OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral
fluid diagnostics, today announced revenues of $19.2 million for
the three months ended June 30, 2010, compared to $17.3 million
recorded for the three months ended June 30, 2009.
Revenues in the current quarter reflect increases for each of
the Company's product lines and include a $1.0 million milestone
payment received under the terms of a collaboration agreement for
the development and promotion of the Company's OraQuick® rapid HCV
test in international markets. Second quarter 2009 revenues reflect
the impact of a manufacturing issue related to the Company's
OraQuick® rapid HIV-1/2 antibody test during that quarter, which
resulted in a $2.2 million back log of orders as of June 30,
2009.
The Company recorded a net loss of $553,000, or $0.01 per share,
for the second quarter of 2010, compared to a net loss of $5.2
million, or $0.11 per share, for the second quarter of 2009.
Second quarter 2009 results 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.
"Our financial performance exceeded our guidance for the second
quarter, with increased sales across all product lines and the
early receipt of an HCV milestone payment from Merck," said Douglas
A. Michels, President and CEO of OraSure Technologies. "We
also received several important regulatory approvals during the
quarter for our OraQuick ADVANCE® HIV and OraQuick® HCV
tests. In addition, a pre-market approval supplement was
recently sent to the FDA seeking approval of our OraQuick® HCV test
with fingerstick whole blood and we are working to address recent
FDA comments with respect to an oral fluid claim for the OraQuick®
HCV Test. During the remainder of the year, we intend to
continue advancing our OraQuick® HCV and HIV OTC clinical
programs."
For the six months ended June 30, 2010, the Company recorded
revenues of $37.2 million, an increase of 8% when compared to
revenues of $34.5 million for the six months ended June 30,
2009. The Company recorded a net loss of $2.7 million, or
$0.06 per share, for the six months ended June 30, 2010, compared
to a net loss of $6.8 million, or $0.15 per share, for the six
months ended June 30, 2009. The net loss for the six months
ended June 30, 2009 includes the $3.0 million pre-tax impairment
charge described above.
Gross margin in the second quarter of 2010 was 63%, compared to
57% in the second quarter of 2009. For the first six months of
2010, gross margin was also 63%, compared to 60% in the first half
of 2009. Gross margin for the current quarter and six month
periods benefited from the $1.0 million HCV milestone payment, a
more favorable product revenue mix and an improvement in scrap and
spoilage levels when compared to 2009.
Operating expenses for the second quarter of 2010 decreased to
$12.7 million, from $15.2 million in the comparable period in 2009.
This decrease was primarily attributable to the $3.0 million
impairment charge recorded in the second quarter of 2009 and a
decrease in general and administrative costs, partially offset by
higher research and development and sales and marketing
expenses. Operating expenses for the six months ended June 30,
2010 were $26.3 million, compared to $28.0 million for the
comparable period in 2009. Increases in research and
development and sales and marketing expenses for the first six
months of 2010 were partially offset by a decrease in general and
administrative expense and the absence of the $3.0 million
impairment charge recorded in the first half of 2009.
Cash, cash equivalents and short-term investments totaled $74.5
million and working capital was $77.0 million at June 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 June 30, 2010 was
$1.9 million, compared to $1.0 million generated for the three
months ended June 30, 2009.
Third Quarter 2010 Outlook
The Company expects total revenues for the third quarter of 2010
to range from approximately $17.5 to $18.0 million. The Company is
currently projecting a loss per share for the third quarter of 2010
of approximately $0.03 to $0.04.
OraQuick ADVANCE® HIV Shelf
Life
The Company's OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test
previously has had a shelf life of 12 months from the date of
manufacture. The U.S. Food and Drug Administration ("FDA") recently
approved an extension of this dating to 18 months. The Company has
also recently received approval to extend dating to 18 months in
Europe. As a result, the Company will soon be selling its OraQuick®
HIV test, both domestically and internationally, with an 18-month
shelf life.
OraQuick® HCV Clinical Update
As previously disclosed, the FDA required the Company to conduct
an additional clinical study in support of the Company's premarket
approval ("PMA") application for use of its OraQuick® HCV Rapid
Antibody test with fingerstick whole blood and oral fluid
specimens. The Company completed the study and was prepared to
submit a PMA supplement for both claims once a venous whole blood
claim was approved by the FDA. In advance of submitting the
PMA supplement, and in connection with discussions related to the
CLIA (Clinical Laboratory Improvement Amendments of 1988) waiver
protocols for this product, the Company shared its additional
clinical data for fingerstick whole blood and oral fluid with the
FDA. The FDA has recently provided feedback on this data to the
Company.
