8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 24, 2006

IMCLONE SYSTEMS INCORPORATED

(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
Incorporation) 0-19612
(Commission File Number) 04-2834797
(IRS Employer Identification No.)

180 Varick Street

New York, New York 10014

(Address of principal executive offices) (Zip Code)

(212) 645-1405

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers

ImClone Systems Incorporated (the “Company”) announced today that Joseph L. Fischer, age 55, a member of the Company’s Board of Directors since 2003 as well as a member of its Audit and Compensation Committees, has been named Interim Chief Executive Officer, replacing Philip Frost, M.D., Ph.D.  Mr. Fischer brings over 20 years of global managerial and operational experience to the Company.  As a result of being named Interim Chief Executive Officer, Mr. Fischer will no longer serve on the Audit and Compensation Committees of the Board of Directors.  Dr. Frost will remain as Executive Vice President and Chief Scientific Officer of the Company, a position he has held since March 1, 2005.

Mr. Fischer will receive $40,000 per month in base salary while he serves as Interim Chief Executive Officer, which amount shall be pro-rated to reflect service commencing on January 24, 2006.  While he serves as Interim Chief Executive Officer, Mr. Fischer will no longer be entitled to receive the annual $40,000 fee payable to non-employee directors of the Company, although Mr. Fischer will be entitled to receive a pro-rated portion of such fee reflecting service as a director through January 23, 2006. In addition, during such time Mr. Fischer will no longer receive fees for attending meetings of the Board of Directors or its committees.  With respect to 2006 service on the Board of Directors, Mr. Fischer was granted 20,000 options to purchase shares of Company common stock on January 18, 2006.  Compensation guidelines for Company directors are set forth in greater detail in the Company’s 2005 proxy statement filed with the SEC on April 22, 2005, as supplemented by the Company’s Current Report on Form 8-K dated September 16, 2005.

The text of the related press release, which is attached as Exhibit 99.1, is incorporated by reference herein in its entirety.

Item 8.01 Other Events

The Company also announced today that the Board of Directors has engaged Lazard to conduct, in conjunction with management, a full review of the Company’s strategic alternatives to maximize shareholder value. These alternatives could include a merger, sale or strategic alliance.  The Company is proceeding in consultation with its existing partners as the process moves forward.  There can be no assurances, however, that any particular strategic alternative will be pursued or that any transaction will occur, or on what terms.  The Company does not plan to release additional information about the status of the review of alternatives until a definitive agreement is entered into or the process is otherwise completed.  The text of the related press release, which is attached as Exhibit 99.1, is incorporated by reference herein in its entirety.

In addition, the Company announced preliminary fourth quarter and full year 2005 financial results today.  The text of the related press release, which is attached as Exhibit 99.2, is incorporated by reference herein in its entirety.

2

ITEM 9.01.  Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release of ImClone Systems Incorporated dated January 24, 2006.
99.2	Press Release of ImClone Systems Incorporated dated January 24, 2006.

3

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 hereunto duly authorized.

	IMCLONE SYSTEMS INCORPORATED (Registrant)
Dated: January 24, 2006	By:	/s/   Erik D. Ramanathan
		Erik D. Ramanathan
		Vice President, General Counsel

4

EX-99.1

Exhibit 99.1

ImClone Systems
Incorporated
	180 Varick Street
	New York, NY 10014
	Tel: (212) 645-1405
	Fax: (212) 645-2054
	www.imclone.com

ImClone Systems Incorporated
Investors:	Media:
Andrea F. Rabney	David M. F. Pitts
(646) 638-5058	(646) 638-5058
Stefania Bethlen
(646) 638-5058

IMCLONE SYSTEMS ENGAGES LAZARD TO REVIEW
STRATEGIC ALTERNATIVES FOR THE COMPANY

ImClone Systems Announces Joseph L. Fischer, Director, Named Interim
Chief Executive Officer

New York, NY – January 24, 2006 – ImClone Systems Incorporated (NASDAQ: IMCL) announced today that the Board of Directors has engaged Lazard to conduct, in conjunction with management, a full review of the Company’s strategic alternatives to maximize shareholder value. These alternatives could include a merger, sale or strategic alliance.  The Company is proceeding in consultation with its existing partners as the process moves forward.

