and Development: Research and development expenses increased by $58.0 million for the
six-month period ended June 30, 2007 compared to the six-month period ended June 30, 2006 primarily
due to higher clinical development expenses in support of multiple programs, including
REVLIMID® and other IMiDs® across a broad range of cancers,
including NHL and CLL. Expenses to support ongoing research of other compounds, such as our
kinase and ligase inhibitor programs and placental-derived stem cell program also increased.
For the six-month period ended June 30, 2007, research and development expenses consisted of $69.5
million spent on human pharmaceutical clinical programs; $71.9 million spent on other
pharmaceutical programs, including toxicology, analytical research and development, drug discovery,
quality and regulatory affairs; $21.2 million spent on biopharmaceutical discovery and development
programs; and $6.9 million spent on placental stem cell and biomaterials programs. For the
six-month period ended June 30, 2006, expenses consisted of $41.7 million spent on human
pharmaceutical clinical programs; $45.4 million spent on other pharmaceutical programs, including
toxicology, analytical research and development, drug discovery, quality and regulatory affairs;
$18.9 million spent on biopharmaceutical discovery and development programs; and $5.5 million spent
on placental stem cell and biomaterials programs.
27
Selling, General and Administrative: Selling, general and administrative expenses increased for
the six-month period ended June 30, 2007 by $71.5 million compared to the six-month period ended
June 30, 2006 primarily due to an increase in donations to non-profit agencies that assist patients
with the co-payments of REVLIMID® ; higher marketing and sales costs related to
product launch preparation activities in Europe, and continued international expansion throughout
Europe, Japan, Australia and Canada; plus an increase in general administrative expenses primarily
related to increased personnel levels and professional and other outside service costs due to our
continued growth.
Interest and Investment Income, Net: Interest and investment income, net was $51.2 million for the
six-month period ended June 30, 2007, representing an increase of $38.4 million over the $12.8
million recorded for the six-month period ended June 30, 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 six-month periods ended June 30, 2007 and 2006 included
other-than-temporary impairment losses on marketable securities available for sale of $1.2 million
and $3.6 million, respectively.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $2.2 million and $4.5 million for the six-month periods ended June 30, 2007 and 2006,
respectively. The decrease in losses was due to a charge of $3.1 million for in-process research
and development related to EntreMeds acquisition of Miikana Therapeutics Inc. in the six-month
period ended June 30, 2006.
Interest Expense: Interest expense was $5.3 million and $4.7 million for the six-month periods
ended June 30, 2007 and 2006, respectively. The $0.6 million increase related to the note payable
to Siegfried in connection with our December 2006 purchase of an API manufacturing facility in
Zofingen, Switzerland.
Other Income (Expense), Net: Other income (expense), net was a net expense of $4.1 million and net
income of $3.1 million for the six-month periods ended June 30, 2007 and 2006, respectively. The
decrease was due to a decrease in foreign exchange gains and termination benefit resulting from the modification of certain outstanding
stock options of a terminated employee.
Income Tax Provision: The income tax provision for the six-month period ended June 30, 2007 was
$126.9 million and reflects an effective tax rate of 53.1%. The effective tax rate reflects the
tax expense impact of 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 effective tax rate also
reflects a tax benefit of approximately $7.0 million related to a research and experimentation tax
credit study covering prior years. The income tax provision for the six-month period ended June
30, 2006 was $41.8 million and reflects an effective tax rate of 71%, 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.
28
Liquidity and Capital Resources
Cash flows from operating, investing and financing activities for the six-month periods ended June
30, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six-Month Period Ended |
|
|
|
|
|
|
June 30, |
|
|
Increase / |
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
Net cash provided by (used in) operating activities |
|
$ |
192,118 |
|
|
$ |
(31,848 |
) |
|
$ |
223,966 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
$ |
(817,970 |
) |
|
$ |
(60,152 |
) |
|
$ |
(757,818 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
$ |
151,697 |
|
|
$ |
86,226 |
|
|
$ |
65,471 |
|
|
|
|
|
|
|
|
|
|
|
Operating Activities: Net cash provided by operating activities increased in the six-month
period ended June 30, 2007, as compared to net cash used in operating activities in the six-month
period ended June 30, 2006, primarily due to higher earnings, higher accruals for income taxes
payable, accounts payable and accrued expenses driven by the growth of our business and net tax
refunds of $11.2 million in the six-month period ended June 30, 2007 versus payments of $23.6
million in the six-month period ended June 30, 2006
Investing Activities: Net cash used in investing activities in the six-month period ended June 30,
2007 included $789.2 million for net purchases of available-for-sale marketable securities and
$26.2 million for capital expenditures. 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 six-month period ended
June 30, 2007. Net cash used in investing activities in the six-month period ended June 30, 2006
included $40.2 million for net purchases of marketable securities available for sale and $17.4
million for capital expenditures.
