Filed by Bowne Pure Compliance
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
(Mark one)
|
|
|
þ |
|
QUARTERLY REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2008
OR
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____________to _____________
Commission File Number 0-16132
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 is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule
12b-2 of the Exchange Act.
(check one):
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-Accelerated filer o
|
|
Smaller Reporting Company o |
|
|
|
|
|
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
At May 5, 2008, 435,866,274 shares of Common Stock, par value $.01 per share, were outstanding.
CELGENE CORPORATION
FORM 10-Q TABLE OF CONTENTS
2
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(Dollars in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
431,374 |
|
|
$ |
269,796 |
|
Collaborative agreements and other revenue |
|
|
4,768 |
|
|
|
4,804 |
|
Royalty revenue |
|
|
26,455 |
|
|
|
18,815 |
|
|
|
|
|
|
|
|
Total revenue |
|
|
462,597 |
|
|
|
293,415 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization expense) |
|
|
44,724 |
|
|
|
22,055 |
|
Research and development |
|
|
156,877 |
|
|
|
79,575 |
|
Selling, general and administrative |
|
|
140,451 |
|
|
|
105,206 |
|
Amortization of acquired intangible assets |
|
|
9,842 |
|
|
|
2,215 |
|
Acquired in-process research and development |
|
|
1,740,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
2,091,894 |
|
|
|
209,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(1,629,297 |
) |
|
|
84,364 |
|
|
|
|
|
|
|
|
|
|
Other income and expense: |
|
|
|
|
|
|
|
|
Interest and investment income, net |
|
|
29,623 |
|
|
|
24,774 |
|
Equity in losses of affiliated companies |
|
|
5,079 |
|
|
|
1,283 |
|
Interest expense |
|
|
2,210 |
|
|
|
2,688 |
|
Other income, net |
|
|
922 |
|
|
|
931 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before income taxes |
|
|
(1,606,041 |
) |
|
|
106,098 |
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
35,047 |
|
|
|
48,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(1,641,088 |
) |
|
$ |
57,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per common share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(3.98 |
) |
|
$ |
0.15 |
|
Diluted |
|
$ |
(3.98 |
) |
|
$ |
0.14 |
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
412,263 |
|
|
|
377,599 |
|
|
|
|
|
|
|
|
Diluted |
|
|
412,263 |
|
|
|
429,306 |
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
3
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Dollars in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
938,125 |
|
|
$ |
1,218,273 |
|
Marketable securities available for sale |
|
|
1,088,367 |
|
|
|
1,520,645 |
|
Accounts receivable, net of allowances of $5,447 and $4,213
at March 31, 2008 and December 31, 2007, respectively |
|
|
258,385 |
|
|
|
167,252 |
|
Inventory |
|
|
96,313 |
|
|
|
49,076 |
|
Deferred income taxes |
|
|
54,863 |
|
|
|
20,506 |
|
Other current assets |
|
|
121,211 |
|
|
|
108,669 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
2,557,264 |
|
|
|
3,084,421 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
227,225 |
|
|
|
197,428 |
|
Investment in affiliated companies |
|
|
10,682 |
|
|
|
14,422 |
|
Intangible assets, net |
|
|
530,480 |
|
|
|
92,658 |
|
Goodwill |
|
|
530,294 |
|
|
|
39,033 |
|
Other assets |
|
|
55,519 |
|
|
|
183,322 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
3,911,464 |
|
|
$ |
3,611,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
64,072 |
|
|
$ |
37,876 |
|
Accrued expenses |
|
|
290,670 |
|
|
|
159,220 |
|
Income taxes payable |
|
|
4,004 |
|
|
|
4,989 |
|
Convertible notes |
|
|
196,512 |
|
|
|
196,555 |
|
Current portion of deferred revenue |
|
|
1,307 |
|
|
|
7,666 |
|
Other current liabilities |
|
|
34,265 |
|
|
|
26,625 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
590,830 |
|
|
|
432,931 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion |
|
|
3,061 |
|
|
|
60,303 |
|
Non-current income taxes payable |
|
|
226,721 |
|
|
|
211,307 |
|
Other non-current liabilities |
|
|
61,378 |
|
|
|
62,799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
881,990 |
|
|
|
767,340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value per share, 5,000,000 shares
authorized; none outstanding at March 31, 2008 and December 31, 2007, respectively |
|
|
|
|
|
|
|
|
Common stock, $.01 par value per share, 575,000,000 shares authorized; issued
439,745,644 and 407,150,694 shares at March 31, 2008 and December 31, 2007,
respectively |
|
|
4,397 |
|
|
|
4,072 |
|
Common stock in treasury, at cost; 4,053,715 and 4,026,116 shares
at March 31, 2008 and December 31, 2007, respectively |
|
|
(151,073 |
) |
|
|
(149,519 |
) |
Additional paid-in capital |
|
|
4,640,100 |
|
|
|
2,780,849 |
|
(Accumulated deficit) retained earnings |
|
|
(1,516,428 |
) |
|
|
124,660 |
|
Accumulated other comprehensive income |
|
|
52,478 |
|
|
|
83,882 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
3,029,474 |
|
|
|
2,843,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
3,911,464 |
|
|
$ |
3,611,284 |
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
4
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(1,641,088 |
) |
|
$ |
57,409 |
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net income to net cash
provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization of long-term assets |
|
|
7,497 |
|
|
|
4,698 |
|
Amortization of acquired intangible assets |
|
|
9,942 |
|
|
|
2,215 |
|
Provision for accounts receivable allowances |
|
|
2,046 |
|
|
|
3,445 |
|
Deferred income taxes |
|
|
(392 |
) |
|
|
(9,571 |
) |
Acquired In-process research and development |
|
|
1,740,000 |
|
|
|
|
|
Share-based compensation expense |
|
|
21,276 |
|
|
|
9,573 |
|
Equity in losses of affiliated companies |
|
|
5,079 |
|
|
|
1,283 |
|
Shares issued for employee benefit plans |
|
|
2,135 |
|
|
|
1,287 |
|
Other, net |
|
|
47 |
|
|
|
(711 |
) |
|
|
|
|
|
|
|
|
|
Change in current assets and liabilities, excluding the effect of
acquisition: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(38,147 |
) |
|
|
(5,058 |
) |
Inventory |
|
|
(7,235 |
) |
|
|
(4,790 |
) |
Other operating assets |
|
|
(4,362 |
) |
|
|
8,616 |
|
Accounts payable and accrued expenses |
|
|
(48,657 |
) |
|
|
(15,134 |
) |
Income tax payable |
|
|
14,548 |
|
|
|
37,330 |
|
Deferred revenue |
|
|
871 |
|
|
|
(795 |
) |
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
63,560 |
|
|
|
89,797 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sales of marketable securities |
|
|
563,272 |
|
|
|
706,204 |
|
Purchases of marketable securities available for sale |
|
|
(194,629 |
) |
|
|
(1,256,255 |
) |
Payments for acquisition of business, net of cash acquired |
|
|
(746,009 |
) |
|
|
|
|
Capital expenditures |
|
|
(18,149 |
) |
|
|
(10,754 |
) |
Investment in affiliated companies |
|
|
(1,339 |
) |
|
|
|
|
Purchases of investment securities |
|
|
(4,762 |
) |
|
|
(1,406 |
) |
Other |
|
|
8,275 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(393,341 |
) |
|
|
(562,211 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Net proceeds from exercise of common stock options and warrants |
|
|
23,249 |
|
|
|
31,302 |
|
Excess tax benefit from share-based compensation arrangements |
|
|
12,303 |
|
|
|
19,525 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
35,552 |
|
|
|
50,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of currency rate changes on cash and cash equivalents |
|
|
14,081 |
|
|
|
795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
(280,148 |
) |
|
$ |
(420,792 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
$ |
1,218,273 |
|
|
$ |
1,439,415 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
938,125 |
|
|
$ |
1,018,623 |
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
5
CELGENE CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(Unaudited)
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing activity: |
|
|
|
|
|
|
|
|
Change in net unrealized loss (gain) on marketable
securities available for sale |
|
$ |
91,226 |
|
|
$ |
2,259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matured shares tendered in connection with stock option
exercises |
|
$ |
(1,554 |
) |
|
$ |
(963 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible notes |
|
$ |
43 |
|
|
$ |
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
1,067 |
|
|
$ |
1,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
528 |
|
|
$ |
|
|
|
|
|
|
|
|
|
See accompanying Notes to Consolidated Financial Statements
6
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
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. On March 7, 2008, the Company acquired all of the
outstanding common stock and stock options of Pharmion Corporation, or Pharmion,
which prior to the acquisition was a global
biopharmaceutical company that acquired, developed and commercialized innovative products for the
treatment of hematology and oncology patients for $2.67 billion in cash and Celgene common stock.
The Companys commercial stage products included REVLIMID®, THALOMID®,
VIDAZA®, ALKERAN® and FOCALIN®. FOCALIN® is sold
exclusively to Novartis Pharma AG, or Novartis. The Company also derived revenues from a licensing
agreement with Novartis, which entitled it to royalties on FOCALIN XR® and the entire
RITALIN® family of drugs, and sales of bio-therapeutic products and services through its
Cellular Therapeutics subsidiary.
The accompanying unaudited consolidated financial statements have been prepared from the books and
records of the Company pursuant to U.S. generally accepted accounting principles for interim
information and the rules and regulations of the Securities and Exchange Commission for reporting
on Form 10-Q. Pursuant to such rules and regulations, certain information and footnote disclosures
normally included in complete annual financial statements have been condensed or omitted. The
consolidated financial statements include the accounts of Celgene Corporation and its subsidiaries.
All inter-company transactions and balances have been eliminated. Investments in limited
partnerships and interests in which the Company has an equity interest of 50% or less and does not
otherwise have a controlling financial interest are accounted for by either the equity or cost
method. Certain reclassifications have been made to the prior periods consolidated financial
statements in order to conform to the current periods presentation. The interim consolidated
financial statements should be read in conjunction with the consolidated financial statements and
notes thereto included in the Companys Annual Report on Form 10-K for the year ended December 31,
2007.