The Company also announced today that Joseph L. Fischer, a member of ImClone Systems’ Board of Directors since 2003 as well as a member of its Audit and Compensation Committees, has been named Interim Chief Executive Officer, replacing Philip Frost, M.D., Ph.D.  Mr. Fischer brings over 20 years of global managerial and operational experience to the Company.  As a result of being named Interim Chief Executive Officer, Mr. Fischer will no longer serve on the Audit and Compensation Committees of the Board of Directors.  Dr. Frost will remain as Executive Vice President and Chief Scientific Officer.

“Following a review of the Company’s business, products, assets and current strategic position, the Board of Directors has determined that it is now appropriate to initiate an external process to explore ways of enhancing shareholder value,” stated Mr. Fischer.  “During this process, the Company will continue to move forward in the ordinary course, with the goal of maximizing the potential of Erbitux and developing novel oncology therapeutics to benefit patients with cancer.”

“We thank Phil for his efforts as Interim Chief Executive Officer,” said David M. Kies, Chairman of ImClone Systems’ Board of Directors.  “In light of the significant strategic review being embarked upon, the Board of Directors decided it was important to have an executive with Joe’s financial and managerial background leading the company.”

Mr. Fischer served in a variety of senior management positions at international companies, including Dial Corporation and Johnson and Johnson (J&J). Mr. Fischer served as a Senior Vice President of Dial Corporation and in a variety of senior management positions at J&J, most notably as Group President of Global Personal Care Products, President of J&J Canada and Corporate Controller.

With respect to the review of strategic alternatives, there can be no assurances that any particular alternative will be pursued or that any transaction will occur, or on what terms.  The Company does not plan to release additional information about the status of the review of alternatives until a definitive agreement is entered into or the process is otherwise completed.

About ImClone Systems Incorporated

ImClone Systems Incorporated is committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers.  The Company’s research and development programs include growth factor blockers and angiogenesis inhibitors.   ImClone Systems’ strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market.  ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws.  Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved.  Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected.  Many of these factors are beyond the company’s ability to control or predict.  Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company’s filings with the Securities and Exchange Commission including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K.  For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

#  #  #

EX-99.2

Exhibit 99.2

ImClone Systems
Incorporated
	180 Varick Street
	New York, NY 10014
	Tel: (212) 645-1405
	Fax: (212) 645-2054
	www.imclone.com

ImClone Systems Incorporated
Investors:	Media:
Andrea F. Rabney	David M. F. Pitts
(646) 638-5058	(646) 638-5058
Stefania Bethlen
(646) 638-5058

IMCLONE SYSTEMS REPORTS FOURTH QUARTER AND FULL YEAR 2005
FINANCIAL RESULTS

Erbitux® U.S. In-Market Sales Reach $121.2 Million for the Quarter and
$413.1 Million for the Full Year

Diluted Earnings Per Share of $.15 in the Fourth Quarter and $1.14 for the Full Year

New York, NY – January 24, 2006 – ImClone Systems Incorporated (NASDAQ: IMCL) announced today its financial results for the fourth quarter and full year ended December 31, 2005.

Total revenues for the fourth quarter of 2005 were $98.2 million as compared with $107.3 million for the fourth quarter of 2004. Revenues include four principal components:

•Royalty revenue of $52.6 million in the fourth quarter of 2005 compared with $36.5 million in the fourth quarter of 2004. Royalty revenue for the fourth quarter of 2005 includes $47.3 million representing 39% of Bristol-Myers Squibb’s in-market Erbitux net sales of $121.2 million, compared with third quarter 2005 in-market net sales of $107.0 million, an increase of 13%, and fourth quarter 2004 net sales of $87.8 million, an increase of 38%. These in-market sales, reflecting a drop-ship distribution methodology, represent Erbitux shipments to end-user accounts only, with no wholesaler stocking;

