Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2009
OR
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 0-16132
CELGENE CORPORATION
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
|
22-2711928 |
|
|
|
(State or other jurisdiction of incorporation
|
|
(I.R.S. Employer Identification |
or organization)
|
|
Number) |
|
|
|
86 Morris Avenue, Summit, NJ
|
|
07901 |
|
|
|
(Address of principal executive offices)
|
|
(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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
At April 29, 2009, 460,288,544 shares of Common Stock, par value $.01 per share, were outstanding.
CELGENE CORPORATION
FORM 10-Q TABLE OF CONTENTS
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(Dollars in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
576,232 |
|
|
$ |
431,374 |
|
Collaborative agreements and other revenue |
|
|
2,244 |
|
|
|
4,768 |
|
Royalty revenue |
|
|
26,577 |
|
|
|
26,455 |
|
|
|
|
|
|
|
|
Total revenue |
|
|
605,053 |
|
|
|
462,597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization
of acquired intangible assets) |
|
|
64,299 |
|
|
|
44,724 |
|
Research and development |
|
|
181,248 |
|
|
|
156,877 |
|
Selling, general and administrative |
|
|
173,440 |
|
|
|
140,451 |
|
Amortization of acquired intangible assets |
|
|
23,625 |
|
|
|
9,842 |
|
Acquired in-process research and development |
|
|
|
|
|
|
1,740,000 |
|
|
|
|
|
|
|
|
Total expenses |
|
|
442,612 |
|
|
|
2,091,894 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
162,441 |
|
|
|
(1,629,297 |
) |
|
|
|
|
|
|
|
|
|
Other income and expense: |
|
|
|
|
|
|
|
|
Interest and investment income, net |
|
|
17,453 |
|
|
|
29,623 |
|
Equity in losses of affiliated companies |
|
|
771 |
|
|
|
5,079 |
|
Interest expense |
|
|
464 |
|
|
|
2,210 |
|
Other income, net |
|
|
32,610 |
|
|
|
922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
211,269 |
|
|
|
(1,606,041 |
) |
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
48,386 |
|
|
|
35,047 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
162,883 |
|
|
$ |
(1,641,088 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.35 |
|
|
$ |
(3.98 |
) |
Diluted |
|
$ |
0.35 |
|
|
$ |
(3.98 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares (in thousands): |
|
|
|
|
|
|
|
|
Basic |
|
|
459,583 |
|
|
|
412,263 |
|
|
|
|
|
|
|
|
Diluted |
|
|
468,105 |
|
|
|
412,263 |
|
|
|
|
|
|
|
|
See accompanying Notes to Unaudited Consolidated Financial Statements
1
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Dollars in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
953,705 |
|
|
$ |
1,092,386 |
|
Marketable securities available for sale |
|
|
1,439,640 |
|
|
|
1,129,705 |
|
Accounts receivable, net of allowances of $11,434 and $9,391
at March 31, 2009 and December 31, 2008, respectively |
|
|
339,902 |
|
|
|
312,243 |
|
Inventory |
|
|
97,255 |
|
|
|
100,176 |
|
Deferred income taxes |
|
|
18,200 |
|
|
|
16,415 |
|
Other current assets |
|
|
173,801 |
|
|
|
190,441 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
3,022,503 |
|
|
|
2,841,366 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
251,114 |
|
|
|
248,971 |
|
Investment in affiliated companies |
|
|
18,685 |
|
|
|
18,392 |
|
Intangible assets, net |
|
|
407,681 |
|
|
|
434,764 |
|
Goodwill |
|
|
586,326 |
|
|
|
588,822 |
|
Other assets |
|
|
320,083 |
|
|
|
312,955 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
4,606,392 |
|
|
$ |
4,445,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
60,579 |
|
|
$ |
53,859 |
|
Accrued expenses |
|
|
271,130 |
|
|
|
306,120 |
|
Income taxes payable |
|
|
13,026 |
|
|
|
51,162 |
|
Current portion of deferred revenue |
|
|
1,860 |
|
|
|
1,419 |
|
Other current liabilities |
|
|
69,633 |
|
|
|
114,688 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
416,228 |
|
|
|
527,248 |
|
|
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion |
|
|
3,125 |
|
|
|
3,127 |
|
Non-current income taxes payable |
|
|
366,980 |
|
|
|
358,578 |
|
Other non-current liabilities |
|
|
64,980 |
|
|
|
64,989 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
851,313 |
|
|
|
953,942 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value per share, 5,000,000 shares
authorized; none outstanding at March 31, 2009 and December 31, 2008, respectively |
|
|
|
|
|
|
|
|
Common stock, $.01 par value per share, 575,000,000 shares authorized; issued
464,107,256 and 463,274,296 shares at March 31, 2009 and December 31, 2008,
respectively |
|
|
4,641 |
|
|
|
4,633 |
|
Common stock in treasury, at cost; 4,000,498 and 4,144,667 shares
at March 31, 2009 and December 31, 2008, respectively |
|
|
(151,706 |
) |
|
|
(157,165 |
) |
Additional paid-in capital |
|
|
5,272,944 |
|
|
|
5,180,397 |
|
Accumulated deficit |
|
|
(1,246,110 |
) |
|
|
(1,408,993 |
) |
Accumulated other comprehensive loss |
|
|
(124,690 |
) |
|
|
(127,544 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
3,755,079 |
|
|
|
3,491,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
4,606,392 |
|
|
$ |
4,445,270 |
|
|
|
|
|
|
|
|
See accompanying Notes to Unaudited Consolidated Financial Statements
2
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
162,883 |
|
|
$ |
(1,641,088 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation of long-term assets |
|
|
9,521 |
|
|
|
7,497 |
|
Amortization of intangible assets |
|
|
23,762 |
|
|
|
9,942 |
|
Allocation of pre-paid royalties |
|
|
7,844 |
|
|
|
|
|
Provision for accounts receivable allowances |
|
|
1,242 |
|
|
|
2,046 |
|
Deferred income taxes |
|
|
(11,681 |
) |
|
|
(392 |
) |
Acquired in-process research and development |
|
|
|
|
|
|
1,740,000 |
|
Share-based compensation expense |
|
|
32,421 |
|
|
|
21,276 |
|
Equity in losses of affiliated companies |
|
|
771 |
|
|
|
5,079 |
|
Share-based employee benefit plan expense |
|
|
1,773 |
|
|
|
2,135 |
|
Unrealized change in value of foreign currency forward contracts |
|
|
(15,485 |
) |
|
|
817 |
|
Other, net |
|
|
(3,531 |
) |
|
|
(770 |
) |
|
|
|
|
|
|
|
|
|
Change in current assets and liabilities, excluding the effect of acquisition: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(30,931 |
) |
|
|
(38,147 |
) |
Inventory |
|
|
(2,564 |
) |
|
|
(7,235 |
) |
Other operating assets |
|
|
(3,124 |
) |
|
|
(4,362 |
) |
Accounts payable and other operating liabilities |
|
|
(18,550 |
) |
|
|
(48,657 |
) |
Income tax payable |
|
|
(27,724 |
) |
|
|
14,548 |
|
Deferred revenue |
|
|
490 |
|
|
|
871 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
127,117 |
|
|
|
63,560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sales of marketable securities available for sale |
|
|
412,606 |
|
|
|
563,272 |
|
Purchases of marketable securities available for sale |
|
|
(704,613 |
) |
|
|
(194,629 |
) |
Payments for acquisition of business, net of cash acquired |
|
|
|
|
|
|
(746,009 |
) |
Capital expenditures |
|
|
(20,974 |
) |
|
|
(18,149 |
) |
Investment in affiliated companies |
|
|
(1,064 |
) |
|
|
(1,339 |
) |
Purchases of investment securities |
|
|
(750 |
) |
|
|
(4,762 |
) |
Other |
|
|
3,333 |
|
|
|
8,275 |
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(311,462 |
) |
|
|
(393,341 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Net proceeds from exercise of common stock options and warrants |
|
|
11,860 |
|
|
|
23,249 |
|
Excess tax benefit from share-based compensation arrangements |
|
|
44,751 |
|
|
|
12,303 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
56,611 |
|
|
|
35,552 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of currency rate changes on cash and cash equivalents |
|
|
(10,947 |
) |
|
|
14,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(138,681 |
) |
|
|
(280,148 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
1,092,386 |
|
|
|
1,218,273 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
953,705 |
|
|
$ |
938,125 |
|
|
|
|
|
|
|
|
See accompanying Notes to Unaudited Consolidated Financial Statements
3
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(Unaudited)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing activity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in net unrealized loss on marketable securities available for sale |
|
$ |
(16 |
) |
|
$ |
91,226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matured shares tendered in connection with stock option exercises |
|
$ |
|
|
|
$ |
(1,554 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes |
|
$ |
|
|
|
$ |
43 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
1,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
42,491 |
|
|
$ |
528 |
|
|
|
|
|
|
|
|
See accompanying Notes to Unaudited Consolidated Financial Statements
4
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
(In all accompanying tables, amounts of dollars expressed in thousands,
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. The Companys commercial stage products include
REVLIMID®, THALOMID® (inclusive of Thalidomide PharmionTM,
subsequent to the acquisition of Pharmion Corporation, or Pharmion), VIDAZA® and
FOCALIN®. ALKERAN® was licensed from GlaxoSmithKline, or GSK, and sold under
the Celgene label through March 31, 2009, the conclusion of the ALKERAN® license with
GSK. FOCALIN® is sold exclusively to Novartis Pharma AG, or Novartis. The Company also
derives revenues from a licensing agreement with Novartis, which entitles it to royalties on
FOCALIN XR® and the entire RITALIN® family of drugs, and sales of
bio-therapeutic products and services through the Companys 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 interim
reporting. 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 intercompany 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 immaterial reclassifications have been made to the
prior period consolidated financial statements in order to conform to
the current period 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, 2008, or the 2008 Annual Report on Form 10-K.
The preparation of the consolidated financial statements requires management to make estimates and
assumptions that affect reported amounts and disclosures. Actual results could differ from those
estimates. The Company is subject to certain risks and uncertainties related to product
development, regulatory approval, market acceptance, scope of patent and proprietary rights,
competition, technological change and product liability.
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.
Significant Accounting Policies: The Companys significant accounting policies are described in
Note 1 of the Notes to the Consolidated Financial Statements included in the 2008 Annual Report on
Form 10-K.
New Accounting Pronouncements: In September 2006, the Financial Accounting Standards Board, or
FASB, issued Statement of Financial Accounting Standards, or SFAS, No. 157, Fair Value
Measurements, or SFAS 157, which establishes a framework for measuring fair value and expands
disclosures about fair value measurements. The FASB partially deferred the effective date of SFAS
157 for non-financial assets and liabilities that are recognized or disclosed at fair value in the
financial statements on a nonrecurring basis to fiscal years beginning after November 15, 2008.
The Companys adoption of SFAS 157 related to non-financial assets beginning January 1, 2009 did
not have a material impact on the Companys consolidated financial statements.
5
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In December 2007, the FASB ratified Emerging Issues Task Force, or EITF, Issue No. 07-1,
Accounting for Collaborative Arrangements Related to the Development and Commercialization of
Intellectual Property, or EITF 07-1, which provides guidance on how the parties to a collaborative
agreement should account for costs incurred and revenue generated on sales to third parties, how
sharing payments pursuant to a collaboration agreement should be presented in the income statement
and certain related disclosure requirements. EITF 07-1 was effective for the Company beginning
January 1, 2009 on a retrospective basis and did not have any impact on the Companys consolidated
financial statements.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations, or SFAS 141R, which
replaces FASB Statement No. 141, Business Combinations, and requires an acquirer to recognize the
assets acquired, the liabilities assumed and any noncontrolling interest in the acquiree at the
acquisition date, measured at their fair values as of that date, with limited exceptions.
