OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral
fluid diagnostics, today announced revenues of $75.0 million and
$18.8 million for the year and quarter ended December 31, 2010,
respectively. This compares to revenues of $77.0 million and $20.9
million for the year and quarter ended December 31, 2009.
The Company recorded a net loss of $3.5 million, or $0.08 per
share, and $1.0 million, or $0.02 per share, for the year and
quarter ended December 31, 2010, respectively. This compares to a
net loss of $7.8 million, or $0.17 per share, and $2.8 million, or
$0.06 per share, for the year and quarter ended December 31, 2009,
respectively. Fourth quarter and full year 2009 results include
$1.5 million in pre-tax litigation settlement expense. Also
included in the full year 2009 results is a $3.0 million pre-tax
impairment charge related to the net book value of payments
previously capitalized under an HCV patent license agreement.
"We exceeded our fourth quarter guidance on both the top and
bottom lines and are pleased to have ended 2010 on a strong note,"
said Douglas A. Michels, President and CEO of OraSure
Technologies. "During this past year, we also made good
progress advancing our clinical programs, most notably with the
receipt of a venous whole blood approval and the FDA submission for
a finger stick whole blood claim for our OraQuick® HCV
test. We also initiated the final clinical study phase for our
at-home HIV test and expanded our infectious disease portfolio by
acquiring rights to a rapid flu test. I believe OraSure is
very well positioned to begin 2011."
For the year ended December 31, 2010, revenues decreased 3%
compared to the year ended December 31, 2009, primarily as a result
of lower sales of infectious disease products partially offset by
an increase in sales of the Company's cryosurgical systems products
and an increase in licensing and product development
revenues. The decrease in the Company's infectious disease
revenues was largely due to lower international sales. This
decrease was offset by higher sales of the Company's Histofreezer®
cryosurgical product to physician offices in the United
States. Current year licensing and product development revenue
includes $2.0 million in milestone payments received under the
terms of a collaboration agreement for the development and
promotion of the Company's OraQuick® rapid HCV test.
For the quarter ended December 31, 2010, revenues decreased 10%
compared to the quarter ended December 31, 2009, primarily as a
result of lower sales of infectious disease products in the
international marketplace and lower cryosurgical systems sales
primarily due to the absence in the current quarter of stocking
orders associated with the launch of the Company's over-the-counter
("OTC") cryosurgical product in Brazil.
The Company's gross margin was 63% and 64% for the year and
quarter ended December 31, 2010, respectively. This compares
to gross margin of 61% for the full year 2009 and 59% for the
quarter ended December 31, 2009. Full year 2010 gross margin
increased largely as a result of the receipt of $2.0 million in
milestone payments under the Company's HCV collaboration agreement
with Merck. Gross margin in the fourth quarter of 2010
benefited from a reduction in royalty expense related to the
Company's OraQuick® HIV product.
Operating expenses for the year ended December 31, 2010 were
$50.7 million, a $5.2 million decrease from the $55.9 million
reported in 2009. Prior year results include the $3.0 million
impairment charge and $1.5 million litigation settlement expense
mentioned above. Research and development costs were
comparable year over year at $13.2 million and $13.4 million for
2010 and 2009, respectively. Sales and marketing expenses
decreased slightly from $21.2 million in 2009 to $20.7 million in
2010 primarily due to lower relocation expenses. General and
administrative costs remained relatively unchanged at $16.8 million
in each year.
Fourth quarter operating expenses decreased $2.9 million from
$15.8 million in 2009 to $12.9 million in the fourth quarter of
2010. Fourth quarter 2009 expenses included the $1.5 million
litigation settlement expense mentioned above. Research and
development expenses for the fourth quarter of 2010 decreased
approximately $613,000 from the comparable period in 2009 as lower
clinical trial expenses related to the Company's OraQuick® HCV test
were partially offset by higher costs related to the clinical
development of the Company's OraQuick® HIV OTC test. Sales and
marketing expenses decreased approximately $854,000 in the fourth
quarter of 2010 primarily as a result of lower market research and
travel costs. General and administrative expenses for the
fourth quarter of 2010 remained flat at approximately $4.0 million
compared to $3.9 million for the fourth quarter of 2009.
