EX-99.1 2 a07-2655_1ex99d1.htm EX-99.1

 

Exhibit 99.1

ImClone Systems Incorporated

 

Investors:

Media:

Andrea F. Rabney

David M. F. Pitts

(646) 638-5058

(646) 638-5058

 

IMCLONE SYSTEMS REPORTS FOURTH QUARTER AND FULL YEAR 2006
FINANCIAL RESULTS

ERBITUX U.S. In-Market Sales of $167.2 Million for the Quarter and $652.2 Million for the Full Year

ERBITUX Global Sales for the Full Year 2006 Reach $1.1 Billion

Diluted Earnings per Share for the Quarter of $0.53 and $4.11 for the Full Year

New York, NY — January 25, 2007 — ImClone Systems Incorporated (NASDAQ: IMCL) announced today its financial results for the quarter and full year ended December 31, 2006.

Total revenues for the fourth quarter of 2006 were $132.2 million as compared with $99.0 million for the fourth quarter of 2005, an increase of 34%.  Global sales for the full year 2006 reached $1.1 billion.

·                  Royalty revenue of $77.1 million in the fourth quarter of 2006 compared with $52.6 million in the fourth quarter of 2005, an increase of 47%. Royalty revenue for the fourth quarter of 2006 includes 39% of Bristol-Myers Squibb’s in-market ERBITUX net sales of $167.2 million, compared with fourth quarter 2005 in-market net sales of $121.2 million, an increase of 38%;

·                  License fees and milestone revenue of $19.5 million in the fourth quarter of 2006 compared with $21.1 million in the fourth quarter of 2005;

·                  Manufacturing revenue of $17.9 million in the fourth quarter of 2006 compared with $14.4 million in the fourth quarter of 2005. The increase of $3.5 million reflects an increase in volume purchases by Bristol-Myers Squibb; and

·                  Collaborative agreement revenue of $17.7 million in the fourth quarter of 2006 compared with $10.9 million in the fourth quarter of 2005. The increase of $6.8 million principally reflects a higher level of clinical materials shipped to Merck KGaA versus the comparable quarter in 2005.

Total operating expenses for the fourth quarter of 2006 were $83.1 million, compared with $103.8 million in the fourth quarter of 2005. Operating expenses included:

·                  Research and development expenses for the fourth quarter of 2006 were $25.1 million, including stock option expense of $0.4 million, compared with $24.7 million in the fourth quarter of 2005;




·                  Clinical and regulatory expenses in the fourth quarter of 2006 were $10.7 million, including stock option expense of $0.3 million, compared with $18.8 million in the fourth quarter of 2005.  The decrease is principally attributed to decreased expenses associated with Erbitux clinical trials;

·                  Marketing, general and administrative expenses were $15.5 million in the fourth quarter of 2006, including stock option expense of $1.5 million, compared with $18.4 million in the fourth quarter of 2005. The decrease in the fourth quarter of 2006 is principally due to a decrease in legal expenses and the fact that the fourth quarter of 2005 results included approximately $2.9 million of severance expense related to our former Chief Executive Officer;

·                  Royalty expenses were $17.4 million in the fourth quarter of 2006 compared with $16.3 million in the fourth quarter of 2005 as the result of higher sales;

·                  Cost of manufacturing revenue was $14.6 million in the fourth quarter of 2006 compared with $11.4 million in the fourth quarter of 2005.  The 2006 costs represent fully absorbed manufacturing costs, as substantially all previously expensed material was sold through to our partners in 2005; and

·                  Withholding tax recovery of $264,000 in the fourth quarter of 2006 represents excess withholding tax liability accrued in 2005 in connection with the withholding tax settlement for which the Company recorded $14.2 million in the fourth quarter of 2005.

Operating income in the fourth quarter of 2006 was $49.0 million compared with an operating loss of $4.8 million in the fourth quarter of last year.

The effective tax rates for the fourth quarter and full year 2006, excluding the discrete portion of our valuation allowance release were approximately 42% and 19%, respectively.  The fourth quarter rate includes an adjustment to the portion of our valuation allowance release that is reflected in our operating rate, thereby increasing our effective rate for the quarter by approximately 23%.

