OraSure Technologies, Inc. (NASDAQ:OSUR), a market leader in
oral fluid diagnostics, today announced revenues of $17.3 million
for the three months ended March 31, 2009, compared to $18.1
million recorded for the three months ended March 31, 2008.
Increased sales of the Company�s OraQuick ADVANCE� rapid HIV-1/2
antibody test and insurance risk assessment products during the
first quarter 2009 were offset by decreased sales of the Company�s
cryosurgical systems and substance abuse testing products and lower
licensing and product development revenue.
The Company recorded a net loss of $1.6 million, or $0.04 per
share, for the first quarter of 2009, compared to net income of
$2.0 million, or $0.04 per share on a fully-diluted basis, for the
first quarter of 2008, on a GAAP1 basis. The first quarter 2008
results include a $4.9 million pre-tax gain related to a settlement
and licensing agreement entered into during that quarter. On a
non-GAAP basis, the Company would have reported a $2.1 million
pre-tax loss in 2008 excluding the gain, compared to a pre-tax loss
for the first quarter of 2009 of $1.6 million, an improvement of
approximately $532,000 which is largely attributable to a higher
gross margin and an overall decrease in operating expenses.
During the fourth quarter of 2008, the Company established a
full valuation allowance against its net deferred tax asset. As a
result, the Company will not record Federal income tax expense or
benefit in 2009. The Company incurred income tax expense of
$732,000 for the three months ended March 31, 2008.
Gross margin in the first quarter of 2009 was 64% compared with
59% in the first quarter of 2008, due to improved margins derived
from implementing a direct sales model for the OraQuick ADVANCE�
HIV-1/2 test in the U.S. hospital market beginning in January 2009
and a decrease in scrap and spoilage levels.
Operating expenses for the first quarter of 2009 decreased
$823,000 to $12.8 million, from $13.7 million in the comparable
period in 2008. This decrease was primarily attributable to a
decrease in research and development costs associated with the
Company�s OraQuick� HCV and OraQuick� HIV over-the-counter (�OTC�)
clinical development programs and lower staffing costs. Sales and
marketing expenses were also down in the first quarter of 2009 due
to cost-cutting measures in many categories, partially offset by an
increase in staffing costs required to implement the direct sales
model for the hospital market. General and administrative expenses
were higher in the current quarter due to an increase in legal fees
related to pending patent litigation.
�We are pleased with our performance during the first
quarter of 2009, as we exceeded expectations on both the top and
bottom lines,� said Douglas A. Michels, President and Chief
Executive Officer of OraSure Technologies. �Sales of our OraQuick
ADVANCE� HIV-1/2 test remained strong, in part because of the
successful transition of the hospital market to a direct sales
model. At the same time, we continued advancing our two most
critical clinical programs for an OraQuick� HCV test and OraQuick�
HIV OTC test. Our first quarter performance is a great start to
what we expect will be a very successful 2009.�
Cash, cash equivalents and short-term investments totaled $78.6
million and working capital was $90.1 million at March 31, 2009,
compared to $82.5 million and $90.9 million, respectively, at
December 31, 2008.
Second Quarter 2009 Outlook
The Company expects total revenues for the second quarter of
2009 to range from approximately $18.5 to $19.0 million. The
Company is currently projecting a loss per share for the second
quarter of 2009 of approximately $0.06 to $0.07.
Pending Litigation
The Company also announced today that the United States District
Court for the District of New Jersey issued an order denying,
without prejudice, the motion for summary judgment on infringement
filed by Inverness Medical and Church & Dwight against the
Company in a pending patent lawsuit. The plaintiffs were granted
leave to reinstate their motion upon completion of the Markman
hearing where the Court will define certain claims in the asserted
patent. A Markman hearing has been scheduled for August 12, 2009.
The Company continues to believe that none of its products,
including the OraQuick ADVANCE� HIV-1/2 test, infringe the patent
or other intellectual property rights of any party.
