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OraSure Technologies Announces 2007 First Quarter Results

OraSure Technologies, Inc. (NASDAQ: OSUR), a market leader in oral fluid diagnostics, today announced record quarterly revenues of $20.1 million for the three months ended March 31, 2007, compared to $15.2 million in revenues recorded for the three months ended March 31, 2006. Increased sales of the Companys OraQuick ADVANCE® rapid HIV-1/2 antibody test, substance abuse testing products and cryosurgery products, together with an increase in funded research and development related to the Companys rapid Hepatitis C (HCV) test, contributed to the 32% increase in total revenues during the first quarter.

The Companys net income increased 65% to $1,487,000, or $0.03 per share on a fully-diluted basis, for the first quarter of 2007 compared to net income of $900,000, or $0.02 per share on a fully-diluted basis, during the first quarter of 2006. The 2007 results include a gain from the sale of the Companys equity interest in a foreign distributor.

Gross margin in the first quarter of 2007 was 62% compared with 63% in the first quarter of 2006. Gross margin was affected by increased product support costs, offset by the benefit derived from increased licensing and product development revenue.

Operating expenses for the first quarter of 2007 increased $3.2 million to $11.9 million, from $8.7 million in the comparable period in 2006. This increase was primarily attributable to higher research and development costs associated with the product development and clinical work for an OraQuick ADVANCE® HIV test for home use and an OraQuick® HCV test for professional use, higher staffing related expenses and additional consulting expenses related to the successful implementation of the Companys new enterprise resource planning system.

Our business performed very well during the first quarter, and this outstanding performance provides a great start for the year, said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. We are particularly pleased with the continued strong performance of our infectious disease and substance abuse testing businesses and the increase in cryosurgical systems revenues. During the quarter, we also made very good progress on several of our most important strategic initiatives, including the ongoing development of our over-the-counter OraQuick® HIV test and an OraQuick® HCV test for professional use. We continue to believe 2007 will be a very successful year and we are creating a solid foundation for the future.

Cash, cash equivalents and short-term investments were $86.5 million and working capital was $100.2 million at March 31, 2007, compared to $91.0 million and $96.0 million, respectively, at December 31, 2006. The decrease in cash, cash equivalents and short-term investments is primarily the result of the Companys $4.0 million payment for patents and licenses during the current quarter.

Cash flow used in operating activities was $1.0 million in the first quarter of 2007 compared to $2.6 million of cash flow provided by operating activities in the first quarter of 2006.

Financial Guidance

Based on the Companys performance in the first quarter and the recent receipt of an additional order for approximately $1.0 million from Prestige Brands for delivery of over-the-counter (OTC) cryosurgery product in the second quarter of 2007, the Company expects revenues to approximate $20.0 million in the second quarter and $81.0 million for the full year. Fully diluted earnings per share are expected to range from breakeven to $0.01 per share in the second quarter and from $0.03 to $0.05 per share for the full year.

(in thousands, except per-share data and percentages)

Three months ended

March 31,

(Unaudited)
20072006
Results of Operations
Revenues $ 20,109  $ 15,217 
Cost of products sold 7,584  5,618 
Gross profit 12,525  9,599 
Operating expenses:
Research and development 2,920  1,649 
Sales and marketing 4,771  4,106 
General and administrative 4,237  2,958 
Total operating expenses 11,928  8,713 
Operating income 597  886 
Other income, net 2,389  791 
Pre-tax income 2,986  1,677 
Income tax provision 1,499  777 
Net income $ 1,487  $ 900 
Earnings per share
Basic $ 0.03  $ 0.02 
Diluted $ 0.03  $ 0.02 
Weighted average shares:
Basic 46,114  45,840 
Diluted 46,554  46,833 

Three months ended March 31,

Market Revenues20072006

% Change

Infectious disease testing $ 8,932  $ 6,142  45%
Substance abuse testing 3,929  3,442  14 
Cryosurgical systems 5,680  4,458  27 
Insurance risk assessment 889  1,086  (18)
Product revenues 19,430  15,128  28 
Licensing and product development 679  89  663 
Total revenues $ 20,109  $ 15,217  32%

Three months ended March 31,

OraQuick® Revenues20072006

% Change

Direct to U.S. Public Health $ 4,342  $ 2,897  50%
Abbott 2,151  1,482  45 
SAMHSA 329  256  29 
CDC 620  N/A 
International 747  561  33 
Total OraQuick® revenues $ 8,189  $ 5,196  58%

Three months ended March 31,

Intercept® Revenues20072006

% Change

Workplace testing $ 1,545  $ 1,280  21%
Criminal Justice 645  534  21 
International 600  557 
Direct 202  137  47 
Total Intercept® revenues $ 2,992  $ 2,508  19%

Three months ended March 31,

Cryosurgery Revenues20072006

% Change

Professional domestic $ 1,053  $ 1,089  (3)%
Professional international 467  370  26 
OTC domestic 2,150  1,819  18 
OTC international 2,010  1,180  70 
Total cryosurgery revenues $ 5,680  $ 4,458  27%
Balance SheetsMarch 31, 2007December 31, 2006

(Unaudited)

Assets

Cash, cash equivalents and short-term investments

$ 86,542  $ 91,001 
Accounts receivable, net 14,844  10,357 
Inventories 6,089  5,535 
Deferred income taxes 4,269  3,676 
Other current assets 1,936  1,990 
Property and equipment, net 18,004  17,375 
Deferred income taxes 18,276  19,845 
Other non-current assets 6,184  6,786 
Total assets $ 156,144  $ 156,565 

Liabilities and Stockholders Equity

Current portion of long-term debt $ 597  $ 609 
Accounts payable 4,176  3,312 
Accrued expenses 8,722  12,659 
Long-term debt 10,007  10,030 
Other liabilities 525  451 
Stockholders equity 132,117  129,504 

Total liabilities and stockholders equity

$ 156,144  $ 156,565 
Three months ended March 31,
Additional Financial Data20072006
Capital expenditures $ 898  $ 665 
Depreciation and amortization $ 656  $ 447 

Accounts receivable days sales outstanding

66 days

58 days

Conference Call

The Company will host a conference call and audio webcast today to discuss the Company's 2007 first quarter financial results, business developments and the Companys 2007 outlook, beginning 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 Operating Officer and Chief Financial Officer. The call will include remarks by management and a question and answer session.

In order to listen to the conference call, please dial 888-742-2024 (Domestic) or 706-643-0033 (International) and reference 5389843 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 15, 2007, by dialing 800-642-1687 (Domestic) or 706-645-9291 (International) and entering the Conference ID #5389843.

About OraSure Technologies

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices and tests and other diagnostic products using its 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, net income and products. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products; 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 Companys products; 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; 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; 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; 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, patent infringement, 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 complete consolidation or restructuring activities; 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, 2006, 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.

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