Highlighted announcements:
- Expects total fourth quarter revenue of $713 million, an
increase of 10% compared to the fourth quarter of 2023, with
Screening revenue of $553 million and Precision Oncology revenue of
$161 million
- Anticipates total full-year 2024 revenue of $2.76 billion, an
increase of 10% compared to full-year 2023
- Plans to launch three new cancer tests in 2025: Cologuard
PlusTM, next-generation colorectal cancer screening test,
OncodetectTM, molecular residual disease test, and CancerguardTM,
multi-cancer screening test
Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of
cancer screening and diagnostic tests, today announced that the
company expects to report revenue of $713 million for the fourth
quarter ended December 31, 2024.
"The Exact Sciences team delivered strong results to finish
2024, setting us up for sustained growth and profitability in the
years to come," said Kevin Conroy, chairman and CEO. "We look
forward to expanding our impact as the platform supporting
Cologuard® and Oncotype DX® powers three new cancer diagnostics
launching in 2025, enabling Exact Sciences to advance cancer
prevention, early detection, and personalized treatment."
Preliminary, Unaudited Fourth Quarter 2024 Financial
Results
For the three-month period ended December 31, 2024, as compared
to the same period of 2023:
- Total revenue of $713 million, an increase of 10 percent
- Screening revenue of $553 million, an increase of 14
percent
- Precision Oncology revenue of $161 million, an increase of 0.4
percent
Preliminary, Unaudited 2024 Financial Results
For the twelve-month period ended December 31, 2024, as compared
to the same period of 2023:
- Total revenue of $2.759 billion, an increase of 10 percent, or
11 percent excluding COVID-19 testing
- Screening revenue of $2.104 billion, an increase of 13
percent
- Precision Oncology revenue of $655 million, an increase of 4
percent
Screening primarily includes laboratory service revenue from
Cologuard tests and PreventionGenetics. Precision Oncology includes
laboratory service revenue from global Oncotype DX and therapy
selection tests.
Important Note Regarding Preliminary, Unaudited Financial
Results
Exact Sciences has not completed preparation of its financial
statements for the fourth quarter or full year of 2024. The revenue
figures presented in this news release for the fourth quarter of
2024 and for the year ended December 31, 2024 are preliminary and
unaudited and are thus inherently uncertain and subject to change
as we complete our financial results for the fourth quarter of
2024. Exact Sciences is in the process of completing its customary
year-end close and review procedures as of and for the year ended
December 31, 2024, 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 December
31, 2024, 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 2024 financial results during its
February 2025 earnings call.
About the Cologuard and Cologuard Plus tests
Developed in collaboration with Mayo Clinic, the Cologuard and
Cologuard Plus tests are non-invasive colorectal cancer (CRC)
screening options for the 110 million U.S. adults ages 45 or older
who are at average risk for the disease.
The Cologuard test revolutionized CRC screening by detecting
specific DNA markers and blood associated with cancer and precancer
in stool, allowing patients to use the test at home without special
preparation or time off. It is covered by Medicare and included in
national screening guidelines from both the American Cancer Society
(2018) and the U.S. Preventive Services Task Force (2021). Since
its launch in 2014, the Cologuard test has been used to screen for
CRC 18 million times.
Building on this success, the FDA-approved Cologuard Plus test
raises the performance bar even further and features novel
biomarkers, improved laboratory processes, and enhanced sample
stability. The Cologuard Plus test is expected to reduce false
positives by nearly 40%, to help minimize unnecessary follow-up
colonoscopies. Both tests demonstrate Exact Sciences’ commitment to
improving CRC screening access and outcomes. Exact Sciences expects
to launch the Cologuard Plus test with Medicare coverage and
guideline inclusion in 2025.
About the Cancerguard test
The Cancerguard test, currently in development, is designed to
detect multiple cancers in their earliest stages from a single
blood draw. Building upon decades of research, Exact Sciences
intends to harness the additive sensitivity of multiple biomarker
classes to detect more cancers in earlier stages. The Cancerguard
test will utilize a streamlined and standardized imaging-based
diagnostic pathway, which may result in fewer follow-up procedures.
