Use these links to rapidly review the document
TABLE OF CONTENTS



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


Form 10-Q

x

ý

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


For the Quarterly Period Ended March 31,September 30, 2007


o


TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


For the Transition period from                        to                         

For the Transition period from                  to

Commission file number 0-19612


ImClone Systems Incorporated
(Exact name of registrant as specified in its charter)

Delaware

04-2834797


(State or other jurisdiction of

(IRS Employer


incorporation or organization)

04-2834797
(IRS Employer
Identification No.)


180 Varick Street, New York, NY

10014


(Address of principal executive offices)



10014
(Zip Code)

(212) 645-1405
(Registrant’sRegistrant's telephone number, including area code)

Not Applicable
(Former name, former address and former fiscal year, if changed since last report)


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 xý No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated"accelerated filer and large accelerated filer”filer" in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer xý

Accelerated filer o

Non-accelerated filer o

Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act). Yes o No xý

Indicate the number of shares outstanding of each of the issuer’sissuer's classes of common stock, as of the latest practicable date.

Class


Outstanding as of April 30,October 31, 2007


Common Stock, par value $0.001

85,632,79386,252,110 Shares







IMCLONE SYSTEMS INCORPORATED
INDEX

INDEX

PART I—FINANCIAL INFORMATION

Item 1.

Financial Statements

1

Unaudited Consolidated Balance Sheets—March 31,September 30, 2007 and December 31, 2006

1

Unaudited Consolidated Statements of Operations—Three months ended March 31,Months and Nine Months Ended September 30, 2007 and 2006

2

Unaudited Consolidated Statements of Cash Flows—Three months ended March 31,Nine Months Ended September 30, 2007 and 2006

3

Notes to Unaudited Consolidated Financial Statements

4

Item 2.

Management’sManagement's Discussion and Analysis of Financial Condition and Results of Operations

17

18

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

27

33

Item 4.

Controls and Procedures

28

34


PART II—OTHER INFORMATION



Item 1.

Legal Proceedings

29

35

Item 1A.

Risk Factors

31

37

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

31

37

Item 3.

Defaults Upon Senior Securities

31

37

Item 4.

Submission of Matters to a Vote of Security Holders

31

37

Item 5.

Other Information

31

38

Item 6.

Exhibits

31

38

Signatures

32

39

i


i




PART I. FINANCIAL INFORMATION

Item 1.Financial Statements

IMCLONE SYSTEMS INCORPORATED
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share and share data)
(Unaudited)

 

 

March 31,

 

December 31,

 

 

 

2007

 

2006

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

22,921

 

 

$

20,568

 

 

Securities available for sale

 

1,047,096

 

 

1,023,609

 

 

Prepaid expenses

 

2,571

 

 

3,972

 

 

Amounts due from corporate partners

 

76,619

 

 

78,030

 

 

Inventories

 

112,534

 

 

102,215

 

 

Deferred income taxes, net

 

33,200

 

 

29,715

 

 

Other current assets

 

15,180

 

 

12,123

 

 

Total current assets

 

1,310,121

 

 

1,270,232

 

 

Property, plant and equipment, net

 

415,097

 

 

423,000

 

 

Deferred financing costs, net

 

7,890

 

 

8,818

 

 

Deferred income taxes, net

 

100,809

 

 

124,033

 

 

Other assets

 

13,171

 

 

13,753

 

 

Total assets

 

$

1,847,088

 

 

$

1,839,836

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable (including $2,836 and $4,765 due Bristol-Myers Squibb Company (“BMS”) at March 31, 2007 and December 31, 2006, respectively)

 

$

21,951

 

 

$

26,421

 

 

Accrued expenses (including $20,523 and $21,705 due BMS at March 31, 2007 and December 31, 2006, respectively)

 

62,644

 

 

69,080

 

 

Current portion of deferred revenue

 

134,674

 

 

142,013

 

 

Other current liabilities

 

4,265

 

 

1,418

 

 

Total current liabilities

 

223,534

 

 

238,932

 

 

Deferred revenue, less current portion

 

215,909

 

 

237,864

 

 

Long-term debt

 

600,000

 

 

600,000

 

 

Share-based compensation, less current portion

 

622

 

 

261

 

 

Other liabilities

 

3,259

 

 

3,130

 

 

Total liabilities

 

1,043,324

 

 

1,080,187

 

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock, $1.00 par value; authorized 4,000,000 shares; reserved 1,200,000 series B participating cumulative preferred stock, none issued or outstanding

 

 

 

 

 

Common stock, $0.001 par value; authorized 200,000,000 shares; issued 86,514,434 and 86,143,604 at March 31, 2007 and December 31, 2006, respectively; outstanding 85,509,760 and 85,138,930 at March 31, 2007 and December 31, 2006, respectively

 

87

 

 

86

 

 

Additional paid-in capital

 

877,907

 

 

865,560

 

 

Accumulated deficit

 

(41,523

)

 

(71,785

)

 

Treasury stock, at cost 1,004,674 at March 31, 2007 and December 31, 2006, respectively

 

(29,149

)

 

(29,149

)

 

Accumulated other comprehensive loss:

 

 

 

 

 

 

 

Net unrealized loss on securities available for sale

 

(3,558

)

 

(5,063

)

 

Total stockholders’ equity

 

803,764

 

 

759,649

 

 

Total liabilities and stockholders’ equity

 

$

1,847,088

 

 

$

1,839,836

 

 

 
 September 30,
2007

 December 31,
2006

 
ASSETS       
Current assets:       
 Cash and cash equivalents $414,323 $20,568 
 Securities available for sale  642,441  1,023,609 
 Prepaid expenses  3,159  3,972 
 Amounts due from corporate partners  92,640  78,030 
 Inventories  117,394  102,215 
 Deferred income taxes, net  14,708  29,715 
 Other current assets  13,244  12,123 
  
 
 
  Total current assets  1,297,909  1,270,232 
  
 
 
Property, plant and equipment, net  404,464  423,000 
Deferred financing costs, net  6,034  8,818 
Deferred income taxes, net  107,767  124,033 
Other assets  27,496  13,753 
  
 
 
  Total assets $1,843,670 $1,839,836 
  
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY       
Current liabilities:       
 Accounts payable (including $1,387 and $4,765 due Bristol-Myers Squibb Company ("BMS") at September 30, 2007 and December 31, 2006, respectively) $24,424 $26,421 
 Accrued expenses (including $3,079 and $21,705 due BMS at September 30, 2007 and December 31, 2006, respectively)  58,355  69,080 
 Current portion of deferred revenue  66,203  142,013 
 Other current liabilities  4,719  1,418 
  
 
 
  Total current liabilities  153,701  238,932 
  
 
 
Deferred revenue, less current portion  238,529  237,864 
Long-term debt  600,000  600,000 
Share-based compensation, less current portion  734  261 
Deferred rent, less current portion  3,505  3,130 
  
 
 
  Total liabilities  996,469  1,080,187 
  
 
 
Commitments and contingencies (Note 8)       

Stockholders' equity:

 

 

 

 

 

 

 
 Preferred stock, $1.00 par value; authorized 4,000,000 shares; reserved 1,200,000 series B participating cumulative preferred stock, none issued or outstanding     
 Common stock, $0.001 par value; authorized 200,000,000 shares; issued 87,169,631 and 86,143,604 at September 30, 2007 and December 31, 2006, respectively; outstanding 86,178,566 and 85,138,930 at September 30, 2007 and December 31, 2006, respectively  87  86 
 Additional paid-in capital  905,291  865,560 
 Accumulated deficit  (10,534) (71,785)
 Treasury stock, at cost; 991,065 and 1,004,674 at September 30, 2007 and December 31, 2006, respectively  (28,754) (29,149)
 Accumulated other comprehensive loss:       
  Net unrealized loss on securities available for sale  (18,889) (5,063)
  
 
 
  Total stockholders' equity  847,201  759,649 
  
 
 
Total liabilities and stockholders' equity $1,843,670 $1,839,836 
  
 
 

See accompanying notes to consolidated financial statements.


1




IMCLONE SYSTEMS INCORPORATED

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(Unaudited)

 

 

Three Months
Ended March 31,

 

 

 

2007

 

2006

 

Revenues:

 

 

 

 

 

Royalty revenue

 

$

76,363

 

$

60,270

 

License fees and milestone revenue

 

29,294

 

144,403

 

Manufacturing revenue

 

16,458

 

19,349

 

Collaborative agreement revenue

 

19,385

 

21,109

 

Total revenues

 

141,500

 

245,131

 

Operating expenses:

 

 

 

 

 

Research and development

 

34,875

 

32,993

 

Clinical and regulatory

 

13,808

 

15,081

 

Marketing, general and administrative

 

15,359

 

18,001

 

Royalty expense

 

16,786

 

20,066

 

Cost of manufacturing revenue

 

13,855

 

15,402

 

Total operating expenses

 

94,683

 

101,543

 

Operating income

 

46,817

 

143,588

 

Other (income) expense:

 

 

 

 

 

Interest income

 

(12,517

)

(7,164

)

Interest expense

 

2,972

 

1,462

 

Other income, net

 

(9,545

)

(5,702

)

Income before income taxes

 

56,362

 

149,290

 

Income tax provision (benefit)

 

27,607

 

(80,301

)

Net income

 

$

28,755

 

$

229,591

 

Income per common share:

 

 

 

 

 

Basic

 

$

0.34

 

$

2.75

 

Diluted

 

$

0.33

 

$

2.51

 

Shares used in calculation of income per common share:

 

 

 

 

 

Basic

 

85,255

 

83,624

 

Diluted

 

92,364

 

91,817

 

 
 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 
 
 2007
 2006
 2007
 2006
 
Revenues:             
 Royalties $87,853 $78,599 $242,360 $213,483 
 License fees and milestones  19,226  34,948  81,965  212,807 
 Manufacturing  21,973  20,884  61,456  68,589 
 Collaborative agreement reimbursements  18,495  16,266  53,698  50,805 
  
 
 
 
 
  Total revenues  147,547  150,697  439,479  545,684 
  
 
 
 
 
Operating expenses:             
 Research and development  43,626  26,437  112,224  87,013 
 Clinical and regulatory  4,761  13,527  33,389  43,537 
 Selling, general and administrative  20,748  15,977  54,674  56,941 
 Royalties  19,324  18,051  55,098  56,531 
 Cost of manufacturing revenue  22,256  19,187  59,110  61,466 
 Litigation settlement  50,000    50,000   
  
 
 
 
 
  Total operating expenses  160,715  93,179  364,495  305,488 
  
 
 
 
 
   Operating income (loss)  (13,168) 57,518  74,984  240,196 
  
 
 
 
 
Other income (expense):             
 Interest income  13,369  11,058  39,203  28,444 
 Interest expense  (3,100) (2,974) (9,062) (6,350)
 Gain on insurance settlement  3,775    3,775   
  
 
 
 
 
  Other income, net  14,044  8,084  33,916  22,094 
  
 
 
 
 
   Income before income taxes  876  65,602  108,900  262,290 
  Income tax provision (benefit)  1,792  8,286  49,156  (61,826)
  
 
 
 
 
   Net income (loss) $(916)$57,316 $59,744 $324,116 
  
 
 
 
 
Earnings (loss) per common share:             
 Basic $(0.01)$0.68 $0.70 $3.86 
  
 
 
 
 
 Diluted $(0.01)$0.65 $0.69 $3.58 
  
 
 
 
 
Shares used in calculation of earnings (loss) per common share:             
 Basic  85,957  84,335  85,649  84,013 
  
 
 
 
 
 Diluted  85,957  91,915  86,568  91,974 
  
 
 
 
 

See accompanying notes to consolidated financial statements.


2




IMCLONE SYSTEMS INCORPORATED

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

Three Months Ended
March 31,

 

 

 

2007

 

2006

 

Cash flows from operating activities:

 

 

 

 

 

Net income

 

$

28,755

 

$

229,591

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

7,834

 

3,069

 

Amortization of deferred financing costs

 

927

 

927

 

Share-based compensation

 

614

 

1,861

 

Tax benefit from share-based compensation

 

(7,033

)

(31,601

)

Loss on disposal of fixed assets

 

3,229

 

 

Deferred income taxes

 

19,739

 

(119,207

)

Other

 

21

 

 

Changes in:

 

 

 

 

 

Prepaid expenses

 

1,401

 

1,890

 

Amounts due from corporate partners

 

1,411

 

(11,088

)

Inventories

 

(10,319

)

6,322

 

Other current assets

 

(3,057

)

97

 

Other assets

 

537

 

430

 

Accounts payable

 

(4,470

)

(15,985

)

Accrued expenses

 

116

 

35,133

 

Share-based compensation

 

361

 

325

 

Other current liabilities

 

2,847

 

2,063

 

Deferred revenue

 

(29,294

)

105,597

 

Other liabilities

 

129

 

177

 

Net cash provided by operating activities

 

13,748

 

209,601

 

Cash flows from investing activities:

 

 

 

 

 

Acquisitions of property, plant and equipment

 

(3,135

)

(16,414

)

Purchases of securities available for sale

 

(470,432

)

(101,923

)

Proceeds from sale of securities available for sale

 

417,500

 

133,250

 

Proceeds from maturities of securities available for sale

 

30,950

 

5,475

 

Net cash (used in) provided by investing activities

 

(25,117

)

20,388

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from exercise of stock options

 

6,512

 

10,613

 

Proceeds from issuance of common stock under the employee stock purchase plan

 

177

 

255

 

Tax benefit from share-based compensation

 

7,033

 

31,601

 

Net cash provided by financing activities

 

13,722

 

42,469

 

Net increase in cash and cash equivalents

 

2,353

 

272,458

 

Cash and cash equivalents at beginning of period

 

20,568

 

3,403

 

Cash and cash equivalents at end of period

 

$

22,921

 

275,861

 

Supplemental cash flow information:

 

 

 

 

 

Cash paid for:

 

 

 

 

 

Income taxes

 

$

2,210

 

$

7

 

Non-cash investing and financing activity:

 

 

 

 

 

Change in net unrealized loss in securities available-for-sale

 

$

(1,505

)

$

1,333

 

 
 Nine Months Ended
September 30,

 
 
 2007
 2006
 
Cash flows from operating activities:       
 Net income $59,744 $324,116 
 Adjustments to reconcile net income to net cash provided by (used in) operating activities:       
 Depreciation and amortization  23,593  22,054 
 Amortization of deferred financing costs  2,784  2,784 
 Share-based compensation  4,480  6,264 
 Tax benefit from share-based compensation  (14,040) (69,133)
 Loss on disposal of fixed assets  3,969   
 Deferred income taxes  31,273  (146,764)
 Other  40   
 Changes in:       
  Prepaid expenses  813  (1,974)
  Amounts due from corporate partners  (14,610) (33,512)
  Inventories  (15,179) (5,732)
  Other current assets  (1,121) (2,910)
  Other assets  (14,037) 903 
  Accounts payable  (1,997) (7,557)
  Accrued expenses  1,753  86,088 
  Share-based compensation, less current portion  473  661 
  Other current liabilities  3,301  2,063 
  Withholding tax liability    (31,736)
  Deferred revenue  (75,145) 40,314 
  Deferred rent, less current portion  375  493 
  
 
 
   Net cash (used in) provided by operating activities  (3,531) 186,422 
  
 
 
Cash flows from investing activities:       
 Acquisitions of property, plant and equipment  (8,772) (41,118)
 Purchases of securities available for sale  (1,229,228) (1,213,832)
 Proceeds from sale of securities available for sale  1,346,750  872,665 
 Proceeds from maturities of securities available for sale  249,820  120,800 
  
 
 
   Net cash provided by (used in) investing activities  358,570  (261,485)
  
 
 
Cash flows from financing activities:       
 Proceeds from exercise of stock options  23,620  17,166 
 Proceeds from issuance of common stock under the employee stock purchase plan  556  669 
 Tax benefit from share-based compensation  14,040  69,133 
 Proceeds from sale of treasury stock  500   
  
 
 
   Net cash provided by financing activities  38,716  86,968 
  
 
 
Net increase in cash and cash equivalents  393,755  11,905 
Cash and cash equivalents at beginning of period  20,568  3,403 
  
 
 
Cash and cash equivalents at end of period $414,323 $15,308 
  
 
 
Supplemental cash flow information:       
 Cash paid for:       
  Interest, net of amounts capitalized $4,215 $1,503 
  
 
 
  Income taxes $3,722 $4,058 
  
 
 
Non-cash investing and financing activity:       
 Change in net unrealized loss in securities available-for-sale $13,826 $(2,832)
  
 
 

See accompanying notes to consolidated financial statements.


3




IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

(Unaudited)

(1) Business Overview and Basis of Presentation

The accompanying consolidated financial statements of ImClone Systems Incorporated (“("ImClone Systems”Systems" or the “Company”"Company") as of March 31,September 30, 2007 and for the three and nine months ended March 31,September 30, 2007 and 2006 are unaudited. The accompanying unaudited consolidated balance sheets, statements of operations and statements of cash flows have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”("GAAP") for interim financial information and in conjunction with the rules and regulations of the Securities and Exchange Commission (“SEC”("SEC"). Accordingly, they do not include all of the disclosures required by GAAP for complete financial statements. The financial statements reflect all adjustments, consisting only of normal, recurring adjustments, which are in the opinion of management, necessary for a fair presentation for the interim periods. Management of the Company has made a number of estimates and assumptions relating to the reporting of assets and liabilities and related revenue and expense accounts and the disclosure of contingent assets and liabilities to prepare these consolidated financial statements in conformity with GAAP. Actual results could differ materially from those estimates. These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’sCompany's Annual Report on Form 10-K for the fiscal year ended December 31, 2006, as filed with the SEC.

The results of operations for the interim periods are not necessarily indicative of results to be expected for the entire fiscal year or any other period.

