OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral
fluid diagnostics, today announced revenues of $77.0 million and
$20.9 million for the year and quarter ended December 31, 2009,
respectively. This compares to revenues of $71.1 million and
$17.2 million for the year and quarter ended December 31, 2008.
The Company recorded a net loss of $7.8 million or $0.17 per
share, and $2.8 million or $0.06 per share, on a GAAP1
basis, for the year and quarter ended December 31, 2009,
respectively. This compares to a net loss of $31.3 million or
$0.67 per share and $29.3 million or $0.64 per share, on a GAAP¹
basis for the year and quarter ended December 31, 2008,
respectively. The net loss for the 2008 periods includes a
non-cash charge of $26.0 million reflected in the income tax
provision, which resulted from establishing a full valuation
allowance against the Company's net deferred tax asset.
For the year ended December 31, 2009, revenues increased 8%
compared to the year ended December 31, 2008. The increase
reflects revenue growth of 21% in the Company's infectious disease
testing business and increased sales of the Company's cryosurgical
systems and insurance risk assessment testing
products. Partially offsetting these increases were a decline
in substance abuse testing sales and a reduction in licensing and
product development revenues.
For the quarter ended December 31, 2009, revenues increased 21%
compared to the quarter ended December 31, 2008. This increase
reflects 44% growth in the Company's infectious disease testing
business and increased sales of cryosurgical systems
products. These increases were partially offset by lower
substance abuse testing and insurance risk assessment sales.
"We ended 2009 with a strong fourth quarter – exceeding our
quarterly guidance on both the top and bottom lines," said Douglas
A. Michels, President and CEO of OraSure Technologies. "In 2009, we
improved on several key metrics – growing our revenues, improving
our gross margin, and reducing our use of cash flow from
operations. We also continued to advance our major clinical
programs, all of which provide significant momentum heading into
2010."
Results for the year ended December 31, 2009 included a $3.0
million pre-tax impairment charge related to the net book value of
previously capitalized payments under a Hepatitis C ("HCV") patent
license agreement and $1.5 million in expense associated with the
settlement of patent infringement litigation with Inverness
Medical. Results for the fourth quarter ended December 31,
2009 also include the litigation settlement expense. Results
for the year ended December 31, 2008 included a $4.9 million
pre-tax gain related to a lump sum payment received as a result of
the settlement of patent infringement litigation during the
year. Excluding the impact of these items, the Company's
pre-tax loss, on a non-GAAP basis, would have been $4.0 million and
$2.0 million for the year and quarter ended December 31, 2009,
respectively. These results would compare to a pre-tax loss on a
non-GAAP basis of $13.6 million and $5.7 million for the year and
quarter ended December 31, 2008.
The Company's gross margin was 61% and 59% for the year and
quarter ended December 31, 2009, respectively. This compares
to gross margin of 58% for the full year 2008 and 56% for the
quarter ended December 31, 2008. Gross margin for both 2009
periods benefited from the Company's switch in January 2009 to a
direct selling model in the U.S. hospital market as well as
increased manufacturing efficiencies. Gross margin for the
fourth quarter of 2009 also benefited from a reduction in scrap and
spoilage expense.
Operating expenses for the year and quarter ended December 31,
2009 were $55.9 million and $15.8 million, respectively. This
compares to $52.6 million and $15.8 million for the year and
quarter ended December 31, 2008.
A $6.9 million decrease in research and development costs in the
full year of 2009 was offset by the $3.0 million impairment charge
and $1.5 million litigation settlement described above. Research
and development costs were lower as a result of reduced clinical
trial spending on the Company's OraQuick® HIV OTC and
OraQuick® HCV tests. The research and development
decrease was also offset by a $307,000 increase in sales and
marketing expenses and a $561,000 increase in general and
administrative expenses. In addition, operating expenses for
the full year of 2008 included the $4.9 million litigation
settlement gain discussed above.
Fourth quarter operating expenses remained flat as decreases in
research and development and general and administrative expenses
were offset by an increase in sales and marketing costs and the
litigation settlement expense.
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. This compares to an income tax provision of $22.5
million and $23.6 million for the full year and fourth quarter of
2008, respectively. As previously disclosed, in the fourth
quarter of 2008 the Company recorded a $26.0 million valuation
allowance against its net deferred tax asset.
Cash, cash equivalents and short-term investments totaled $79.7
million and working capital was $89.4 million at December 31, 2009,
compared to $82.5 million and $90.9 million, respectively, at
December 31, 2008. Cash flow used in operating activities for
the year ended December 31, 2009 was $293,000, an improvement of
$2.2 million when compared to the $2.5 million used in operating
activities for the year ended December 31, 2008.
First Quarter 2010 Outlook
The Company expects total revenues for the first quarter of 2010
to range from approximately $19.0 to $19.5 million and is
projecting a net loss per share for the first quarter of 2010 of
approximately $0.06 to $0.07.
Non-GAAP Financial Measures
The Company's management considers the use of non-GAAP financial
measures helpful in assessing the Company's current period's
financial performance, especially in comparison to the same period
of the prior year. As such, the Company has presented non-GAAP
loss before income taxes in the table below.
