-----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, OL42IKKieNDCpzILq9eYSOhJ6afqpVcN/020tQzAwsE9o4Xr0FyAM4yr40f8vcEu oPE42Z3Dq6abHRfkIaaPyw== 0001104659-06-027142.txt : 20060425 0001104659-06-027142.hdr.sgml : 20060425 20060425093748 ACCESSION NUMBER: 0001104659-06-027142 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060425 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060425 DATE AS OF CHANGE: 20060425 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: 06776740 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 a06-6845_58k.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): April 25, 2006

 

IMCLONE SYSTEMS INCORPORATED

(Exact name of registrant as specified in its charter)

 

Delaware

 

0-19612

 

04-2834797

(State or other jurisdiction of
Incorporation)

 

(Commission File Number)

 

(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 8.01. Other Events

 

ImClone Systems Incorporated announced today its financial results for the three month period ended March 31, 2006. The text of the press release, which is attached as Exhibit 99.1, is incorporated by reference herein in its entirety.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release of ImClone Systems Incorporated dated April 25, 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)

 

 

 

 

 

By:

/s/  Erik D. Ramanathan

 

 

Erik D. Ramanathan

Dated: April 25, 2006

 

Vice President, General Counsel

 

 

 

 

 

 

 

3


EX-99.1 2 a06-6845_5ex99d1.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 FIRST QUARTER 2006 FINANCIAL RESULTS

 

ERBITUX U.S. In-Market Sales Reach $138.0 Million for the Quarter

 

Diluted Earnings Per Share of $2.51

 

Release of Tax Valuation Allowance Results in Positive
Diluted Earnings Per Share Impact of $1.08

 

New York, NY – April 25, 2006 – ImClone Systems Incorporated (NASDAQ: IMCL) announced today its financial results for the quarter ended March 31, 2006.

 

Total revenues for the first quarter of 2006 were $245.1 million as compared with $85.8 million for the first quarter of 2005. First quarter revenues this year included a “catch-up” amortization effect of approximately $112.7 million associated with the $250 million milestone payment received on March 31, 2006 from our partner, Bristol-Myers Squibb. Revenues include four principal components:

                  Royalty revenue of $60.3 million in the first quarter of 2006 compared with $36.4 million in the first quarter of 2005, an increase of 66%. Royalty revenue for the first quarter of 2006 includes $53.8 million, representing 39% of Bristol-Myers Squibb’s in-market ERBITUX net sales of $138.0 million, compared with first quarter 2005 in-market net sales of $87.1 million, an increase of 58%, and fourth quarter 2005 in-market sales of $121.2 million, an increase of 14%. 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 $144.4 million in the first quarter of 2006 compared with $24.5 million in the first quarter of 2005. The increase is principally attributable to the above-mentioned “catch-up” amortization effect;

                  Manufacturing revenue of $19.3 million in the first quarter of 2006 compared with $11.0 million in the first quarter of 2005. The year-to-year increase reflects a 33% 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. Manufacturing revenue

 



 

for the first quarter of 2006 also includes, for the first time, $2.7 million of commercial product sold to our partner, Merck KGaA; and

                  Collaborative agreement revenue of $21.1 million in the first quarter of 2006 compared with $13.8 million in the first quarter of 2005. The year-to-year increase reflects reimbursement for higher purchases of clinical materials by Bristol-Myers Squibb and Merck KGaA and higher reimbursements for royalty payments.

 

Total operating expenses for the first quarter of 2006 were $101.5 million (including $1.9 million of stock option expenses as determined in accordance with FAS 123R), compared with $61.5 million in the first quarter of 2005. Operating expenses included:

                  Research and development expenses for the first quarter of 2006 were $33.0 million (including $.5 million of FAS 123R stock option expenses), compared with $21.2 million in the first quarter of 2005. The year-to-year increase reflects expenses associated with higher shipments of clinical materials to our partners, higher utility costs and increased headcount, principally in product and process development;

                  Clinical and regulatory expenses in the first quarter of 2006 were $15.1 million (including $.3 million of FAS 123R stock option expenses), compared with $9.4 million in the first 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 $18.0 million in the first quarter of 2006 (including $1.1 million of FAS 123R stock option expenses), compared with $17.6 million in the first quarter of 2005;

                  Royalty expenses were $20.1 million in the first quarter of 2006 compared with $12.6 million in the first quarter of 2005 as the result of higher ERBITUX sales. Approximately $8.6 million of the 2006 expenses are reimbursed as a component of Collaborative agreement revenue, resulting in net royalty expenses of $11.5 million for the first quarter of 2006 compared with $8.1 million in the first quarter of last year; and

                  Cost of manufacturing revenue was $15.4 million in the first quarter of 2006 compared with $.7 million in the first 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.