The Company is a biopharmaceutical company whose mission is to advance oncology care by developing and commercializing a portfolio of targeted treatments designeddesignated to address the medical needsneed of patients with cancer. Our commercially available product, ERBITUX® (cetuximab) binds specifically to epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. We are conducting, and in some cases have completed, clinical studies evaluating ERBITUX for broader use in colorectal cancer, squamous cell carcinoma of the head and neck (“SCCHN”("SCCHN"), for the potential treatment of lung and pancreatic cancers, as well as other potential indications. The Company does not operate separate lines of business or separate business entities and does not conduct any of its operations outside of the United States. Accordingly, the Company does not prepare discrete financial information with respect to separate product areas or by location and does not have separately reportable segments.

On February 12, 2004, the United States Food and Drug Administration (“FDA”) approved ERBITUX for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. In September 2005, Health Canada approved the use of ERBITUX for use in combination with irinotecan for the treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to other irinotecan-based chemotherapy regimens and for use as a single agent for the treatment of EGFR expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy. On March 1, 2006, the FDA approved ERBITUX for use in combination with radiation therapy for the treatment of locally or regionally advanced SCCHN and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed.


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

Please see full prescribing information, available at www.ERBITUX.com, for important safety information relating to ERBITUX, including boxed warnings.

On December 1, 2003, Swissmedic, the Swiss agency for therapeutic products, approved ERBITUX in Switzerland for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. Merck KGaA licensed the right to market ERBITUX outside the United States and Canada from the Company in 1998. In Japan, Merck KGaA has marketing rights to ERBITUX, which are co-exclusive to the co-development rights of the Company and BMS. On June 30, 2004, Merck KGaA received marketing approval by the European Commission to sell ERBITUX for use in combination with irinotecan for the treatment of patients with EGFR-expressing metastatic colorectal cancer after failure of irinotecan including cytotoxic therapy. On December 22, 2005, Swissmedic approved ERBITUX in Switzerland in combination with radiation in the treatment of patients with previously untreated, advanced SCCHN. On April 3, 2006, Merck KGaA was granted marketing authorization by the European Commission to extend the use of ERBITUX, in combination with radiotherapy, to the treatment of patients with locally advanced SCCHN. In February 2007, an application was submitted with the Japanese Pharmaceuticals and Medical Devices Agency for the use of ERBITUX in treating patients with advanced colorectal cancer. ERBITUX is the first IgG1 monoclonal antibody that inhibits EGFR to be submitted for marketing authorization in Japan.

Impact of Recent Accounting Pronouncements

In September 2006, the Financial Accounting Standards Board (“FASB”("FASB") issued Statement of Financial Accounting Standards (SFAS) No. 157, “Accounting"Accounting for Fair Value Measurements” (“Measurements" ("SFAS 157”157"). SFAS 157 defines fair value, and establishes a framework for measuring fair value in accordance with accounting principles generally accepted in the United States of America,GAAP, and expands disclosure about fair value measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007. The Company is currently evaluating the requirements of SFAS 157.

In February 2007, the FASB issued SFAS No. 159, “The"The Fair Value Option for Financial Assets and Financial Liabilities” (“Liabilities" ("SFAS 159”159"). SFAS 159 permits the measurement of certain financial instruments and certain other items at fair value. Entities may choose to measure eligible items at fair value at specified election dates, reporting unrealized gains and losses on such items at each subsequent reporting period. SFAS 159 is effective for fiscal years beginning after November 15, 2007. The Company is currently evaluating the requirements of SFAS 159.


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(1) Business Overview and Basis of Presentation (Continued)

In December 2006,June 2007, the FASB issued FASB Staff PositionEmerging Issues Task Force reached a consensus on Issue No. EITF 00-19-2, “Accounting07-3, "Accounting for Registration Payment Arrangements” (“FSP 00-19-2”). FSP 00-19-2 addresses an issuer’s accountingNonrefundable Advance Payments for registration payment arrangementsGood or Services to Be Used in Future Research and specifiesDevelopment Activities." This Issue requires that the contingent obligation to make futurenonrefundable advance payments or otherwise transfer consideration under a registration payment arrangement, whether issued as a separate agreement or included as a provision of a financial instrument or other agreement,for research and development activities be deferred and capitalized. Such amounts should be separately recognized and measured in accordance with SFAS No. 5, “Accounting for Contingencies.” FSP 00-19-2 isas an expense as the related goods are delivered or the services are performed or when the goods or services are no longer expected to be provided. This Issue will be effective immediately for registration payment arrangements and financial instruments subject to those arrangements that were entered into or modified subsequent to the issuance of FSP 00-19-2. For registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of FSP 00-19-2, it is effective for financial statements issued for fiscal years beginning after December 15, 2006.2007, and earlier adoption is not permitted. This consensus is to be applied prospectively for new contracts entered into after that date. The Company has adoptedis currently evaluating the provisionspotential impact of FSP 00-19-2 as of


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

January 1, 2007, and has determined that it had no impactthis consensus on ourits consolidated financial statements. See Note 10—“Long-term Debt” for additional information.

Comprehensive Income (Loss)

The following table reconciles net income to comprehensive income:income (loss): (in thousands)

 

Three Months
Ended March 31,

 

 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 

2007

 

2006

 

 2007
 2006
 2007
 2006

Net income

 

$

28,755

 

$

229,591

 

Net income (loss) $(916)$57,316 $59,744 $324,116

Other comprehensive income (loss):

 

 

 

 

 

        

Unrealized gain (loss) on marketable securities during the period

 

1,505

 

(1,333

)

 (15,286) 4,835 (13,826) 2,832
 
 
 
 

Total other comprehensive income (loss)

 

1,505

 

(1,333

)

 (15,286) 4,835 (13,826) 2,832

Total comprehensive income

 

$

30,260

 

$

228,258

 

 
 
 
 
Total comprehensive income (loss) $(16,202)$62,151 $45,918 $326,948
 
 
 
 

        

The tax benefit (provision) benefit on the items included in other comprehensive lossincome (loss) assuming they were recognized in income would be approximately $(617,000)$6.3 million and $173,000$(687,000) for the three months ended March 31,September 30, 2007 and 2006, respectively, and $5.7 million and $(388,000) for the nine months ended September 30, 2007 and 2006, respectively.

        The increase in unrealized losses for the three and nine months ended September 30, 2007 is due to a decline in the fair market value of certain debt securities. These investments are all AAA/Aaa rated and interest continues to be paid by the holder of the instruments. The Company believes that this loss position is temporary and that no asset impairment charge is needed at this time.

Fair Value of Financial Instruments

The fair value of the Company’sCompany's 13¤/8% convertible senior notes of $600.0 million was approximately $559.9$559.5 million and $545.6 million at March 31,September 30, 2007 and December 31, 2006, respectively, based on their quoted market price.

Treasury Stock

        John H. Johnson was appointed as the Company's Chief Executive Officer ("CEO") in August 2007. On September 7, 2007, the Company sold 13,609 shares of treasury stock to Mr. Johnson for an aggregate consideration of $500,000, or $36.74 per share, which was the fair value of our common stock on such date, in order to enable Mr. Johnson to satisfy his obligation under his employment agreement to purchase $500,000 worth of Company common stock within three months of his commencement of employment.


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(1) Business Overview and Basis of Presentation (Continued)

Insurance Reimbursement

        Other income for the third quarter of 2007 includes a gain of $3.8 million from the proceeds of an insurance reimbursement primarily for lost royalties on an ERBITUX shipment that was damaged in-transit during 2006.

(2) Inventories          Inventories

Inventories are stated at the lower of cost, determined on the first-in-first-out method, or market. Inventories consist of the following: (in thousands)

 

March 31,
2007

 

December 31,
2006

 


 September 30,
2007

 December 31,
2006

Raw materials and supplies

 

$

15,223

 

 

$

17,818

 

 

Raw materials and supplies $16,153 $17,818

Work in process

 

89,406

 

 

79,048

 

 

Work in process 89,763 79,048

Finished goods

 

7,905

 

 

5,349

 

 

Finished goods 11,478 5,349

Total

 

$

112,534

 

 

$

102,215

 

 

 
 
Total $117,394 $102,215
 
 

        

In June 2006, the Company began producing ERBITUX for commercial use at its multiple product manufacturing facility (“BB50”("BB50"), located in Branchburg, New Jersey. The Company filed a supplemental Biological License Application with the FDA for approval of BB50 in April 2007. Until such time asOn August 20, 2007, the Company receivesreceived approval of BB50 from the FDA,U.S. Food and Drug Administration ("FDA") for the manufacture of ERBITUX in BB50, and therefore is now able to sell the ERBITUX inventory produced in BB50 cannot be used for commercial distribution. Based on management’s current expectations, the Company expects that the costs of such inventory will be fully realizable once the Company obtains approval of BB50, which is anticipated in the second half of 2007. As of March 31,BB50. Effective July 2007, the Company has capitalized approximately $40.0 million relatedtransitioned its BB50 plant from the production of ERBITUX to the costsproduction of producing ERBITUX in BB50.pipeline products and is expensing the cost of manufacturing these products as Research and Development expense. The Company will continueCompany's current plan is to


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

capitalize the costs of producing ERBITUX produce pipeline products in BB50 as long as management can conclude thatduring the costsremainder of such inventory will be fully realizable in the future.2007.

(3) Property, Plant and Equipment

Property, plant and equipment are recorded at cost and consist of the following: (in thousands)

 

March 31,
2007

 

December 31,
2006

 


 September 30,
2007

 December 31,
2006

 

Land

 

$

4,899

 

 

$

4,899

 

 

Land $4,899 $4,899 

Building

 

281,559

 

 

281,556

 

Building 282,811 281,556 

Leasehold improvements

 

23,933

 

 

14,595

 

Leasehold improvements 24,266 14,595 

Machinery and equipment

 

169,560

 

 

164,869

 

Machinery and equipment 174,577 164,869 

Furniture and fixtures

 

6,690

 

 

6,368

 

Furniture and fixtures 6,957 6,368 

Construction in progress

 

31,476

 

 

45,924

 

Construction in progress 28,839 45,924 

Total cost

 

518,117

 

 

518,211

 

 

 
 
 
Total cost 522,349 518,211 

Less accumulated depreciation

 

(103,020

)

 

(95,211

)

 

Less accumulated depreciation (117,885) (95,211)

Property, plant and equipment, net

 

$

415,097

 

 

$

423,000

 

 

 
 
 
Property, plant and equipment, net $404,464 $423,000 
 
 
 

        

In the first quarter of 2007, the Company determined that it was not cost effective to develop its Spring Street facility to house its Research organization. As a result, the Company recorded a write-off of approximately $3.2$3.6 million related to design and engineering costs associated with this facility that were included in construction in progress as of December 31, 2006. This write-off is included in Research and Development expenses in the Company’s StatementsCompany's Statement of Operations for the threenine months


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(3) Property, Plant and Equipment (Continued)


ended March 31,September 30, 2007. The Company is in the process of evaluating alternative uses for this facility.

The process of preparing consolidated financial statements in accordance with GAAP requires the Company to evaluate the carrying values of its long-lived assets. The recoverability of the carrying values of long-lived assets depends on the Company’sCompany's ability to earn sufficient returns on ERBITUX. Other than the asset impairment discussed above, based on management’smanagement's current estimates, the Company expects to recover the carrying value of such assets.

(4) Share-Based Compensation Plans

On February 15, 2007, the Company awarded, for no consideration, 268,283 Restricted Stock Units (“RSU”("RSU") to its employees under its 2006 Stock Incentive Plan (the “06 Plan”"06 Plan"). The grant date fair value of the Company’sCompany's RSU awards was calculated using the closing market price of the Company’sCompany's common stock as listed on the Nasdaq Global Select Market on February 15, 2007. The RSU granted in this issuance vest 331¤/3% annually over the three-year vesting period.


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED) On August 27, 2007, the Company awarded 31,347 RSU to its new CEO under the 06 Plan. The grant date fair value of the such RSU awards was calculated using the closing market price of the Company's common stock as listed on the Nasdaq Global Select Market on August 27, 2007. The RSU granted to the CEO vest 25% annually over the four-year vesting period.

RSU activity for the threenine months ended March 31,September 30, 2007 is summarized as follows:

 

 

Number of
Shares

 

Weighted
Average
Remaining
Contractual
Term (Years)

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

(in thousands)

 

Outstanding at December 31, 2006

 

 

 

 

 

 

 

 

 

 

 

 

Granted

 

 

268,283

 

 

 

 

 

 

 

 

 

 

Forfeitures

 

 

(6,255

)

 

 

 

 

 

 

 

 

 

Outstanding at March 31, 2007

 

 

262,028

 

 

 

1.88

 

 

 

$

10,683

 

 

Expected to vest

 

 

215,352

 

 

 

1.81

 

 

 

$

8,780

 

 

 
 Number of
Shares

 Weighted
Average
Remaining
Contractual
Term (Years)

 Aggregate
Intrinsic Value
(in thousands)

Outstanding at December 31, 2006      
 Granted 299,630     
 Forfeitures (41,230)    
  
     
Outstanding at September 30, 2007 258,400 1.50 $10,682
  
     
Expected to vest 211,184 1.43 $8,730
  
     

        

The weighted average grant date fair value of the RSU was $29.60.$29.84. The aggregate intrinsic value of RSU outstanding as of March 31,September 30, 2007 is calculated as the number of shares multiplied by the closing market price of our common stock at March 31, 2007,on that date, which was $40.77.$41.34.

The Company recognized for the three and nine months ended March 31,September 30, 2007 approximately $197,000$426,000 and $1.0 million, respectively, in share-based compensation expense, net of amounts capitalized, for RSU granted under the 06 Plan. As of March 31,September 30, 2007, there was $6.3$5.0 million of total unrecognized compensation cost related to the RSU. This amount assumesconsiders the Company’sCompany's expected forfeiture rate. That cost is expected to be recognized over a weighted average period of 2.92.6 years. The Company will utilize newly issued shares to satisfy the vesting of RSU.


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(4) Share-Based Compensation Plans (Continued)

In addition to the RSU discussed above, the Company also granted stock options for promotions and new hire grants. The activity related to stock options for the threenine months ended March 31,September 30, 2007 is summarized as follows:

 

 

Number of
Shares

 

Weighted
Average
Exercise Price
Per Share

 

Weighted
Average
Remaining
Contractual
Term (Years)

 

Aggregate
Intrinsic Value

 

 

 

 

 

 

 

 

 

(in thousands)

 

Outstanding at December 31, 2006

 

10,509,294

 

 

$

38.55

 

 

 

 

 

 

 

 

 

 

Granted

 

141,400

 

 

$

29.87

 

 

 

 

 

 

 

 

 

 

Exercised

 

(365,732

)

 

$

17.80

 

 

 

 

 

 

 

 

 

 

Forfeitures

 

(341,611

)

 

$

41.50

 

 

 

 

 

 

 

 

 

 

Outstanding at March 31, 2007

 

9,943,351

 

 

$

39.09

 

 

 

5.91

 

 

 

$

57,612

 

 

Vested and expected to vest

 

9,684,034

 

 

$

39.25

 

 

 

5.82

 

 

 

$

55,673

 

 

Exercisable at March 31, 2007

 

8,762,399

 

 

$

39.88

 

 

 

5.48

 

 

 

$

48,684

 

 

 
 Number of
Shares

 Weighted Average
Exercise Price
Per Share

 Weighted Average
Remaining
Contractual
Term (Years)

 Aggregate
Intrinsic Value
(in thousands)

Outstanding at December 31, 2006 10,509,294 $38.55     
 Granted 936,000 $34.19     
 Exercised (1,009,335)$23.40     
 Forfeitures (755,838)$44.79     
  
        
Outstanding at September 30, 2007 9,680,121 $39.23 5.78 $55,056
  
        
Vested and expected to vest 9,286,028 $39.45 5.64 $52,160
  
        
Exercisable at September 30, 2007 7,927,616 $40.38 5.04 $42,107
  
        

        

The weighted average fair value of options granted during the three months ended March 31,September 30, 2007 and 2006 was $13.13$14.34 and $15.20,$14.27, respectively. The weighted average fair value of options granted during the nine months ended September 30, 2007 and 2006 was $14.77 and $14.74, respectively. The aggregate intrinsic value of options outstanding at March 31,September 30, 2007 is calculated as the difference between the exercise price of the underlying options and the market price of the Company’sCompany's common stock for the 5,400,6355,384,197 options that had exercise prices that were lower than the market price of ourthe Company's common stock at March 31,September 30, 2007. The total intrinsic value of options exercised during the three months ended March 31,September 30, 2007 and 2006 was $5.8$4.2 million and $10.1$7.8 million, respectively, determined as of the date of exercise.


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)
The total intrinsic value of options exercised during the nine months ended September 30, 2007 and 2006 was $15.6 million and $21.0 million, respectively, determined as of the date of exercise.

