MADISON, Wis., Jan. 6, 2019 /PRNewswire/ -- Exact Sciences
Corp. (Nasdaq: EXAS) today announced that the company expects to
report revenue between $142.5 million
and $143.5 million for the fourth
quarter ended Dec. 31, 2018, an
increase of 64 percent from the same quarter of 2017. The company
completed approximately 292,000 Cologuard tests during the fourth
quarter of 2018, which represents 66-percent growth from the same
period of 2017.
For full-year 2018, the company anticipates reporting total
revenue between $454 million and
$455 million, a year-over-year
increase of 71 percent. Completed Cologuard test volume during 2018
was approximately 934,000 tests, a 64-percent increase from
2017.
Nearly 15,000 health care providers ordered Cologuard for the
first time during the fourth quarter of 2018. The number of
providers who have ordered Cologuard since its launch increased to
nearly 147,000 during 2018.
"2018 was a landmark year for Exact Sciences," said Kevin Conroy, chairman and CEO of Exact
Sciences. "We helped more than 930,000 people get screened for
colorectal cancer, launched a partnership with Pfizer to help bring
Cologuard to more patients, and scaled our operations to meet
rising demand. Our team continues working hard to deliver
life-changing innovations in early cancer detection. In 2019,
we expect to open a new clinical lab, integrate Epic software into
our operations, and advance our pipeline of liquid biopsy
tests."
Exact Sciences has not completed preparation of its financial
statements for the fourth quarter or full year of 2018. The revenue
ranges presented in this news release for the fourth quarter of
2018 and for the year ended Dec. 31,
2018 are preliminary and unaudited and are thus inherently
uncertain and subject to change as we complete our financial
results for the fourth quarter of 2018. We are in the process of
completing our customary year-end close and review procedures as of
and for the year ended Dec. 31, 2018,
and there can be no assurance that our final results for this
period will not differ from these estimates. During the course of
the preparation of our consolidated financial statements and
related notes as of and for the year ended Dec. 31, 2018, we or our independent registered
public accountants may identify items that could cause our final
reported results to be materially different from the preliminary
financial estimates presented herein.
Exact Sciences plans to report 2018 financial results and
provide guidance during its February
2019 earnings call.
About Cologuard
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences'
prospective 90-site, point-in-time, 10,000-patient pivotal trial
were published in the New England Journal of Medicine in
March 2014. Cologuard is included in
the American Cancer Society's (2018) colorectal cancer screening
guidelines and the recommendations of the U.S. Preventive Services
Task Force (2016) and National Comprehensive Cancer Network (2016).
Cologuard is indicated to screen adults of either sex, 50 years or
older, who are at average risk for colorectal cancer. Cologuard is
not for everyone and is not a replacement for diagnostic
colonoscopy or surveillance colonoscopy in high-risk individuals.
False positives and false negatives do occur. Any positive test
result should be followed by a diagnostic colonoscopy. Following a
negative result, patients should continue participating in a
screening program at an interval and with a method appropriate for
the individual patient. Cologuard performance when used for repeat
testing has not been evaluated or established. Medicare and most
major insurers cover Cologuard. For more information about
Cologuard, visit www.cologuardtest.com. Rx Only.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused
on the early detection and prevention of the deadliest forms of
cancer. The company has exclusive intellectual property protecting
its non-invasive, molecular screening technology for the detection
of colorectal cancer. For more information, please visit the
company's website at www.exactsciences.com, follow Exact Sciences
on Twitter @ExactSciences or find Exact Sciences on Facebook.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
that are intended to be covered by the "safe harbor" created by
those sections. Forward-looking statements, which are based on
certain assumptions and describe our future plans, strategies and
expectations, can generally be identified by the use of
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "would," "could," "seek," "intend," "plan," "goal,"
"project," "estimate," "anticipate" or other comparable terms. All
statements other than statements of historical facts included in
this news release regarding our strategies, prospects, financial
condition, operations, costs, plans and objectives are
forward-looking statements. Examples of forward-looking statements
include, among others, statements we make regarding expected future
operating results, anticipated results of our sales and marketing
efforts, expectations concerning payer reimbursement and the
anticipated results of our product development efforts.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results and financial
condition may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the following: our ability to successfully
and profitably market our products and services; the acceptance of
our products and services by patients and healthcare providers; our
ability to meet demand for our products and services; the
willingness of health insurance companies and other payers to cover
our products and services and adequately reimburse us for such
products and services; the amount and nature of competition from
other cancer screening and diagnostic products and services; the
effects of the adoption, modification or repeal of any healthcare
reform law, rule, order, interpretation or policy; the effects of
changes in pricing, coverage and reimbursement for our products and
services, including without limitation as a result of the
Protecting Access to Medicare Act of 2014; recommendations,
guidelines and quality metrics issued by various organizations such
as the U.S. Preventive Services Task Force, the American Cancer
Society, and the National Committee for Quality Assurance regarding
cancer screening or our products and services; our ability to
successfully develop new products and services; our ability to
effectively utilize strategic partnerships and acquisitions; our
success establishing and maintaining collaborative, licensing and
supplier arrangements; our ability to maintain regulatory approvals
and comply with applicable regulations; and the other risks and
uncertainties described in the Risk Factors and in Management's
Discussion and Analysis of Financial Condition and Results of
Operations sections of our most recently filed Annual Report on
Form 10-K and our subsequently filed Quarterly Reports on Form
10-Q. We undertake no obligation to publicly update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
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SOURCE EXACT SCIENCES CORP