In the full year and the fourth quarter of 2009, the Company
recorded an income tax benefit of $622,000, primarily related to
refundable alternative minimum taxes paid in previous years.
Cash, cash equivalents and short-term investments totaled $75.7
million and working capital was $77.8 million at December 31, 2010,
compared to $79.7 million and $89.4 million, respectively, at
December 31, 2009. This change in working capital reflects 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 as well as the reduction of cash, cash
equivalents and short-term investments. Cash flow provided by
operating activities for the year ended December 31, 2010 was $3.9
million compared to $293,000 used in operating activities for the
year ended December 31, 2009.
First Quarter 2011 Outlook
The Company expects total revenues for the first quarter of 2011
to range from approximately $16.75 million to $17.25 million and is
projecting a net loss per share for the first quarter of 2011 of
approximately $0.08.
Financial Data
OraSure Technologies,
Inc. |
|
|
|
|
|
|
Condensed Financial
Data (In thousands, except per-share
data) |
|
|
|
|
|
|
Unaudited |
|
|
|
|
|
|
Three months ended
December 31, |
Year ended December
31, |
|
2010 |
2009 |
2010 |
2009 |
Results of Operations |
|
|
|
|
Revenues |
$ 18,817 |
$ 20,887 |
$ 75,015 |
$ 77,026 |
Cost of products sold |
6,853 |
8,512 |
27,656 |
29,896 |
Gross profit |
11,964 |
12,375 |
47,359 |
47,130 |
Operating expenses: |
|
|
|
|
Research and development |
4,048 |
4,661 |
13,192 |
13,371 |
Sales and marketing |
4,830 |
5,684 |
20,727 |
21,224 |
General and administrative |
4,018 |
3,982 |
16,794 |
16,848 |
Litigation settlement |
− |
1,451 |
− |
1,451 |
Impairment of patent and product
rights |
− |
− |
− |
3,028 |
Total operating expenses |
12,896 |
15,778 |
50,713 |
55,922 |
Operating loss |
(932) |
(3,403) |
(3,354) |
(8,792) |
Other income (expense), net |
(91) |
(54) |
(143) |
357 |
Loss before income taxes |
(1,023) |
(3,457) |
(3,497) |
(8,435) |
Income tax benefit |
− |
(622) |
− |
(622) |
Net loss |
$ (1,023) |
$ (2,835) |
$ (3,497) |
$ (7,813) |
Loss per share: |
|
|
|
|
Basic and Diluted |
$ (0.02) |
$ (0.06) |
$ (0.08) |
$ (0.17) |
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|
|
|
|
Weighted average shares: |
|
|
|
|
Basic and Diluted |
46,221 |
45,921 |
46,187 |
45,878 |
|
|
|
|
|
Three months
ended December 31, |
|
|
|
|
|
Dollars |
% |
Percentage of
Total Revenues |
Market
Revenues (Unaudited) |
2010 |
2009 |
Change |
2010 |
2009 |
|
|
|
|
|
|
Infectious disease testing |
$11,437 |
$12,691 |
(10)% |
61% |
61% |
Substance abuse testing |
2,886 |
3,137 |
(8) |
15 |
15 |
Cryosurgical systems |
2,844 |
3,160 |
(10) |
15 |
15 |
Insurance risk assessment |
1,355 |
1,604 |
(16) |
7 |
8 |
Product revenues |
18,522 |
20,592 |
(10) |
98 |
99 |
Licensing and product development |
295 |
295 |
− |
2 |
1 |
Total revenues |
$18,817 |
$20,887 |
(10)% |
100% |
100% |
|
|
|
|
|
|
|
Year ended
December 31, |
|
|
|
|
|
Dollars |
% |
Percentage of
Total Revenues |
Market
Revenues (Unaudited) |
2010 |
2009 |
Change |
2010 |
2009 |
|
|
|
|
|
|
Infectious disease testing |
$41,738 |
$46,098 |
(9)% |
55% |
60% |
Substance abuse testing |
11,671 |