The FDA's primary comments related to the lower sensitivity of
the OraQuick® HCV test for oral fluid and fingerstick whole blood
when compared to venous whole blood. As a result of these comments,
the Company has decided to separate the PMA submissions for the
fingerstick whole blood and oral fluid claims. A PMA supplement for
fingerstick whole blood was recently sent to the FDA.
The Company intends to continue to pursue an oral fluid claim
for its OraQuick® HCV test. However, the filing of a PMA
supplement for oral fluid has been delayed pending additional
discussions with the FDA. The Company also believes it is
likely that more clinical data will be needed to support an oral
fluid PMA submission for the OraQuick® HCV test.
Financial Data
|
|
Condensed Financial Data
(In thousands, except per-share data)
Unaudited |
|
|
|
|
|
|
|
Three months ended June
30, |
|
Six months ended June
30, |
|
|
2010 |
|
2009 |
|
2010 |
2009 |
Results of
Operations |
|
|
|
|
|
|
|
Revenues |
|
$ 19,218 |
|
$ 17,274 |
|
$ 37,163 |
$ 34,530 |
Cost of products sold |
|
7,040 |
|
7,394 |
|
13,582 |
13,678 |
Gross profit |
|
12,178 |
|
9,880 |
|
23,581 |
20,852 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
3,029 |
|
2,433 |
|
6,135 |
5,785 |
Sales and marketing |
|
5,610 |
|
5,289 |
|
11,305 |
10,312 |
General and administrative |
|
4,074 |
|
4,435 |
|
8,852 |
8,892 |
Impairment of patent and
product rights |
|
-- |
|
3,028 |
|
-- |
3,028 |
Total operating expenses |
|
12,713 |
|
15,185 |
|
26,292 |
28,017 |
Operating loss |
|
(535) |
|
(5,305) |
|
(2,711) |
(7,165) |
Other income (expense), net |
|
(18) |
|
145 |
|
(37) |
387 |
Loss before income taxes |
|
(553) |
|
(5,160) |
|
(2,748) |
(6,778) |
Income tax benefit |
|
-- |
|
-- |
|
-- |
-- |
Net loss |
|
$ (553) |
|
$ (5,160) |
|
$ (2,748) |
$ (6,778) |
Loss per share:
Basic and Diluted |
|
$ (0.01) |
|
$ (0.11) |
|
$ (0.06) |
$ (0.15) |
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic and
Diluted |
|
46,202 |
|
45,871 |
|
46,157 |
45,854 |
|
|
|
|
|
|
|
|
|
|
Three
months ended June 30, |
|
|
|
|
Percentage
of |
|
|
Dollars |
% |
Total
Revenues |
Market Revenues
(Unaudited) |
|
2010 |
|
2009 |
Change |
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
Infectious disease testing |
|
$ 9,974 |
|
$ 9,417 |
6% |
52% |
|
54% |
Substance abuse testing |
|
3,052 |
|
2,932 |
4 |
16 |
|
17 |
Cryosurgical systems |
|
3,120 |
|
2,901 |
8 |
16 |
|
17 |
Insurance risk assessment |
|
1,558 |
|
1,499 |
4 |
8 |
|
9 |
Product revenues |
|
17,704 |
|
16,749 |
6 |
92 |
|
97 |
Licensing and product development |
|
1,514 |
|
525 |
188 |
8 |
|
3 |
Total revenues |
|
$ 19,218 |
|
$ 17,274 |
11% |
100% |
|
100% |
|
|
|
|
|
Six
months ended June 30, |
|
|
|
|
Percentage
of |
|
|
Dollars |
% |
Total
Revenues |
Market
Revenues (Unaudited) |
|
2010 |
|
2009 |
Change |
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
Infectious disease testing |
|
$ 19,454 |
|
$ 19,867 |
(2)% |
52% |
|
58% |
Substance abuse testing |
|
5,766 |
|
5,622 |
3 |
16 |
|
16 |
Cryosurgical systems |
|
6,114 |
|
5,046 |
21 |
16 |
|
15 |
Insurance risk assessment |
|
2,942 |
|
3,134 |
(6) |
8 |
