EXACT Sciences Announces First Quarter 2005 Results.MARLBOROUGH Marl·bor·ough or Marl·bo·ro A city of east-central Massachusetts east-northeast of Worcester. Settled in 1657, it was nearly destroyed in 1676 during King Philip's War. Population: 38,100. , Mass. -- EXACT Sciences Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : EXAS) today announced results for the first quarter ending March 31, 2005. For the quarter ending March 31, 2005, total revenues of $1.2 million were equal to the total revenues for the quarter ending March 31, 2004. These revenues reflect the amortization of up-front license fee payments from Laboratory Corporation of America(R) Holdings (LabCorp(R)), royalties on LabCorp's sales of PreGen-Plus(TM), and sales of Effipure(TM) units to LabCorp. Net loss for the quarter ending March 31, 2005 totaled $4.6 million, or $0.17 per share, compared to a net loss of $5.3 million, or $0.23 per share, for the same quarter last year. In February, the Company took steps to focus its research and development efforts primarily on improving the sensitivity and other performance aspects of PreGen-Plus, which allowed the Company to reduce its cost structure accordingly. This restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). involved a workforce reduction of 10 employees, principally in the research and development functions, and a reduction in the space leased at the Company's corporate headquarters from 56,000 square feet to 37,000 square feet. A charge of $0.6 million was recorded in the first quarter of 2005 in connection with the restructuring. During the quarter, 771 PreGen-Plus tests were accessioned by LabCorp as compared to 757 accessions for the comparable quarter of the prior year. As of March 31, 2005, EXACT Sciences had approximately $44 million in cash, cash equivalents and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments. "We are excited about the positive review that PreGen-Plus received in March from Blue Shield's California California (kăl'ĭfôr`nyə), most populous state in the United States, located in the Far West; bordered by Oregon (N), Nevada and, across the Colorado River, Arizona (E), Mexico (S), and the Pacific Ocean (W). Technology Assessment Forum (CTAF CTAF Common Traffic Advisory Frequency CTAF Canadian Tactical Assault Force ), which lends important independent support to our belief that EXACT's technology is an important tool for colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. screening," stated Don Hardison, EXACT Sciences' President and Chief Executive Officer. "In addition to the CTAF decision, we continue to work with LabCorp on new sales initiatives designed to increase product adoption. Although inclusion into screening guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. and major payor payor (payer) n. The one who must make payment on a promissory note. reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. policy decisions, including the Medicare Medicare, national health insurance program in the United States for persons aged 65 and over and the disabled. It was established in 1965 with passage of the Social Security Amendments and is now run by the Centers for Medicare and Medicaid Services. program, are most critical to our success, there is much we are doing now to help support our market goals. These efforts include a cost reduction program that could allow LabCorp to lower the price, and the implementation of a medical service organization to help improve patient screening compliance rates." The following first quarter highlights will also be among the topics discussed on the Company's conference call on April 26, 2005 at 8:30 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT : --Blue Shield's California Technology Assessment Forum's decision that PreGen-Plus is safe, effective, and improves net health outcomes for the general population; --The launch of a medical service program in connection with PreGen-Plus aimed at increasing patient screening compliance and maximizing the number of tests accessioned and --Observations from the Company's six-month sales pilot program and the implications for the overall PreGen-Plus sales strategy. First Quarter 2005 Conference Call EXACT Sciences will host a conference call for its first quarter 2005 financial and operating results on Tuesday, April 26, 2005 at 8:30 a.m. EDT. A live Webcast of the conference call, as well as an archived version following the completion of the call, will be available at www.exactsciences.com by clicking on the Investor Relations Investor relations The process by which the corporation communicates with its investors. link. The conference call and Webcast are open to all interested parties. Information for the call is as follows: Domestic callers: 800-573-4840 International callers: 617-224-4326 Participant Passcode: 48842720 The conference call replay information is as follows: Domestic callers: 888-286-8010 International callers: 617-801-6888 Passcode: 25606483 About EXACT Sciences Corporation EXACT Sciences Corporation uses applied genomics applied genomics Molecular genetics Molecular medicine The use of genetic information to diagnose, prognosticate and manage disease, based on the techniques of PCR, real time-PCR, DNA sequencing, and gene rearrangement studies for leukemia and lymphoma. to develop effective, patient-friendly screening methods to detect cancer early. Its first commercial test, PreGen-Plus(TM), is used for screening colorectal cancer in the average-risk population. Colorectal cancer, which is the most deadly cancer among non-smokers, is curable cur·a·ble adj. Capable of being cured or healed. if detected early. Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, however, the rate of early detection of colorectal cancer remains low, and deaths from colorectal cancer remain high. EXACT Sciences believes its genomics-based technologies will enable early detection of colorectal cancer so that more people can be effectively treated. Founded in 1995, EXACT Sciences is based in Marlborough, Mass. Detailed information on EXACT Sciences and PreGen-Plus can be found on the World Wide Web at www.exactsciences.com and www.pregenplus.com. Certain statements made in this press release that are not based on historical information are express or implied 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. relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc , among other things, EXACT Sciences' expectations concerning, among other things, its future sales volumes, revenues and expenses, its business outlook and business, the likelihood of third-party reimbursement of its technologies and the future inclusion of its products in reimbursement guidelines, the Company's marketing and sales strategies and programs and their likely future success and the effectiveness and market acceptance of its technologies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences' control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the ability of EXACT Sciences to become profitable; the success of its strategic relationship with LabCorp; its ability to license certain technologies or obtain raw materials for its technologies; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences' products and services; the ability to convince medical practitioners to order tests using EXACT Sciences' technologies; the ability to increase the performance of the PreGen-Plus test; the ability of EXACT Sciences or LabCorp to lower costs through automating and simplifying key operational processes; the inclusion of PreGen-Plus in cancer screening guidelines cancer screening guideline Any guideline promulgated by an authoritative organization–eg Am Cancer Society, for early detection of a malignancy common in a particular population, the diagnosis of which, if caught early, results in a complete cure or improved ; the number of people who decide to be screened for colorectal cancer using EXACT Sciences' technologies; competition; the ability to comply with federal and state statutes and regulations relating to EXACT Sciences' products and services, including FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. requirements, the U.S. Department of Transportation and the Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. ; the ability to protect EXACT Sciences' intellectual property and the cost of enforcing or defending EXACT Sciences in 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. relating to intellectual property rights; the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer; and the ability to raise additional capital on acceptable terms. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" . EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or or otherwise. For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences' public filings with the Securities and Exchange Commission including, without limitation, its most recent 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. and subsequent SEC filings.
EXACT SCIENCES CORPORATION
Selected Unaudited Financial Information
Statements of Operation Data
(In thousands, except per share data)
Three Months Ended
March 31,
------------------
2005 2004
-------- ---------
Revenue:
Product royalty fees $ 68 $ 22
License fees 1,128 1,128
Product 51 27
-------- ---------
1,247 1,177
Gross profit (loss):
Product royalty fees 64 21
License fees 1,128 1,128
Product 7 (4)
-------- ---------
1,199 1,145
-------- ---------
Operating Expenses:
Research and development 2,281 3,134
Sales and marketing 1,599 1,327
General and administrative 1,221 1,967
Restructuring 626 -
Stock-based compensation 303 126
-------- ---------
6,030 6,554
-------- ---------
Loss from operations (4,831) (5,409)
Interest income 246 118
-------- ---------
Net loss $(4,585) $ (5,291)
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Net loss per share - basic and diluted $ (0.17) $ (0.23)
======== =========
Weighted average common shares outstanding - basic
and diluted 26,203 22,949
======== =========
EXACT SCIENCES CORPORATION
Condensed Unaudited Balance Sheet Data
(In thousands)
March 31, Dec. 31,
2005 2004
-------- ---------
Assets
Cash and cash equivalents $ 9,333 $ 13,092
Short-term investments 35,001 37,188
Prepaid expenses 2,112 1,835
Property and equipment, net 1,485 1,954
Patent costs, net and other assets 1,922 2,042
-------- --------
Total assets $49,853 $ 56,111
======== =========
Liabilities and stockholders' equity
Total current liabilities 5,919 6,858
Deferred licensing fees, less current portion 10,180 11,270
Total stockholders' equity 33,754 37,983
-------- ---------
Total liabilities and stockholders' equity $49,853 $ 56,111
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This selected financial information should be read in conjunction with the consolidated financial statements Consolidated Financial Statements The combined financial statements of a parent company and its subsidiaries. Notes: Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they enable you to gauge and notes thereto there·to adv. 1. To that, this, or it. 2. Archaic In addition to that; furthermore. thereto Adverb Formal 1. to that or it 2. included in the Company's Annual Report on Form 10-K for the year ended December 31, 2004 and the Company's Form 10-Q Form 10-Q See 10-Q. for the three months ended March 31, 2005. |
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