•License fees and milestone revenue of $20.3 million in the fourth quarter of 2005 compared with $20.8 million in the fourth quarter of 2004;

•Manufacturing revenue of $14.4 million in the fourth quarter of 2005 compared with $28.8 million in the fourth quarter of 2004. The decrease principally reflects a 72% increase in volume purchases by Bristol-Myers Squibb in the fourth quarter of this year that was more than fully offset by a significantly lower selling price to Bristol-Myers Squibb in 2005 as compared with 2004. Purchases by Bristol-Myers Squibb are timed at their discretion to accommodate forecasts and safety stock needs, and are not necessarily indicative of historical in-market sales or future sales expectations. No commercial product was sold to Merck KGaA during the fourth quarter of 2005; and

•Collaborative agreement revenue of $10.9 million in the fourth quarter of 2005 compared with $21.2 million in the fourth quarter of 2004. The year-to-year decline principally

reflects the fact that 2004 includes reimbursement for shipments of clinical materials to Merck KGaA of approximately $9.2 million; no such shipments were included in the fourth quarter of 2005.

Total operating expenses for the fourth quarter of 2005 were $90.9 million, compared with $127.8 million in the fourth quarter of 2004. Operating expenses in the fourth quarter of 2004 included a one-time charge of $55.4 million related to the settlement, net of insurance reimbursement, of shareholder and derivative suits from 2002. Operating expenses included:

•Research and development expenses for each of the fourth quarters of 2005 and 2004 were $26.0 million;

•Clinical and regulatory expenses in the fourth quarter of 2005 were $18.8 million, compared with $9.4 million in the fourth quarter of 2004. The increase principally reflects higher clinical trial expenses associated with Erbitux and the Company’s pipeline;

•Marketing, general and administrative expenses were $18.4 million in the fourth quarter of 2005 compared with $19.8 million in the fourth quarter of 2004;

•Royalty expenses were $16.3 million in the fourth quarter of 2005 compared with $16.7 million in the fourth quarter of 2004. Royalty expenses decreased, despite the fact that sales were higher, principally because of lower contractual obligations to certain of our licensors. Approximately $5.9 million of these expenses were reimbursed as a component of collaborative agreement revenue, resulting in net royalty expenses of $10.4 million for the fourth quarter of 2005; and

•Cost of manufacturing revenue was $11.4 million in the fourth quarter of 2005 compared with $.5 million in 2004, primarily because the majority of materials shipped during the fourth quarter of 2005 reflect full absorption costing.

The effective tax rate for the full year of 2005 is 1% excluding the effect of an adjustment recorded in the third quarter of 2005 of approximately $440,000, resulting from the reconciliation of the prior year’s tax provision to the Company’s filed tax returns.  The resulting tax rates for the fourth quarter and full year of 2005, including such adjustment, are .2% and 1.3%, respectively.

Net income for the fourth quarter of 2005 was $13.1 million compared with a net loss of $13.2 million in the fourth quarter of 2004.  Diluted earnings per share in the fourth quarter of 2005 were $.15, compared with a net loss per share of $.16 in the fourth quarter of 2004.

Total revenues for the full year ended December 31, 2005 were $382.9 million compared with $388.7 million for the full year 2004. Revenues in 2004 included the “catch-up” effect of the receipt of a milestone from Bristol-Myers Squibb of approximately $42.5 million. Full-year 2005 in-market sales of Erbitux were $413.1 million in the U.S. compared to $260.8 million for 2004, an increase of 58%.  Operating expenses for the full year ended December 31, 2005 were $303.9 million compared with $263.4 million for 2004. Net income for the full year 2005 was $98.9 million with diluted income per share of $1.14 compared with net income in 2004 of $113.7 million, with net income per common diluted share of $1.33.

