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First-quarter revenue and Cologuard test volume increased 79 percent to $162 million and 334,000, respectively

- Estimated Cologuard market share increased to 4.6 percent during the first quarter

- Nearly 14,000 health care providers ordered their initial Cologuard test during the first quarter, and more than 160,000 have ordered since the test was launched

- Submitted an application to the FDA to expand Cologuard's label to the 45-49 age group

MADISON, Wis., April 30, 2019 /PRNewswire/ -- Exact Sciences Corp. (EXAS) today announced that the company generated revenue of $162.0 million and screened approximately 334,000 people with Cologuard during the quarter ended March 31, 2019. First-quarter 2019 revenue and test volume both grew 79 percent from the same period of 2018.

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"Cologuard is changing how Americans get screened for colorectal cancer," said Kevin     Conroy, chairman and CEO of Exact Sciences. "The strong start to 2019 gives us confidence our investments in people, facilities and partnerships will help us achieve our goal of screening at least 40 percent of the eligible U.S. population with Cologuard."

First-Quarter 2019 Financial Results

For the three-month period ended March 31, 2019, as compared to the same period of 2018 (where applicable):

  • Revenue was $162.0 million, an increase of 79 percent, and test volume was 334,000, an increase of 79 percent
  • Average Cologuard recognized revenue per test was $483, a decrease of $2
  • Average Cologuard cost per test was $128, an increase of $4
  • Gross margin was 73 percent, a decrease of 130 basis points
  • Operating expenses were $187.0 million, an increase of 80 percent
  • Net loss was $83.1 million, or $0.66 per share, compared to $39.4 million, or $0.33 per share
  • Non-cash interest expense related to convertible debt was $19.6 million, or $0.16 per share, which included a one-time, non-cash loss on the extinguishment of debt of $10.6 million, or $0.08 per share
  • Cash utilization was $77.0 million, compared to $53.7 million
  • Cash, cash equivalents and marketable securities were $1.3 billion at the end of the quarter, including $236 million, net, raised in relation to the issuance of new convertible notes and the repayment of a portion of our previously-issued convertible notes
  • Nearly 14,000 healthcare providers ordered their first Cologuard test during the first quarter, and more than 160,000 have ordered since the test was launched

2019 Outlook

  • The company anticipates revenue of $725-$740 million during 2019, an increase from prior guidance of $710-730 million

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 "Forward-Looking Statements" section of this news release.

First-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, April 30, 2019, at 5 p.m. ET to discuss first-quarter 2019 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 4989449. 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 (2018) 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, including those with a history of colorectal cancer and advanced adenoma, a family history of colorectal cancer, IBD or certain hereditary syndromes. 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 some 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.

Forward-Looking Statements

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 our products and services and adequately reimburse us for such products and services; 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 law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; 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 ability to effectively utilize strategic partnerships, such as our Promotion Agreement with Pfizer, Inc., and acquisitions; 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.

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

 

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Statements of Operations

(Amounts in thousands, except per share data)








Three Months Ended



March 31,



2019


2018






Revenue


$              162,043


$               90,296






Cost of sales


43,252


22,914

  Gross margin


118,791


67,382






Operating expenses:





  Research and development


32,016


14,935

  General and administrative


64,030


35,567

  Sales and marketing


90,939


53,408

    Total operating expenses


186,985


103,910

    Loss from operations


(68,194)


(36,528)






Other income (expense)





  Investment income


6,655


3,673

  Interest expense


(21,990)


(6,510)

    Total other income


(15,335)


(2,837)






    Net loss before tax


(83,529)


(39,365)






Income tax benefit (expense)


470


(59)






    Net loss


$              (83,059)


$              (39,424)






Net loss per share - basic and diluted


$                 (0.66)


$                 (0.33)






Weighted average common shares outstanding - basic and diluted


126,248


121,016

 

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Balance Sheets

(Amounts in thousands)








March 31,


 December 31, 



2019


2018

Assets





Cash and cash equivalents


$     285,200


$           160,430

Marketable securities


997,506


963,752

Accounts receivable, net


56,095


44,239

Inventory, net


44,269


39,148

Prepaid expenses and other current assets


24,050


20,498

Property and equipment, net


291,629


245,259

Intangibles, net


45,610


46,281

Other long-term assets


26,189


4,415

Total assets


$  1,770,548


$        1,524,022






Liabilities and stockholders' equity 





Total current liabilities


$     167,657


$           136,169

Convertible notes, net


770,510


664,749

Long-term debt


24,787


24,494

Other long-term liabilities


6,821


9,475

Long-term obligations


23,833


8,194

Total stockholders' equity


776,940


680,941

Total liabilities and stockholders' equity 


$  1,770,548


$        1,524,022

 

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