EXACT Sciences Corp. (NASDAQ: EXAS) today announced its financial
results for the fourth quarter and year ended Dec. 31, 2008.
EXACT reported net revenues for the fourth quarter of 2008 of ($0.1)
million, compared to net revenues of ($0.6) million for the same period
of 2007. The quarterly increase in net revenues compared to the same
quarter of 2007 was driven by lower charges to product royalty revenue
in connection with a third-party royalty reimbursement obligation to
Laboratory Corporation of America Holdings (LabCorp). During the
quarters ended Dec. 31, 2007, and Dec. 31, 2008, EXACT recorded $1.0
million and $0.45 million, respectively, in charges related to the
third-party royalty obligation to LabCorp. These charges resulted in
negative net product royalty revenue in both quarters. Based on LabCorp
sales volumes as of Dec. 31, 2008, and future LabCorp sales volumes
anticipated by the company, EXACT had accrued a total of $3.45 million
related to the potential $3.5 million total obligation to LabCorp,
compared to $1.2 million at Dec. 31, 2007. To the extent payments are
due to LabCorp for the last two measurement periods, $1.0 million would
be due in each of January 2010 and January 2011.
The company reported net revenues for the year ended Dec. 31, 2008 of
($0.9) million, compared to $1.8 million for full-year 2007. This
decrease was due primarily to a $1.5 million reduction in non-cash
license fee amortization revenues in 2008, compared to the prior year.
This reduction resulted from the June 2007 amendment of the company’s
license agreement with LabCorp, which extended the agreement’s exclusive
period to December 2010. As a result of this extension, the remaining
unamortized up-front license fees that LabCorp previously paid to EXACT
are now being recognized over a longer period of time, resulting in
lower non-cash license fee amortization as compared to prior periods.
The revenue decrease was also due to an increase of approximately $1.0
million in charges to product royalty revenue in connection with a
third-party royalty obligation payable to LabCorp, as discussed above.
The company recorded charges of $1.2 million and $2.25 million during
the years ended Dec. 31, 2007, and Dec. 31, 2008, respectively, in
connection with the third-party royalty obligation to LabCorp.
EXACT reported a net loss for the fourth quarter of 2008 of $2.1
million, or $0.08 a share, compared to $4.0 million, or $0.15 a share,
for the same period of 2007. For full-year 2008, the company reported a
net loss of $9.7 million, or $0.36 a share, compared to $12.0 million,
or $0.44 a share for the prior year.
EXACT’s total operating expenses decreased by 44 percent to $2.0 million
for the quarter ended December 31, 2008, from $3.6 million for the same
period of 2007. This decrease was due primarily to a reduction of $1.2
million in research and development expenses resulting from the July
2008 cost-reduction actions, which included the suspension of the
company’s proposed clinical validation study of its Version 2
technology, the elimination of eight positions, and the renegotiation of
certain fixed commitments. The company also recorded lower restructuring
charges during the fourth quarter of 2008, compared to the fourth
quarter of 2007. These charges related to the consolidation and sublease
of certain of the company’s leased space.
EXACT reported total operating expenses for full-year 2008 of $9.1
million, a decrease of 38 percent from $14.6 million in full-year 2007.
This decrease was due mainly to lower expenses across the company’s
research and development activities, which resulted from the previously
referenced cost reduction actions. General and administrative expenses
decreased by approximately 14 percent during full-year 2008 compared to
full-year 2007 as a result of a $1.8 million combined decrease from
lower non-cash stock-based compensation expense and decreases in salary,
benefit and other costs due to lower general and administrative
headcount. These decreases were partially offset by an increase of $0.8
million in professional fees in connection with the company’s strategic
review process, its reimbursement efforts with the Centers for Medicare
& Medicaid Services and its regulatory efforts with the U.S. Food and
Drug Administration. There were no sales and marketing expenses for the
year ended December 31, 2008, compared with $1.0 million for the prior
year, as a result of the elimination of the company’s sales and
marketing functions on August 31, 2007.
