On January 9, 2022 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $472 million and $475 million for the fourth quarter ended Dec. 31, 2021 (Press release, Exact Sciences, JAN 9, 2022, View Source [SID1234598443]).
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"The Exact Sciences team delivered outstanding results to finish 2021, setting us up for years of strong growth and a clear path to profitability," said Kevin Conroy, chairman and CEO of Exact Sciences. "Our goal is to make earlier cancer detection a routine part of medical care. Led by our top brands, Cologuard and Oncotype DX, and an exciting pipeline of tests in colon cancer screening, multi-cancer early detection, and minimal residual disease and recurrence monitoring, we plan to fundamentally change how cancer patients are diagnosed and treated."
Preliminary, Unaudited Fourth Quarter 2021 Financial Results
For the three-month period ended Dec. 31, 2021, as compared to the same period of 2020:
Total revenue between $472 million and $475 million, an increase of 2 percent
Total revenue, excluding COVID-19 testing, increased 16 percent
Screening revenue between $277 million and $278 million, an increase of 11 percent
Precision Oncology revenue between $148.5 million and $149.5 million, an increase of 27 percent
COVID-19 testing revenue between $46.5 million and $47.5 million, a decrease of 53 percent
Preliminary, Unaudited 2021 Financial Results
For the twelve-month period ended Dec. 31, 2021, as compared to the same period of 2020:
Total revenue between $1,765.3 million and $1,768.3 million, an increase of 18 percent
Total revenue, excluding COVID-19 testing, increased 29 percent
Screening revenue between $1,061.6 million and $1,062.6 million, an increase of 30 percent
Precision Oncology revenue between $561.1 million and $562.1 million, an increase of 27 percent
COVID-19 testing revenue between $142.5 million and $143.5 million, a decrease of 39 percent
For the fourth quarter and 2021, Screening includes laboratory service revenue from Cologuard tests and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype and GEM ExTra laboratory service revenue.
Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2021. The revenue ranges presented in this news release for the fourth quarter of 2021 and for the year ended Dec. 31, 2021 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2021. 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, 2021, 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, 2021, 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 2021 financial results during its February 2022 earnings call.
About Cologuard
The Cologuard test 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. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test 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 the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test 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. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.