(5)          Income Earnings (Loss) Per Common Share

Basic incomeearnings per common share is computed by dividing net income by the weighted-average number of common shares outstanding during the period. Diluted incomeearnings per common share is computed by dividing net income by the weighted-average number of common shares outstanding during the period increased to include all additional common shares that would have been outstanding assuming potentially dilutive common share equivalents had been issued. Dilutive common share equivalents include 1)(1) the dilutive effect of in-the-money shares related to stock options, which is calculated based on the average share price for each period using the treasury stock method. Under the treasury stock method, the exercise price of an option, the average amount of compensation cost, if any, for future service that the Company has not yet recognized, and the amount of tax benefits that would be recorded in additional paid-in capital, if any, when the option is exercised, are assumed to be used to repurchase shares in the current period and 2)(2) the conversion of convertible debt which is calculated using an “if-converted”"if-converted" basis. In addition, in computing the dilutive effect of convertible debt, the numerator is adjusted to add back the after-tax amount of interest recognized in the period and 3)(3) the dilutive effect of RSU which is calculated under the treasury stock method. Under the treasury stock method for RSU, the average amount of compensation cost, if any, for future service that the Company has not yet recognized, and the amount of tax benefits that would be recorded in


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(5) Earnings (Loss) Per Common Share (Continued)


additional paid-in capital, if any, are assumed to be used to repurchase shares in the current period. For the three months ended March 31,September 30, 2007 and 2006, there were an aggregate of 8,396,93116,231,000 and 8,510,704,9,132,000, respectively, potential common shares excluded from the diluted incomeearnings per share computation because their inclusion would have had an anti-dilutive effect. For the nine months ended September 30, 2007 and 2006, there were an aggregate of 10,107,000 and 8,574,000, respectively, potential common shares excluded from the diluted earnings per share computation because their inclusion would have had an anti-dilutive effect. The potential common shares excluded from the computation consist of anti-dilutive stock options for all periods and anti-dilutive shares related to the RSU and 13/8% convertible notes for the three months ended September 30, 2007, and anti-dilutive shares related to the 13/8% convertible notes for the nine months ended September 30, 2007.

Basic and diluted incomeearnings (loss) per common share (EPS) were computed using the following: (in thousands, except per share data)

 
 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 
 2007
 2006
 2007
 2006
EPS Numerator—Basic:            
 Net Income (Loss) $(916)$57,316 $59,744 $324,116
  
 
 
 
EPS Denominator—Basic:            
 Weighted-average number of shares of common stock outstanding  85,957  84,335  85,649  84,013
  
 
 
 
EPS Numerator—Diluted:            
 Net Income (Loss) $(916)$57,316 $59,744 $324,116
Adjustment for interest, net of amounts capitalized and income tax effect    2,610    5,481
  
 
 
 
 Net income (loss), adjusted $(916)$59,926 $59,744 $329,597
  
 
 
 
EPS Denominator—Diluted:            
 Weighted-average number of shares of common stock outstanding  85,957  84,335  85,649  84,013
  
 
 
 
Effect of dilutive securities:            
 Stock options    1,244  864  1,625
 Restricted stock units      55  
 Convertible subordinated notes    6,336    6,336
  
 
 
 
 Dilutive potential common shares    7,580  919  7,961
  
 
 
 
Weighted-average common shares and dilutive potential common shares  85,957  91,915  86,568  91,974
  
 
 
 
Basic earnings (loss) per common share $(0.01)$0.68 $0.70 $3.86
Diluted earnings (loss) per common share $(0.01)$0.65 $0.69 $3.58

 

 

Three Months
Ended March 31,

 

 

 

2007

 

2006

 

EPS Numerator—Basic:

 

 

 

 

 

Net income

 

$

28,755

 

$

229,591

 

EPS Denominator—Basic:

 

 

 

 

 

Weighted-average number of shares of common stock outstanding

 

85,255

 

83,624

 

EPS Numerator—Diluted:

 

 

 

 

 

Net income

 

$

28,755

 

$

229,591

 

Adjustment for interest, net of amounts capitalized and income tax effect

 

1,753

 

1,274

 

Net income, adjusted

 

$

30,508

 

$

230,865

 

EPS Denominator—Diluted:

 

 

 

 

 

Weighted-average number of shares of common stock outstanding

 

85,255

 

83,624

 

Effect of dilutive securities:

 

 

 

 

 

Stock options

 

766

 

1,857

 

Restricted stock units

 

7

 

 

Convertible subordinated notes

 

6,336

 

6,336

 

Dilutive potential common shares

 

7,109

 

8,193

 

Weighted-average common shares and dilutive potential common shares

 

92,364

 

91,817

 

Basic income per common share

 

$

0.34

 

$

2.75

 

Diluted income per common share

 

$

0.33

 

$

2.51

 


9




IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

(Unaudited)

(6) Taxes

The Company’sCompany's estimated annual effective operating income tax rate for 2007 is expected to be approximately 41%. Additionally, during41.5%, excluding the first quartereffect of any discrete charges. For the nine months ended September 30, 2007, the Company has recognized a net discrete charge of approximately $4.5 million$4.3 millon primarily related to certain tax return method changes filed as well as certain deferred charges. The difference between the statutory rate and the Company's expected annual effective income tax charges.rate primarily relates to state taxes. Actual cash tax payments in 2007 are estimated to be approximately $4.0 million.

In July 2006, the FASB issued FASB Interpretation No. 48, “Accounting"Accounting for Uncertainty in Income Taxes” (“Taxes" ("FIN 48”48"), which clarifies the accounting and disclosure for uncertainty in tax positions. The Company adopted the provisions of FIN 48 effective January 1, 2007, and as a result of the adoption the Company recorded a decrease to beginning accumulated deficit of approximately $1.5 million and an offsetting amount to additional paid-in capital. As of the adoption date, the Company hashad unrecognized tax benefits of approximately $38.3 million. Of this amount $36.1 million would impacthave impacted the effective income tax rate. A portion of the $36.1 million if recognized could requirehave required an additional valuation allowance to be recorded.

The Company recognizes both interest and penalties accrued related to unrecognized tax benefits as elements of income tax expense in the Consolidated Statements of Operations. As of the adoption date, the total amount of accrued interest and penalties iswas approximately $787,000. Additionally, during the three and nine months ended March 31,September 30, 2007, the Company recorded approximately $365,000$229,000 and $857,000, respectively, of net interest and penalties.

The Company is subject to United StatesU.S. federal income tax as well as income tax of multiple state jurisdictions. The statute of limitations on the Company’sCompany's federal income tax returns through 2002 has expired. The Company is currently underA New Jersey State audit in the State of New Jerseywas recently concluded for income tax years 2001 through 2004. The outcome of this audit isdid not expected to have a material impact on the Company’sCompany's results of operations or financial position. The statute of limitations on the Company’sCompany's New Jersey income tax returns through 20002002 has expired.

(7) Collaborative Agreements

(a)          Merck KGaA

The following represents an update of the Company’sCompany's contractual relationship with Merck KGaA and BMS during the quarternine months ended March 31,September 30, 2007. For a more detailed description of the Company’sCompany's contractual relationship,agreements with our partners Merck KGaA and BMS, reference Note 10(a)10 of the Notes to the Consolidated Financial Statements included in the Company’sCompany's Annual Report on Form 10-K for the fiscal year ended December 31, 2006.

(a) Merck KGaA

In July 2006, the Company and Merck KGaA entered into agreements amending and supplementing the 1998 development and license agreement. As part of the agreements, the Company consented to Merck KGaA’sKGaA's sublicense of certain intellectual property rights relating to the development and commercialization of an anti-EGFR antibody to Takeda Pharmaceutical Company (“Takeda”("Takeda"). Merck KGaA and Takeda signed an alliance in September 2005 for the development and commercialization of matuzumab (EMD-72000), a humanized EGFR-targeting monoclonal antibody. In consideration for the Company’sCompany's consent, Merck KGaA agreed to pay the Company 2.5 million within 30 days of the execution of the agreements and a further 5.0 million within 30 days of the Company’s Company's


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(7) Collaborative Agreements (Continued)


written consent to the sublicense. The Company received the first paymentpayments of 2.5 million and € 5.0 million in August 2006 and August 2007, respectively and has deferred the revenue associated with this paymentthese payments and is recognizing itthem over the estimated service period. The Company expects to give written consent to sublicense in the second quarter of 2007. In addition, Merck KGaA


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

agreed to increase its fixed royalty to 9.5% on net sales of ERBITUX outside the U.S. and Canada, effective July 1, 2006. The agreements also promote freedom to operate in the development and commercialization of matuzumab outside the United States and Canada and of IMC-11F8 (a fully-human EGFR-targeted IgG1 monoclonal antibody being developed by ImClone Systems) within the United States and Canada through the granting of certain reciprocal rights, including the sharing of confidential technical information. This is in addition to the exclusive rights held by the Company to develop and commercialize IMC-11F8 outside of the United States and Canada. The agreements do not extend to key intellectual property rights in the U.S. and Canada, where the Company and its partner BMS continue to hold exclusive licenses to key patents covering certain uses of EGFR-targeted monoclonal antibodies. The Company has a liability due Merck KGaA of approximately $58,000 as of March 31,September 30, 2007 and December 31, 2006.

(b) Bristol-Myers Squibb Company

The following represents an update        In July 2007, the Company and BMS amended the terms of their commercial agreement for the Company’s contractual relationship withco-development and co-promotion of ERBITUX in North America (the "BMS Amendment"). Under the BMS duringAmendment, the quarter ended March 31, 2007. For a more detailed description ofcompanies have jointly agreed to expand the Company’s contractual relationship, reference Note 10(b) of the Notes to the Consolidated Financial Statements includedinvestment in the Company’s Annual Report on Form 10-Kongoing clinical development plan for ERBITUX by up to several hundred million dollars. Development costs, up to a threshold amount, will be the sole responsibility of BMS; costs in excess of this threshold will be shared by both companies according to a pre-determined ratio. With this additional funding, the companies will further explore the use of ERBITUX in additional tumor types including brain, breast, bladder, esophageal, gastric, lung, pancreas and prostate.

        Under the BMS Amendment, ERBITUX clinical development costs, up to a threshold amount, are the sole responsibility of BMS, with costs in excess of this threshold shared by both companies according to a predetermined ratio effective January 1, 2007. As a result, reimbursable ERBITUX clinical development costs from BMS increased by $2.8 million for the fiscal yearnine months ended December 31, 2006.September 30, 2007, including $2.3 million for costs previously recorded by the Company in the first half of 2007 that are now reimbursable. Also, an adjustment of $7.6 million was recorded in clinical and regulatory expenses to reduce the Company's share of ERBITUX clinical development costs incurred by BMS that were previously recorded, which the Company is no longer required to reimburse.

Development of the Product—ProductTheCompany incurred approximately $3.0 million$943,000 and $6.9$4.1 million pursuant to cost sharing agreements with BMS for the three months ended March 31,September 30, 2007 and 2006, respectively and $2.6 million and $17.7 million for the nine months ended September 30, 2007 and 2006, respectively. The decreases versus the comparable periods are due to more development costs being the responsibility of BMS as a result of the BMS Amendment. The Company has also incurred $829,000$601,000 and $531,000$1.0 million for the three months ended March 31,September 30, 2007 and 2006, respectively, and $1.9 million and $2.2 million for the nine months ended September 30, 2007 and 2006, respectively, related to the agreement with respect to development in Japan.

Royalty revenue consists of the following: (in thousands)

 

 

Three Months
 Ended March 31,

 

 

 

2007

 

2006

 

BMS

 

$

62,455

 

$

53,832

 

Merck KGaA

 

13,862

 

6,276

 

Other

 

46

 

162

 

Total royalty revenue

 

$

76,363

 

$

60,270

 

 
 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 
 2007
 2006
 2007
 2006
BMS—ERBITUX $71,957 $68,100 $197,627 $189,158
Merck KGaA—ERBITUX  15,860  10,442  44,651  24,055
Other  36  57  82  270
  
 
 
 
 Total royalty revenue $87,853 $78,599 $242,360 $213,483
  
 
 
 

IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(7) Collaborative Agreements (Continued)

License fees and milestone revenue consists of the following: (in thousands)

 

 

Three Months
Ended March 31,

 

 

 

2007

 

2006

 

BMS:

 

 

 

 

 

ERBITUX license fee revenue

 

$

29,176

 

$

144,347

 

Merck KGaA:

 

 

 

 

 

ERBITUX license fee revenue

 

118

 

56

 

Total license fees and milestone revenue

 

$

29,294

 

$

144,403

 

 
 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 
 2007
 2006
 2007
 2006
BMS—ERBITUX $18,958 $34,830 $81,460 $212,578
Merck KGaA—ERBITUX  268  118  505  229
  
 
 
 
 Total license fees and milestone revenue $19,226 $34,948 $81,965 $212,807
  
 
 
 

        

Manufacturing revenue from corporate partners consists of the following: (in thousands)

 

 

Three Months
Ended March 31,

 

 

 

2007

 

2006

 

BMS

 

$

16,458

 

$

16,631

 

Merck KGaA

 

 

2,718

 

Total manufacturing revenue

 

$

16,458

 

$

19,349

 

 
 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 
 2007
 2006
 2007
 2006
BMS—ERBITUX $20,923 $20,305 $57,781 $64,541
Merck KGaA—ERBITUX  1,050  579  3,675  4,048
  
 
 
 
 Total manufacturing revenue $21,973 $20,884 $61,456 $68,589
  
 
 
 

        


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

Collaborative agreement reimbursement revenue from partners consists of the following: (in thousands)

 

 

Three Months
Ended March 31,

 

 

 

2007

 

2006

 

BMS:

 

 

 

 

 

ERBITUX supplied for clinical trials

 

$

2,474

 

$

3,382

 

ERBITUX clinical and regulatory expenses

 

3,761

 

3,369

 

ERBITUX marketing, general and administrative

 

258

 

251

 

ERBITUX royalty expenses

 

4,004

 

6,211

 

Total BMS

 

10,497

 

13,213

 

Merck KGaA:

 

 

 

 

 

ERBITUX supplied for clinical trials

 

7,713

 

5,437

 

ERBITUX marketing, general and administrative

 

62

 

63

 

ERBITUX royalty expenses

 

1,113

 

2,387

 

Total Merck KGaA

 

8,888

 

7,887

 

Other

 

 

9

 

Total collaborative agreement revenue

 

$

19,385

 

$

21,109

 

 
 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 
 2007
 2006
 2007
 2006
BMS:            
 ERBITUX supplied for clinical trials $2,736 $1,936 $7,875 $6,329
 ERBITUX clinical and regulatory expenses  7,040  3,277  14,430  9,419
 ERBITUX selling, general and administrative  387  297  878  848
 ERBITUX royalty expenses  4,612  7,858  12,668  21,826
  
 
 
 
  Total BMS  14,775  13,368  35,851  38,422
Merck KGaA:            
 ERBITUX supplied for clinical trials  1,815  1,651  11,477  7,215
 ERBITUX selling, general and administrative  1  10  89  109
 ERBITUX royalty expenses  1,904  1,238  5,681  5,044
  
 
 
 
  Total Merck KGaA  3,720  2,899  17,247  12,368
Other    (1) 600  15
  
 
 
 
  Total collaborative agreement reimbursement revenue $18,495 $16,266 $53,698 $50,805
  
 
 
 

IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(7) Collaborative Agreements (Continued)

        

Amounts due from corporate partners consists of the following: (in thousands)

 

 

March 31,
2007

 

December 31,
2006

 

BMS:

 

 

 

 

 

 

 

 

 

ERBITUX

 

 

$

61,483

 

 

 

$

64,991

 

 

Merck KGaA:

 

 

 

 

 

 

 

 

 

ERBITUX

 

 

15,136

 

 

 

13,039

 

 

Total amounts due from corporate partners

 

 

$

76,619

 

 

 

$

78,030

 

 

 
 September 30,
2007

 December 31,
2006

BMS—ERBITUX $75,008 $64,991
Merck KGaA—ERBITUX  17,632  13,039
  
 
 Total amounts due from corporate partners $92,640 $78,030
  
 

        

Deferred revenue consists of the following: (in thousands)

 

 

March 31,
2007

 

December 31,
2006

 

BMS:

 

 

 

 

 

 

 

ERBITUX commercial agreement

 

$

345,040

 

 

$

374,215

 

 

Merck KGaA:

 

 

 

 

 

 

 

ERBITUX development and license agreement

 

5,543

 

 

5,662

 

 

Total deferred revenue

 

350,583

 

 

379,877

 

 

Less: current portion

 

(134,674

)

 

(142,013

)

 

Total long-term deferred revenue

 

$

215,909

 

 

$

237,864

 

 

 
 September 30,
2007

 December 31,
2006

 
BMS—ERBITUX commercial agreement $292,755 $374,215 
Merck KGaA—ERBITUX development and license agreement  11,977  5,662 
  
 
 
 Total deferred revenue  304,732  379,877 
Less current portion  (66,203) (142,013)
  
 
 
 Total long term deferred revenue $238,529 $237,864 
  
 
 

(c) Merck KGaA/Bristol-Myers Squibb Company Japan Commercial Agreement

        On October 12, 2007, the Company entered into agreements with Merck KGaA and BMS for the co-development and co-commercialization of ERBITUX in Japan. Under the terms of the agreements, the Company, BMS and Merck KGaA will collaborate on a joint effort to develop and, following regulatory approval, market ERBITUX in Japan for the treatment of EGFR-expressing mCRC, as well as for the treatment of any other cancers the parties agree to pursue. BMS and Merck KGaA will utilize their respective sales forces in Japan, and the three companies will share development costs incurred and profits/losses realized as a result of their collaboration. Merck Serono Japan will distribute the product and record the sales for the collaboration. The agreements have a term of twenty-five years; provided that either BMS or Merck KGaA may terminate the agreement without cause upon three months' notice if ERBITUX is not launched in Japan by December 31, 2009 and without cause upon six months' notice following the earlier of a launch of a biosimilar product in Japan and the tenth anniversary of the agreements.

        The Company, BMS and Merck KGaA submitted an application in Japan earlier this year for the use of ERBITUX in treating patients with EGFR-expressing mCRC. The submission is a result of a collaboration among the three companies and is based on results from studies conducted in North America, Europe and Japan. ERBITUX is the first monoclonal antibody that inhibits EGFR to be submitted for marketing authorization in Japan.

        The terms of these new agreements provide that Merck KGaA will receive 50% of the profit/loss from sales in Japan and bear 50% of the related development expense, and the Company and BMS will each receive 25% of the profit/loss and bear 25% of the related development expense. The sharing of profit/loss reflect the co-exclusive rights to ERBITUX in Japan previously granted by the Company to Merck KGaA and BMS. In addition to its percentage of profit/loss, ImClone Systems will receive from Merck KGaA a royalty equal to 4.75% of total net sales in Japan. Any bulk ERBITUX supplied by the Company pursuant to the agreements for use in Japan will be at its fully burdened manufacturing cost.