Interim results may not be indicative of the results that may be expected for the full year. In the
opinion of management, these financial statements include all normal and recurring adjustments
considered necessary for a fair presentation of these interim consolidated financial statements.
Recent Accounting Principles: In September 2006, the Financial Accounting Standards Board, or
FASB, issued Statement of Financial Accounting Standards, or SFAS, No. 157, Fair Value
Measurements, 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 effective date for financial assets and liabilities that are recognized on a recurring basis was
effective beginning January 1, 2008. The Company has determined that its adoption of SFAS 157 on
January 1, 2008 for financial assets did not have a material impact on its consolidated financial
statements. The Company does not expect the adoption of SFAS 157 related to non-financial assets
to have a material impact on its consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, or SFAS 159, which provides companies with an option to report selected
financial assets and liabilities at fair value. SFAS 159 establishes presentation and disclosure
requirements designed to facilitate comparisons between companies that choose different measurement
attributes for similar types of assets and liabilities and highlights the effect of a companys
choice to use fair value on its earnings. It also requires a company to display the fair value of
those assets and liabilities for which it has chosen to use fair value on the face of the balance
sheet. SFAS 159 was effective for the Company beginning January 1, 2008 and did not have a material
impact on its consolidated financial statements.
7
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
In June 2007, the FASB ratified Emerging Issues Task Force, or EITF, Issue No. 07-3, Accounting
for Non-Refundable Advance Payments for Goods or Services to be Used in Future Research and
Development Activities, or EITF 07-3, which provides that non-refundable advance payments for
future research and development activities should be deferred and capitalized until the related
goods are delivered or the related services are performed. EITF 07-3 was
effective for the Company on a prospective basis beginning January 1, 2008 and did not have a
material impact on its consolidated financial statements.
In December 2007, the FASB ratified 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 will be effective for the Company beginning January 1, 2009 on a retrospective basis.
The Company is currently evaluating the impact that the adoption of EITF 07-1 will have, if any, on
its 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 specified
in the Statement. It is effective prospectively to business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning on or after
December 15, 2008.
In
December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated Financial
Statements, an Amendment of ARB No. 51, or SFAS 160. This Standard changes the accounting for and
reporting of noncontrolling interests (formerly known as minority interests) in consolidated
financial statements. This Standard is effective January 1, 2009. When implemented, prior periods
will be recast for the changes required by SFAS 160. The Company is currently evaluating the impact
that the adoption of SFAS 160 will have, if any, on its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging
Activites, 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.
It is effective for financial statements issued for fiscal years and interim periods beginning
after November 15, 2008, with early adoption encouraged. The Company is currently evaluating the
impact that the adoption of SFAS 161 will have, if any, on its consolidated financial statements.
8
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
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. Under the purchase method of accounting, the assets acquired and liabilities assumed
of Pharmion are recorded as of the acquisition date, at their respective fair values, and
consolidated with those of Celgene. The reported consolidated financial condition and results of
operations of Celgene after completion of the acquisition reflect these fair values. Pharmions
results of operations are included in the Companys consolidated financial statements from the date
of acquisition.
Celgene paid a total purchase price of $2.761 billion to acquire all of the outstanding Pharmion
common shares and stock options. Each Pharmion stockholder received $25.00 in cash plus 0.8367
shares of Celgene common shares for a total payment of $2.67 billion. The combination of cash and
Celgene stock to Pharmion stockholders consisted of $921.0 million in cash and approximately 30.8
million shares of Celgene common stock valued at $1.749 billion. The total purchase price included
acquisition-related costs of $25.5 million, the fair value of vested Celgene stock options issued
of $44.9 million and the amortized cost of Celgenes investment in Pharmion common shares prior to
the acquisition.
Prior to the acquisition, Pharmion was a global biopharmaceutical company that acquired, developed
and commercialized innovative products for the treatment of hematology and oncology patients.
Celgene acquired Pharmion to enhance its portfolio of therapies for patients with life-threatening
illnesses worldwide with the addition of Pharmions marketed products, and several products in
development for the treatment of hematological and solid tumor cancers. By combining this new
product portfolio with the Companys existing operational and financial capabilities, Celgene will
be able to enlarge its global market share through increased product offerings and expanded
clinical, regulatory and commercial capabilities.
|
|
|
|
|
(Amounts in thousands)
Purchase Price Summary: |
|
|
|
|
|
Stock issued at fair value |
|
$ |
1,749,222 |
|
Cash paid |
|
|
920,805 |
|
Acquisition-related costs |
|
|
25,448 |
|
Fully vested stock options issued |
|
|
44,924 |
|
Pharmion shares previously owned |
|
|
20,212 |
|
|
|
|
|
Total purchase price paid |
|
$ |
2,760,611 |
|
|
|
|
|
9
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
The acquisition was accounted for using the purchase method of accounting for business combinations
and the purchase price allocation resulted in the following amounts being allocated to the assets
acquired and liabilities assumed at the acquisition date based upon their respective fair values.
|
|
|
|
|
(Amounts in thousands) |
|
March 7, 2008 |
|
|
|
|
|
|
Current assets |
|
$ |
340,415 |
|
Fixed assets |
|
|
8,404 |
|
Developed product rights |
|
|
510,986 |
|
In-process research and development |
|
|
1,740,000 |
|
Other noncurrent assets |
|
|
304 |
|
|
|
|
|
Assets acquired |
|
|
2,600,109 |
|
Restructuring |
|
|
(69,000 |
) |
Net deferred taxes |
|
|
(128,352 |
) |
Liabilities assumed |
|
|
(141,748 |
) |
|
|
|
|
Net assets acquired |
|
|
2,261,009 |
|
Goodwill |
|
|
499,602 |
|
|
|
|
|
Acquisition cost |
|
$ |
2,760,611 |
|
|
|
|
|
The fair value of the acquired identifiable intangible assets consists primarily of developed
product rights for the following currently marketed products: Vidaza® IV in the U.S. market,
Thalidomide Pharmion in certain foreign markets and other minor commercialized products and was
derived using a valuation from an independent third-party valuation
firm. It also includes the fair value
associated with certain compassionate use rights in Europe. The weighted average amortization
period for these assets, in total, is 6.5 years. The weighted average amortization period for
compassionate use rights is 1.2 years, while the weighted average amortization period for the
developed product rights is 7.1 years.
In-process research and development, or IPR&D, 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 alternative 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, as determined by a valuation
from an independent third-party valuation firm. The IPR&D primarily related to development and approval initiatives for Vidaza® IV
in the E.U. market, Vidaza® Oral in the U.S. and E.U. markets and Thalidomide
Pharmion® 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.
For Vidaza® IV in the E.U. market, the related future net cash flows were estimated
using a risk-adjusted discount rate of 10.0% and an anticipated regulatory approval
date in late 2008 with market exclusivity rights expected to continue through 2019. For
Vidaza® Oral in the U.S. and E.U., the future net cash flows were estimated using a
risk-adjusted discount rate of 11.0% for each market. The anticipated regulatory
approval in the E.U. was assumed for 2013 with exclusivity continuing through 2023, and the
anticipated regulatory approval in the U.S. was assumed for 2013 with exclusivity continuing
through 2018. For Thalidomide Pharmion® in the E.U. market, the future net cash flows
were estimated using a risk-adjusted discount rate of 9.5% and an anticipated
regulatory approval date in 2008 with exclusivity continuing through 2018.
In accordance with FASB Interpretation No. 4, Applicability of FASB Statement No. 2 to Business
Combinations Accounted for by the Purchase Method, the purchase price allocated to IPR&D
intangible assets has been expensed to income immediately subsequent to the acquisition because the
compounds do not have any alternative future use. This charge is not deductible for tax purposes.
The excess of purchase price over the fair value amounts assigned to the assets acquired and
liabilities assumed represents the goodwill amount resulting from the acquisition. The amount
allocated to goodwill is preliminary and subject to change, depending on the results of the final
purchase price allocation. We do not expect any portion of this goodwill to be deductible for tax
purposes. The goodwill attributable to the Companys acquisition of Pharmion has been recorded as
a noncurrent asset in our Consolidated Balance Sheet and will not be amortized, but is subject to
review for impairment in accordance with SFAS No. 142, Goodwill and Other Intangible Assets.
The allocation of the purchase price is subject to finalization of Celgenes management analysis of
the fair value of the assets acquired and liabilities assumed of Pharmion as of the acquisition
date. The final allocation of the purchase price may result in additional adjustments to the
recorded amounts of assets and liabilities and may also result in adjustments to depreciation,
amortization and acquired in-process research and development. The final allocation is expected to
be completed as soon as practicable but no later than 12 months after the acquisition date.
10
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
Prior to the acquisition, Celgene had licensed exclusive rights relating to the development and
commercial use for thalidomide and its distribution system to Pharmion, and also maintained a
thalidomide supply agreement with Pharmion. The Company accounted for these arrangements in
accordance with EITF Issue No. 04-1, Accounting for Preexisting Relationships between the Parties
to a Business Combination. In addition, the Company has valued the reacquired thalidomide-related
rights in the valuation of developed product rights described above. Any assets and liabilities
that existed between Celgene and Pharmion as of the acquisition date have been eliminated in the
accompanying unaudited consolidated financial statements.
The following table provides pro forma financial information for the three-month periods ended
March 31, 2008 and 2007 as if the acquisition had occurred as of the beginning of each period
presented. For each period presented, the unaudited pro forma results include the nonrecurring
charge for 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 consolidation of the
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 each period presented, nor are they intended to represent or be indicative of
future results of operations.
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
(Amounts in thousands, except per share amounts) |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
483,728 |
|
|
$ |
329,883 |
|
Net loss |
|
|
(1,650,543 |
) |
|
|
(1,708,655 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share: basic and diluted |
|
$ |
(4.09 |
) |
|
$ |
(3.75 |
) |
3. Restructuring
The acquisition cost of Pharmion includes liabilities related primarily to the planned exit of
certain business activities, involuntary terminations and the relocation of certain Pharmion
employees. The cost of these restructuring activities is estimated to be approximately $69.0
million, which includes employee severance costs of $16.8 million, early lease and contract
termination costs of $45.0 million, facility closing costs of $3.8 million and various other costs
primarily associated with exiting certain business activities of Pharmion. The Company is in the
process of initiating the above-noted actions included in the restructuring plan and expects that
all actions will be substantially completed within one year of the effective date of the
acquisition.
