BETHLEHEM, Pa.--(BW HealthWire)--July 27, 2001--
-Revenues Increase by 19%-
-Operating Loss Improves by $540,000-
OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader for
oral fluid diagnostics of infectious disease and drugs of abuse, today
announced record revenues for the second quarter of approximately $8.5
million compared to $7.2 million for the same period a year ago, a 19%
increase. This record was achieved despite revenue lost as a result of
the discontinuation of the Serum Western Blot product in January 2001.
Excluding revenue from the prior period for the discontinued Serum
Western Blot product, total revenue would have increased approximately
24%.
The operating loss was approximately $612,000 for the quarter
ended June 30, 2001, representing an improvement of $540,000 from a
year ago. The net loss was approximately $444,000 or $(0.01) per share
for the quarter, compared to a net loss of $337,000 or $(0.01) per
share for the second quarter of 2000, which included a one-time gain
of $600,000 on the sale of securities in 2000. The Company experienced
positive cash flow from operations, as measured by EBITDA (earnings
before interest expense, taxes, depreciation and amortization), of
approximately $175,000 for the quarter.
During the second quarter, the Company achieved two significant
regulatory milestones with respect to the UPlink(TM) and OraQuick(R)
products. The Company filed a 510(k) application with the U.S. Food
and Drug Administration (FDA) for its UPlink(TM) reader and six oral
fluid drugs of abuse assays - cocaine, opiates, amphetamine,
methamphetamine, PCP and marijuana. In addition, the Company filed
with the FDA for pre-market approval of its OraQuick(R) HIV test for
serum and whole blood applications. A similar filing for oral fluid
specimens is expected to be made in the fourth quarter of 2001.
Revenues from the sale of oral fluid collection devices and
related immunoassay tests increased approximately 21% due to continued
penetration into the public health, insurance and drugs of abuse
testing markets. License and product development revenues related to
UPlink(TM) increased approximately $310,000, or 263%, as a result of
the receipt of milestone payments under existing development
arrangements. Revenues were negatively impacted by the delay of
OraQuick(R) sales to the Centers for Disease Control and Prevention
and the Company's distributor in Africa. The Company anticipates the
sales of OraQuick(R) to both customers to occur in the third quarter.
Robert D. Thompson, Chief Executive Officer of OraSure
Technologies stated, "The steady growth in sales of OraSure(R) and
Intercept(TM) collection devices and related assays confirms the
continuing adoption of oral fluid diagnostics in many markets. Despite
the delay in OraQuick(R) shipments, we achieved record revenues for
the quarter. Furthermore, by hitting our UPlink(TM) and OraQuick(R)
regulatory milestones, OraSure Technologies is positioning itself for
another strong year of growth in 2002."
Gross margins improved to approximately 65% for the quarter ended
June 30, 2001, compared to 64% last year, principally as a result of
the Company's manufacturing reorganization in the first quarter of
2001 and higher license and product development revenues. The
Company's gross margin is anticipated to continue to improve during
the remainder of the year.
Operating expenses increased approximately 10% to $9.1 million for
the quarter ended June 30, 2001, as compared to the comparable quarter
last year. Research and development expenses increased approximately
15% to $2.4 million as a result of continued development and clinical
trial expenses for both the OraQuick(R) and UPlink(TM) products. Sales
and marketing expenses increased approximately 14% to $2.1 million as
a result of increased spending levels intended to expand product sales
globally and prepare for a market launch of UPlink(TM) in the third
quarter. General and administrative expenses declined approximately 9%
to $1.6 million as a result of cost savings associated with the merger
of Epitope, Inc. and STC Technologies, Inc. into OraSure Technologies
last year.
Internet Audio Broadcast
OraSure Technologies will host a conference call with analysts to
discuss these results beginning at 11:00 a.m. Eastern Time (8:00 a.m.
Pacific Time) today. In order to listen to the conference call, please
go to OraSure Technologies' web site, www.orasure.com, at least ten
minutes prior to the start of the call to register, download and
install any necessary audio software. In addition, a replay will be
archived on OraSure Technologies' web site shortly after the call has
ended and will be available for 30 days.
A replay of the call can also be accessed until July 30, 2001, by
dialing 888/203-1112 (Domestic) or 719/457-0820 (International)
and entering the confirmation number 437867.
