- Revenue guidance raised to $230-240 million for 2017, from $195-205 million
- Guidance for Cologuard tests to be completed during 2017 increased to at least 550,000 tests, from at least 470,000
- 11,000 additional providers ordered Cologuard for the first time during the second quarter, and insurance coverage expanded to 86 percent of target population

MADISON, Wis., July 25, 2017 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company generated revenue of $57.6 million and completed approximately 135,000 Cologuard tests during the quarter ended June 30, 2017. Second-quarter 2017 revenue and completed Cologuard test volume grew 172 percent and 149 percent from the same period of 2016, respectively.

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"As patient and physician demand for Cologuard continues to grow, momentum is increasing toward Cologuard becoming part of the standard of care in colon cancer screening," said Kevin Conroy, chairman and CEO of Exact Sciences. "We will continue investing in the long-term and sustainable growth of Cologuard to ensure the millions of people who need to be screened for colon cancer have access to our non-invasive test."

Second-Quarter 2017 Financial Results

For the three-month period ended June 30, 2017, as compared to the same period of 2016 (where applicable):

  • Average recognized revenue per test was $428, an increase of 9 percent
  • Average cost per test was $133, an improvement of 28 percent
  • Gross margin was 69 percent, an increase of 1,650 basis points
  • Operating expenses were $71.1 million, an increase of 26 percent
  • Net loss was $30.8 million or $0.27 per share, compared to $44.8 million or $0.46 per share during the same period of 2016
  • Cash utilization was $43.9 million, including $15 million paid to MDx Health as previously disclosed for the acquisition of certain patent rights
  • Cash, cash equivalents and marketable securities were $484.3 million at the end of the quarter

Second-Quarter 2017 and Recent Business Highlights

Provider growth

  • Roughly 11,000 healthcare providers ordered their first Cologuard test during the second quarter of 2017.
  • Since Cologuard was launched, approximately 81,000 providers have ordered the test through the end of the second quarter of 2017.

Coverage progress

  • As of July 24, 2017, approximately 235 million Americans are members of health plans that cover Cologuard.
  • 86 percent of those who should be screened for colorectal cancer are covered.

Updated 2017 Outlook

  • The company anticipates revenue of $230-240 million and completed Cologuard test volume of at least 550,000 tests during 2017.
  • The company's previous guidance was $195-205 million in revenue and at least 470,000 completed Cologuard tests.
  • The company anticipates completing at least 150,000 Cologuard tests during the third quarter of 2017.

The company's guidance for revenue and completed tests are forward-looking statements. They are subject to various risks and uncertainties that could cause the company's actual results to differ materially from the anticipated targets. The anticipated targets are not predictions of the company's actual performance. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

Second-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, July 25, 2017, at 5 p.m. ET to discuss second-quarter 2017 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast and a replay of the conference call will be available at www.exactsciences.com or by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the conference call and replay is 51121804. The conference call, webcast and replay are open to all interested parties.

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 (2014) 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. 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.

Safe Harbor Statement

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," "goal," "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 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 the adoption, modification or repeal of any healthcare reform law, rule, order, interpretation or policy; the effects of 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.

 

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Statements of Operations

(Amounts in thousands, except per share data)

               
 

Three Months Ended

 

Six Months Ended

 

June 30,

 

June 30,

 

2017

 

2016

 

2017

 

2016

               

Laboratory service revenue

$   57,646

 

$   21,185

 

$  106,009

 

$   36,020

 

57,646

 

21,185

 

106,009

 

36,020

               

Cost of sales

17,991

 

10,097

 

34,972

 

19,156

Gross margin

39,655

 

11,088

 

71,037

 

16,864

               

Operating Expenses:

             

     Research and development

9,737

 

8,640

 

17,739

 

18,766

     General and administrative

24,609

 

17,284

 

44,679

 

35,108

     Sales and marketing

36,728

 

30,301

 

75,529

 

56,012

        Total operating expenses

71,074

 

56,225

 

137,947

 

109,886

               

       Loss from operations

(31,419)

 

(45,137)

 

(66,910)

 

(93,022)

               

Investment income

683

 

425

 

1,278

 

891

Interest expense

(54)

 

(53)

 

(104)

 

(107)

               

    Net loss

$  (30,790)

 

$  (44,765)

 

$  (65,736)

 

$  (92,238)

               

Net loss per share - basic and diluted

$     (0.27)

 

$     (0.46)

 

$      (0.59)

 

$     (0.95)

               

Weighted average common shares

             

 

 

outstanding - basic and diluted

 

 

 

112,847

 

97,902

 

111,721

 

97,578

 

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Balance Sheets

(Amounts in thousands)

       
 

June 30,

 

 December 31, 

 

2017

 

2016

Assets

     

Cash and cash equivalents

$  180,407

 

$             48,921

Marketable securities

303,853

 

262,179

Accounts receivable, net

22,591

 

8,526

Inventory, net

12,410

 

6,833

Prepaid expenses and other current assets

6,872

 

7,114

Property and equipment, net

42,048

 

38,142

Other long-term assets

14,420

 

5,325

Total assets

$  582,601

 

$           377,040

       

Liabilities and stockholders' equity 

     

Total current liabilities

$    31,293

 

$             30,692

Long term debt

4,552

 

4,633

Long term other liabilities

5,684

 

5,734

Lease incentive obligation, less current portion

378

 

686

Total stockholders' equity

540,694

 

335,295

Total liabilities and stockholders' equity 

$  582,601

 

$           377,040

 

Contact: 
Megan Reiss
Exact Sciences Corp.
meganreiss@exactsciences.com 
608-535-8815

 

 

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SOURCE EXACT SCIENCES CORP