Reports Total Revenue of Approximately $152.9
Million, a 31% Year Over Year Increase; Reports 67,375 Clinical
Tests in 2017, a 54% Year Over Year Increase
Increases Biopharma Revenue Approximately 27%
Year-Over-Year with New and Expanded Collaborations
Achieves Significant Milestone with FDA
Approval and Preliminary National Coverage Determination (NCD) for
FoundationOne CDx™
Foundation Medicine (NASDAQ:FMI) today announced preliminary
unaudited total revenue of approximately $48.9
million for the fourth quarter of 2017 and approximately
$152.9 million for the full year ended December 31, 2017,
representing a 70% and 31% increase from the $28.8
million and $116.9 million recorded in the fourth
quarter and full year ended December 31, 2016,
respectively.
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“2017 was a year of significant milestones for Foundation
Medicine, including posting record revenue and achieving our
largest annual increase in recorded clinical volume,”
stated Troy Cox, chief executive officer of Foundation
Medicine. “Our most notable achievement was the successful
completion of the parallel review process during the fourth quarter
which culminated with FDA approval and a preliminary National
Coverage Determination (NCD) for FoundationOne CDx™ from CMS. This
approval and preliminary NCD are transformational for our company,
clinicians, biopharma partners and most importantly, for patients
with advanced cancer, as we continue to meaningfully improve access
to personalized cancer care.”
Revenue from biopharmaceutical companies is expected to be
approximately $33.4 million in the fourth quarter of 2017 and
approximately $99.7 million for the full year ended December 31,
2017, compared to $19.0 million and $78.8 million in the fourth
quarter and full year ended December 31, 2016, respectively. The
company reported 6,206 tests to biopharmaceutical customers in this
year’s fourth quarter.
Revenue from clinical testing is expected to be approximately
$15.5 million in the fourth quarter of 2017 and approximately $53.1
million for the full year ended December 31, 2017, compared to $9.8
million and $38.1 million in the fourth quarter and full year ended
December 31, 2016, respectively. The company reported 20,044
clinical tests to ordering physicians in the fourth quarter of
2017, compared to a total of 12,788 tests reported during the
fourth quarter of 2016, an increase of 57%. A total of 67,375
clinical tests were reported to ordering physicians for the full
year ended December 31, 2017, compared to 43,686 clinical
tests reported in 2016, an increase of 54%.
Based on the new revenue reporting the company initiated during
2017, Molecular Information Services revenue is expected to be
approximately $37.4 million in the fourth quarter of 2017 and
approximately $117.1 million for the full year ended December 31,
2017, compared to $20.4 million and $81.8 million in the fourth
quarter and full year ended December 31, 2016, respectively. Pharma
Research and Development Services revenue is expected to be
approximately $11.5 million in the fourth quarter of 2017 and
approximately $35.8 million for the full year ended December 31,
2017, compared to $8.4 million and $35.1 million in the fourth
quarter and full year ended December 31, 2016, respectively.
Cash and cash equivalents at December 31, 2017 was
approximately $71.4 million, including $30 million in new
borrowings received during the fourth quarter under the company’s
Credit Facility Agreement with Roche Finance.
2017 Enterprise Highlights:
- Received approval from the U.S. Food
& Drug Administration (FDA) under the parallel review process
for FoundationOne CDx, the first broad genomic profiling test
incorporating multiple companion diagnostics. Simultaneously, the
Centers for Medicare and Medicaid Services (CMS) issued a
preliminary NCD for FoundationOne CDx, which is expected to improve
access to molecular information for personalized healthcare. The
NCD is expected to be finalized during the first quarter of
2018.
- Grew the biopharma business with new
and expanded collaborations for molecular information solutions
including companion diagnostics, molecular profiling, data
insights, and biomarker discovery.
- Presented validation data for a novel
assay measuring tumor mutational burden in blood (bTMB) providing
evidence that response to immunotherapy can be predicted using a
blood sample. Based on these findings, Foundation Medicine’s bTMB
assay is being integrated as part of Roche/Genentech's
prospective, randomized Phase III Blood First Assay Screening Trial
(BFAST) as a companion diagnostic assay investigating the use of
bTMB as a non-invasive biomarker of response to first-line
atezolizumab in advanced NSCLC patients.
- Received approval from the State of New
York Department of Health for FoundationACT®, the company’s liquid
biopsy assay.
- Announced a collaboration with
the American Society of Clinical Oncology (ASCO) to
identify patients for its Targeted Agent and Profiling Utilization
Registry (TAPUR) study.
- Announced a collaboration with
the National Cancer Institute (NCI) and ECOG-ACRIN Cancer
Research Group to identify patients for the NCI-Match (Molecular
Analysis for Therapy Choice) study.
- Increased FoundationCORE™, the
company’s molecular information database, to nearly 180,000
clinical cases.
- Expanded the company’s global footprint
and patient access to personalized healthcare by commencing
operations at the company’s laboratory in Penzberg, Germany. The
Penzberg location is supporting continued growth and expansion in
Europe through the company’s commercial collaboration with
Roche.
- Published 95 peer-reviewed manuscripts
in top medical and scientific journals and presented 141 podium
talks and posters at scientific and medical meetings.
Complete 2017 fourth quarter and full year financial results
will be announced during the company's fourth quarter and fiscal
year 2017 financial results conference call. The company also
anticipates providing 2018 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.
Mr. Cox is scheduled to present at the
36th Annual J.P. Morgan Healthcare
Conference on Monday, January 8, 2017, at 3:30 p.m.
PST, in San Francisco. Additionally, Mr. Cox will participate
in a panel discussion focused on the FDA and CMS parallel review
process on Monday, January 8, 2018 at 5:15 p.m. PST. Live,
listen-only webcasts of these presentations and the breakout
session may be accessed by visiting the investors section of the
company's website at investors.foundationmedicine.com. A
replay of these webcasts will be available shortly after the
conclusion of the presentations 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 FoundationACT® are registered
trademarks, and FoundationOne CDx™ 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 FDA approval and a preliminary NCD for FoundationOne
CDx to Foundation Medicine, physicians, biopharmaceutical
companies, and patients in the treatment of cancer; the scope and
timing of any finalization of the NCD; and the ability of the
company’s laboratories to support any growth or expansion plans.
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 any final NCD is not issued by CMS or if CMS
is delayed in finalizing such NCD; the company’s new facilities 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; and the
risks described under the caption "Risk Factors" in Foundation
Medicine's Annual Report on Form 10-K for the year
ended December 31, 2016, 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
testing revenue, biopharma revenue, Molecular Information Services
revenue, Pharma Research and Development Services revenue, clinical
tests and other financial and business results as of and for the
year ended December 31, 2017, 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, 2017. 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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version on businesswire.com: http://www.businesswire.com/news/home/20180108005713/en/
Foundation MedicineMedia Contact:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor
Contact:Kimberly Brown,
617-418-2215ir@foundationmedicine.com
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