Financing Activities: Net cash provided by financing activities in the six-month period ended June
30, 2007 included $74.4 million from the exercise of employee stock options and $77.3 million from
excess tax benefits recognized upon exercise of such options, as compared to $45.9 million from the
exercise of employee stock options and $40.3 million from excess tax benefits recognized upon
exercise of such options in the six-month period ended June 30, 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.
The following table summarizes our cash, cash equivalents and marketable securities and our working
capital:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
|
(In thousands $) |
|
2007 |
|
|
2006 |
|
|
Increase |
|
Cash, cash equivalents and marketable securities |
|
$ |
2,321,812 |
|
|
$ |
1,982,220 |
|
|
$ |
339,592 |
|
Working capital(1) |
|
$ |
2,407,471 |
|
|
$ |
1,990,969 |
|
|
$ |
416,502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes cash, cash equivalents and marketable securities, accounts receivable, net of
allowances, inventory, other current assets, accounts payable, accrued expenses, income taxes
payable and other current liabilities. |
29
Cash, Cash Equivalents and Marketable Securities: The increase of $339.6 million was
primarily due to $166.0 million of free cash flows (operating cash flows less capital expenditures)
plus $151.7 million of net cash provided by financing activities.
Working Capital: The $416.5 million increase in our working capital was primarily attributable to
the following:
|
|
|
Cash, Cash Equivalents and Marketable Securities increased $339.6 million, as noted
above. |
|
|
|
Income taxes payable decreased $83.9 million primarily due to the reclassification of
$85.2 million of certain income tax liabilities to non-current income taxes payable in
accordance with FIN 48. |
|
|
|
Inventory increased $22.8 million during the six-month period ended June 30, 2007.
ALKERAN® inventories increased $10.5 million due to the timing of our
purchases from GSK. REVLIMID® inventories increased $6.7 million in anticipation of our European
product launch and to support continued increases in our U.S. sales. |
|
|
|
Accounts receivable, net of allowances increased $17.9 million during the six-month
period ended June 30, 2007 primarily due to an 83% increase in our net product sales,
partially offset by an improvement in our Days Sales Outstanding from 45 days at December
31, 2006 to 42 days at June 30, 2007. |
And was partially offset by a decrease in working capital primarily due to the following:
|
|
|
Accounts payable, accrued expenses and other current liabilities increased $52.4 million
primarily due to $20 million of marketable securities purchased at the end of June 2007,
which had not yet been settled, $8.7 million related to accrued inventory purchases,
increased accruals to support our European launch of REVLIMID® and continued
research and development and other outside service costs to support our continued growth. |
Financial Condition
We invest our excess cash primarily in money market funds and in highly liquid debt instruments of
the U.S. Treasury, government-sponsored agencies and U.S. corporations. 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.
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.
Our convertible 1.75% notes mature in June 2008 and are convertible at any time into 33,013,778
shares of common stock at a stock-adjusted conversion price of $12.1125 per share. The dilution
effect of our convertible debt is included in our diluted earnings per share calculation. Based on
the current price of our common stock, we 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.
30
Contractual Obligations
For a discussion of our contractual obligations, see Item 7. Managements Discussion and Analysis
of Financial Condition and Results of Operations in our Annual Report on Form 10-K for fiscal year
2006. During the six-month period ended June 30, 2007, we purchased product from GSK of $24.5
million related to our ALKERAN® supply agreements. We have provided a liability for
unrecognized tax benefits related to various federal, state and foreign income tax matters of
$133.7 million, at June 30, 2007. The timing of the settlement of these amounts was not reasonably
estimable at June 30, 2007. There were no other significant changes to our contractual obligations
during the six months ended June 30, 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 fiscal year ended December 31, 2006. Our critical accounting policies are disclosed in the
Managements Discussion and Analysis of Financial Condition and Results of Operations of our Annual
Report on Form 10-K for the fiscal 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. We had no cumulative effect adjustment related to the adoption. We account for
interest and penalties related to uncertain tax positions as part of our provision for income
taxes. We provide estimates for unrecognized tax benefits. If our estimates are not
representative of actual outcomes, our results could be materially impacted.
|
|
|
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 June 30, 2007, our market risk
sensitive instruments consisted of derivatives, marketable securities available for sale, unsecured
convertible notes issued by us and our note payable to Siegfried.
31
Derivatives: We periodically utilize foreign currency denominated forward contracts to hedge
currency fluctuations of transactions denominated in currencies other than the functional currency.
At June 30, 2007, we had foreign currency forward contracts outstanding to hedge non-functional
currency assets denominated in Swiss Francs, Euros and U.S. dollars. The aggregate notional amount
of these contracts was $51.0 million and they expire within one year. As the hedges are
undesignated for accounting purposes, changes in the fair
value are re-measured through income each period. At June 30, 2007, the net unrealized gain on the
forward contracts was approximately $0.8 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
were to change by a hypothetical 10% decrease in the underlying currencies, the fair value of the
contracts would decrease by approximately $4.1 million. Conversely, a hypothetical 10% increase in
the underlying exchange rates would increase the fair value of the contracts by approximately $4.7
million. However, since the contracts hedge assets denominated in currencies other than the
entitys functional currency, any change in the fair value of the contract would be offset by a
change in the underlying value of the hedged items.
