Cologuard® revenue increased 78 percent to $103 million during second quarter

More than 10,000 healthcare providers ordered their initial Cologuard

- More than 10,000 healthcare providers ordered their initial Cologuard test during the second quarter, and nearly 121,000 have ordered since the test was launched

MADISON, Wis., Aug. 1, 2018 /PRNewswire/ -- EXACT Sciences Corp. Nasdaq: EXAS) today announced that the company generated revenue of $102.9 million and completed approximately 215,000 Cologuard tests during the quarter ended June 30, 2018. Second-quarter 2018 revenue and Cologuard test volume grew by 78 percent and 59 percent, respectively, from the same period of 2017.

"We are excited about the continued growth of our physician ordering base, as well as their increasing Cologuard utilization, which led to a record quarter for revenue, volume and gross profit," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are optimistic about the company's future, including the opportunity to expand Cologuard's label to reach even more people in the 45 to 49 age group, given the American Cancer Society's recent guideline update."

Second-Quarter 2018 Financial Results

For the three-month period ended June 30, 2018, as compared to the same period of 2017 (where applicable):

  • Revenue was $102.9 million, an increase of 78 percent, and test volume was 215,000, an increase of 59 percent
  • Average recognized revenue per test was $479, an improvement of 12 percent
  • Average cost per test was $125, an improvement of 6 percent
  • Gross margin was 74 percent, an increase of 510 basis points
  • Operating expenses were $108.7 million, an increase of 53 percent
  • Net loss was $36.4 million or $0.30 per share, compared to $30.8 million or $0.27 per share
  • Non-cash interest expense related to convertible debt was $6.7 million, or $0.05 per share
  • Cash utilization was $45.3 million, compared to $43.9 million
  • Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
  • More than 10,000 healthcare providers ordered their first Cologuard test during the second quarter, and nearly 121,000 have ordered since the test was launched

2018 Outlook

  • The company continues to anticipate revenue of $420-$430 million for 2018

The company's guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company's actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. 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 Wednesday, Aug. 1, 2018, at 5 p.m. ET to discuss second-quarter 2018 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 will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4260268. The webcast, conference call 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. Medicare and most major insurers cover Cologuard. 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," "would," "could," "seek," "intend," "plan," "goal," "project," "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 adequately reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening and diagnostic 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 pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; 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 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 Balance Sheets

                                           (Amounts in thousands)


                                             June 30,                      December 31,

                                                           2018                             2017
                                                           ----                             ----

    Assets

    Cash
     and
     cash
     equivalents                                       $225,662                          $77,491

     Marketable
     securities                                         996,500                          347,224

     Accounts
     receivable,
     net                                                 36,268                           26,419

     Inventory,
     net                                                 35,409                           26,027

     Prepaid
     expenses
     and
     other
     current
     assets                                              16,465                           10,055

     Property
     and
     equipment,
     net                                                140,467                           79,986

     Intangibles,
     net                                                 23,108                           24,205

    Other
     long-
     term
     assets                                               8,773                            7,153

    Total
     assets                                          $1,482,652                         $598,560
                                                     ==========                         ========


    Liabilities and stockholders'
     equity

    Total
     current
     liabilities                                        $82,962                          $68,124

     Convertible
     notes,
     net                                                647,923                                -

    Long-
     term
     debt                                                   878                            4,269

    Other
     long-
     term
     liabilities                                          6,501                            5,749

    Total
     stockholders'
     equity                                             744,388                          520,418

    Total
     liabilities
     and
     stockholders'
     equity                                          $1,482,652                         $598,560
                                                     ==========                         ========

 

                                         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,
                                                --------                       --------

                                                 2018                    2017                 2018         2017
                                                 ----                    ----                 ----         ----


    Laboratory service
     revenue                                 $102,894                 $57,646             $193,190     $106,009


    Cost of sales                              26,888                  17,991               49,802       34,972
                                               ------                  ------               ------       ------

    Gross margin                               76,006                  39,655              143,388       71,037


    Operating expenses:

    Research and
     development                               14,712                   9,737               29,647       17,739

    General and
     administrative                            39,565                  24,609               75,132       44,679

    Sales and marketing                        54,431                  36,728              107,839       75,529
                                               ------                                     -------       ------

      Total operating
       expenses                               108,708                  71,074              212,618      137,947
                                              -------                  ------              -------      -------

      Loss from operations                   (32,702)               (31,419)            (69,230)    (66,910)


    Other income (expense)

    Investment income                           4,917                     683                8,590        1,278

    Interest expense                          (8,603)                   (54)            (15,113)       (104)
                                               ------                     ---              -------         ----

      Total other income                      (3,686)                    629              (6,523)       1,174


      Net loss before tax                    (36,388)               (30,790)            (75,753)    (65,736)
                                              =======                 =======              =======      =======


    Income tax benefit
     (expense)                                      1                       -                (58)           -


      Net loss                              $(36,387)              $(30,790)           $(75,811)   $(65,736)
                                             ========                ========             ========     ========


    Net loss per share -
     basic and diluted                        $(0.30)                $(0.27)             $(0.62)     $(0.59)
                                               ======                  ======               ======       ======


    Weighted average common shares

    outstanding -basic
     and diluted                              122,129                 112,847              121,578      111,721
                                              =======                 =======              =======      =======

 

Investor Contact:
Megan Jones
Exact Sciences Corp.
meganjones@exactsciences.com
608-535-8815

Media Contact:
J.P. Fielder
Exact Sciences Corp.
jpfielder@exactsciences.com
608-210-5220

 

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SOURCE EXACT SCIENCES CORP

Company Codes: NASDAQ-SMALL:EXAS

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