EX-99.1 2 a05-2202_2ex99d1.htm 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 REPORTS FOURTH-QUARTER AND FULL-YEAR 2004

FINANCIAL RESULTS

 

Erbitux U.S. In-Market Sales Reach $87.8 Million for the Quarter and
$260.8 Million for the Full Year

 

One-Time Litigation Settlement Charge Results in $0.16 Per Share Loss in the Fourth Quarter; Pro-Forma Earnings Per Share of $0.48 Excluding Settlement Expenses

 

New York, NY – January 26, 2005 – ImClone Systems Incorporated (NASDAQ: IMCL) announced today its financial results for the fourth quarter and full year ended December 31, 2004.

 

Total revenues for the fourth quarter of 2004 were $107.3 million as compared with $19.8 million for the fourth quarter of 2003 and $94.8 million in the third quarter of 2004. Revenues include four principal components:

      License fees and milestone revenue of $20.8 million in the fourth quarter of 2004 compared with $12.0 million in the fourth quarter of 2003 and $23.0 million in the third quarter of 2004;

      Manufacturing revenue of $28.8 million in the fourth quarter of 2004 (no manufacturing revenue was recorded in 2003) compared with $30.0 million in the third quarter of 2004. The quarter-to-quarter decrease principally reflects lower volume purchases by Bristol-Myers Squibb in the fourth quarter. Purchases by BMS 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 2004;

      Royalty revenue of $36.5 million in the fourth quarter of 2004 (no royalty revenue was recorded in 2003) compared with $34.1 million in the third quarter of 2004. Royalty revenue for the fourth quarter of 2004 includes $34.2 million representing 39% of BMS’s in-market Erbitux net sales of $87.8 million, compared with third quarter in-market net sales of $84.1 million, an increase of 4%. These in-market sales, reflecting a drop-ship

 



 

distribution methodology, represent Erbitux shipments to end-user accounts only, with no wholesaler stocking; and

      Collaborative agreement revenue of $21.2 million in the fourth quarter of 2004 compared with $7.8 million in the fourth quarter of 2003 and $7.8 million in the third quarter of 2004. The quarter-to-quarter and year-to-year increases principally reflect higher purchases of clinical materials by Merck KGaA. Included in the fourth quarter 2004 amount are reimbursements for royalty expenses of approximately $4.4 million. In previous quarters of 2004, no reimbursement for royalty expenses was reflected for licenses which were then under negotiation; now that licenses have been executed, gross royalty expenses for all licenses are reflected in Royalty Expenses (described below), and appropriate reimbursements are reflected in collaborative agreement revenue.

 

Total operating expenses for the fourth quarter of 2004, including one-time charges of $55.4 million associated with the settlement of shareholder litigation, were $127.8 million, compared with $44.9 million in the fourth quarter of 2003 and $47.3 million in the third quarter of 2004. Operating expenses included:

      Research and development expenses for the fourth quarter of 2004 were $26.0 million compared with $27.5 million in the fourth quarter of 2003 and $17.6 million in the third quarter of 2004. The quarter-to-quarter increase in 2004 reflects the inclusion, in the fourth quarter, of costs to manufacture clinical materials that were sold to Merck KGaA during the quarter and reflected as a component of collaborative agreement revenue. Previously expensed materials (i.e., those manufactured prior to FDA approval of Erbitux on February 12, 2004) continue to be utilized for commercial use;

      Clinical and regulatory expenses in the fourth quarter of 2004 were $9.4 million, compared with $6.6 million in the fourth quarter of 2003 and $7.6 in the third quarter of 2004;

      Marketing, general and administrative expenses were $19.8 million in the fourth quarter of 2004 compared with $11.1 million in the fourth quarter of 2003 and $14.8 million in the third quarter of 2004. The quarter-to-quarter increase in 2004 is principally attributable to higher legal and audit fees, as well as incremental marketing programs in the fourth quarter.

      Royalty Expenses were $16.7 million in the fourth quarter of 2004 (no such expenses were incurred in 2003) compared with $7.0 million in the third quarter of 2004. Approximately $4.4 million of these expenses were reimbursed as a component of Collaborative Agreement Revenue, resulting in net royalty expenses of $12.3 million for the fourth quarter of 2004. These expenses reflect actual obligations relating to certain Erbitux license agreements with respect to intellectual property, and no longer include estimated amounts as had been the case through the first nine months of 2004. Fourth-quarter expenses include adjustments of approximately $4.0 million required to bring estimated royalty expenses through the first nine months of the year in line with actual obligations. In addition, royalty expenses now include the gross royalty obligations under all licenses; previously, only the net obligations relating to those licenses which had been under negotiation were included.

      Litigation Settlement expenses include one-time charges of $55.4 million related to the settlement, net of insurance reimbursement, of shareholder and derivative suits from 2002. These expenses are not deductible for tax purposes in 2004, but will be deductible in the period in which actually paid, presumably during 2005.

 



 

The tax provision for the full year 2004, which excludes any deductions associated with litigation settlement expenses, results in a full-year effective tax rate of 13.25% and a tax benefit for the fourth quarter of 2004.

