EX-99.2 3 a06-3156_2ex99d2.htm EXHIBIT 99

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