EX-99 2 a18-38222_1ex99.htm EX-99

Exhibit 99

 

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

 

For Immediate Release

 

Cologuard® revenue increased 63 percent to $118 million, and Cologuard test volume grew 49 percent to 241,000 during third quarter

 

·                  Demand accelerated from healthcare providers as more than 11,000 ordered their initial Cologuard test during the third quarter, and nearly 132,000 have ordered since the test was launched

·                  Gross margin increased 320 basis points to 75 percent

·                  Exact Sciences now has in-network contracts with all five top commercial health plans, increasing patient access to Cologuard with no out-of-pocket cost

 

MADISON, Wis., Oct. 30, 2018 — Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company generated revenue of $118.3 million and screened approximately 241,000 people with Cologuard during the quarter ended September 30, 2018. Third-quarter 2018 revenue and Cologuard test volume grew by 63 percent and 49 percent, respectively, from the same period of 2017.

 

“The Exact Sciences team delivered another strong quarter, highlighted by significantly increased patient access to Cologuard with no out-of-pocket cost and continued progress toward our 2018 priorities,” said Kevin Conroy, chairman and CEO of Exact Sciences. “We are enthusiastic about our partnership with Pfizer and launched Cologuard to their internal medicine team in early October. We look forward to working with such a tremendous partner in the fight against colon cancer.”

 

Third-Quarter 2018 Financial Results

 

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

 

 

·                  Revenue was $118.3 million, an increase of 63 percent, and test volume was 241,000, an increase of 49 percent

·                  Average recognized revenue per test was $492, an improvement of 9 percent

·                  Average cost per test was $125, an improvement of 3 percent

·                  Gross margin was 75 percent, an increase of 320 basis points

·                  Operating expenses were $129.2 million, an increase of 61 percent

·                  Net loss was $45.4 million or $0.37 per share, compared to $26.9 million or $0.23 per share

·                  Non-cash interest expense related to convertible debt was $8.4 million, or $0.07 per share

·                  Cash utilization was $36.9 million, compared to $21.7 million

·                  Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter

·                  More than 11,000 healthcare providers ordered their first Cologuard test during the third quarter, and nearly 132,000 have ordered since the test was launched

 

2018 Outlook

 

·                  The company anticipates revenue of $435-$440 million for 2018, an increase from prior guidance of $420-$430 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 “Safe Harbor Statement” section of this press release.

 

Third-Quarter Conference Call & Webcast

 

Company management will host a conference call and webcast on Tuesday, Oct. 30, 2018, at 5 p.m. ET to discuss third-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 6870368. 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 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 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 ability to effectively utilize strategic partnerships 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.

 

 

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Statements of Operations

(Amounts in thousands, except per share data)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

 

 

 

 

 

 

 

 

Laboratory service revenue

 

$

118,291

 

$

72,574

 

$

311,481

 

$

178,583

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

30,020

 

20,729

 

79,822

 

55,701

 

Gross margin

 

88,271

 

51,845

 

231,659

 

122,882

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

17,631

 

11,725

 

47,278

 

29,464

 

General and administrative

 

46,729

 

30,763

 

121,861

 

75,442

 

Sales and marketing

 

64,836

 

37,768

 

172,675

 

113,297

 

Total operating expenses

 

129,196

 

80,256

 

341,814

 

218,203

 

Loss from operations

 

(40,925

)

(28,411

)

(110,155

)

(95,321

)

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

 

 

 

 

 

 

 

Investment income

 

6,292

 

1,334

 

14,882

 

2,612

 

Interest expense

 

(10,704

)

(51

)

(25,817

)

(155

)

Total other income

 

(4,412

)

1,283

 

(10,935

)

2,457

 

 

 

 

 

 

 

 

 

 

 

Net loss before tax

 

(45,337

)

(27,128

)

(121,090

)

(92,864

)

 

 

 

 

 

 

 

 

 

 

Income tax benefit (expense)

 

(27

)

231

 

(85

)

231

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(45,364

)

$

(26,897

)

$

(121,175

)

$

(92,633

)

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(0.37

)

$

(0.23

)

$

(0.99

)

$

(0.81

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

122,671

 

119,215

 

121,946

 

114,246

 

 

 

EXACT SCIENCES CORPORATION

Selected Unaudited Financial Information

Condensed Consolidated Balance Sheets

(Amounts in thousands)

 

 

 

September 30,

 

December 31,

 

 

 

2018

 

2017

 

Assets

 

 

 

 

 

Cash and cash equivalents

 

$

161,705

 

$

77,491

 

Marketable securities

 

1,023,512

 

347,224

 

Accounts receivable, net

 

41,916

 

26,419

 

Inventory, net

 

38,617

 

26,027

 

Prepaid expenses and other current assets

 

23,832

 

10,055

 

Property and equipment, net

 

188,486

 

79,986

 

Intangibles, net

 

22,493

 

24,205

 

Other long-term assets

 

9,015

 

7,153

 

Total assets

 

$

1,509,576

 

$

598,560

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Total current liabilities

 

$

106,735

 

$

68,124

 

Convertible notes, net

 

656,341

 

—

 

Long-term debt

 

17,080

 

4,269

 

Other long-term liabilities

 

12,691

 

5,749

 

Total stockholders’ equity

 

716,729

 

520,418

 

Total liabilities and stockholders’ equity

 

$

1,509,576

 

$

598,560