 

The effective tax rate for the first quarter of 2006, and the estimate for the full year, is approximately 13%. In addition, in the first quarter of 2006, the Company released a portion of its deferred tax asset valuation allowance. The impact of the release resulted in a benefit to tax expense of approximately $99.5 million, which was recognized in the first quarter of 2006. The combination of both these items resulted in a net tax benefit, in the first quarter of 2006 of $80.3 million.

 

Net income for the first quarter of 2006 was $229.6 million compared with $28.8 million in the first quarter of last year. Diluted earnings per share were $2.51 in the first quarter of 2006 compared with $.33 in the first quarter of 2005. 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. Non-GAAP earnings per share, excluding the effects of the one-time tax benefit, were $1.43 in the first quarter of 2006.

 



 

(Diluted per share amounts)

(Unaudited)

 

 

 

Three Months
Ended
March 31, 2006

 

Three Months
Ended
March 31, 2005

 

GAAP diluted earnings per share

 

$

2.51

 

$

.33

 

Release of valuation allowance

 

(1.08

)

 

Non-GAAP diluted earnings per share

 

$

1.43

 

n/a

 

 

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 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 first quarter 2006 financial results today, Tuesday, April 25, 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 April 25, 2006.

 

Those parties interested in participating via telephone may join by dialing (888) 562-3356 domestically, or (973) 582-2700 for calls outside of Canada and the United States, and referencing conference identification number 7268694. A telephone replay of the conference call will be available shortly after the call until May 2, 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 7268694.

 

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

Consolidated Condensed Statements of Operations

(Unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2006

 

2005

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

Royalty revenue

 

$

60,270

 

$

36,372

 

License fees and milestone revenue

 

144,403

 

24,534

 

Manufacturing revenue

 

19,349

 

11,019

 

Collaborative agreement revenue

 

21,109

 

13,846

 

Total revenues

 

245,131

 

85,771

 

Operating expenses:

 

 

 

 

 

Research and development

 

32,993

 

21,173

 

Clinical and regulatory

 

15,081

 

9,398

 

Marketing, general and administrative

 

18,001

 

17,623

 

Royalty expense

 

20,066

 

12,566

 

Cost of manufacturing revenue

 

15,402

 

743

 

Total operating expenses

 

101,543

 

61,503

 

 

 

 

 

 

 

Operating income

 

143,588

 

24,268

 

 

 

 

 

 

 

Other income, net

 

(5,702

)

(4,932

)

 

 

 

 

 

 

Income before income taxes

 

149,290

 

29,200

 

Income tax (benefit) provision

 

(80,301

)

380

 

 

 

 

 

 

 

Net income

 

$

229,591

 

$

28,820

 

 

 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

Basic

 

$

2.75

 

$

0.35

 

Diluted

 

$

2.51

 

$

0.33

 

Shares used in calculation of income per share:

 

 

 

 

 

Basic

 

83,624

 

83,278

 

Diluted

 

91,817

 

92,648

 

 



 

IMCLONE SYSTEMS INCORPORATED

Consolidated Condensed Balance Sheets

(Unaudited)

(in thousands)

 

 

 

March 31,

 

December 31,

 

 

 

2006

 

2005

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

275,861

 

$

3,403

 

Securities available for sale

 

714,838

 

752,973

 

Inventories

 

75,072

 

81,394

 

Other current assets

 

89,761

 

71,348

 

Total current assets

 

1,155,532

 

909,118

 

 

 

 

 

 

 

Property, plant and equipment, net

 

419,970

 

406,595

 

Other assets

 

116,516

 

27,702

 

Total assets

 

$

1,692,018

 

$

1,343,415

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

291,560

 

$

242,119

 

Deferred revenue, long term

 

304,074

 

246,401

 

Long-term obligations

 

602,993

 

602,491

 

Total liabilities

 

1,198,627

 

1,091,011

 

 

 

 

 

 

 

Stockholders’ equity

 

493,391

 

252,404

 

Total liabilities and stockholders’ equity

 

$

1,692,018

 

$

1,343,415

 

 


