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Investors: Media:
Andrea F. Rabney Andrew Merrill
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or David Pitts
Stefania A. Bethlen Abernathy MacGregor Group
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Corporate Communications
ImClone Systems Incorporated
(646) 638-5058
FOR IMMEDIATE RELEASE
IMCLONE SYSTEMS REPORTS THIRD QUARTER 2003 FINANCIAL RESULTS
NEW YORK, NY - NOVEMBER 12, 2003 -- ImClone Systems Incorporated (Nasdaq: IMCL)
announced today its financial results for the quarter ended September 30, 2003.
Total revenues for the third quarter of 2003 were $23.6 million as compared with
$15.0 million for the third quarter of 2002. Net loss was $16.5 million, or
$0.22 per common share for the third quarter of 2003, compared with a net loss
of $42.0 million, or $0.57 per common share for the same period in 2002.
Year-to-date revenues for the nine months ended September 30, 2003 were $61.0
million as compared with $45.2 million for the same period in 2002. Year-to-date
net loss for the nine months ended September 30, 2003 was $86.2 million, or
$1.16 per common share, compared with a year-to-date net loss of $118.6 million,
or $1.62 per common share, for the same period in 2002.
The Company had $138.4 million in cash, cash equivalents and securities
available for sale at September 30, 2003, compared with $247.7 million at
December 31, 2002.
THIRD QUARTER 2003 OVERVIEW
Filing and Acceptance of BLA
In October 2003 ImClone Systems and Bristol-Myers Squibb announced that the U.S.
Food and Drug Administration (FDA) notified ImClone Systems that it accepted for
filing and review the Company's Biologics License Application (BLA) for the use
of ERBITUX(TM) (cetuximab) in combination with irinotecan for the treatment of
patients with EGFR-expressing irinotecan-refractory metastatic colorectal
cancer. The Companies previously announced that ImClone Systems had filed the
BLA on August 14, 2003. The Companies also announced that, as requested, the
application will be reviewed for accelerated approval and has been granted
priority review designation by the FDA. Based on the priority review
designation, the FDA has six months from the submission date, or until February
13, 2004 to take action on the BLA filing.
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ImClone Systems Incorporated
Page two
Appointment of Joseph L. Fischer to Board of Directors
In September 2003, the Company announced the appointment of Joseph L. Fischer to
the Company's Board of Directors and Audit Committee. Mr. Fischer brings over 20
years of global managerial and operational experience in areas including
consumer products and finance with specific expertise in commercialization of
new products.
Achievement of Two Regulatory Milestones in ERBITUX Agreement with Merck KGaA
In July 2003, the Company announced that it achieved two equity-based milestones
in its license agreement with Merck KGaA. The milestones were triggered by Merck
KGaA's submission of applications for authorization to market ERBITUX(TM) for
the treatment of metastatic colorectal cancer in the European Union and
Switzerland. Merck KGaA's regulatory submissions were made with the European
Agency for Evaluation of Medicinal Products (EMEA), the pharmaceutical
regulatory body of the E.U., and with Swissmedic, the Swiss agency for
therapeutic products.
ImClone Systems received a milestone payment of $3 million for each of the two
submissions. Upon receipt of these payments, ImClone Systems issued 92,276
shares and 90,944 shares of the Company's common stock to Merck KGaA for the
Swiss and European Union submissions respectively. Both issuances represent the
sale of these shares at a ten percent premium to market value, as defined, at
the time each milestone was achieved, as provided in the Companies' license
agreement. In December 1998, Merck KGaA licensed from ImClone Systems the right
to develop ERBITUX outside of the U.S. and Canada and the co-exclusive right to
develop ERBITUX in Japan.
Advancements in Several Pipeline Programs
In July 2003, ImClone Systems presented preclinical data highlighting progress
made in the development of several pipeline programs at the 94th Annual Meeting
of the American Association for Cancer Research (AACR) held July 11 - 14th. The
Company presented a number of abstracts at the conference, including
presentations on monoclonal antibody therapeutics being developed as
angiogenesis and growth factor inhibitors.
