OraSure Technologies, Inc. (NASDAQ:OSUR), a market leader in oral
fluid diagnostics, today announced quarterly revenues of $18.1
million for the three months ended March 31, 2008, compared to
$20.1 million in revenues recorded for the three months ended March
31, 2007. Increased sales of the Company�s OraQuick ADVANCE� rapid
HIV-1/2 antibody test, professional cryosurgical products and
insurance risk assessment products during the first quarter 2008,
were offset by decreased sales of the Company�s over-the-counter
(�OTC�) cryosurgical wart removal products and substance abuse
testing products and lower licensing and product development
revenue. The Company�s net income increased 35% to $2.0 million, or
$0.04 per share on a fully-diluted basis, for the first quarter of
2008, compared to net income of $1.5 million, or $0.03 per share on
a fully-diluted basis, for the first quarter of 2007. The 2008
results include a previously announced $4.9 million pre-tax gain
related to a settlement and licensing agreement entered into during
the quarter with Schering-Plough Healthcare Products, Inc. The 2007
results include a $1.4 million pre-tax gain from the sale of the
Company�s equity interest in a foreign distributor. Gross margin in
the first quarter of 2008 was 59% compared with 62% in the first
quarter of 2007. Gross margin was affected by a less favorable
product mix, increased scrap and spoilage expense, and higher
unabsorbed overhead. Operating expenses for the first quarter of
2008 increased $1.7 million to $13.6 million, from $11.9 million in
the comparable period in 2007. This increase was primarily
attributable to higher research and development costs associated
with the Company�s OraQuick� HIV OTC and OraQuick� HCV clinical
development programs. �Our first quarter financial performance was
in line with our most recent guidance, and we continue to make very
good progress against our strategic initiatives,� said Douglas A.
Michels, President and Chief Executive Officer of OraSure
Technologies. �Our clinical trials for FDA and European approval of
an OraQuick� HCV test are on schedule and progressing well, and we
have initiated the observed use study for our OraQuick� OTC test.
We have also continued to advance the development of fully
automated homogeneous oral fluid drug assays for use with our
Intercept� collector under our collaboration with Roche
Diagnostics. Despite these positive developments, however, we are
also facing a number of challenges to our business, against which
we will intensify our efforts during the remainder of the year.�
Cash, cash equivalents and short-term investments were $90.4
million and working capital was $106.0 million at March 31, 2008,
compared to $95.6 million and $105.6 million, respectively, at
December 31, 2007. Cash flow used in operating activities was $3.7
million in the first quarter of 2008 compared to $1.0 million in
the first quarter of 2007. First quarter 2008 net operating cash
out-flows included a $5.6 million decrease in accounts payable and
accrued expenses reflecting reductions in year-end royalty and
legal accruals and an increase in accounts receivable balances.
Full Year and Second Quarter 2008 Outlook As previously announced,
a patent infringement lawsuit against the Company was recently
filed by Inverness Medical and Church & Dwight, which will
result in an unexpected increase in legal costs during 2008. In
addition, there was an unanticipated inventory buildup at the
Company�s OTC cryosurgical distributor in Mexico and a recent
change in funding sources for the purchase of OraQuick� HIV tests
in Africa, both of which are impacting the Company�s business. In
the U.S., the Company is experiencing lower than expected growth of
OraQuick ADVANCE� sales in the U.S. hospital market, and the
slowing economy continues to impact hiring and workplace drug
testing. In view of these developments, the Company has decided to
lower its financial guidance for 2008. The Company expects total
revenues for second quarter 2008 to range from approximately $18.5
to $19.0 million and a second quarter loss per share to be between
$0.06 and $0.07. Full year 2008 revenues are projected to be
approximately $83.0 million with a loss per share ranging from
approximately $0.10 to $0.11. � Financial Data � � Condensed
Financial Data (In thousands, except per-share data and
percentages) (Unaudited) � Three months ended March 31, 2008 � 2007
Results of Operations Revenues $ 18,089 $ 20,109 Cost of products
sold � 7,446 � � 7,584 Gross profit � 10,643 � � 12,525 Operating
expenses: Research and development 4,598 2,920 Sales and marketing
5,216 4,771 General and administrative � 3,841 � � 4,237 Total
operating expenses � 13,655 � � 11,928 Operating income (loss)
(3,012 ) 597 Other income, net � 5,746 � � 2,389 Pre-tax income
2,734 2,986 Income tax provision � 732 � � 1,499 Net income $ 2,002
� $ 1,487 Earnings per share Basic $ 0.04 � $ 0.03 Diluted $ 0.04 �
$ 0.03 Weighted average shares: Basic � 46,784 � � 46,114 Diluted �
47,268 � � 46,554 � � � Three months ended March 31, %Change Market
Revenues 2008 � 2007 � Infectious disease testing $ 9,480 $ 8,932 6
% Substance abuse testing 3,277 3,929 (17 ) Cryosurgical systems
3,336 5,680 (41 ) Insurance risk assessment � 1,538 � 889 73
Product revenues 17,631 19,430 (9 ) Licensing and product
development � 458 � 679 (33 ) Total revenues $ 18,089 $ 20,109 (10
)% � � � Three months ended March 31, %Change OraQuick� Revenues
2008 � 2007 � Direct to U.S. Public Health $ 6,282 $ 4,342 45 %
Abbott 1,925 2,151 (11 ) SAMHSA ? 329 (100 ) CDC ? 620 (100 )
International � 646 � 747 (14 ) Total OraQuick� revenues $ 8,853 $
8,189 8 % � � � Three months ended March 31, %Change Intercept�
Revenues 2008 � 2007 � Workplace testing $ 1,016 $ 1,545 (34 )%
Criminal justice 619 645 (4 ) International 525 600 (13 ) Direct �
271 � 202 34 Total Intercept� revenues $ 2,431 $ 2,992 (19 )% � � �
Three months ended March 31, %Change Cryosurgery Revenues 2008 �
2007 � Professional domestic $ 1,034 $ 1,053 (2 )% Professional
international 737 467 58 OTC domestic ? 2,150 (100 ) OTC
international � 1,565 � 2,010 (22 ) Total cryosurgery revenues $