The following table summarizes the charges recorded for restructuring at the March 7, 2008
effective date of the Pharmion acquisition. No payments have been made as of March 31, 2008.
|
|
|
|
|
(Amounts in thousands) |
|
|
|
|
Severance costs |
|
$ |
16,800 |
|
Contract termination fees |
|
|
45,000 |
|
Facility closing costs |
|
|
3,800 |
|
Other |
|
|
3,400 |
|
|
|
|
|
Total restructuring costs |
|
$ |
69,000 |
|
|
|
|
|
11
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
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.
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
(Amounts in thousands except per share) |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(1,641,088 |
) |
|
$ |
57,409 |
|
Interest expense on convertible debt, net of tax |
|
|
|
|
|
|
1,393 |
|
|
|
|
|
|
|
|
Net (loss) income for diluted computation |
|
$ |
(1,641,088 |
) |
|
$ |
58,802 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
412,263 |
|
|
|
377,599 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
Options, warrants and other incentives |
|
|
|
|
|
|
18,693 |
|
Convertible debt |
|
|
|
|
|
|
33,014 |
|
Diluted |
|
|
412,263 |
|
|
|
429,306 |
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(3.98 |
) |
|
$ |
0.15 |
|
Diluted |
|
$ |
(3.98 |
) |
|
$ |
0.14 |
|
The total number of potential common shares excluded from the diluted earnings per share
computation because their inclusion would have been anti-dilutive was 50,546,244 and 2,681,971
shares for the three-month periods ended March 31, 2008 and 2007, respectively. The convertible
debt for the period ended March 31, 2008 was determined to be anti-dilutive; therefore, 16,223,892
potential shares and the interest expense related to the debt were excluded from the diluted
earnings per share calculation.
12
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
5. Comprehensive (Loss) Income
The components of comprehensive (loss) income consist of net (loss) income, changes in currency
translation adjustments and the after-tax effects of
changes in net unrealized gains (losses) on marketable securities classified as available for sale.
A summary of comprehensive (loss) income for the three-month periods ended March 31, 2008 and 2007
follows:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(1,641,088 |
) |
|
$ |
57,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
Net unrealized gains on marketable securities available for sale, net of tax |
|
|
6,967 |
|
|
|
1,306 |
|
Reversal of unrealized gains on Pharmion investment, net of tax |
|
|
(62,806 |
) |
|
|
|
|
Reclassification adjustment for losses included in net income (loss) |
|
|
(1,289 |
) |
|
|
64 |
|
|
|
|
|
|
|
|
Net unrealized (losses) gains on marketable securities
available for sale, net of tax |
|
|
(57,128 |
) |
|
|
1,370 |
|
Currency translation adjustments |
|
|
25,724 |
|
|
|
1,557 |
|
|
|
|
|
|
|
|
Total other comprehensive (loss) income |
|
|
(31,404 |
) |
|
|
2,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive (loss) income |
|
$ |
(1,672,492 |
) |
|
$ |
60,336 |
|
|
|
|
|
|
|
|
6. Financial Instruments and Fair Value Measurement
The following tables present information about assets and liabilities that are measured at fair
value on a recurring basis as of March 31, 2008, and indicate the fair value hierarchy of 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. Fair values determined based on Level 2 inputs utilize 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. 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Price in |
|
|
Significant |
|
|
Significant |
|
|
|
Balance at |
|
|
Active Markets for |
|
|
Other Observable |
|
|
Unobservable |
|
(Amounts in thousands) |
|
March 31, 2008 |
|
|
Identical Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
securities |
|
$ |
1,088,367 |
|
|
$ |
3,800 |
|
|
$ |
1,062,828 |
|
|
$ |
21,739 |
|
Forward currency
contracts |
|
|
(700 |
) |
|
|
|
|
|
|
(700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,087,667 |
|
|
$ |
3,800 |
|
|
$ |
1,062,128 |
|
|
$ |
21,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair values of the available-for-sale securities and derivative instruments are determined
through market, observable and corroborated sources.
The following table is a roll forward of the fair value of the private cash fund, whose fair value
is determined by Level 3 inputs:
|
|
|
|
|
|
|
Fair Value |
|
|
|
Measurements |
|
|
|
Using Significant |
|
(Amounts in thousands) |
|
Unobservable Inputs |
|
Beginning balance |
|
$ |
37,038 |
|
Total gains or losses (realized and unrealized) |
|
|
|
|
Settlements |
|
|
(15,299 |
) |
Transfers in and/or out of Level 3 |
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
21,739 |
|
|
|
|
|
13
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
7. Cash, Cash Equivalents and Marketable Securities Available for Sale
Money market funds of $754.4 million and $1.006 billion at March 31, 2008 and December 31, 2007,
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, 2008 and December 31, 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
(Amounts in thousands) |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
March 31, 2008 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations |
|
$ |
201,284 |
|
|
$ |
3,850 |
|
|
$ |
(152 |
) |
|
$ |
204,982 |
|
U.S. Treasury securities |
|
|
152,814 |
|
|
|
4,249 |
|
|
|
(5 |
) |
|
|
157,058 |
|
U.S. government-sponsored agency securities |
|
|
675,206 |
|
|
|
14,641 |
|
|
|
|
|
|
|
689,847 |
|
Corporate debt securities |
|
|
10,928 |
|
|
|
13 |
|
|
|
|
|
|
|
10,941 |
|
Private cash fund shares |
|
|
21,739 |
|
|
|
|
|
|
|
|
|
|
|
21,739 |
|
Marketable equity securities |
|
|
4,480 |
|
|
|
|
|
|
|
(680 |
) |
|
|
3,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,066,451 |
|
|
$ |
22,753 |
|
|
$ |
(837 |
) |
|
$ |
1,088,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
(Amounts in thousands) |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
December 31, 2007 |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations |
|
$ |
216,255 |
|
|
$ |
2,253 |
|
|
$ |
(108 |
) |
|
$ |
218,400 |
|
U.S. Treasury securities |
|
|
150,175 |
|
|
|
1,410 |
|
|
|
(28 |
) |
|
|
151,557 |
|
U.S. government-sponsored agency securities |
|
|
969,312 |
|
|
|
10,690 |
|
|
|
(131 |
) |
|
|
979,871 |
|
Corporate debt securities |
|
|
13,448 |
|
|
|
19 |
|
|
|
(1,611 |
) |
|
|
11,856 |
|
Private cash fund shares |
|
|
37,038 |
|
|
|
|
|
|
|
|
|
|
|
37,038 |
|
Marketable equity securities |
|
|
20,212 |
|
|
|
101,711 |
|
|
|
|
|
|
|
121,923 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale marketable securities |
|
$ |
1,406,440 |
|
|
$ |
116,083 |
|
|
$ |
(1,878 |
) |
|
$ |
1,520,645 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mortgage-backed obligations include fixed rate asset-backed securities issued by the Federal
National Mortgage Association, the Federal Home Loan Bank, the Federal Home Loan Mortgage
Corporation and the Government National Mortgage Association. U.S. government-sponsored agency
securities include general unsecured obligations of the issuing agency. Private cash fund shares
are investments in enhanced cash comingled funds. Marketable equity securities at December 31,
2007 consisted of the Companys investment in the common shares of Pharmion, which were
subsequently eliminated with the acquisition of Pharmion in March 2008. Unrealized losses for
mortgage-backed obligations, U.S. Treasury securities and U.S. government-sponsored agency
securities were primarily due to increases in interest rates. Unrealized losses for corporate debt
at December 31, 2007 were due to increases in interest rates as well as widening credit spreads.
Duration of debt securities classified as available-for-sale at March 31, 2008 was as follows:
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
(Amounts in thousands) |
|
Cost |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
Duration of one year or less |
|
$ |
506,324 |
|
|
$ |
511,674 |
|
Duration of one through three years |
|
|
475,875 |
|
|
|
490,131 |
|
Duration of three through five years |
|
|
69,912 |
|
|
|
71,779 |
|
Duration of five years or more |
|
|
9,860 |
|
|
|
10,983 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,061,971 |
|
|
$ |
1,084,567 |
|
|
|
|
|
|
|
|
14
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
8. Inventory
A summary of inventories by major category at March 31, 2008 and December 31, 2007 follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
11,955 |
|
|
$ |
8,899 |
|
Work in process |
|
|
22,839 |
|
|
|
21,214 |
|
Finished goods |
|
|
61,519 |
|
|
|
18,963 |
|
|
|
|
|
|
|
|
Total |
|
$ |
96,313 |
|
|
$ |
49,076 |
|
|
|
|
|
|
|
|
Inventory for the three-month period ended March 31, 2008 increased $47.2 million compared to the
end of December 31, 2007 primarily due to $36.7 million in inventory obtained from the Pharmion
acquisition and stated at fair value and increased inventories of REVLIMIDâ and
ALKERANâ.
9. Investment in Affiliated Companies
A summary of the Companys equity investment in affiliated companies follows:
|
|
|
|
|
|
|
|
|
(Amounts in thousands) |
|
March 31, |
|
|
December 31, |
|
Investment in Affiliated Companies |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Investment in affiliated companies (1) |
|
$ |
3,530 |
|
|
$ |
2,191 |
|
Excess of investment over share of equity (2) |
|
|
7,152 |
|
|
|
12,231 |
|
|
|
|
|
|
|
|
Investment in affiliated companies |
|
$ |
10,682 |
|
|
$ |
14,422 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
(Amounts in thousands) |
|
March 31, |
|
Equity in Losses of Affiliated Companies |
|
2008 |
|
|
2007 |
|
Affiliated companies losses (1) |
|
$ |
5,079 |
|
|
$ |
1,208 |
|
Amortization of intangibles |
|
|
|
|
|
|
75 |
|
|
|
|
|
|
|
|
Equity in losses of affiliated companies |
|
$ |
5,079 |
|
|
$ |
1,283 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The Company records its interest and share of losses based on its ownership
percentage. |
|
(2) |
|
Consists of goodwill at March 31, 2008 and December 31, 2007, respectively. |
For the three-month period ended March 31, 2008, the Company recorded an other-than-temporary loss
of $4.4 million related to an affiliate company investee based on a decrease in fair value below
our cost in this quarter along with an evaluation of several other factors affecting this investee.
