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Press Release

OraSure Technologies Announces First Quarter Results

April 30, 2001 at 6:05 AM EDT
BETHLEHEM, Penn.--(BW HealthWire)--April 30, 2001-- Loss Narrows to $547,000 Excluding Non-Recurring Charges; Manufacturing Realignment Substantially Complete

OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader for oral fluid diagnostics of infectious disease and drugs-of-abuse, today announced its financial results for the quarter ended March 31, 2001.

Total revenue for the quarter ended March 31, 2001, rose approximately 12% to $7.4 million compared to $6.6 million for the same period a year ago. Revenue from the OraSure(R) oral fluid collection device and OraQuick(R) rapid HIV 1-2 test increased approximately 38% as a result of continued penetration in the public health market and the market introduction of OraQuick in sub-Saharan Africa. License and product development revenue increased 286% as the Company achieved certain milestone payments from its Uplink development partners. These increases were offset by revenue lost as a result of the discontinuance of the Serum Western Blot product in January 2001 and lower Histofreezer sales. Excluding revenue from the prior period for the discontinued Serum Western Blot product, total revenue would have increased approximately 18%.

"The first quarter was primarily one of integration and execution for the Company. Successful implementation of our manufacturing reorganization, continued marketing progress, and hitting our development milestones have set the stage for an excellent year. Solid execution allowed us to beat our profit expectations for the quarter, and we expect to attain our financial goals for the year," said Robert D. Thompson, Chief Executive Officer of OraSure Technologies.

The net loss was $997,000 or $(0.03) per share for the quarter ended March 31, 2001, including non-recurring manufacturing restructuring charges of $450,000 as described below. Excluding the effect of non-recurring manufacturing restructuring charges, the Company would have had a net loss of $547,000 or $(0.02) per share. These results compare to a net loss of $834,000 or $(0.03) per share in the comparable quarter last year.

In February 2001, the Company announced plans to realign its manufacturing operations. The Company has since eliminated OraQuick manufacturing in Beaverton, Oregon and has commenced OraQuick assembly in Thailand. As a result, the Company incurred $450,000 of non-recurring restructuring costs in the first quarter, but does not anticipate any additional costs from the realignment of manufacturing operations. The restructuring provides greatly expanded capacity for OraQuick production and is expected to have no financial impact in 2001 and to result in approximately $1.5 million in annual cost savings to the Company beginning in 2002.

As of March 31, 2001, the Company had a backlog of orders for approximately 225,000 OraQuick units. New capacity from the Thailand facility, currently estimated at 2.5 million units annually, should allow the Company to work off this backlog during the second quarter. Manufacturing capacity is expected to reach up to 5 million units annually by May 2001. In addition to the economic benefits of the Thailand facility, the Company believes that capacity can be quickly increased to meet higher demand levels.

The gross margin improved to 64% for the quarter ended March 31, 2001 compared to 62% last year, as a result of improved product mix, negotiated contract savings, and higher license and product development revenues, partially offset by the incremental costs associated with the ramp-up of OraQuick manufacturing. The Company's gross margin is anticipated to continue to improve in the second quarter, primarily as a result of the Company's manufacturing reorganization.

Operating expenses, including non-recurring items, increased 15% for the quarter ended March 31, 2001. Research and development expenses increased approximately 26% to $2.2 million as a result of continued development of the OraQuick and Uplink products. Sales and marketing expenses increased approximately 33% to $1.9 million as a result of increased staffing levels to create market awareness for the Company's new products. General and administrative expenses declined approximately 23% to $1.5 million as a result of cost savings associated with the merger. Excluding cost of goods sold and non-recurring items, operating expenses increased 10% for the quarter.

Total annual savings from the integration of the overhead structure as a result of the merger and the restructuring of manufacturing operations are expected to be approximately $2.5 million in 2001, and approximately $4.0 million in 2002.

The Company is targeting revenue growth of 50% for 2001 to approximately $43 million as OraQuick, Intercept, and UPlink revenues ramp up throughout the year, and expects to achieve profitability in the second half of 2001 and for the year as a whole.

Internet Audio Broadcast

OraSure will host a conference call with analysts to discuss these results beginning at 11:00 a.m. Eastern Time (1:00 p.m. Pacific Time) today. In order to listen to the conference call, please go to OraSure's web site, www.orasure.com, at least ten minutes prior to the start of the call to register, download and install any necessary audio software. In addition, a replay will be archived on OraSure's web site shortly after the call has ended and will be available for 30 days.

A replay of the call can also be accessed until May 2, 2001 by dialing 888/203-1112 (Domestic) or 719/457-0820 (International) and entering the confirmation number 634697.

                                      Condensed Financial Data       
                                (In thousands, Except Per-Share Data)
                                             (Unaudited)

                                                Quarter ended
                                                  March 31,
                                            2001             2000
                                            ----             ----
Results of Operations                                     
Revenues                                $   7,404       $    6,619
Operating costs and expenses                8,183            7,512
Manufacturing restructuring costs             450               -
Other income (expense), net                   232               59 
Net loss                                     (997)            (834)
Basic and diluted net loss per share        (0.03)           (0.03)
Shares used in computing basic
 and diluted net loss per share            36,457           33,442 

   Product Revenue Summary

   Three Months Ended March 31,
                                                       Percentage  of
                               Dollars                 Total Revenues
                               -------            %    --------------
                            2001        2000    Change   2001   2000 
Product Sales               ----        ----    ------   ----   ---- 
 Oral Specimen                                         
  collection devices   $   3,253   $   2,528      29%     44%    38%
 OraQuick                    234          --      N/A      3%     0%
 Histofreezer                                          
  cryosurgical systems     1,220       1,364     -11%     16%    21%
 Immunoassay Tests         1,670       1,762      -5%     23%    27%
 Western Blot HIV                                      
  Confirmatory Tests         224         416     -46%      3%     6%
 Other product sales         290         416     -30%      4%     6%
                      -----------  ----------            ----   ----
                           6,891   $   6,486       6%     93%    98%
License and                                            
 product development         513         133     286%      7%     2%
                      -----------  ----------            ----   ----
Total Revenues         $   7,404   $   6,619      12%    100%   100%
                      ===========  ==========            ====   ====

About OraSure

OraSure Technologies, Inc. develops, manufactures and markets medical devices and diagnostic products for use by public- and private-sector clients, clinical laboratories, physicians' offices and workplace testing. OraSure Technologies is the leading supplier of oral fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV. In addition, the company supplies oral fluid testing solutions for drugs-of-abuse testing. For more information on the Company please visit www.orasure.com.

This press release contains certain forward-looking statements, including with respect to revenues, earnings, expenses, gross margins, integration savings, manufacturing capacity, publication of technical data, and product development, performance, shipments and markets. Actual results could be significantly different. Factors that could affect results include ability to market products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing products and up-converting phosphor technology products; ability to fund research and development and other projects and operations; ability to obtain and timing of obtaining necessary regulatory approvals; ability to develop product distribution channels; uncertainty relating to patent protection and potential patent infringement claims; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; loss or impairment of sources of capital; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; changes in relationships with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; changes in accounting practices or interpretation of accounting requirements; equipment failures and ability to obtain needed raw materials and components; and general business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission filings of OraSure Technologies, including its Annual Report on Form 10-K for the year ended December 31, 2000. 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.

CONTACT:
OraSure Technologies, Inc.
Michelle Sells, 503/641-6115
or
Rich Hooper, 610/882-1820
Investorinfo@orasure.com
www.orasure.com
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