OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral
fluid diagnostics, today announced total revenues of $17.4 million
for the three months ended March 31, 2011, compared to $17.9
million recorded for the three months ended March 31, 2010.
Product revenues for the quarter increased 3% as higher sales of
the Company's infectious disease and substance abuse testing
products were partially offset by lower sales of its cryosurgical
systems and insurance risk assessment products. The higher product
revenues were offset by a reduction in licensing and product
development revenues caused by the absence of a $1.0 million
milestone payment received in the first quarter of 2010 under the
terms of the Company's collaboration with Merck related to the
development and promotion of the OraQuick® rapid HCV test.
The Company reported a net loss of $2.6 million, or $0.06 per
share, for the first quarter of 2011, compared to a net loss of
$2.2 million, or $0.05 per share, for the first quarter of
2010.
Cash used in operating activities for the three months ended
March 31, 2011 was $2.0 million, an improvement of $3.0 million
when compared to the $5.0 million used during the three months
ended March 31, 2010.
"Our financial results for the first quarter came in better than
expected," said Douglas A. Michels, President and CEO of OraSure
Technologies, Inc. "We exceeded our guidance for both revenues and
the bottom line. Despite continued economic and funding challenges,
we made solid progress on our goals for the quarter, including the
ongoing clinical development of our OraQuick® HIV OTC test, which
is a testament to the quality of our team."
Gross margin in the first quarter of 2011 was 65%, compared to
64% in the first quarter of 2010. Gross margin for the current
period benefited from increased manufacturing efficiencies and a
more favorable product mix.
Operating expenses for the first quarter of 2011 increased to
$13.8 million, from $13.6 million in the comparable period of 2010,
primarily as a result of higher research and development expenses
due to clinical trial spending related to the Company's OraQuick®
HIV over-the-counter product study. This increase was partially
offset by lower sales and marketing and general and administrative
expenses.
Cash, cash equivalents and short-term investments totaled $72.4
million and working capital was $76.0 million at March 31, 2011,
compared to $75.7 million and $77.8 million, respectively, at
December 31, 2010.
Second Quarter 2011 Outlook
The Company expects total revenues for the second quarter of
2011 to range from approximately $17.75 to $18.25 million. The
Company is currently projecting a loss per share for the second
quarter of 2011 of approximately $0.07 to $0.08.
Financial Data
|
Condensed Financial
Data |
|
(In thousands, except
per‑share data) |
|
(Unaudited) |
|
|
|
Three months
ended March 31, |
|
2011 |
2010 |
Results of Operations |
|
|
Revenues |
$17,414 |
$17,945 |
Cost of products sold |
6,147 |
6,541 |
Gross profit |
11,267 |
11,404 |
Operating expenses: |
|
|
Research and development |
4,420 |
3,107 |
Sales and marketing |
4,932 |
5,694 |
General and administrative |
4,468 |
4,779 |
Total operating expenses |
13,820 |
13,580 |
Operating loss |
(2,553) |
(2,176) |
Other expense |
(45) |
(19) |
Pre-tax loss |
(2,598) |
(2,195) |
Income tax benefit |
− |
− |
Net loss |
$ (2,598) |
$ (2,195) |
Loss per share |
$ (0.06) |
$ (0.05) |
Basic and diluted |
Weighted average shares: |
|
|
Basic and diluted |
46,518 |
46,112 |
|
|
|
|
|
Three months
ended March 31, |
|
|
|
Percentage
of |
|
Dollars |
% |
Total
Revenues |
Market
Revenues (Unaudited) |
2011 |
2010 |
Change |
2011 |
2010 |
|
|
|
|
|
|
Infectious disease testing |
$9,962 |
$9,481 |
5% |
57% |
53% |
Substance abuse testing |
3,061 |
2,713 |
13 |
18 |
15 |
Cryosurgical systems |
2,710 |
2,994 |
(9) |
15 |
17 |
Insurance risk assessment |
1,317 |
1,384 |
(5) |
8 |
7 |
Product revenues |
17,050 |
16,572 |
3 |
98 |
92 |
Licensing and product development |
364 |
1,373 |
(73) |
2 |
8 |
Total revenues |
$17,414 |
$17,945 |
(3)% |
100% |
100% |
|
|
|
|
|
|
Three months ended |
|
|
|
March
31, |
% |
OraQuick® HIV
Revenues |
|
2011 |
2010 |
Change |
Domestic |
|
$8,866 |
$8,733 |
2% |
International |
|
698 |
324 |
115% |
Total OraQuick® HIV revenues |
|
$9,564 |
$9,057 |
6% |
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
|
|
March
31, |
% |
Intercept®
Revenues |
|
2011 |
2010 |
Change |
Domestic |
|
$1,877 |
$1,528 |
23% |
International |
|
519 |
517 |
− |
Total Intercept® revenues |
|
$2,396 |