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

(Unaudited)

(8) Commitments and Contingencies

On October 28, 2003, a complaint was filed by Yeda Research and Development Company Ltd. (“Yeda”("Yeda") against ImClone Systems and Aventis Pharmaceuticals, Inc. (“Aventis”("Aventis") in the U.S. District Court for the Southern District of New York (03 CV 8484). This action did not seek damages, but rather alleged that three individuals associated with Yeda should also be named as co-inventors on U.S. Patent No. 6,217,866, which relates to the therapeutic use of EGFR antibodies (such as ERBITUX, the Company’sCompany's EGFR antibody product) in combination with chemotherapy. The Company has exclusively licensed this patent from Rhone-Poulenc Rorer Pharmaceuticals, now known as Sanofi-Aventis. On June 7, 2005, Yeda amended its U.S. complaint to seek sole inventorship of the subject patent. On November 4,2, 2005, the Court denied the Company’sCompany's motion for summary judgment with respect to this matter, as filed with the Court on June 24, 2005. At the same time, the Court granted summary judgment to Yeda dismissing two of ImClone’sthe Company's affirmative defenses. A bench trial on the merits of Yeda’sYeda's complaint was held between June 5, 2006 and July 19, 2006. On September 18, 2006, the Court ruled in favor of Yeda by awarding it sole inventorship rights to the patent. The Company then appealed the Court’sCourt's decision to the Court of Appeals for the Federal Circuit. The appeal was docketed on October 5, 2006 (as No. 2007-1012). On March 16,Briefing is now complete. A hearing is scheduled for December 7, 2007 and a decision from the Company submitted its opening briefFederal Circuit is expected in the appeal.due course. The Company, having had the advice of its patent counsel, believes the positions raised on appeal are sound, and it plans to vigorously pursue this appeal.

On September 20, 2006, subsequent to the Court’sCourt's inventorship decision, the Company also filed an action (06 CV 7190) against Yeda in the U.S. District Court for the Southern District of New York seeking a declaratory judgment that the patentU.S. Patent No. 6,217,866 is invalid due to the removal of the originally named inventors.invalid. On October 31, 2006, Yeda filed an answer and counterclaim to the Company’sCompany's declaratory judgment complaint in which Yeda alleges the Company is liable to Yeda for willful patent infringement, unjust enrichment and conversion, and seeks damages from the Company and an order requiring the Company to license the patent and pay Yeda royalties until the patent expires. The declaratory judgment action is inCompany filed an answer denying all counterclaims. In addition, on November 7, 2007, the Company filed a first amended answer to defendant's counterclaims asserting that the Company's activities are protected by the safe harbor provisions of 35 U.S.C 271(e)(1), that Yeda's claims for damages for any infringement more than six years prior to filing of its early stages.counterclaims are barred by the statute of limitations, and that federal law preempts Yeda's claims for unjust enrichment and conversion. The Company, having had the advice of its patent counsel, believes that the claims asserted in the declaratory judgment action are sound, and that Yeda’s counterclaims are not sound, and it plans to vigorously pursue this action. The Company is unable to predict the outcome of these actions at this time. If the Company’sCompany's appeal is unsuccessful and Yeda’sYeda's sole inventorship rights to the patent are upheld and the Company is unsuccessful with respect to its declaratory judgment action, the Company may become obligated to pay Yeda a royalty and may be liable to Yeda for other damages.

On March 25, 2004, an action was filed in the United Kingdom Patent Office entitled Referrer’s Statement requesting transfer of co-ownership to Yeda and amendment of patent EP (UK) 0 667 165 to add three YedaWeizmann former employees as inventors. AlsoThe Company was not named as a party in this action which relates to the European equivalent of U.S. Patent No. 6,217,866 discussed above. Accordingly, the Company intervened. On June 29, 2005, Yeda sought to amend its pleadings to seek sole ownership. That amendment was refused by the High Court and the Court of Appeal but was further appealed by Yeda to the House of Lords. The House of Lords heard Yeda's appeal on July 23-25, 2007. On October 24, 2007, the House of Lords issued a decision that reinstated the permission given by the Patent office, namely, that Yeda may proceed with a claim in relation to the EP (UK) to sole entitlement,


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(8) Commitments and Contingencies (Continued)


alternatively to joint entitlement with Aventis. A hearing on the substantive case relating to entitlement to the EP (UK) will now likely occur in 2008.

        On March 25, 2004, a German action entitled Legal Action was filed in the Munich District Court I, Patent Litigation Division, in which Yeda soughtclaims a 75% ownership interest in patent EP (DE) 0 667 165 based on its allegation that the inventorship on that patent was incorrect. The Company was not named as a party in these actionsthis action which relaterelates to the European equivalent of U.S. Patent No. 6,217,866 discussed above. Accordingly, the Company has intervened in the U.K. and German actions.intervened. On October 7, 2005, Yeda sought to amend its pleadings in the United Kingdom and Germanyclaim to seek sole inventorshipownership. That amendment was refused by the Munich District Court and sole ownership. Following hearings, bothon appeal by the U.K. and German courts held that Yeda was not entitled to amend its pleadings. In the U.K., Yeda sought leave from the House of Lords to appeal the High Court’s decision, and such leave was granted in November 2006. In Germany, Yeda has appealed the lower court’s decision to theMunich Higher Regional Court in a Decision dated September 20, 2007. That decision will likely be appealed by Yeda to the German Supreme Court. Presently, Yeda's claim in respect of Munich. Additionally, on or aboutthe EP (DE) remains restricted to joint entitlement.

        On March 25, 2005, and March 29,


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

2005, respectively, Yeda filed legal actionsan action in Austria and Francethe Austrian Patent Office ("APO") against both Aventis and ImClone Systems seeking full inventorshipsole entitlement of EP (AU) 0 667 165 and EP (FR) 0 667 165, as well as payment of legal costs and fees. The Company was not named as a party to this action which relates to the European equivalent of US Pat. No. 6,217,866 discussed above. Accordingly, the Company intervened. Aventis' Defence and the Company's Intervention were filed on February 15, 2006. Yeda's Reply to the Defence/Intervention was filed on February 12, 2007. The Company's Rejoinder was filed on September 14, 2007. The case has been sent to the Technical Examiner, who will report back to the Nullity Division of the APO in due course. The Company, having had the advice of its patent counsel, believes there are sound defenses to these actions, and it presently plans to vigorously defend against the claims asserted.

        On March 29, 2005, Yeda filed an action in the Tribunal de Grande Instance, Paris jointly against Aventis and the Company seeking sole entitlement of EP (FR) 0 667 165, as well as payment of damages, legal costs and fees. This is the European equivalent of US Pat. No. 6,217,866. Aventis and the Company filed their Defences on September 22, 2006. Yeda submitted a Reply to Defence on September 17, 2007. Additionally, Yeda requested the French Court to take jurisdiction over the 9 non-French counterparts of the '165 EP in: Belgium, The Netherlands, Luxembourg, Liechtenstein, Sweden, Switzerland, Spain, Italy and Greece. A preliminary challenge to the jurisdiction of the French Court to hear Yeda's claim to those non-French parts of the European Patent will be made and that preliminary challenge is likely to be heard in early 2008. The Company, is unablehaving had the advice of its patent counsel, believes there are sound defenses to predict the outcome of these actions, at this time. In addition, in December 2002, Opposition Proceedings seekingand it plans to revokevigorously defend against the European patent discussed above were brought by the Scripps Research Institute, Amgen Inc., Abgenix, Inc., and YM Biosciences Inc. An Opposition Proceeding is an administrative process, the outcome of which may be that the European patent will be revoked. The Opposition Proceedings are suspended pending a final determination of the Yeda matter discussed above.claims asserted.

On May 4, 2004, a complaintan action was filed against the Company by Massachusetts Institute of Technology (“MIT”("MIT") and Repligen Corporation (“Repligen”("Repligen") in the U.S. District Court for the District of Massachusetts (04-10884 RGS). This action allegesalleged that ERBITUX infringes U.S. Patent No. 4,663,281, which is owned by MIT and exclusively licensed to Repligen and that the Company should therefore pay damages. On July 28, 2006,In September 2007, the Court denied the Company’s motionparties signed a settlement and certain sublicensing agreements, for summary judgment seeking to dismiss all claims on the basis that the patent rights at issue were exhausted as a matter of law and granted MIT and Repligen’s cross motion that their patent rights were not exhausted. On September 26, 2006, a hearing was held in response to a Motion for Sanctions filed by Repligen, which alleged that the Company’s counsel, Kenyon & Kenyon, and the Company acted improperly duringpaid $65.0 million in cash for full and afterfinal settlement of the deposition of one of Repligen’s potential witnesses. Repligen seeks evidentiary sanctions which may limit the Company’s proofs on non-infringement issues, and the Court has raised the possibility that Kenyon & Kenyon may be disqualified from further representation ofclaims against the Company in the case.matter, as well as for a royalty-free, irrevocable worldwide sublicense to technology patented under U.S. Patents No. 4,663,281. The Companytotal settlement was $65.0 million, of which $50.0 million was attributable to an expired Repligen patent and Kenyon & Kenyon deny any improper conduct. The Court has not ruled on the motion, and it is not possible to predict what impact, if any, this collateral matter may havewas expensed in the case. Upon a ruling byperiod and $15.0 million was attributed to the Court, the case will proceed to trial on the meritssublicensed Abbott patents. Repligen is responsible for providing MIT with its portion of the Company’ssettlement payment. Repligen also granted to the Company a royalty-free, irrevocable worldwide sublicense for the future use of other defenses. Thepatented technology, including U.S. Patent No. 5,665,578, which is owned by Abbott Laboratories ("Abbott"), but


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(8) Commitments and Contingencies (Continued)


to which Repligen has the power to sublicense under an agreement between Abbott and Repligen. U.S. Patent No. 5,665,578 is the patent upon which Abbott sued the Company having had the advice of itsfor patent counsel, believes that its defenses are sound, and it presently plans to vigorously defend against the claims assertedinfringement earlier this year.

On February 5, 2007, a complaint was filed against the Company by Abbott Laboratories (“Abbott”) in the U.S. District Court for the District of Massachusetts (07-cv-10216). This action alleges that the manufacture and sale of ERBITUX infringes U.S. Patent No. 5,665,578, which is owned by Abbott and that the Company should therefore pay damages. On April 24, 2007, the Company filed an answer, which it amended on May 17, 2007, to this complaint denying all claims. The court has ordered a mediation hearing to occur on December 20, 2007. The Company, having had the advice of its patent counsel, believes that its defenses are sound, and it presently plans to vigorously defend against the claims asserted.

        In December 2002, Opposition Proceedings seeking to revoke EP (UK) 0 667 165 were brought by Scripps Research Institute, Amgen Inc., Abgenix, Inc., and YM Biosciences Inc. The Opposition Proceedings are suspended pending a final determination of the entitlement cases in Europe.

        On May 2, 2007, the Company filed an Opposition in the European Patent Office against EP 1,058,562 B1, which is unablea patent directed to, predictinter alia, the outcomeuse of this action ateither radiation or chemotherapy in concert with an EGFR antibody that inhibits receptor dimerization. The patent is assigned to the present time.University of Pennsylvania. Oppositions to that European Patent have also been filed by Amgen, Merck KGaA, Oncoscience, Genmab and Hoffmann La-Roche.

No reserve has been established in the financial statements for any of the intellectual property-related legal proceedings described above becauseas the Company does not believe that such a reserve is required to be established at this time under Statement of Financial Accounting StandardsSFAS No. 5. However, if in a future period, events in any such legal proceedings render it probable that a loss will be incurred and if such loss is reasonably estimable at that time, the Company will establish such a reserve. Thus, it is possible that legal proceedings and settlements arising therefrom,there from, if any, may have a material adverse impact on operating results for that period, on our balance sheet or both.

In October 2001, the Company entered into a sublease (the “Sublease”"Sublease") for a four-story building at 325 Spring Street, New York, New York, which includes approximately 100,000 square feet of usable


IMCLONE SYSTEMS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
(UNAUDITED)

space. The Sublease has a term of 22 years, followed by two five-year renewal option periods. In order to induce the sublandlord to enter into the Sublease, the Company made a loan to the sublandlord in the principal amount of a $10.0 million note receivable, of which $8.2$8.0 million is outstanding as of March 31,September 30, 2007. The loan is secured by a leasehold mortgage on the prime lease as well as a collateral assignment of rents by the sublandlord. The loan is payable by the sublandlord over 20 years and bears interest at 51¤/2% in years one through five, 61¤/2% in years six through ten, 71¤/2% in years eleven through fifteen and 81¤/2% in years sixteen through twenty. In addition, the Company paid the owner a consent fee in the amount of $500,000. Effective March 1, 2005, the Company amended the Sublease to add an additional 6,500 square feet of space upon all the same terms and conditions set forth in the Sublease. In connection with this amendment, the Company paid an up-front fee of $1.7 million which is being amortized to lease expense over the respective term of the Sublease. The future minimum lease payments remaining at March 31,as of September 30, 2007, are approximately $45.9$44.7 million.


IMCLONE SYSTEMS INCORPORATED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Unaudited)

(9) Employee Benefit Plans

Defined Contribution Plan

All employees of the Company who meet certain minimum age and period of service requirements are eligible to participate in a 401(k) defined contribution plan. The 401(k) plan allows eligible employees to defer up to 25 percent25% of their annual compensation, subject to certain limitations imposed by federal law. The amounts contributed by employees are immediately vested and non-forfeitable. Under the 401(k) plan, the Company, at management’smanagement's discretion, may match employee contributions and/or make discretionary contributions. Neither the employee contributions nor voluntary matching contributions are invested in the Company’sCompany's securities. Total expense incurred by the Company was $646,000$502,000 and $681,000$607,000 for the three months ended March 31,September 30, 2007 and 2006, respectively, and approximately $1.6 million and $1.8 million for the nine months ended September 30, 2007 and 2006, respectively.

(10) Long-term Debt

The Company’sCompany's long-term debt was $600.0 million at March 31,September 30, 2007 and December 31, 2006. For a more detailed description of the Company’sCompany's long-term debt, reference Note 8 toof the Notes to the Consolidated Financial Statements included in the Company’sCompany's Annual Report on Form 10-K for the fiscal year ended December 31, 2006.

        In December 2006, the FASB issued FASB Staff Position Issue No.EITF 00-19-2, "Accounting for Registration Payment Arrangements" ("FSP 00-19-2"). FSP 00-19-2 addresses an issuer's accounting for registration payment arrangements and specifies that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement, whether issued as a separate agreement or included as a provision of a financial instrument or other agreement, should be separately recognized and measured in accordance with SFAS No. 5. FSP 00-19-2 is effective immediately for registration payment arrangements and financial instruments subject to those arrangements that were entered into or modified subsequent to the issuance of FSP 00-19-2. For registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of FSP 00-19-2, it is effective for financial statements issued for fiscal years beginning after December 15, 2006. The Company has adopted the provisions of FSP 00-19-2 as of January 1, 2007, and has determined that it had no impact on the consolidated financial statements.

Under the Registration Rights Agreement for these convertible notes, 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 redemption of the convertible notes, the repayment of the convertible notes, or certain corporate events as defined in the convertible note agreement. The Company believes the likelihood of such an event occurring is remote and, as such we havehas not recorded a liability as of March 31,September 30, 2007. In the unlikely event that it becomes probable that wethe Company would have to pay liquidated damages under the Registration Rights Agreement, until a shelf registration statement covering the convertible debt is again effective, the potential liquidated damages would be 0.25% of the outstanding amount of notes for the first 90 days and 0.50% of the outstanding amount of notes thereafter. Such damages (i) would accrue only with respect to the shares of the Company’sCompany's common stock that were not already sold by the holder (using the registration statement or pursuant to SEC Rule 144) and that were not eligible for sale without a registration statement; (ii) would accrue only over the period during which the registration statement was not effective; and (iii) would be settled in cash in accordance with the terms of the Registration Rights Agreement.


16




Item 2.    ITEM 2.Management’sManagement's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis is provided to further the reader’sreader's understanding of the consolidated financial statements, financial condition and results of operations of ImClone Systems in this Quarterly Report on Form 10-Q. This discussion should be read in conjunction with the consolidated financial statements and the accompanying notes included in our filings with the SEC, including our 2006 Annual Report on Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risk and uncertainties. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below and under “Risk Factors” set forth in Part II- Item 1A"Risk Factors" and elsewhere in our 2006 Annual Report on Form 10-K.

OVERVIEW

ImClone Systems is a biopharmaceutical company whose mission is to advance oncology care by developing and commercializing a portfolio of targeted treatments designed to address the medical needs of patients with cancer. Our commercially available product, ERBITUX® (cetuximab) binds specifically to epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. We are conducting, and in some cases have completed, clinical studies evaluating ERBITUX for broader use in colorectal cancer, squamous cell carcinoma of the head and neck ("SCCHN"), for the potential treatment of lung and pancreatic cancers, as well as other potential indications.

On February 12, 2004, the United States Food and Drug Administration (“FDA”) approved ERBITUX for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.        In September 2005, Health Canada approved the use of ERBITUX for use in combination with irinotecan for the treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to other irinotecan-based chemotherapy regimens and for use as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy. On March 1, 2006, the FDA approved ERBITUX for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (“SCCHN”) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed. Please see full prescribing information, available at www.ERBITUX.com, for important safety information relating to ERBITUX, including boxed warnings.