Conference Call

ImClone Systems will host a conference call with the financial community to discuss 2005 fourth quarter and full year financial results, today, January 24, 2006 at 11:00 AM Eastern Time.

The conference call will be webcast live and may be accessed by visiting ImClone Systems’ website at www.imclone.com. A replay of the audio webcast will be available under “Earnings

Webcast” in the “Investor Relations” section of the Company’s website starting shortly after the call on January 24, 2006.

Those parties interested in participating via telephone may join by dialing (888) 694-4641, or (973) 935-8512 for calls outside of Canada and the United States. A telephone replay of the conference call will be available shortly after the call until February 1, 2006 at midnight Eastern Time. To access the telephone replay, dial (877) 519-4471 domestically, or (973) 341-3080 for calls outside of Canada and the United States, and enter passcode number 4697335.

About ImClone Systems Incorporated

ImClone Systems Incorporated is committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company’s three programs include growth factor blockers, angiogenesis inhibitors and cancer vaccines. ImClone Systems’ strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company’s ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company’s filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise.

(see attached tables)

IMCLONE SYSTEMS INCORPORATED

Consolidated Condensed Statements of Operations

(Unaudited)

(in thousands, except per share data)

	Three Months Ended December 31,						Year Ended December 31,
	2005			2004			2005			2004
Revenues:
Royalty revenue	$	52,630		$	36,532		$	177,440		$	106,274
License fees and milestone revenue	20,271			20,782			96,442			129,386
Manufacturing revenue	14,429			28,789			44,090			99,041
Collaborative agreement revenue	10,865			21,194			64,904			53,989
Total revenues	98,195			107,297			382,876			388,690
Operating expenses:
Research and development	25,954			25,976			100,518			82,658
Clinical and regulatory	18,779			9,395			50,136			30,254
Marketing, general and administrative	18,415			19,779			72,334			59,800
Royalty expense	16,307			16,725			58,376			36,065
Litigation settlement expense	—			55,363			—			55,363
Cost of manufacturing revenue	11,419			540			16,367			1,099
Discontinuation of small molecule research program	—			—			6,200			—
Other	—			—			—			(1,815		)
Total operating expenses	90,874			127,778			303,931			263,424
Operating income (loss)	7,321			(20,481		)	78,945			125,266
Other income, net	(5,809		)	(4,017		)	(21,295		)	(5,748		)
Income (loss) before income taxes	13,130			(16,464		)	100,240			131,014
Provision (benefit) for income taxes	27			(3,286		)	1,335			17,361
Net income (loss)	$	13,103		$	(13,178	)	$	98,905		$	113,653
Income (loss) per common share:
Basic	$	0.16		$	(0.16	)	$	1.18		$	1.43
Diluted	$	0.15		$	(0.16	)	$	1.14		$	1.33
Shares used in calculation of income (loss) per share:
Basic	83,642			82,789			83,582			79,500
Diluted	85,531		(1)	82,789		(2)	92,183			91,193

(1) The computation of diluted shares does not assume conversion of convertible securities because such effect would be antidilutive.

(2) The computation of diluted shares does not assume conversion of options or convertible securities because such effect would be antidilutive.

IMCLONE SYSTEMS INCORPORATED

Consolidated Condensed Balance Sheets

(Unaudited)

(in thousands)

	December 31,		December 31,
	2005		2004
Assets
Current assets:
Cash and cash equivalents	$	3,403	$	79,321
Securities available for sale	752,973		840,451
Inventories	81,394		40,618
Other current assets	70,407		102,047
Total current assets	908,177		1,062,437
Property, plant and equipment, net	406,595		339,293
Other assets	27,702		33,046
Total assets	$	1,342,474	$	1,434,776
Liabilities and Stockholders’ Equity
Current liabilities	$	228,215	$	303,690
Deferred revenue, long term	247,198		348,814
Long-term obligations	602,491		603,434
Total liabilities	1,077,904		1,255,938
Stockholders’ equity	264,570		178,838
Total liabilities and stockholders’ equity	$	1,342,474	$	1,434,776