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Anticipates fourth-quarter earnings, expects full-year 2024 earnings of $2. 83 billion, and submits next-generation Cologuard® to FDA
Announce CFO succession plan
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Total fourth-quarter profit is expected to be between $645. 5 million and $647. 5 million, an increase of 17% from the fourth quarter of 2022, with testing profit of $486. 0 million to $487. 0 million and precision oncology profit of $159. 5 million to $160. 5 million.
It forecasts a total of $2. 5 billion for the full year 2023 and $2. 83 billion for 2024.
Final Module of the Next-Generation Cologuard Premarket Approval Application Submitted to the FDA
Announces Jeff Elliott Will Step Down as Executive Vice President and Chief Financial Officer
MADISON, Wis., Jan. 7, 2024 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the company expects to report revenue between $645.5 million and $647.5 million for the fourth quarter ended December 31, 2023.
The company also announced that Jeff Elliott plans to step down as executive vice president and chief financial officer (CFO) in 2024 for personal reasons. Elliott will retain his role as chief financial officer until a successor is named. To facilitate a smooth transition, upon the appointment of a successor, Elliott will serve as special advisor to the CEO. The company hired a nationally identified executive search firm to evaluate internal and external candidates for its next chief financial officer.
Preliminary Unaudited Financial Results for the Fourth Quarter of 2023
“Exact Sciences’ fourth quarter results demonstrate the strength of our business and reflect our unwavering commitment to helping eliminate cancer by preventing it, detecting it early and guiding personalized treatment,” said Kevin Conroy, president and CEO. “To advance this mission, our team is intensely focused on impacting the lives of millions of people with Cologuard, Oncotype DX® and the next wave of cutting-edge cancer diagnostics.
For the three-month era ending December 31, 2023, up to the same era in 2022:
Total profit between $645. 5 million and $647. 5 million, an increase of 17 percent, or 18 percent COVID-19 Testing
Projected revenue between $486. 0 million and $487. 0 million, a cumulative of 21 consistent with percent
Precision Oncology revenue between $159.5 million and $160.5 million, an increase of 12 percent
Preliminary, Unaudited 2023 Financial Results
For the twelve-month era ending December 31, 2023, up to the same era in 2022:
Total profit between $2,498. 5 million and $2,500. 5 million, a 20% or 23% increase in COVID-19 testing
Projected revenue between $1,864. 0 million and $1,865. 0 million, a cumulative of 31 consistent with one percent
Precision Oncology’s diversity gains from $628. 5 million to $629. 5 million, up 5%
COVID-19 profit of approximately $6. 0 million, a 90% decrease compared to the penny
Testing primarily includes lab gains from Cologuard and PreventionGenetics testing. Precision Oncology includes lab earnings from global Oncotype DX testing and treatment selection.
Revenue outlook for 2024
The company anticipates revenue of $2.83 billion during 2024.
CFO Succession
“On behalf of the board of directors and the control team, I would like to express our deepest gratitude to Jeff for his unwavering leadership and valuable contributions in his career at Exact Sciences,” added Mr. Conroy. From his early days as Vice President Jeff, President of Strategy and Business Development during his tenure as COO and Chief Financial Officer, he has helped consultant Exact Sciences through an incredible expansion and transformation. I appreciate you staying with us to facilitate a smooth leadership transition and we wish you all the best. “It’s better to move on. “
“It has been a privilege to work alongside such a talented and committed team at Exact Sciences,” said Mr. Elliott. “With our strong industry leadership and developing portfolio of complex, life-changing cancer diagnostics, I am completely confident in the continued expansion and good luck of Exact Sciences. “Having committed nearly a decade to the mission of Exact Sciences, as well as helping Cologuard grow from its initial stages of commercialization to lasting financial strength, this represents an excellent time for me to transition from my role and spend more time with my wife and children.