Condensed Financial Data
(In thousands, Except Per-Share Data)
(Unaudited)
Three months ended Six months ended
June 30, June 30,
-------- --------
2001 2000 2001 2000
---- ---- ---- ----
Results of
Operations
Revenues $ 8,508 $ 7,161 $ 15,912 $ 13,780
Operating costs
and expenses 9,120 8,313 17,303 15,824
Manufacturing
restructuring
costs -- -- 450 --
-------- -------- -------- --------
Operating loss (612) (1,152) (1,841) (2,044)
Other income
(expense), net 168 815 400 873
-------- -------- -------- --------
Net loss (444) (337) (1,441) (1,171)
======== ======== ======== ========
Basic and
diluted net
loss per share $ (0.01) $ (0.01) $ (0.04) $ (0.03)
======== ======== ======== ========
Shares used in
computing basic
and diluted net
loss per share 36,702 34,818 36,580 34,130
======== ======== ======== ========
Product Revenue Summary
Three Months Ended June 30,
Percentage of
Dollars Total Revenues
------- % --------------
2001 2000 Change 2001 2000
---- ---- ------ ---- ----
Product Sales
Oral specimen
collection
devices $3,464 $2,887 20% 41% 40%
OraQuick(R) 6 -- N/A 0% 0%
Histofreezer(R)
cryosurgical
systems 1,559 1,580 -1% 18% 22%
Immunoassay
tests 2,138 1,752 22% 25% 24%
Western Blot
HIV confirmatory
tests 104 470 -78% 1% 7%
Other product
sales 809 354 128% 10% 5%
----- ----- ---- --- ---
8,080 7,043 15% 95% 98%
License and
product
development 428 118 263% 5% 2%
----- ----- ---- --- ---
Total revenues $8,508 $7,161 19% 100% 100%
===== ===== ==== ==== ====
Six Months Ended June 30,
Percentage of
Dollars Total Revenues
------- % -------------
2001 2000 Change 2001 2000
---- ---- ------ ---- ----
Product Sales
Oral specimen
collection
devices $ 6,717 $ 5,415 24% 42% 39%
OraQuick(R) 240 -- N/A 2% 0%
Histofreezer(R)
cryosurgical
systems 2,779 2,944 -6% 17% 21%
Immunoassay
tests 3,808 3,514 8% 24% 26%
Western Blot
HIV confirmatory
tests 328 886 -63% 2% 6%
Other product
sales 1,099 771 43% 7% 6%
------ ------ ---- --- ---
14,971 13,530 11% 94% 98%
License and
product
development 941 250 275% 6% 2%
------ ------ ---- ---- ----
Total revenues $15,912 $13,780 15% 100% 100%
====== ====== ==== ==== ====
About OraSure Technologies
OraSure Technologies, Inc. develops, manufactures and markets
medical devices and diagnostic products for use by public- and
private-sector clients, clinical laboratories, physicians' offices and
workplace testing.
OraSure Technologies is the leading supplier of oral fluid
collection devices and assays to the life insurance industry and
public health markets for the detection of antibodies to HIV. In
addition, the Company supplies oral fluid testing solutions for drugs
of abuse testing. For more information on the Company, please visit
www.orasure.com.
This press release contains certain forward-looking statements,
including with respect to revenues, earnings, gross margins, product
shipments, sales and markets, and regulatory filings. Actual results
could be significantly different.
Factors that could affect results include ability to market
products; impact of competitors, competing products and technology
changes; ability to develop, commercialize and market new products;
market acceptance of oral fluid testing products and up-converting
phosphor technology products; ability to fund research and development
and other projects and operations; ability to obtain and timing of
obtaining necessary regulatory approvals; ability to develop product
distribution channels; uncertainty relating to patent protection and
potential patent infringement claims; ability to enter into
international manufacturing agreements; obstacles to international
marketing and manufacturing of products; loss or impairment of sources
of capital; exposure to product liability and other types of
litigation; changes in international, federal or state laws and
regulations; changes in relationships with strategic partners and
reliance on strategic partners for the performance of critical
activities under collaborative arrangements; changes in accounting
practices or interpretation of accounting requirements; equipment
failures and ability to obtain needed raw materials and components;
and general business and economic conditions.
These and other factors are discussed more fully in the Securities
and Exchange Commission filings of OraSure Technologies, including its
Annual Report on Form 10-K for the year ended December 31, 2000.
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.
www.orasure.com
| CONTACT: |
OraSure Technologies, Inc. |
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Rich Hooper, 610/882-1820 x3042 |
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Investorinfo@orasure.com |
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