SFAS 141R amended SFAS No. 109, Accounting for Income Taxes, or SFAS 109, and FASB Interpretation
No., or FIN, 48, Accounting for Uncertainty in Income Taxes an Interpretation of FASB Statement
No. 109, or FIN 48. Previously, SFAS 109 and FIN 48, respectively, generally required
post-acquisition adjustments to a business combination related deferred tax asset valuation
allowance and liabilities related to uncertain tax positions to be recorded as an increase or
decrease to goodwill. SFAS 141R does not permit this accounting and generally will require any
such changes to be recorded in current period income tax expense. Thus, after SFAS 141R is
adopted, all changes to valuation allowances and liabilities related to uncertain tax positions
from an acquisition (whether the combination was accounted for under SFAS 141 or SFAS 141R) must be
recognized in current period income tax expense. SFAS 141R was effective for the Company beginning
January 1, 2009 and the Company will account for future business combinations in accordance with
its provisions.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an Amendment of ARB No. 51, or SFAS 160, which changes the accounting for and
reporting of noncontrolling interests (formerly known as minority interests) in consolidated
financial statements. SFAS 160 was effective for the Company beginning January 1, 2009 and did not
have any impact on the Companys consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging
Activities, or SFAS 161, which is intended to improve financial reporting about derivative
instruments and hedging activities by requiring enhanced disclosures to enable investors to better
understand their effects on an entitys financial position, financial performance and cash flows.
SFAS 161 was effective for the Company beginning January 1, 2009. See Note 6 for expanded
disclosures required by SFAS 161.
In April 2008, the FASB issued FASB Staff Position, or FSP, No. FAS 142-3, Determination of the
Useful Life of Intangible Assets, or FSP FAS 142-3. FSP FAS 142-3 amends the factors that should
be considered in developing renewal or extension assumptions used to determine the useful life of a
recognized intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets. FSP
FAS142-3 was effective for the Company beginning January 1, 2009 and did not have any impact on the
Companys consolidated financial statements.
In May 2008, the FASB issued FSP No. APB 14-1, Accounting for Convertible Debt Instruments That
May Be Settled in Cash upon Conversion (Including Partial Cash Settlement), or FSP APB 14-1, which
requires separate accounting for the debt and equity components of convertible debt issuances that
have a cash settlement feature permitting settlement partially or fully in cash upon conversion. A
component of such debt issuances representative of the approximate fair value of the conversion
feature at inception should be bifurcated and recorded to equity, with the resulting debt discount
amortized to interest expense in a manner that reflects the issuers nonconvertible, unsecured debt
borrowing rate. The requirements for separate accounting must be applied retrospectively to
previously issued convertible debt issuances as well as prospectively to newly issued convertible
debt issuances, negatively affecting both net income and earnings
per share, in financial statements issued for fiscal years beginning after December 15, 2008.
Since the Companys past convertible debt issuance did not include a cash settlement feature, the
adoption of FSP APB 14-1 did not have any impact on its consolidated financial statements.
6
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In June 2008, the FASB issued FSP EITF No. 03-6-1, Determining Whether Instruments Granted in
Share-Based Payment Transactions Are Participating Securities, or FSP EITF 03-6-1. The FSP
addresses whether instruments granted in share-based payment transactions are participating
securities prior to vesting and therefore need to be included in the earnings allocation in
calculating earnings per share under the two-class method described in SFAS No. 128, Earnings per
Share. The FSP requires companies to treat unvested share-based payment awards that have
non-forfeitable rights to dividends or dividend equivalents as a separate class of securities in
calculating earnings per share. FSP EITF 03-6-1 was effective for the Company beginning January 1,
2009. Since the Companys past share-based payment awards did not include non-forfeitable rights
to dividends or dividend equivalents, the adoption of FSP EITF 03-6-1 did not have any impact on
its consolidated financial statements.
In November 2008, the FASB ratified EITF Issue No. 08-6, Equity Method Investment Accounting
Considerations, or EITF 08-6, which clarifies the accounting for certain transactions and
impairment considerations involving equity method investments. EITF 08-6 was effective for the
Company beginning January 1, 2009 and did not have any impact on the Companys consolidated
financial statements.
In November 2008, the FASB ratified EITF Issue No. 08-7, Accounting for Defensive Intangible
Assets, or EITF 08-7, which clarifies the accounting for certain separately identifiable
intangible assets which an acquirer does not intend to actively use but intends to hold to prevent
its competitors from obtaining access to them. EITF 08-7 requires an acquirer in a business
combination to account for a defensive intangible asset as a separate unit of accounting which
should be amortized to expense over the period the asset diminishes in value. EITF 08-7 was
effective for the Company beginning January 1, 2009 and the Company will account for defensive
intangible assets acquired in future business combinations in accordance with its provisions.
In April 2009, the FASB issued FSP FAS 157-4, Determining Fair Value When the Volume and Level of
Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That
Are Not Orderly, or FSP FAS 157-4. FSP FAS 157-4 amends SFAS 157 and provides additional guidance
for estimating fair value in accordance with SFAS 157 when the volume and level of activity for the
asset or liability have significantly decreased and also includes guidance on identifying
circumstances that indicate a transaction is not orderly for fair value measurements. This FSP
shall be applied prospectively with retrospective application not permitted. This FSP shall be
effective for interim and annual periods ending after June 15, 2009, with early adoption permitted
for periods ending after March 15, 2009. An entity early adopting this FSP must also early adopt
FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments, or
FSP FAS 115-2 and FAS 124-2. Additionally, if an entity elects to early adopt either FSP FAS 107-1
and APB 28-1, Interim Disclosures about Fair Value of Financial Instruments, or FSP FAS 107-1 and
APB 28-1, or FSP FAS 115-2 and FAS 124-2, it must also elect to early adopt this FSP. The Company
did not early adopt FSP FAS 157-4 and is currently evaluating the impact that the adoption of FSP
FAS 157-4 will have, if any, on its consolidated financial statements.
7
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In April 2009, the FASB issued FSP FAS 115-2 and FAS 124-2. This FSP amends SFAS 115, Accounting
for Certain Investments in Debt and Equity Securities, SFAS 124, Accounting for Certain
Investments Held by Not-for-Profit Organizations, and EITF Issue No. 99-20, Recognition of
Interest Income and Impairment on Purchased Beneficial Interests and Beneficial Interests That
Continue to Be Held by a Transferor in Securitized Financial Assets, to make the
other-than-temporary impairments guidance more operational and to improve the presentation of
other-than-temporary impairments in the financial statements. This FSP will replace the existing
requirement that the entitys management assert it has both the intent and ability to hold an
impaired debt security until recovery with a requirement that management assert it does not have
the intent to sell the security, and it is more likely than not it will not have to sell the
security before recovery of its cost basis. This FSP provides increased disclosure about the
credit and noncredit components
of impaired debt securities that are not expected to be sold and also requires increased and more
frequent disclosures regarding expected cash flows, credit losses, and an aging of securities with
unrealized losses. Although this FSP does not result in a change in the carrying amount of debt
securities, it does require that the portion of an other-than-temporary impairment not related to a
credit loss for a held-to-maturity security be recognized in a new category of other comprehensive
income and be amortized over the remaining life of the debt security as an increase in the carrying
value of the security. This FSP shall be effective for interim and annual periods ending after
June 15, 2009, with early adoption permitted for periods ending after March 15, 2009. An entity
may early adopt this FSP only if it also elects to early adopt FSP FAS 157-4. Also, if an entity
elects to early adopt either FSP FAS 157-4 or FSP FAS 107-1 and APB 28-1, the entity also is
required to early adopt this FSP. The Company did not early adopt FSP FAS 115-2 and FAS 124-2 and
is currently evaluating the impact that the adoption of FSP FAS 115-2 and FAS 124-2 will have, if
any, on its consolidated financial statements.
In April 2009, the FASB issued FSP FAS 107-1 and APB 28-1. This FSP amends SFAS No. 107,
Disclosures about Fair Value of Financial Instruments, to require disclosures about fair value of
financial instruments not measured on the balance sheet at fair value in interim financial
statements as well as in annual financial statements. Prior to this FSP, fair values for these
assets and liabilities were only disclosed annually. This FSP applies to all financial instruments
within the scope of SFAS 107 and requires all entities to disclose the method(s) and significant
assumptions used to estimate the fair value of financial instruments. This FSP shall be effective
for interim periods ending after June 15, 2009, with early adoption permitted for periods ending
after March 15, 2009. An entity may early adopt this FSP only if it also elects to early adopt FSP
FAS 157-4 and FSP FAS 115-2 and FAS 124-2. This FSP does not require disclosures for earlier
periods presented for comparative purposes at initial adoption. In periods after initial adoption,
this FSP requires comparative disclosures only for periods ending after initial adoption. The
Company did not early adopt FSP FAS 107-1 and APB 28-1 and is currently evaluating the impact that
the adoption of FSP FAS 107-1 and APB 28-1 will have, if any, on its consolidated financial
statements.
In April 2009, the FASB issued FSP FAS 141R-1, Accounting for Assets Acquired and Liabilities
Assumed in a Business Combination That Arise from Contingencies, or FSP FAS 141R-1. FSP FAS
141R-1 amends and clarifies SFAS No. 141R to address application issues associated with initial
recognition and measurement, subsequent measurement and accounting, and disclosure of assets and
liabilities arising from contingencies in a business combination. FSP FAS 141R-1 was effective for
the Company beginning January 1, 2009 and the Company will account for assets or liabilities
arising from contingencies acquired in future business combinations in accordance with its
provisions.
8
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. Acquisition of Pharmion Corporation
On March 7, 2008, Celgene acquired all of the outstanding common stock and stock options of
Pharmion in a transaction accounted for under the purchase method of accounting for business
combinations. Celgene paid a combination of $920.8 million in cash and approximately 30.8 million
shares of Celgene common stock valued at $1.749 billion to Pharmion shareholders. The operating
results of Pharmion are included in the Companys consolidated financial statements from the date
of acquisition.
The following table provides unaudited pro forma financial information for the quarter ended March
31, 2008 as if the acquisition of Pharmion had occurred as of the beginning of the quarter
presented. For the quarter presented, the unaudited pro forma results include the nonrecurring
charge for in-process research and development, or IPR&D, amortization of acquired intangible
assets, elimination of expense and income related to pre-acquisition agreements with Pharmion,
reduced interest and investment income attributable to cash paid for the acquisition and the
amortization of the inventory step-up to fair value of acquired Pharmion product inventories. The
unaudited pro forma results do not reflect any operating efficiencies or potential cost savings
that may result from the combined operations of Celgene and Pharmion. Accordingly, these unaudited
pro forma results are presented for illustrative purposes and are not intended to represent or be
indicative of the actual results of operations of the combined company that would have been
achieved had the acquisition occurred at the beginning of the period presented, nor are they
intended to represent or be indicative of future results of operations.
|
|
|
|
|
|
|
Three-Month Period |
|
|
|
Ended |
|
|
|
March 31, 2008 |
|
|
|
Total revenue |
|
$ |
483,728 |
|
Net loss |
|
$ |
(1,650,543 |
) |
|
|
|
|
|
Net loss per common share: basic and diluted |
|
$ |
(4.09 |
) |
3. Restructuring
The March 7, 2008 acquisition cost of Pharmion included $58.6 million in restructuring liabilities
primarily related to the planned exit of certain business activities, involuntary terminations and
the relocation of certain Pharmion employees. The remaining balance of these restructuring
liabilities totaled $27.6 million as of December 31, 2008. The following table summarizes changes
to the restructuring liabilities during the three-month period ended March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
Cumulative |
|
|
|
December 31, 2008 |
|
|
Payments |
|
|
Adjustments(1) |
|
|
March 31, 2009 |
|
|
Payments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Severance costs |
|
$ |
1,654 |
|
|
$ |
(1,229 |
) |
|
$ |
|
|
|
$ |
425 |
|
|
$ |
17,013 |
|
Contract termination fees |
|
|
22,485 |
|
|
|
(150 |
) |
|
|
(434 |
) |
|
|
21,901 |
|
|
|
8,816 |
|
Facility closing costs |
|
|
2,664 |
|
|
|
(572 |
) |
|
|
|
|
|
|
2,092 |
|
|
|
3,503 |
|
Other |
|
|
834 |
|
|
|
(342 |
) |
|
|
|
|
|
|
492 |
|
|
|
3,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total restructuring costs |
|
$ |
27,637 |
|
|
$ |
(2,293 |
) |
|
$ |
(434 |
) |
|
$ |
24,910 |
|
|
$ |
33,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Purchase accounting now closed as of March 31, 2009. |
The
Company expects to finalize the contractual terms of all restructuring activities
during 2009.