While the Company believes that disclosing the following
non-GAAP financial measures allow for greater transparency in the
review of its underlying financial performance, it does not
consider such measures to be substitutes for, or superior to, loss
before income taxes as determined in accordance with
GAAP. For purposes of calculating the non-GAAP loss
before income taxes, the Company excluded the $3.0 million pre-tax
impairment of patent and product rights which occurred during the
second quarter of 2009, the $1.5 million pre-tax litigation
settlement expense incurred during the fourth quarter of 2009, and
the $4.9 million pre-tax gain related to a lump sum litigation
settlement payment received during the first quarter of 2008, since
comparable transactions did not occur during the comparative
periods.
The following table reconciles the GAAP loss before income taxes
to the non-GAAP loss before income taxes for the periods indicated,
as well as the period-to-period change.
|
Three months ended
December 31,
|
Change
|
|
2009
|
2008
|
|
Loss before income taxes, as reported under GAAP
|
$(3,457)
|
$(5,665)
|
$2,208
|
Pre-tax litigation settlement
|
1,451
|
--
|
1,451
|
Loss before income taxes, non-GAAP
|
$(2,006)
|
$(5,665)
|
$3,659
|
|
Year ended
December 31,
|
Change
|
|
2009
|
2008
|
|
Loss before income taxes, as reported under GAAP
|
$(8,435)
|
$(8,748)
|
$313
|
Pre-tax impairment of patent and product
rights
|
3,028
|
--
|
3,028
|
Pre-tax litigation settlement
|
1,451
|
(4,884)
|
6,335
|
Loss before income taxes, non-GAAP
|
$(3,956)
|
$(13,632)
|
$9,676
|
Financial Data
|
Condensed Financial Data
(In thousands, except per-share
data and percentages)
Unaudited
|
|
|
|
|
Three months ended
December 31,
|
Year ended
December 31,
|
|
2009
|
2008
|
2009
|
2008
|
Results of Operations
|
|
|
|
|
Revenues
|
$20,887
|
$17,209
|
$77,026
|
$71,104
|
Cost of products sold
|
8,512
|
7,583
|
29,896
|
29,976
|
Gross profit
|
12,375
|
9,626
|
47,130
|
41,128
|
Operating expenses:
|
|
|
|
|
Research and development
|
4,661
|
5,392
|
13,371
|
20,255
|
Sales and marketing
|
5,684
|
5,411
|
21,224
|
20,917
|
General and administrative
|
3,982
|
4,994
|
16,848
|
16,287
|
Litigation settlement
|
1,451
|
--
|
1,451
|
(4,884)
|
Impairment of patent and product
rights
|
--
|
--
|
3,028
|
--
|
Total operating expenses
|
15,778
|
15,797
|
55,922
|
52,575
|
Operating loss
|
(3,403)
|
(6,171)
|
(8,792)
|
(11,447)
|
Other income (expense), net
|
(54)
|
506
|
357
|
2,699
|
Loss before income taxes
|
(3,457)
|
(5,665)
|
(8,435)
|
(8,748)
|
Income tax provision (benefit)
|
(622)
|
23,607
|
(622)
|
22,527
|
Net loss
|
$(2,835)
|
$(29,272)
|
$(7,813)
|
$(31,275)
|
Loss per share:
|
|
|
|
|
Basic and Diluted
|
$(0.06)
|
$(0.64)
|
$(0.17)
|
$(0.67)
|
|
|
|
|
|
Weighted average shares:
|
|
|
|
|
Basic and Diluted
|
45,921
|
45,882
|
45,878
|
46,550
|
|
Three months ended December 31,
|
|
|
|
Percentage of
|
|
Dollars
|
%
|
Total Revenues
|
Market Revenues
|
2009
|
2008
|
Change
|
2009
|
2008
|
|
|
|
|
|
|
Infectious disease testing
|
$12,691
|
$8,837
|
44%
|
61%
|
51%
|
Substance abuse testing
|
3,137
|
3,452
|
(9)
|
15
|
20
|
Cryosurgical systems
|
3,160
|
2,928
|
8
|
15
|
17
|
Insurance risk assessment
|
1,604
|
1,690
|
(5)
|
8
|
10
|
Product revenues
|
20,592
|
16,907
|
22
|
99
|
98
|
Licensing and product development
|
295
|
302
|
(2)
|
1
|
2
|
Total revenues
|
$20,887
|
$17,209
|
21%
|
100%
|
100%
|
|
Year ended December 31,
|
|
|
|
Percentage of
|
|
Dollars
|
%
|
Total Revenues
|
Market Revenues
|
2009
|
2008
|
Change
|
2009
|
2008
|
|
|
|
|
|
|
Infectious disease testing
|
$46,098
|
$38,096
|
21%
|
60%
|
54%
|
Substance abuse testing
|
12,026
|
14,006
|
(14)
|
16
|
20
|
Cryosurgical systems
|
10,888
|
10,655
|
2
|
14
|
15
|
Insurance risk assessment
|
6,157
|
6,085
|
1
|
8
|
8
|
Product revenues
|
75,169
|
68,842
|
9
|
98
|
97
|
Licensing and product development
|
1,857
|
2,262
|
(18)
|
2
|
3
|
Total revenues
|
$77,026
|
$71,104
|
8%
|
100%
|
100%
|
|
Three months ended
|
|
Year ended
|
|
|
December 31,
|
%
|
December 31,
|
%
|
OraQuick® Revenues
|
2009
|
2008
|
Change
|
2009
|
2008
|
Change
|
|
|
|
|
|
|
|
Direct to U.S. Public Health
|
$7,351
|
$6,177
|
19%
|
$28,308