On December 1, 2003, Swissmedic, the Swiss agency for therapeutic products, approved ERBITUX in Switzerland for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. Merck KGaA licensed the right to market ERBITUX outside the United States and Canada from the Company in 1998. In Japan, Merck KGaA has marketing rights to ERBITUX, which are co-exclusive to the co-development rights ofJuly 2007, the Company and Bristol-Myers Squibb (“BMS”). On June 30, 2004, Merck KGaA received marketing approval byBMS amended the European Commission to sell ERBITUX for use in combination with irinotecanterms of their agreement for the treatmentco-development and co-promotion of patients with EGFR-expressing metastatic colorectal cancer after failure of irinotecan including cytotoxic therapy. On December 22, 2005, Swissmedic approved ERBITUX in Switzerland in combination with radiationNorth America ("the BMS Amendment"). Under this amendment, the companies have jointly agreed to expand the investment in the treatmentongoing clinical development plan for ERBITUX by up to several hundred million dollars. Development costs, up to a threshold amount, will be the sole responsibility of patients with previously untreated, advanced SCCHN. On April 3, 2006, Merck KGaA was granted marketing authorizationBMS; costs in excess of this threshold amount will be shared by both companies according to a pre-determined ratio. With this additional funding, the European Commission to extendcompanies will further explore the use of ERBITUX in combination with radiotherapy,additional tumor types including brain, breast, bladder, esophageal, gastric, lung, pancreas and prostate. In 2007 and beyond, the BMS Agreement will allow us to significantly reduce our clinical and regulatory expenses for ERBITUX while at the treatment of patients with locally advanced SCCHN. In February 2007, an application was submitted withsame time expanding the Japanese Pharmaceuticals and Medical Devices Agency for the use of ERBITUX in treating patients with advanced colorectal cancer. ERBITUX is the first IgG1 monoclonal antibody that inhibits EGFR to be submitted for marketing authorization in Japan.antibody's development.


Our revenues, as well as our results of operations, have fluctuated and are expected to continue to fluctuate significantly from period to period due to several factors, including but not limited to:

·


As a result of our substantial investment in research and development, we have incurred significant operating losses prior to fiscal 2004 and have an accumulated deficit of approximately $41.5$10.5 million as of March 31,September 30, 2007. We anticipate that our accumulated deficit maywill continue to decrease in the future


as we earn revenues on commercial sales of ERBITUX and generate net income. There is no assurance that we will be able to continue to successfully manufacture market or commercialize ERBITUX or that potential customers will buy ERBITUX. We rely entirely on third-party manufacturers for filling and finishing services with respect to ERBITUX. If our current third-party manufacturers or critical raw material suppliers fail to meet our expectations, we cannot be assured that we will be able to enter into new agreements with other suppliers or third-partythird party manufacturers without an adverse effect on our business.

HIGHLIGHTS AND OUTLOOK

A great deal        John H. Johnson was appointed as the Company's Chief Executive Officer in August 2007. Mr. Johnson has more than two decades of activity is taking placeexecutive and operational management experience in the biopharmaceutical and healthcare industries. He has held senior management positions of increasing responsibility at Johnson & Johnson and most recently served as Company Group Chairman of its worldwide biopharmaceuticals unit. Additionally, in July 2007, ImClone and we expect thatfurther strengthened its Board of Directors with the levelappointment of activity will increase.Dr. Thomas Deuel, a preeminent scientist with a strong background in oncology.

Our strategic focus consists of three key elements: (i) to maximize ERBITUX through insuring excellent commercialization and full clinical development, (ii) to develop our pipeline as aggressively as possible while considering some select partnering opportunities, and (iii) to invest in other key growth areas such as research and manufacturing.        In addition, we are dedicated to addressing a number of specific issues at the Company including our BMS relationship, the search for a chief executive officer, ongoing litigation, and cutting costs and improving operational efficiency. In the last quarter, significant progress has been made in each of these areas.

The first quarter ofAugust 2007, has been marked by several decisions and milestones. We believe that the entirety of clinical data on EGFR antibodies that was released by the Company over the past few months establishes ERBITUX’s position as a drug with major clinical importance. Also, we were excited that two of the three trials that the American Association of Cancer Research chose to highlight at their annual meeting were ImClone trials. Importantly, we recentlySystems received FDA approval in August 2007 for a second facility to manufacture ERBITUX. The approval of this new 250,000-square-foot multi-product state-of-the-art manufacturing facility, referred to as "BB50", more than doubles the Company's total available production volume capacity for ERBITUX. This approval, in conjunction with ImClone Systems' existing "BB36"manufacturing facility, enhances the Company's ability to meet increasing demand for ERBITUX in the worldwide market while advancing its clinical development pipeline.

        In September 2007, ImClone Systems signed settlement and sublicensing agreements with MIT and Repligen to end litigation related to U.S. Patent No. 4,663,281, which is owned by the Massachusetts Institute of Technology ("MIT") and exclusively licensed to Repligen Corporation ("Repligen"). In addition to a full and final settlement of the claims against ImClone in the matter, Repligen granted to ImClone Systems a royalty-free, irrevocable worldwide sublicense for the future use of other patented technology, including U.S. Patent No. 5,665,578, which is owned by Abbott Laboratories ("Abbott"), but to which Repligen has the power to sublicense under an agreement between Abbott and Repligen. U.S. Patent No. 5,665,578 is the patent upon which Abbott sued ImClone Systems for patent infringement earlier this year.

        The U.S. in-market third quarter sales of ERBITUX continued to increase as compared to both the third quarter of 2006 and sequentially over the second quarter of 2007. We have built on the positive sales trend with increased promotional efforts to establish ERBITUX as the standard of care in refractory colorectal and head and neck cancers. With our expanded field force, we hope to increase share in markets where ERBITUX has proven to provide significant clinical benefit and has received FDA approvals. Overall, we are encouraged by the performance of ERBITUX and optimistic about our prospects for the future.

ERBITUX Clinical Development Update

        In October 2007, ImClone Systems, BMS and Merck KGaA established an agreement for the co-development and co-commercialization of ERBITUX in Japan. Under the terms of the agreement, the companies will collaborate on a joint effort to develop and, following regulatory approval, market ERBITUX in Japan for the treatment of EGFR expressing metastatic colorectal cancer (mCRC), as well as for the treatment of any other cancers the parties agree to pursue. The companies submitted an application in Japan earlier this year for the use of ERBITUX in treating patients with EGFR-expressing mCRC. ERBITUX is the first and only monoclonal antibody that inhibits the EGFR to be submitted for marketing authorization in Japan.


        In October 2007, the FDA approved an additional dose configuration—update to the 100 mg vial - giving customers greater flexibility and convenience in drug preparation. In addition, in April 2007 we submitted a supplemental Biologics License Application (“sBLA”) seeking the approval of our manufacturing facility, BB50,ERBITUX product labeling to include overall survival data as a second manufacturing sourcesingle agent in EGFR-expressing mCRC patients after failure of both irinotecan- and oxaliplatin-based regimens. With this approval, ERBITUX is the only approved biologic therapy to demonstrate improved overall survival as a single agent in patients with mCRC.

        In September 2007, the Company announced that a Phase III study of ERBITUX in combination with platinum-based chemotherapy (vinorelbine plus cisplatin) met its primary endpoint of increasing overall survival compared with chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC). This large, randomized multi-national study, known as FLEX, was conducted by Merck KGaA and enrolled patients with Stage IIIB or Stage IV NSCLC who had not previously received chemotherapy. Based on the FLEX results, ERBITUX is the only member of the class of epidermal growth factor inhibitors to demonstrate survival in the first-line treatment of patients with advanced NSCLC. Results from this study will be submitted for presentation at an upcoming medical conference.

        In July 2007, ImClone Systems and BMS amended the terms of their commercial agreement for the co-development and co-promotion of ERBITUX in North America. The amendment significantly increases BMS' financial investment in ERBITUX by up to several hundred million dollars. With this additional funding, the companies will seek to add numerous Phase II and Phase III clinical trials that will further explore the activity of ERBITUX in a wide variety of therapeutic settings. The companies intend to utilize the results of these studies to support new registration opportunities for ERBITUX.

With respect to our operating expenses, our goal is to continue to manage expenditures aggressively in areas where we can generate economiesPipeline Clinical Development

        A number of scale and redirect our investment to areas that we believe will derive long-term benefit to our shareholders. Our primary emphases are to continue to invest in the


development of ERBITUX, to actively develop our Company's clinical pipeline candidates have progressed into Phase II during the second half of 2007. Patient enrollment commenced for Phase II studies of IMC-A12 for mCRC and prostate cancer, for a Phase II study of IMC-1121B for renal cell cancer, and for a Phase II study of IMC-11F8 for mCRC. The Company plans to strategically invest in our ability to reach our customer base.

With respect to our infrastructure, ininitiate additional Phase II and Phase III studies of these clinical pipeline candidates over the first quarter of this year we concludednext several quarters. Also, the Company announced that it would not be cost effective for us to develop the Spring Street facility in Manhattan as the headquarters for our research organization. As a result, we have expensed approximately $3.2 million of fixed assets related to this facility, in the first quarter of this year. This write-off is included in Research and Development expenses.

We are also making significant investments in our commercial and clinical capabilities. From a commercial perspective, in the first quarter of 2007 we made the strategic decision to expand our field force. Specifically, we added 27 oncology sales professionals to our existing 37 to make a total salesforce size of 64. With this increase in our sales force, it will now be possible for us to reach almost all prescribing medical oncologists, as well as those who influence the decision to use ERBITUX for approved indications. This expansion is currently underway and we expect to have the new organization fully trained and mobilized before the end of June 2007. We believe this expansion will generate a significant return for ERBITUX. From a clinical perspective, we have been spending considerable resources to expand and strengthen our Clinical Development, Medical Affairs, and Regulatory departments to accomplish several goals. First, we are developing coherent regulatory strategies to expand on ERBITUX’s current indications and to enable compendia listings. Secondly, we are developing a series of randomized, multicenter trials to quantify relevant activity with ERBITUX in other tumor types such as cancersCancer Therapy Evaluation Program (CTEP) of the rectum, bladder, prostate, esophagus, stomach,Division of Cancer Treatment and others, as well as evaluating ERBITUX on less frequent dosing schedules.Diagnosis (DCTD), National Cancer Institute (NCI), has selected 10 proposals for Phase I/II clinical trials of IMC-A12.

We are enthusiastic about ImClone and are encouraged by the positive changes and the progress that has been made thus far in the areas noted above.

CRITICAL ACCOUNTING POLICIES

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. We base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances. Estimates are deemed critical when a different methodology could have reasonably been used or where changes in the estimate from period to period may have a material impact on our financial condition or results of operations. Our critical accounting policies that require management to make significant judgments, estimates, and assumptions are set forth below. The development and selection of the critical accounting policies, and the related disclosure below, have been reviewed with the Audit Committee of our Board of Directors.

Revenue Recognition—RecognitionOurrevenues are derived from four primary sources: royalty revenue, license fees and milestone payments, manufacturing revenue, royalty revenue, and collaborative agreement reimbursement revenue.

        Royalty revenues from licensees, which are based on third-party sales of licensed products and technology, are recorded as earned in accordance with contract terms when third-party sales can be reliably measured and collection of funds is reasonably assured.


Revenues from license fees and milestone payments primarily consist of up-front license fees and milestone payments received under the Commercial Agreement with BMS, relating to ERBITUX, and milestone payments received under the development and license agreement with Merck KGaA. We recognize all non-refundable up-front license fees as revenues in accordance with the guidance provided in the SEC’sSEC's Staff Accounting Bulletin No. 104. Our most critical application of this policy to date, relates to the $900.0 million in license fees and milestones received from BMS under the Commercial Agreement which are being deferredAgreement. We recognize license fees and recognized as revenuemilestones received from BMS based upon the actual productERBITUX clinical and development costs incurred since September 19, 2001 to date by BMS and ImClone as a percentage of the estimated total of such costs to be incurred over the 17-yearprojected term of the Commercial Agreement. TheERBITUX clinical development plan. Any future changes in the estimated total of such costs is based onof the clinical development budget which establishes joint responsibilities thatplan will be carried out by


both the Company and BMS for certain clinical and other studies.addressed on a prospective basis. Of the $900.0 million in payments received to date, $29.2$19.0 million and $81.5 million was recognized as revenue infor the first quarter ofthree and nine months ended September 30, 2007, respectively, and $555.0$607.3 million from the commencement of the Commercial Agreement in 2001 through March 31,September 30, 2007. The methodology used to recognize deferred revenue involves a number of estimates and judgments, such as the estimate of total productERBITUX clinical and development costs to be incurred under the Commercial Agreement.BMS Amendment. Changes in these estimates and judgments can have a significant effect on the size and timing of revenue recognition. In addition, if management had chosen a different methodology to recognize the license feefees and milestone payments received under the Commercial Agreement, the Company’sCompany's financial position and results of operations could have differed materially. For example, if the Company were to recognize the revenues earned from the Commercial Agreement on a straight-line basis over the life of the agreement, the Company would have recognized approximately $16.0 million and $205.2$48.0 million as revenue infor the first quarter ofthree and nine months ended September 30, 2007, respectively, and $237.1 million from the commencement of the Commercial Agreement respectively, through March 31,September 30, 2007. Management believes that the current methodology used to recognize revenues under the Commercial Agreement, which reflects the level of effort consistent with theour product development activities, is the most appropriate methodology because it reflects the level of expenditure and activity in the period in which it is being spent as compared to the total expected expenditure over the life of the Commercial Agreement.ERBITUX clinical development plan. This cost to costcost-to-cost approach is systematic and rational, it provides a factually supportable pattern to track progress, and is reflective of the level of effort, which varies over time.

Non-refundable upfront payments received from Merck KGaA were deferred due to our significant continuing involvement and are being recognized as revenue on a straight-line basis over the estimated service period because the activities specified in the agreement between the Company and Merck KGaA will be performed over the estimated service period and there is no other pattern or circumstances that indicate a different way in which the revenue is earned. In addition, the development and license agreement with Merck KGaA does not contain any provisions for establishing a clinical budget and none has been established between the parties. This agreement does not call for co-development with the Company in Merck KGaA’sKGaA's territory; rather Merck KGaA is solely responsible for regulatory efforts in its territory. Non-refundable milestone payments, which represent the achievement of a significant step in the research and development process, pursuant to collaborative agreements other than the Commercial Agreement, are recognized as revenue upon the achievement of the specified milestone. This is because each milestone payment represents the achievement of a substantive step in the research and development process and Merck KGaA has the right to evaluate the technology to decide whether to continue with the research and development program as each milestone is reached.

Manufacturing revenue consists of revenue earned on the sale of ERBITUX to our corporate partners for subsequent commercial sale. The Company recognizes manufacturing revenue when the product is shipped, which is when our partners take ownership and title has passed, collectibility is reasonably assured, the sales price is fixed or determinable, and there is persuasive evidence of an arrangement. We are contractually obligated to sell ERBITUX to BMS at our cost of production plus a 10% markup on bulk. We sell bulk inventory to Merck KGaA at our full absorption cost of production. The



continuing level of manufacturing revenue in future periods may fluctuate significantly based on market demand, our cost of production, as well as BMS’sBMS's required level of safety stock inventory for ERBITUX and whether Merck KGaA continues to order ERBITUX for commercial use.

Royalty revenues from licensees, which are based on third-party sales of licensed products and technology, are recorded as earned in accordance with contract terms when third-party sales can be reliably measured and collection of funds is reasonably assured.

Collaborative agreement reimbursement revenue consists of reimbursements received from BMS and Merck KGaA related to clinical and regulatory studies, ERBITUX provided to them for use in clinical studies, reimbursement of a portion of royalty expense and certain marketing and administrative costs.


Collaborative agreement revenue is recorded as earned based on the performance requirements under the respective contracts.

Inventories—        InventoriesOur policy is to capitalize inventory costs associated with our products when, based on management’smanagement's judgment, future economic benefit is expected to be realized. Our accounting policy addresses the attributes that should be considered in evaluating whether the costs to manufacture a product have met the definition of an asset as stipulated in FASB Concepts Statement No. 6. If applicable, we assess the regulatory and approval process including any known constraints and impediments to approval. We also consider the shelf-life of the product in relation to the expected timeline for approval. We review our inventory for excess or obsolete inventory and write down obsolete or otherwise unmarketable inventory to its estimated net realizable value.

In June 2006, we began producing ERBITUX for commercial use at our BB50 manufacturing facility. We filed a sBLA withfacility and on August 20, 2007, we received approval from the FDA for approvalthe manufacture of ourERBITUX in BB50, facility in April 2007. Until such time as we receive approval of BB50 from the FDA, we will not beand are now able to sell the ERBITUX inventory produced in BB50. Based on management’s current expectations, we expect that the costs of such inventory will be fully realizable once we obtain approval of BB50. Therefore, in June 2006 we began to capitalize the costs of producing ERBITUX in BB50 and will continue to do so, as long as we can conclude that the costs of such inventory will be fully realizable. As of March 31, 2007, we have capitalized approximately $40.0 million of inventory produced in BB50.

Litigation—        LitigationThe Company is currently involved in certain legal proceedings more fully described under Part II—Item 1—"Legal Proceedings”Proceedings" and as disclosed in the notes to the consolidated financial statements. As of March 31,September 30, 2007, we have not established a legal reserve in our financial statements becauseas we do not believe that such a reserve is required to be established at this time, in accordance with Statement of Financial Standards ("SFAS") No. 5.5, "Accounting for Contingencies." However, if in a future period, events in any such legal proceedings render it probable that a loss will be incurred, and if such loss is reasonably estimable at that time, we will establish such a reserve. Thus, it is possible that legal proceedings and settlements arising therefrom,there from, if any, may have a material adverse impact on the operating results for that period, on our balance sheet or both.