Important Note Regarding Unaudited Preliminary Financial ResultsExact Sciences has not completed the preparation of its monetary statements for the fourth quarter or full year of 2023. The earnings levels presented in this press release for the fourth quarter of 2023 and for the year ended December 31, 2023 are initial and unaudited and are inherently doubtful and subject to replacement as we finalize our financial effects for the fourth quarter of 2023. Exact Sciences is in the process of finalizing its last regular year-end close and reviewing current procedures and for the year ended. . 31 December 2023, and there can be no certainty that the final effects for this era will not differ from those estimates. During the preparation of Exact Sciences’ consolidated monetary statements and their notes as of December 31, 2023 and for the year ended December as of January 31, 2023, the Company’s independent CPAs would possibly identify pieces that may also cause the final effects presented to differ materially from the initial effects. Financial estimates presented here.
Exact Sciences plans to release its 2023 currency results in its February 2024 earnings call.
About CologuardThe 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 portfolioExact 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 PreventionGeneticsFounded 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.
About Exact Sciences Corp. As a leading provider of cancer screening and diagnostic testing, Exact Sciences gives patients and healthcare professionals the clarity they want to take life-changing action as soon as possible. Building on the good fortune of the Cologuard and Oncotype DX assays, Exact Sciences is investing across its portfolio to expand cutting-edge responses for use before, during and after a cancer diagnosis. For more information, visit ExactSciences. com, follow Exact Sciences on X (formerly Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.
Forward-Looking StatementsThis press release comprises forward-looking statements relating to our expectations, anticipations, intentions, ideals or long-term methods. These forward-looking statements are based on assumptions we have made as of the date hereof and are subject to known and unknown dangers and uncertainties that may cause actual effects, situations and occasions to differ materially from those anticipated. Accordingly, do not place undue reliance on forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements we make relating to the expected effects of long-term operations; expectations for the progression of new or advanced products and facilities and their effects on patients; our methods, positioning, resources, functions, and expectations related to long-term events or performance; and the expected benefits of our acquisitions, adding estimated synergies and other monetary effects.
Important points that could also cause actual events, situations and occasions to differ materially from those indicated in the forward-looking statements include, but are not limited to: our ability to fully and profitably commercialize our products and facilities; acceptance of our products and facilities by patients and physical care providers; our ability to meet demands for our products and facilities; our dependence on certain suppliers, adding suppliers who are the sole source of certain products; the willingness of fitness insurance corporations and other payers to cover our products and facilities and adequately reimburse us for those products and facilities; the scope and nature of the festival of our products and facilities; the effects of any judicial, executive or legislative action affecting us or the fitnesscare system; recommendations, rules and quality measures issued through various organizations related to cancer screening or our products and facilities; our ability to fully expand new products and facilities and compare potential market opportunities; our ability to engage in and make good use of strategic partnerships and acquisitions; our good fortune in building and maintaining collaboration, licensing and supplier agreements; our ability to discharge and maintain regulatory approvals and comply with applicable regulations; the effects of our validation studies and clinical trials, adding the danger that the effects of long-term studies and trials may differ materially from the effects of studies and trials conducted in the past; our ability to manage a foreign business and our expectations related to our expansion and opportunities abroad; our ability to raise required capital to assist our operations or meet our legal payment responsibilities under our indebtedness; the potential effects of converting macroeconomic situations, adding the effects of inflation and fluctuations in interest rates and exchange rates and any efforts to hedge such effects; our ability to well and flexibly manage our business amid uncertainties similar to the coronavirus (“COVID-19”) pandemic; the option that the expected benefits of our business acquisitions may not be fully or at all known or may take longer than expected to become known; the option that prices or relevant difficulties with the integration of the operations of the acquired businesses or the divestiture of the business operations are greater than expected and the option that the integration or divestiture efforts disrupt our operations and put pressure on control of time and resources; the final results of any litigation, government investigation, enforcement action or other legal proceeding; our ability to retain and recruit key personnel; and the effect of hard labor shortages, worker turnover, and the increased costs of hard labor. The dangers included above are not exhaustive. Other life hazards and insecurities are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and upcoming Quarterly Reports on Form 10-Q, as well as in our other reports filed with the Securities and Exchange Commission. Stock Market and Securities. We undertake no legal responsibility to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, long-term developments or otherwise.
Investor Contact: Nathan HarrillExact Sciences Corp. investorrelations@exactsciences. com608-535-8659
Media Contact:Morry SmulevitzExact Sciences [email protected]
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SOURCE Exact Sciences Company