Marketable Securities Available for Sale: At June 30, 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.
As of June 30, 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 |
|
|
More Than 5 |
|
|
|
|
(In thousands $) |
|
Year |
|
|
Years |
|
|
Years |
|
|
Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
$ |
212,177 |
|
|
$ |
773,248 |
|
|
$ |
301,424 |
|
|
$ |
34,400 |
|
|
$ |
1,321,249 |
|
Fair value |
|
$ |
211,456 |
|
|
$ |
768,905 |
|
|
$ |
286,242 |
|
|
$ |
31,142 |
|
|
$ |
1,297,745 |
|
Stated average interest rate |
|
|
5.3 |
% |
|
|
5.5 |
% |
|
|
5.5 |
% |
|
|
3.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmion Common Stock: At June 30, 2007, we held a total of 1,939,598 shares of Pharmion
Corporation common stock, which had an estimated fair value of approximately $56.2 million (based
on the closing price reported by the NASDAQ Global Market), and which exceeded the cost by
approximately $35.9 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 33,013,778
shares of common stock at a stock-split adjusted conversion price of $12.1125 per share. At June
30, 2007, the fair value of the convertible notes exceeded the carrying value of $399.9 million by
approximately $1.493 billion, which we believe reflects the increase in the market price of our
common stock to $57.33 per share as of June 30, 2007.
32
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 June 30, 2007, the fair value of our note payable to Siegfried approximated the
carrying value of the note of $33.0 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.
(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 Annual Report on
Form 10-K for fiscal year 2006. There have not been any material changes as it pertains to such
legal proceedings nor have we engaged in any additional material legal proceedings during the six
months ended June 30, 2007.
The risk factors included in our Annual Report on Form 10-K for fiscal year 2006 have not
materially changed as of June 30, 2007.
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
None.
|
|
|
Item 3. |
|
Defaults Upon Senior Securities |
None.
33
|
|
|
Item 4. |
|
Submission of Matters to a Vote of Security Holders |
We held our Annual Meeting of stockholders on June 12, 2007. At this meeting, our stockholders
were asked to elect nine directors and to ratify the appointment of KPMG LLP as our registered
public accounting firm for the fiscal year ending December 31, 2007. All nine nominated directors
were elected and the proposal to appoint KPMG LLP as auditors was approved. The election of
directors and appointment of KPMG LLP were approved by the following votes:
A. Election of Directors:
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
Name |
|
For |
|
Withheld |
Sol J. Barer, Ph.D |
|
|
332,155,147 |
|
|
|
9,038,576 |
|
Robert J. Hugin |
|
|
330,294,986 |
|
|
|
10,898,737 |
|
Michael D. Casey |
|
|
334,169,292 |
|
|
|
7,024,431 |
|
Rodman L. Drake |
|
|
334,685,771 |
|
|
|
6,507,952 |
|
Arthur Hull Hayes, Jr., M.D. |
|
|
332,017,723 |
|
|
|
9,176,000 |
|
Gilla Kaplan, Ph.D |
|
|
338,023,238 |
|
|
|
3,170,485 |
|
James J. Loughlin |
|
|
338,329,757 |
|
|
|
2,863,966 |
|
Richard C.E. Morgan |
|
|
331,589,946 |
|
|
|
9,603,777 |
|
Walter L. Robb, Ph.D |
|
|
332,149,432 |
|
|
|
9,044,291 |
|
B. Appointment of KPMG LLP as auditors:
|
|
|
|
|
Number of Shares |
For |
|
Against |
|
Abstained |
338,314,087
|
|
1,000,820
|
|
1,878,816 |
|
|
|
ITEM 5. |
|
OTHER INFORMATION |
None.
10.1 |
|
Amendment No. 5 to the Celgene Corporation 1995 Non-Employee Directors Incentive Plan (amended and restated
as of June 22, 1999 and as further amended). |
31.1 |
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Sec. 1350, as
adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 |
|
Certification by the Companys Chief Financial Officer Officer pursuant to 18 U.S.C. Sec.
1350, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 |
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350 as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2 |
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
34
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 August 6, 2007 |
By: |
/s/David W. Gryska
|
|
|
|
David W. Gryska |
|
|
|
Sr. Vice President and
Chief Financial Officer |
|
|
|
|
|
DATE August 6, 2007 |
By: |
/s/Andre Van Hoek
|
|
|
|
Andre Van Hoek |
|
|
|
Controller and
Chief Accounting Officer |
|
|
35
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No. |
|
Description |
|
|
|
10.1 |
|
Amendment No. 5 to the Celgene
Corporation 1995 Non-Employee Directors Incentive Plan (amended and restated as of June 22, 1999 and as further amended). |
|
|
|
31.1
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Sec. 1350, as
adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification by the Companys Chief Financial Officer Officer pursuant to 18 U.S.C. Sec.
1350, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350 as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2
|
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
36