Long-Lived Assets—AssetsWe review long-lived assets for impairment when events or changes in business conditions indicate that their full carrying value may not be recovered. Assets are considered to be impaired and written down to fair value if expected associated undiscounted cash flows are less than carrying amounts. Fair value is generally determined as the present value of the expected associated cash flows. We own a number of buildings that are primarily dedicated to the manufacturing of ERBITUX and other clinical products in our pipeline. Based on management’smanagement's current estimates, we expect to recover the carrying value of such assets. Changes in regulatory or other business conditions in the future could change our judgments about the carrying value of these facilities, which could result in the recognition of material impairment losses.

Income Taxes—TaxesIncome taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Significant estimates are required in determining our provision for income taxes. In 2006, we released a portion of our valuation allowance against our deferred tax assets. This partial release was based on revised expectations of our projected book and taxable income which caused us to conclude that it is more likely than not that a portion of the benefits of these deferred taxes would be realized. The financial projections supporting our conclusion to release a portion of our valuation allowance contain significant assumptions based on current facts about our market share and our competitive landscape. If such assumptions were to differ significantly, it may have a material impact on our ability to realize our deferred tax assets. We will continue to



monitor our current performance and


future financial projections, including market share and competitive landscape, in order to determine the effect on the valuation allowance.

Impact of Recent Accounting Pronouncements

In September 2006, the Financial Accounting Standards Board (“FASB”)FASB issued Statement of Financial Accounting Standards (SFAS)SFAS No. 157, “Accounting"Accounting for Fair Value Measurements” (“Measurements" ("SFAS 157”157"). SFAS 157 defines fair value, and establishes a framework for measuring fair value in accordance with accounting principles generally accepted in the United States of America,GAAP, and expands disclosure about fair value measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007. The Company is currently evaluating the requirements of SFAS 157.

In February 2007, the FASB issued SFAS No. 159, “The"The Fair Value Option for Financial Assets and Financial Liabilities” (“Liabilities" ("SFAS 159”159"). SFAS 159 permits the measurement of certain financial instruments and certain other items at fair value. Entities may choose to measure eligible items at fair value at specified election dates, reporting unrealized gains and losses on such items at each subsequent reporting period. SFAS 159 is effective for fiscal years beginning after November 15, 2007. The Company is currently evaluating the requirements of SFAS 159.

        In June 2007, the Emerging Issues Task Force reached a consensus on Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Good or Services to Be Used in Future Research and Development Activities." This Issue requires that nonrefundable advance payments for research and development activities be deferred and capitalized. Such amounts should be recognized as an expense as the related goods are delivered or the services are performed or when the goods or services are no longer expected to be provided. This Issue will be effective for fiscal years beginning after December 15, 2007, and earlier adoption is not permitted. This consensus is to be applied prospectively for new contracts entered into after that date. The Company is currently evaluating the potential impact of this consensus on its consolidated financial statements.

RESULTS OF OPERATIONS

Selected financial and operating data for the three and nine months ended March 31,September 30, 2007 and 2006 are as follows: (in thousands)

 
 Three Months Ended
September 30,

 Nine Months Ended
September 30,

 
 
 2007
 2006
 Variance
 2007
 2006
 Variance
 
Results of Operations:                   
Royalties $87,853 $78,599 $9,254 $242,360 $213,483 $28,877 
License fees and milestones  19,226  34,948  (15,722) 81,965  212,807  (130,842)
Manufacturing  21,973  20,884  1,089  61,456  68,589  (7,133)
Collaborative agreement reimbursements  18,495  16,266  2,229  53,698  50,805  2,893 
  
 
 
 
 
 
 
 Total revenues  147,547  150,697  (3,150) 439,479  545,684  (106,205)
  
 
 
 
 
 
 
Research and development  43,626  26,437  17,189  112,224  87,013  25,211 
Clinical and regulatory  4,761  13,527  (8,766) 33,389  43,537  (10,148)
Selling, general and administrative  20,748  15,977  4,771  54,674  56,941  (2,267)
Royalties  19,324  18,051  1,273  55,098  56,531  (1,433)
Cost of manufacturing revenue  22,256  19,187  3,069  59,110  61,466  (2,356)
Litigation settlement  50,000    50,000  50,000    50,000 
  
 
 
 
 
 
 
 Total operating expenses  160,715  93,179  67,536  364,495  305,488  59,007 
  
 
 
 
 
 
 
  Operating income (loss) $(13,168)$57,518 $(70,686)$74,984 $240,196 $(165,212)
  
 
 
 
 
 
 

 

 

Three Months Ended
March 31,

 

 

 

 

 

2007

 

2006

 

Variance

 

Results of Operations:

 

 

 

 

 

 

 

Royalty revenue

 

$

76,363

 

$

60,270

 

$

16,093

 

License fees and milestone revenue

 

29,294

 

144,403

 

(115,109

)

Manufacturing revenue

 

16,458

 

19,349

 

(2,891

)

Collaborative agreement revenue

 

19,385

 

21,109

 

(1,724

)

Total revenues

 

141,500

 

245,131

 

(103,631

)

Research and development

 

34,875

 

32,993

 

1,882

 

Clinical and regulatory

 

13,808

 

15,081

 

(1,273

)

Marketing, general and administrative

 

15,359

 

18,001

 

(2,642

)

Royalty expense

 

16,786

 

20,066

 

(3,280

)

Cost of manufacturing revenue

 

13,855

 

15,402

 

(1,547

)

Total operating expenses

 

94,683

 

101,543

 

(6,860

)

Operating income

 

$

46,817

 

$

143,588

 

$

(96,771

)


Three Months Ended March 31,September 30, 2007 and 2006

Revenues

Royalty revenues consist primarily of royalty payments earned on the sales of ERBITUX by our partners, BMS and Merck KGaA. Under our agreement with BMS, we are entitled to royalty payments equal to 39% of BMS’sBMS's net sales of ERBITUX in the United States and Canada. Under our agreement with Merck KGaA, we were previously entitled to royalty payments based on a percentage of gross margin of Merck KGaA’s sales of ERBITUX outside the United States and Canada. Beginning inbeginning July 2006, we are entitled to royalty payments equal to 9.5% of Merck KGaA’sMerck's KGaA's net sales outside of the United States and Canada.

22




In the firstthird quarter of 2007, our royalty revenue increased by approximately $16.1$9.3 million, or 27%12%, from the comparable period in 2006 due to an increase in domestic and international net sales of ERBITUX. In North America,U.S. in-market net sales by BMS in the firstthird quarter of 2007 amounted to $160.1$184.5 million compared to the comparable period in 2006 of $174.6 million, an increase of $22.1$9.9 million, or 16%6%. OutsideApproximately $9.0 million of North America, in-marketthis increase resulted from BMS transitioning from a drop-shipment methodology to a more traditional wholesaler distribution model in the third quarter of 2007 whereby currently three domestic wholesalers are now maintaining an inventory of ERBITUX for distribution in the U.S. International net sales of ERBITUX by our partner Merck KGaA in the firstthird quarter of 2007 amounted to approximately $145.9$166.9 million, an increase of $56.1$56.8 million or 62%,52% from the comparable period in 2006.

License fees and milestone revenues consist of the recognition of up-front license fees and milestone payments received under the Commercial Agreement with BMS and recognition of payments received under the development and license agreements with Merck KGaA. In the firstthird quarter of 2007, total license feefees and milestone revenue consisted of approximately $29.2$19.0 million earned from BMS and $118,000$268,000 from Merck KGaA, as compared to the same period onin 2006, in which approximately $144.3$34.8 million was earned from BMS and $56,000$118,000 was earned from Merck KGaA.

The decrease of $115.1 million, or 80%, from the comparable period in 2006license fees and milestone revenues is mainly dueattributable to the fact that in March 2006 we received the last milestone payment from BMS of $250.0 million, as a result of obtaining approval from the FDA for ERBITUX in the head and neck indication. The first quarter milestone revenue in 2006 contained a “catch-up” adjustment of approximately $112.7 million related to the actual product research and development costs incurred from inception through December 31, 2005 as a percentageimpact of the estimated total costs to be incurred over the term of the Commercial Agreement.

We have updated our guidance on milestone revenues basedBMS Amendment on the most recent clinical budget for 2007ERBITUX clinicial development cost estimates used to calculate BMS license fees and we expect that milestone revenues will range between $115 million and $135 million.revenues.

Manufacturing revenues consist of sales of ERBITUX to our corporate partners for commercial use. In accordance with the Commercial Agreement, we are contractually obligated to sell ERBITUX to BMS at our cost of production plus a 10% markup.markup on bulk. We sell bulk inventory to Merck KGaA at our full absorption cost of production.

During the firstthird quarter of 2007, volume purchases from BMSmanufacturing revenue increased by 23% over$1.1 million from the comparable period in 2006. The decrease2006 primarily due to an increase in revenue is due tothe number of vials sold by both of our corporate partners year over year. This increase was partially offset by efficiencies in the manufacturing process of ERBITUX resulting in a decrease in the price we charge our partners for ERBITUX. In addition, there were no purchases of commercial product from Merck KGaA in the first quarter 2007 while there was $2.7 million of purchases from Merck KGaA in the first quarter of 2006.

Collaborative agreement reimbursement revenue consists primarily of reimbursements from our partners BMS and Merck KGaA under our collaborative agreements. There are certain categories for which we receive reimbursement from our partners: the cost of ERBITUX supplied to our partners for use in clinical studies, clinical and regulatory expenses, certain marketing and administrative expenses, and a portion of royalty expense. During the firstthird quarter of 2007, we earned approximately $19.4


$18.5 million in collaborative agreement revenues,revenue, which consists of which approximately $10.5$14.8 million was earned from BMS and $8.9$3.7 million was earned from Merck KGaA, as compared to $21.1$16.3 million earned in the comparable period in 2006, of which approximately $13.2$13.4 million was earned from BMS and $7.9$2.9 million was earned from Merck KGaA.


The decreaseincrease from the comparable period of $1.7$2.2 million, or 8%14%, is principallyprimarily due to decreasesan increase in reimbursements of clinical expenses following the BMS Amendment. As a result of the BMS Amendment, ERBITUX clinical development costs, up to a threshold amount, are the sole responsibility of BMS, with costs in excess of this threshold amount shared by both companies according to a predetermined ratio, effective January 1, 2007. As a result, reimbursable ERBITUX clinical development costs from BMS increased by $2.8 million for the quarter, including $2.3 million for costs previously recorded by us in the first half of 2007 that are now reimbursable. The increase is also due to more reimbursable clinical trial activity year over year of approximately $1.0 million as well as an increase in clinical shipments of ERBITUX to our partners of approximately $1.0 million. These increases were offset by a decrease in reimbursement for royalty expenses of $3.5$2.6 million primarily as a result ofresulting from the fact that starting in the first quarter of 2007 thelower reimbursement rate from BMS for third party royalty expense decreasedthird-party royalties, which dropped from 4.5% to 2.5% based on our contractual agreement, partly offset by increases in the reimbursement of clinical drugs of approximately $1.4 million and clinical and regulatory expenses of approximately $392,000 as compared to the same period in 2006., effective January 1, 2007.

Expenses

Research and development expenses include costs associated with our in-house research programs, product and process development expenses, costcosts to manufacture our product candidates for clinical studies, quality assurance, and quality control infrastructure and costs of ERBITUX supplied to our corporate partners, BMS and Merck KGaA, for use in clinical studies.infrastructure. Research and development expenses also include our cost of inventory that is supplied to our corporate partners for use in clinical studies that are reimbursable from our corporate partners. As a result, approximately $10.2Approximately $4.6 million and $8.8$3.6 million of costs representing research and development expenses in the firstthird quarters of 2007 and 2006, respectively, were reimbursable and included under collaborative agreement reimbursement revenue since they represent inventory supplied to our partners for use in clinical studies.

The increase        Research and development expenses in the third quarter of 2007 of $43.6 million increased from the comparable period of $1.9in 2006 by $17.2 million, or 6%,65%. This increase is primarily due to the transition of our BB50 manufacturing facility from the production of ERBITUX to pipeline products on July 1, 2007. This transition resulted in approximately $14 million of inventory production costs for pipeline products being recorded as research and development expense as compared to the prior year when these costs were incurred and capitalized into the production of ERBITUX. In addition, there was an increase of $5.6 million in shipments of ERBITUX sold to our partners for clinical studies of approximately $4.0 million, the write-off of previously capitalizedmaterial costs associated with the developmentproduction of our Spring Street location of approximately $3.2 million, and approximately $1.3 million of additional depreciation expense due to the fact that we began to depreciate BB50 in June of 2006.pipeline products which were expensed. These increases were partially offset by decreased costs for third-party clinical manufacturing of $2.2 million, $2.0 million related to reduced headcount and reductionsdecreases in various other categories as a resultexpense categories.

        For the full year of cost saving initiatives.2007, we expect research and development expenses to be in the range of approximately $155 to $160 million.

Clinical and regulatory expenses consist of costs to conduct our clinical studies and associated regulatory activities. Clinical and regulatory expenses also includein the third quarter of 2007 amounted to $4.8 million, a decrease of $8.8 million or 65% from the comparable period in 2006. Clinical and regulatory expenses includes certain amounts that are reimbursable from our corporate partners. As a result, approximately $3.8$7.0 million and $3.4$3.3 million of the costs included in this category for the firstthird quarters of 2007 and 2006, respectively, are reflected as revenues under collaborative agreement reimbursement revenue since they represent costs that are reimbursable by our corporate partners.


Clinical and regulatory expenses in

        The BMS Amendment specifies that each year BMS will fund nearly all of the first quarter of 2007 amounted to $13.8 million, a decrease of $1.3 million or 8% from the comparable period in 2006. The decrease is primarily dueannual ERBITUX development costs up to a $3.9specific threshold amount and that we will contribute a portion of the costs in excess of that threshold amount. For 2007, this threshold amount is effective January 1, 2007, therefore, a $7.6 million cost sharing liability due BMS,adjustment was recorded inby the first quarter of 2006, forCompany to reduce previously expensed ERBITUX clinical development costs incurred during the period prior to signing the BMS Amendment, which fell under the newly established threshold amount and therefore are the sole responsibility of BMS.

        For the full year of 2007, we expect clinical and regulatory expense to be in excessthe range of the annual clinical budget. We do not have an obligationapproximately $50 to reimburse BMS for clinical development costs in excess of the 2007 annual clinical budget. This decrease was partially offset by increased clinical trial expenses associated with ERBITUX and the Company’s pipeline products.$55 million.

Marketing,        Selling, general and administrative expenses include marketingselling and administrative personnel costs, including related facility costs, additional costs to develop internal marketingselling and field operations capabilities and expenses associated with applying for patent protection for our technology and products. Marketing,

        Selling, general and administrative expenses alsoin the third quarter of 2007 amounted to $20.7 million, an increase of $4.8 million or 30% from the comparable period in 2006. Expenses in this category have increased from the comparable period in 2006, mainly due to the expansion of our field sales force during the second quarter of 2007 as well as an increase in legal fees associated with patent litigation matters. Selling, general and administrative expenses include amounts reimbursable from our corporate partners. As a result,partners of which approximately $320,000$388,000 and $314,000$307,000 of costs representing marketing and general


expenses in the firstthird quarters of 2007 and 2006, respectively, were reimbursable and included in collaborative agreement reimbursement revenue.

Marketing,        For the full year of 2007, we expect total selling, general and administrative expenses to be in the first quarterrange of 2007 amountedapproximately $75 to $15.4 million, a decrease of $2.6 million, or 15%, from the comparable period in 2006. Expenses in this category have decreased from the comparable period in 2006, mainly due to reduced headcount, which resulted in reduced salaries and benefits of $2.5 million, including $953,000 less stock-based compensation costs.$80 million.

Royalty Expense

Royalty expense consists of obligations related to certain licensing agreements related toregarding ERBITUX. We are obligated toIn July 2007, a patent we licensed expired and therefore the royalty rate we pay royalties of approximately 9.25% ofon North American net sales anddecreased from 9.25% to 8.50%. We pay a low single-digit royalty on net sales outside of North America, which will increase if net sales outside of North America consist of ERBITUX produced in the United States. In 2007, we receivedreceive reimbursements from our corporate partners of 2.5% on North American net sales and a single-digit percentage on net sales outside of North America, which is reflected in collaborative agreement reimbursement revenue. As a result, approximately $5.1Approximately $6.5 million and $8.6$9.1 million of royalty expense waswere reimbursable by our corporate partners and included as collaborative agreement reimbursement revenue in the firstthird quarters of 2007 and 2006, respectively.

In the firstthird quarter of 2007, we incurred royalty expense of $16.8$19.3 million as compared to $20.1 million, a decreasean increase of $3.3$1.3 million, or 16%7%, from the comparable period in 2006. This decreaseThe increase is primarily due to the fact thatan increase in global net sales of ERBITUX in the firstthird quarter of 2006, we paid royalties of approximately 12.25% of North American net sales and effective2007 from the comparable period in the second quarter of 2006, our obligation, as noted above decreased by 3%.2006.

We sell ERBITUX to BMS at our costscost of production plus a 10% mark-up on bulk and to Merck KGaA at our cost of production. Therefore, depending on certain circumstances, such as the mix of demand from our partners, and the costs of filling and finishing ERBITUX bulk (for which we do not charge a 10% markup when selling to BMS), we expect that our gross margins on sales of ERBITUX may fluctuate from quarter to quarter.


Cost of manufacturing revenue in the firstthird quarter of 2007 amounted to $13.9$22.3 million, representingwhich includes a $2.1 million expense for batches of ERBITUX that were damaged during the period, compared to approximately $19.2 million for the same period of 2006. Excluding the costs of the damaged batches, our gross margin was 8% for the third quarter of approximately 16% compared to costs2007.

        Litigation settlement expense of manufacturing revenue$50.0 million was recorded in the comparablethird quarter of 2007 resulting from the settlement agreement executed in September 2007 with MIT and Repligen. The total settlement was $65.0 million, of which $50.0 million was attributable to an expired Repligen patent and was expensed in the period of 2006 of approximately $15.4and $15.0 million or a gross margin of 20%.was attributed to the sublicensed Abbott patents.

