Achieves Total Revenue of Approximately $116.9 Million, a 25% Year
Over Year Increase
Reports 43,686 Clinical Tests in 2016, a 32% Year Over Year Increase
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Medicine (NASDAQ:FMI) today announced preliminary unaudited total
revenue of approximately $28.8 million in the fourth quarter of 2016
and approximately $116.9 million for the full year ended December 31,
2016, an 11% and 25% increase from the $26.1 million and $93.2
million recorded in the fourth quarter and full year ended December 31,
2015, respectively. Revenue from biopharmaceutical companies is expected
to be approximately $19.0 million in the fourth quarter of 2016 and
approximately $78.8 million for the full year ended December 31, 2016,
compared to $14.1 million and $44.0 million in the fourth quarter and
full year ended December 31, 2015, respectively. Revenue from clinical
testing is expected to be approximately $9.8 million in the fourth
quarter of 2016 and approximately $38.1 million for the full year ended
December 31, 2016, compared to $12.0 million and $49.2 million in the
fourth quarter and full year ended December 31, 2015, respectively.
The company reported 12,788 clinical tests to ordering physicians in the
fourth quarter of 2016, compared to a total of 8,286 tests reported
during the fourth quarter of 2015. A total of 43,686 clinical tests were
reported to ordering physicians for the full year ended December 31,
2016, compared to 32,998 clinical tests reported in 2015. Cash, cash
equivalents and marketable securities at December 31, 2016, was
approximately $143 million.
"Foundation Medicine evolved significantly in 2016, most notably through
continued growth in clinical and biopharma product demand and
utilization, product diversification through the launch of
FoundationACT™ and the achievement of FoundationFocus™ CDxBRCA,
our first FDA-approved companion diagnostic, and expanded reimbursement
coverage with third party and government payers," stated Michael J.
Pellini, M.D., chief executive officer of Foundation Medicine. "As we
look ahead to 2017, we believe we are well positioned for continued
growth and further competitive differentiation, particularly as a result
of our ongoing Parallel Review process with FDA and CMS for FoundationOne®."
2016 Enterprise Highlights:
Announced acceptance of FoundationOne for Parallel Review by FDA and
CMS. The FDA also accepted Foundation Medicine's request for review as
part of its Expedited Access Pathway (EAP) for breakthrough devices.
If approved, FoundationOne could be the first FDA-approved
comprehensive genomic profiling (CGP) assay to incorporate multiple
companion diagnostics to support precision medicine in oncology and
would be offered as a covered benefit to Medicare beneficiaries
Launched FoundationACT, the company's ctDNA assay, to clinical
customers. FoundationACT was developed with the same rigorous
analytical validation standards as FoundationOne and FoundationOne
Received FDA Approval of FoundationFocus CDxBRCA as a
companion diagnostic for Rubraca™ (rucaparib) for the treatment of
women with ovarian cancer. FoundationFocus is the first next
generation sequencing companion diagnostic approved by the FDA and
marks important progress towards the development of the company's
universal pan-cancer companion diagnostic assay.
Expanded patient access to CGP through Palmetto, a Medicare
administrative contractor in North Carolina, who broadened a Local
Coverage Determination covering CGP for all stage IIIb and IV
non-small cell lung cancer patients at diagnosis.
Added new immunotherapy clinical markers, Tumor Mutational Burden
(TMB) and Microsatellite Instability (MSI), to FoundationOne and
FoundationOne Heme to help guide personalized, immunotherapy-based
Grew biopharmaceutical revenue by approximately 79% in 2016 and added
several new molecular information, SmartTrials™ and companion
Increased FoundationCORE™, the company's molecular information
database, to more than 100,000 clinical cases.
Expanded the company's laboratory footprint to include sites at
Research Triangle Park (RTP) in North Carolina and Penzberg, Germany.
The RTP facility became operational in September, increasing
operational flexibility and broadening commercial opportunities. Once
operational, the Penzberg location will support continued growth and
expansion in Europe through our commercial collaboration with Roche.
Published 72 peer-reviewed manuscripts in top medical and scientific
journals and presented 129 podium talks and posters at scientific and
Dr. Pellini continued, "As we enter the year transitioning the chief
executive officer post to Troy Cox, which will be completed in early
February, we look forward to advancing our patient-centric mission and
improving patient access to precision cancer care."
As part of Foundation Medicine's commitment to being a partner for the
patient journey, the company expects to advance a number of key business
objectives in 2017. These include: advancing its universal, pan-cancer
companion diagnostic assay through the FDA and CMS parallel review
process to decision and launch in the second half of 2017; broadening
Medicare and third-party payer coverage for its clinical CGP products;
growing clinical volume across its product portfolio, including expanded
global market presence; and expanding its biopharma business, including
additional companion diagnostic collaborations and SmartTrials clinical
trial access programs.
Complete 2016 fourth quarter and full year financial results will be
announced during the company's fourth quarter and fiscal year 2016
financial results conference call in February. The company also
anticipates providing 2017 financial guidance at that time. 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 35th Annual J.P.
Morgan Healthcare Conference on Tuesday, January 10, 2017, at 9:00 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 offers a full suite of
comprehensive genomic profiling assays to identify the molecular
alterations in a patient's cancer and match them with relevant targeted
therapies, immunotherapies 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 FoundationACT™, FoundationFocus™ and
FoundationCORE™ are trademarks, 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 benefits of
FoundationOne, FoundationOne Heme, FoundationACT and FoundationFocus CDxBRCA
to physicians and patients in the treatment of cancer; the benefits
provided by a FDA-approved version of FoundationOne; the scope and
timing of any approval of FoundationOne as a medical device by
the FDA and any coverage decision by CMS; strategies for achieving
Medicare coverage decisions at the local or national level and new and
expanded coverage from third-party payers; and the growth of clinical
volumes within and outside the United States. 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 the FDA
does not approve FoundationOne as a medical device or that CMS does not
decide to offer FoundationOne as a covered benefit under Medicare;
the FDA or CMS is delayed in the completion of the Parallel Review
process; the company's new facilities in North Carolina and Germany do
not facilitate the company's ability to achieve it business objectives;
the company's distribution partner outside the United States is not able
to achieve market penetration in new and existing markets as quickly or
as extensively as projected; Foundation Medicine's relationships
with third-party or government payers do not increase or expand;
Foundation Medicine is unable to sustain or grow relationships with
biopharmaceutical partners; the company's expectations and beliefs
regarding the future conduct and growth of its 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-K for the
year ended December 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, total
revenue, clinical revenue and biopharma revenue, clinical tests and
other financial and business results as of and for the year
ended December 31, 2016, 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,
2016. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170109005425/en/
Pure Communications, Inc.
Kimberly Brown, 617-418-2215
Source: Foundation Medicine
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