9
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. 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 as if the outstanding convertible debt was converted into shares
of common stock and assuming potentially dilutive common shares, resulting from option exercises,
had been issued and any proceeds thereof used to repurchase common stock at the average market
price during the period. The assumed proceeds used to repurchase common stock are 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. As of their maturity
date, June 1, 2008, substantially all of the Companys convertible notes were converted into shares
of common stock.
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
Net income (loss) for basic and diluted computation |
|
$ |
162,883 |
|
|
$ |
(1,641,088 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
459,583 |
|
|
|
412,263 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
Options, warrants and other incentives |
|
|
8,522 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
468,105 |
|
|
|
412,263 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.35 |
|
|
$ |
(3.98 |
) |
Diluted |
|
$ |
0.35 |
|
|
$ |
(3.98 |
) |
The total number of potential common shares excluded from the diluted earnings per share
computation because their inclusion would have been anti-dilutive was 17,662,587 and 50,546,244
shares for the three-month periods ended March 31, 2009 and 2008, respectively. All of the
potentially dilutive securities for the three-month period ended March 31, 2008 were determined to
be anti-dilutive due to the net loss reported.
10
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. Comprehensive Income (Loss)
The components of comprehensive income (loss) consist of net income (loss), changes in pension
liability, the after-tax effects of changes in net unrealized gains (losses) on marketable
securities classified as available-for-sale, net unrealized gains (losses) related to cash flow
hedges and changes in foreign currency translation adjustments.
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
Net income (loss) |
|
$ |
162,883 |
|
|
$ |
(1,641,088 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on marketable
securities available for sale, net of tax |
|
|
1,827 |
|
|
|
6,967 |
|
Reversal of unrealized gains on Pharmion
investment, net of tax |
|
|
|
|
|
|
(62,806 |
) |
Reclassification adjustment for losses
included in net income (loss) |
|
|
(4,967 |
) |
|
|
(1,289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive losses related to
marketable securities available for sale, net of tax |
|
|
(3,140 |
) |
|
|
(57,128 |
) |
Net unrealized gains related to cash flow
hedges, net of tax |
|
|
52,759 |
|
|
|
|
|
Currency translation adjustments |
|
|
(46,765 |
) |
|
|
25,724 |
|
|
|
|
|
|
|
|
Total other comprehensive income (loss) items |
|
|
2,854 |
|
|
|
(31,404 |
) |
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
165,737 |
|
|
$ |
(1,672,492 |
) |
|
|
|
|
|
|
|
6. Financial Instruments and Fair Value Measurement
The table below presents information about assets and liabilities that are measured at fair value
on a recurring basis as of March 31, 2009 and the valuation techniques the Company utilized to
determine such fair value. In general, fair values determined based on Level 1 inputs utilize
quoted prices (unadjusted) in active markets for identical assets or liabilities. The Companys
Level 1 assets consist of marketable equity securities. Fair values determined based on Level 2
inputs utilize observable quoted prices for similar assets and liabilities in active markets and
observable quoted prices for identical or similar assets in markets that are not very active. The
Companys Level 2 assets consist of U.S. Treasury fixed rate securities, U.S. government-sponsored
agency fixed rate securities, U.S. government-sponsored agency mortgage-backed fixed rate
obligations, Federal Deposit Insurance Corporation, or FDIC, guaranteed fixed rate corporate debt,
forward currency contracts and warrants for the purchase of equity securities. Fair values
determined based on Level 3 inputs utilize unobservable inputs and include valuations of assets or
liabilities for which there is little, if any, market activity. The Companys Level 3 assets
consist of a private cash fund with a carrying value calculated pursuant to the amortized cost
method, which values each investment at its acquisition cost as adjusted for amortization of
premium or accumulation of discount over the investments remaining life, net of impairment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant |
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Other Observable |
|
|
Unobservable |
|
|
|
Balance at |
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
March 31, 2009 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities |
|
$ |
1,439,640 |
|
|
$ |
510 |
|
|
$ |
1,430,812 |
|
|
$ |
8,318 |
|
Cash equivalents |
|
|
29,840 |
|
|
|
|
|
|
|
29,840 |
|
|
|
|
|
Forward currency contracts |
|
|
11,231 |
|
|
|
|
|
|
|
11,231 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,480,711 |
|
|
$ |
510 |
|
|
$ |
1,471,883 |
|
|
$ |
8,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant |
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Other Observable |
|
|
Unobservable |
|
|
|
Balance at |
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
December 31, 2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities |
|
$ |
1,129,705 |
|
|
$ |
407 |
|
|
$ |
1,118,244 |
|
|
$ |
11,054 |
|
Forward currency contracts |
|
|
(57,486 |
) |
|
|
|
|
|
|
(57,486 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,072,219 |
|
|
$ |
407 |
|
|
$ |
1,060,758 |
|
|
$ |
11,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table is a roll-forward of the fair value of the private cash fund, determined by
Level 3 (significant unobservable) inputs:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Balance at beginning of period |
|
$ |
11,054 |
|
|
$ |
37,038 |
|
Total gains or losses (realized and unrealized) |
|
|
|
|
|
|
|
|
Settlements |
|
|
(2,736 |
) |
|
|
(15,299 |
) |
Transfers in and/or out of Level 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of period |
|
$ |
8,318 |
|
|
$ |
21,739 |
|
|
|
|
|
|
|
|
Foreign Currency Forward Contracts: Effective January 1, 2009, the Company adopted SFAS 161 and
enhanced its disclosures for derivative instruments and hedging activities by providing additional
information about its objectives for using derivative instruments, the level of derivative activity
the Company engages in, as well as how derivative instruments and related hedged items affect its
financial position and performance. Since SFAS 161 requires only additional disclosures concerning
derivatives and hedging activities, the adoption of SFAS 161 did not affect the presentation of the
Companys financial position or results of operations.
The Company uses foreign currency forward contracts to hedge specific forecasted transactions
denominated in foreign currencies and to reduce exposures to foreign currency fluctuations of
certain assets and liabilities denominated in foreign currencies.
The Company enters into foreign currency forward contracts to protect against changes in
anticipated foreign currency cash flows resulting from changes in foreign currency exchange rates,
primarily associated with non-functional currency denominated revenues and expenses of foreign
subsidiaries. The foreign currency forward hedging contracts outstanding at March 31, 2009 and
December 31, 2008 had settlement dates within 24 months. These foreign currency forward contracts
are designated as cash flow hedges under SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities, as amended, or SFAS 133, and, accordingly, to the extent effective, any
unrealized gains or losses on them are reported in other comprehensive income (loss), or OCI, and
reclassified to operations in the same periods during which the underlying hedged transactions
affect operations. Any ineffectiveness on these foreign currency forward contracts is reported in
other income, net.
12
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Foreign currency forward contracts entered into to hedge forecasted revenue and expenses were as
follows:
|
|
|
|
|
|
|
|
|
|
|
Notional Amount |
|
Foreign Currency |
|
March 31, 2009 |
|
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
Euro |
|
$ |
587,789 |
|
|
$ |
704,198 |
|
Yen |
|
|
23,829 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
611,618 |
|
|
$ |
704,198 |
|
|
|
|
|
|
|
|
The notional settlement amounts of the foreign currency forward contracts outstanding as of
March 31, 2009 and December 31, 2008 were approximately $611.6 million and $704.2 million,
respectively. The Company considers the impact of its own and the counterparties credit risk on
the fair value of the contracts as well as the ability of each party to execute its obligations
under the contract. As of March 31, 2009 and December 31, 2008, credit risk did not materially
change the fair value of the Companys foreign currency forward contracts.
The Company recognized reductions in net product sales for the settlement of certain effective cash
flow hedge instruments of $0.8 million for the three-month
period ended March 31, 2009 and no reductions for the three-month period ended March 31, 2008. These settlements were recorded in the same period as the related
forecasted sales occurred. The Company recognized reductions in research and development expenses
for the settlement of certain effective cash flow hedge instruments
of $1.0 million for the three-month period ended March 31,
2009 and no reductions for the three-month period ended March 31, 2008. These settlements were
recorded in the same period as the related forecasted research and development expenses occurred.
Changes in time value, which the Company excluded from the hedge effectiveness assessment for the
three-month period ended March 31, 2009, were included in other income, net.
The Company also enters into foreign currency forward contracts to reduce exposures to foreign
currency fluctuations of certain recognized assets and liabilities denominated in foreign
currencies. These foreign currency forward contracts have not been designated as hedges under SFAS
133 and, accordingly, any changes in their fair value are recognized in other income, net in the
current period. The aggregate notional amount of the foreign currency forward non-designated
hedging contracts outstanding at March 31, 2009 and December 31, 2008 were approximately $80.6
million and $56.6 million, respectively.
13
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table summarizes the fair value and presentation in the consolidated balance sheets
for derivative instruments as of March 31, 2009 and December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
|
Asset Derivatives |
|
|
Liability Derivatives |
|
|
|
Balance Sheet |
|
|
|
|
|
Balance Sheet |
|
|
|
Instrument |
|
Location |
|
Fair Value |
|
|
Location |
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts designated as hedging instruments under SFAS 133 |
|
Other current assets |
|
$ |
3,934 |
|
|
Other current liabilities |
|
$ |
5,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts not designated as hedging instruments under SFAS 133 |
|
Other current assets |
|
$ |
13,117 |
|
|
Other current liabilities |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
$ |
17,051 |
|
|
|
|
$ |
5,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
|
Asset Derivatives |
|
|
Liability Derivatives |
|
|
|
Balance Sheet |
|
|
|
|
|
Balance Sheet |
|
|
|
Instrument |
|
Location |
|
Fair Value |
|
|
Location |
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
forward contracts
designated as
hedging instruments
under SFAS 133 |
|
Other current assets |
|
$ |
1,552 |
|
|
Other current liabilities |
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
forward contracts
not designated as
hedging instruments
under SFAS 133 |
|
Other current assets |
|
$ |
30 |
|
|
Other current liabilities |
|
$ |
9,068 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
$ |
1,582 |
|
|
|
|
$ |
59,068 |
|
|
|
|
|
|
|
|
|
|
|
|
14
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table summarizes the effect of derivative instruments designated as hedging
instruments under SFAS 133 on the consolidated statements of operations for the three months ended
March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
|
Amount of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
|
Gain/(Loss) |
|
|
|
|
|
|
|
Location of |
|
|
Amount of |
|
|
Recognized in |
|
|
Recognized in |
|
|
|
Amount of |
|
|
Gain/(Loss) |
|
|
Gain/(Loss) |
|
|
Income on |
|
|
Income on |
|
|
|
Gain/(Loss) |
|
|
Reclassified from |
|
|
Reclassified from |
|
|
Derivative |
|
|
Derivative |
|
|
|
Recognized in OCI |
|
|
Accumulated OCI |
|
|
Accumulated OCI |
|
|
(Amount Excluded |
|
|
(Amount Excluded |
|
|
|
on Derivative |
|
|
into Income |
|
|
into Income |
|
|
From Effectiveness |
|
|
From Effectiveness |
|
Instrument |
|
(Effective Portion) |
|
|
(Effective Portion) |
|
|
(Effective Portion) |
|
|
Testing) |
|
|
Testing) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts |
|
$ |
53,025 |
(1) |
|
Net product sales |
|
$ |
(750 |
) |
|
Other income, net |
|
$ |
(4,610 |
)(2) |
|
|
|
|
|
|
Research and development |
| |
$ |
1,016 |
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Losses of $5,194 are expected to be reclassified from Accumulated OCI into operations in the
next 12 months. |
|
(2) |
|
Hedge ineffectiveness was insignificant and included with the amount excluded from
effectiveness testing. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
|
Amount of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) |
|
|
Gain/(Loss) |
|
|
|
|
|
|
|
Location of |
|
|
Amount of |
|
|
Recognized in |
|
|
Recognized in |
|
|
|
Amount of |
|
|
Gain/(Loss) |
|
|
Gain/(Loss) |
|
|
Income on |
|
|
Income on |
|
|
|
Gain/(Loss) |
|
|
Reclassified from |
|
|
Reclassified from |
|
|
Derivative |
|
|
Derivative |
|
|
|
Recognized in OCI |
|
|
Accumulated OCI |
|
|
Accumulated OCI |
|
|
(Amount Excluded |
|
|
(Amount Excluded |
|
|
|
on Derivative |
|
|
into Income |
|
|
into Income |
|
|
From Effectiveness |
|
|
From Effectiveness |
|
Instrument |
|
(Effective Portion) |
|
|
(Effective Portion) |
|
|
(Effective Portion) |
|
|
Testing) |
|
|
Testing) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
forward contracts |
|
$ |
|
|
|
|
N/A |
|
|
$ |
|
|
|
|
N/A |
|
|
$ |
|
|
The following table summarizes the effect of derivative instruments not designated as hedging
instruments under SFAS 133 on the consolidated statements of operations for the three months ended
March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Location of |
|
|
|
|
|
|
Gain/(Loss) |
|
|
Amount of Gain/(Loss) Recognized in Income |
|
|
|
Recognized in |
|
|
on Derivative |
|
|
|
Income on |
|
|
Three Month periods Ended March 31, |
|
Instrument |
|
Derivative |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts |
|
Other income, net |
|
|
$ |
15,948 |
|
|
$ |
(580 |
) |
15
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. Cash, Cash Equivalents and Marketable Securities Available-for-Sale
Money market funds of $538.9 million and $691.0 million at March 31, 2009 and December 31, 2008,
respectively, were recorded at cost, which approximates fair value and are included in cash and
cash equivalents.
