OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral
fluid diagnostics, today announced its consolidated financial
results for the first quarter of 2013.
Quarterly Highlights
- Consolidated net revenues were $21.2 million for the first
quarter of 2013, a 1% increase from the comparable quarter of 2012.
Net product revenues increased 6% primarily due to sales of the
Company's OraQuick® In-Home HIV test and higher sales from the
Company's molecular collection systems subsidiary, DNA Genotek
("DNAG").
- Included in the 2013 first quarter net revenues were $1.5
million in gross sales of the OraQuick® In-Home HIV test,
which were reduced by customer allowances for cooperative
advertising, cash discounts and other allowances, resulting in net
revenues of $1.4 million recorded for the period. Most revenue
for this product is currently recognized upon the consummation of a
sale to a retail customer either in a store or over the internet.
- Net revenues generated by DNAG during the first quarter of 2013
were $3.9 million, a 19% increase from the comparable period in
2012. This increase was primarily the result of higher sales to
commercial customers.
- Consolidated net loss for the first quarter of 2013 was $10.2
million, or $0.18 per share, which compares to a net loss of $3.3
million, or $0.07 per share, for the first quarter of
2012. The net loss for the first quarter of 2013 included $6.9
million in advertising and promotional expenses for the Company's
newly-launched OraQuick® In-Home HIV test.
"We are pleased to see the first quarter performance by our
molecular collection systems business and the increasing sales of
our OraQuick® In-Home HIV test," said Douglas A. Michels, President
and Chief Executive Officer of OraSure Technologies, Inc. "We
continue to refine our advertising and promotion strategies as we
learn more about how consumers are responding to the availability
of our In-Home HIV test."
Financial Results
Consolidated net product revenues for the quarter increased 6%,
primarily as a result of the higher sales of the Company's
molecular collection systems, infectious disease testing, and
substance abuse testing products. These increases were
partially offset by lower sales of the Company's cryosurgical
systems and insurance risk assessment products.
Consolidated licensing and product development revenues for the
first quarter of 2013 decreased to $202,000 from $1.2 million in
the first quarter of 2012. This decrease was primarily attributed
to the absence of a $1.0 million milestone payment received in the
first quarter of 2012 under the Company's HCV collaboration
agreement with Merck. No similar payment was received in the first
quarter of 2013.
Consolidated gross margin for the three months ended March 31,
2013 was 57% compared to 66% for the three months ended March 31,
2012. The current quarter gross margin was negatively impacted by a
change in product mix, the absence in the current quarter of the
$1.0 milestone payment received in the first quarter of 2012,
higher royalties paid on sales of the Company's OraQuick® products,
and an increase in scrap, spoilage, and unabsorbed overhead costs
as a result of production issues that were identified and corrected
in the current quarter.
Consolidated operating expenses increased to $22.6 million for
the first quarter of 2013, from $17.4 million in the comparable
period of 2012. This increase was primarily the result of higher
promotional and advertising expense associated with the Company's
OraQuick® In-Home HIV test. The current quarter expenses
included $6.9 million of promotional and advertising costs related
to this product compared to $1.0 million spent on launch
preparation costs in the first quarter of 2012.
For the three months ended March 31, 2013 and 2012, the Company
recorded an income tax benefit of $410,000 and $521,000,
respectively, associated with the loss before income taxes and
certain Canadian research and development and investment tax
credits at DNAG.
Cash totaled $79.3 million at March 31, 2013 compared to $87.9
million at December 31, 2012. Working capital was $94.9
million at March 31, 2013 compared to $103.5 million at December
31, 2012. For the three months ended March 31, 2013, the
Company used $7.7 million to fund operations, including the
advertising and promotional activities related to the OraQuick®
In-Home HIV test.
Second Quarter 2013
Outlook
The Company expects consolidated net revenues to range from
$23.5 to $24.0 million and is projecting a consolidated net loss of
approximately $0.15 - $0.16 per share for the second quarter of
2013.