3,336 $ 5,680 (41 )% � � � Balance Sheets March 31, 2008 December
31, 2007 (Unaudited) Assets Cash, cash equivalents and short-term
investments $ 90,396 $ 95,566 Accounts receivable, net 13,729
11,296 Inventories 9,929 9,410 Deferred income taxes 2,200 5,061
Other current assets 2,433 2,456 Property and equipment, net 21,172
20,911 Deferred income taxes 19,328 17,266 Other non-current assets
� 5,113 � 5,387 Total assets $ 164,300 $ 167,353 � Liabilities and
Stockholders� Equity Current portion of long-term debt $ 557 $ 557
Accounts payable 3,654 5,616 Accrued expenses 8,440 11,996
Long-term debt 8,720 8,818 Other liabilities 69 312 Stockholders�
equity � 142,860 � 140,054 Total liabilities and stockholders�
equity $ 164,300 $ 167,353 � � Three months ended March 31,
Additional Financial Data 2008 � 2007 � Capital expenditures $ 755
$ 898 Depreciation and amortization $ 691 $ 656 Accounts receivable
� days sales outstanding 69 days 66 days � Conference Call The
Company will host a conference call and audio webcast today to
discuss the Company's 2008 first quarter financial results,
business developments and the Company�s 2008 outlook, beginning at
5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will
be Douglas A. Michels, President and Chief Executive Officer, and
Ronald H. Spair, Chief Operating Officer and Chief Financial
Officer. The call will include remarks by management and a question
and answer session. In order to listen to the conference call,
please dial 888-742-2024 (Domestic) or 706-643-0033 (International)
and reference 43942293 or go to OraSure Technologies� web site,
www.orasure.com, and click on the Investor Info link. A replay of
the call will be archived on OraSure Technologies' web site shortly
after the call has ended and will be available for seven days. A
replay of the call can also be accessed until May 13, 2008, by
dialing 800-642-1687 (Domestic) or 706-645-9291 (International) and
entering the Conference ID #43942293. About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid
specimen collection devices and tests and other diagnostic products
using proprietary technologies, including immunoassays and other in
vitro diagnostic tests and other medical devices. These products
are sold in the United States and certain foreign countries to
clinical laboratories, hospitals, clinics, community-based
organizations and other public health organizations, distributors,
government agencies, physicians� offices, and commercial and
industrial entities. For more information on the Company, please
visit www.orasure.com. Important Information This press release
contains certain forward-looking statements, including with respect
to revenues, net income, earnings/loss per share and products.
Actual results could be significantly different. Factors that could
affect results include the ability to market and sell products;
changes in relationships, including disputes or disagreements, with
strategic partners and reliance on strategic partners for the
performance of critical activities under collaborative
arrangements; failure of distributors or other customers to meet
purchase forecasts or minimum purchase requirements for the
Company�s products; inventory levels at distributors and other
customers; impact of competitors, competing products and technology
changes; ability to develop, commercialize and market new products;
market acceptance of oral fluid testing or other products; changes
in market acceptance of products based on product performance;
continued bulk purchases by customers, including governmental
agencies, and the ability to fully deploy those purchases in a
timely manner; ability to fund research and development and other
products and operations; ability to obtain and maintain new or
existing product distribution channels; reliance on sole supply
sources for critical product components; availability of related
products produced by third parties or products required for use of
our products; ability to obtain, and timing and cost of obtaining,
necessary regulatory approvals for new products or new indications
or applications for existing products; ability to comply with
applicable regulatory requirements; history of losses and ability
to achieve sustained profitability; volatility of our stock price;
uncertainty relating to patent protection and potential patent
infringement claims; uncertainty and costs of litigation relating
to patents and other intellectual property; availability of
licenses to patents or other technology; ability to enter into
international manufacturing agreements; obstacles to international
marketing and manufacturing of products; ability to sell products
internationally, including changes in international funding
sources; loss or impairment of sources of capital; ability to meet
financial covenants in agreements with financial institutions;
ability to retain qualified personnel; exposure to patent
infringement, product liability, and other types of litigation;
changes in international, federal or state laws and regulations;
customer consolidations and inventory practices; equipment failures
and ability to obtain needed raw materials and components; the
impact of terrorist attacks and civil unrest; ability to complete
consolidation or restructuring activities; ability to identify,
complete and realize the full benefits of potential acquisitions;
and general political, business and economic conditions. These and
other factors are discussed more fully in the Securities and
Exchange Commission (�SEC�) filings of OraSure Technologies,
including its registration statements, its Annual Report on Form
10-K for the year ended December 31, 2007, its Quarterly Reports on
Form 10-Q, and its other filings with the SEC. Although
forward-looking statements help to provide complete information
about future prospects, readers should keep in mind that
forward-looking statements may not be reliable. The forward-looking
statements are made as of the date of this press release and
OraSure Technologies undertakes no duty to update these statements.
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