The amortized cost, gross unrealized holding gains, gross unrealized holding losses and estimated
fair value of available-for-sale securities by major security type and class of security at March
31, 2009 and December 31, 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
March 31, 2009 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury securities |
|
$ |
374,937 |
|
|
$ |
5,839 |
|
|
$ |
(5 |
) |
|
$ |
380,771 |
|
U.S. government-sponsored agency securities |
|
|
489,652 |
|
|
|
11,172 |
|
|
|
(82 |
) |
|
|
500,742 |
|
U.S. government-sponsored agency MBS |
|
|
392,452 |
|
|
|
5,810 |
|
|
|
(649 |
) |
|
|
397,613 |
|
FDIC guaranteed corporate debt |
|
|
150,826 |
|
|
|
932 |
|
|
|
(72 |
) |
|
|
151,686 |
|
Private cash fund shares |
|
|
8,318 |
|
|
|
|
|
|
|
|
|
|
|
8,318 |
|
Marketable equity securities |
|
|
407 |
|
|
|
103 |
|
|
|
|
|
|
|
510 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,416,592 |
|
|
$ |
23,856 |
|
|
$ |
(808 |
) |
|
$ |
1,439,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
December 31, 2008 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury securities |
|
$ |
263,541 |
|
|
$ |
8,394 |
|
|
$ |
|
|
|
$ |
271,935 |
|
U.S. government-sponsored agency securities |
|
|
571,072 |
|
|
|
16,985 |
|
|
|
(212 |
) |
|
|
587,845 |
|
U.S. government-sponsored agency MBS |
|
|
229,847 |
|
|
|
3,241 |
|
|
|
(429 |
) |
|
|
232,659 |
|
FDIC guaranteed corporate debt |
|
|
25,546 |
|
|
|
265 |
|
|
|
(6 |
) |
|
|
25,805 |
|
Private cash fund shares |
|
|
11,054 |
|
|
|
|
|
|
|
|
|
|
|
11,054 |
|
Marketable equity securities |
|
|
407 |
|
|
|
|
|
|
|
|
|
|
|
407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,101,467 |
|
|
$ |
28,885 |
|
|
$ |
(647 |
) |
|
$ |
1,129,705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government-sponsored agency securities include general unsecured obligations of the issuing
agency. U.S. government-sponsored mortgage-backed securities, or MBS, include fixed rate
asset-backed securities issued by the Federal National Mortgage Association, the Federal Home Loan
Mortgage Corporation and the Government National Mortgage Association. FDIC guaranteed corporate
debt include obligations of bank holding companies that meet certain criteria set forth under the
Temporary Liquidity Guaranty Program, or TLGP, and are unconditionally guaranteed by the
FDIC. Private cash fund shares are investments in enhanced cash commingled funds. Net unrealized
gains in U.S. Treasury fixed rate securities, U.S. government-sponsored agency fixed rate
securities and U.S. government-sponsored agency mortgage-backed fixed rate obligations, primarily
reflect the impact of decreased interest rates at March 31, 2009 and December 31, 2008.
16
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
During the three-month period ended March 31, 2008, the Company determined that certain securities
had sustained an other-than-temporary impairment partly due to a reduction in future estimated cash
flows and an adverse change in an investees business operations. The Company recognized
impairment losses of $2.5 million, which was recorded in interest and investment income, net.
Duration periods of available-for-sale debt securities were as follows at March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
Duration of one year or less |
|
$ |
270,233 |
|
|
$ |
273,684 |
|
Duration of one through three years |
|
|
1,030,089 |
|
|
|
1,045,233 |
|
Duration of three through five years |
|
|
99,393 |
|
|
|
102,146 |
|
Duration of over five years |
|
|
16,470 |
|
|
|
18,067 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,416,185 |
|
|
$ |
1,439,130 |
|
|
|
|
|
|
|
|
8. Inventory
A summary of inventories by major category at March 31, 2009 and December 31, 2008 follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
16,371 |
|
|
$ |
16,910 |
|
Work in process |
|
|
35,288 |
|
|
|
33,170 |
|
Finished goods |
|
|
45,596 |
|
|
|
50,096 |
|
|
|
|
|
|
|
|
Total |
|
$ |
97,255 |
|
|
$ |
100,176 |
|
|
|
|
|
|
|
|
9. Investment in Affiliated Companies
A summary of the Companys equity investment in affiliated companies follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
Investment in Affiliated Companies |
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Investment in affiliated companies (1) |
|
$ |
15,494 |
|
|
$ |
14,862 |
|
Excess of investment over share of equity (2) |
|
|
3,191 |
|
|
|
3,530 |
|
|
|
|
|
|
|
|
Investment in affiliated companies |
|
$ |
18,685 |
|
|
$ |
18,392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
Equity in Losses of Affiliated Companies |
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Affiliated companies losses (1) |
|
$ |
771 |
|
|
$ |
5,079 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The Company records its interest and share of losses based on its ownership
percentage. |
|
(2) |
|
Consists of goodwill. |
Additional equity investments totaling $1.1 million were made during the three-month period ended
March 31, 2009. The three-month period ended March 31, 2008 included other-than-temporary
impairment losses of $4.4 million. These impairment losses were based on an evaluation of several
factors, including a decrease in fair value of the equity investment below its cost.
17
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Intangible Assets and Goodwill
Intangible Assets: The Companys intangible assets consist of developed product rights from the
Pharmion acquisition, contract-based licenses, technology and an acquired workforce. Remaining
amortization periods related to these categories range from 3 to 12 years. A summary of intangible
assets by category follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
March 31, 2009 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired developed product rights |
|
$ |
530,000 |
|
|
$ |
(125,956 |
) |
|
$ |
404,044 |
|
|
|
6.5 |
|
License |
|
|
4,250 |
|
|
|
(998 |
) |
|
|
3,252 |
|
|
|
13.8 |
|
Technology |
|
|
280 |
|
|
|
(64 |
) |
|
|
216 |
|
|
|
12.6 |
|
Acquired workforce |
|
|
316 |
|
|
|
(147 |
) |
|
|
169 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
534,846 |
|
|
$ |
(127,165 |
) |
|
$ |
407,681 |
|
|
|
6.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
|
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
December 31, 2008 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired developed product rights |
|
$ |
533,339 |
|
|
$ |
(102,331 |
) |
|
$ |
431,008 |
|
|
|
6.5 |
|
License |
|
|
4,250 |
|
|
|
(922 |
) |
|
|
3,328 |
|
|
|
13.8 |
|
Technology |
|
|
290 |
|
|
|
(59 |
) |
|
|
231 |
|
|
|
12.6 |
|
Acquired workforce |
|
|
337 |
|
|
|
(140 |
) |
|
|
197 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
538,216 |
|
|
$ |
(103,452 |
) |
|
$ |
434,764 |
|
|
|
6.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in gross carrying value of intangibles at March 31, 2009 compared to December 31, 2008
was primarily due to elimination of the $3.3 million intangible related to RIMIFON®,
which was obtained in the Pharmion acquisition and sold in March of 2009.
Amortization of intangible assets was $23.8 million and $9.9 million for the three-month periods
ended March 31, 2009 and 2008, respectively. Amortization expense for the three-month period ended
March 31, 2008 only included amortization of the intangible assets related to the Pharmion
acquisition for the period subsequent to the March 7, 2008 acquisition date. Assuming no changes in
the gross carrying amount of intangible assets, the amortization of intangible assets for the next
five years is estimated to be approximately $83.8 million for the year ending December 31, 2009 and
approximately $64.4 million for each of the years ending December 31, 2010 through 2013.
Goodwill: At March 31, 2009, the Companys goodwill related to the March 7, 2008 acquisition of
Pharmion and the October 21, 2004 acquisition of Penn T Limited. The goodwill related to the
Pharmion acquisition reflects the final allocation of the Pharmion purchase price.
The change in carrying value of goodwill is summarized as follows:
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
588,822 |
|
Tax benefit on the exercise of Pharmion converted stock options |
|
|
(118 |
) |
Adjustments to Pharmion assets acquired |
|
|
(444 |
) |
Adjustments to Pharmion restructuring liabilities |
|
|
(434 |
) |
Foreign currency translation |
|
|
(1,500 |
) |
|
|
|
|
Balance at March 31, 2009 |
|
$ |
586,326 |
|
|
|
|
|
18
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. Share-Based Compensation
The following table summarizes the components of share-based compensation expense in the
consolidated statements of operations for the three-month periods ended March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Cost of good sold |
|
$ |
971 |
|
|
$ |
528 |
|
Research and development |
|
|
14,699 |
|
|
|
9,616 |
|
Selling, general and administrative |
|
|
16,854 |
|
|
|
11,132 |
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
32,524 |
|
|
$ |
21,276 |
|
|
|
|
|
|
|
|
Share-based compensation cost included in inventory was $1.3 million at March 31, 2009 and $0.8
million at December 31, 2008.
As of March 31, 2009, there was $297.4 million of unrecognized compensation expense related to the
Companys various stock-based plans. These costs will be recognized over an expected remaining
weighted-average period of 2.6 years.
The weighted-average grant date fair value of the stock options issued during the three-month
periods ended March 31, 2009 and 2008 was $23.85 per share and $21.79 per share, respectively.
There have been no significant changes to the assumptions used to estimate the fair value of
options granted during the three-month period ended March 31, 2009, as compared to those disclosed
for the year ended December 31, 2008 in Note 15 to the Consolidated Financial Statements included
in the Companys 2008 Annual Report on Form 10-K.
Stock option transactions for the three-month period ended March 31, 2009 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, 2008 |
|
|
33,805,610 |
|
|
$ |
40.39 |
|
|
|
6.5 |
|
|
$ |
617,873 |
|
Changes during the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
2,221,942 |
|
|
|
50.60 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(819,960 |
) |
|
|
14.48 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(372,859 |
) |
|
|
59.22 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(27,903 |
) |
|
|
59.76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2009 |
|
|
34,806,830 |
|
|
$ |
41.45 |
|
|
|
6.6 |
|
|
$ |
385,146 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at March 31, 2009 or expected
to vest in the future |
|
|
34,303,254 |
|
|
$ |
41.18 |
|
|
|
6.5 |
|
|
$ |
385,030 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at March 31, 2009 |
|
|
18,823,756 |
|
|
$ |
26.94 |
|
|
|
4.6 |
|
|
$ |
366,920 |
|
The total fair value of shares vested during the three-month periods ended March 31, 2009 and 2008
were $4.1 million and $3.7 million, respectively. The total intrinsic value of stock options
exercised during the three-month periods ended March 31, 2009 and 2008 was $28.9 million and $68.0
million, respectively. The Company primarily utilizes newly issued shares to satisfy the exercise
of stock options.