$2,045 |
17% |
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Cryosurgical Systems |
|
March
31, |
% |
Revenues |
|
2011 |
2010 |
Change |
Professional domestic |
|
$1,342 |
$1,210 |
11% |
Professional international |
|
339 |
270 |
26 |
Over-the-counter |
|
1,029 |
1,514 |
(32) |
Total cryosurgical systems |
|
|
|
|
revenues |
|
$2,710 |
$2,994 |
(9)% |
|
|
|
|
|
|
|
|
Balance
Sheets (Unaudited) |
March 31,
2011 |
|
December 31,
2010 |
Assets |
|
|
|
Cash, cash equivalents and short-term |
$72,439 |
|
$75,738 |
investments |
|
|
|
Accounts receivable, net |
12,120 |
|
12,471 |
Inventories |
7,750 |
|
7,346 |
Other current assets |
1,938 |
|
1,930 |
Property and equipment, net |
19,850 |
|
19,611 |
Other non-current assets |
5,096 |
|
5,424 |
Total assets |
$119,193 |
|
$122,520 |
|
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
Current portion of long-term debt |
$7,667 |
|
$7,791 |
Accounts payable |
3,506 |
|
2,899 |
Accrued expenses |
7,048 |
|
8,987 |
Stockholders' equity |
100,972 |
|
102,843 |
Total liabilities and stockholders'
equity |
$119,193 |
|
$122,520 |
|
|
|
|
|
Three months
ended |
|
March 31, |
Additional Financial
Data (Unaudited) |
2011 |
|
2010 |
|
|
|
|
Capital expenditures |
$882 |
|
$532 |
Depreciation and amortization |
$829 |
|
$650 |
Stock based compensation |
$973 |
|
$891 |
Cash used in operating activities |
$2,049 |
|
$5,004 |
Accounts receivable – days sales |
|
|
|
outstanding |
63 days |
|
61 days |
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2011 first quarter financial results,
business developments and certain 2011 financial guidance,
beginning today 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 Financial Officer and
Chief Operating Officer. The call will include prepared remarks by
management and a question and answer session.
In order to listen to the conference call, please either dial
877-348-9357 (Domestic) or 970-315-0488 (International) and
reference Conference ID #61775799, 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 11,
2011, by dialing 800-642-1687 (Domestic) or 706-645-9291
(International) and entering the Conference ID #61775799.
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.
The OraSure Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6440
Important Information
This press release contains certain forward-looking statements,
including with respect toexpected revenues and earnings/loss per
share. Forward-looking statements are not guarantees of future
performance or results. Known and unknown factors that could cause
actual performance or results to be materially different from those
expressed or implied in these statements include, but are not
limited to: ability to market and sell products, whether through an
internal, direct sales force or third parties; ability to
manufacture products in accordance with applicable specifications,
performance standards and quality requirements; changes in
relationships, including disputes or disagreements, with strategic
partners or other parties 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; impact of replacing distributors and success of
direct sales efforts; inventory levels at distributors and other
customers; impact of competitors, competing products and technology
changes; impact of the economic downturn, high unemployment and
poor credit conditions; reduction or deferral of public funding
available to customers; competition from new or better technology
or lower cost products; 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, extended shelf life or other factors; 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; ability to utilize net operating loss carry forwards
or other deferred tax assets; 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 the impact of changes in international
funding sources and testing algorithms; loss or impairment of
sources of capital; ability to meet financial covenants in
agreements with financial institutions; ability to retain qualified
personnel; exposure to 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 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 Company's Securities and Exchange Commission
filings, including its registration statements, Annual Report on
Form 10-K for the year ended December 31, 2010, Quarterly Reports
on Form 10-Q, and other filings with the SEC. Although
forward-looking statements help to provide 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.
CONTACT: Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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