BETHLEHEM, Pa., Oct 24, 2001 (BW HealthWire) -- OraSure Technologies, Inc.
(Nasdaq NM:OSUR), the market leader for oral fluid diagnostics, today announced
record third quarter revenues of $8.6 million, a 19 percent increase over the
$7.2 million reported in the same period a year ago.
The net profit for the quarter was $16,000, an improvement of $7.9 million over
the third quarter of 2000, which included a one-time charge of $5.9 million for
merger-related expenses. Excluding revenue from the prior period for the
discontinued Serum Western Blot product, total revenue would have increased by
27 percent in the third quarter.
Cash flow from operations, as measured by EBITDA (earnings before interest
expense, taxes, depreciation and amortization), was $620,000 for the quarter.
This was the Company's second consecutive quarter of positive cash flow.
For the first nine months of 2001, revenues were also a record of $24.5 million,
17 percent above the comparable period in 2000. The net loss for the nine-month
period was $1.4 million, an improvement of $7.7 million over the first nine
months of 2000, which included a one-time charge of $5.9 million for
merger-related expenses.
Excluding revenue from the prior period for the discontinued Serum Western Blot
product, total revenue would have increased by 24 percent in the first nine
months.
Robert D. Thompson, Chief Executive Officer of OraSure Technologies, Inc.,
stated, "We are very pleased with the strong revenue growth and achieving
profitability. Our Intercept(R) and OraQuick(R) products have driven our growth
this year. Intercept(R) is showing strong momentum, as oral fluid drug testing
gains marketplace acceptance, in both the occupational health and correctional
health settings. This momentum will be aided by the recent inclusion of oral
fluid drug testing in the new draft federal drug program guidelines for all
uses, including pre-employment, random, and post-accident testing. We shipped
our first OraQuick(R) order to the Centers for Disease Control and Prevention
(CDC) for use in more than fifteen African countries participating in the LIFE
Initiative. Additionally, OraQuick(R) was selected for use in the CDC's MIRIAD
Project, a program focused on reducing mother-to-child transmission of HIV in
the United States." The Company showed significant improvement in its cost
structure during the third quarter. Gross margins improved to 67% from 57% in
the comparable quarter of 2000. Operating expenses totaled approximately $5.7
million for the quarter, a decline of $700,000 from the total of $6.4 million
recorded in the comparable quarter of 2000, reflecting synergies from the
merger.
The Company announced today it has received FDA feedback on its OraQuick(R)
submission filed in late June. The FDA responded to the OraQuick(R) submission
in a very timely manner with its first round of questions on the data submitted.
The Company promptly answered those questions, and the FDA's review is
progressing as anticipated.
The FDA also responded to the Company's UPlink(TM) submission, which was filed
in late June. Because this is the first reader-based oral fluid point-of-care
testing system submitted to the FDA, and due to UPlink's(TM) very broad clinical
utility, the FDA has requested approximately sixty additional trial samples for
each of the six drug assays.
Consequently, the Company is now expecting full clearance of all of the drugs of
abuse assays in the first quarter of 2002. However, the Company expects revenue
in the fourth quarter of 2001 and first quarter of 2002 from initial UPlink(TM)
reader shipments to development partners.
"Despite our impressive revenue gains, we are disappointed with the unforeseen
delays of OraQuick(R) orders from our African distributor, which were the result
of government purchase process delays in Africa," said Mr. Thompson. "We expect
to work through these delays and continue to develop these opportunities in the
future," he added.
In light of these developments, the Company's new revenue projection for the
fourth quarter of 2001 is set in excess of $10 million, more than 28 percent
higher than revenues in the fourth quarter of 2000. The Company also expects to
report a net profit in the fourth quarter.
Excluding revenues from the discontinued Serum Western Blot product line,
projected fourth quarter 2001 revenues would represent growth of more than 35
percent over 2000.
For 2002, the Company expects revenue growth of at least 30 percent over 2001,
and continued strong growth in earnings. Mr. Thompson continued, "We are
positioning the Company to achieve even higher growth. The key milestones
include FDA approval of both the OraQuick(R) HIV and UPlink(TM) Drugs of Abuse
products in the United States, the recruiting of new marketing partners for
UPlink(TM), Intercept(R), and OraQuick(R), and the execution of additional joint
development agreements to pursue new markets with our platform technologies."
