-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NLWOY+BvSuiB7VWFlbvhgt9r8uSM5zWDKjjFjWT8DzZj6rL5zLAt/DIz4j/tAE+G 5Tpxb59grOiqmFwxzAF4VQ== 0001104659-06-047839.txt : 20060720 0001104659-06-047839.hdr.sgml : 20060720 20060720071554 ACCESSION NUMBER: 0001104659-06-047839 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060720 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060720 DATE AS OF CHANGE: 20060720 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMCLONE SYSTEMS INC CENTRAL INDEX KEY: 0000765258 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042834797 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19612 FILM NUMBER: 06970447 BUSINESS ADDRESS: STREET 1: 180 VARICK STREET - 6TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10014 BUSINESS PHONE: 646-638-5078 MAIL ADDRESS: STREET 1: 180 VARICK STREET - 6TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10014 FORMER COMPANY: FORMER CONFORMED NAME: IMCLONE SYSTEMS INC/DE DATE OF NAME CHANGE: 19940211 8-K 1 a06-16422_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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): July 20, 2006

IMCLONE SYSTEMS INCORPORATED
(Exact name of registrant as specified in its charter)

 

Delaware

 

0-19612

 

04-2834797

(State or other jurisdiction of

 

(Commission File Number)

 

(IRS Employer

Incorporation)

 

 

 

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 2.02 Other Events

ImClone Systems Incorporated announced today its financial results for the three and six month periods ended June 30, 2006. A copy of the press release is attached as Exhibit 99.1 to this report.

The press release is being furnished pursuant to Item 2.02, and the information contained therein shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities under that Section.  Furthermore, the information in Exhibit 99.1 shall not be deemed to be incorporated by reference into the filings of ImClone Systems Incorporated under the Securities Act of 1933.

ITEM 9.01.  Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release of ImClone Systems Incorporated dated July 20, 2006.

 

2




 

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: July 20, 2006

By:

/s/ Erik D. Ramanathan

 

 

 

 

Erik D. Ramanathan

 

 

Senior Vice President, Secretary and General Counsel

 

 

3




EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release of ImClone Systems Incorporated dated July 20, 2006.

 

4



EX-99.1 2 a06-16422_1ex99d1.htm EX-99

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 SECOND QUARTER AND FIRST HALF 2006 FINANCIAL RESULTS

ERBITUX U.S. In-Market Sales Reach $172.8 Million for the Quarter,
an Increase of 77% Over Second Quarter 2005

Company Reports Diluted Earnings Per Share of $.42

New York, NY — July 20, 2006 — ImClone Systems Incorporated (NASDAQ: IMCL) announced today its financial results for the quarter and six months ended June 30, 2006.

Total revenues for the second quarter of 2006 were $149.9 million as compared with $92.4 million for the second quarter of 2005, an increase of 62%.

·                  Royalty revenue of $74.6 million in the second quarter of 2006 compared with $41.8 million in the second quarter of 2005, an increase of 79%. Royalty revenue for the second quarter of 2006 includes 39% of Bristol-Myers Squibb’s in-market ERBITUX net sales of $172.8 million, compared with second quarter 2005 in-market net sales of $97.9 million, an increase of 77%, and first quarter 2006 net sales of $138.0 million, an increase of 25%. 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 $33.5 million in the second quarter of 2006 compared with $24.5 million in the second quarter of 2005;

·                  Manufacturing revenue of $28.4 million in the second quarter of 2006 compared with $7.9 million in the second quarter of 2005. The year-to-year increase principally reflects an increase in volume purchases by Bristol-Myers Squibb. 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; and

·                  Collaborative agreement revenue of $13.4 million in the second quarter of 2006 compared with $18.2 million in the second quarter of 2005. The year-to-year decrease principally reflects a reduction in clinical materials shipped to Merck KGaA versus the prior year.