Financial Data
Condensed Consolidated
Financial Data |
(In thousands, except
per-share data) |
|
|
|
Unaudited |
|
|
|
Three months
ended |
|
March
31, |
|
2013 |
2012 |
Results of Operations |
|
|
Net revenues |
$ 21,164 |
$ 20,944 |
Cost of products sold |
9,135 |
7,212 |
Gross profit |
12,029 |
13,732 |
Operating expenses: |
|
|
Research and development |
3,357 |
3,444 |
Sales and marketing |
13,874 |
7,874 |
General and administrative |
5,387 |
6,066 |
Total operating expenses |
22,618 |
17,384 |
Operating loss |
(10,589) |
(3,652) |
Other expense |
(47) |
(121) |
Loss before income taxes |
(10,636) |
(3,773) |
Income tax benefit |
(410) |
(521) |
Net loss |
$ (10,226) |
$ (3,252) |
Loss per share: |
|
|
Basic and Diluted |
$ (0.18) |
$ (0.07) |
|
|
|
Weighted average shares: |
|
|
Basic and Diluted |
55,449 |
47,807 |
|
Summary of Revenues by
Market and Product (Unaudited) |
|
|
|
|
|
|
|
Three Months
Ended March 31, |
|
Dollars |
|
Percentage of
Total Net Revenues |
Market |
2013 |
2012 |
% Change |
2013 |
2012 |
|
|
|
|
|
|
Infectious disease testing |
$ 10,687 |
$ 9,776 |
9% |
49% |
47% |
Substance abuse testing |
2,249 |
2,087 |
8 |
11 |
10 |
Cryosurgical systems |
3,085 |
3,478 |
(11) |
15 |
16 |
Molecular collection systems |
3,932 |
3,298 |
19 |
19 |
16 |
Insurance risk assessment |
1,009 |
1,099 |
(8) |
5 |
5 |
Net product revenues |
20,962 |
19,738 |
6 |
99 |
94 |
Licensing and product development |
202 |
1,206 |
(83) |
1 |
6 |
Net revenues |
$ 21,164 |
$ 20,944 |
1% |
100% |
100% |
|
|
|
Three Months
Ended |
|
March
31, |
OraQuick® Revenues |
2013 |
2012 |
% Change |
|
|
|
|
Domestic HIV |
$ 7,672 |
$ 8,148 |
(6)% |
International HIV |
554 |
660 |
(16) |
Domestic HIV OTC |
1,442 |
-- |
N/A |
Domestic HCV |
428 |
536 |
(20) |
International HCV |
240 |
282 |
(15) |
Net OraQuick® revenues |
$ 10,336 |
$ 9,626 |
7% |
|
|
|
Three Months
Ended |
|
March
31, |
Intercept® Revenues |
2013 |
2012 |
% Change |
|
|
|
|
Domestic |
$ 1,274 |
$ 1,523 |
(16)% |
International |
388 |
46 |
743 |
Net Intercept® revenues |
$ 1,662 |
$ 1,569 |
6% |
|
|
|
Three Months
Ended |
|
March
31, |
Cryosurgical Systems
Revenues |
2013 |
2012 |
% Change |
|
|
|
|
Professional domestic |
$ 891 |
$ 1,371 |
(35)% |
Professional international |
348 |
287 |
21 |
Over-the-Counter |
1,846 |
1,820 |
1 |
Net cryosurgical systems
revenues |
$ 3,085 |
$ 3,478 |
(11)% |
|
|
|
Condensed Consolidated Balance
Sheets (Unaudited) |
March 31, 2013 |
December 31,
2012 |
Assets |
|
|
|
|
|
Cash |
$ 79,276 |
$ 87,888 |
Accounts receivable, net |
16,955 |
17,545 |
Inventories |
13,056 |
12,758 |
Other current assets |
3,599 |
2,212 |
Property and equipment, net |
18,297 |
18,546 |
Intangible assets, net |
25,749 |
27,207 |
Goodwill |
24,823 |
25,445 |
Other non-current assets |
281 |
124 |
Total assets |
$ 182,036 |
$ 191,725 |
|
|
|
Liabilities and Stockholders' Equity |
|
|
Accounts payable |
$ 5,622 |
$ 3,380 |
Deferred revenue |
5,611 |
5,580 |
Accrued expenses |
6,756 |
7,960 |
Other non-current liabilities |
249 |
89 |
Deferred income taxes |
3,881 |
4,401 |
Stockholders' equity |
159,917 |
170,315 |
Total liabilities and
stockholders' equity |
$ 182,036 |
$ 191,725 |
|
|
|
Three months
ended |
|
March
31, |
Additional Financial
Data (Unaudited) |
2013 |
2012 |
|
|
|
Capital expenditures |
$ 480 |
$ 306 |
Depreciation and amortization |
$ 1,602 |
$ 1,809 |
Stock based compensation |
$ 1,394 |
$ 1,192 |
Cash used in operating activities |
$ 7,674 |
$ 1,356 |
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2013 first quarter financial results,
business developments and financial guidance for the second quarter
of 2013, 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, Ronald H. Spair, Chief Financial
Officer and Chief Operating Officer, and Kathleen Weber, Senior
Vice President and General Manager, Consumer Products. 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 #42321505 or go to OraSure Technologies'
web site, www.orasure.com, and click on the Investor Relations
page. Please click on the webcast link and follow the prompts for
registration and access 10 minutes prior to the call. 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 15, 2013, by
dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and
entering the Conference ID #42321505.
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 July
2012, the Company received approval from the U.S. Food and Drug
Administration for the Company's OraQuick® In-Home HIV Test for
sale directly to consumers in the over-the-counter (OTC) market –
making it the first and only rapid OTC HIV test approved in the
U.S. 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.
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 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; inventory levels at distributors and other
customers; ability to integrate and realize the full benefits of
the Company's acquisition of DNA Genotek; ability of DNA Genotek to
achieve its financial and strategic objectives; 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, including the OraQuick®
In-Home HIV test; 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 products and
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 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, 2012, 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: Company Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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