Net income for the fourth quarter of 2006 was $46.6 million compared with $694,000 in the fourth quarter of last year. Diluted earnings per share were $0.53 in the fourth quarter of 2006 compared with $0.01 in the fourth quarter of 2005.

Total revenues and net income for the full year ended December 31, 2006 were $677.8 million and $370.7 million, respectively, compared with $383.7 million and $86.5 million for the full year in 2005. Diluted earnings per share were $4.11 for the full year of 2006 compared with $1.01 in 2005. The results for the full year of 2006 include the effect of the receipt of the $250.0 million milestone from Bristol-Myers Squibb and the partial release of the tax valuation allowance mentioned above.

Erbitux and Pipeline Clinical Development Update

Building on the results from clinical trials that were released in the fourth quarter of 2006 and earlier this month, ImClone Systems anticipates that several pivotal, Phase III studies of ERBITUX combined with standards of care in multiple tumor types will reach or near maturation in the balance of 2007. These include:

·                  A Southwest Oncology Group study evaluating the addition of ERBITUX to gemcitabine in the first-line treatment of patients with metastatic pancreatic cancer;

·                  The CAIRO II study, which is evaluating the combination of Erbitux, XELOX and Avastin in the first-line treatment of patients with metastatic colorectal cancer;




·                  Two studies assessing the combination of ERBITUX with different chemotherapy regimens as first-line treatment of patients with metastatic non-small-cell lung cancer; and

·                  The EXTREME study, which is evaluating the addition of ERBITUX to chemotherapy in the first-line treatment of patients with metastatic head and neck cancer.

Also in 2007, ImClone Systems’ clinical pipeline, which currently consists of five fully-human IgG1 antibodies, will enter further clinical evaluation.  Broadly, ImClone Systems’ plans in 2007 with respect to these antibodies consist of the following:

·                  In the first half of 2007, the Company expects to complete Phase I studies of its fully-human IgG1 antibodies targeting vascular endothelial growth factor receptor-2 (or VEGFR-2) and insulin-like growth factor-1 receptor (or IGF-1R), known as IMC-1121B and IMC-A12, respectively.  Following this, the Company plans to move into a number of randomized clinical trials, which will include registrational studies.

·                  In 2007, the Company’s IgG1 fully-human antibody against the epidermal growth factor receptor (EGFR), known as IMC-11F8, which has successfully completed Phase I evaluations, will begin clinical development directed at global registration.

·                  The Company’s two earliest stage antibodies, which target vascular endothelial growth factor receptor-1 (IMC-18F1) and platelet-derived growth factor alpha (IMC-3G3), will progress through phase 1 in 2007.

The Company’s development plans will focus not only on the therapeutic value of its individual antibodies, but on their potential value in combination with one another.

GAAP to Non-GAAP Reconciliation

To provide investors with a clearer picture of the Company’s growth versus last year, a reconciliation of non-GAAP diluted earnings per share to diluted earnings per share prepared in accordance with GAAP is set forth below. For 2006, non-GAAP diluted earnings per share for the quarter exclude the effects of stock option expense and, for the full year, exclude the effects of stock option expense and the tax benefit associated with the release of a portion of the Company’s deferred asset valuation allowance in the first quarter of 2006. For 2005, non-GAAP diluted earnings per share for the full year exclude expenses associated with the discontinuance of the Company’s small molecule research operation.

 

 

(Diluted per share amounts)
(Unaudited)

 

 

 

Three Months Ended

 

Year Ended

 

 

 

December 31, 2006

 

December 31, 2005

 

December 31, 2006

 

December 31, 2005

 

GAAP diluted earnings per share

 

$

0.53

 

$

0.01

 

$

4.11

 

$

1.01

 

Release of deferred tax valuation allowance

 

$

(0.14

)

 

$

(1.21

)

 

Stock option expense

 

$

0.01

 

 

$

0.07

 

 

Impact of discontinuance of small molecule research

 

 

 

 

$

0.07

 

Non-GAAP diluted earnings per share

 

$

0.40

 

$

0.01

 

$

2.97

 

$

1.08

 

 

The Company believes that it is useful to present non-GAAP diluted earnings per share financial measures because it provides investors with a more complete understanding of the Company’s




underlying operational results and trends.  You should not consider non-GAAP diluted earnings per share financial measures in isolation or as a substitute for such measures determined in accordance with U.S. GAAP, as set forth above.  Our definition of non-GAAP earnings may differ from other such measures.

