OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral
fluid diagnostics, today announced revenues of $19.0 million for
the three months ended September 30, 2010, compared to $21.6
million recorded for the three months ended September 30, 2009.
Revenues in the third quarter of 2009 were higher primarily because
they included the elimination of a $2.2 million backlog for
OraQuick® HIV orders which existed at June 30, 2009. Revenues in
the current quarter also reflect increased sales of the Company's
cryosurgical systems and insurance risk assessment products, offset
by decreased sales of its substance abuse testing products and
lower licensing and product development revenues.
The Company recorded net income of $274,000, or $0.01 per share,
for the third quarter of 2010, compared to net income of $1.8
million, or $0.04 per share, for the third quarter of 2009.
"We exceeded our guidance on both the top and bottom lines and
our business performed well during the third quarter," said Douglas
A. Michels, President and CEO of OraSure Technologies. "We
also made good progress on our clinical programs in support of a
finger stick whole blood claim and CLIA waiver for our OraQuick®
HCV test and the final phase of clinical studies for our at-home
HIV test."
For the nine months ended September 30, 2010, the Company
recorded revenues of $56.2 million compared to revenues of $56.1
million for the nine months ended September 30, 2009. The
Company recorded a net loss of $2.5 million, or $0.05 per share,
for the nine months ended September 30, 2010, compared to a net
loss of $5.0 million, or $0.11 per share, for the nine months ended
September 30, 2009. The net loss for the nine months ended
September 30, 2009 included a $3.0 million pre-tax impairment
charge related to the net book value of payments previously
capitalized under an HCV patent license agreement.
Gross margin in the third quarter of 2010 was 62%, compared to
64% in the third quarter of 2009. For the first nine months of
2010, gross margin was 63%, compared to 62% in the same period of
2009. Gross margin in the third quarter of 2009 benefited from the
significant increase in production required to fill the backlog of
OraQuick® HIV orders existing at June 30, 2009. Gross margin
in the third quarter of 2010 is more representative of normal
production levels and benefited from a more favorable product mix
and lower scrap. Gross margin for the nine-month period ended
September 30, 2010 reflects the receipt of $2.0 million in HCV
milestone payments, a more favorable product mix and an improvement
in scrap and spoilage levels when compared to the same period in
2009.
Operating expenses for the third quarter of 2010 decreased to
$11.5 million, from $12.1 million in the comparable period in 2009,
primarily as a result of a decrease in sales and marketing
expenses. Operating expenses for the nine months ended
September 30, 2010 were $37.8 million, compared to $40.1 million
for the same period in 2009. Increases in research and
development and sales and marketing expenses for the first nine
months of 2010 were offset by a decrease in general and
administrative expense and the absence of a $3.0 million impairment
charge recorded in 2009.
Cash, cash equivalents and short-term investments totaled $73.7
million and working capital was $78.4 million at September 30,
2010, compared to $79.7 million and $89.4 million, respectively, at
December 31, 2009. Working capital declined due to the
reclassification of the Company's remaining unpaid principal
balance of its debt obligation to a current liability as a result
of its maturity in June 2011 and the reduction of cash, cash
equivalents and short-term investments. Cash flow provided by
operating activities for the three months ended September 30, 2010
was $3.3 million, compared to $4.3 million for the three months
ended September 30, 2009.
Fourth Quarter 2010 Outlook
The Company expects total revenues for the fourth quarter of
2010 to range from approximately $18.0 to $18.5 million.
The Company also anticipates an increase in research and
development expenses during the fourth quarter of 2010, primarily
related to the initiation of CLIA waiver studies for its OraQuick®
HCV test, the commencement of the final OraQuick® HIV
over-the-counter clinical trial and the ongoing development of a
next generation OraQuick® HIV test. These expenditures,
together with the projected revenues for the period, are expected
to produce a net loss per share of approximately $0.08 to $0.09 for
the fourth quarter of 2010.
Financial Data
OraSure Technologies,
Inc. |
|
|
|
|
|
|
Condensed Financial
Data |
|
(In thousands, except
per-share data) |
|
|
|
Unaudited |
|
|
|
|
Three
months ended September 30, |
Nine months ended
September 30, |
|
2010 |
2009 |
2010 |
2009 |
Results of Operations |
|
|
|
|
Revenues |
$19,034 |
$21,609 |
$56,197 |
$56,139 |
Cost of products sold |
7,220 |
7,706 |
20,802 |
21,384 |
Gross profit |
11,814 |
13,903 |
35,395 |
34,755 |
Operating expenses: |
|
|
|
|
Research and development |
3,008 |
2,925 |
9,143 |
8,710 |
Sales and marketing |
4,593 |
5,228 |
15,898 |
15,540 |
General and administrative |