|
$25,450
|
11%
|
Hospital Market
|
2,598
|
1,137
|
128
|
10,998
|
6,625
|
66
|
International
|
2,141
|
930
|
130
|
4,511
|
3,234
|
39
|
Total OraQuick® revenues
|
$12,090
|
$8,244
|
47%
|
$43,817
|
$35,309
|
24%
|
|
Three months ended
|
|
Year ended
|
|
|
December 31,
|
%
|
December 31,
|
%
|
Intercept® Revenues
|
2009
|
2008
|
Change
|
2009
|
2008
|
Change
|
|
|
|
|
|
|
|
Workplace testing
|
$1,025
|
$1,270
|
(19)%
|
$3,895
|
$4,750
|
(18)%
|
Criminal Justice
|
675
|
698
|
(3)
|
2,593
|
2,663
|
(3)
|
International
|
479
|
598
|
(20)
|
2,003
|
2,168
|
(8)
|
Direct
|
272
|
299
|
(9)
|
917
|
1,204
|
(24)
|
Total Intercept® revenues
|
$2,451
|
$2,865
|
(14)%
|
$9,408
|
$10,785
|
(13)%
|
|
Three months ended
|
|
Year ended
|
|
Cryosurgical Systems
|
December 31,
|
%
|
December 31,
|
%
|
Revenues
|
2009
|
2008
|
Change
|
2009
|
2008
|
Change
|
|
|
|
|
|
|
|
Professional domestic
|
$933
|
$970
|
(4)%
|
$3,902
|
$3,911
|
--%
|
Professional international
|
318
|
725
|
(56)
|
1,919
|
2,529
|
(24)
|
OTC domestic
|
87
|
--
|
N/A
|
144
|
--
|
N/A
|
OTC international
|
1,822
|
1,233
|
48
|
4,923
|
4,215
|
17
|
Total cryosurgical systems
revenues
|
$3,160
|
$2,928
|
8%
|
$ 10,888
|
$ 10,655
|
2%
|
Balance Sheets
|
December 31, 2009
|
December 31, 2008
|
Assets
|
|
|
Cash, cash equivalents and short-term
investments
|
$79,670
|
$82,523
|
Accounts receivable, net
|
13,693
|
11,571
|
Inventories
|
8,845
|
10,704
|
Other current assets
|
2,610
|
1,418
|
Property and equipment, net
|
20,014
|
21,235
|
Other non-current assets
|
2,159
|
4,467
|
Total assets
|
$126,991
|
$131,918
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
Current portion of long-term debt
|
$510
|
$558
|
Accounts payable
|
3,370
|
3,926
|
Accrued expenses
|
11,503
|
10,796
|
Long-term debt
|
7,792
|
8,301
|
Other liabilities
|
9
|
12
|
Stockholders' equity
|
103,807
|
108,325
|
Total liabilities and stockholders' equity
|
$126,991
|
$131,918
|
|
Year ended
December 31,
|
Additional Financial Data
|
2009
|
2008
|
|
|
|
Capital expenditures
|
$1,200
|
$2,643
|
Depreciation and amortization
|
$ 3,050
|
$3,387
|
Purchase and retirement of common stock
|
$309
|
$5,121
|
Cash flows used in operating activities
|
$293
|
$2,460
|
Accounts receivable – days sales
outstanding
|
65 days
|
60 days
|
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2009 fourth quarter and full-year financial
results, business developments and first quarter 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
888-221-3902 (Domestic) or 913-312-0417 (International) and
reference Conference ID #5213543, 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 17, 2010, by dialing 888-203-1112 (Domestic) or
719-457-0820 (International) and entering the Conference ID
#5213543.
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 revenues, expenses, net income/loss,
earnings/loss per share and products. Actual results could be
significantly different. Factors that could affect results include
the 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 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 credit crisis; 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 and
extended shelf life; 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 and ability to utilize net operating loss
carryforwards or other deferred tax assets; volatility of the
Company's 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 changes in international
funding sources; loss or impairment of sources of capital; ability
to meet financial covenants in agreements with financial
institutions; ability to retain qualified personnel; exposure to
patent infringement, 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 Securities and Exchange Commission ("SEC") filings of
OraSure Technologies, including its registration statements, its
Annual Report on Form 10-K for the year ended December 31, 2008,
its Quarterly Reports on Form 10-Q, and its other filings with the
SEC. 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.
1 GAAP is defined as U.S. Generally Accepted
Accounting Principles
CONTACT: OraSure Technologies, Inc.
Ronald H. Spair, Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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