Exact Sciences Corp. (Nasdaq: EXAS) today announced its business and
financial results for the quarter ending March 31, 2015, reporting that
11,000 Cologuard tests were completed and that the number of ordering
physicians more than doubled, increasing from 4,100 at the end of 2014
to 8,300 in the first quarter of 2015.
“We are pleased with the strong launch trajectory of Cologuard,” said
Kevin Conroy, Exact Sciences’ chairman and CEO. “Demand among patients
and physicians and acceptance among commercial insurers is accelerating.”
The company expanded its team of sales professionals from 80 to 140
during the first quarter and also entered into an exclusive co-promotion
agreement with Ironwood Pharmaceuticals, Inc. The arrangement will bring
Cologuard to even more physicians and their patients through Ironwood’s
160 sales professionals.
Exact Sciences also made steady progress securing coverage from
commercial insurers during the first quarter. This included positive
medical policy coverage decisions from Anthem BlueCross BlueShield (37
million covered lives), Tufts Health Plan (1 million), CareFirst
BlueCross BlueShield PPO (2 million) and Excellus BlueCross BlueShield
of Western New York (1 million). The company also formally extended its
collaboration with the Mayo Foundation for Medical Education and
Research by an additional five years and expanded its licensing
agreement to include additional gastrointestinal conditions.
Financial Results
Exact Sciences reported total revenues of $4.3 million for the first
quarter of 2015, compared to $0.3 million for the first quarter of 2014.
Cologuard received approval from the U.S. Food and Drug Administration
in August 2014 and a final National Coverage Decision from the Centers
for Medicare and Medicaid Services in October 2014.
For the first quarter of 2015 the company reported a net loss of ($35.8)
million, or ($0.40) a share. The company had a net loss of ($16.1)
million, or ($0.23) a share, for the same period of 2014.
Operating expenses for the quarter ended March 31, 2015, were $36.1
million, compared to $16.5 million for the first quarter of 2014.
Exact Sciences ended the first quarter of 2015 with cash, cash
equivalents and marketable securities of $245.2 million, compared to
$282.8 million at Dec. 31, 2014.
First-Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Monday,
May 4, 2015, at 10 a.m. ET to discuss first-quarter results. The webcast
will be available at www.exactsciences.com.
Domestic callers should dial 877-212-6082 and international callers
should dial 707-287-9332. An archive of the webcast and a replay of the
conference call will be available at www.exactsciences.com
or by calling 855-859-2056 domestically or 404-537-3406 internationally.
The access code for the conference call and replay is 29563689. The
conference call, webcast and replay are open to all interested parties.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on
colorectal cancer. The company has exclusive intellectual property
protecting its non-invasive, molecular screening technology for the
detection of colorectal cancer. Stool-based DNA technology is included
in the colorectal cancer screening guidelines of the American Cancer
Society and the U.S. Multi-Society Task Force on Colorectal Cancer. For
more information, please visit the company’s website at www.exactsciences.com.
Certain statements made in this news release contain forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities and Exchange Act of
1934, as amended that are intended to be covered by the "safe harbor"
created by those sections. Forward-looking statements 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 press 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; the acceptance of our products by
patients and health care providers; the amount and nature of competition
from other cancer screening products and procedures; our ability to
maintain regulatory approvals and comply with applicable regulations;
our success establishing and maintaining collaborative and licensing
arrangements; our ability to successfully develop new products; 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.
EXACT SCIENCES CORPORATION
|
Selected Unaudited Financial Information
|
Condensed Consolidated Statements of Operation Data
|
(Amounts in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
March 31,
|
|
|
|
|
2015
|
|
|
2014
|
|
|
|
|
|
|
|
|
Laboratory service revenue
|
|
|
|
$
|
4,266
|
|
|
|
$
|
-
|
|
License fees
|
|
|
|
|
-
|
|
|
|
|
294
|
|
|
|
|
|
|
4,266
|
|
|
|
|
294
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
4,212
|
|
|
|
|
-
|
|
Gross margin
|
|
|
|
|
54
|
|
|
|
|
294
|
|
|
|
|
|
|
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
6,571
|
|
|
|
|
7,430
|
|
General and administrative
|
|
|
|
|
12,971
|
|
|
|
|
4,586
|
|
Sales and marketing
|
|
|
|
|
16,524
|
|
|
|
|
4,456
|
|
|
|
|
|
|
36,066
|
|
|
|
|
16,472
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
(36,012
|
)
|
|
|
|
(16,178
|
)
|
|
|
|
|
|
|
|
|
Investment income
|
|
|
|
|
222
|
|
|
|
|
86
|
|
Interest expense
|
|
|
|
|
(11
|
)
|
|
|
|
(15
|
)
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(35,801
|
)
|
|
|
$
|
(16,107
|
)
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted
|
|
|
|
$
|
(0.40
|
)
|
|
|
$
|
(0.23
|
)
|
|
|
|
|
|
|
|
|
Weighted average common shares
|
|
|
|
|
|
|
|
outstanding - basic and diluted
|
|
|
|
|
88,662
|
|
|
|
|
70,987
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXACT SCIENCES CORPORATION
|
Selected Unaudited Financial Information
|
Condensed Consolidated Balance Sheet Data
|
(Amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
|
2015
|
|
|
2014
|
Assets
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
40,679
|
|
|
$
|
58,131
|
Marketable securities
|
|
|
|
|
204,472
|
|
|
|
224,625
|
Accounts receivable
|
|
|
|
|
1,581
|
|
|
|
1,376
|
Inventory, net
|
|
|
|
|
5,423
|
|
|
|
4,017
|
Prepaid expenses and other current assets
|
|
|
|
|
3,892
|
|
|
|
3,528
|
Property and equipment, net
|
|
|
|
|
21,567
|
|
|
|
19,947
|
Other long-term assets
|
|
|
|
|
1,200
|
|
|
|
-
|
Total assets
|
|
|
|
$
|
278,814
|
|
|
$
|
311,624
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
|
$
|
14,476
|
|
|
$
|
17,521
|
Long term debt
|
|
|
|
|
1,000
|
|
|
|
1,000
|
Long term other liabilities
|
|
|
|
|
3,541
|
|
|
|
2,399
|
Long term accrued interest
|
|
|
|
|
112
|
|
|
|
106
|
Lease incentive obligation, less current portion
|
|
|
|
|
1,476
|
|
|
|
1,614
|
Total stockholders’ equity
|
|
|
|
|
258,209
|
|
|
|
288,984
|
Total liabilities and stockholders' equity
|
|
|
|
$
|
278,814
|
|
|
$
|
311,624
|
|
|
|
|
|
|
|
|
|
|
Copyright Business Wire 2015