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™
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
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.
This press release features multimedia. View the full release here:
"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
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
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20180108005713/en/
Kimberly Brown, 617-418-2215
Source: Foundation Medicine
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