On October 29, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $218.8 million and screened approximately 456,000 people with Cologuard during the quarter ended September 30, 2019. Third-quarter 2019 revenue and test volume grew 85 percent and 89 percent, respectively, from the same period of 2018 (Press release, Exact Sciences, OCT 29, 2019, View Source [SID1234549970]).
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"The Exact Sciences team delivered another strong quarter and most importantly, has screened more than 3 million people with Cologuard over the last 5 years," said Kevin Conroy, chairman and CEO of Exact Sciences. "The team made significant progress enhancing our internal infrastructure with the opening of our new lab and implementation of Epic’s best-in-class electronic health record system. The foundation we’ve built for Cologuard and our planned combination with Genomic Health position Exact Sciences to be the cancer diagnostics leader for years to come."
Third-Quarter 2019 Financial Results
For the three-month period ended September 30, 2019, as compared to the same period of 2018 (where applicable):
Revenue was $218.8 million, an increase of 85 percent, and Cologuard test volume was 456,000, an increase of 89 percent
Average Cologuard recognized revenue per test was $479, a decline of $13
Average Cologuard cost per test was $114, an improvement of $10 per test
Gross margin was 76 percent, an increase of 130 basis points
Operating expenses were $201.7 million, an increase of 56 percent
Transaction-related costs for the planned Genomic Health combination were $7.1 million, and integration-related costs were $2.1 million
Net loss was $40.5 million, or $0.31 per share, compared to $45.4 million, or $0.37 per share
Non-cash interest expense related to convertible debt was $11.0 million, or $0.08 per share, compared to $8.4 million, or $0.07 per share
Cash utilization was $78.9 million, compared to $36.9 million; the third quarter cash use included $43.2 million of fees paid to Pfizer for services incurred from October 2018 through the end of June 2019
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
2019 Outlook
The company anticipates revenue of $802-$810 million during 2019. The company’s revenue guidance does not include the impact of the pending combination with Genomic Health.
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.
Third-Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Tuesday, October 29, 2019, at 5 p.m. ET to discuss third-quarter 2019 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171.
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 4168628. 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 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer or precancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative).
Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.