Cologuard® revenue and completed tests increased 87 percent to $90.3 million and 186,000

- Nearly 9,000 healthcare providers ordered their initial Cologuard test during the first quarter, and more than 110,000 have ordered since the test was launched

MADISON, Wis., April 26, 2018 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company generated revenue of $90.3 million and completed approximately 186,000 Cologuard tests during the quarter ended Mar. 31, 2018. First-quarter 2018 revenue and Cologuard test volume both grew 87 percent from 2017.

"The Exact Sciences team delivered strong growth to Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)start the year by remaining relentlessly focused on our core priorities. By increasing awareness and adoption of Cologuard, we are making strides toward our mission of playing a role in the eradication of colon cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The success of Cologuard also positions us to develop tests that facilitate the early, accurate detection of other forms of cancer."

First-Quarter 2018 Financial Results

For the three-month period ended Mar. 31, 2018, as compared to the same period of 2017 (where applicable):

  • Revenue was $90.3 million, an increase of 87 percent, and test volume was 186,000, an increase of 87 percent
  • Average recognized revenue per test was unchanged at $485; note that the prior period included approximately $4.3 million, or $43 per test, related to the one-time impact of certain payers meeting the company's revenue recognition criteria for accrual-basis revenue accounting
  • Average cost per test was $123, an improvement of 28 percent
  • Gross margin was 75 percent, an increase of 970 basis points
  • Operating expenses were $103.9 million, an increase of 55 percent
  • Net loss was $39.4 million or $0.33 per share, compared to $34.9 million or $0.32 per share
  • Non-cash interest expense related to convertible debt was $5.1 million, or $0.04 per share
  • Cash utilization was $53.7 million, compared to $36.4 million
  • Cash, cash equivalents and marketable securities were $1.0 billion at the end of the quarter
  • Nearly 9,000 healthcare providers ordered their first Cologuard test during the first quarter, and 110,000 (rounded) have ordered since the test was launched

2018 Outlook

  • The company continues to anticipate revenue of $420-$430 million and completed Cologuard test volume of 900,000-920,000 tests during 2018
  • For the second quarter, the company anticipates completing 220,000-230,000 Cologuard tests

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. 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.

First-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Thursday, Apr. 26, 2018, at 5 p.m. ET to discuss first-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 8289286. 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. 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.

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

 

         

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Balance Sheets

(Amounts in thousands)

         
   

March 31,

 

 December 31, 

   

2018

 

2017

Assets

       

Cash and cash equivalents

 

$     148,695

 

$             77,491

Marketable securities

 

893,474

 

347,224

Accounts receivable, net

 

34,575

 

26,419

Inventory, net

 

32,380

 

26,027

Prepaid expenses and other current assets

 

12,867

 

10,055

Property and equipment, net

 

103,448

 

79,986

Other long-term assets

 

31,477

 

31,358

Total assets

 

$  1,256,916

 

$           598,560

         

Liabilities and stockholders' equity 

       

Total current liabilities

 

$       73,330

 

$             68,124

Convertible notes, net

 

486,688

 

-

Long term debt

 

4,237

 

4,269

Long term other liabilities

 

5,643

 

5,749

Total stockholders' equity

 

687,018

 

520,418

Total liabilities and stockholders' equity 

 

$  1,256,916

 

$           598,560

 

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Statements of Operations

(Amounts in thousands, except per share data)

         
   

Three Months Ended

   

March 31,

   

2018

 

2017

         

Laboratory service revenue

 

$   90,296

 

$   48,363

         

Cost of sales

 

22,914

 

16,981

  Gross margin

 

67,382

 

31,382

         

Operating expenses:

       

  Research and development

 

14,935

 

8,002

  General and administrative

 

35,567

 

20,070

  Sales and marketing

 

53,408

 

38,801

    Total operating expenses

 

103,910

 

66,873

    Loss from operations

 

(36,528)

 

(35,491)

         

Other income (expense)

       

  Investment income

 

3,673

 

595

  Interest expense

 

(6,510)

 

(50)

    Total other income

 

(2,837)

 

545

         

    Net loss before tax

 

(39,365)

 

(34,946)

         

Income tax expense

 

(59)

 

-

         

    Net loss

 

$  (39,424)

 

$  (34,946)

         

Net loss per share - basic and diluted

 

$     (0.33)

 

$     (0.32)

         

Weighted average common shares

       

outstanding - basic and diluted

 

121,016

 

110,582

         
         

 

 

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SOURCE EXACT SCIENCES CORP