12,026 |
(3) |
16 |
16 |
Cryosurgical systems |
11,965 |
10,888 |
10 |
16 |
14 |
Insurance risk assessment |
5,825 |
6,157 |
(5) |
8 |
8 |
Product revenues |
71,199 |
75,169 |
(5) |
95 |
98 |
Licensing and product development |
3,816 |
1,857 |
105 |
5 |
2 |
Total revenues |
$75,015 |
$77,026 |
(3)% |
100% |
100% |
|
|
|
|
|
|
Three months
ended December 31, |
% |
Year ended
December 31, |
% |
OraQuick®
Revenues |
2010 |
2009 |
Change |
2010 |
2009 |
Change |
|
|
|
|
|
|
|
Domestic |
$10,137 |
$9,949 |
2% |
$38,218 |
$39,306 |
(3)% |
International |
829 |
2,141 |
(61) |
1,919 |
4,511 |
(57) |
Total OraQuick® revenues |
$10,966 |
$12,090 |
(9)% |
$40,137 |
$43,817 |
(8)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended December 31, |
% |
Year ended
December 31, |
% |
Intercept® Revenues |
2010 |
2009 |
Change |
2010 |
2009 |
Change |
|
|
|
|
|
|
|
Domestic |
$1,883 |
$1,972 |
(5)% |
$7,274 |
$7,405 |
(2)% |
International |
454 |
479 |
(5) |
1,976 |
2,003 |
(1) |
Total Intercept® revenues |
$2,337 |
$2,451 |
(5)% |
$9,250 |
$9,408 |
(2)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended December 31, |
% |
Year
ended December 31, |
% |
Cryosurgical Systems
Revenues |
2010 |
2009 |
Change |
2010 |
2009 |
Change |
|
|
|
|
|
|
|
Professional domestic |
$1,492 |
$933 |
60% |
$5,967 |
$3,902 |
53% |
Professional international |
520 |
318 |
64 |
1,385 |
1,919 |
(28) |
Over-the-counter |
832 |
1,909 |
(56) |
4,613 |
5,067 |
(9) |
Total cryosurgical systems revenues |
$2,844 |
$3,160 |
(10)% |
$11,965 |
$10,888 |
10% |
|
|
|
|
|
|
|
Balance
Sheets (Unaudited) |
December 31,
2010 |
December 31,
2009 |
Assets |
|
|
Cash, cash equivalents and short-term
investments |
$75,738 |
$79,670 |
Accounts receivable, net |
12,471 |
13,693 |
Inventories |
7,346 |
8,845 |
Prepaid expenses |
1,930 |
2,610 |
Property and equipment, net |
19,611 |
20,014 |
Other non-current assets |
5,424 |
2,159 |
Total assets |
$122,520 |
$126,991 |
|
|
|
Liabilities and Stockholders'
Equity |
|
|
Current portion of long-term debt |
$7,791 |
$510 |
Accounts payable |
2,899 |
3,370 |
Accrued expenses |
8,987 |
11,503 |
Long-term debt |
− |
7,792 |
Other liabilities |
− |
9 |
Stockholders' equity |
102,843 |
103,807 |
Total liabilities and stockholders'
equity |
$122,520 |
$126,991 |
|
|
|
|
Year ended December
31, |
Additional Financial
Data (Unaudited) |
2010 |
2009 |
|
|
|
Capital expenditures |
$2,106 |
$1,200 |
Depreciation and amortization |
$3,012 |
$3,050 |
Cash flows provided by (used in) operating
activities |
$3,887 |
$(293) |
Accounts receivable – days sales
outstanding |
61 days |
65 days |
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2010 fourth quarter and full-year financial
results, business developments and first quarter 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 #41326273, 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
February 16, 2011, by dialing 800-642-1687 (Domestic) or
706-645-9291 (International) and entering the Conference ID
#41326273.
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, 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: Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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