ImClone Systems Incorporated is committed to advancing oncology care by
developing 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, cancer vaccines 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 is headquartered in New York with
manufacturing facilities in Branchburg, New Jersey.
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ImClone Systems Incorporated
Page three
The matters discussed in this news release may include forward-looking
statements which involve potential risks and uncertainties. Important factors
that may cause actual results to differ materially include, but are not limited
to, the risks and uncertainties associated with completing pre-clinical and
clinical trials of the company's compounds that demonstrate such compounds'
safety and effectiveness; manufacturing losses and risks associated therewith;
obtaining additional financing to support the company's operations; obtaining
and maintaining regulatory approval for such compounds and complying with other
governmental regulations applicable to the company's business; obtaining the raw
materials necessary in the development of such compounds; consummating and
maintaining collaborative arrangements with corporate partners for product
development; achieving milestones under collaborative arrangements with
corporate partners; developing the capacity to manufacture, market and sell the
company's products, either directly or with collaborative partners; developing
market demand for and acceptance of such products; competing effectively with
other pharmaceutical and biotechnological products; obtaining adequate
reimbursement from third party payers; attracting and retaining key personnel;
legal costs and the outcome of outstanding legal proceedings and investigations
including but not limited to our investigations pertaining to withholding tax
issues; complying with covenants in the indenture for the company's Convertible
Subordinated Notes and with the terms of other contractual obligations;
obtaining patent protection for discoveries and risks associated with commercial
limitations imposed by patents owned or controlled by third parties. The company
does not undertake any obligation to update 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
(in thousands, except per share data)
(unaudited)
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
------------------------- -------------------------
2003 2002 2003 2002
--------- --------- --------- ---------
Revenues $ 23,583 $ 15,034 $ 61,029 $ 45,150
Operating expenses:
Research and development 28,780 43,504 117,212 119,449
Marketing, general and administrative 13,750 12,341 30,852 36,943
(Recovery) write-down of withholding tax asset (3,384) -- (3,384) 3,384
Industrial Development Revenue Bonds tax expense -- 25 65 75
Expenses associated with BMS amended Commercial Agreement -- -- -- 2,250
--------- --------- --------- ---------
Total operating expenses 39,146 55,870 144,745 162,101
--------- --------- --------- ---------
Operating loss (15,563) (40,836) (83,716) (116,951)
--------- --------- --------- ---------
Other:
Interest income (897) (2,259) (3,580) (7,427)
Interest expense 2,240 3,162 7,000 10,003
Gain on securities available for sale (509) (264) (1,314) (1,500)
--------- --------- --------- ---------
Net interest and other expense 834 639 2,106 1,076
--------- --------- --------- ---------
Loss before income taxes (16,397) (41,475) (85,822) (118,027)
Provision for income taxes 123 550 337 550
--------- --------- --------- ---------
Net loss $ (16,520) $ (42,025) $ (86,159) $(118,577)
========= ========= ========= =========
Net loss per common share - basic and diluted $ (0.22) $ (0.57) $ (1.16) $ (1.62)
========= ========= ========= =========
Weighted average shares outstanding 74,505 73,385 74,009 73,350
========= ========= ========= =========
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
SEPTEMBER 30, DECEMBER 31,
2003 2002
------------- ------------
ASSETS
Current assets:
Cash and cash equivalents $ 38,765 $ 72,877
Securities available for sale 99,642 174,778
Withholding tax assets 370 10,150
Other current assets 23,884 27,380
---------- ----------
Total current assets 162,661 285,185
Property and equipment, net 226,846 183,539
Other assets 13,802 15,782
---------- ----------
Total assets $ 403,309 $ 484,506
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities (excluding deferred revenue and
withholding tax liability) $ 44,144 $ 68,768
Withholding tax liability 21,006 38,811
Deferred revenue 349,214 322,504
Long-term obligations 240,044 240,052
------- -------
Total liabilities 654,408 670,135
Stockholders' deficit (251,099) (185,629)
---------- ----------
Total liabilities and stockholders'
equity (deficit) $ 403,309 $ 484,506
========== ==========