19
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. Income Taxes
The Company periodically evaluates the likelihood of the realization of its 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.
During the three months ended March 31, 2009, the Company effectively settled an examination with
the Internal Revenue Service, or IRS, for the years ended December 31, 2004 and 2005. The Companys
U.S. federal income tax returns have now been audited by the IRS through the year ended December
31, 2005. The Company is also subject to audits by various state and foreign taxing authorities,
including, but not limited to, most U.S. states and major European and Asian countries where the
Company has operations.
The Company regularly reevaluates its tax positions and the associated interest and potential
penalties, if applicable, resulting from audits of federal, state and foreign income tax filings,
as well as changes in tax law (including regulations, administrative pronouncements, judicial
precedents, etc.) 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. The
Company applies a variety of methodologies in making these estimates and assumptions which include
studies performed by independent economists, advice from industry and subject experts, evaluation
of public actions taken by the IRS and other taxing authorities, as well as the Companys industry
experience. 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, generally represented by liabilities on the balance sheet and all
subject to tax examinations, 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. 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 potential penalties
related to uncertain tax positions as part of its provision for income taxes. During the first
quarter of 2009, the Company effectively settled examinations with the IRS and with a foreign
taxing jurisdiction. The foreign examination related to a subsidiary acquired in the Pharmion
acquisition. These settlements resulted in a net tax benefit of $5.3 million, a decrease in the
liability for unrecognized tax benefits related to tax positions taken in prior years of $35.1
million and an increase in tax assets of $7.3 million. The Company believes that it is reasonably
possible that unrecognized tax benefits, as of March 31, 2009, could decrease by approximately
$16.0 million over the next 12 months related to the settlement of routine examinations or through
the expiration of the statute of limitations. Increases to the amount of unrecognized tax benefits
from January 1, 2009 of approximately $17.6 million relate primarily to current year operations.
The liability for unrecognized tax benefits is expected to increase in the next 12 months relating
to operations occurring in that period.
During the three-month period ended March 31, 2008, the Companys effective tax rate was negatively
impacted by non-deductible IPR&D charges incurred in connection with the acquisition of Pharmion.
20
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. Sponsored Research, License and Other Agreements
Novartis Pharma AG: The Company entered into an agreement with Novartis in which the Company
granted to Novartis an exclusive worldwide license (excluding Canada) to develop and market
FOCALIN® (d-methylphenidate, or d MPH) and FOCALIN XR®, the long-acting
drug formulation. The Company has retained the exclusive commercial rights to FOCALIN®
and FOCALIN XR® for oncology-related disorders, such as chronic fatigue associated with
chemotherapy. The Company also granted Novartis rights to all of its related intellectual property
and patents, including new formulations of the currently marketed RITALIN LA®. The
Company also sells FOCALIN® to Novartis and receives royalties on sales of all of
Novartis FOCALIN XR® and RITALIN® family of ADHD-related products.
Array BioPharma Inc.: The Company has a research collaboration agreement with Array BioPharma Inc.,
or Array, focused on the discovery, development and commercialization of novel therapeutics in
cancer and inflammation. As part of this agreement, the Company made an upfront payment in
September 2007 of $40.0 million, which was recorded as research and development expense, to Array
in return for an option to receive exclusive worldwide rights for certain mutually selected
discovery target drugs developed under the collaboration, except for Arrays limited U.S.
co-promotional rights. Array will be responsible for all discovery and clinical development through
Phase I or Phase IIa and be entitled to receive, for each drug, potential milestone payments of
approximately $200.0 million, if certain discovery, development and regulatory milestones are
achieved and $300.0 million if certain commercial milestones are achieved, as well as royalties on
net sales.
PTC Therapeutics, Inc.: In September 2007, the Company invested $20 million, of which $1.1 million
represented research and development expense, in Series 1 Convertible Preferred Stock of PTC
Therapeutics, Inc., or PTC, and also entered into a separate collaboration agreement whereby PTC
would perform discovery research activities. If both parties subsequently agree to advance research
on certain discovery targets, a separate pre-negotiated research agreement would be entered into.
Acceleron Pharma: The Company has a worldwide strategic collaboration with Acceleron Pharma, or
Acceleron, for the joint development and commercialization of ACE-011, a first-in-class, novel
bone-forming compound. The collaboration combines both companies resources and commitment to
developing products for the treatment of cancer and cancer-related bone loss. The Company also
signed an option agreement for certain discovery stage programs. Under the terms of the agreement,
Celgene and Acceleron will jointly develop, manufacture and commercialize Accelerons products for
bone loss. Celgene made an upfront payment to Acceleron in February 2008 of $50.0 million, which
included a $5.0 million equity investment in Acceleron, with the remainder recorded as research and
development expense. In addition, in the event of an initial public offering of Acceleron, Celgene
will purchase a minimum of $7.0 million of Acceleron common stock.
Acceleron will retain responsibility for initial activities, including research and development,
through the end of Phase IIa clinical trials, as well as manufacturing the clinical supplies for
these studies. In turn, Celgene will conduct the Phase IIb and Phase III clinical studies and will
oversee the manufacture of Phase III and commercial supplies. Acceleron will pay a share of the
development expenses and is eligible to receive development, regulatory and commercial milestones
of up to $510.0 million for the ACE-011 program and up to an additional $437.0 million for each of
the three discovery stage programs. The companies will co-promote the products in North America.
Acceleron will receive tiered royalties on worldwide net sales.
21
CELGENE CORPORATION AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Cabrellis Pharmaceuticals Corp.: The Company, as a result of its acquisition of Pharmion, obtained
an exclusive license to develop and commercialize amrubicin in North America and Europe pursuant to
a license agreement with Dainippon Sumitomo Pharma Co. Ltd, or DSP. Pursuant to Pharmions
acquisition of Cabrellis Pharmaceutics Corp., or Cabrellis, the Company will pay $12.5 million for
each approval of amrubicin in an initial indication by regulatory authorities in the United States
and the European Union, or E.U., to the former shareholders of Cabrellis. Upon approval of amrubicin for a
second indication in the United States or E.U., the Company will pay an additional
payment of $10.0 million for each market to the former shareholders of Cabrellis. Under the terms
of the license agreement for amrubicin, the Company is required to make milestone payments of $7.0
million and $1.0 million to DSP upon regulatory approval of amrubicin in the United States and the
E.U., respectively, and up to $17.5 million upon achieving certain annual sales levels in
the United States. Pursuant to the supply agreement for amrubicin, the Company is to pay DSP a
semiannual supply price calculated as a percentage of net sales for a period of ten years. In
September 2008, amrubicin was granted fast track product designation by the U.S. Food and Drug
Administration, or FDA, for the treatment of small cell lung cancer after first-line chemotherapy.
14. Commitments and contingencies
Collaboration Arrangements: The Company has entered into certain research and development
collaboration arrangements with third parties that include the funding of certain development,
manufacturing and commercialization efforts with the potential for future milestone and royalty
payments upon the achievement of pre-established developmental, regulatory and/or commercial
targets. The Companys obligation to fund these efforts is contingent upon continued involvement in
the programs and/or the lack of any adverse events which could cause the discontinuance of the
programs. Due to the nature of these arrangements, the future potential payments are inherently
uncertain, and accordingly no amounts have been recorded in the Companys consolidated balance
sheets at March 31, 2009 or December 31, 2008.
Contingencies: The Company believes it maintains insurance coverage adequate for its current needs.
The Companys operations are subject to environmental laws and regulations, which impose
limitations on the discharge of pollutants into the air and water and establish standards for the
treatment, storage and disposal of solid and hazardous wastes. The Company reviews the effects of
such laws and regulations on its operations and modifies its operations as appropriate. The Company
believes it is in substantial compliance with all applicable environmental laws and regulations.
15. Subsequent Event
On April 24, 2009, the Board of Directors approved a share repurchase program, which was publicly
announced by the Company on April 27, 2009. The program authorizes the purchase of up to $500.0
million (or approximately 12.5 million shares at the approval date) of the outstanding common stock
of the Company, in the open market or through privately negotiated transactions, directly or
through brokers or agents, and expires April 2011.
22
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 include REVLIMID®, THALOMID® (inclusive of
Thalidomide PharmionTM, subsequent to the acquisition of Pharmion Corporation, or
Pharmion) and VIDAZA®. ALKERAN® was licensed from GlaxoSmithKline, or GSK,
and sold under our label through March 31, 2009, the conclusion of the ALKERAN® license
with GSK. REVLIMID® is an oral immunomodulatory drug marketed in the U.S. and Europe
for patients with multiple myeloma who have received at least one prior therapy and in the U.S. and
Canada for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk
myelodysplastic syndromes, or MDS, associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities. THALOMID® is marketed for patients with
newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of
moderate to severe erythema nodosum leprosum, or ENL, an inflammatory complication of leprosy.
VIDAZA® is a pyrimidine nucleoside analog that has been shown to reverse the effects of
DNA hypermethylation and promote subsequent gene re-expression. VIDAZA® was licensed
from Pharmacia & Upjohn, now part of Pfizer, Inc., and is marketed in the U.S. for the treatment of
all subtypes of MDS. In Europe, VIDAZA® is marketed for the treatment of adult patients
who are not eligible for haematopoietic stem cell transplantation with Intermediate-2 and high-risk
MDS according to the International Prognostic Scoring System, or IPSS, or chronic myelomonocytic
leukaemia, or CMML, with 10-29 percent marrow blasts without myeloproliferative disorder, or acute
myeloid leukemia, or AML, with 20-30 percent blasts and multi-lineage dysplasia, according to World
Health Organization, or WHO, classification. VIDAZA® was granted orphan drug
designation by the U.S. Food and Drug Administration, or FDA, for the treatment of MDS in the
United States through May 2011. In addition, VIDAZA® has received orphan drug
designation for the treatment of MDS and AML in the European Union,
or E.U., expiring December 2018.
We continue to invest substantially in research and development, and the drug candidates in our
pipeline are at various stages of preclinical and clinical development. These candidates include
our IMiDs® compounds, which are a class of compounds proprietary to us and having
certain immunomodulatory and other biologically important properties in addition to our leading
oral anti-inflammatory agents and cell products. We believe that continued acceptance of our
primary commercial stage products, depth of our product pipeline, regulatory approvals of both new
products and expanded use of existing products, provide the catalysts for future growth. See also
Risk Factors contained in Part I, Item 1A of our 2008 Annual Report on Form 10-K.
23
The following table summarizes total revenues and earnings for the three-month periods ended March
31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
Percent |
|
(Amounts in thousands, except earnings per share) |
|
2009 |
|
|
2008 |
|
|
Increase |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
605,053 |
|
|
$ |
462,597 |
|
|
$ |
142,456 |
|
|
|
30.8 |
% |
Net income (loss) |
|
$ |
162,883 |
|
|
$ |
(1,641,088 |
) |
|
$ |
1,803,971 |
|
|
|
N/A |
|
Diluted earnings (loss) per share |
|
$ |
0.35 |
|
|
$ |
(3.98 |
) |
|
$ |
4.33 |
|
|
|
N/A |
|
The increase in revenue for the three-month period ended March 31, 2009 compared to the three-month
period ended March 31, 2008 was primarily due to the inclusion of a full three months of sales for
VIDAZA® and Thalidomide PharmionTM as well as continued growth of
REVLIMID® in both U.S. and international markets. The three-month period ended March
31, 2008 only included VIDAZA® and Thalidomide PharmionTM sales subsequent to
the March 7, 2008 acquisition of Pharmion. Net income and diluted earnings per share for the
three-month period ended March 31, 2009 reflect the continued growth in sales of our products,
partly offset by increased spending from the inclusion of Pharmions operations and for new product
launches, research and development and expansion of our international operations. The net loss in
the three-month period ended March 31, 2008 was primarily due to an in-process research and
development, or IPR&D, charge of $1.74 billion and amortization of acquisition intangibles related
to our acquisition of Pharmion.