|
9 |
Product revenues |
|
34,276 |
|
33,669 |
2 |
92 |
|
98 |
Licensing and product development |
|
2,887 |
|
861 |
235 |
8 |
|
2 |
Total revenues |
|
$ 37,163 |
|
$ 34,530 |
8% |
100% |
|
100% |
|
|
|
|
|
|
|
|
Three months
ended |
|
Six months
ended |
|
|
|
June
30, |
% |
June
30, |
% |
OraQuick®
Revenues |
|
2010 |
|
2009 |
Change |
2010 |
|
2009 |
Change |
|
|
|
|
|
|
|
|
|
|
Domestic |
|
$ 9,248 |
|
$ 8,291 |
12% |
$ 17,979 |
|
$ 17,591 |
2% |
International |
|
317 |
|
496 |
(36) |
655 |
|
953 |
(31) |
Total OraQuick® revenues |
|
$ 9,565 |
|
$ 8,787 |
9% |
$ 18,634 |
|
$ 18,544 |
0% |
|
|
|
|
|
|
|
|
Three months
ended |
|
Six months
ended |
|
|
|
June
30, |
% |
June
30, |
% |
Intercept®
Revenues |
|
2010 |
|
2009 |
Change |
2010 |
|
2009 |
Change |
|
|
|
|
|
|
|
|
|
|
Domestic |
|
$ 1,949 |
|
$ 1,771 |
10% |
$ 3,477 |
|
$ 3,348 |
4% |
International |
|
443 |
|
523 |
(15) |
960 |
|
1,045 |
(8) |
Total Intercept® revenues |
|
$ 2,392 |
|
$ 2,294 |
4% |
$ 4,437 |
|
$ 4,393 |
1% |
|
|
|
|
|
|
|
|
Three months
ended |
|
Six months
ended |
|
Cryosurgical Systems |
|
June
30, |
% |
June
30, |
% |
Revenues |
|
2010 |
|
2009 |
Change |
2010 |
|
2009 |
Change |
|
|
|
|
|
|
|
|
|
|
Professional domestic |
|
$ 1,575 |
|
$ 807 |
95% |
$ 2,787 |
|
$ 1,749 |
59% |
Professional international |
|
270 |
|
636 |
(58) |
539 |
|
1,265 |
(57) |
Over-the-counter |
|
1,275 |
|
1,458 |
(13) |
2,788 |
|
2,032 |
37 |
Total cryosurgical systems
revenues |
|
$ 3,120 |
|
$ 2,901 |
8% |
$ 6,114 |
|
$ 5,046 |
21% |
|
|
|
|
|
Balance
Sheets (Unaudited) |
June 30, 2010 |
|
December 31,
2009 |
|
Assets |
|
|
|
|
Cash, cash equivalents and short-term
investments |
$ 74,546 |
|
$ 79,670 |
|
Accounts receivable, net |
13,021 |
|
13,693 |
|
Inventories |
8,881 |
|
8,845 |
|
Other current assets |
2,403 |
|
2,610 |
|
Property and equipment, net |
19,958 |
|
20,014 |
|
Other non-current assets |
5,124 |
|
2,159 |
|
Total assets |
$ 123,933 |
|
$ 126,991 |
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
Current portion of long-term debt |
$ 8,042 |
|
$ 510 |
|
Accounts payable |
3,005 |
|
3,370 |
|
Accrued expenses |
10,796 |
|
11,503 |
|
Long-term debt |
-- |
|
7,792 |
|
Other liabilities |
2 |
|
9 |
|
Stockholders' equity |
102,088 |
|
103,807 |
|
Total liabilities and stockholders'
equity |
$ 123,933 |
|
$ 126,991 |
|
|
|
|
Six months
ended June 30, |
Additional Financial
Data (Unaudited) |
2010 |
|
2009 |
|
|
|
|
|
|
Capital expenditures |
$ 1,113 |
|
$ 741 |
|
Depreciation and amortization |
$ 1,331 |
|
$ 1,673 |
|
Purchase and retirement of common stock |
$ -- |
|
$ 309 |
|
Cash flows used in operating activities |
$ 3,080 |
|
$ 1,641 |
|
Accounts receivable – days sales
outstanding |
62 days |
|
58 days |
|
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2010 second 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 #88789490, 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 August
11, 2010, by dialing 800-642-1687 (Domestic) or 706-645-9291
(International) and entering the Conference ID #88789490.
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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