 

The net loss for the fourth quarter of 2004 was $13.2 million with a net loss per basic and diluted common share of $0.16 compared with a net loss of $26.3 million in the fourth quarter of 2003 with a loss per basic and diluted common share of $0.35. Excluding the settlement of shareholder litigation, income per diluted share would have been $0.48 in the fourth quarter of 2004.

 

Total revenues for the full year ended December 31, 2004 were $388.7 million compared with $80.8 million for the full year 2003. Full-year in-market sales of Erbitux were $260.8 million in the U.S. Operating expenses for the full year ended December 31, 2004 were $263.4 million compared with $189.7 million for 2003. Net income for the full year 2004 was $113.7 million with basic income per share of $1.43 and diluted income per share of $1.33 compared with a net loss in 2003 of $112.5 million, with a net loss per basic and diluted common share of $1.52. Excluding the settlement of shareholder litigation described previously, income per diluted share would have been $1.94 for the full year 2004.

 

“ImClone Systems has experienced dramatic and immediate transition, growth and profitability in 2004 with the approval of Erbitux®,” stated Daniel S. Lynch, Chief Executive Officer of ImClone Systems. “As we move into 2005, we look forward to the continued evolution of our business model and the implementation of a disciplined, focused investment program for the growth of our business.”

 

Conference Call

ImClone Systems will host a conference call with the financial community to discuss 2004 fourth quarter financial results, today, January 26, 2005 at 11:00 AM Eastern Time. The Company intends to provide supporting details underlying actual in-market sales and will provide summary guidance regarding certain key trends and assumptions related to its income statement for the full year 2005.

 

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 26, 2005.

 

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 2, 2005 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

(in thousands, except per share data)

 

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

 

 

2004

 

2003

 

2004

 

2003

 

Revenues:

 

 

 

 

 

 

 

 

 

License fees and milestone revenue

 

$

20,782

 

$

11,983

 

$

129,386

 

$

47,970

 

Manufacturing revenue

 

28,789

 

 

99,041

 

 

Royalty revenue

 

36,532

 

58

 

106,274

 

575

 

Collaborative agreement revenue

 

21,194

 

7,760

 

53,989

 

32,285

 

Total revenues

 

107,297

 

19,801

 

388,690

 

80,830

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

25,976

 

27,491

 

82,658

 

121,111

 

Clinical and regulatory

 

9,395

 

6,562

 

30,254

 

30,154

 

Marketing, general and administrative

 

19,779

 

11,095

 

59,800

 

41,947

 

Litigation settlement expense

 

55,363

 

 

55,363

 

 

Royalty expense

 

16,725

 

 

36,065

 

 

Cost of manufacturing revenue

 

540

 

 

1,099

 

 

Other

 

 

(212

)

(1,815

)

(3,531

)

Total operating expenses

 

127,778

 

44,936

 

263,424

 

189,681

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

(20,481

)

(25,135

)

125,266

 

(108,851

)

 

 

 

 

 

 

 

 

 

 

Other (income) expense, net

 

(4,017

)

1,054

 

(5,748

)

3,160

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

(16,464

)

(26,189

)

131,014

 

(112,011

)

(Benefit) provision for income taxes

 

(3,286

)

154

 

17,361

 

491

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(13,178

)

$

(26,343

)

$

113,653

 

$

(112,502

)

 

 

 

 

 

 

 

 

 

 

Income (loss) per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.16

)

$

(0.35

)

$

1.43

 

$

(1.52

)

Diluted

 

$

(0.16

)

$

(0.35

)

$

1.32

 

$

(1.52

)

Shares used in calculation of income (loss) per share:

 

 

 

 

 

 

 

 

 

Basic

 

82,789

 

74,964

 

79,500

 

74,250

 

Diluted

 

82,789

(2)

74,964

(2)

91,194

(1)

74,250

 

 


(1) Diluted shares include the weighted average number of shares underlying the $600 million convertible notes outstanding.

(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

(in thousands)

 

 

 

December 31,
2004

 

December 31,
2003

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

257,811

 

$

56,850

 

Securities available for sale

 

661,961

 

49,498

 

Inventories, net

 

40,618

 

0

 

Other current assets

 

103,388

 

16,222

 

Total current assets

 

1,063,778

 

122,570

 

 

 

 

 

 

 

Property, plant and equipment, net

 

339,293

 

245,901

 

Other assets

 

31,705

 

13,124

 

Total assets

 

$

1,434,776

 

$

381,595

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity (Deficit)

 

 

 

 

 

Current liabilities

 

$

305,450

 

$

125,785

 

Deferred revenue, long term

 

348,814

 

286,362

 

Long-term obligations

 

600,000

 

240,041

 

Total liabilities

 

1,254,264

 

652,188

 

 

 

 

 

 

 

Stockholders’ equity (deficit)

 

180,512

 

(270,593

)

Total liabilities and stockholders’ equity

 

$

1,434,776

 

$

381,595