SOUTH SAN FRANCISCO, Calif.,
March 15, 2012 /PRNewswire/ --
diaDexus, Inc. (OTC Bulletin Board: DDXS), a company focused on the
development and commercialization of proprietary cardiovascular
diagnostic products, today announced financial results for the 2011
fourth quarter and year-end.
Fourth quarter 2011
Total revenues for the 2011 fourth quarter were $4.9 million, a 48% increase over $3.3 million for the fourth quarter of 2010,
representing the highest quarterly revenues in the history of the
company. Total expenses for the quarter were $5.8 million, unchanged from the fourth quarter
of 2010. The company's net loss for the quarter was $1.0 million compared to a $2.1 million net loss in the fourth quarter of
2010. The decrease in net loss for the quarter was largely due to a
$1.6 million increase in fourth
quarter sales of the PLAC® Test for Lp-PLA(2) versus the comparable
2010 period. Net cash used in operating activities for the
fourth quarter of 2011 was $1.6
million versus $2.8 million
for the same period the year prior.
Year-end 2011
Total revenues for the 12-month period ended December 31, 2011 were $16.4 million compared to $11.8 million for
2010. This 39% increase was due to accelerated demand for the
company's PLAC® Test for Lp-PLA(2) and represents record annual
revenues. Total operating expenses for 2011 were $24.2 million compared to total operating
expenses of $20.4 million in 2010.
The company reduced its net loss to $7.5
million for the year ended December
31, 2011, compared to a net loss of $8.4 million in 2010. Net cash used in operating
activities was $6.7 million in 2011
versus $7.5 million in 2010, also
primarily a result of higher revenues.
Cash and investments at December 31,
2011 were $17.2 million
compared to $20.4 million at
December 31, 2010.
Guidance
diaDexus maintained its guidance for 2012 total revenues at
$20 million to $21 million,
projecting year-over-year growth of approximately 26% compared to
2011. The company believes it will use approximately
$6 million in operations. Future
financing needs will depend on the company's ability to increase
the rate of adoption for the company's products by physicians,
progress in achieving additional positive coverage decisions from
insurers for the PLAC® Test for Lp-PLA(2), and commercialization
needs.
"diaDexus had an outstanding fiscal 2011, the strongest fourth
quarter in the history of the company, and grew revenues to a
record of $16.4 million," said
Brian Ward, Ph.D., diaDexus' Chief
Executive Officer. "We are gaining strong momentum with acceptance
of the PLAC Lp-PLA(2) Mass testing as an essential biomarker that
aids physicians by indicating the risk of cardiovascular heart
disease and stroke in the United
States. With the launch of diaDexus' new PLAC® Test for
Lp-PLA(2) Activity in Europe in
the first quarter of 2012, we are now positioned for further
long-term sales momentum. The recent hire of Jean Viret as our Chief Financial Officer
completes our executive management team, and allows us to maintain
our sales momentum and deliver increased value to our
shareholders."
Webcast
diaDexus will host a webcast on Thursday,
March 15 at 1:15 PM PDT
(4:15 PM EDT) to discuss the 2011
fourth quarter and year-end financial results. The webcast may be
accessed via the company's website at www.diadexus.com/webcast.
About diaDexus, Inc.