This reduced the Companys investment to $7.2 million, which represented the fair value of its
common stock ownership in the investee at the end of March 31, 2008 based on the market closing price
of the investee on that date.
15
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
10. Convertible Debt
In June 2003, the Company issued an aggregate principal amount of $400.0 million of unsecured
convertible notes due June 2008, referred to herein as the convertible notes. The convertible
notes have a five-year term and a coupon rate of 1.75% payable semi-annually on June 1 and December
1. Each $1,000 principal amount of convertible notes is convertible into 82.5592 shares of common
stock as adjusted, or a conversion price of $12.1125 per share, which represented a 50% premium to
the closing price on May 28, 2003 of the Companys common stock of $8.075 per share, after
adjusting prices for the two-for-one stock splits effected on February 17, 2006 and October 22,
2004. The debt issuance costs related to these convertible notes, which totaled approximately $12.2
million, are classified under other assets on the consolidated balance sheet and are being
amortized over five years. Under the terms of the purchase agreement, the noteholders at March 31,
2008 can convert the outstanding notes at any time into 16,223,892 shares of common stock at the
conversion price. In addition, the noteholders have the right to require the Company to redeem the
notes in cash at a price equal to 100% of the principal amount to be redeemed, plus accrued
interest, prior to maturity in the event of a change of control and certain other transactions
defined as a fundamental change in the indenture governing the notes. Subsequent to the
September 2003 issuance date, $203.5 million of principal has been converted into 16,799,788 shares
of common stock.
The Companys convertible notes are classified as current liabilities due to their maturity in June
2008. Based on the price of the Companys common stock at March 31, 2008, the Company expects the
remaining noteholders to convert the notes into shares of common stock and does not expect such
conversion to have a material impact on its financial condition, liquidity or capital resources.
On May 9, 2008, the Company entered into a supplemental indenture with respect to its convertible
notes. See Note 15, Subsequent Event.
At March 31, 2008 and December 31, 2007, the fair value of the Companys convertible notes
outstanding exceeded the carrying value by approximately $798.0 million and $514.4 million,
respectively.
Under the Registration Rights Agreement for the notes, or the Registration Rights Agreement, the
Company could be subject to liquidated damages if the effectiveness of the registration statement
covering the convertible debt is not maintained at any time prior to the earlier of: (i) two years
after the conversion of the last convertible note into common stock or (ii) September 2010. The
Company believes the likelihood of occurrence of such event is remote and, as such, the Company has
not recorded a liability for liquidated damages at March 31, 2008. In the unlikely event that it
becomes probable that the Company would have to pay liquidated damages under the Registration
Rights Agreement, the Company has estimated the maximum potential liquidated damages as of March
31, 2008 to be approximately $2.0 million per year.
Such damages would (a) accrue only with respect to the shares of the Companys common stock
(underlying the notes) that were not already sold by the holder (under the registration statement
or pursuant to Rule 144 promulgated under the Securities Act of 1933, as amended) and that were not
eligible for sale without a registration statement, (b) accrue only for the period during which the
registration statement was not effective, subsequent to its initial effectiveness and (c) be
settled in cash in accordance with the terms of the Registration Rights Agreement.
16
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
11. Intangible Assets and Goodwill
Intangible Assets: A summary of intangible assets by category follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
(Amounts in thousands) |
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
March 31, 2008 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired developed product rights |
|
$ |
534,593 |
|
|
$ |
(8,205 |
) |
|
$ |
526,388 |
|
|
|
6.5 |
|
License |
|
|
4,250 |
|
|
|
(691 |
) |
|
|
3,559 |
|
|
|
13.8 |
|
Technology |
|
|
312 |
|
|
|
(44 |
) |
|
|
268 |
|
|
|
12.6 |
|
Acquired workforce |
|
|
362 |
|
|
|
(97 |
) |
|
|
265 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
539,517 |
|
|
$ |
(9,037 |
) |
|
$ |
530,480 |
|
|
|
6.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Intangible |
|
|
Weighted |
|
(Amounts in thousands) |
|
Carrying |
|
|
Accumulated |
|
|
Assets, |
|
|
Average |
|
December 31, 2007 |
|
Value |
|
|
Amortization |
|
|
Net |
|
|
Life (Years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Penn T supply agreements |
|
$ |
109,982 |
|
|
$ |
(21,470 |
) |
|
$ |
88,512 |
|
|
|
12.9 |
|
License |
|
|
4,250 |
|
|
|
(614 |
) |
|
|
3,636 |
|
|
|
13.8 |
|
Technology |
|
|
297 |
|
|
|
(36 |
) |
|
|
261 |
|
|
|
12.6 |
|
Acquired workforce |
|
|
318 |
|
|
|
(69 |
) |
|
|
249 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
114,847 |
|
|
$ |
(22,189 |
) |
|
$ |
92,658 |
|
|
|
12.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The gross carrying value of intangibles increased by $424.7 million from December 31, 2007 to March
31, 2008, primarily due to the fair value assigned to pharmaceutical product rights obtained in the
Pharmion acquisition in March 2008. Partly offsetting the increase was the elimination of an
intangible asset related to a product supply agreement entered into with Pharmion prior to the
acquisition. An immaterial amount of the increase in gross carrying value of intangibles was due
to changes in foreign exchange rates.
Amortization of acquired intangible assets was approximately $9.8 million and $2.3 million for the
three-month periods ended March 31, 2008 and 2007, respectively. The increase in amortization
expense was due to amortization of the intangible assets resulting from the Pharmion acquisition.
Assuming no changes in the gross carrying amount of intangible assets, the amortization of
intangible assets for the next five fiscal years is estimated to be approximately $101.8 million
for year ending December 31, 2008, $84.8 million for the year ending December 31, 2009 and $64.0
million for each of the years ending December 31, 2010 through 2012.
17
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
Goodwill: At March 31, 2008, the Companys goodwill related to the March 7, 2008 acquisition of
Pharmion and the October 21, 2004 acquisition of Penn T Limited. The change in carrying value of
goodwill is summarized as follows:
|
|
|
|
|
(Amounts in thousands) |
|
|
|
|
Balance, December 31, 2007 |
|
$ |
39,033 |
|
Acquisition of Pharmion |
|
|
499,602 |
|
Tax benefit on the exercise of Pharmion converted stock options |
|
|
(8,275 |
) |
Foreign currency translation |
|
|
(66 |
) |
|
|
|
|
Balance, March 31, 2008 |
|
$ |
530,294 |
|
|
|
|
|
12. 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, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
|
|
|
March 31, |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Cost of good sold |
|
$ |
528 |
|
|
$ |
387 |
|
Research and development |
|
|
9,616 |
|
|
|
2,602 |
|
Selling, general and administrative |
|
|
11,132 |
|
|
|
6,584 |
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
21,276 |
|
|
$ |
9,573 |
|
|
|
|
|
|
|
|
Share-based compensation expense included in inventory was $0.5 million at March 31, 2008 and $0.4
million at December 31, 2007.
As of March 31, 2008, there was $178.1 million of unrecognized compensation expense related to
Companys various stock-based plans. This expense will be recognized over an expected remaining
weighted-average period of 2.2 years.
The weighted-average grant date fair value of the stock options issued during the three-month
periods ended March 31, 2008 and 2007 was $21.79 per share and $22.09 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, 2008, as compared to December 31,
2007.
18
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
Stock option transactions for the three months ended March 31, 2008 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, 2007 |
|
|
32,739,159 |
|
|
$ |
28.05 |
|
|
|
6.1 |
|
|
$ |
702,341 |
|
Changes during the period: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted Celgene |
|
|
1,762,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued Pharmion acquisition |
|
|
1,206,031 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,659,326 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(140,149 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Expired |
|
|
(10,925 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2008 |
|
|
33,897,256 |
|
|
$ |
29.55 |
|
|
|
6.0 |
|
|
$ |
1,095,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest at
March 31, 2008 |
|
|
33,388,641 |
|
|
$ |
29.18 |
|
|
|
6.0 |
|
|
$ |
1,091,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2008 |
|
|
22,278,086 |
|
|
$ |
20.17 |
|
|
|
4.7 |
|
|
$ |
916,319 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total fair value of shares vested during the three-month periods ended March 31, 2008 and 2007
was $3.7 million and $4.3 million, respectively. The total intrinsic value of stock options
exercised during the three-month periods ended March 31, 2008 and 2007 was $68.0 million and $146.4
million, respectively. The Company primarily utilizes newly issued shares to satisfy the exercise
of stock options.
13. Income Taxes
The Company periodically evaluates the likelihood of the realization of deferred tax assets, and
reduces the carrying amount of those deferred tax assets by a valuation allowance to the extent it
believes a portion will not be realized. The Company considers many factors when assessing the
likelihood of future realization of its deferred tax assets, including recent cumulative earnings
experience by taxing jurisdiction, expectations of future taxable income, the carryforward periods
available to it for tax reporting purposes and other relevant factors. Significant judgment is
required in making this assessment.
The Companys tax returns have been audited by the Internal Revenue Service, or IRS, through the
fiscal year ended December 31, 2003. Tax returns for the fiscal years ended December 31, 2004 and
2005 are currently under examination by the IRS. The Company is also subject to audits by various
state and foreign taxing authorities, including, but not limited to the major countries of Europe,
the Far East, and most U.S. states.
The Company regularly reevaluates its tax positions and the associated interest and penalties, if
applicable, resulting from audits of federal, state and foreign income tax filings, as well as
changes in tax law that would reduce the technical merits of the position to below more likely than
not. The Company believes that its accruals for tax liabilities are adequate for all open years.
Many factors are considered in making these evaluations, including past history, recent
interpretations of tax law and the specifics of each matter. Because tax regulations are subject
to interpretation and tax litigation is inherently uncertain, these evaluations can involve a
series of complex judgments about future events and can rely heavily on estimates and assumptions.