Interest income in the firstthird quarter of 2007 amounted to $12.5$13.4 million, an increase of approximately $5.4$2.3 million, or 75%21% from the comparable period in 2006. This increase is attributable to increases inhigher average interest rates and balance of our investment portfolio from the comparable period in 2006.

        Interest expense in the third quarter of 2007 amounted to $3.1 million, an increase of $126,000 from the comparable period in 2006.

        Other income for the third quarter of 2007 includes a gain of $3.8 million from the proceeds of an insurance reimbursement primarily for lost royalties on an ERBITUX shipment that was damaged in-transit during 2006.

        Our estimated annual effective income tax rate for 2007 is approximately 41.5%, excluding the effect of any discrete charges. The income tax provision for the quarter ended September 30, 2007 reflects the cumulative impact of the increased estimated annual effective tax rate. Additionally, during the three months ended September 30, 2007, the Company recorded a benefit of approximately $786,000 primarily related to the reconcilation of estimates to actual filed tax returns. The estimated annual income tax rate is higher than the prior year's rate mainly due to the utilization in 2006 of fully reserved deferred tax assets. Cash taxes in 2007 are expected to be approximately $4 million.

        In the third quarter of 2007 we had a net loss of $916,000, or $(0.01) per diluted common share, compared with net income of $57.3 million, or $0.65 per diluted common share for the comparable period in 2006. The fluctuation in results was due to the factors noted above.

Nine Months Ended September 30, 2007 and 2006

Revenues

        Royalty revenues consist primarily of royalty payments earned on net sales of ERBITUX by our partners, BMS and Merck KGaA. Under our agreement with BMS, we are entitled to royalty payments equal to 39% of BMS's net sales of ERBITUX in the United States and Canada. Under our agreement with Merck KGaA, beginning July 2006, we are entitled to royalty payments equal to 9.5% of Merck's KGaA's net sales outside of the United States and Canada.

        For the nine months ended September 30, 2007, royalty revenue amounted to $242.4 million, an increase of $28.9 million, or 14%, from the comparable period in 2006. This increase is due to an



increase in global net sales of ERBITUX. U.S. in-market sales by BMS for the first nine months of 2007 amounted to $506.7 million, an increase of $21.7 million, or 4% compared to the prior year period. Approximately $10.6 million of this increase resulted from BMS's switch from a drop-shipment methodology to a more traditional wholesaler distribution model in the third quarter of 2007 whereby currently three domestic wholesalers are now maintaining an inventory of ERBITUX for distribution in the U.S. Outside of North America. Net sales of ERBITUX by Merck KGaA in the first nine months of 2007 amounted to $470.0 million, an increase of $167.6 million or 55% from the comparable period in 2006.

        License fees and milestone revenues consist of the recognition of up-front license fees and milestone payments received under the Commercial Agreement with BMS and recognition of payments received under the development and license agreements with Merck KGaA. For the nine months ended September 30, 2007, license fees and milestone revenue consisted of $81.5 million earned from BMS and $505,000 from Merck KGaA, as compared to the same period in 2006 in which $212.6 million was earned from BMS and $229,000 was earned from Merck KGaA.

        The decrease of $130.8 million, or 60%, from the comparable period in 2006 is due to the fact that in March 2006, we received the last milestone payment from BMS of $250.0 million, as a result of obtaining approval from the FDA for ERBITUX in a head and neck indication. The milestone revenue in the first quarter of 2006 included a "catch-up" adjustment of approximately $112.7 million related to the actual product clinical development costs incurred from inception through December 31, 2005 as a percentage of the estimated total costs to be incurred over the term of the Commercial Agreement.

        Manufacturing revenues consist of sales of ERBITUX to our corporate partners for commercial use. In accordance with the Commercial Agreement, we are contractually obligated to sell ERBITUX to BMS at our cost of production plus a 10% markup on bulk. We sell bulk inventory to Merck KGaA at our cost of production.

        During the first nine months of 2007, manufacturing revenue decreased by $7.1 million from the comparable period in 2006 due primarily to efficiencies in the manufacturing process of ERBITUX resulting in a decrease in the price we charge our partners for ERBITUX. Total volume purchases from our partners in the first nine months of 2007 increased by approximately 5% from the comparable period in 2006.

        Collaborative agreement reimbursement revenue consists primarily of reimbursements from our partners BMS and Merck KGaA under our collaborative agreements. There are certain categories for which we receive reimbursement from our partners: the cost of ERBITUX supplied to our partners for use in clinical studies, clinical and regulatory expenses, certain selling and administrative expenses, and a portion of royalty expense. During the nine months ended September 30, 2007, we earned $53.7 million in collaborative agreement revenue, which primarily consists of approximately $35.9 million earned from BMS, approximately $17.2 million earned from Merck KGaA and $600,000 as final payment from a former corporate partner, as compared to $50.8 million earned in the comparable period in 2006, of which $38.4 million was earned from BMS and approximately $12.4 million was earned from Merck KGaA. The increase in collaborative agreement revenue of $2.9 million is principally due to increases in reimbursement for clinical drugs of approximately $5.8 million and in the reimbursement of clinical expenses of approximately $5.0 million, $2.3 million for costs previously recorded by the Company in the first half of 2007 that are now reimbursable by


BMS. These increases were partially offset by a decrease in reimbursement for royalty expense of $8.5 million, primarily resulting from the lower reimbursement rate from BMS for third-party royalties, which dropped from 4.5% to 2.5% on January 1, 2007.

        Research and development expenses include costs associated with our in-house research programs, product and process development expenses, costs to manufacture our product candidates for clinical studies, quality assurance and quality control infrastructure. Research and development expenses also include our cost of inventory that is supplied to our corporate partners for use in clinical studies that are reimbursable from our corporate partners. Approximately $19.4 million and $13.5 million of costs representing research and development expenses in the first nine months of 2007 and 2006, respectively, were reimbursable and included under collaborative agreement reimbursement revenue as they represent inventory supplied to our partners for use in clinical studies.

        Research and development expenses for the nine months ended September 30, 2007 of $112.2 million increased by approximately $25.2 million, or 29%, from the comparable period in 2006. The increase is due primarily to the transition of our BB50 manufacturing facility from the production of ERBITUX to pipeline products on July 1, 2007. This transition resulted in inventory production costs for pipeline products being recorded as research and development expense as compared to the prior year when these costs were incurred and capitalized into the production of ERBITUX. As part of this transition we also experienced increased material costs associated with the development of our pipeline products of approximately $7.5 million which were expensed. In addition, we had an increase in shipments of ERBITUX to our partners for clinical studies of approximately $7.1 million, as well as the write-off of $3.6 million of previously capitalized costs associated with the development of our Spring Street location. These increases were partially offset by smaller decrease across various categories.

        For the full year of 2007, we expect research and development expenses to be in the range of approximately $155 to $160 million.

        Clinical and regulatory expenses consist of costs to conduct our clinical studies and associated regulatory activities. Clinical and regulatory expenses also include certain amounts that are reimbursable from our corporate partners. As a result, approximately $14.4 million and $9.4 million of the costs included in this category for the first nine months of 2007 and 2006, respectively, are reflected as revenues under collaborative agreement reimbursement revenue since they represent costs that are reimbursable by our corporate partners.

        Clinical and regulatory expenses for the nine months ended September 30, 2007 amounted to $33.4 million, a decrease of $10.1 million, or 23%, from the comparable period in 2006. This decrease is due primarily to an adjustment of $7.6 million that was recorded by the Company as a result of the BMS Amendment, to reduce previously expensed ERBITUX development costs incurred during the period prior to signing the BMS Amendment, which fell under the newly established threshold amount and therefore are the sole responsibility of BMS.

        For the full year of 2007, we expect clinical and regulatory expense to be in the range of approximately $50 to $55 million.

        Selling, general and administrative expenses include selling and administrative personnel costs, including related facility costs, additional costs to develop internal selling and field operations


capabilities and expenses associated with applying for patent protection for our technology and products. Selling, general and administrative expenses also include amounts reimbursable from our corporate partners. Approximately $967,000 and $957,000 of costs in the first nine months of 2007 and 2006, respectively, were reimbursable and included in collaborative agreement reimbursement revenue.

        Selling, general and administrative expenses for the nine months ended September 30, 2007 amounted to $54.7 million, a decrease of $2.3 million or 4% from the comparable period in 2006. Expenses in this category have decreased from the comparable period in 2006, mainly due to a $4.2 million decrease in personnel costs as a result of the turnover of executive level employees, some of whom have not been replaced. This decrease was partly offset by small increases in various other categories.

        For the full year of 2007, we expect total selling, general and administrative expenses to be in the range of approximately $75 to $80 million.

        Royalty expense consists of obligations related to certain licensing agreements regarding ERBITUX. Due to the expiration of a patent we licensed, in July 2007 the royalty rate we pay on North American net sales decreased from 9.25% to 8.50%. We pay a low single-digit royalty on sales outside of North America, which will increase if sales outside of North America consist of ERBITUX produced in the United States. In 2007, we receive reimbursements from our corporate partners of 2.5% on North American net sales and a single-digit percentage on net sales outside of North America, which is reflected in collaborative agreement revenue. As a result, approximately $18.3 million and $26.9 million of royalty expense were reimbursable by our corporate partners and included as collaborative agreement revenue in the first nine months of 2007 and 2006, respectively.

        During the nine months ended September 30, 2007, we incurred royalty expense of $55.1 million, a decrease of $1.4 million, or 3% from the comparable period in 2006. The decrease is primarily due the fact that (1) prior to the second quarter of 2006, we paid royalties of approximately 12.25% of North American net sales and effective in the second quarter of 2006, our obligation decreased by 3%; and (2) as previouisly dicussed, as a result of the expiration in July 2007 of a patent we licensed, our total domestic royalty expense decreased from 9.25% to 8.5% These decreases in royalty rates were partially offset by the increased worldwide net sales of ERBITUX from $787.5 million for the first nine months of 2006 to $976.7 million in the first nine months of 2007.

        We sell ERBITUX to BMS at our cost of production plus a 10% mark-up on bulk and to Merck KGaA at our cost of production. Therefore, depending on certain circumstances, such as the mix of demand from our partners, and the costs of filling and finishing ERBITUX bulk (for which we do not charge a 10% markup when selling to BMS), we expect that our gross margins on sales of ERBITUX may fluctuate from quarter to quarter.

        Cost of manufacturing revenue for the nine months ended September 30, 2007 amounted to $59.1 million, which includes a $3.1 million charge for batches of ERBITUX that were damaged during the period, compared to approximately $61.5 million in the comparable period of 2006. Excluding the costs of the damaged batches, our gross margin was 9%.

        Litigation settlement expense of $50.0 million was recorded in the third quarter of 2007 resulting from the settlement agreement executed in September 2007 with MIT and Repligen. The total


settlement was $65.0 million, of which $50.0 million was attributable to an expired Repligen patent and was expensed in the period and $15.0 million was attributed to the sublicensed Abbott patents.

        Interest income for the nine months ended September 30, 2007 amounted to $39.2 million, an increase of approximately $10.8 million, or 38% from the comparable period in 2006. This increase is attributable to higher average balance ofinterest rates and balances in our investment portfolio from the comparable period in 2006, due primarily to the receipt of a $250$250.0 million milestone payment we received from BMS on March 31, 2006.


Interest expense infor the first quarter ofnine months ended September 30, 2007 amounted to $3.0approximately $9.1 million, an increase of $1.5approximately $2.7 million, or 103%43% from the comparable period in 2006. The increase is primarily due to the fact that we finalized construction of our BB50 manufacturing facility in May 2006, and therefore, ceased capitalizing interest on the construction of thisthe facility at that time.

        Other income for the third quarter of 2007 includes a gain of $3.8 million from the proceeds of an insurance reimbursement primarily for lost royalties on an ERBITUX shipment that was damaged in-transit during 2006.

The Company’s        Our estimated annual effective operating income tax rate for 2007 is approximately 41%.41.5%, excluding the effect of any discrete charges. Additionally, duringfor the first quarter ofnine months ended September 30, 2007, the Company has recognized a net discrete charge of approximately $4.5$4.3 million primarily related to certain tax return method changes filed as well as certain deferred tax charges. The estimated annual income tax rate is higher than the prior year's rate mainly due to the utilization in 2006 of fully reserved deferred tax assets. For the nine months ended September 30, 2006, the Company had also recorded a discrete benefit related to the partial release of the valuation allowance. We expect to pay cash taxes of approximately $4 million in 2007.

We        For the nine months ended September 30, 2007, we had net income of $28.8$59.7 million, or $0.34 per basic common share and $0.33$0.69 per diluted common share for the first quarter of 2007, compared with net income of $229.6$324.1 million, or $2.75 per basic common share and $2.51$3.58 per diluted common share for the comparable period in 2006. The fluctuation in results was due to the factors noted above.

LIQUIDITY AND CAPITAL RESOURCES

At March 31,September 30, 2007, our principal sources of liquidity consisted of cash and cash equivalents and securities available for sale of approximately $1.1 billion. Historically, we have financed our operations through a variety of sources, most significantly through the issuance of public and private equity and convertible notes, license fees and milestone payments and reimbursements from our corporate partners. Since the approval of ERBITUX on February 12, 2004, we began to generate royalty revenue and manufacturing revenue from the commercial sale of ERBITUX by our corporate partners and we have generated income from operations since 2004. As we continue to generate income, our cash flows from operating activities are expected to increase as a source to fund our operations. Therefore, we anticipate that our future financial condition and our future operating performance will continue to experience significant changes and that past performance will not likely be indicative of our future performance.


SUMMARY OF CASH FLOWS

 

 

Three Month ended

 

 

 

 

 

March 31,
2007

 

March 31,
2006

 

Variance

 

Cash provided by (used in):

 

 

 

 

 

 

 

Operating activities

 

$

13,748

 

$

209,601

 

$

(195,853

)

Investing activities

 

(25,117

)

20,388

 

(45,505

)

Financing activities

 

13,722

 

42,469

 

(28,747

)

Net increase in cash and cash equivalents

 

$

2,353

 

$

272,458

 

$

(270,105

)

 
 September 30,
2007

 September 30,
2006

 Variance
 
Cash provided by (used in):          
 Operating activities $(3,531)$186,422 $(189,953)
 Investing activities  358,570  (261,485) 620,055 
 Financing activities  38,716  86,968  (48,252)
  
 
 
 
  Net increase in cash and cash equivalents $393,755 $11,905 $381,850 
  
 
 
 

        

Historically our cash flows from operating activities have fluctuated significantly due to the nature of our operations and the timing of our cash receipts. During the first quarternine months of 2007, we generatedused approximately $13.7$3.5 million in cash from operating activities, as compared to $209.6generating $186.4 million in the comparable period of 2006. The decrease in operating cash flows in the first quarternine months of 2007 is primarily due to the receipt of a $250.0 million milestone payment from our corporate partner BMS in March 2006, as a result of obtaining approval from the FDA for ERBITUX in a second indication.indication, and the payment of $65.0 million to settle the Repligen/MIT litigation in September 2007, partially offset by an increase in cash flows from royalty revenues in 2007.

Our primary sources and uses of cash underfrom investing activities consist of purchases and sales activity in our investment portfolio, which we manage based on our liquidity needs, possible business development transactions and amounts used for capital expenditures. During the first quarternine months of 2007, we used netgenerated cash from investing activities of $25.1$358.6 million comprisedwhich consists of net proceeds of $367.4 million from sales and maturities of securities available for sale due to our decision to increase our money market fund investments until more stability returns to the financial markets. The proceeds were partially offset by approximately $3.1$8.8 million in acquisition of fixed


assets, offset by net purchases assets. As of additional securities in our investment portfolioSeptember 30, 2007, we had approximately $149.2 million of $22.0 million. Since we generated positive cash flows from operating activitiesvariable-rate financial instruments that failed at auction during the first quarterquarter. These investments are all AAA/Aaa rated and the interest continues to be paid by the holder of 2007, we invested the excess cash in our investment portfolio.notes. The Company believes that this loss position is temporary and that no asset impairment charge is needed at this time.

Net cash flows generated in financing activities in 2007 were approximately $13.7$38.7 million, of which approximately $6.7$24.2 million of proceeds were generated from the exercise of stock options and sales under the Company’sCompany's employee stock purchase plan, and $7.0$14.0 million was generated from tax benefits associated with equity net operating losses that will be taken as a reduction on our tax returns. In the first quarter of 2006, net cash flows generated in financing activities were approximately $42.5 million, of which approximately $10.9 million of proceeds were generated from the exercise of stock optionsreturns, and sales under the Company’s employee stock purchase plan and $31.6 million$500,000 was generated from tax benefits associate with equity net operating losses that will be taken as a reduction on our tax returns.through the sale of treasury stock.

Our future working capital and capital requirements will depend upon numerous factors, including, but not limited to:

·



OFF-BALANCE SHEET ARRANGEMENTS

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.


Item 3.
Quantitative and Qualitative Disclosures About Market Risk

Our holdings of financial instruments comprise a mix of U.S. dollar denominated securities that may include U.S. corporate debt, foreign corporate debt, U.S. government debt, foreign government debt, asset-backed securities, auction rate securities, and commercial paper. All such instruments are classified as securities available for sale. Generally, we do not invest in portfolio equity securities,investments, commodities, foreign exchange contracts or use financial derivatives for trading purposes.purposes, however, we may make these investments depending upon our needs. Our debt security portfolio represents funds held temporarily pending use in our business and operations. We manage these funds accordingly. We seek reasonable assuredness of the safety of principal and market liquidity by investing in investment grade fixed income securities while at the same time seeking to achieve a favorable rate of return. Our market risk exposure consists principally of exposure to changes in interest rates. Our holdings are also exposed to the risks of changes in the credit quality of issuers. We invest in securities that have a range of maturity dates.


