Exhibit 99.1
EXACT SCIENCES ANNOUNCES SECOND QUARTER 2003 RESULTS
MARLBOROUGH, Mass.—(July 21, 2003)—EXACT Sciences Corporation (NASDAQ: EXAS) announced today financial results for the second quarter ending June 30, 2003.
For the quarter ending June 30, 2003, revenues totaled $0.4 million versus revenues of $0.04 million for the quarter ending June 30, 2002. Net loss for the second quarter of 2003 totaled $7.9 million, or $0.42 per share, compared to a net loss of $7.9 million, or $0.43 per share, for the second quarter of 2002. Pro forma net loss for the second quarter of 2003, which excludes $0.3 million of non-cash stock-based compensation charges, totaled $7.6 million, or $0.40 per share, compared to pro forma net loss of $7.3 million, or $0.40 per share for the second quarter of 2002, which excludes $0.5 million of non-cash stock-based compensation charges.
Revenues for the six months ending June 30, 2003 totaled $0.8 million compared to revenues of $0.08 million for the comparable six-month period in 2002. For the six months ending June 30, 2003, net loss totaled $15.8 million, or $0.84 per share, compared to a net loss of $15.5 million, or $0.85 per share, for the six months ended June 30, 2002. Pro forma net loss for the first half of 2003, which excludes $0.7 million of non-cash stock-based compensation charges, totaled $15.1 million, or $0.81 per share, compared to pro forma net loss of $14.3 million, or $0.79 per share, for the first half of 2002, which excludes $1.1 million of non-cash stock-based compensation charges.
Revenues for the first six months of 2002 and 2003 were primarily attributable to the amortization of up-front license fee payments related to the Company's two strategic partnership agreements with Laboratory Corporation of America® Holdings (LabCorp®), which were consummated in July 2001 and June 2002. The increase in net loss for the first half of 2003 versus the first half of 2002 was due primarily to an increase in selling, general and administrative expenses related to preparations for the launch of PreGen-Plus™, the Company's non-invasive, DNA-based assay for the early detection of colorectal cancer. This increase was offset to some extent by lower research and development expense related to the recent completion of patient enrollment in the Company's multi-center study.
As of June 30, 2003, EXACT Sciences had approximately $27 million in cash, cash equivalents and marketable securities available to fund its operations.
"Second quarter of 2003 was important to the Company both commercially and scientifically," said Don Hardison, EXACT Sciences' President and CEO. "We advanced our preparations for the commercial launch of PreGen-Plus, which we and LabCorp anticipate will occur in August of this year. We are looking forward to moving from pre-launch activities to actually selling PreGen-Plus. On the research front, we had an important announcement at the annual meeting of the American Association for Cancer Research. At that meeting, Tony Shuber, our Chief Technology Officer, presented data supporting an increase in sensitivity in the commercial version of PreGen-Plus as a result of the inclusion of our novel technology, Effipure™, in the assay. All of us at EXACT Sciences are excited about the imminent availability of PreGen-Plus, and the step that commercial launch represents towards achieving the mission of our company—the eradication of the mortality associated with colorectal cancer."
Operating Highlights
Commercial
others, such as the technology transfer and licensing and contracting with suppliers, must be completed prior to commercial launch.
Business Development
Clinical
Research and Development
Corporate Move
As of June 30, 2003, the Company has new contact information:
100 Campus Drive
Marlborough, MA 01752
(phone) 508-683-1200
(fax) 508-683-1201
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Second Quarter 2003 Conference Call
EXACT Sciences will host a conference call discussing the Company's second quarter 2003 operating and financial results, and discussing the outlook for the remainder of 2003, at 8:30 a.m. EDT on Tuesday, July 22, 2003. A live Webcast of the conference call, as well as an archived version following the completion of the call, will be available atwww.exactsciences.com by clicking on the Investor Relations link. The conference call and Webcast are open to all interested parties.
Information for the call is as follows:
| Domestic callers: | 877-809-1575 | ||
International callers: | 706-679-5918 | ||
PIN#: | 1649075 |
A replay of the conference call will be available two hours following the completion of the conference call, for 48 hours. Information for the replay is as follows:
| Domestic callers: | 800-642-1687 | ||
International callers: | 706-645-9291 | ||
PIN #: | 1649075 |
About EXACT Sciences Corporation
EXACT Sciences Corporation is an applied genomics company that has developed proprietary technologies that may be used for the early detection of several common cancers. EXACT Sciences has selected colorectal cancer as the first application of its technologies. Colorectal cancer is the most deadly cancer among non-smokers, and is curable if detected early. Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, the rate of early detection of colorectal cancer remains low. 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 can be found on the World Wide Web atwww.exactsciences.com
Certain statements made in this press release that are not based on historical information are forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release contains express or implied forward-looking statements relating to, among other things, EXACT Sciences' expectations concerning its future revenues and expenses, its business outlook and business momentum, its clinical trials, the commercial launch of its technologies, 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, 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 inability of EXACT Sciences to automate and develop processes that make its assays commercially attractive; that the completion of clinical studies may not prove the superiority of EXACT Sciences' technologies; the inability to recruit a sufficient number of patients for clinical studies/trials; the inability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences' products and services; the failure to convince medical practitioners to order tests using EXACT Sciences' technologies; the lack of market acceptance of PreGen-26, PreGen-Plus, and other PreGen technologies to screen for colorectal cancer; the inability of EXACT Sciences to control its commercial partners' operations, performance or sales performance, including sales of products utilizing EXACT Sciences' technologies; the inability of EXACT Sciences' commercial partners to create a market for and sell products using EXACT Sciences' technologies; the
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failure of EXACT Sciences' strategic and collaborative partners to satisfy their obligations under agreements with the Company; the loss of support of key scientific collaborators; the failure to comply with federal and state statutes and regulations relating to EXACT Sciences' products and services, including FDA requirements, and relating to the operation of EXACT Sciences' laboratory, including the Clinical Laboratory Improvement Amendments; competition; the inability of EXACT Sciences or its strategic or collaborative partners to obtain in a timely manner any third-party licenses or manufacture and supply agreements that may be necessary to commercialize its technologies; a decrease in available raw materials; and the inability to protect EXACT Sciences' intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. 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 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 and subsequent Forms 10-Q.