The company recorded restructuring charges of $0.6 million for the year
ended December 31, 2008, compared with $1.2 million in full-year 2007.
Restructuring charges in 2008 consisted of approximately $0.5 million
during the third quarter in connection with the previously-referenced
July 2008 cost-reduction actions. The company recorded an additional
charge of $0.1 million during the fourth quarter of 2008 in connection
with the sublease of certain of its leased space at its headquarters.
The company had approximately $4.9 million in unrestricted cash and cash
equivalents at Dec. 31, 2008, compared to unrestricted cash, cash
equivalents and short term investments of $12.6 million at Dec. 31,
2007. As previously announced, on Jan. 27, 2009, EXACT consummated a
strategic relationship with Genzyme Corp. In connection with the
transaction, EXACT received $22.65 million at closing, with an
additional $1.85 million to be received by July 2010, subject to the
non-occurrence of certain events.
EXACT will not hold a conference call to discuss its fourth-quarter and
year-end 2008 results. On March 18, 2009, the company announced the
hiring of Kevin T. Conroy as president and chief executive, and Maneesh
K. Arora as chief financial officer. The company plans to resume
quarterly conference calls with its new management team in connection
with the release of its first-quarter 2009 financial results.
About EXACT Sciences Corp.
EXACT Sciences Corp. is a molecular diagnostics company focused on
colorectal cancer. The company has exclusive intellectual property
protecting its non-invasive, molecular screening technology for the
detection of colorectal cancer. Stool-based DNA technology is included
in the colorectal cancer screening guidelines of the American Cancer
Society and the U.S. Multi-Society Task Force on Colorectal Cancer.
Certain statements made in this press release that are not based on
historical information are express or implied forward-looking statements
relating to, among other things, EXACT Sciences' expectations concerning
LabCorp's future sales volumes and the timing of future investor
conference calls. 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, and 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, EXACT Sciences' ability to regain compliance with NASDAQ
continued listing requirements, changes in FDA guidance or policy; the
success of EXACT’s strategic relationship with Genzyme; the risks of
litigation; the ability to attract prospective collaborators or other
parties to enter into a collaboration, acquisition or other strategic
transaction with EXACT; the ability to raise additional capital on
acceptable terms; the success of its strategic relationship with
LabCorp; EXACT Sciences' ability to license certain technologies or
obtain raw materials for its technologies; the ability to convince
Medicare and other third-party payors to provide adequate reimbursement
for EXACT Sciences' technologies; the ability to increase the
performance its technologies; the ability of EXACT Sciences or LabCorp
to lower the cost of stool-based DNA screening technologies through
automating and simplifying key operational processes; the ability to
protect EXACT Sciences' intellectual property and the cost of enforcing
or defending EXACT Sciences in litigation relating to intellectual
property rights; and the possibility that other companies will develop
and market novel or improved methods for detecting colorectal cancer.
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
Quarterly Reports on Form 10-Q filed with the SEC.