The table below presents the principal amounts and related weighted average interest rates by year of maturity for our fixed and variable rate securities within our investment portfolio as of March 31,September 30, 2007: (in thousands, except interest rates)

 

2007

 

2008

 

2009

 

2010

 

2011

 

2012 and
Thereafter

 

Total

 

Fair
Value

 

 2007
 2008
 2009
 2010
 2011
 2012 and
Thereafter

 Total
 Fair
Value

Fixed Rate

 

$

189,900

 

$

100,000

 

$

85,170

 

$

88,320

 

 

$

 

 

 

$

 

 

$

463,390

 

$

459,829

 

 $60,000 $115,015 $55,000 $193,397 $20,000 $10,012 $453,424 $452,856

Average Interest Rate

 

3.52

%

3.86

%

4.75

%

5.22

%

 

 

 

 

 

 

4.14

%

 

 

  3.53% 4.10% 4.33% 5.39% 5.5% 5.70% 4.70%  

Variable Rate(1)

 

 

1,802

 

 

 

 

 

 

 

585,462

 

 

587,264

 

587,267

 

    1,801        175,020  176,821  158,487

Average Interest Rate

 

 

5.70

%

 

 

 

 

 

 

5.33

%

 

5.33

%

 

 

    5.70%       5.69% 5.69%  

 

$

189,900

 

$

101,802

 

$

85,170

 

$

88,320

 

 

$

 

 

 

$

585,462

 

 

$

1,050,654

 

$

1,047,096

 

 
 
 
 
 
 
 
 
 $60,000 $116,816 $55,000 $193,397 $20,000 $185,032 $630,245 $611,343
 
 
 
 
 
 
 
 

(1)
These holdings primarily consist of U.S. corporate and foreign corporate floating rate notes. Interest on the securities is adjusted monthly, quarterly or semi-annually, depending on the instrument, using prevailing interest rates. These holdings are highly liquid and we consider the potential for loss of principal to be minimal

minimal.

Our outstanding 13¤/8% fixed rate convertible senior notes in the principal amount of $600.0 million due May 15, 2024 are convertible into our common stock at a conversion price of $94.69 per share, subject to certain restrictions as outlined in the indenture agreement. The fair value of fixed interest rate instruments is affected by changes in interest rates and in the case of the convertible notes by changes in the price of our common stock as well. The fair value of the convertible senior notes was approximately $559.9$559.5 million at March 31,September 30, 2007.



Item 4.
Controls and Procedures

Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Committee of the Board, ChairmanOfficer and SeniorInterim Vice President, Finance, has evaluated the effectiveness of our “disclosure"disclosure controls and procedures”procedures" (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based on such evaluation, our Chief Executive Committee of the Board, ChairmanOfficer and SeniorInterim Vice President, Finance have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information that we are required to disclose in the reports that we file or submit under the Exchange Act.

Changes In Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting during the three months ended March 31,September 30, 2007 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


28




PART II.


PART II
OTHER INFORMATION

Item 1.    Legal Proceedings

Intellectual Property Litigation

As previously reported, on October 28, 2003, a complaint was filed by Yeda Research and Development Company Ltd. (“Yeda”("Yeda") against ImClone Systems and Aventis Pharmaceuticals, Inc. (“Aventis”("Aventis") in the U.S. District Court for the Southern District of New York (03 CV 8484). This action did not seek damages, but rather alleged that three individuals associated with Yeda should also be named as co-inventors on U.S. Patent No. 6,217,866, which relates to the therapeutic use of EGFR antibodies (such as ERBITUX, the Company’sCompany's EGFR antibody product) in combination with chemotherapy. The Company has exclusively licensed this patent from Rhone-Poulenc Rorer Pharmaceuticals, now known as Sanofi-Aventis. On June 7, 2005, Yeda amended its U.S. complaint to seek sole inventorship of the subject patent. On November 4, 2005, the Court denied the Company’sCompany's motion for summary judgment with respect to this matter, as filed with the Court on June 24, 2005. At the same time, the Court granted summary judgment to Yeda dismissing two of ImClone’sthe Company's affirmative defenses. A bench trial on the merits of Yeda’sYeda's complaint was held between June 5, 2006 and July 19, 2006. On September 18, 2006, the Court ruled in favor of Yeda by awarding it sole inventorship rights to the patent. The Company then appealed the Court’sCourt's decision to the Court of Appeals for the Federal Circuit. The appeal was docketed on October 5, 2006 (as No. 2007-1012). On March 16,Briefing is now complete. A hearing is scheduled for December 7, 2007 and a decision from the Company submitted its opening briefFederal Circuit is expected in the appeal.due course. The Company, having had the advice of its patent counsel, believes the positions raised on appeal are sound, and it plans to vigorously pursue this appeal.

On        As previously reported, on September 20, 2006, subsequent to the Court’sCourt's inventorship decision, the Company also filed an action (06 CV 7190) against Yeda in the U.S. District Court for the Southern District of New York seeking a declaratory judgment that the patentU.S. Patent No. 6,217,866 is invalid due to the removal of the originally named inventors.invalid. On October 31, 2006, Yeda filed an answer and counterclaim to the Company’sCompany's declaratory judgment complaint in which Yeda alleges the Company is liable to Yeda for willful patent infringement, unjust enrichment and conversion, and seeks damages from the Company and an order requiring the Company to license the patent and pay Yeda royalties until the patent expires. The declaratory judgment action is inCompany filed an answer denying all counterclaims. In addition, on November 7, 2007, the Company filed a first amended answer to defendant's counterclaims asserting that the Company's activities are protected by the safe harbor provisions of 35 U.S.C. 271(e)(1), that Yeda's claims for damages for any infringement more than six years prior to filing of its early stages.counterclaims are barred by the statute of limitations, and that federal law preempts Yeda's claims for unjust enrichment and conversion. The Company, having had the advice of its patent counsel, believes that the claims asserted in the declaratory judgment action are sound, and that Yeda’s counterclaims are not sound, and it plans to vigorously pursue this action. The Company is unable to predict the outcome of these actions at this time. If the Company’sCompany's appeal is unsuccessful and Yeda’sYeda's sole inventorship rights to the patent are upheld and the Company is unsuccessful with respect to its declaratory judgment action, the Company may become obligated to pay Yeda a royalty and may be liable to Yeda for other damages.

As previously reported, on        On March 25, 2004, an action was filed in the United Kingdom Patent Office entitled Referrer’s Statement requesting transfer of co-ownership to Yeda and amendment of patent EP (UK) 0 667 165 to add three YedaWeizmann former employees as inventors. AlsoThe Company was not named as a party in this action which relates to the European equivalent of U.S. Patent No. 6,217,866 discussed above. Accordingly, the Company intervened. On June 29, 2005, Yeda sought to amend its pleadings to seek sole ownership. That amendment was refused by the High Court and the Court of Appeal but was further appealed by Yeda to the House of Lords. The House of Lords heard Yeda's appeal on July 23-25, 2007. On October 24, 2007, the House of Lords issued a decision that reinstated the permission given by the Patent office, namely, that Yeda may proceed with a claim in relation to the EP (UK) to sole entitlement,



alternatively to joint entitlement with Aventis. A hearing on the substantive case relating to entitlement to the EP (UK) will now likely occur in 2008.

        On March 25, 2004, a German action entitled Legal Action was filed in the Munich District Court I, Patent Litigation Division, in which Yeda soughtclaims a 75% ownership interest in patent EP (DE) 0 667 165 based on its allegation that the inventorship on that patent was incorrect. The Company was not named as a party in these actionsthis action which relaterelates to the European equivalent of U.S. Patent No. 6,217,866 discussed above. Accordingly, the Company intervened in the U.K. and German actions.intervened. On October 7, 2005, Yeda sought to amend its pleadings in the United Kingdom and Germanyclaim to seek sole inventorshipownership. That amendment was refused by the Munich District Court and sole ownership. Following hearings, bothon appeal by the U.K. and German courts held that Yeda was not entitled to amend its pleadings. In the U.K., Yeda sought leave from the House of Lords to appeal the High Court’s decision, and such leave was granted in November 2006. In Germany, Yeda has appealed the lower court’s decision to theMunich Higher Regional Court in a Decision dated September 20, 2007. That decision will likely be appealed by Yeda to the German Supreme Court. Presently, Yeda's claim in respect of Munich. Additionally, on or aboutthe EP(DE) remains restricted to joint entitlement.

        On March 25, 2005, and March 29, 2005, respectively, Yeda filed legal actionsan action in Austria and Francethe Austrian Patent Office ("APO") against both Aventis and ImClone Systems seeking full inventorshipsole entitlement of EP


(AU) 0 667 165 and EP (FR) 0 667 165, as well as payment of legal costs and fees. The Company was not named as a party to this action which relates to the European equivalent of US Pat. No. 6,217,866 discussed above. Accordingly, the Company intervened. Aventis' Defence and the Company's Intervention were filed on February 15, 2006. Yeda's Reply to the Defence/Intervention was filed on February 12, 2007. The Company's Rejoinder was filed on September 14, 2007. The case has been sent to the Technical Examiner, who will report back to the Nullity Division of the APO in due course. The Company, having had the advice of its patent counsel, believes there are sound defenses to these actions, and it presently plans to vigorously defend against the claims asserted. In addition,

        On March 29, 2005, Yeda filed an action in December 2002, Opposition Proceedingsthe Tribunal de Grande Instance, Paris jointly against Aventis and the Company seeking to revokesole entitlement of EP (FR) 0 667 165, as well as payment of damages, legal costs and fees. This is the European patent discussed above were brought by Scripps Research Institute, Amgen Inc., Abgenix, Inc.,equivalent of US Pat. No. 6,217,866. Aventis and YM Biosciences Inc. An Opposition Proceeding is an administrative process, the outcomeCompany filed their Defences on September 22, 2006. Yeda submitted a Reply to Defence on September 17, 2007. Additionally, Yeda requested the French Court to take jurisdiction over the 9 non-French counterparts of which may be thatthe "165 EP in: Belgium, The Netherlands, Luxembourg, Liechtenstein, Sweden, Switzerland, Spain, Italy and Greece. A preliminary challenge to the jurisdiction of the French Court to hear Yeda's claim to those non-French parts of the European patentPatent will be revoked.made and that preliminary challenge is likely to be heard in early 2008. The Opposition ProceedingsCompany, having had the advice of its patent counsel, believes there are suspended pending a final determination onsound defenses to these actions, and it plans to vigorously defend against the Yeda matter discussed above.claims asserted.

As previously reported, on May 4, 2004, a complaintan action was filed against the Company by Massachusetts Institute of Technology (“MIT”("MIT") and Repligen Corporation (“Repligen”("Repligen") in the U.S. District Court for the District of Massachusetts (04-10884 RGS). This action allegesalleged that ERBITUX infringes U.S. Patent No. 4,663,281, which is owned by MIT and exclusively licensed to Repligen and that the Company should therefore pay damages. On July 28, 2006,In September 2007, the Court denied the Company’s motionparties signed settlement and certain sublicensing agreements, for summary judgment seeking to dismiss all claims on the basis that the patent rights at issue were exhausted as a matter of law and granted MIT and Repligen’s cross motion that their patent rights were not exhausted. On September 26, 2006, a hearing was held in response to a Motion for Sanctions filed by Repligen, which alleged that the Company’s counsel, Kenyon & Kenyon, and the Company acted improperly duringpaid $65.0 million in cash for full and afterfinal settlement of the deposition of one of Repligen’s potential witnesses. Repligen seeks evidentiary sanctions which may limit the Company’s proofs on non-infringement issues, and the Court has raised the possibility that Kenyon & Kenyon may be disqualified from further representation ofclaims against the Company in the case. The Company and Kenyon & Kenyon deny any improper conduct. The Court has not ruled on the motion, and itmatter, as well as for a royalty-free, irrevocable worldwide sublicense to technology patented under U.S. Patent No. 4,663,281. Repligen is not possible to predict what impact, if any, this collateral matter may have in the case. Upon a ruling by the Court, the case will proceed to trial on the meritsresponsible for providing MIT with its portion of the Company’ssettlement payment. Repligen also granted to the Company a royalty-free, irrevocable worldwide sublicense for the future use of other defenses. Thepatented technology, including U.S. Patent No. 5,665,578, which is owned by Abbott but to which Repligen has the power to sublicense under an agreement between Abbott and Repligen. U.S. Patent No. 5,665,578 is the patent upon which Abbott sued the Company having had the advice of itsfor patent counsel, believes that its defenses are sound, and it presently plans to vigorously defend against the claims asserted.infringement earlier this year.

On        As previously reported, on February 5, 2007, a complaint was filed against the Company by Abbott Laboratories (“Abbott”) in the U.S. District Court for the District of Massachusetts (07-cv-10216). This action alleges that the manufacture and sale of ERBITUX infringes U.S. Patent No. 5,665,578, which is owned by Abbott and that the Company should therefore pay damages. On April 24, 2007, the Company filed an answer, which it amended on May 17, 2007, to this complaint denying all claims. The court has ordered a



mediation hearing to occur on December 20, 2007. The Company, having had the advice of its patent counsel, believes that its defenses are sound, and it presently plans to vigorously defend against the claims asserted.

        In December 2002, Opposition Proceedings seeking to revoke EP (UK) 0 667 165 were brought by Scripps Research Institute, Amgen Inc., Abgenix, Inc., and YM Biosciences Inc. The Opposition Proceedings are suspended pending a final determination of the entitlement cases in Europe.

        On May 2, 2007, the Company filed an Opposition in the European Patent Office against EP 1,058,562 B1, which is unablea patent directed to, predictinter alia, the outcomeuse of this action ateither radiation or chemotherapy in concert with an EGFR antibody that inhibits receptor dimerization. The patent is assigned to the present time.University of Pennsylvania. Oppositions to that European Patent have also been filed by Amgen, Merck KGaA, Oncoscience, Genmab and Hoffmann La-Roche.

No reserve has been established in the financial statements for any of the items described above in this Part II. Item 1- “Legal Proceedings, 1—"Legal Proceedings—Intellectual Property Litigation”Litigation" because the Company does not believe that such a reserve is required to be established at this time under Statement of Financial Accounting Standards No. 5. However, if in a future period, events in any such legal proceedings render it probable that a loss will be incurred and if such loss is reasonably estimable, the Company will establish such a reserve. Thus, it is possible that legal proceedings and settlements arising therefrom, if any, may have a material adverse impact on operating results for that period, on our balance sheet or both.


Item 1A.    Risk Factors

There have been no material changes to the risk factors as set forth in the Company’sCompany's Annual Report filed on Form 10-K for the year ended December 31, 2006.


Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds

        On September 7, 2007, the Company sold 13,609 shares of treasury stock in a private placement exempt from registration in reliance on Section 4(2) under the Securities Act of 1933 to John H. Johnson, the Company's Chief Executive Officer, for an aggregate consideration of $500,000, or $36.74 per share, in order to enable Mr. Johnson to satisfy his obligation under his employment agreement to purchase $500,000 worth of Company common stock within three months of his commencement of employment.


Not applicable

Item 3.    Defaults upon Senior Securities

Not applicable


Item 4.    Submission of Matters to a Vote of Security Holders


(a)


The Company held its annual meeting of stockholders on August 2, 2007 (the "Annual Meeting").

(b)


No response is required to Paragraph (b) because (i) proxies for the meeting were solicited pursuant to Regulation 14A under the Securities Exchange Act of 1934, as amended; (ii) there was no solicitation in opposition to those nominees listed in the proxy statement; and (iii) all such nominees were elected.

(c)


Each of the matters voted upon at the Annual Meeting were approved by the margins set forth below.

    (i)
    Proposal to approve nominees for the Board of Directors:

Name

 In Favor
 Withheld
Andrew R.J. Bonfield 63,823,716 498,289
Alexander J. Denner 45,758,217 18,561,788
Thomas F. Deuel 63,923,195 396,810
Jules Haimovitz 63,916,490 403,515
Carl C. Icahn 63,198,467 1,121,538
Peter S. Liebert 63,905,436 411,569
Richard C. Mulligan 63,784,408 535,597
David Sidransky 63,903,605 416,400
Charles Woler 63,912,894 407,111
    (ii)
    Proposal to ratify the appointment of KPMG LLP to serve as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2007:

FOR63,461,501
AGAINST778,734
ABSTAIN79,770


Item 5.    Other Information

Not applicable

Item 5.       Other Information

On April 24, 2007, John A. Fazio resigned as a director of the Company, as disclosed in the Current Report on Form 8-K dated April 26, 2007, and as further described in the amended Annual Report filed on Form 10-K/A dated April 30, 2007. Mr. Fazio was the Chairman of the Company’s Audit Committee.

Item 6.    Exhibits

Exhibit No.


Description



10.41



Amendment No. 2 to the Development, Promotion, Distribution and Supply Agreement, dated as of July 27, 2007, among the Company, Bristol-Myers Squibb Company and E.R. Squibb & Sons, L.L.C.


10.42

31.1



Employment Agreement between the Company and John H. Johnson dated August 8, 2007

31.1



Certification of the Company’sCompany's Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002


31.2

31.2



Certification of the Company’sCompany's Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002


32

32



Certification of the Company’sCompany's Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002


31




SIGNATURES


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.

IMCLONE SYSTEMS INCORPORATED
(Registrant)


Date: November 9, 2007

By:



By:


/s/  ALEXANDER J. DENNER

Alexander J. Denner

JOHN H. JOHNSON      


John H. Johnson

Chief Executive Committee of the Board, Chairman

Officer
Principal Executive Officer


Date: May 8,November 9, 2007



By:

By:


/s/  ANA I. STANCIC

Ana I. Stancic

PETER R. BORZILLERI      


Peter R. Borzilleri
SeniorInterim Vice President, Finance


Principal Financial Officer

Date: May 8, 2007

32