These evaluations are based on estimates and assumptions that have been deemed reasonable by
management. However, if managements estimates are not representative of actual outcomes, the
Companys results of operations could be materially impacted.
19
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
Unrecognized tax benefits, represented by liabilities on the balance sheet and all subject to
audit, arise when the estimated benefit recorded in the financial statements differs from the
amounts taken or expected to be taken in a tax return because of the uncertainties described above.
These unrecognized tax benefits relate primarily to issues common among multinational
corporations. Virtually all of these unrecognized tax benefits, if recognized, would impact the
effective income tax rate. The Company accounts for interest and penalties related to uncertain
tax positions as part of its provision for income taxes. Changes to the amount of unrecognized tax
benefits from January 1, 2008 relate primarily to current year operations. There are no
unrecognized tax benefits as of March 31, 2008 for which it is reasonably possible that there will
be a significant change in the next 12 months. 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, 2007, the Company recorded a deferred tax benefit of
approximately $7.5 million, as a result of a research and experimentation tax credit study covering
prior years. In addition, the Company generated research and experimentation tax credits of $19.1
million related to stock option compensation for which no deferred tax benefit was recorded at
March 31, 2007. Under SFAS 123R, excess tax benefits related to stock option compensation are
recognized in the period in which such benefits are realized through the reduction of income taxes
payable. These tax benefits will be recorded as an increase in additional paid-in capital when
realized.
14. Committments and contingencies
With the Pharmion acquisition, the Company assumed several arrangements for which future
contractual obligations are as follows:
Inventory Purchase Commitments. Pharmion had entered into product supply contracts under which
Pharmion provides its suppliers with rolling 12-24 month supply forecasts, with the initial 3-6
month periods representing binding purchase commitments. These
commitments totaled $13.2 million
at March 31, 2008.
Research and Development. In December 2005, Pharmion entered into a co-development and licensing
agreement for satraplatin with GPC Biotech. Pursuant to the agreement, Pharmion was required to
provide $22.2 million for future development costs, of which $13.2 million remains at March 31,
2008.
Contingent Product Acquisition Payments. Pharmion had entered into contractual payment
obligations, the amount and timing of which are contingent upon future events. Under an agreement
with MethylGene, milestone payments for MGCD0103 could reach $141 million, based on the achievement
of significant development, regulatory and sales goals. In addition, up to $100 million for each
additional HDAC inhibitor may be paid, also based on the achievement of significant development,
regulatory and sales milestones.
20
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2008
Under the terms of an agreement related to Cabrellis Pharmaceuticals Corporation, Pharmion agreed
to pay $12.5 million for each approval of AMRUBICINTM by regulatory authorities in each
of the U.S. and E.U. In addition, upon approval of AMRUBICINTM for a second indication
in the U.S. or E. U., Pharmion agreed to pay an additional payment of $10 million for each market.
Under the terms of the license agreement for AMRUBICINTM, Pharmion was also required to
make milestone payments up to $8.0 million to Dainippon Sumitomo Pharma Co. Ltd. upon
regulatory approval of AMRUBICINTM in the U.S. and the E.U., and up to $17.5 million upon
achieving certain annual sales levels in the U.S.
15. Subsequent Event
On May 9, 2008, the Company entered into a supplemental indenture to the indenture dated June 3,
2003 with the Bank of New York, as trustee, governing the Companys convertible notes, wherein the
parties agreed to certain clarifying modifications with respect to the final conversion date and
final interest payment.
21
Item 2. Managements Discussion and Analysis of Financial Condition And Results of Operations
Forward-Looking Information
Certain statements contained or incorporated by reference in this Quarterly Report on Form 10-Q are
forward-looking statements concerning our business, results of operations, economic performance and
financial condition based on our current expectations. These forward-looking statements are not
guarantees of future performance and involve risks and uncertainties that could cause actual
results to differ materially from those implied by such forward-looking statements. Given these
risks and uncertainties, you are cautioned not to place undue reliance on any forward-looking
statements.
Executive Summary
Celgene Corporation and its subsidiaries (collectively we or our) is a global integrated
biopharmaceutical company primarily engaged in the discovery, development and commercialization of
innovative therapies designed to treat cancer and immune-inflammatory related diseases. Our
primary commercial stage products are REVLIMID® (lenalidomide), THALOMID®
(thalidomide) and VIDAZA® (azacitidine for injection). REVLIMID® was
approved by the U.S. Food and Drug Administration, or FDA, the European Commission, or the EC, the
Swiss Agency for Therapeutic Products, or Swissmedic and the Australian Therapeutic Goods
Administration, for treatment in combination with dexamethasone for multiple myeloma patients who
have received at least one prior therapy. In addition, REVLIMID® was approved by the
FDA and the Canadian Therapeutic Products Directorate for treatment of patients with
transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes, or MDS,
associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic
abnormalities. THALOMID® was approved by the FDA for treatment in combination with
dexamethasone for patients with newly diagnosed multiple myeloma and is also approved for the
treatment and suppression of cutaneous manifestations of 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® is licensed from Pharmacia & Upjohn, now part of Pfizer, Inc.,
and was approved by the FDA for the treatment of all subtypes of MDS. We also sell
ALKERAN®, which we obtain through a supply and distribution agreement with
GlaxoSmithKline, or GSK, and FOCALIN®, which we sell exclusively to Novartis Pharma AG,
or Novartis. Other sources of revenue include royalties which we primarily receive from Novartis
on its sales of the entire family of RITALIN® drugs and FOCALIN XR®, in
addition to revenues from collaborative agreements and licensing fees.
On March 7, 2008, we acquired all of the outstanding common stock and stock options of Pharmion
Corporation in a transaction accounted for under the purchase method of accounting. Under the
purchase method of accounting, the assets and liabilities of Pharmion were recorded as of the
acquisition date, at their respective fair values, and consolidated with our financial statements.
Prior to the acquisition, Pharmion was a global biopharmaceutical company that acquired, developed
and commercialized innovative products for the treatment of hematology and oncology patients. We
acquired Pharmion to enhance our portfolio of therapies for patients with life-threatening
illnesses worldwide with the addition of Pharmions marketed products, and several products in
development for the treatment of hematological and solid tumor cancers. Pharmions results of
operations are included in our consolidated financial statements from the date of acquisition. The
definitive agreement to acquire Pharmion was announced on November 18, 2007 for a total value of $
2.9 billion. This amount was based on the estimated total number of Pharmion shares outstanding,
including Pharmion shares owned by Celgene at that time and Pharmion stock options outstanding. The
purchase price, including acquisition related fees and all other costs, as determined on March 7,
2008 was $ 2.761 billion and includes the previously owned Pharmion shares at historical cost.
22
The impact of purchase accounting, based on a preliminary valuation, resulted in charges in the
three-month period ended March 31, 2008 which included $1.74 billion for acquired in-process
research and development (IPR&D), $8.2 million for amortization of acquired intangible assets which
will be amortized over a weighted average period of 6.5 years and $2.5 million for amortization of
the step-up to fair value of Pharmions product inventory. The $1.74 billion IPR&D charge related
to various research and development projects which have not been completed and for which there is
no alternative future use. The amount of the charge was determined by estimating the risk-adjusted
future value of these projects discounted at rates between 9 percent and 11 percent.
We are dedicated to innovative research and development designed to bring new therapies to market
and are involved in research in several scientific areas that may deliver proprietary
next-generation therapies, such as intracellular signaling, immunomodulation and placental stem
cell research. The drug and cell therapies we develop are designed to treat life-threatening
diseases or chronic debilitating conditions where patients are poorly served by current therapies.
Building on our growing knowledge of the biology underlying hematological and solid tumor cancers
and immune-inflammatory diseases, we are investing in a range of innovative therapeutic programs
that are investigating ways to treat and manage chronic diseases by targeting the disease source
through multiple mechanisms of action. In March 2008, AMRUBICINTM, a third-generation
fully synthetic anthracyclin obtained in the Pharmion acquisition, was granted orphan drug
designation by the FDA for the treatment of small cell lung cancer. In April 2008, the Australian
Therapeutic Goods Administration, or TGA, approved a supplemental filing granting Thalidomide
Pharmion® marketing approval for use in combination with melphalan and prednisone for
patients with untreated multiple myeloma or ineligible for high dose chemotherapy. Thalidomide
Pharmion® was also granted marketing approval in combination with dexamethasone for
induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the
treatment of patients with untreated multiple myeloma. In addition, in April 2008, Thalidomide
Pharmion® was granted full marketing authorization by the EC for use in combination with
melphalan and prednisone as a treatment for patients with newly diagnosed multiple myeloma.
Our future growth and operating results will depend on the successful integration of Pharmion,
continued acceptance of our currently marketed products, regulatory approvals of both new products
and the expanded use of existing products, depth of our product pipeline and ability to
commercialize these products, competition to our marketed products and challenges to our
intellectual property. See also Risk Factors contained in Part I, Item 1A of our Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 and Part II, Item 1A of this Quarterly Report
on Form 10-Q.
For the three-month period ended March 31, 2008, we reported revenue of $462.6 million,
representing an increase of $169.2 million, or 57.7%, compared to the three-month period ended
March 31, 2007. The increase was primarily due to the continued growth of REVLIMID® and
inclusion of sales of former Pharmion products. We reported a net loss of $1.641 billion and a
diluted loss per share of $3.98 for the three-month period ended March 31, 2008 compared to net
income of $57.4 million, or $0.14 per diluted share for the three-month period ended March 31,
2007. The loss in the three-month period ended March 31, 2008 was primarily due to the in-process research
and development charge related to our acquisition of Pharmion, which offset the favorable impact of
increased revenues.
