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

August 1, 2018
- 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.

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"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