EXHIBIT 99.1
FOR IMMEDIATE RELEASE
FOR FURTHER INFORMATION:
INVESTOR RELATIONS &
MEDIA: CORPORATE COMMUNICATIONS: COO & CFO:
Amy Turner Amy Hedison John McCarthy
Fleishman-Hillard EXACT Sciences EXACT Sciences
P: (617) 267-8223 P: (978) 897-2800, ext. 252 P: (978) 897-2800, ext. 275
E: turnera@fleishman.com E: ahedison@exactsciences.com E: jmccarthy@exactsciences.com
EXACT SCIENCES ANNOUNCES FIRST QUARTER 2003 RESULTS
MAYNARD, MASS. - (APRIL 28, 2003) - EXACT Sciences Corporation (NASDAQ: EXAS)
announced today financial results for the first quarter ending March 31, 2003.
For the quarter ending March 31, 2003, revenues totaled $0.4 million, versus
revenues of $0.04 million for the quarter ending March 31, 2002. Net loss for
the first quarter of 2003 totaled $7.9 million, or $0.42 per share, compared to
a net loss of $7.6 million, or $0.42 per share, for the first quarter of 2002.
Pro forma net loss for the first quarter of 2003, which excludes $0.3 million of
non-cash stock-based compensation charges, totaled $7.6 million, or $0.40 per
share, compared to pro forma net loss of $7.0 million, or $0.39 per share for
the first quarter of 2002, which excludes $0.6 million of non-cash stock-based
compensation charges.
Revenues for the first quarters ending March 31, 2002 and 2003 were primarily
attributable to the amortization of upfront license fee payments related to the
Company's two strategic partnerships with Laboratory Corporation of America(R)
Holdings (LabCorp(R)), which were consummated in July 2001 and June 2002.
Selling, general and administrative expenses for the quarter ending March 31,
2003, increased primarily due to increases in marketing and sales personnel and
programs in preparation for the anticipated mid-year commercialization of
PreGen-Plus(TM).
As of March 31, 2003, EXACT Sciences had approximately $35 million in cash, cash
equivalents and marketable securities available to fund its operations.
"During the first quarter of 2003 we continued to lay the foundation for the
commercial availability of PreGen-Plus, our non-invasive, DNA-based assay for
the early detection of colorectal cancer," said Don Hardison, EXACT Sciences'
President and CEO. "We anticipate that LabCorp will make PreGen-Plus
commercially available by the middle of this year, and teams from both companies
have been working very hard to ensure a successful launch. Pre-launch activities
are on schedule, and I am extremely pleased with the progress to date. We
believe that PreGen-Plus will not only be a tremendous step forward in
colorectal cancer screening, but, in the end, will contribute to numerous lives
being saved from this silent killer."
OPERATING HIGHLIGHTS
COMMERCIAL
o Virtually all of EXACT Sciences' available resources are
focused on working with LabCorp to prepare for the anticipated
mid-year commercial availability of PreGen-Plus. Product
launch activities currently underway include technology
transfer and licensing, contracting with suppliers, physician
education, demand creation, broad-based reimbursement
initiatives, and sales force training. While some of these
efforts will be ongoing after the launch of PreGen-Plus,
others, such as the technology transfer and licensing and
contracting with suppliers, must be completed prior to
commercial launch.
ALLIANCES AND BUSINESS DEVELOPMENT
o EXACT Sciences signed an exclusive long-term licensing
agreement with Johns Hopkins University relating to the
digital-PCR technology developed by Dr. Bert Vogelstein's
laboratory at the Johns Hopkins Kimmel Cancer Center. The
Company believes that the agreement provides EXACT Sciences
with a platform that, in conjunction with its proprietary
technologies, may lead to future generations of PreGen-Plus.
o The Company signed a manufacturing and supply agreement with
Becton Dickinson relating to certain DNA isolation
technologies that are proprietary to EXACT. These technologies
provide for the isolation of target DNA sequences that are
present in complex, heterogeneous, biological samples.
CLINICAL
o EXACT Sciences' multi-center study completed enrollment on
March 28, 2003 with a final patient enrollment census of
approximately 5,500. The Company expects that test completion
by the final patients enrolled in the study should take
approximately 12 weeks, which represents the Company's
historical experience in the study. The Company expects that
it will complete processing of the final samples by the end of
the summer, and that results from the study will be available
in the fourth quarter of 2003.
o Overall, the Company has tested its PreGen(TM) technology on
approximately 200 samples from patients with cancer across
several different studies, excluding the multi-center study
described above and the ongoing- Mayo/NCI study. Based on
these studies, the average range of sensitivity for
PreGen-Plus has been 65 - 70 percent for invasive colorectal
cancer. In addition, to date, the results from these studies
indicate a specificity of approximately 96 percent for
PreGen-Plus.
o The Company expects that clinical results on PreGen-Plus in
more than 50 of these patients, and more than 100 patients
with negative colonoscopy, will be published in the May issue
of the journal, CLINICAL COLORECTAL CANCER.
RESEARCH AND DEVELOPMENT
o Six abstracts relating to various aspects of EXACT Sciences'
PreGen technologies were accepted at this year's Digestive
Diseases Week Conference, to be held in May in Orlando. Three
of the abstracts were accepted for oral presentation, and the
remaining three will be poster presentations.
FIRST QUARTER 2003 CONFERENCE CALL
EXACT Sciences will host a conference call discussing the Company's first
quarter 2003 operating and financial results, and 2003 outlook, at 8:30 a.m. EDT
on Tuesday, April 29, 2003. A live Webcast of the conference call, as well as an
archived version following the completion of the call, will be available at
www.exactsciences.com by clicking on the Investor Relations link. The conference
call and Webcast are open to all interested parties.