23
Results of Operations:
Three-Month Periods Ended March 31, 2008 and 2007
Total Revenue: Total revenue and related percentages for the three-month periods ended March 31,
2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
|
|
|
March 31, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID ® |
|
$ |
286,846 |
|
|
$ |
146,233 |
|
|
$ |
140,613 |
|
|
|
96.2 |
% |
THALOMID ® |
|
|
113,927 |
|
|
|
106,034 |
|
|
|
7,893 |
|
|
|
7.4 |
% |
VIDAZA ® |
|
|
13,820 |
|
|
|
|
|
|
|
13,820 |
|
|
|
N/A |
|
ALKERAN ® |
|
|
15,114 |
|
|
|
15,964 |
|
|
|
(850 |
) |
|
|
-5.3 |
% |
Other |
|
|
1,667 |
|
|
|
1,565 |
|
|
|
102 |
|
|
|
6.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
$ |
431,374 |
|
|
$ |
269,796 |
|
|
$ |
161,578 |
|
|
|
59.9 |
% |
Collaborative agreements and
other revenue |
|
|
4,768 |
|
|
|
4,804 |
|
|
|
(36 |
) |
|
|
-0.7 |
% |
Royalty revenue |
|
|
26,455 |
|
|
|
18,815 |
|
|
|
7,640 |
|
|
|
40.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
462,597 |
|
|
$ |
293,415 |
|
|
$ |
169,182 |
|
|
|
57.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID® net sales increased for the three-month period ended March 31, 2008 compared
to the three-month period ended March 31, 2007 primarily due to increased unit sales in the United
States and international markets, which reflected the June 2007 ECs approval for the use of
REVLIMID® for treatment in combination with dexamethasone of patients with multiple
myeloma who have received at least one prior therapy.
THALOMID® net sales increased for the three-month period ended March 31, 2008 compared
to the three-month period ended March 31, 2007 primarily due to the inclusion of sales recorded by
former Pharmion entities and the introduction of a 150mg dosage in March 2007.
VIDAZA® was acquired in the purchase of Pharmion effective March 7, 2008. Net sales for
2008 represent sales recorded for the period March 8, 2008 through March 31, 2008.
ALKERANâ net sales were slightly lower for the three-month period ended March 31,
2008 compared to the three-month period ended March 31, 2007 primarily due to a decrease in unit
sales of the injectable form.
Net
product sales for the three-month period ended March 31, 2008 increased $161.6 million,
or 59.9% compared to the three-month period ended March 31, 2007. The change was comprised of volume
increases of $143.0 million, or 53.0%, as well as price
increases of $13.6 million, or 5.0% and
impact of foreign exchange of $5.0 million, or 1.9%.
24
Collaborative Agreements and Other Revenue: Revenues from collaborative agreements and other
sources were relatively flat for the three-month periods ended March 31, 2008 and 2007,
respectively.
Royalty Revenue: Royalty revenue totaled $26.5 million for the three-month period ended March 31,
2008, representing an increase of $7.6 million compared to the three-month period ended March 31,
2007. The increase was primarily due to amounts received from Novartis on sales of their entire
family of RITALIN® drugs and FOCALIN XR®, partly due to higher levels of
wholesaler inventories at the end of March 2008.
Gross to Net Sales Accruals: We record gross to net sales accruals for sales returns, sales
discounts, government rebates and distributor chargebacks and 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 and inventory centralization and
rationalization initiatives conducted by major pharmacy chains. 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 contracted pharmacies lending
itself to tighter controls of inventory quantities within the supply channel and, thus, resulting
in lower returns activity to date. VIDAZA® is sold in the United States to
pharmaceutical wholesalers, who in turn distribute product to physicians, retail pharmacies,
hospitals and other institutional customers. Sales discount accruals are based on payment terms
extended to customers.
Government rebate accruals are based on estimated payments due to US and international governmental
agencies for purchases made by third parties under various governmental programs. US 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.
Distributor chargeback 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. See Critical Accounting Policies for
further discussion.
25
Gross to net sales accruals and the balance in the related allowance accounts for the three-month
periods ended March 31, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
Chargebacks |
|
|
|
|
2008 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
and Services |
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
|
|
|
|
Distributor |
|
|
|
|
(Amounts in thousands) |
|
and |
|
|
|
|
|
|
Government |
|
|
Chargebacks |
|
|
|
|
2007 |
|
Allowances |
|
|
Discounts |
|
|
Rebates |
|
|
and Services |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
$ |
9,480 |
|
|
$ |
2,296 |
|
|
$ |
7,468 |
|
|
$ |
10,633 |
|
|
$ |
29,877 |
|
Allowances for sales during 2007 |
|
|
7,961 |
|
|
|
5,679 |
|
|
|
5,976 |
|
|
|
15,204 |
|
|
|
34,820 |
|
Credits/deductions issued for prior year sales |
|
|
(7,127 |
) |
|
|
(2,104 |
) |
|
|
(5,708 |
) |
|
|
(8,525 |
) |
|
|
(23,464 |
) |
Credits/deductions issued for sales during 2008 |
|
|
(907 |
) |
|
|
(3,621 |
) |
|
|
|
|
|
|
(8,888 |
) |
|
|
(13,416 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2007 |
|
$ |
9,407 |
|
|
$ |
2,250 |
|
|
$ |
7,736 |
|
|
$ |
8,424 |
|
|
$ |
27,817 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A comparison of allowances for sales within each of the four categories noted above for the
three-month periods ended March 31, 2008 and 2007, respectively, follows:
Returns and allowances increased by $2.6 million for the three-month period ended March 31, 2008
compared to the three-month period ended March 31, 2007 primarily due to higher returns of
THALOMIDâ .
Discounts increased by $3.2 million for the three-month period ended March 31, 2008 compared to the
three-month period ended March 31, 2007 primarily due to increased sales of
REVLIMIDâ.
Government rebates increased by $7.8 million in the three-month period ended March 31, 2008
compared to the three-month period ended March 31, 2007 primarily due to the increased
international government rebates resulting from our global expansion, as well as the inclusion of
Pharmion rebates.
Distributor chargebacks increased by $2.0 million in the three-month period ended March 31, 2008
compared to the three-month period ended March 31, 2007 primarily due to the inclusion of Pharmion
and ALKERANâ tablet volume increases.
26
Operating Costs and Expenses: Operating costs, expenses and related percentages for the
three-month periods ended March 31, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
Increase |
|
|
Percent |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization expense) |
|
$ |
44,724 |
|
|
$ |
22,055 |
|
|
$ |
22,669 |
|
|
|
102.8 |
% |
Percent of net product sales |
|
|
10.4 |
% |
|
|
8.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
156,877 |
|
|
|
79,575 |
|
|
|
77,302 |
|
|
|
97.1 |
% |
Percent of total revenue |
|
|
33.9 |
% |
|
|
27.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
140,451 |
|
|
|
105,206 |
|
|
|
35,244 |
|
|
|
33.5 |
% |
Percent of total revenue |
|
|
30.4 |
% |
|
|
35.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development |
|
|
1,740,000 |
|
|
|
|
|
|
|
1,740,000 |
|
|
|
N/A |
|
|
Amortization of acquired intangible assets |
|
|
9,842 |
|
|
|
2,215 |
|
|
|
7,627 |
|
|
|
344.3 |
% |
Cost of Goods Sold (excluding amortization expense): Cost of goods sold increased by $22.7 million
for the three-month period ended March 31, 2008 compared to the three-month period ended March 31,
2007 primarily due to increased material and royalty costs for REVLIMIDâ and
THALOMIDâ, increased material costs for ALKERANâ for injection
and the inclusion of $8.1 million in cost of sales related to former Pharmion products,
particularly VIDAZAâ and Thalidomide Pharmionâ. As a percentage
of net product sales, cost of goods sold (excluding amortization expense) increased to 10.4% in
2008 from 8.2% in 2007 primarily due to the inclusion of higher costs for VIDAZAâ
and Thalidomide Pharmionâ and higher costs for THALOMIDâ.
Research and Development: Research and development expenses increased by $77.3 million for the
three-month period ended March 31, 2008 compared to the three-month period ended March 31, 2007
primarily due to $45.0 million in upfront payments made to Acceleron Pharma, Inc. in 2008 related
to a research and development collaboration arrangement, the inclusion of $6.6 million in expense
for Pharmion entities which were partly related to AMRUBICINTM and the MethylGene HDAC
program in addition to an increase of $16.4 million 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. Regulatory spending
increased primarily due to the expansion of REVLIMIDâ in international markets.
The following table provides an additional breakdown of research and development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
March 31, |
|
|
|
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
Increase |
|
|
Human pharmaceutical clinical programs |
|
$ |
49,141 |
|
|
$ |
32,719 |
|
|
$ |
16,422 |
|
Other pharmaceutical programs |
|
|
92,804 |
|
|
|
33,341 |
|
|
|
59,463 |
|
Biopharmaceutical discovery and development |
|
|
10,868 |
|
|
|
10,010 |
|
|
|
858 |
|
Placental stem cell and biomaterials |
|
|
4,064 |
|
|
|
3,505 |
|
|
|
559 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
156,877 |
|
|
$ |
79,575 |
|
|
$ |
77,302 |
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceutical programs for the three-month period ended March 31, 2008, includes $45.0
million for the Acceleron Pharma collaborative research and development arrangement, in addition to
spending for toxicology, analytical research and development, drug discovery, quality and
regulatory affairs.
27
Research and development expenditures support ongoing clinical progress in multiple proprietary
development programs for REVLIMIDâ and THALOMIDâ, and
for other compounds such as: CC-10004, our lead anti-inflammatory compound that inhibits PDE-4,
which results in the inhibition of multiple
proinflammatory mediators such as TNF-a and which is currently being evaluated in Phase II clinical
trials in the treatment of psoriasis and psoriatic arthritis; CC-4047, CC-11006 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; and 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
$35.2 million for the three-month period ended March 31, 2008 compared to the three-month period
ended March 31, 2007, reflecting an increase in marketing of $18.4 million, sales force costs of
$6.3 million related to the expansion of our international operations throughout Europe, Australia
and Canada, and the inclusion of expenses related to Pharmion of $11.1 million.
Acquired In-Process Research and Development:
IPR&D 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 alternative 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, as
determined by a valuation from an independent third-party valuation
firm. The IPR&D primarily related to
development and approval initiatives for Vidaza® IV in the E.U. market,
Vidaza® Oral in the U.S. and E.U. markets and Thalidomide Pharmion® 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.