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 October 29, 2001, by dialing
888/203-1112 (Domestic) or 719/457-0820 (International) and entering the access
code 683274.
Important Information
This press release contains certain forward-looking statements, including with
respect to revenues, earnings, and product development, performance, regulatory
approvals, shipments and markets. 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; ability to sell products internationally; 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.
Condensed Financial Data
(In thousands, Except Per-Share Data)
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
------------- -------------
2001 2000 2001 2000
---- ---- ---- ----
Results of
Operations
Revenues $ 8,599 $ 7,222 $ 24,510 $ 21,002
Cost of
goods sold 2,873 3,097 8,580 8,211
-------- -------- -------- --------
Gross margin 5,726 4,125 15,930 12,791
Operating expenses 5,737 6,418 17,332 17,128
Merger related
costs -- 5,920 -- 5,920
Manufacturing
restructuring
costs -- -- 450 --
-------- -------- -------- --------
Operating
Income (loss) (11) (8,213) (1,852) (10,257)
Other income
(expense), net 27 289 427 1,162
-------- -------- -------- --------
Net income
(loss) 16 (7,924) (1,425) (9,095)
======== ======== ======== ========
Earnings (loss)
per common
share:
Basic $ 0.00 $ (0.22) $ (0.04) $ (0.26)
======== ======== ======== ========
Diluted $ 0.00 $ (0.22) $ (0.04) $ (0.26)
======== ======== ======== ========
Average shares
of common stock
outstanding:
Basic 37,057 35,370 36,741 34,546
======== ======== ======== ========
Diluted 39,009 35,370 36,741 34,546
======== ======== ======== ========
Product Revenue Summary
Three Months Ended
September 30, Percentage of
Dollars % Total Revenues
------- --------------
2001 2000 Change 2001 2000
---- ---- ------ ---- ----
Product Revenues
Oral specimen
collection
devices $3,139 $2,856 10% 36% 40%
OraQuick(R) 415 -- N/A 5% 0%
Histofreezer(R)
cryosurgical
systems 1,954 1,737 12% 23% 24%
Immunoassay
tests 2,027 1,445 40% 23% 20%
Western Blot
HIV
confirmatory
tests 143 538 (73)% 2% 7%
Other product
revenues 559 291 92% 7% 4%
------ ------ ------ ------ ------
8,237 6,867 20% 96% 95%
License and product
development 362 355 2% 4% 5%
------ ------ ------ ------
Total revenues $8,599 $7,222 19% 100% 100%
====== ====== ====== ======
Nine Months Ended
September 30, Percentage of
Dollars % Total Revenues
------- --------------
2001 2000 Change 2001 2000
---- ---- ------ ---- ----
Product Revenues
Oral specimen
collection
devices $ 9,855 $ 8,271 19% 40% 39%
OraQuick(R) 655 -- N/A 3% 0%
Histofreezer(R)
cryosurgical
systems 4,733 4,681 1% 19% 22%
Immunoassay
tests 5,835 4,959 18% 24% 24%
Western Blot
HIV
confirmatory
tests 471 1,424 (67)% 2% 7%
Other product
revenues 1,658 1,062 56% 7% 5%
------- ------- ------- -------
23,207 20,397 14% 95% 97%
License and product
development 1,303 605 115% 5% 3%
------- ------- ------- -------
Total revenues $24,510 $21,002 17% 100% 100%
======= ======= ======= =======
About OraSure Technologies
OraSure Technologies, Inc. is the market leader for oral fluid diagnostics. The
Company develops, manufactures and markets medical devices and diagnostic
products for use by insurance companies, public health agencies, clinical
laboratories, physicians' offices and workplace sites. For more information on
the Company, please visit www.orasure.com.
www.orasure.com
CONTACT: OraSure Technologies, Inc.
Rich Hooper, 610/882-1820 x 3042
Investorinfo@orasure.com