Total operating expenses for the second quarter of 2006 were $110.8 million (or $108.6 million excluding the effects of stock options expenses as determined in accordance with FAS123R of

1




 

$2.2 million), compared with $71.3 million in the second quarter of 2005. Operating expenses included:

·                  Research and development expenses for the second quarter of 2006 were $27.6 million (or $27.1 million excluding FAS123R expense of $.5 million), compared with $24.4 million in the second quarter of 2005. The year-to-year increase reflects higher third-party expenses to manufacture clinical supplies of pipeline products, the commencement of depreciation associated with the Company’s BB50 manufacturing facility, and higher occupancy costs attributable to utility expenses;

·                  Clinical and regulatory expenses in the second quarter of 2006 were $14.9 million (or $14.6 million excluding FAS123R expense of $.3 million), compared with $8.4 million in the second quarter of 2005. The increase principally reflects higher clinical trial expenses associated with ERBITUX and the Company’s pipeline;

·                  Marketing, general and administrative expenses were $23.0 million in the second quarter of 2006 (or $21.6 million excluding FAS123R expense of $1.4 million), compared with $16.8 million in the second quarter of 2005, reflecting additional sales and marketing expenses associated with the launch of ERBITUX in head and neck cancer;

·                  Royalty expenses were $18.4 million in the second quarter of 2006 compared with $14.3 million in the second quarter of 2005 as the result of higher sales. Approximately $9.2 million of the 2006 expenses were reimbursed as a component of collaborative agreement revenue, resulting in net royalty expenses of $9.2 million for the second quarter of 2006 compared with $9.3 million in the second quarter of last year; and

·                  Cost of manufacturing revenue was $26.9 million in the second quarter of 2006 compared with $1.1 million in the second quarter of last year.  These costs represent fully absorbed manufacturing costs in 2006, as substantially all previously expensed material has been sold through to our partners.

Operating income in the second quarter of 2006 was $39.1 million compared with $21.1 million in the second quarter of last year.  Operating income for the second quarter as well as the first six months of 2006 was positive excluding the revenue from amortization of license fees and milestones.

Our estimate of the effective tax rate for the full year has been revised to 15%, resulting in an effective rate in the second quarter of 2006 of 21%. These estimated rates exclude the release of a portion of the Company’s tax valuation allowance in the first quarter of 2006.  This estimate for the quarter and full-year rates is higher than the Company’s previous estimate of 13%, reflecting higher projected income for the full-year 2006 than previously estimated, including the taxability of the up-front payment from Merck KGaA referenced in the Company’s announcement this morning. The effective tax rate in the second quarter of 2005 was less than 1%.

Net income for the second quarter of 2006 was $37.2 million compared with $26.0 million in the second quarter of last year. Diluted earnings per share were $.42 in the second quarter of 2006 compared with $.30 in the second quarter of 2005.

Total revenues and net income for the six months ended June 30, 2006 were $395.0 million and $266.8 million, respectively, compared with $178.2 million and $54.9 million in the first six months of last year. Diluted earnings per share were $2.93 for the first six months of 2006 compared with $.63 for the first six months of 2005.  The results for the first six months of 2006 include the receipt of the $250 million milestone from Bristol-Myers Squibb and the partial release of the tax valuation allowance mentioned above.

2




 

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 FAS123R and, for the six months year-to-date, exclude the effects of both FAS123R and the one-time tax benefit associated with the release of a portion of the Company’s deferred asset valuation allowance reported in the first quarter of 2006. For 2005, non-GAAP diluted earnings per share for the second quarter and first six months exclude expenses associated with the discontinuance of the Company’s small molecule research operation.

 

 

 

(Diluted per share amounts)
(Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,
2006

 

June 30,
2005

 

June 30,
2006

 

June 30,
2005

 

GAAP diluted earnings per share

 

$

.42

 

$

.30

 

$

2.93

 

$

.63

 

Release of valuation allowance

 

-

 

-

 

($1.08

)

-

 

Impact of FAS123R

 

$

.02

 

-

 

$

.04

 

-

 

Impact of discontinuance of small molecule research

 

-

 

$

.07

 

-

 

$

.07

 

Non-GAAP diluted earnings per share

 

$

.44

 

$

.37

 

$

1.89

 

$

.70

 

 

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 adjusted earnings may differ from other such measures.

