OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral
fluid diagnostics, today announced its consolidated financial
results for the first quarter of 2012.
Financial Highlights
- Consolidated revenues were $20.9 million for the first quarter
of 2012, a 20% increase from the comparable quarter of 2011.
Revenues for the current quarter included $3.3 million in revenues
from the Company's molecular diagnostic collection subsidiary, DNA
Genotek Inc. ("DNAG"), acquired in August 2011.
- Consolidated net loss for the first quarter of 2012 was $3.3
million, or $0.07 per share, which compares to a net loss of $2.6
million, or $0.06 per share, for the first quarter of 2011.
"We are pleased to deliver first quarter financial results that
are in line with expectations," said Douglas A. Michels, President
and CEO of OraSure Technologies. "Our molecular collection systems
business was an important contributor for the quarter and we are
starting to see some positive impact on sales of our OraQuick® HCV
test resulting from the CLIA waiver received in late 2011. We are
also pleased that the FDA's Blood Products Advisory Committee will
consider our OraQuick® At-Home HIV test submission at its upcoming
meeting on May 15."
Financial Results
Product revenues for the quarter increased 16% primarily as a
result of the $3.3 million of molecular collection system sales and
higher sales of the Company's cryosurgical systems
products. These increases were partially offset by lower sales
of the Company's infectious disease testing, substance abuse
testing and insurance risk assessment products. Licensing and
product development revenues for the first quarter of 2012
increased by $842,000 primarily as a result of the receipt of a
$1.0 million milestone payment received under the terms of the
Company's HCV collaboration agreement with Merck. Licensing
and product development revenues for the current quarter also
reflect a decrease in royalties received under a Settlement and
License Agreement with Merck related to the Company's cryosurgical
patents.
Consolidated gross margin for the three months ended March 31,
2012 was 66% compared to 65% for the three months ended March 31,
2011. The increase in gross margin in the current quarter was
largely due to the benefit of the $1.0 million milestone payment,
partially offset by an increase in product support costs and a
decline in the absorption of labor costs when compared to the first
quarter of 2011.
Consolidated operating expenses increased $3.6 million to $17.4
million in the first quarter of 2012 from $13.8 million in the
comparable period of 2011. This increase reflects the inclusion of
$3.1 million of DNAG operating expenses, increased sales and
marketing spending associated with the preparation for
commercialization of the Company's HIV-OTC product and increased
consulting and staffing costs. These increases were partially
offset by a decrease in spending on clinical trials related to the
Company's OraQuick® HIV-OTC product.
For the quarter ended March 31, 2012, the Company also recorded
an income tax benefit of $0.5 million associated with the DNAG loss
before income taxes and certain Canadian research and development
and investment tax credits.
Cash totaled $22.8 million at March 31, 2012 compared to $23.9
million at December 31, 2011. Working capital remained
relatively flat at $30.8 million at March 31, 2012 compared to
$30.9 million at December 31, 2011.
Second Quarter 2012
Outlook
The Company expects total consolidated revenues for the second
quarter of 2012 to range from $22.0 to $22.5 million and is
projecting a consolidated net loss of approximately $0.09 - $0.10
per share for the second quarter of 2012.
Financial Data
Condensed Consolidated
Financial Data |
(In thousands, except
per-share data) |
|
|
|
|
Unaudited |
|
|
|
Three months
ended |
|
March
31, |
|
2012 |
2011 |
Results of Operations |
|
|
Revenues |
$ 20,944 |
$ 17,414 |
Cost of products sold |
7,212 |
6,147 |
Gross profit |
13,732 |
11,267 |
Operating expenses: |
|
|
Research and development |
3,444 |
4,420 |
Sales and marketing |
7,874 |
4,932 |
General and administrative |
6,066 |
4,468 |
Total operating expenses |
17,384 |
13,820 |
Operating loss |
(3,652) |
(2,553) |
Other expense |
(121) |
(45) |
Loss before income taxes |
(3,773) |
(2,598) |
Income tax benefit |
(521) |
-- |
Net loss |
$ (3,252) |
$ (2,598) |
Loss per share: |
|
|
Basic and Diluted |
$ (0.07) |
$ (0.06) |
|
|
|
Weighted average shares: |
|
|
Basic and Diluted |
47,807 |
46,518 |
|
|
|
|
|
Three Months
Ended March 31, |
|
Dollars |
|
Percentage of
Total Revenues |
Market |
2012 |
2011 |
% Change |
2012 |
2011 |
|
|
|
|
|
|
Infectious disease testing |
$ 9,776 |
$ 9,962 |
(2)% |
47% |
57% |
Substance abuse testing |
2,087 |
3,061 |
(32) |
10 |
18 |
Cryosurgical systems |
3,478 |
2,710 |
28 |
16 |
15 |
Molecular collection systems |
3,298 |
-- |
N/A |
16 |
0 |