Results of Operations:
Three-Month Periods Ended March 31, 2009 and 2008
Total Revenue: Total revenue and related percentages for the three-month periods ended March 31,
2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
March 31, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® |
|
$ |
362,516 |
|
|
$ |
286,846 |
|
|
$ |
75,670 |
|
|
|
26.4 |
% |
THALOMID® |
|
|
113,964 |
|
|
|
113,927 |
|
|
|
37 |
|
|
|
0.0 |
% |
VIDAZA® |
|
|
75,382 |
|
|
|
13,820 |
|
|
|
61,562 |
|
|
|
445.5 |
% |
ALKERAN® |
|
|
19,862 |
|
|
|
15,114 |
|
|
|
4,748 |
|
|
|
31.4 |
% |
Other |
|
|
4,508 |
|
|
|
1,667 |
|
|
|
2,841 |
|
|
|
170.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
$ |
576,232 |
|
|
$ |
431,374 |
|
|
$ |
144,858 |
|
|
|
33.6 |
% |
Collaborative agreements and
other revenue |
|
|
2,244 |
|
|
|
4,768 |
|
|
|
(2,524 |
) |
|
|
-52.9 |
% |
Royalty revenue |
|
|
26,577 |
|
|
|
26,455 |
|
|
|
122 |
|
|
|
0.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
605,053 |
|
|
$ |
462,597 |
|
|
$ |
142,456 |
|
|
|
30.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® net sales increased for the three-month period ended March 31, 2009 compared
to the three-month period ended March 31, 2008 primarily due to increased unit sales in both U.S.
and international markets. Increased market penetration and the increase in duration of patients
using REVLIMID® in multiple myeloma contributed to U.S. growth. The growth in
international sales reflects the expansion of our commercial activities in over 75 countries.
24
THALOMID® net sales totaled $114.0 million for each of the three-month periods ended
March 31, 2009 and 2008, respectively. An increase in international sales was mostly offset by a
decrease in U.S. sales. The international sales increase was primarily due to the April 2008 full
marketing authorization by the European Commission, or EC, of THALOMID® for use in
combination with melphalan and prednisone as a treatment for patients with newly diagnosed multiple
myeloma. The three-month period ended March 31, 2008 only included THALOMID® sales in
international markets formerly supplied by Pharmion for the period subsequent to the March 7, 2008
Pharmion acquisition date to the end of the quarter. The decrease in U.S. sales was primarily due
to lower unit volumes resulting from increased use of REVLIMID® and was partly offset by
increased prices.
VIDAZA®
net sales increased for the three-month period ended March 31,
2009 compared to the three-month period ended March 31, 2008 primarily
due to the December 2008 full marketing authorization by the EC for the treatment of adult patients
who are not eligible for haematopoietic stem cell transplantation with Intermediate-2 and high-risk
MDS according to the IPSS, or CMML with 10-29 percent marrow blasts without myeloproliferative
disorder, or AML with 20-30 percent blasts and multi-lineage dysplasia, according to WHO
classification of VIDAZA®. The three-month period ended March 31, 2008 only including
sales subsequent to the March 7, 2008 acquisition of Pharmion.
ALKERANâ net sales increased for the three-month period ended March 31, 2009
compared to the three-month period ended March 31, 2008. ALKERAN® was licensed from
GlaxoSmithKline, or GSK, and sold under the Celgene label through March 31, 2009, the conclusion
date of the ALKERAN® license with GSK.
Total net product sales for the three-month period ended March 31, 2009 increased $144.9 million,
or 33.6%, compared to the three-month period ended March 31, 2008. The change was comprised of net
volume increases of $144.7 million and price increases of $13.5 million, partly offset by a
decrease from the impact of foreign exchange of $13.3 million.
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources declined by $2.5 million for the three-month period ended March 31, 2009 compared to the
three-month period ended March 31, 2008 due to the elimination of license fees and amortization of
deferred revenues related to Pharmion subsequent to the March 7, 2008 acquisition date.
Royalty Revenue: Royalty revenue totaled $26.6 million for the three-month period ended March 31,
2009 and was approximately equal to that for the three-month period ended March 31, 2008. Royalty
income primarily reflects amounts received from Novartis Pharma AG, or Novartis, on sales of the
entire family of RITALIN® drugs and FOCALIN XR®.
Gross to Net Sales Accruals: We record gross to net sales accruals for sales returns and
allowances; sales discounts; government rebates; and chargebacks and distributor service fees.
|
|
|
We base our sales returns allowance on estimated on-hand retail/hospital inventories,
measured end-customer demand as reported by third-party sources, actual returns history and
other factors, such as the trend experience for lots where product is still being returned
or inventory centralization and rationalization initiatives conducted by major pharmacy
chains, as applicable. If the historical data we use to calculate these estimates does not
properly reflect future returns, then a change in the allowance would be made in the period
in which such a determination is made and revenues in that period could be materially
affected. Under this methodology, we track actual returns by individual production lots.
Returns on closed lots, that is, lots no longer eligible for return credits, are analyzed
to determine historical returns experience. Returns on open lots, that is, lots still
eligible for return credits, are monitored and compared with historical return trend rates.
Any changes from the historical trend rates are considered in determining the current
sales return allowance. THALOMID® is drop-shipped directly to the prescribing
pharmacy and, as a result, wholesalers do not stock the product. REVLIMID® is
distributed primarily through hospitals and contracted pharmacies lending itself to tighter
controls of inventory quantities within the supply channel and, thus, resulting in lower
returns activity to date. VIDAZA® and ALKERAN® are sold in the
United States to pharmaceutical wholesalers, who in turn distribute product to physicians,
retail pharmacies, hospitals and other institutional customers. |
25
|
|
|
Sales discount accruals are based on payment terms extended to customers. |
|
|
|
Government rebate accruals are based on estimated payments due to governmental agencies
for purchases made by third parties under various governmental programs. U.S. Medicaid
rebate accruals are based on historical payment data and estimates of future Medicaid
beneficiary utilization applied to the Medicaid unit rebate amount formula established by
the Center for Medicaid and Medicare Services. Certain foreign markets have
government-sponsored programs that require rebates to be paid and accordingly the rebate
accruals are determined primarily on estimated eligible sales. |
|
|
|
Chargebacks and distributor service fees 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. On January 28, 2008, the Fiscal Year 2008 National Defense Authorization Act was
enacted, which expands TRICARE to include prescription drugs dispensed by TRICARE retail
network pharmacies. TRICARE is a health care program of the U.S. Department of Defense
Military Health System that provides civilian health benefits for military personnel,
military retirees and their dependents. TRICARE rebate accruals reflect this program
expansion and are based on estimated Department of Defense eligible sales multiplied by the
TRICARE rebate formula. |
See Critical Accounting Estimates and Significant Accounting Policies for further discussion of
gross to net sales accruals.
Gross to net sales accruals and the balance in the related allowance accounts for the three-month
periods ended March 31, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2009 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
17,799 |
|
|
$ |
3,659 |
|
|
$ |
10,810 |
|
|
$ |
23,386 |
|
|
$ |
55,654 |
|
Allowances for sales during 2009 |
|
|
1,269 |
|
|
|
8,278 |
|
|
|
8,815 |
|
|
|
22,319 |
|
|
|
40,681 |
|
Credits/deductions issued for prior year sales |
|
|
(5,828 |
) |
|
|
(2,177 |
) |
|
|
(9,349 |
) |
|
|
(7,646 |
) |
|
|
(25,000 |
) |
Credits/deductions issued for sales during 2009 |
|
|
(2 |
) |
|
|
(4,281 |
) |
|
|
(1,345 |
) |
|
|
(8,087 |
) |
|
|
(13,715 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2009 |
|
$ |
13,238 |
|
|
$ |
5,479 |
|
|
$ |
8,931 |
|
|
$ |
29,972 |
|
|
$ |
57,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
and Dist. |
|
|
|
|
2008 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
Service Fees |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
16,734 |
|
|
$ |
2,895 |
|
|
$ |
9,202 |
|
|
$ |
8,839 |
|
|
$ |
37,670 |
|
Pharmion balance at March 7, 2008 |
|
|
926 |
|
|
|
283 |
|
|
|
1,266 |
|
|
|
2,037 |
|
|
|
4,512 |
|
Allowances for sales during 2008 |
|
|
10,511 |
|
|
|
8,911 |
|
|
|
13,775 |
|
|
|
17,239 |
|
|
|
50,436 |
|
Credits/deductions issued for prior year sales |
|
|
(7,415 |
) |
|
|
(2,785 |
) |
|
|
(6,889 |
) |
|
|
(4,016 |
) |
|
|
(21,105 |
) |
Credits/deductions issued for sales during 2008 |
|
|
(495 |
) |
|
|
(5,596 |
) |
|
|
(151 |
) |
|
|
(15,772 |
) |
|
|
(22,014 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2008 |
|
$ |
20,261 |
|
|
$ |
3,708 |
|
|
$ |
17,203 |
|
|
$ |
8,327 |
|
|
$ |
49,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26
A comparison of allowances for sales within each of the four categories noted above for the
three-month periods ended March 31, 2009 and 2008, respectively, follows:
Returns and allowances decreased by $9.2 million for the three-month period ended March 31, 2009
compared to the three-month period ended March 31, 2008 primarily due to reserve decreases
resulting from the completion of an inventory centralization and rationalization initiative
conducted by a major pharmacy chain during the current quarter, partially offset by a reserve
increase for ALKERAN® in the current quarter for returns anticipated in the second
quarter of 2009 following the conclusion of the license with GSK. In addition, the 2008 period
includes an increase in THALOMID® returns resulting from the anticipated increase in use
of REVLIMID® in multiple myeloma.
Discounts decreased by $0.6 million for the three-month period ended March 31, 2009 compared to the
three-month period ended March 31, 2008 primarily due to a decrease in discounts occurring outside
the United States.
Government rebates decreased by $5.0 million in the three-month period ended March 31, 2009
compared to the three-month period ended March 31, 2008 primarily due to reduced international
government rebates. Certain international government rebate programs were modified from 2008 to
2009 resulting in lower rebates in the 2009 period.
Chargebacks and distributor service fees increased by $5.1 million in the three-month period ended
March 31, 2009 compared to the three-month period ended
March 31, 2008 primarily due to the new
TRICARE rebate program.
Operating Costs and Expenses: Operating costs, expenses and related percentages for the
three-month periods ended March 31, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
Percent |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
Increase |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible assets) |
|
$ |
64,299 |
|
|
$ |
44,724 |
|
|
$ |
19,575 |
|
|
|
43.8 |
% |
Percent of net product sales |
|
|
11.2 |
% |
|
|
10.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
181,248 |
|
|
$ |
156,877 |
|
|
$ |
24,371 |
|
|
|
15.5 |
% |
Percent of total revenue |
|
|
30.0 |
% |
|
|
33.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
173,440 |
|
|
$ |
140,451 |
|
|
$ |
32,989 |
|
|
|
23.5 |
% |
Percent of total revenue |
|
|
28.7 |
% |
|
|
30.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets |
|
$ |
23,625 |
|
|
$ |
9,842 |
|
|
$ |
13,783 |
|
|
|
140.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development |
|
$ |
|
|
|
$ |
1,740,000 |
|
|
$ |
(1,740,000 |
) |
|
|
N/A |
|
Cost of Goods Sold (excluding amortization of acquired intangible assets): Cost of goods sold
increased by $19.6 million for the three-month period ended March 31, 2009 compared to the
three-month period ended March 31, 2008 primarily due to increased unit volume for
REVLIMIDâ and VIDAZAâ and a charge of $3.3 million related to the
write-down of ALKERANâ inventories to net realizable value as we concluded the
ALKERAN® license with GSK on March 31, 2009. As a percent of net product sales, cost of
goods sold (excluding amortization of acquired intangible assets) increased to 11.2% in the
2009 three-month period from 10.4% in the 2008 three-month period primarily due to the inclusion of
a full three-months sales of VIDAZAâ, which carries a higher cost compared to the
other major products and the charge related to the write-down of ALKERANâ
inventories to net realizable value.
27
Research and Development: Research and development expenses increased by $24.4 million for the
three-month period ended March 31, 2009 compared to the three-month period ended March 31, 2008,
primarily
due to increases in spending related to clinical research and development in support of multiple
programs, including REVLIMIDâ, other IMiDsâ and other compounds
across a broad range of diseases and increased spending for medical grants.