Conference Call

ImClone Systems will host a conference call with the financial community to discuss second quarter 2006 financial results on Thursday, July 20, 2006 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 July 20, 2006.

Those parties interested in participating via telephone may join by dialing (877) 692-2591 domestically, or (973) 582-2845 for calls outside of Canada and the United States, and referencing conference identification number 7595422.  A telephone replay of the conference call will be available shortly after the call until July 27, 2006 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 7595422.

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

3




 

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)

4




 

IMCLONE SYSTEMS INCORPORATED

Consolidated Condensed Statements of Operations

(Unaudited)

(in thousands, except per share data)

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

74,614

 

$

41,791

 

$

134,884

 

$

78,163

 

License fees and milestone revenue

 

33,456

 

24,491

 

177,859

 

49,025

 

Manufacturing revenue

 

28,356

 

7,894

 

47,705

 

18,913

 

Collaborative agreement revenue

 

13,430

 

18,209

 

34,539

 

32,055

 

Total revenues

 

149,856

 

92,385

 

394,987

 

178,156

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

27,583

 

24,433

 

60,576

 

45,606

 

Clinical and regulatory

 

14,929

 

8,376

 

30,010

 

17,774

 

Marketing, general and administrative

 

22,963

 

16,833

 

40,964

 

34,456

 

Royalty expense

 

18,414

 

14,338

 

38,480

 

26,904

 

Cost of manufacturing revenue

 

26,877

 

1,106

 

42,279

 

1,849

 

Discontinuation of small molecule research program

 

 

6,200

 

 

6,200

 

Total operating expenses

 

110,766

 

71,286

 

212,309

 

132,789

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

39,090

 

21,099

 

182,678

 

45,367

 

 

 

 

 

 

 

 

 

 

 

Other income, net

 

(8,308

)

(5,106

)

(14,010

)

(10,038

)

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

47,398

 

26,205

 

196,688

 

55,405

 

Provision for income taxes

 

10,189

 

174

 

(70,112

)

554

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

37,209

 

$

26,031

 

$

266,800

 

$

54,851

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.44

 

$

0.31

 

$

3.18

 

$

0.66

 

Diluted

 

$

0.42

 

$

0.30

 

$

2.93

 

$

0.63

 

Shares used in calculation of income per share:

 

 

 

 

 

 

 

 

 

Basic

 

84,072

 

83,616

 

83,849

 

83,448

 

Diluted

 

92,184

 

92,074

 

92,001

 

92,362

 

 

5




 

IMCLONE SYSTEMS INCORPORATED

Consolidated Condensed Balance Sheets

(Unaudited)

(in thousands)

 

 

June 30,

 

December 31,

 

Assets

 

2006

 

2005

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

26,095

 

$

3,403

 

Securities available for sale

 

937,684

 

752,973

 

Inventories

 

77,220

 

81,394

 

Other current assets

 

131,033

 

71,348

 

Total current assets

 

1,172,032

 

909,118

 

 

 

 

 

 

 

Property, plant and equipment, net

 

424,533

 

406,595

 

Other assets

 

131,308

 

27,702

 

Total assets

 

$

1,727,873

 

$

1,343,415

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

256,175

 

$

242,119

 

Deferred revenue, long term

 

285,285

 

246,401

 

Long-term obligations

 

603,699

 

602,491

 

Total liabilities

 

1,145,159

 

1,091,011

 

 

 

 

 

 

 

Stockholders’ equity

 

582,714

 

252,404

 

Total liabilities and stockholders’ equity

 

$

1,727,873

 

$

1,343,415

 

 

 

6



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