On January 8, 2023 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company expects to report revenue between $550.7 million and $552.7 million for the fourth quarter ended Dec. 31, 2022 (Press release, Exact Sciences, JAN 8, 2023, View Source [SID1234625998]).
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"Exact Sciences’ fourth quarter results show the strength of our business and the momentum building behind the best brands in cancer diagnostics, Cologuard and Oncotype DX," said Kevin Conroy, chairman and CEO. "The foundation supporting Cologuard and Oncotype DX will fuel consistent revenue growth and profitability, putting Exact Sciences in a leading position to deliver the next wave of innovation in cancer diagnostics to patients, health systems, and health care providers globally."
Preliminary, Unaudited Fourth Quarter 2022 Financial Results
For the three-month period ended Dec. 31, 2022, as compared to the same period of 2021:
Total revenue between $550.7 million and $552.7 million, an increase of 16 percent, or 28 percent excluding COVID-19 testing
Screening revenue between $401.8 million and $402.8 million, an increase of 45 percent, or 41 percent excluding the PreventionGenetics acquisition
Precision Oncology revenue between $142.9 million and $143.9 million, a decrease of 4 percent, or an increase of 1 percent excluding the divested Oncotype DX Genomic Prostate Score test and the impact of foreign currency exchange rates
COVID-19 testing revenue of approximately $5.9 million, a decrease of 87 percent
Preliminary, Unaudited 2022 Financial Results
For the twelve-month period ended Dec. 31, 2022, as compared to the same period of 2021:
Total revenue between $2,082.0 million and $2,084.0 million, an increase of 18 percent, or 25 percent excluding COVID-19 testing
Screening revenue between $1,423.0 million and $1,424.0 million, an increase of 34 percent, or 30 percent excluding the PreventionGenetics acquisition
Precision Oncology revenue between $601.0 million and $602.0 million, an increase of 7 percent, or 11 percent excluding the divested Oncotype DX Genomic Prostate Score test and the impact of foreign currency exchange rates
COVID-19 testing revenue of approximately $58.0 million, a decrease of 59 percent
Screening includes laboratory service revenue from Cologuard tests, PreventionGenetics, and immaterial revenue from Biomatrica and Oncoguard Liver products. Precision Oncology includes laboratory service revenue from global Oncotype DX products and therapy selection products.
Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2022. The revenue ranges presented in this news release for the fourth quarter of 2022 and for the year ended Dec. 31, 2022 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2022. 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, 2022, 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, 2022, 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 2022 financial results during its February 2023 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 the Cologuard test. For more information about the Cologuard test, visit cologuard.com. Rx only.