Financial Data
�
Condensed Financial Data
(In thousands, except
per-share
data and percentages)
(Unaudited)
�
Three months ended March 31,
2009
�
2008
Results of Operations Revenues $ 17,256 $ 18,089 Cost of
products sold � 6,284 � � 7,446 � Gross profit � 10,972 � � 10,643
� Operating expenses: Research and development 3,352 4,598 Sales
and marketing 5,023 5,216 General and administrative � 4,457 � �
3,841 � Total operating expenses � 12,832 � � 13,655 � Operating
loss (1,860 ) (3,012 ) Other income, net � 242 � � 5,746 � Pre-tax
income (loss) (1,618 ) 2,734 Income tax provision � ? � � 732 � Net
income (loss) $ (1,618 ) $ 2,002 � Earnings (loss) per share
�
Basic and diluted
$
(0.04
)
$ 0.04 � Weighted average shares: Basic � 45,838 � � 46,784 �
Diluted � 45,838 � � 47,268 � �
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
income (loss) before income taxes in the table below. While the
Company believes that disclosing the following non-GAAP financial
measures allows for greater transparency in the review of its
underlying financial performance, it does not consider such
measures to be substitutes for, or superior to, income (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 $4.9 million pre-tax gain related to a
settlement and license agreement entered into during the first
quarter of 2008, since such a significant or comparable transaction
did not occur during the first quarter of 2009.
The following table reconciles the GAAP income (loss) before
income taxes to the non-GAAP income (loss) before income taxes for
the periods indicated, as well as the period-to-period change.
� �
Three months ended
March 31,
Change
2009
�
2008
Income (loss) before income taxes, as reported under GAAP $ (1,618
) $ 2,734 $ (4,352 ) Pre-tax gain adjustment � ? � � (4,884 ) �
4,884 � Income (loss) before income taxes, non-GAAP $ (1,618 ) $
(2,150 ) $ 532 � � �
Three months ended March 31, � �
Percentage of Dollars % Total Revenues
Market Revenues 2009 �
2008
Change 2009 �
2008 � Infectious
disease testing $ 10,451 $ 9,480 10 % 61 % 52 % Substance abuse
testing 2,690 3,277 (18 ) 16 18 Cryosurgical systems 2,145 3,336
(36 ) 12 18 Insurance risk assessment � 1,635 � 1,543 6 9 � 9 �
Product revenues 16,921 17,636 (4 ) 98 97 Licensing and product
development � 335 � 453 (26 ) 2 � 3 � Total revenues $ 17,256 $
18,089 (5 )% 100 % 100 % � � �
Three months ended March
31, % OraQuick�
Revenues 2009 �
2008 Change � Direct to U.S. Public Health $ 6,577 $
6,282 5 % Hospital Market 2,722 1,925 41 International � 459 � 646
(29 ) Total OraQuick� revenues $ 9,758 $ 8,853 10 % � � �
Three
months ended March 31, % Intercept�
Revenues 2009 �
2008 Change � Workplace
testing $ 857 $ 1,016 (16 )% Criminal justice 552 619 (11 )
International 523 525 ? Direct � 168 � 271 (38 ) Total Intercept�
revenues $ 2,100 $ 2,431 (14 )% � � �
Three months ended
March 31, %
Cryosurgical Systems
Revenues
2009 �
2008 Change
�
Professional domestic $ 942 $ 1,034 (9 )% Professional
international 629 737 (15 ) OTC domestic 57 ? ? OTC international �
517 � 1,565 (67 )
Total cryosurgical systems
revenues
$ 2,145 $ 3,336 (36 )% � � �
Balance Sheets March 31,
2009 December 31, 2008
Assets
Cash, cash equivalents and
short-term investments
$ 78,620 $ 82,523 Accounts receivable, net 11,237 11,571
Inventories 9,917 10,704 Other current assets 1,642 1,418 Property
and equipment, net 21,078 21,235 Other non-current assets � 4,266 �
4,467 Total assets $ 126,760 $ 131,918 �
Liabilities and Stockholders� Equity
Current portion of long-term debt $ 553 $ 558 Accounts payable
2,545 3,926 Accrued expenses 8,202 10,796 Long-term debt 8,167
8,301 Other liabilities 5 12 Stockholders� equity � 107,288 �
108,325 Total liabilities and stockholders� equity $ 126,760 $
131,918 � �
Three months ended March 31, Additional
Financial Data 2009 �
2008 � Capital expenditures
$ 453 $ 755 Depreciation and amortization $ 848 $ 691 Purchase and
retirement of common stock $ 309 ?
Cash flows used in operating
activities
$ 2,650 $ 3,709
Accounts receivable � days sales
outstanding
59 days 69 days �
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company�s 2009 first quarter financial results,
business developments and second quarter 2009 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
888-742-2024 (Domestic) or 706-643-0033 (International) and
reference Conference ID #96095225, 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 13, 2009, by dialing
800-642-1687 (Domestic) or 706-645-9291 (International) and
entering the Conference ID #96095225.
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.
Important Information
This press release contains certain forward-looking statements,
including with respect to revenues, expenses, net income,
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; 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.
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