Achieves Revenue of Approximately $93.2 Million, a 53% Year Over Year
Reports Approximately 33,000 Clinical Tests in 2015, a 36% Year Over
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Medicine (NASDAQ:FMI) today announced preliminary unaudited total
revenue of approximately $26.1 million in the fourth quarter of 2015 and
$93.2 million for the full year ended December 31, 2015, a 39% and 53%
increase from the $18.7 million and $61.1 million recorded in the fourth
quarter and full year ended December 31, 2014, respectively. The company
reported 8,286 clinical tests to ordering physicians in the fourth
quarter of 2015, compared to a total of 7,233 tests reported during the
fourth quarter of 2014. A total of 32,998 clinical tests were reported
to ordering physicians for the full year ended December 31, 2015,
compared to 24,271 clinical tests reported in 2014. Cash, cash
equivalents and marketable securities at December 31, 2015, was
approximately $232 million.
"Foundation Medicine achieved significant strategic and operational
advances across all aspects of our molecular information business in
2015 that position the Company for continued growth in 2016 and beyond,"
stated Michael J. Pellini, M.D., chief executive officer of Foundation
Medicine. "Specifically, we grew our commercial business and our
molecular information platform to more than 68,000 cases, expanded our
biopharmaceutical business both in terms of the number of partners and
revenue, strengthened our leadership position through our collaboration
with Roche, and secured our first national payer contract for metastatic
non-small cell lung cancer with United Healthcare."
2015 Enterprise Highlights:
Completed a strategic transaction with Roche to further advance
Foundation Medicine's market-leading position in molecular information
and expand access to the company's products globally.
Grew biopharmaceutical revenue by approximately 80% in 2015 and added
new molecular information and companion diagnostic collaborations with
Roche, H3 Biomedicine, Mirati Therapeutics, and several other partners.
Improved patient access to comprehensive genomic profiling by signing
a national agreement with United Healthcare for FoundationOne® in
metastatic non-small cell lung cancer. Additionally, Palmetto GBA, a
Medicare Administrative Contractor (MAC), announced a final local
coverage determination for comprehensive genomic profiling in a subset
of patients with non-small cell lung cancer.
Expanded its molecular information platform to more than 68,000 cases.
Advanced its circulating tumor DNA (ctDNA) assay program by initiating
a large, multi-center clinical study to support the anticipated
commercial launch of the assay in 2016. The ctDNA assay was launched
to biopharmaceutical partners in 2015, as planned.
Launched the Precision Medicine Exchange Consortium™ (PMEC) with
leading academic medical centers and community oncology networks to
advance the integration of molecular information into clinical
oncology and accelerate the adoption of precision care.
Launched decision support tools to help improve utilization of
molecular information by oncologists and pathologists, including
enhancements to FoundationICE™, such as PatientMatchTM and
the introduction of GeneKitTM, a genomics solutions portal
Published 56 peer-reviewed manuscripts in top medical and scientific
journals and presented 101 podium talks and posters at scientific and
The company expects revenue in 2016 will be in the range of $110 to $120
million and operating expenses will be in the range of $175 and $185
million. The company expects to deliver between 37,000 and 40,000
FoundationOne® and FoundationOne® Heme clinical tests in 2016. The
company also expects to expand upon progress made in 2015 with Palmetto
and commercial payers and drive additional coverage decisions.
As part of its commitment to providing healthcare practitioners with a
full suite of analytically validated genomic profiling assays to support
precision medicine in oncology, the company plans to expand its offering
of molecular information products with the commercial launch of its
ctDNA assay in the first quarter 2016. The assay is being rigorously
evaluated as part of an ongoing, multi-center study to identify patients
who are most likely to benefit from liquid-based genomic profiling. The
study will also provide the analytic validation mandated for clinical
use of a commercial ctDNA assay. To further support the commercial
launch of the assay, the laboratory will have expansion capability for a
QSR-compliant version of the assay to support companion diagnostics for
potential FDA approval.
Complete quarterly and full year financial results will be announced
during the company's fourth quarter and fiscal year 2015 financial
results conference call in February. 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.
Dr. Pellini is scheduled to present at the 34th Annual J.P.
Morgan Healthcare Conference on Wednesday, January 13, 2016, at 9:30
a.m. PST, in San Francisco. A live, listen-only webcast of the
presentation and breakout session may be accessed by visiting the
investors section of the company's website at investors.foundationmedicine.com.
A replay of the webcast will be available shortly after the conclusion
of the presentation and breakout session and will be archived on the
company's website for two weeks.
About Foundation Medicine
Foundation 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 assays,
FoundationOne® for solid tumors and FoundationOne® Heme for hematologic
malignancies and sarcomas, provide a comprehensive genomic profile to
identify the molecular alterations in a patient's cancer 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 http://www.FoundationMedicine.com
or follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne®
are registered trademarks, and FoundationICETM,
and Precision Medicine Exchange ConsortiumTM
are trademarks, of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for Foundation
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. 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 test, revenue or operating expense projections may
turn out to be inaccurate because of the preliminary nature of the
forecasts; the launch of a ctDNA clinical assay is delayed or
discontinued; the company's expectations and beliefs regarding the
future conduct and growth of Foundation Medicine's business are
inaccurate; Foundation Medicine is unable to 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2015, 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. With respect to Foundation Medicine's estimated cash,
revenue, clinical tests and other financial and business results as of
and for the year ended December 31, 2015, it should be noted that this
information is unaudited and that the company has not finalized its
financial and business results for the three and twelve months ended
December 31, 2015. 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 by law.
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Pure Communications, Inc.
Kimberly Brown, 617-418-2215
Matt Clawson, 949-370-8500
Source: Foundation Medicine
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