OraSure Technologies Announces First Quarter Results.Health/Medical Writers BETHLEHEM, Penn.--(BW HealthWire)--April 30, 2001 Loss Narrows to $547,000 Excluding Non-Recurring Charges; Manufacturing Realignment re·a·lign tr.v. re·a·ligned, re·a·lign·ing, re·a·ligns 1. To put back into proper order or alignment. 2. To make new groupings of or working arrangements between. Substantially Complete OraSure Technologies, Inc. (Nasdaq:OSUR OSUR Ohio State University Reactor (Columbus, OH) ), the market leader for oral fluid diagnostics of infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. 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 (1) Transmitting from an earth station to a satellite. Contrast with downlink. (2) A port on a network device that is used to connect to another network device rather than a client or server. See MDI port. development partners. These increases were offset by revenue lost as a result of the discontinuance Cessation; ending; giving up. The discontinuance of a lawsuit, also known as a dismissal or a non-suit, is the voluntary or involuntary termination of an action. DISCONTINUANCE, pleading. A chasm or interruption in the pleading. 2. of the Serum Western Blot Western blot A technique developed in 1979 that is used to confirm ELISA results. HIV antigen is purified by electrophoresis and attached by blotting to a nylon or nitrocellulose filter. product in January 2001 and lower Histofreezer sales. Excluding revenue from the prior period for the discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: 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 restructuring charge The expense of reorganizing a company's operations. A restructuring charge is an infrequent expense that generally results from asset writedowns or facility closings. 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 $844,000 million or $(0.03) per share in the comparable quarter last year. In February 2001, the Company announced plans to realign re·a·lign tr.v. re·a·ligned, re·a·lign·ing, re·a·ligns 1. To put back into proper order or alignment. 2. To make new groupings of or working arrangements between. its manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. . The Company has since eliminated OraQuick manufacturing in Beaverton, Oregon Beaverton is a city in Washington County, Oregon, United States, seven miles west of Portland in the Tualatin River Valley. As of May 2006, its population is estimated to be 84,270,[1] 9.1% more than the 2000 census figure of 76,129. 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 Costs which are additional costs to the Service appropriations that would not have been incurred absent support of the contingency operation. See also financial management. 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 Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. , 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 Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. 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 Ramp Up To increase a company's operations in anticipation of increased demand. Notes: A company might 'ramp up' operations if they just signed a contract creating substantially more demand for their product. See also: Demand, Economies of Scale throughout the year, and expects to achieve profitability in the second half of 2001 and for the year as a whole. Internet Audio See RealAudio. 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%
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-0-
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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. , 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 A rare earth material used to coat the inside face of a CRT. When struck by an electron beam, the phosphor emits a visible light for a few milliseconds. In color displays, red, green and blue phosphor dots are grouped as a cluster. See screen burn. 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 relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc patent protection and potential patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. claims; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; loss or impairment Impairment 1. A reduction in a company's stated capital. 2. The total capital that is less than the par value of the company's capital stock. Notes: 1. This is usually reduced because of poorly estimated losses or gains. 2. of sources of capital; exposure to product liability and other types of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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. |
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