GRAPHIC 3 g68455mmi001.jpg GRAPHIC begin 644 g68455mmi001.jpg M_]C_X``02D9)1@`!`0$`8`!@``#_VP!#``H'!P@'!@H("`@+"@H+#A@0#@T- M#AT5%A$8(Q\E)"(?(B$F*S7J#A(6&AXB)BI*3E)66EYB9FJ*CI*6FIZBIJK*SM+6VM[BYNL+#Q,7& MQ\C)RM+3U-76U]C9VN'BX^3EYN?HZ>KQ\O/T]?;W^/GZ_\0`'P$``P$!`0$! M`0$!`0````````$"`P0%!@<("0H+_\0`M1$``@$"!`0#!`<%!`0``0)W``$" M`Q$$!2$Q!A)!40=A<1,B,H$(%$*1H;'!"2,S4O`58G+1"A8D-.$E\1<8&1HF M)R@I*C4V-S@Y.D-$149'2$E*4U155E=865IC9&5F9VAI:G-T=79W>'EZ@H.$ MA8:'B(F*DI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4 MU=;7V-G:XN/DY>;GZ.GJ\O/T]?;W^/GZ_]H`#`,!``(1`Q$`/P#V6D+*"`2` M3P,GK39)8X8VDED6-%&69C@#\:\FUBXU'7O'\NGRW%M*%#"R1B/+5,!PVY>0 M2!]X=",4`;FH?$FY&M3:?I^G(([:1D>>X8[9"K;=HQ]S)!`)SVXYK&NO'>N: MOK5S)I-W+;Z9`H\Q5MU9HTRH+$D'!W$\],*?K6MX1TG198;RYBNDU>YD9H;V M0WF4W;MS``CD$XY.-B"593@C(ZUE7NDZ=M`6/;J*RO#=_/J&B6TUXZ&Z9-SA<`[23M)7L2N#CWK5IB.(^*;:D- M!M_L<8-LLP>YD*;]FWEW5KF>2W6%F3 MD%(F7C@DDMWXXQ76>/M6D7Q=<6%V9GLA$FU64E4ROS%4W`/[D].E=-J?A73_ M`!/X7M].N(KF>`0J;:X:=2R?+\KC\.HI#/"])U6_\%:Q#JFFR)=6DP(&]D)J5E-;["/WJ&S),+8R5;!XQ7A-YH6I>%=>_X1 M[68-]M=NHX/RN"<+(A[,,_S!K]>!QUAO[0^'(FALP7NKN5XEFZL ML>%^51V+;L$^@P.IKTWX-(&TQY9@G[F:*6W$3A#C>S@'Y=O;/4]*]?KR3Q/# MO6ZHEG"?$^Z$=M9VMU;H]C<% ME9]@)+\$+G!*#`))`SQCZW?#M[I]WHMN(;NQNV@0122&S=6W`#.0<'TKH=5T M?3];M1;:E:K<1*V]0205/J",$=:\KT7Q)8^%]3O4F6^M(#EIK.W7B*0D8^^> M-JC!.?F)I`CL]=T/2M>LTANA:(T,@EBFBMF5XV!SP?3CD5YEH]KJ`TQR]Q!) MLCWQDH<@%AP?7&:]AM;I;^S%S9S7<\+KE7CFB(Z>QZUY;I7_`""Y/^O=?_0E MKR\Q?NQ7K^1[F31O.3OV_,TO`7AZUEEEU359H+J\M;EUB$D+,B[E0[@/4=!Z M5WY:U`)(L`!U)M6KGO`*RG3K_8+HC[8?]4Z`?ZM/6H?%/BF,Z=?6&F7E^UU& M@W2PO&Z)SDJ2IR"0",CID5W4'>E%OLCS,5%1KS2[O\S'AN9/^%E6M[I_D7\- M].B*1:E4CC&,[=P&T@!F#*><5ZU7#?#?2;.70K74YM/=+F(LD,LK/\Z8P'"L M<`D'&0.<'UKN:W.4*QM4\+Z5J5Q)?O80/J!B*1S2+D`X(4D=#C/7%;-%`'CT M>C^+[741H]EI[6'F%'\]5#QD!`N68`C:,'Y>IR*H:5<1)I.U>X4;5]!^5]OP/&M*BU<65WJ%B)+BS:X,8CA MC+@MY:YW@#)!!P&'W2*Z3P3X#,&D3)XCTV`2.ZM%&K_.@V`'++C@^F>U>@XQ GTXHK:G#D@H]CFK5'5J2F^KN-1$BC6.-0J(`JJ!@`#H*=115F1__9 ` end
-----END PRIVACY-ENHANCED MESSAGE-----