Achieves Revenue of Approximately $29 Million and Reports Over 9,000
Clinical Tests in 2013
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced preliminary
unaudited total revenue of approximately $29 million for the year ended
December 31, 2013, as compared to $10.6 million for the prior year.
Approximately 3,750 FoundationOne™ clinical tests were reported to
ordering oncologists during the fourth quarter of 2013, compared with
2,577 reported in the third quarter of 2013. More than 9,000
FoundationOne clinical tests were reported to ordering oncologists in
all of 2013. FoundationOne, the company's initial clinical product, is a
fully informative genomic profile used by oncologists to identify the
molecular alterations in a patient's tumor and match them with relevant
targeted therapies and clinical trials.
"The strong clinical adoption in the fourth quarter was driven by our
expanding commercial team and the increase in repeat testing in both
academic medical centers and in the community setting," said Michael J.
Pellini, M.D., president and chief executive officer, Foundation
Medicine. "We are also looking forward to the impact that our new test,
FoundationOne Heme, will have in 2014 for patients who are diagnosed
with hematologic malignancies and sarcomas, and for pediatric patients."
The company also highlighted today several other accomplishments in 2013:
FoundationOne Heme, the company's second clinical product, was
successfully commercially launched in December. The test was developed
in collaboration with Memorial Sloan-Kettering Cancer Center.
To support clinical adoption and reimbursement efforts, 16
peer-reviewed manuscripts were published in top medical and scientific
journals, and more than 40 podium talks and posters were presented at
scientific and medical meetings in 2013.
The company expanded its operational capacity with a newly constructed
laboratory facility in October 2013.
The company currently expects to deliver between 22,000 and 25,000
clinical tests in 2014, driven by FoundationOne and FoundationOne Heme,
and anticipates 2014 revenue will be in the range of $52 - $58 million.
In addition, the company will continue to support the publication of
papers and studies targeting the clinical benefits of its products in
clinical practice and the solutions those products can provide to the
payor community. The company anticipates launching an updated version of
FoundationOne with an expanded set of genes for solid tumors in the
first half of 2014. In addition, the company plans to introduce new
features for its Interactive Cancer Explorer physician portal in the
second half of 2014, including outcomes collection capabilities.
Dr. Pellini is scheduled to present at the 32nd Annual J.P. Morgan
Healthcare Conference on Wednesday, January 15, 2014 at 8:00 a.m. PST in
Complete quarterly and full year results will be announced during the
company's fourth quarter and fiscal year 2013 financial results call.
This press release contains certain unaudited financial results for the
company. These unaudited results could change as a result of further
review by the company's management and its independent auditors.
About Foundation Medicine
Medicine® (NASDAQ:FMI) is a molecular information
company dedicated to a transformation in cancer care in which treatment
is informed by a deep understanding of the genomic changes that
contribute to each patient's unique cancer. The company's clinical
for solid tumors and FoundationOneTM
Heme for hematologic malignancies, sarcomas and pediatric cancers, each
provide a fully informative genomic profile to identify the molecular
alterations in a patient's tumor and match them with relevant targeted
therapies and clinical trials. Foundation Medicine's molecular
information platform aims to improve day-to-day care for patients by
serving the needs of clinicians, academic researchers and drug
developers to help advance the science of molecular medicine in cancer.
For more information, please visit www.FoundationMedicine.com
or follow Foundation Medicine on Twitter
Foundation Medicine® is a registered trademark, and FoundationOneTM
is a trademark, of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the impact of
FoundationOne™ Heme, the generation of revenue and the delivery of
clinical test reports in 2014, the publication of papers and studies in
2014 demonstrating clinical utility and benefits to the payor community,
the 2014 launch of an updated version of FoundationOne™ and a new
version of the company's Interactive Cancer Explorer, and further review
of the financial results for the quarter and fiscal year ended December
31, 2013 to be conducted by the company's management and independent
auditors. All such forward-looking statements are based on management's
current expectations of future events and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include the
risks that Foundation Medicine's revenue or test projections may turn
out to be inaccurate because of the preliminary nature of the forecasts;
that FoundationOneTM, FoundationOneTM
Heme and any subsequent products may never achieve significant
commercial adoption; the company's expectations and beliefs regarding
the future conduct and growth of Foundation Medicine's business and the
markets in which we operate; delays or denials in obtaining coverage and
reimbursement decisions for FoundationOne, FoundationOne Heme andsubsequent
products; the inability of Foundation Medicineto achieve
profitability, to compete successfully, to manage its growth, or to
develop its molecular information platform; and the risks described
under the caption "Risk Factors" in Foundation Medicine's Registration
Statement Quarterly Report on Form 10-Q for the quarter ended September
30, 2013, which is on file with the Securities and Exchange Commission,
as well as other risks detailed in Foundation Medicine's subsequent
filings with the Securities and Exchange Commission. All information in
this press release is as of the date of the release, and Foundation
Medicine undertakes no duty to update this information unless required
Source: Foundation Medicine, Inc.