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EXACT SCIENCES CORPORATION
Selected Unaudited Financial Information
Statement of Operations Data
| | Three Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| | 2003 | 2002 | ||||||
| | In thousands, except per share data | |||||||
| Revenues: | $ | 406 | $ | 40 | ||||
Expenses: | ||||||||
| Cost of revenues | — | 2 | ||||||
| Research and development | 4,592 | 5,066 | ||||||
| Selling, general and administrative | 3,494 | 2,534 | ||||||
| Stock-based compensation (1) | 330 | 544 | ||||||
| Total expenses | 8,416 | 8,146 | ||||||
Loss from operations | (8,010 | ) | (8,106 | ) | ||||
Interest income | 126 | 231 | ||||||
Net loss | $ | (7,884 | ) | $ | (7,875 | ) | ||
Pro forma net loss (2) | $ | (7,554 | ) | $ | (7,331 | ) | ||
Net loss per share: | ||||||||
| Basic and diluted | $ | (0.42 | ) | $ | (0.43 | ) | ||
| Pro forma basic and diluted (2) | $ | (0.40 | ) | $ | (0.40 | ) | ||
Weighted average common shares outstanding: | ||||||||
| Basic and diluted | 18,801 | 18,376 | ||||||
| Pro forma basic and diluted | 18,801 | 18,376 | ||||||
Pro forma reconciliation: | ||||||||
| Net loss | $ | (7,884 | ) | $ | (7,875 | ) | ||
| Stock-based compensation (1) | 330 | 544 | ||||||
| Pro forma net loss | $ | (7,554 | ) | $ | (7,331 | ) | ||
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EXACT SCIENCES CORPORATION
Selected Unaudited Financial Information
Statement of Operations Data
| | Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| | 2003 | 2002 | ||||||
| | In thousands, except per share data | |||||||
| Revenues: | $ | 814 | $ | 79 | ||||
Expenses: | ||||||||
| Cost of revenues | 3 | 2 | ||||||
| Research and development | 9,605 | 10,109 | ||||||
| Selling, general and administrative | 6,608 | 4,823 | ||||||
| Stock-based compensation (1) | 658 | 1,112 | ||||||
| Total expenses | 16,874 | 16,046 | ||||||
Loss from operations | (16,060 | ) | (15,967 | ) | ||||
Interest income | 293 | 506 | ||||||
Net loss | $ | (15,767 | ) | $ | (15,461 | ) | ||
Pro forma net loss (2) | $ | (15,109 | ) | $ | (14,349 | ) | ||
Net loss per share: | ||||||||
| Basic and diluted | $ | (0.84 | ) | $ | (0.85 | ) | ||
| Pro forma basic and diluted (2) | $ | (0.81 | ) | $ | (0.79 | ) | ||
Weighted average common shares outstanding: | ||||||||
| Basic and diluted | 18,764 | 18,271 | ||||||
| Pro forma basic and diluted | 18,764 | 18,271 | ||||||
Pro forma reconciliation: | ||||||||
| Net loss | $ | (15,767 | ) | $ | (15,461 | ) | ||
| Stock-based compensation (1) | 658 | 1,112 | ||||||
| Pro forma net loss | $ | (15,109 | ) | $ | (14,349 | ) | ||
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EXACT SCIENCES CORPORATION
Condensed Unaudited Balance Sheet Data
(In thousands)
| | June 30, 2003 | December 31, 2002 | ||||
|---|---|---|---|---|---|---|
| Assets | ||||||
| Cash and cash equivalents | $ | 14,736 | $ | 17,439 | ||
| Short-term investments | 12,386 | 26,407 | ||||
| Prepaid expenses | 1,454 | 1,110 | ||||
| Property and equipment, net | 2,655 | 2,256 | ||||
| Patent costs, net and other assets | 2,738 | 2,874 | ||||
| Total assets | $ | 33,969 | $ | 50,086 | ||
Liabilities and stockholders' equity | ||||||
| Total current liabilities | 4,698 | 5,244 | ||||
| Deferred licensing fees, less current portion | 5,683 | 6,493 | ||||
| Total stockholders' equity | 23,588 | 38,349 | ||||
| Total liabilities and stockholders' equity | $ | 33,969 | $ | 50,086 | ||
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