Information for the call is as follows:
Domestic callers: 877-809-1575
International callers: 706-679-5918
PIN#: 9672707
A replay of the conference call will be available two hours following the
completion of the conference call, for 48 hours. Information for the replay is
as follows:
Domestic callers: 800-642-1687
International callers: 706-645-9291
PIN #: 9672707
About EXACT Sciences Corporation
EXACT Sciences Corporation is an applied genomics company that has developed
proprietary technologies that may be used for the early detection of several
common cancers. EXACT Sciences has selected colorectal cancer as the first
application of its technologies. Colorectal cancer is the most deadly cancer
among non-smokers, and is curable if detected early. Despite the availability of
colorectal cancer screening and diagnostic tests for more than 20 years, the
rate of early detection of colorectal cancer remains low. EXACT Sciences
believes its genomics-based technologies will enable early detection of
colorectal cancer so that more people can be effectively treated. Founded in
1995, EXACT Sciences is based in Maynard, Mass. Detailed information on EXACT
Sciences can be found on the World Wide Web at www.exactsciences.com
Certain statements made in this press release that are not based on historical
information are forward-looking statements which are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. This
press release contains express or implied forward-looking statements relating
to, among other things, EXACT Sciences' expectations concerning its future
revenues and expenses, its business outlook and business momentum, its clinical
trials, the commercial launch of its technologies, and the effectiveness and
market acceptance of its technologies. These statements are neither promises nor
guarantees, but are subject to a variety of risks and uncertainties, many of
which are beyond EXACT Sciences' control, which could cause actual results to
differ materially from those contemplated in these forward-looking statements.
In particular, the risks and uncertainties include, among other things, the
inability of EXACT Sciences to automate and develop processes that make its
assays commercially attractive; that the completion of clinical studies may not
prove the superiority of EXACT Sciences' technologies; the inability to recruit
a sufficient number of patients for clinical studies/trials; the inability to
convince Medicare and other third-party payors to provide adequate reimbursement
for EXACT Sciences' products and services; the failure to convince medical
practitioners to order tests using EXACT Sciences' technologies; the lack of
market acceptance of PreGen-26, PreGen-Plus, and other PreGen technologies to
screen for colorectal cancer; the inability of EXACT Sciences to control its
commercial partners' operations, performance or sales performance, including
sales of products utilizing EXACT Sciences' technologies; the inability of EXACT
Sciences' commercial partners to create a market for and sell products using
EXACT Sciences' technologies; the failure of EXACT Sciences' strategic and
collaborative partners to satisfy their obligations under agreements with the
Company; the loss of support of key scientific collaborators; the failure to
comply with federal and state statutes and regulations relating to EXACT
Sciences' products and services, including FDA requirements, and relating to the
operation of EXACT Sciences' laboratory, including the Clinical Laboratory
Improvement Amendments; competition; the ability of EXACT Sciences or its
strategic or collaborative partners to obtain in a timely manner any third-party
licenses or manufacture and supply agreements that may be necessary to
commercialize its technologies; a decrease in available raw materials; and the
inability to protect EXACT Sciences' intellectual property and the cost of
enforcing or defending EXACT Sciences in litigation relating to intellectual
property rights. Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date hereof. EXACT Sciences undertakes no obligation to update or revise the
information contained in this press release, whether as a result of new
information, future events or circumstances or otherwise. For additional
disclosure regarding these and other risks faced by EXACT Sciences, see the
disclosure contained in EXACT Sciences' public filings with the Securities and
Exchange Commission including, without limitation, its most recent Annual Report
on Form 10-K and subsequent Forms 10-Q.
EXACT SCIENCES CORPORATION
SELECTED FINANCIAL INFORMATION
STATEMENT OF OPERATIONS DATA
IN THOUSANDS, EXCEPT PER SHARE DATA
THREE MONTHS ENDED
MARCH 31,
--------------------------------
2003 2002
--------------------------------
REVENUES: $ 408 $ 39
EXPENSES:
Cost of revenues 3 -
Research and development 5,013 5,043
Selling, general and administrative 3,114 2,289
Stock-based compensation (1) 328 568
--------------------------------
TOTAL EXPENSES 8,458 7,900
LOSS FROM OPERATIONS (8,050) (7,861)
INTEREST INCOME 167 275
--------------------------------
NET LOSS $ (7,883) $ (7,586)
================================
PRO FORMA NET LOSS (2) $ (7,555) $ (7,018)
================================
NET LOSS PER SHARE:
Basic and diluted $ (0.42) $ (0.42)
================================
Pro forma basic and diluted (2) $ (0.40) $ (0.39)
================================
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and diluted 18,808 18,165
================================
Pro forma basic and diluted 18,808 18,165
================================
PRO FORMA RECONCILIATION:
Net loss $ (7,883) $ (7,586)
Stock-based compensation (1) 328 568
--------------------------------
Pro forma net loss $ (7,555) $ (7,018)
================================
(1) REPRESENTS A NON-CASH EXPENSE.
(2) EXCLUDES NON-CASH STOCK-BASED COMPENSATION.
EXACT SCIENCES CORPORATION
CONDENSED BALANCE SHEET DATA
(IN THOUSANDS)
MARCH 31, DECEMBER 31,
2003 2002
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ASSETS
Cash and cash equivalents $ 11,783 $ 17,439
Short-term investments 23,302 26,407
Prepaid expenses 1,805 1,110
Property and equipment, net 2,230 2,256
Patent costs, net and other assets 2,870 2,874
------------------------------------
TOTAL ASSETS $ 41,990 $ 50,086
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LIABILITIES AND STOCKHOLDERS' EQUITY
Total current liabilities 4,908 5,244
Deferred licensing fees, less current portion 6,088 6,493
Total stockholders' equity 30,994 38,349
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 41,990 $ 50,086
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