Conference Call

ImClone Systems will host a conference call with the financial community to discuss fourth quarter and full year 2006 financial results on Thursday, January 25, 2007 at 11:00 AM Eastern Daylight 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 25, 2007.

Those parties interested in participating via telephone may join by dialing (888) 693-3477 domestically, or (973) 582-2710 for calls outside of Canada and the United States, and referencing conference identification number 8326050.  A telephone replay of the conference call will be available shortly after the call until February 1, 2007 at midnight Eastern Daylight 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 the conference identification number 8326050.

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.

(see attached tables)

 




IMCLONE SYSTEMS INCORPORATED
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)

 

 

Three Months Ended

 

Year Ended

 

 

 

December 31,

 

December 31,

 

 

 

2006

 

2005

 

2006

 

2005

 

Revenues:

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

77,116

 

$

52,630

 

$

290,599

 

$

177,440

 

License fees and milestone revenue

 

19,462

 

21,068

 

232,269

 

97,239

 

Manufacturing revenue

 

17,887

 

14,429

 

86,476

 

44,090

 

Collaborative agreement revenue

 

17,698

 

10,865

 

68,503

 

64,904

 

Total revenues

 

132,163

 

98,992

 

677,847

 

383,673

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

25,132

 

24,739

 

112,145

 

99,303

 

Clinical and regulatory

 

10,707

 

18,779

 

54,244

 

50,136

 

Marketing, general and administrative

 

15,535

 

18,415

 

72,476

 

72,334

 

Royalty expense

 

17,427

 

16,307

 

73,958

 

58,376

 

Cost of manufacturing revenue

 

14,597

 

11,419

 

76,063

 

16,367

 

Discontinuation of small molecule research program

 

 

 

 

6,200

 

Withholding tax (recovery) expense

 

(264

)

14,178

 

(264

)

14,178

 

Total operating expenses

 

83,134

 

103,837

 

388,622

 

316,894

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

49,029

 

(4,845

)

289,225

 

66,779

 

 

 

 

 

 

 

 

 

 

 

Other income, net

 

(9,001

)

(5,809

)

(31,095

)

(21,295

)

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

58,030

 

964

 

320,320

 

88,074

 

Provision (benefit) for income taxes

 

11,472

 

270

 

(50,354

)

1,578

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

46,558

 

$

694

 

$

370,674

 

$

86,496

 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.55

 

$

0.01

 

$

4.40

 

$

1.03

 

Diluted

 

$

0.53

 

$

0.01

 

$

4.11

 

$

1.01

 

Shares used in calculation of income per share:

 

 

 

 

 

 

 

 

 

Basic

 

84,894

 

83,642

 

84,235

 

83,582

 

Diluted

 

92,119

 

85,531

(1)

92,012

 

92,183

 


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




IMCLONE SYSTEMS INCORPORATED
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)

 

 

December 31,

 

December 31,

 

 

 

2006

 

2005

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

20,568

 

$

3,403

 

Securities available for sale

 

1,023,609

 

752,973

 

Inventories

 

102,215

 

81,394

 

Other current assets

 

152,925

 

71,348

 

Total current assets

 

1,299,317

 

909,118

 

 

 

 

 

 

 

Property, plant and equipment, net

 

423,000

 

406,595

 

Other assets

 

117,519

 

27,702

 

Total assets

 

$

1,839,836

 

$

1,343,415

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

238,545

 

$

242,119

 

Deferred revenue, long term

 

237,864

 

246,401

 

Long-term obligations

 

603,778

 

602,491

 

Total liabilities

 

1,080,187

 

1,091,011

 

 

 

 

 

 

 

Stockholders’ equity

 

759,649

 

252,404

 

Total liabilities and stockholders’ equity

 

$

1,839,836

 

$

1,343,415