On January 11, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $464.5 million and $467.5 million for the fourth quarter ended Dec. 31, 2020 (Press release, Exact Sciences, JAN 11, 2021, View Source [SID1234573753]).
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"I’m incredibly proud of how the Exact Sciences team came together during 2020 to make progress towards our mission of eradicating cancer and the suffering it causes," said Kevin Conroy, chairman and CEO of Exact Sciences. "Following our combination with Thrive, we are confident in making blood-based, multi-cancer screening a reality and being a leading provider of earlier, smarter cancer tests for patients at every step of their journey. We’ve never been more excited about the impact Exact Sciences will have on patient lives with Cologuard, Oncotype, and our future tests."
Preliminary, Unaudited Fourth Quarter 2020 Financial Results
For the three-month period ended December 31, 2020, as compared to the same period of 2019 (where applicable):
Expected total revenue between $464.5 million and $467.5 million
Expected Screening revenue between $249 million and $250 million, an increase of 9 percent
Expected Precision Oncology revenue between $117 million and $118 million
Expected COVID-19 testing revenue between $98.5 million and $99.5 million
Preliminary, Unaudited 2020 Financial Results
For the twelve-month period ended December 31, 2020, as compared to the same period of 2019 (where applicable):
Expected total revenue between $1.490 billion and $1.493 billion
Expected Screening revenue between $814.5 million and $815.5 million, an increase of 1 percent
Expected Precision Oncology revenue between $440 million and $441 million
Expected COVID-19 testing revenue between $235 million and $236 million
For the fourth quarter and 2020, Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products.
Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2020. The revenue ranges presented in this news release for the fourth quarter of 2020 and for the year ended Dec. 31, 2020 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2020. Exact Sciences is in the process of completing its customary year-end close and review procedures as of and for the year ended Dec. 31, 2020, and there can be no assurance that final results for this period will not differ from these estimates. During the course of the preparation of Exact Sciences’ consolidated financial statements and related notes as of and for the year ended Dec. 31, 2020, the company’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.
Exact Sciences plans to report 2020 financial results during its February 2021 earnings call.
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.
Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.
About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.