For Vidaza® IV in the E.U. market, the related future net cash flows were estimated
using a risk-adjusted discount rate of 10.0% and an anticipated regulatory approval
date in late 2008 with market exclusivity rights expected to continue through 2019. For
Vidaza® Oral in the U.S. and E.U., the future net cash flows were estimated using a
risk-adjusted discount rate of 11.0% for each market. The anticipated regulatory
approval in the E.U. was assumed for 2013 with exclusivity continuing through 2023, and the
anticipated regulatory approval in the U.S. was assumed for 2013 with exclusivity continuing
through 2018. For Thalidomide Pharmion® in the E.U. market, the future net cash flows
were estimated using a risk-adjusted discount rate of 9.5% and an anticipated
regulatory approval date in 2008 with exclusivity continuing through 2018. In April 2008,
Thalidomide Pharmion® was granted full marketing authorization by the EC for use in
combination with melphalan and prednisone as a treatment for patients with newly diagnosed multiple
myeloma.
Amortization of Acquired Intangible Assets: The $9.8 million in amortization of acquired
intangible assets for the three-month period ended March 31, 2008 included $8.2 million related to
intangible assets resulting from the March 2008 acquisition of Pharmion and $1.6 million resulting
from the October 2004 acquisition of Penn T Limited. The $2.2 million amortization of acquisition
intangibles for the three-month period ended March 31, 2007 all related to the acquisition of Penn
T Limited.
Interest and Investment Income, Net: Interest and investment income, net increased by $4.8 million
for the three-month period ended March 31, 2008 compared to the three-month period ended March 31,
2007 due to increased interest income on higher average cash, cash equivalents and marketable
securities balances and an increase in gains on the sale of marketable securities.
Equity in Losses of Affiliated Companies: Under the equity method of accounting, we recorded
losses of $5.1 million and $1.3 million for the three-month periods ended March 31, 2008 and 2007,
respectively. The loss in the three-month period ended March 31, 2008 included an impairment
charge of $4.4 million
related to an affiliate company investee based on a decrease in fair value below our cost in this
quarter along with our evaluation of several other factors affecting this investee. This reduced
our investment to $7.2 million, which was the fair value of our common stock ownership at the end
of March 31, 2008 based on the closing price of the affiliate companys common stock on that date.
Interest Expense: Interest expense was $2.2 million and $2.7 million for the three-month periods
ending March 31, 2008 and 2007, respectively. The $0.5 million decrease was primarily due to the
$203.4 million conversion of convertible debt into our common stock between the two periods.
Other Income, Net: Other income, net was $0.9 million for each of the three-month periods ended
March 31, 2008 and 2007. The income in each year was primarily due to foreign exchange gains.
28
Income Tax Provision: The income tax provision for the three-month period ended March 31, 2008 was
$35.0 million and reflects an effective tax rate of negative 2.2%. The effective tax rate was
impacted by non-deductible in-process research and development 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. The income tax provision for the three-month period ended March 31, 2007 was $48.7
million and reflected an effective tax rate of 53.0%, net of a deferred tax benefit of
approximately $7.5 million primarily related to the recognition of research and experimentation tax
credits, resulting from a study covering
prior years, conducted in the first quarter of 2007. The income tax provision for the three-month
period ended March 31, 2007 also reflected the impact of certain expenses incurred in taxing
jurisdictions outside the United States for which we did not receive a tax benefit and
nondeductible expenses which included share-based compensation expense related to incentive stock
options.
Liquidity and Capital Resources
Cash flows from operating, investing and financing activities for the three-month periods ended
March 31, 2008 and 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended |
|
|
|
|
|
|
March 31, |
|
|
Increase |
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
63,560 |
|
|
$ |
89,797 |
|
|
$ |
(26,237 |
) |
Net cash (used in) investing activities |
|
$ |
(393,341 |
) |
|
$ |
(562,211 |
) |
|
$ |
168,870 |
|
Net cash provided by financing activities |
|
$ |
35,552 |
|
|
$ |
50,827 |
|
|
$ |
(15,275 |
) |
Operating Activities: Net cash provided by operating activities for the three-month period ended
March 31, 2008 decreased by $26.2 million as compared to the three-month period ended March 31,
2007.
Investing Activities: Net cash used in investing activities for the three-month period ended March
31, 2008 primarily includes net proceeds from maturities of available-for-sale marketable securities and
acquired assets related to the acquisition of Pharmion.
Financing Activities: Net cash provided by financing activities for the three-month periods ended
March 31, 2008 and March 31, 2007 primarily included cash received from the exercise of employee
stock options and the related excess tax benefit recognized.
Cash, Cash Equivalents, Marketable Securities Available for Sale and Working Capital: Working
capital and cash, cash equivalents and marketable securities available for sale as of March 31,
2008 and December 31, 2007 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
|
(Amounts in thousands) |
|
2008 |
|
|
2007 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities available for sale |
|
$ |
2,026,492 |
|
|
$ |
2,738,918 |
|
|
$ |
(712,426 |
) |
Working capital (1) |
|
$ |
2,109,390 |
|
|
$ |
2,835,205 |
|
|
$ |
(722,603 |
) |
|
|
|
(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 and in U.S. government debt, U.S. government agency debt, U.S.
government-sponsored agency debt, and 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 decrease in
cash, cash equivalents and marketable securities available for sale from December 31, 2007 to March
31, 2008 was primarily due to the net payment of $746.0 million
relating to the
Pharmion acquisition.
29
Accounts Receivable, Net: Accounts receivable, net increased by $91.1 million to $258.4 million as
of March 31, 2008 compared to December 31, 2007 partly due to the inclusion of $53.7 million in net
receivables obtained in the acquisition of Pharmion and increased sales of REVLIMID®.
Days of sales
outstanding at March 31, 2008 was 52 days including Pharmion and 45 days excluding Pharmion
compared to 41 days at December 31, 2007. Excluding Pharmion, the increase was primarily due to
increased international sales for which the collection period is longer than for U.S. sales.
Inventory: Inventory as of March 31, 2008 of $96.3 million increased by $47.2 million compared to
December 31, 2007 primarily due to the inclusion of $36.7 million in the fair value of product
inventory obtained in the acquisition of Pharmion, a $6.7 million increase in ALKERAN®
inventories, which fluctuate depending on the purchase price of the specific units purchased during
a given period, and a $4.9 million increase in REVLIMID® inventories, resulting from the
products increased sales volume.
Other Current Assets: Other current assets increased $12.5 million to $121.2 million as of March 31,
2008 compared to December 31, 2007 partly due to the inclusion of $10.2 million in Pharmion assets,
consisting primarily of miscellaneous receivables, prepaids and deposits.
Accounts Payable, Accrued Expenses and Other Current Liabilities: Accounts payable, accrued
expenses and other current liabilities increased $165.3 million to $389.0 million as of March 31,
2008 compared to December 31, 2007 primarily due to restructuring reserves of $69.0 million and the
inclusion of $96.9 million from Pharmion.
Income Taxes Payable (Current and non-current): Income taxes payable increased $14.4 million for
the three-month period ended March 31, 2008 compared to December 31, 2007 primarily from provisions
for income taxes of $35.1 million offset by a tax benefit on stock option exercises of $20.6
million.
We anticipate that existing cash, cash equivalents and marketable securities available for sale,
combined with cash received from expected net product sales and revenues from various research,
collaboration and royalty agreements, will provide sufficient capital resources to fund our
operations for the foreseeable future.
Financial Condition
We invest our excess cash primarily in money market funds and in highly liquid debt instruments of
the U.S. Treasury, government-sponsored agencies and U.S. corporations.
As of March 31, 2008, we have certain financial assets and liabilities recorded at fair value. In accordance with
Statement of Financial Accounting Standards 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 the companys marketable equity security. Fair values determined based on Level 2 inputs utilize
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. Our Level 2 assets consists of U.S. Treasury
securities, U.S. government-sponsored agency securities, mortgage-backed obligations and corporate debt securities.
Fair values determined based on Level 3 inputs utilize unobservable inputs and includes valuations or assets or
liabilities for which there is little, if any, market activity. Our Level 3 assets consist of the 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 only asset with fair values based on Level 3 inputs was the private cash fund, which represent approximately 2.0%
of total fair value for available-for-sale securities at March 31, 2008.
During the quarter ended March 31, 2008 we did not change the valuation methods for our marketable securities.
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, existing cash, cash equivalents and marketable
securities available for sale, combined with cash received from expected net product sales and
revenues from royalty agreements, are expected to provide sufficient capital resources to fund our
operations for the foreseeable future.
Our convertible 1.75% notes mature in June 2008 and are convertible at any time into 16,223,892
shares of common stock as of March 31, 2008 at a stock-adjusted conversion price of $12.1125 per
share. Based on the current price of our common stock, we expect noteholders to convert the
notes into shares of common stock and do not expect such conversion to have a material impact on
our financial condition, liquidity or capital resources. On May 9, 2008, we entered into a
supplemental indenture with respect to our convertible notes. See Item 5, Other Information.
30
Contractual Obligations
The following table sets forth our contractual obligations as of March 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due By Period |
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
|
|
|
(Amounts in thousands) |
|
1 Year |
|
|
1 to 3 Years |
|
|
3 to 5 Years |
|
|
5 Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible note obligations |
|
$ |
196,512 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
196,512 |
|
Operating leases |
|
|
19,094 |
|
|
|
33,871 |
|
|
|
18,538 |
|
|
|
7,929 |
|
|
|
79,432 |
|
ALKERAN® supply agreements |
|
|
21,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,219 |
|
Manufacturing facility note payable |
|
|
4,127 |
|
|
|
8,253 |
|
|
|
8,153 |
|
|
|
16,104 |
|
|
|
36,637 |
|
Other contract commitments |
|
|
37,969 |
|
|
|
11,914 |
|
|
|
|
|
|
|
|
|
|
|
49,883 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
278,921 |
|
|
$ |
54,038 |
|
|
$ |
26,691 |
|
|
$ |
24,033 |
|
|
$ |
383,683 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Taxes Payable: We have provided a liability for unrecognized tax benefits related to
various federal, state and foreign income tax matters of $226.7 million at March 31, 2008. The
timing of the settlement of these amounts was not reasonably estimable at March 31, 2008. The
Company does not expect a settlement within the next twelve months.