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EXACT SCIENCES CORPORATION
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Selected Unaudited Financial Information
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Condensed Consolidated Statements of Operation Data
|
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months Ended
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Twelve Months Ended
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December 31,
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December 31,
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In thousands, except per share data
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2008
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2007
|
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2008
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2007
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product royalty fees
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|
$
|
(447
|
)
|
|
$
|
(943
|
)
|
|
$
|
(2,234
|
)
|
|
$
|
(1,137
|
)
|
|
License fees
|
|
|
338
|
|
|
|
337
|
|
|
|
1,351
|
|
|
|
2,857
|
|
|
Product
|
|
|
-
|
|
|
|
6
|
|
|
|
16
|
|
|
|
78
|
|
|
|
|
|
(109
|
)
|
|
|
(600
|
)
|
|
|
(867
|
)
|
|
|
1,798
|
|
|
Gross profit (loss):
|
|
|
|
|
|
|
|
|
|
Product royalty fees
|
|
|
(447
|
)
|
|
|
(943
|
)
|
|
|
(2,235
|
)
|
|
|
(1,141
|
)
|
|
License fees
|
|
|
338
|
|
|
|
337
|
|
|
|
1,351
|
|
|
|
2,857
|
|
|
Product
|
|
|
-
|
|
|
|
6
|
|
|
|
16
|
|
|
|
33
|
|
|
|
|
|
(109
|
)
|
|
|
(600
|
)
|
|
|
(868
|
)
|
|
|
1,749
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
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Research and development (1)
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|
|
70
|
|
|
|
1,269
|
|
|
|
2,034
|
|
|
|
4,887
|
|
|
General and administrative (1)
|
|
|
1,868
|
|
|
|
1,991
|
|
|
|
6,469
|
|
|
|
7,541
|
|
|
Sales and marketing (1)
|
|
|
-
|
|
|
|
(18
|
)
|
|
|
-
|
|
|
|
991
|
|
|
Restructuring (1)
|
|
|
70
|
|
|
|
358
|
|
|
|
602
|
|
|
|
1,177
|
|
|
|
|
|
2,008
|
|
|
|
3,600
|
|
|
|
9,105
|
|
|
|
14,596
|
|
|
|
|
|
|
|
|
|
|
|
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Loss from operations
|
|
|
(2,117
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)
|
|
|
(4,200
|
)
|
|
|
(9,973
|
)
|
|
|
(12,847
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
8
|
|
|
|
181
|
|
|
|
232
|
|
|
|
888
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,109
|
)
|
|
$
|
(4,019
|
)
|
|
$
|
(9,741
|
)
|
|
$
|
(11,959
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted
|
|
$
|
(0.08
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.36
|
)
|
|
$
|
(0.44
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
|
|
|
|
|
|
|
|
|
|
outstanding - basic and diluted
|
|
|
27,296
|
|
|
|
27,088
|
|
|
|
27,212
|
|
|
|
26,945
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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(1) Non-cash stock-based compensation expense included in
these amounts are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
4
|
|
|
$
|
61
|
|
|
$
|
89
|
|
|
$
|
541
|
|
|
General and administrative
|
|
|
178
|
|
|
|
258
|
|
|
|
918
|
|
|
|
1,889
|
|
|
Sales and marketing
|
|
|
-
|
|
|
|
(18
|
)
|
|
|
-
|
|
|
|
202
|
|
|
Restructuring
|
|
|
-
|
|
|
|
-
|
|
|
|
3
|
|
|
|
174
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXACT SCIENCES CORPORATION
|
|
Condensed Consolidated Unaudited Balance Sheet Data
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2008
|
|
2007
|
|
Assets
|
|
|
|
|
|
Unrestricted cash and cash equivalents
|
|
$
|
4,937
|
|
|
$
|
4,486
|
|
Short-term investments
|
|
|
-
|
|
|
|
8,101
|
|
Prepaid expenses
|
|
|
190
|
|
|
|
275
|
|
Property and equipment, net
|
|
|
76
|
|
|
|
601
|
|
Patent costs, net of accumulated amortization
|
|
|
95
|
|
|
|
432
|
|
Restricted cash
|
|
|
600
|
|
|
|
700
|
|
Total assets
|
|
$
|
5,898
|
|
|
$
|
14,595
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity (deficit)
|
|
|
|
|
|
Total current liabilities
|
|
$
|
5,031
|
|
|
$
|
4,406
|
|
Third party royalty obligation, less current portion
|
|
|
1,950
|
|
|
|
1,200
|
|
Deferred licensing fees, less current portion
|
|
|
1,350
|
|
|
|
2,701
|
|
Total stockholders’ equity (deficit)
|
|
|
(2,433
|
)
|
|
|
6,288
|
|
Total liabilities and stockholders' equity (deficit)
|
|
$
|
5,898
|
|
|
$
|
14,595
|
Exact Sciences Corp.
Karen Dodos, 508-683-1200