UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 20, 2015
EXACT SCIENCES CORPORATION
(Exact Name of Registrant as Specified in Charter)
Delaware |
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001-35092 |
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02-0478229 |
(State or Other Jurisdiction |
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(Commission |
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(I.R.S. Employer |
441 Charmany Drive
Madison, WI 53719
(Address of Principal Executive Offices)(Zip Code)
Registrants telephone number, including area code: (608) 284-5700
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
2.02. Results of Operations and Financial Condition.
On July 20, 2015, Exact Sciences Corporation announced its financial results for the quarter ended June 30, 2015. A copy of the press release is being furnished as Exhibit 99 to this Report on Form 8-K.
The information in this Report on Form 8-K and Exhibit 99 attached hereto is intended to be furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
9.01. Financial Statements and Exhibits.
Exhibits
The exhibits required to be filed as a part of this Current Report on Form 8-K are listed in the Exhibit Index attached hereto and incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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EXACT SCIENCES CORPORATION | |
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Date: July 20, 2015 |
By: |
/s/ William J. Megan |
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William J. Megan |
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Senior Vice President, Finance |
Exhibit 99
Contact:
J.P. Fielder
Exact Sciences Corp.
jpfielder@exactsciences.com
608-210-5220
For Immediate Release
Exact Sciences Highlights Cologuards®
Positive Launch Trajectory in Second Quarter 2015
MADISON, Wis., July 20, 2015 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 Cologuards 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. Were 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 worlds 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 companys 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 www.investorExactSciences.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 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 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 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, 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 Managements 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)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2015 |
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2014 |
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2015 |
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2014 |
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Laboratory service revenue |
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$ |
8,119 |
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$ |
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$ |
12,385 |
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$ |
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License fees |
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294 |
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8,119 |
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12,385 |
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294 |
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Cost of sales |
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5,094 |
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9,306 |
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Gross margin |
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3,025 |
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3,079 |
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294 |
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Operating Expenses: |
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Research and development |
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8,115 |
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7,174 |
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14,686 |
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14,604 |
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General and administrative |
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13,683 |
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6,230 |
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26,654 |
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10,816 |
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Sales and marketing |
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20,593 |
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6,166 |
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37,117 |
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10,622 |
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42,391 |
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19,570 |
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78,457 |
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36,042 |
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Loss from operations |
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(39,366 |
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(19,570 |
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(75,378 |
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(35,748 |
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Investment income |
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193 |
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146 |
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415 |
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232 |
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Interest expense |
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107 |
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(13 |
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96 |
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(28 |
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Net loss |
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$ |
(39,066 |
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$ |
(19,437 |
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$ |
(74,867 |
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$ |
(35,544 |
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Net loss per share - basic and diluted |
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$ |
(0.44 |
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$ |
(0.24 |
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$ |
(0.84 |
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$ |
(0.46 |
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Weighted average common shares outstanding - basic and diluted |
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88,919 |
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82,048 |
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88,791 |
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76,548 |
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EXACT SCIENCES CORPORATION Selected Unaudited Financial Information Condensed Consolidated Balance Sheet Data (Amounts in thousands) | ||||||||||||||
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June 30, |
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December 31, |
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2015 |
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2014 |
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Assets |
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Cash and cash equivalents |
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$ |
33,765 |
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$ |
58,131 |
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Marketable securities |
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177,053 |
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224,625 |
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Accounts receivable |
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2,151 |
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1,376 |
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Inventory, net |
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6,275 |
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4,017 |
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Prepaid expenses and other current assets |
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4,019 |
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3,528 |
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Property and equipment, net |
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27,312 |
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19,947 |
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Other long-term assets |
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2,442 |
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1,200 |
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Total assets |
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$ |
253,017 |
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$ |
312,824 |
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Liabilities and stockholders equity |
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Total current liabilities |
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$ |
18,730 |
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$ |
17,521 |
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Long-term debt |
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3,488 |
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1,000 |
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Other long-term liabilities |
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4,620 |
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3,599 |
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Long-term accrued interest |
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106 |
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Lease incentive obligation, less current portion |
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1,338 |
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1,614 |
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Total stockholders equity |
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224,841 |
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288,984 |
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Total liabilities and stockholders equity |
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$ |
253,017 |
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$ |
312,824 |
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