Exact Sciences Highlights Cologuard's® Positive Launch Trajectory in Second Quarter 2015

MADISON, Wis.—(BUSINESS WIRE)— Exact Sciences Corp. (Nasdaq: EXAS) today announced its business and financial results for the second quarter of 2015, and showed continued strong performance with more than 21,000 completed Cologuard tests for the quarter, up more than 90 percent from the first quarter, which resulted in $8.1 million in revenue. Additionally, the cumulative number of ordering physicians grew to 14,700 during the quarter, a 77 percent increase.

"We are pleased with Cologuard's growth trajectory and that our sales and marketing strategy is driving results," said Kevin Conroy, Exact Sciences' chairman and CEO. "Physician and patient demand are increasing while our compliance rate continues moving upward as well. We're now building on the success of Cologuard to develop tests that will detect lung, pancreatic and esophageal cancers at their earliest stages."

During the second quarter of 2015 the compliance rate for Cologuard increased to 73 percent, up from 71 percent in the first quarter. The patient compliance rate is derived from the number of valid test results generated from collection kits shipped to patients 60 or more days prior to June 30, 2015. Our lab, through its customer care center, is helping to drive this increase by regularly contacting patients for whom Cologuard has been ordered and encouraging them to complete their screening. More than a third of Cologuard users (36 percent) had never been screened before, according to a 3,000-patient survey by the company.

Exact Sciences also announced during the second quarter a landmark partnership with The University of Texas MD Anderson Cancer Center, one of the world's leading cancer centers, to develop a simple blood-based test to detect lung cancer, details of which were presented at Exact Sciences' inaugural Investor & Analyst Day. The investor day event also offered context about Exact Sciences ongoing partnership with Mayo Clinic to develop tests for the early detection of pancreatic and esophageal cancer.

Financial Results

Exact Sciences reported total revenues of $8.1 million for the second quarter of 2015 and total revenues of $12.4 million for the six months ended June 30, 2015. Cologuard received approval from the U.S. Food and Drug Administration in August 2014 and a final National Coverage Decision from the Center for Medicare and Medicaid Services in October 2014.

For the second quarter of 2015, Exact Sciences reported a net loss of ($39.1) million, or ($0.44) a share. The company had a net loss of ($19.4) million, or ($0.24) a share, for the same period of 2014. The company's net loss for the first six months of 2015 was ($74.9) million, or ($0.84) a share. The company had a net loss of ($35.5) million, or ($0.46) a share, for the same period of 2014.

Operating expenses for the quarter ending June 30, 2015, were $42.4 million, compared to $19.6 million for the second quarter of 2014. Operating expenses for the six months ended June 30, 2105 were $78.5 million. The company had operating expenses of $36.0 million for the same period of 2014.

Exact Sciences ended the second quarter of 2015 with cash, cash equivalents and marketable securities of $210.8 million, compared to $282.8 million at Dec. 31, 2014.

Second-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Monday, July 20, 2015, at 10 a.m. ET to discuss second-quarter results. The webcast will be available at http://investor.exactsciences.com. Domestic callers should dial 877-212-6082 and international callers should dial +1 707-287-9332. 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 +1 404-537-3406 internationally. The access code for the conference call and replay is 84732817. 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 the early detection and prevention of some of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.

Certain statements made in this presentation 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 presentation 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 numbers of completed and reported Cologuard tests, anticipated patient compliance rates, the launch trajectory for Cologuard, 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, including without limitation our efforts with regard to tests for lung cancer, pancreatic cancer and esophageal cancer. 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.

Selected Unaudited Financial Information
Condensed Consolidated Statements of Operation Data
(Amounts in thousands, except per share data)
    Three Months Ended   Six Months Ended
    June 30,   June 30,
      2015       2014       2015       2014  
Laboratory service revenue   $ 8,119     $ -     $ 12,385     $ -  
License fees     -       -       -       294  
      8,119       -       12,385       294  
Cost of sales     5,094       -       9,306       -  
Gross margin     3,025       -       3,079       294  
Operating Expenses:                
Research and development     8,115  


  7,174       14,686       14,604  
General and administrative     13,683  


  6,230       26,654       10,816  
Sales and marketing     20,593       6,166       37,117       10,622  
      42,391       19,570       78,457       36,042  
Loss from operations     (39,366 )     (19,570 )     (75,378 )     (35,748 )
Investment income     193       146       415       232  
Interest expense     107       (13 )     96       (28 )
Net loss   $ (39,066 )   $ (19,437 )   $ (74,867 )   $ (35,544 )
Net loss per share - basic and diluted   $ (0.44 )   $ (0.24 )   $ (0.84 )   $ (0.46 )
Weighted average common shares                
outstanding - basic and diluted     88,919       82,048       88,791       76,548  
Selected Unaudited Financial Information
Condensed Consolidated Balance Sheet Data
(Amounts in thousands)
    June 30,   December 31,        
    2015   2014        
Cash and cash equivalents   $ 33,765     $ 58,131          
Marketable securities     177,053       224,625          
Accounts receivable     2,151       1,376          
Inventory, net     6,275       4,017          
Prepaid expenses and other current assets     4,019       3,528          
Property and equipment, net     27,312       19,947          
Other long-term assets     2,442       1,200          
Total assets   $ 253,017     $ 312,824          
Liabilities and stockholders' equity                
Total current liabilities   $ 18,730     $ 17,521          
Long-term debt     3,488       1,000          
Other long-term liabilities     4,620       3,599          
Long-term accrued interest     -       106          
Lease incentive obligation, less current portion     1,338       1,614          
Total stockholders' equity     224,841       288,984          
Total liabilities and stockholders' equity   $ 253,017     $ 312,824          


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Exact Sciences Corp.
J.P. Fielder, 608-210-5220


Source: Exact Sciences Corp.

Topics: Exact Sciences News

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