diaDexus, Inc., based in South San
Francisco, California, is focused on the development and
commercialization of proprietary in vitro diagnostic
products addressing unmet needs in cardiovascular disease. The
company's PLAC® Test for Lp-PLA(2) is the only blood test cleared
by the FDA to aid in assessing risk for both coronary heart disease
and ischemic stroke associated with atherosclerosis. For more
information, please visit the company's website at
www.diaDexus.com
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements include, but are not limited to, statements about
the company's plans, objectives, expectations and intentions with
respect to future financial results, operations and products and
other statements that are not historical in nature, particularly
those that use terminology such as "will," "potential", "could,"
"can," "believe," "intends," "continue," "plans," "expects,"
"estimates" or comparable terminology. Forward-looking statements
are based on current expectations and assumptions, and entail
various known and unknown risks and uncertainties that could cause
actual results to differ materially from those expressed in such
forward-looking statements. Important factors known to diaDexus
that could cause actual results to differ materially from those
expressed in such forward-looking statements include diaDexus'
ability to submit a new 510(k) application for, and obtain FDA
clearance of, its new automated Lp-PLA(2) Activity test; diaDexus'
ability to gain acceptance of its PLAC® Test products in the
marketplace, including its ability to demonstrate that treatment of
individuals based on their Lp-PLA(2) levels improves clinical
outcomes in prospective clinical studies; diaDexus' high degree of
customer concentration, including the downward pressure that its
largest customers may be able to exert on its product pricing;
diaDexus' relationship with key customers, including
GlaxoSmithKline, the licensor of Lp-PLA(2); diaDexus' reliance on a
sole source third party manufacturer to manufacture and supply
diaDexus' PLAC® ELISA Test; third party payors' acceptance of and
reimbursement for the PLAC® Test; diaDexus' ability to develop and
commercialize new products and services; various risks associated
with the international expansion of diaDexus' business; diaDexus'
ability to successfully launch and commercialize the PLAC® Test for
Lp-PLA(2) Activity in Europe, and
its dependence on its distributors for foreign sales of that test;
diaDexus' ability to initiate and continue to manufacture the PLAC®
Test for Lp-PLA(2) Activity at its facility in South San Francisco, California; the adequacy
of diaDexus' intellectual property rights; diaDexus' ability to
satisfy its obligations under its license agreements, to maintain
its license rights under those license agreements and to enter into
any necessary licenses on acceptable terms; diaDexus' ability to
attract, retain and motivate qualified personnel; the effects of
U.S. and foreign government regulations and diaDexus' ability to
comply with such regulations; diaDexus' limited revenue and cash
resources; and diaDexus' significant corporate expenses, including
real estate lease liabilities and expenses associated with being a
public company. Additional factors that could cause diaDexus'
results to differ materially from those described in the
forward-looking statements can be found in diaDexus' most recent
annual report on Form 10-K and subsequent quarterly reports on Form
10-Q and other reports filed with the Securities and Exchange
Commission, and available at the SEC's web site at www.sec.gov. The
information set forth herein speaks only as of the date hereof, and
diaDexus disclaims any intention and does not assume any obligation
to update or revise any forward looking statement, whether as a
result of new information, future events or otherwise.
-- Tables to follow –
DIADEXUS,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December
31,
|
|
|
Years
Ended
December
31,
|
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue
|
|
$
|
76
|
|
|
$
|
76
|
|
|
$
|
305
|
|
|
$
|
305
|
|
|
Royalty revenue
|
|
|
996
|
|
|
|
1,005
|
|
|
|
3,859
|
|
|
|
3,632
|
|
|
Product sales
|
|
|
3,646
|
|
|
|
2,058
|
|
|
|
11,738
|
|
|
|
7,132
|
|
|
Product sales to related
party
|
|
|
161
|
|
|
|
160
|
|
|
|
482
|
|
|
|
681
|
|
|
Total
revenues
|
|
|
4,879
|
|
|
|
3,299
|
|
|
|
16,384
|
|
|
|
11,750
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product costs
|
|
|
1,628
|
|
|
|
1,270
|
|
|
|
5,404
|
|
|
|
4,652
|
|
|
Sales and
marketing
|
|
|
852
|
|
|
|
1,102
|
|
|
|
4,143
|
|
|
|
5,138
|
|
|
Research and
development
|
|
|
923
|
|
|
|
1,351
|
|
|
|
5,138
|
|
|
|
4,935
|
|
|
General and
administrative
|
|
|
2,438
|
|
|
|
2,114
|
|
|
|
9,544
|
|
|
|
5,629
|
|
|
Total
operating costs and expenses
|
|
|
5,841
|
|
|
|
5,837
|
|
|
|
24,229
|
|
|
|
20,354
|
|
|
Loss from
operations
|
|
|
(962)
|
|
|
|
(2,538)
|
|
|
|
(7,845)
|
|
|
|
(8,604)
|
|
|
Interest income, interest
expense and other income (expense), net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
12
|
|
|
|
15
|
|
|
|
56
|
|
|
|
40
|
|
|
Interest
expense
|
|
|
(102)
|
|
|
|
207
|
|
|
|
288
|
|
|
|
(149)
|
|
|
Other income (expense),
net
|
|
|
10
|
|
|
|
(2)
|
|
|
|
19
|
|
|
|
42
|
|
|
Loss before income
tax
|
|
|
(1,042)
|
|
|
|
(2,318)
|
|
|
|
(7,482)
|
|
|
|
(8,671)
|
|
|
Income tax benefit
(provision)
|
|
|
—
|
|
|
|
231
|
|
|
|
(1)
|
|
|
|
226
|
|
|
Net loss
|
|
$
|
(1,042)
|
|
|
$
|
(2,087)
|
|
|
$
|
(7,483)
|
|
|
$
|
(8,445)
|
|
|
Basic and diluted net loss
per share:
|
|
$
|
(0.02)
|
|
|
$
|
(0.04)
|
|
|
$
|
(0.14)
|
|
|
$
|
(0.25)
|
|
|
Weighted average shares
used in computing basic and diluted net loss per share
|
|
|
53,067,045
|
|
|
|
53,067,057
|
|
|
|
53,067,052
|
|
|
|
33,594,033
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DIADEXUS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
2011
|
|
|
December 31,
2010
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
$
|
10,484
|
|
|
$
|
20,394
|
|
|
Short-term
marketable securities
|
|
|
6,492
|
|
|
|
—
|
|
|
Accounts
receivable
|
|
|
2,408
|
|
|
|
1,543
|
|
|
Receivable
from related party
|
|
|
—
|
|
|
|
175
|
|
|
Inventories
|
|
|
117
|
|
|
|
105
|
|
|
Restricted
cash
|
|
|
400
|
|
|
|
—
|
|
|
Assets held
for sale
|
|
|
304
|
|
|
|
308
|
|
|
Prepaid
expenses and other current assets
|
|
|
975
|
|
|
|
1,046
|
|
|
Total current assets
|
|
|
21,180
|
|
|
|
23,571
|
|
|
Long-term investments
|
|
|
250
|
|
|
|
—
|
|
|
Restricted cash
|
|
|
1,400
|
|
|
|
1,800
|
|
|
Property and equipment,
net
|
|
|
1,350
|
|
|
|
580
|
|
|
Other long-term
assets
|
|
|
175
|
|
|
|
128
|
|
|
Total assets
|
|
$
|
24,355
|
|
|
$
|
26,079
|
|
|
|
|
|
|
Liabilities and Stockholders'
Equity
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
882
|
|
|
$
|
445
|
|
|
Deferred
revenues, current portion
|
|
|
331
|
|
|
|
305
|
|
|
Deferred
rent, current portion
|
|
|
—
|
|
|
|
103
|
|
|
Unfavorable
lease obligations
|
|
|
492
|
|
|
|
363
|
|
|
Notes
payable, current portion
|
|
|
372
|
|
|
|
—
|
|
|
Accrued and
other current liabilities
|
|
|
2,469
|
|
|
|
1,930
|
|
|
Total current
liabilities
|
|
|
4,546
|
|
|
|
3,146
|
|
|
Long-term deferred
rent
|
|
|
266
|
|
|
|
52
|
|
|
Non-current portion of
unfavorable lease obligation
|
|
|
3,063
|
|
|
|
3,555
|
|
|
Non-current portion of deferred
revenue
|
|
|
530
|
|
|
|
835
|
|
|
Non-current portion of notes
payable
|
|
|
4,526
|
|
|
|
—
|
|
|
Other long term
liabilities
|
|
|
284
|
|
|
|
646
|
|
|
Total liabilities
|
|
|
13,215
|
|
|
|
8,234
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
—
|
|
|
|
—
|
|
|
Common stock
|
|
|
531
|
|
|
|
531
|
|
|
Additional
paid-in capital
|
|
|
205,557
|
|
|
|
204,774
|
|
|
Accumulated
other comprehensive loss
|
|
|
(5)
|
|
|
|
—
|
|
|
Accumulated
deficit
|
|
|
(194,943)
|
|
|
|
(187,460)
|
|
|
Total stockholders'
equity
|
|
|
11,140
|
|
|
|
17,845
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
24,355
|
|
|
$
|
26,079
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE diaDexus, Inc.