On February 21, 2023 Exact Sciences Reported record revenue, expects revenue of $2,265-2,315 million and positive adjusted EBITDA for full year 2023 (Press release, Exact Sciences, FEB 21, 2023, View Source [SID1234627471]).
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Fourth quarter and 2022 highlights
Total fourth quarter revenue of $553 million, an increase of 17% or 28% excluding COVID-19 testing, with Screening revenue of $404 million and Precision Oncology revenue of $143 million
Total 2022 revenue of $2,084 million, an increase of 18% or 25% excluding COVID-19 testing, with Screening revenue of $1,425 million and Precision Oncology revenue of $601 million
Surpassed 12 million cumulative people tested for cancer, including 10 million with Cologuard
MADISON, Wis., Feb. 21, 2023 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company generated revenue of $553.0 million for the fourth quarter of 2022 and $2,084.3 million for the full year of 2022, both ended Dec. 31, 2022.
"With a strong finish in 2022 and a great start to 2023, Cologuard and Oncotype DX are setting the tone for an impactful year ahead," said Kevin Conroy, chairman and CEO of Exact Sciences. "Our financial strength, scientific capabilities, and deep partnerships with health systems put Exact Sciences in a leading position to deliver innovative tests that help prevent cancer, detect it earlier, and guide treatment to more patients globally."
Fourth quarter 2022 financial results
For the three-month period ended Dec. 31, 2022, as compared to the same period of 2021 (where applicable):
Total revenue was $553.0 million, an increase of 17 percent, or 28 percent excluding COVID-19 testing
Screening revenue was $403.5 million, an increase of 45 percent, or 42 percent excluding the PreventionGenetics acquisition
Precision Oncology revenue was $143.4 million, a decrease of 4 percent, or an increase of 1 percent excluding the divested Oncotype DX Genomic Prostate Score test and a $1.8 million foreign exchange impact
COVID-19 testing revenue was $6.0 million, a decrease of 87 percent
Gross margin including amortization of acquired intangible assets was 70 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 73 percent
Net loss was $127.7 million, or $0.72 per share, compared to a net loss of $220.6 million, or $1.28 per share
EBITDA was $(75.0) million and adjusted EBITDA was $4.9 million
Cash, cash equivalents, and marketable securities were $632.1 million at the end of the quarter
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.
2023 revenue outlook
The company anticipates revenue of $2,265-$2,315 million during 2023, assuming:
Screening revenue of $1,660-$1,690 million,
Precision Oncology revenue of $600-$620 million, and
COVID-19 testing revenue of $5 million
Non-GAAP disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, non-GAAP gross margin, non-GAAP gross profit, and normalized and constant currency growth rates in revenue. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Normalized and constant currency growth rates in revenue are calculated to adjust for acquisitions, divestitures and foreign currency. To exclude the impact of change in currency exchange rates from the prior period under comparison, the Company converts the current period non-U.S. dollar denominated revenue using the prior period exchange rate. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. Additionally, adjusted EBITDA excludes a number of expense items that are included in net loss. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations." Information reconciling forward-looking non-GAAP measures to U.S. GAAP measures is not available without unreasonable effort.
Fourth quarter conference call & webcast
Company management will host a conference call and webcast on Tuesday, February 21, 2023, at 5 p.m. ET to discuss fourth quarter and full year 2022 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.
An archive of the webcast will be available at exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.
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 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 cologuardtest.com. Rx only.
About Exact Sciences’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.
About PreventionGenetics
Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome and whole exome sequencing test, PGxome. PreventionGenetics was acquired by Exact Sciences in December 2021.