Critical Accounting Policies
A critical accounting policy is one that is both important to the portrayal of our financial
condition and results of operation and requires managements most difficult, subjective or complex
judgments, often as a result of the need to make estimates about the effect of matters that are
inherently uncertain. Our significant accounting policies are more fully described in Note 1 of
the Notes to the Consolidated Financial Statements included in our Annual Report on Form 10-K for
the year ended December 31, 2007. 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, 2007.
In addition to the critical
accounting policies referenced above, the following are also applicable:
Valuation of acquired intangible assets and acquired in-process research and development: We have
acquired intangible assets primarily via business combinations. When
significant identifiable intangible assets, and acquired in-process research and development,
are acquired, an independent third-party valuation firm is engaged to assist us in determining the
fair values of these assets as of the acquisition date. Discounted cash flow models are typically
used in these valuations, and the models require the use of significant estimates and assumptions
including but not limited to:
|
|
|
projecting regulatory approvals, |
|
|
|
estimating future cash flows from product sales resulting from completed products and
in-process projects and |
|
|
|
developing appropriate discount rates and probability rates by project. |
We believe the fair values assigned to the intangible assets acquired and acquired in-process
research and development are based upon reasonable estimates and assumptions given available facts
and circumstances as of the acquisition date.
31
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, 2008, our market risk
sensitive instruments consisted of marketable securities available for sale, unsecured convertible
notes issued by us, our notes payable to Siegfried and certain foreign exchange forward contracts.
Derivatives: We periodically utilize forward contracts to economically hedge non-functional
currency exposures. At March 31, 2008, we had foreign currency forward contracts outstanding to
hedge non-functional currency assets denominated in Swiss Francs, British Pounds, Japanese Yen and
U.S. dollars. The aggregate notional amount of these contracts was $40.4 million and they expire
within one year. The contracts are economic hedges of receivables at U.K. and Swiss foreign
entities and are remeasured through earnings each period along with the underlying hedged item. At
March 31, 2008, the net unrealized loss on the forward contracts was approximately $0.7 million in
the aggregate.
Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably
possible near-term change in foreign currency rates. Assuming that the March 31, 2008 exchange
rates were to adversely change by a hypothetical 10% decrease in the underlying currencies, the
fair value of the contracts would decrease by approximately $8.8 million. However, since the
contracts hedge assets denominated in currencies other than the entitys functional currency, any
change in the fair value of the contract would be offset by a change in the underlying value of the
hedged items.
Marketable Securities Available for Sale: At March 31, 2008, our marketable securities available
for sale consisted of mortgage-backed obligations, U.S. Treasury securities, U.S.
government-sponsored agency securities, corporate debt securities and private cash fund shares.
Marketable securities available for sale are carried at fair value, held for an unspecified period
of time and intended for use in meeting our ongoing liquidity needs. Unrealized gains and losses
on available-for-sale securities, which are deemed to be temporary, are reported as a separate
component of stockholders equity, net of tax. The cost of debt securities is adjusted for
amortization of premiums and accretion of discounts to maturity. The amortization, along with
realized gains and losses, is included in interest and investment income, net.
As of March 31, 2008, 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 |
|
$ |
506,319 |
|
|
$ |
476,308 |
|
|
$ |
68,074 |
|
|
$ |
10,000 |
|
|
$ |
1,060,701 |
|
Fair value |
|
$ |
511,674 |
|
|
$ |
490,131 |
|
|
$ |
71,779 |
|
|
$ |
10,983 |
|
|
$ |
1,084,567 |
|
Average interest rate |
|
|
4.3 |
% |
|
|
4.1 |
% |
|
|
3.4 |
% |
|
|
4.1 |
% |
|
|
4.1 |
% |
32
Convertible Debt: In June 2003, we issued an aggregate principal amount of $400.0 million of
unsecured convertible notes. The convertible notes have a five-year term and a coupon rate of
1.75% payable semi-annually. The convertible notes outstanding at March 31, 2008 can be converted
at any time into 16,223,892 shares of common stock at a stock-split adjusted conversion price of
$12.1125 per share (for more information refer to Note 10 of the Notes to the Unaudited
Consolidated Financial Statements). At March 31, 2008, the fair value of the convertible notes
exceeded the carrying value of $196.5 million by approximately $798.0 million, which we believe
reflects the increase in the market price of our common stock to $61.29 per share as of March 31,
2008. Assuming other factors are held constant, an increase in interest rates generally results in
a decrease in the fair value of fixed-rate convertible debt, but does not impact the carrying
value, and an increase in our stock price generally results in an increase in the fair value of
convertible debt, but does not impact the carrying value.
Note Payable: 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 Siegfried) located in Zufingen,
Switzerland. At March 31, 2008, the fair value of our note payable to Siegfried approximated the
carrying value of the note of $30.4 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.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures. As of the end of the period covered by this
quarterly report, we carried out an evaluation, under the supervision and with the participation of
the Companys management, including our Chief Executive Officer and Chief Financial Officer, of the
effectiveness of the design and operation of our disclosure controls and procedures (as defined in
the Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e)), 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 the Company in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the rules and
forms of the Securities and Exchange Commission.
(b) Changes in Internal Control Over Financial Reporting. On March 7, 2008, Celgene acquired
Pharmion Corporation. Until the accounting processes for former Pharmion entities can be fully
integrated, Celgene has relied and will continue to rely on previously established accounting
processes and internal controls of Pharmion. In all other instances, there have not been any other
changes in our internal control over financial reporting during the fiscal quarter to which this
report relates that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Our legal proceedings are described in Part I, Item 3, Legal Proceedings,, of our Annual Report
on Form 10-K for the fiscal year ended December 31, 2007.
There have not been any material changes as it pertains to such legal proceedings nor have we
engaged in any additional material legal proceedings.
33
Item 1A. Risk Factors
The risk factors included in our 2007 Annual Report on Form 10-K have not materially changed,
except that the Pharmion acquisition was completed on March 7, 2008.
The integration of Pharmion may
present significant challenges to us.
Achieving the anticipated benefits of our
acquisition of Pharmion will depend in part upon whether we can integrate our
businesses in an efficient and effective manner. Our integration of Pharmion involves a number
of risks, including, but not limited to:
|
|
demands on management related to the increase in our size after the acquisition;
|
|
|
the diversion of managements attention from the
management of daily operations to the integration of operations; |
|
|
higher integration costs than anticipated; |
|
|
failure to achieve expected synergies and costs savings; |
|
|
difficulties in the assimilation and retention of employees; |
|
|
difficulties in the assimilation of different cultures and practices,
as well as in the assimilation of broad and geographically dispersed personnel
and operations; and
|
|
|
difficulties in the integration of departments, systems,
including accounting systems, technologies, books and records, and
procedures, as well as in maintaining uniform standards, controls,
including internal control over financial reporting required by the
Sarbanes-Oxley Act of 2002 and related procedures and policies.
|
If we cannot successfully integrate Pharmion we may experience
material negative consequences to our business, financial
condition or results of operations. Successful integration
of Pharmion will depend on our ability to manage these operations,
to realize opportunities for revenue growth presented by offerings
and expanded geographic market coverage and, to some degree, to
eliminate redundant and excess costs. Because of difficulties in
combining geographically distant operations, we may not be able to
achieve the benefits that we hope to achieve as a result of the
acquisition with Pharmion.
In addition, risks related to the commercial success and future growth of the acquired
product, VIDAZA®, are summarized as follows:
|
|
our ability to achieve a marketing authorization for VIDAZA® in Europe and in
other countries; |
|
|
our ability to include favorable VIDAZA® survival data from a recent Phase III
study in the approved prescribing information in the United States; |
|
|
continued acceptance by regulators, physicians, patients and other key decision-makers as a
safe, superior therapeutic as compared to currently existing or future treatments for myelodysplastic syndrome, or MDS; |
|
|
our ability to successfully compete with other approved MDS therapies; and |
|
|
our ability to expand the indications for which we can market VIDAZA®. |
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
On May 9, 2008, we entered into a supplemental indenture to the indenture dated June 3, 2003
with the Bank of New York, as trustee, governing our convertible notes, wherein the
parties agreed to certain terms clarifying the modifications with respect to the final conversion
date and final interest payment. A copy of the supplemental indenture is filed as Exhibit 10.5 to
this Quarterly Report on Form 10-Q.
34
Item 6. Exhibits
|
|
|
10.1
|
|
Letter Agreement between the Company and Aart Brouwer, dated November 1, 2005. |
|
|
|
10.2
|
|
Letter Agreement between the Company and Graham Burton, dated June 2, 2003; Amendment to the
Letter Agreement dated April 28, 2008. |
|
|
|
10.3
|
|
Amendment to Letter Agreement between the Company and David W. Gryska, dated April 28, 2008. |
|
|
|
10.4
|
|
Amendment to the 2005 Deferred Compensation Plan. |
|
|
|
10.5
|
|
Supplemental Indenture to the Indenture dated June 3, 2003 between the Company and the Bank
of New York, as Trustee, dated May 9, 2008. |
|
|
|
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. |
35
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 12, 2008 |
By: |
/s/ David W. Gryska
|
|
|
|
David W. Gryska |
|
|
|
Sr. Vice President and Chief Financial Officer |
|
|
|
|
DATE May 12, 2008 |
By: |
/s/ Andre Van Hoek
|
|
|
|
Andre Van Hoek |
|
|
|
Controller and
Chief Accounting Officer |
|
|
36
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
No. |
|
Description |
|
10.1 |
|
|
Letter Agreement between the Company and Aart Brouwer, dated November 1, 2005. |
|
|
|
|
|
|
10.2 |
|
|
Letter Agreement between the Company and Graham Burton, dated June 2, 2003;
Amendment to the Letter Agreement dated April 28, 2008. |
|
|
|
|
|
|
10.3 |
|
|
Amendment to Letter Agreement between the Company and David W. Gryska, dated April
28, 2008. |
|
|
|
|
|
|
10.4 |
|
|
Amendment to the 2005 Deferred Compensation Plan. |
|
|
|
|
|
|
10.5 |
|
|
Supplemental Indenture to the Indenture dated June 3, 2003 between the Company
and the Bank of New York, as Trustee, dated May 9, 2008. |
|
|
|
|
|
|
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. |