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
Foundation 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 nationwide.
- Launched FoundationACT, the company’s
ctDNA assay, to clinical customers. FoundationACT was developed
with the same rigorous analytical validation standards as
FoundationOne and FoundationOne Heme.
- 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 treatment plans.
- Grew biopharmaceutical revenue by
approximately 79% in 2016 and added several new molecular
information, SmartTrials™ and companion diagnostic
collaborations.
- 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 medical meetings.
2017 Outlook
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/
Media Contact:Pure Communications, Inc.Dan Budwick,
973-271-6085dan@purecommunicationsinc.comorInvestor
Contact:Foundation MedicineKimberly Brown,
617-418-2215ir@foundationmedicine.com
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