3,924 |
3,975 |
12,776 |
12,866 |
Impairment of patent and product
rights |
-- |
-- |
-- |
3,028 |
Total operating expenses |
11,525 |
12,128 |
37,817 |
40,144 |
Operating income (loss) |
289 |
1,775 |
(2,422) |
(5,389) |
Other income (expense), net |
(15) |
24 |
(52) |
411 |
Income (loss) before income taxes |
274 |
1,799 |
(2,474) |
(4,978) |
Income taxes |
-- |
-- |
-- |
-- |
Net income (loss) |
$274 |
$1,799 |
$(2,474) |
$(4,978) |
Earnings (loss) per share: |
|
|
|
|
Basic and Diluted |
$0.01 |
$0.04 |
$(0.05) |
$(0.11) |
|
|
|
|
|
Weighted average shares: |
|
|
|
|
Basic |
46,214 |
45,880 |
46,176 |
45,863 |
Diluted |
46,566 |
46,024 |
46,176 |
45,863 |
|
|
|
|
|
Three months
ended September 30, |
|
|
|
|
Percentage
of |
|
Dollars |
% |
Total
Revenues |
Market
Revenues (Unaudited) |
2010 |
2009 |
Change |
2010 |
2009 |
|
|
|
|
|
|
Infectious disease testing |
$10,843 |
$13,540 |
(20)% |
57% |
63% |
Substance abuse testing |
3,019 |
3,269 |
(8) |
16 |
15 |
Cryosurgical systems |
3,008 |
2,682 |
12 |
16 |
12 |
Insurance risk assessment |
1,529 |
1,416 |
8 |
8 |
7 |
Product revenues |
18,399 |
20,907 |
(12) |
97 |
97 |
Licensing and product
development |
635 |
702 |
(10) |
3 |
3 |
Total revenues |
$19,034 |
$21,609 |
(12)% |
100% |
100% |
|
|
|
|
|
|
|
Nine months ended
September 30, |
|
|
|
|
Percentage
of |
|
Dollars |
% |
Total
Revenues |
Market
Revenues (Unaudited) |
2010 |
2009 |
Change |
2010 |
2009 |
|
|
|
|
|
|
Infectious disease testing |
$30,297 |
$33,407 |
(9)% |
54% |
59% |
Substance abuse testing |
8,785 |
8,890 |
(1) |
16 |
16 |
Cryosurgical systems |
9,122 |
7,728 |
18 |
16 |
14 |
Insurance risk assessment |
4,471 |
4,552 |
(2) |
8 |
8 |
Product revenues |
52,675 |
54,577 |
(3) |
94 |
97 |
Licensing and product development |
3,522 |
1,562 |
125 |
6 |
3 |
Total revenues |
$56,197 |
$56,139 |
0% |
100% |
100% |
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Nine months
ended |
|
|
September
30, |
% |
September
30, |
% |
OraQuick®
Revenues |
2010 |
2009 |
Change |
2010 |
2009 |
Change |
|
|
|
|
|
|
|
Domestic |
$10,102 |
$11,767 |
(14)% |
$28,083 |
$29,358 |
(4)% |
International |
436 |
1,415 |
(69) |
1,089 |
2,370 |
(54) |
Total OraQuick® revenues |
$10,538 |
$13,182 |
(20)% |
$29,172 |
$31,728 |
(8)% |
|
|
|
|
|
|
|
|
Three months
ended |
|
Nine months
ended |
|
|
September
30, |
% |
September
30, |
% |
Intercept®
Revenues |
2010 |
2009 |
Change |
2010 |
2009 |
Change |
|
|
|
|
|
|
|
Domestic |
$1,913 |
$2,086 |
(8)% |
$5,391 |
$5,434 |
(1)% |
International |
562 |
479 |
17 |
1,522 |
1,524 |
0 |
Total Intercept® revenues |
$2,475 |
$2,565 |
(4)% |
$6,913 |
$6,958 |
(1)% |
|
|
|
|
|
|
|
|
Three months
ended |
|
Nine months
ended |
|
|
September
30, |
% |
September
30, |
% |
Cryosurgical Systems
Revenues |
2010 |
2009 |
Change |
2010 |
2009 |
Change |
|
|
|
|
|
|
|
Professional domestic |
$1,690 |
$1,220 |
39% |
$4,476 |
$2,969 |
51% |
Professional international |
326 |
337 |
(3) |
865 |
1,601 |
(46) |
Over-the-counter |
992 |
1,125 |
(12) |
3,781 |
3,158 |
20 |
Total cryosurgical systems revenues |
$3,008 |
$2,682 |
12% |
$9,122 |
$7,728 |
18% |
|
|
|
|
|
|
Balance
Sheets (Unaudited) |
September 30,
2010 |
December 31,
2009 |
Assets |
|
|
Cash, cash equivalents and short-term
investments |
$73,694 |
$79,670 |
Accounts receivable, net |
13,145 |
13,693 |
Inventories |
7,979 |
8,845 |
Other current assets |
2,024 |
2,610 |
Property and equipment, net |
19,890 |
20,014 |
Other non-current assets |
4,778 |
2,159 |
Total assets |
$121,510 |
$126,991 |
|
|
|
Liabilities and Stockholders'
Equity |
|
|
Current portion of long-term debt |
$7,917 |
$510 |
Accounts payable |
2,795 |
3,370 |
Accrued expenses |
7,686 |
11,503 |
Long-term debt |
-- |
7,792 |
Other liabilities |
-- |
9 |
Stockholders' equity |
103,112 |
103,807 |
Total liabilities and stockholders'
equity |
$121,510 |
$126,991 |
|
|
|
|
Nine months
ended |
|
September
30, |
Additional Financial
Data (Unaudited) |
2010 |
2009 |
|
|
|
Capital expenditures |
$1,643 |
$989 |
Depreciation and amortization |
$2,101 |
$2,360 |
Purchase and retirement of common stock |
$ -- |
$309 |
Cash flows provided by operating
activities |
$241 |
$2,688 |
Accounts receivable – days sales
outstanding |
64 days |
60 days |
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2010 third quarter financial results,
business developments and certain 2010 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 #20945862, 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
November 16, 2010, by dialing 800-642-1687 (Domestic) or
706-645-9291 (International) and entering the Conference ID
#20945862.
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 to expected revenues, earnings/loss per
share, and expected clinical development, regulatory filings and
approvals. 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;
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; 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, 2009, 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: OraSure Technologies, Inc.
Ronald H. Spair, Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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