The test is being developed to provide high specificity to help
minimize false positives while detecting multiple cancers,
including those with the biggest toll on human health. These
features describe current development goals. The Cancerguard test
has not been cleared or approved by the U.S. Food and Drug
Administration or any other national regulatory authority. To learn
more, visit http://www.exactsciences.com/cancerguard.
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.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests,
Exact Sciences gives patients and health care professionals the
clarity needed to take life-changing action earlier. Building on
the success of the Cologuard and Oncotype DX tests, Exact Sciences
is investing in its pipeline to develop innovative solutions for
use before, during, and after a cancer diagnosis. For more
information, visit ExactSciences.com, follow Exact Sciences on X
(formerly known as Twitter) @ExactSciences, or find Exact Sciences
on LinkedIn and Facebook.
Forward-Looking Statements
This news release contains forward-looking statements concerning
our expectations, anticipations, intentions, beliefs or strategies
regarding the future. These forward-looking statements are based on
assumptions that we have made as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions and events to differ materially from
those anticipated. Therefore, you should not place undue reliance
on forward-looking statements. Examples of forward-looking
statements include, among others, statements we make regarding
expected future operating results; expectations for development of
new or improved products and services and their impacts on
patients; our strategies, positioning, resources, capabilities and
expectations for future events or performance; and the anticipated
benefits of our acquisitions, including estimated synergies and
other financial impacts.
Important factors that could cause actual results, conditions
and events to differ materially from those indicated in the
forward-looking statements include, among others, the following:
our ability to successfully and profitably market our products and
services; the acceptance of our products and services by patients
and healthcare providers; our ability to meet demand for our
products and services; our reliance upon certain suppliers,
including suppliers that are the sole source of certain supplies
and products used in our tests and operations; approval and
maintenance of adequate reimbursement rates for our products and
services within and outside of the U.S.; the amount and nature of
competition for our products and services; the effects of any
judicial, executive or legislative action affecting us or the
healthcare system; recommendations, guidelines and quality metrics
issued by various organizations regarding cancer screening or our
products and services; our ability to successfully develop and
commercialize new products and services and assess potential market
opportunities; our ability to effectively enter into and utilize
strategic partnerships and acquisitions; our success establishing
and maintaining collaborative, licensing and supplier arrangements;
our ability to obtain and maintain regulatory approvals and comply
with applicable regulations; our ability to protect and enforce our
intellectual property; the results of our validation studies and
clinical trials, including the risks that the results of future
studies and trials may differ materially from the results of
previously completed studies and trials; our ability to manage an
international business and our expectations regarding our
international expansion and opportunities; our ability to raise the
capital necessary to support our operations or meet our payment
obligations under our indebtedness; the potential effects of
changing macroeconomic conditions, including the effects of
inflation, interest rate and foreign currency exchange rate
fluctuations, and geopolitical conflict; the possibility that the
anticipated benefits from our business acquisitions will not be
realized in full or at all or may take longer to realize than
expected; the possibility that costs or difficulties related to the
integration of acquired businesses’ operations or the divestiture
of business operations will be greater than expected and the
possibility that integration or divestiture efforts will disrupt
our business and strain management time and resources; the outcome
of any litigation, government investigations, enforcement actions
or other legal proceedings; and our ability to retain and hire key
personnel. The risks included above are not exhaustive. Other
important risks and uncertainties are described in the Risk Factors
sections of our most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q, and in our other reports
filed with the Securities and Exchange Commission. We undertake no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250112030858/en/
Investor Contact: Erik Holznecht Exact Sciences Corp.
investorrelations@exactsciences.com 608-535-8659 Media
Contact: Steph Spanos Exact Sciences Corp.
sspanos@exactsciences.com 608-556-4380
EXACT Sciences (NASDAQ:EXAS)
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