Insurance risk assessment |
1,099 |
1,317 |
(17) |
5 |
8 |
Product revenues |
19,738 |
17,050 |
16 |
94 |
98 |
Licensing and product development |
1,206 |
364 |
231 |
6 |
2 |
Total revenues |
$ 20,944 |
$ 17,414 |
20% |
100% |
100% |
|
|
|
|
|
Three Months
Ended |
|
March
31, |
OraQuick®
Revenues |
2012 |
2011 |
% Change |
|
|
|
|
Domestic HIV |
$ 8,148 |
$ 8,867 |
(8)% |
International HIV |
660 |
698 |
(5) |
Domestic HCV |
536 |
34 |
1,476 |
International HCV |
282 |
48 |
488 |
Total OraQuick® revenues |
$ 9,626 |
$ 9,647 |
0% |
|
|
|
|
|
Three Months
Ended |
|
March
31, |
Intercept® Revenues |
2012 |
2011 |
% Change |
|
|
|
|
Domestic |
$ 1,523 |
$ 1,877 |
(19)% |
International |
46 |
519 |
(91) |
Total Intercept® revenues |
$ 1,569 |
$ 2,396 |
(35)% |
|
|
|
|
|
Three Months
Ended |
|
March
31, |
Cryosurgical Systems
Revenues |
2012 |
2011 |
% Change |
|
|
|
|
Professional domestic |
$ 1,371 |
$ 1,342 |
2% |
Professional international |
287 |
339 |
(15) |
Over-the-Counter |
1,820 |
1,029 |
77 |
Total cryosurgical systems revenues |
$ 3,478 |
$ 2,710 |
28% |
|
|
|
|
|
|
Consolidated Balance
Sheets (Unaudited) |
March 31, 2012 |
December 31,
2011 |
Assets |
|
|
|
|
|
Cash |
$ 22,814 |
$ 23,878 |
Accounts receivable, net |
13,292 |
17,159 |
Inventories |
10,818 |
9,621 |
Other current assets |
3,013 |
2,178 |
Property and equipment, net |
19,376 |
19,855 |
Intangible assets, net |
29,988 |
30,383 |
Goodwill |
25,318 |
24,740 |
Other non-current assets |
53 |
47 |
Total assets |
$ 124,672 |
$ 127,861 |
|
|
|
Liabilities and Stockholders'
Equity |
|
|
Current portion of long-term debt |
$ 7,167 |
$ 7,292 |
Accounts payable |
3,529 |
4,142 |
Accrued expenses |
8,430 |
10,542 |
Other liabilities |
8 |
-- |
Deferred income taxes |
5,249 |
5,636 |
Stockholders' equity |
100,289 |
100,249 |
Total liabilities and stockholders'
equity |
$ 124,672 |
$ 127,861 |
|
|
|
|
|
Three months
ended |
|
March
31, |
Additional Financial
Data (Unaudited) |
2012 |
2011 |
|
|
|
Capital expenditures |
$ 306 |
$ 882 |
Depreciation and amortization |
$ 1,809 |
$ 829 |
Stock based compensation |
$ 1,192 |
$ 973 |
Cash used in operating activities |
$ 1,356 |
$ 2,049 |
Accounts receivable – days sales |
|
|
outstanding |
58 days |
63 days |
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2012 first quarter financial results,
business developments and second quarter 2012 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 Mark L. Kuna, Senior Vice President, Finance
and Controller. 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 #71939275, 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 9,
2012, by dialing 855-859-2056 (Domestic) or 404-537-3406
(International) and entering the Conference ID #71939275.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture
and distribution of oral fluid diagnostic and collection devices
and other technologies designed to detect or diagnose critical
medical conditions. Its innovative products include rapid tests for
the detection of antibodies to HIV and HCV at the point of care and
testing solutions for detecting various drugs of abuse. In
addition, the Company is a leading provider of oral fluid sample
collection, stabilization and preparation products for molecular
diagnostic applications. OraSure's portfolio of products is sold
globally to various clinical laboratories, hospitals, clinics,
community-based organizations and other public health
organizations, research and academic institutions, distributors,
government agencies, physicians' offices, and commercial and
industrial entities. The Company's products enable healthcare
providers to deliver critical information to patients, empowering
them to make decisions to improve and protect their
health. For more information on OraSure Technologies,
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 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; 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 obtain FDA approval of the OraQuick® HIV test
for use in the over-the-counter market; ability to comply with
applicable regulatory 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; ability to integrate and realize the full benefits of
the Company's acquisition of DNA Genotek; ability to identify,
complete, integrate and realize the full benefits of future
acquisitions; 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; 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; adverse movements in
foreign currency exchange rates; loss or impairment of sources of
capital; ability to meet financial covenants in agreements with
financial institutions; ability to refinance outstanding debt under
expiring credit facilities on acceptable terms or at all; 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; 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, 2011, 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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