The following table provides an additional breakdown of research and development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
March 31, |
|
|
Increase |
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Human pharmaceutical clinical programs |
|
$ |
94,715 |
|
|
$ |
49,423 |
|
|
$ |
45,292 |
|
Other pharmaceutical programs |
|
|
64,584 |
|
|
|
87,862 |
|
|
|
(23,278 |
) |
Drug discovery and development |
|
|
18,605 |
|
|
|
15,727 |
|
|
|
2,878 |
|
Placental stem cell and biomaterials |
|
|
3,344 |
|
|
|
3,865 |
|
|
|
(521 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
181,248 |
|
|
$ |
156,877 |
|
|
$ |
24,371 |
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical programs for the three-month period ended March 31, 2008, includes $45.0
million for the Acceleron Pharma Inc., or Acceleron, collaborative research and development
arrangement, in addition to spending for toxicology, analytical research and development, quality
and regulatory affairs.
Research and development expenditures support ongoing clinical progress in multiple proprietary
development programs for REVLIMIDâ and other IMiDsâ
compounds; VIDAZAâ; amrubicin, our lead compound for small cell lung cancer;
apremilast (CC-10004), our lead anti-inflammatory compound that inhibits PDE-4, which results in
the inhibition of multiple proinflammatory mediators such as TNF-α and which is currently being
evaluated in Phase II clinical trials in the treatment of psoriasis and psoriatic arthritis;
CC-4047 and CC-11050, which are currently either being evaluated in Phase I clinical trials or for
which Phase II clinical trials are planned or ongoing; our kinase and ligase inhibitor programs; as
well as the placental stem cell program.
Selling, General and Administrative: Selling, general and administrative expenses increased by
$33.0 million for the three-month period ended March 31, 2009 compared to the three-month period
ended March 31, 2008, primarily reflecting increases in marketing of $21.6 million, sales
operations of $11.0 million and donations to non-profit foundations of $3.9 million, which were
partly offset by a reduction in the provision for doubtful accounts. Marketing and sales related
expenses in the three-month period ended March 31, 2009 include ongoing product launch activities
for REVLIMIDâ, VIDAZAâ and THALOMID® in
Europe, Canada and Australia, in addition to VIDAZAâ relaunch expenses in the
United States upon receipt of an expanded FDA approval to reflect new overall survival data. The
increase in expense also reflects the continued expansion of our international commercial
activities.
Amortization of Acquired Intangible Assets: The $13.8 million increase in amortization of acquired
intangible assets for the three-month period ended March 31, 2009 compared to the three-month
period ended March 31, 2008 was due to the inclusion of a full three months amortization related to
Pharmion intangible assets, partly offset by the elimination of amortization related to Penn T
Limited intangible assets.
Acquired In-Process Research and Development: Acquired IPR&D for the three-month period ending
March 31, 2008 represents compounds under development by Pharmion at the date of acquisition that
had not yet achieved regulatory approval for marketing in certain markets or had not yet been
completed and have no future use. The $1.74 billion estimated fair value of these intangible
assets was derived using the multi-period excess-earnings method, a form of the income approach.
The IPR&D primarily related to development and approval initiatives for Vidazaâ IV
in the E.U. market, the oral form of azacitidine in the U.S. and E.U. markets and
THALOMID® in the E.U. market. The projected cash flows for valuation purposes were
based on key assumptions such as estimates of revenues and operating profits related to the
programs considering their stages of development; the time and resources needed to complete the
regulatory approval process for the products; and the life of the potential commercialized products
and associated risks, including the inherent difficulties and uncertainties in obtaining regulatory
approvals.
28
Interest and Investment Income, Net: Interest and investment income was $17.5 million for the
three-month period ended March 31, 2009, representing a decrease of $12.2 million from the $29.6
million recorded for the three-month period ended March 31, 2008. The decrease was due to reduced
yields on invested balances as well as slightly lower average cash, cash equivalents and marketable
securities available for sale balances. The decrease in cash, cash equivalents and marketable
securities available for sale in the 2009 quarter versus the 2008 quarter was primarily due to the
net payment of $746.8 million relating to the March 7, 2008 Pharmion acquisition and the October 3,
2008 prepayment of our royalty obligation under the June 7, 2001 5-azacytidine license in full for
$425.0 million, which was partly offset by increased cash generated from operations.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $0.8 million and $5.1 million for the three-month periods ended March 31, 2009 and 2008,
respectively. The loss in the three-month period ended March 31, 2008 included an impairment
charge of $4.4 million, which related to an affiliate company investee based on a decrease in fair
value below our cost, along with our evaluation of several other factors affecting the investee.
Interest Expense: Interest expense was $0.5 million and $2.2 million for the three-month periods
ended March 31, 2009 and 2008, respectively. The $1.7 million decrease in expense reflects the
conversion of convertible debt into our common stock which was completed in June 2008.
Other Income, Net: Other income, net was $32.6 million and $0.9 million for the three-month
periods ended March 31, 2009 and 2008, respectively. The $31.7 million increase in other income
was primarily due to hedging and realized and unrealized foreign exchange gains.
Income Tax Provision: The income tax provision for the three-month period ended March 31, 2009 was
$48.4 million and reflects an effective tax rate of 22.9%. The effective tax rate reflects the
growth of our low tax manufacturing operations and our overall global mix of income. Tax expense
also includes a net tax benefit of $5.3 million related to the settlement of tax examinations in
the first quarter. The income tax provision for the three-month period ended March 31, 2008 was
$35.0 million with an effective tax rate of negative 2.2%. The effective tax rate was impacted by
non-deductible IPR&D charges incurred in connection with the acquisition of Pharmion. The
effective tax rate, excluding the impact of the IPR&D charges, was 26.2% which reflects the growth
of our low tax manufacturing operations and our overall global mix of income.
29
Liquidity and Capital Resources
Cash flows from operating, investing and financing activities for the three-month periods ended
March 31, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
Change |
|
|
Net cash provided by operating activities |
|
$ |
127,117 |
|
|
$ |
63,560 |
|
|
$ |
63,557 |
|
Net cash used in investing activities |
|
$ |
(311,462 |
) |
|
$ |
(393,341 |
) |
|
$ |
81,879 |
|
Net cash provided by financing activities |
|
$ |
56,611 |
|
|
$ |
35,552 |
|
|
$ |
21,059 |
|
Operating Activities: Net cash provided by operating activities for the three-month period ended
March 31, 2009 increased by $63.6 million to $127.1 million as compared to the three-month period
ended March 31, 2008. The increase in net cash provided by operating activities was primarily
attributable to:
|
|
|
an expansion of our operations and related increase in net earnings, partially offset by |
|
|
|
the timing of receipts and payments in the ordinary course of business. |
Investing Activities: Net cash used in investing activities for the three-month period ended March
31, 2009 decreased by $81.9 million to $311.5 million as compared to the three-month period ended
March 31, 2008. The 2009 investing activities are principally related to net purchases of
marketable securities available for sale of $292.0 million and capital expenditures of $21.0
million, whereas in 2008 the $746.0 million of cash paid to acquire Pharmion was included.
Financing Activities: Net cash provided by financing activities for the three-month period ended
March 31, 2009 increased by $21.1 million to $56.6 million as compared to the three-month period
ended March 31, 2008. The increase in net cash provided by financing activities was primarily
attributable to:
|
|
|
an increase in the excess tax benefit from share-based compensation arrangements,
partially offset by |
|
|
|
a decrease in the proceeds from the exercise of common stock options and warrants. |
Cash, Cash Equivalents, Marketable Securities Available for Sale and Working Capital: Cash, cash
equivalents, marketable securities available for sale and working capital as of March 31, 2009 and
December 31, 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
|
(Amounts in thousands) |
|
2009 |
|
|
2008 |
|
|
Increase |
|
|
Cash, cash equivalents and marketable securities available for sale |
|
$ |
2,393,345 |
|
|
$ |
2,222,091 |
|
|
$ |
171,254 |
|
Working capital (1) |
|
$ |
2,589,935 |
|
|
$ |
2,299,122 |
|
|
$ |
290,813 |
|
|
|
|
(1) |
|
Includes cash, cash equivalents and marketable securities available for sale, accounts
receivable, net of allowances, inventory and other current assets, less accounts payable,
accrued expenses, income taxes payable and other current liabilities. |
Cash, Cash Equivalents and Marketable Securities Available for Sale: We invest our excess cash
primarily in money market funds, U.S. Treasury fixed rate securities, U.S. government-sponsored
agency fixed rate securities, U.S. government-sponsored agency mortgage-backed fixed rate
securities, and Federal Deposit Insurance Corporation, or FDIC, guaranteed fixed rate corporate
debt. All liquid investments with maturities of three months or less from the date of purchase are
classified as cash equivalents and all investments with maturities of greater than three months
from the date of purchase are classified as marketable securities available for sale. We determine
the appropriate classification of our investments in marketable debt and equity securities at the
time of purchase. The increase in cash, cash equivalents and marketable securities available for
sale from December 31, 2008 to March 31, 2009 was primarily due to increased cash generated from
operations and stock option activities.
30
Accounts Receivable, Net: Accounts receivable, net increased by $27.7 million to $339.9 million as
of March 31, 2009 compared to December 31, 2008 primarily due to increased sales of
REVLIMID® and VIDAZA®. Days of sales outstanding at March 31, 2009 amounted
to 50 days compared to 42 days at December 31, 2008. The increase was primarily due to increased
international sales for which the collection period is longer than for U.S. sales. We expect this
trend to continue as our international sales continue to expand.
Inventory: Inventory balances totaled $97.3 million at March 31, 2009, representing a decrease of
$2.9 million from the $100.2 million balance at December 31, 2008. The decrease reflected the
impact of lower inventories of ALKERAN® resulting from non-renewal of the GSK supply
agreement which was mostly offset by an increase in REVLIMID®
inventories to support
higher sales levels.
Other Current Assets: Other current assets decreased by $16.6 million to $173.8 million as of
March 31, 2009 compared to December 31, 2008 primarily due to timing of cash settlements related to
certain pending sales of marketable securities at December 31, 2008, partially offset by an
increase related to the fair value of foreign currency forward derivative contracts.
Accounts Payable, Accrued Expenses and Other Current Liabilities: Accounts payable, accrued
expenses and other current liabilities decreased by $73.3 million to $401.3 million as of March 31,
2009 compared to December 31, 2008. The decrease was primarily due to the impact of changes in the
fair value of foreign currency forward derivative contracts and a decrease from the payment of
certain compensation accruals, which was partly offset by an increase in clinical trial accruals.
Income Taxes Payable (Current and Non-Current): Income taxes payable decreased by $29.7 million to
$380.0 million as of March 31, 2009 compared to December 31, 2008 primarily from tax payments of
$51.1 million and tax benefit of stock options of $37.5 million, partially offset by a current
provision for income taxes of $59.4 million.
We expect continued growth in our expenditures, particularly those related to research and product
development, clinical trials, regulatory approvals, international expansion, commercialization of
products and capital investments. However, we anticipate that existing cash, cash equivalents and
marketable securities available for sale, combined with cash received from expected net product
sales and royalty agreements, will provide sufficient capital resources to fund our operations for
the foreseeable future.
Financial Condition
At March 31, 2009, our marketable securities available for sale consisted of U.S. Treasury fixed
rate securities, U.S. government-sponsored agency fixed rate securities, U.S. government-sponsored
agency mortgage-backed fixed rate securities, FDIC guaranteed fixed rate corporate debt, private
cash fund shares and a marketable equity security. U.S. government-sponsored agency securities
include general unsecured obligations of the issuing agency, including issues from the Federal Home
Loan Bank, or FHLB, the Federal National Mortgage Association, or Fannie Mae, and the Federal Home
Loan Mortgage Corporation, or Freddie Mac. U.S. government-sponsored agency mortgage-backed
securities include fixed rate asset-backed securities issued by Fannie Mae, Freddie Mac and the
Government National Mortgage Association, or GNMA. FDIC guaranteed corporate debt includes
obligations of bank holding companies that meet certain criteria set forth under the Temporary
Liquidity Guaranty Program, or TLGP, and is unconditionally guaranteed by the FDIC.
