MADISON, Wis., Jan. 8, 2017 /PRNewswire/ -- Exact Sciences
Corp. (Nasdaq: EXAS) announced today that the company expects to
report revenues between $34.9 million and
$35.4 million for the fourth quarter ended Dec. 31, 2016, an increase of 142 percent from
the same quarter of 2015. The company completed approximately
82,000 Cologuard tests during the fourth quarter of 2016, which
represents growth of 114 percent from the same period of 2015.
For the full-year 2016, the company anticipates revenues between
$99.0 million and $99.5 million, a
year-over-year increase of 150 percent. Completed Cologuard test
volume during 2016 was approximately 244,000 tests, a 134-percent
increase from 2015.
More than 9,500 health care providers ordered Cologuard for the
first time during the fourth quarter ended Dec. 31, 2016. The number of providers who
have ordered Cologuard since it was launched increased to nearly
60,000 during 2016, an increase of 122 percent from the prior
year.
Insurance coverage of Cologuard expanded by 67 percent during
2016. Coverage has increased by 62 million lives since June 2016, when Cologuard was included in the
U.S. Preventive Services Task Force's final colorectal cancer
screening recommendations. More than 163 million people are in
health plans that cover Cologuard as of Jan.
6, 2017.
"Cologuard is becoming a standard of care for 80 million
Americans who should be screened for colon cancer," said
Kevin Conroy, Exact Sciences'
chairman and CEO. "Strong demand for Cologuard from both patients
and health care providers reflects the great need for this
innovative, easy-to-use colon cancer screening test."
Exact Sciences has not completed preparation of its financial
statements for the fourth quarter or full year of 2016. The
preliminary, unaudited results presented in this news release for
the quarter and year ended Dec. 31,
2016 are based on current expectations and are subject to
year-end closing adjustments. Actual results may differ.
Exact Sciences will report 2016 financial results and provide
revenue and Cologuard test volume guidance on its February 2017 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 recommendations of the U.S. Preventive Services Task Force
(2016) and the American Cancer Society's (2014) colorectal cancer
screening guidelines. Stool DNA is included in the combined
screening guidelines of the American Cancer Society / U.S.
Multi-Society Task Force/American College of Radiology (2008), the
American College of Gastroenterology guidelines (2009) and the
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. 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 .
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," "could," "seek," "intend," "plan," "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 payor 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; the willingness of health
insurance companies and other payors to cover Cologuard and
reimburse us for our performance of the Cologuard test; the amount
and nature of competition from other cancer screening products and
services; the effects of any healthcare reforms, including the
Affordable Care Act, or changes in healthcare pricing, coverage and
reimbursement; 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 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 Report(s) 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.
Contact:
J.P. Fielder
Exact Sciences Corp.
jpfielder@exactsciences.com
608-210-5220
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SOURCE EXACT SCIENCES CORP