31
Fannie Mae, Freddie Mac, FHLB and GNMA are regulated by the recently established Federal Housing
Finance Agency, or FHFA. Working with the Congress and the Office of the President, the U.S.
Treasury and the Federal Reserve have pledged to continue to provide capital and liquidity to these
U.S. government-sponsored agencies. We have not recorded any impairments against our holdings in
these securities due to the support of the U.S. government of these agencies.
Marketable securities available for sale are carried at fair value, held for an unspecified period
of time and are 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 and other than temporary impairment charges, is included in interest and
investment income, net.
As of March 31, 2009, our financial assets and liabilities were recorded at fair value. In
accordance with SFAS No. 157, Fair Value Measurement, or SFAS 157, we have classified our
financial assets and liabilities as Level 1, 2 or 3 within the fair value hierarchy. Fair values
determined based on Level 1 inputs utilize quoted prices (unadjusted) in active markets for
identical assets or liabilities. Our Level 1 assets consist of marketable equity securities. Fair
values determined based on Level 2 inputs utilize observable quoted prices for similar assets and
liabilities in active markets and observable quoted prices for identical or similar assets in
markets that are not very active. Our Level 2 assets consist of mortgage-backed obligations, U.S.
Treasury securities, U.S. government-sponsored agency securities, corporate debt securities and
forward currency contracts. Fair values determined based on Level 3 inputs utilize unobservable
inputs and include valuations of assets or liabilities for which there is little, if any, market
activity. Our Level 3 assets consist of a private cash fund.
A majority of our financial assets and liabilities have been classified as Level 2. These assets
and liabilities were initially valued at the transaction price and subsequently valued based on
inputs utilizing observable quoted prices for similar assets and liabilities in active markets and
observable quoted prices from identical or similar assets in markets that are not very active.
The asset with fair values based on Level 3 inputs was the private cash fund, which represents
approximately 0.6 % of the total fair value for available-for-sale securities at March 31, 2009.
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 2008 Annual Report on Form 10-K. There
have not been any material changes to such contractual obligations since December 31, 2008.
Critical Accounting Estimates and Significant Accounting Policies
A critical accounting policy is one that is both important to the portrayal of our financial
condition and results of operation and requires managements most difficult, subjective or complex
judgments, often as a result of the need to make estimates about the effect of matters that are
inherently uncertain. Our significant accounting policies are more fully described in Note 1 of
the Notes to the Consolidated Financial Statements included in our Annual Report on Form 10-K for
the year ended December 31, 2008. Our critical accounting policies are disclosed in the
Managements Discussion and Analysis of Financial Condition and Results of Operations section of
our Annual Report on Form 10-K for the year ended December 31, 2008.
32
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The following discussion provides forward-looking quantitative and qualitative information about
our potential exposure to market risk. Market risk represents the potential loss arising from
adverse changes in the value of financial instruments. The risk of loss is assessed based on the
likelihood of adverse changes in fair values, cash flows or future earnings.
We have established guidelines relative to the diversification and maturities of investments to
maintain safety and liquidity. These guidelines are reviewed periodically and may be modified
depending on market conditions. Although investments may be subject to credit risk, our investment
policy specifies credit quality standards for our investments and limits the amount of credit
exposure from any single issue, issuer or type of investment. At March 31, 2009, our market risk
sensitive instruments consisted of marketable securities available for sale, our note payable and
certain foreign currency forward contracts.
Marketable Securities Available for Sale: At March 31, 2009, our marketable securities available
for sale consisted of U.S. Treasury fixed rate securities, U.S. government-sponsored agency fixed
rate securities, U.S. government-sponsored agency mortgage-backed fixed rate securities, Federal
Deposit Insurance Corporation, or FDIC, guaranteed fixed rate corporate debt, private cash fund
shares and a marketable equity security. U.S. government-sponsored agency securities include
general unsecured obligations of the issuing agency, including issues from the Federal Home Loan
Bank, or FHLB, the Federal National Mortgage Association, or Fannie Mae, and the Federal Home Loan
Mortgage Corporation, or Freddie Mac. U.S. government-sponsored agency mortgage-backed securities
include fixed rate asset-backed securities issued by Fannie Mae, Freddie Mac and the Government
National Mortgage Association, or GNMA. FDIC guaranteed corporate debt includes obligations of
bank holding companies that meet certain criteria set forth under the Temporary Liquidity Guaranty
Program, or TLGP, and is unconditionally guaranteed by the FDIC.
Fannie Mae, Freddie Mac, FHLB and GNMA are regulated by the recently established Federal Housing
Finance Agency, or FHFA. Working with the Congress and the Office of the President, the U.S.
Treasury and the Federal Reserve have pledged to continue to provide capital and liquidity to these
U.S. government-sponsored agencies. We have not recorded any impairments against our holdings in
these securities due to the support of the U.S. government of these agencies.
Marketable securities available for sale are carried at fair value, held for an unspecified period
of time and are 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 and other than temporary impairment charges, is included in interest and
investment income, net.
As of March 31, 2009, 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 |
|
|
|
|
|
|
|
|
|
|
More Than |
|
|
|
|
(Amounts in thousands) |
|
1 Year |
|
|
1 to 3 Years |
|
|
3 to 5 Years |
|
|
5 Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
$ |
268,905 |
|
|
$ |
1,016,933 |
|
|
$ |
98,399 |
|
|
$ |
16,381 |
|
|
$ |
1,400,618 |
|
Fair value |
|
$ |
273,684 |
|
|
$ |
1,045,233 |
|
|
$ |
102,146 |
|
|
$ |
18,067 |
|
|
$ |
1,439,130 |
|
Average interest rate |
|
|
1.8 |
% |
|
|
1.7 |
% |
|
|
1.9 |
% |
|
|
3.9 |
% |
|
|
1.8 |
% |
33
Note Payable: In December 2006, we purchased an active pharmaceutical ingredient, or API,
manufacturing facility and certain other assets and liabilities from Siegfried Ltd. and Siegfried
Dienste AG (together referred to herein as Siegfried) located in Zofingen, Switzerland. At March
31, 2009, the fair value of our note payable to Siegfried approximated the carrying value of the
note of $24.7 million. 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 note is denominated in
Swiss francs and its fair value will also be affected by changes in the U.S. dollar / Swiss franc
exchange rate. The carrying value of the note reflects the U.S. dollar / Swiss franc exchange rate
and Swiss interest rates.
Foreign Currency Forward Contracts: We use foreign currency forward contracts to hedge specific
forecasted transactions denominated in foreign currencies and to reduce exposures to foreign
currency fluctuations of certain assets and liabilities denominated in foreign currencies.
We enter into foreign currency forward contracts to protect against changes in anticipated foreign
currency cash flows resulting from changes in foreign currency exchange rates, primarily associated
with non-functional currency denominated revenues and expenses of foreign subsidiaries. The
foreign currency forward hedging contracts outstanding at March 31, 2009 and December 31, 2008 had
settlement dates within 24 months. These foreign currency forward contracts are designated as cash
flow hedges under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, as
amended, or SFAS 133, and, accordingly, to the extent effective, any unrealized gains or losses on
them are reported in other comprehensive income (loss) and reclassified to operations in the same
periods during which the underlying hedged transactions affect operations. Any ineffectiveness on
these foreign currency forward contracts is reported in other income, net. Foreign currency
forward contracts entered into to hedge forecasted revenue and expenses were as follows:
|
|
|
|
|
|
|
|
|
|
|
Notional Amount |
|
Foreign Currency |
|
March 31, 2009 |
|
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
Euro |
|
$ |
587,789 |
|
|
$ |
704,198 |
|
Yen |
|
|
23,829 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
611,618 |
|
|
$ |
704,198 |
|
|
|
|
|
|
|
|
The notional settlement amounts of the foreign currency forward contracts outstanding as of
March 31, 2009 and December 31, 2008 were approximately $611.6 million and $704.2 million,
respectively. We consider the impact of our own and the counterparties credit risk on the fair
value of the contracts as well as the ability of each party to execute its obligations under the
contract. As of March 31, 2009 and December 31, 2008, credit risk did not materially change the
fair value of our foreign currency forward contracts.
We recognized reductions in net product sales for the settlement of certain effective cash flow
hedge instruments of $0.8 million for the three-month period
ended March 31, 2009 and no reduction for the three-month period ended March 31, 2008. These settlements were recorded in the same period as the related forecasted
sales occurred. We recognized reductions in research and development expenses for the settlement
of certain effective cash flow hedge instruments of $1.0 million
for the three-month period ended March 31, 2009 and no reduction
for the three-month period ended March 31, 2008. These settlements were recorded in the same
period as the related forecasted research and development expenses occurred. Changes in time value
which we excluded from the hedge effectiveness assessment for the three-month period ended March
31, 2009, were included in other income, net.
We also enter into foreign currency forward contracts to reduce exposures to foreign currency
fluctuations of certain recognized assets and liabilities denominated in foreign currencies. These
foreign currency forward contracts have not been designated as hedges under SFAS 133 and,
accordingly, any changes in their fair value are recognized in other income, net in the current
period. The aggregate notional amount of the foreign currency forward non-designated hedging
contracts outstanding at March 31, 2009 and December 31, 2008 were approximately $80.6 million and
$56.6 million, respectively.
34
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 March 31, 2009 exchange
rates were to change by a hypothetical 10%, the fair value of the foreign currency forward
contracts would change by approximately $38.5 million. However, since the contracts either hedge
specific forecasted intercompany transactions denominated in foreign currencies or relate to assets
and liabilities denominated in currencies other than the entities functional currencies, any
change in the fair value of the contract would be either reported in other comprehensive income
(loss) and reclassified to earnings in the same periods during which the underlying hedged
transactions affect earnings or remeasured through earnings each period along with the underlying
asset or liability.
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 our 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), or the Exchange Act). 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 us in the
reports that we file or submit 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 and that such information is accumulated and communicated to our
management (including our Chief Executive Officer and Chief Financial Officer) to allow
timely decisions regarding required disclosures. |
|
(b) |
|
In January 2009, we completed the process of implementing the Oracle Enterprise
Business Suite (EBS), including accounting modules used to perform substantially all of
our accounting and financial reporting functions and supply chain modules. In connection
with the EBS implementation, internal controls and procedures have been modified as
necessary to reflect the new system environment; however, we believe our overall internal
controls over financial reporting have not changed significantly as a result of the
implementation. As the EBS system was being implemented, we reviewed each module and the
design of the internal controls over financial reporting impacted by the implementation.
As we continue to utilize the EBS system, there may be impacts to internal controls over
financial reporting. |
|
|
|
|
With the exception of the matter discussed above, there have not been any other changes in
our internal control over financial reporting during the fiscal quarter ended March 31, 2009
that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting. |
35
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Our legal proceedings are described in Part I, Item 3, Legal Proceedings, of our 2008 Annual
Report on Form 10-K There have not been any material changes since December 31, 2008 as it
pertains to such legal proceedings nor have we engaged in any additional material legal
proceedings.
Item 1A. Risk Factors
The risk factors included in our 2008 Annual Report on Form 10-K have not materially changed.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
|
|
|
|
|
|
31.1 |
|
|
Certification by the Companys Chief Executive Officer. |
|
|
|
|
|
|
31.2 |
|
|
Certification by the Companys Chief Financial Officer. |
|
|
|
|
|
|
32.1 |
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
|
|
32.2 |
|
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
36
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
CELGENE CORPORATION
|
|
DATE: May 6, 2009 |
By: |
/s/ David W. Gryska
|
|
|
|
David W. Gryska |
|
|
|
Sr. Vice President and
Chief Financial Officer |
|
|
|
|
DATE: May 6, 2009 |
By: |
/s/ Andre Van Hoek
|
|
|
|
Andre Van Hoek |
|
|
|
Controller and
Chief Accounting Officer |
|
37
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
|
|
|
31.1 |
|
|
Certification by the Companys Chief Executive Officer. |
|
|
|
|
|
|
31.2 |
|
|
Certification by the Companys Chief Financial Officer. |
|
|
|
|
|
|
32.1 |
|
|
Certification by the Companys Chief Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
|
|
|
32.2 |
|
|
Certification by the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350. |
38