Foundation Medicine, Inc. (NASDAQ:FMI) today reported financial
and operating results for its first quarter ended March 31, 2017.
Results and business highlights for the quarter included:
- Reported 13,933 clinical tests in the
first quarter, 55% year-over-year growth;
- Reported first quarter revenue of $26.3
million which included payment for FoundationOne® for patients with
non-small cell lung cancer (NSCLC) under a Local Coverage
Determination (LCD) by Palmetto GBA, the company’s Medicare
Administrative Contractor in North Carolina;
- Announced a collaboration agreement
with Bristol-Myers Squibb in the area of immuno-oncology (IO). BMS
will leverage FMI’s molecular information platform to identify
predictive biomarkers across multiple tumor types in patients
enrolled in clinical trials investigating BMS’ cancer
immunotherapies;
- Published 27 manuscripts in
high-quality, peer-reviewed journals and delivered 37 podium and
poster talks at various medical and scientific meetings; and,
- Increased FoundationCORE™, the
company’s molecular information database, to more than 125,000
clinical cases.
“Foundation Medicine achieved several milestones this quarter
that extend our leadership in molecular information, including
strong growth in clinical volume, payment from Medicare and a
collaboration with Bristol-Myers Squibb in the critical field of
immuno-oncology,” said Troy Cox, chief executive officer of
Foundation Medicine. “Importantly, we believe we are on track to
achieve our 2017 business objectives, including advancing our
universal companion diagnostic assay through the FDA and CMS
parallel review process to a decision during the second half of
this year.”
Foundation Medicine reported total revenue of $26.3 million in
the first quarter of 2017, compared to $30.4 million in the first
quarter of 2016. Total revenue declined year over year due to an
expected decrease in first quarter biopharmaceutical revenue
related to the timing of various research and development projects
with its biopharma partners. Revenue from biopharmaceutical
customers was $14.7 million in the first quarter of 2017 compared
to $20.2 million in the first quarter of 2016. The results of 1,802
tests were reported to biopharmaceutical customers in this year’s
first quarter.
Clinical revenue returned to year over year growth, partially
driven by the receipt of Medicare payment for FoundationOne under
Palmetto’s NSCLC LCD. Revenue from clinical testing in the first
quarter of 2017 was $11.6 million, compared to $10.2 million in the
first quarter of 2016.
The company reported 13,933 tests to clinicians in the first
quarter of 2017, a 55% increase from the same quarter last year.
This number includes 11,005 FoundationOne® tests, 1,284
FoundationOne® Heme tests, 1,355 FoundationACT® tests, and 289
FoundationFocus™ CDxBRCA tests.
Total operating expenses for the first quarter of 2017 were
approximately $55.0 million compared with $36.5 million for the
first quarter of 2016. The increase in operating expenses was
partially driven by investments related to the development of the
company’s universal companion diagnostic assay. Net loss was
approximately $46.5 million in the first quarter of 2017, or a
$1.31 loss per share. At March 31, 2017, the company held
approximately $99.1 million in cash, cash equivalents and
marketable securities.
2017 Outlook
Foundation Medicine’s business and financial outlook for 2017
remains unchanged:
- The company expects 2017 revenue will
be in the range of $135 million to $145 million.
- The company expects to deliver between
53,000 and 56,000 clinical tests in 2017.
- The company expects operating expenses
will be in the range of $205 million and $215 million.
- The company expects to advance its
universal, pan-cancer companion diagnostic assay through the FDA
and CMS Parallel Review process with a decision in the second half
of 2017.
- The company expects to expand upon
reimbursement progress made in 2016 and drive additional coverage
decisions for its CGP assays.
Conference Call and Webcast Details
The company will conduct a conference call today, Tuesday, May
9th at 4:30 p.m. Eastern Time to discuss its financial performance
for the 2017 first quarter and other business activities, including
matters related to future performance. To access the conference
call via phone, dial 1-855-420-0652 from the United States and
Canada, or dial 1-484-365-2939 internationally, and for either
number reference Foundation Medicine and provide the passcode
10842512. Dial in approximately ten minutes prior to the start of
the call. The live, listen-only webcast of the conference call 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 call
and will be archived on the company's website for two weeks
following the call.
About Foundation MedicineFoundation 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®, FoundationOne® and FoundationACT® are
registered trademarks, and FoundationFocus™ and FoundationCORE™ are
trademarks, of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking StatementsThis
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 value of
the company’s business; the benefits of our products to physicians,
biopharmaceutical companies, payers and patients in the treatment
of cancer and personalized cancer care; the company’s financial and
operational forecasts, including projections regarding the
generation of revenue, the number of tests to be conducted, the
incurrence of operating expenses and the expansion of reimbursement
progress; the benefits provided by a FDA-approved and
CMS-covered version of FoundationOne and progress with the Parallel
Review process with FDA and CMS; the scope and timing of
any approval of our universal companion diagnostic assay as a
medical device by the FDA and any coverage decision by
CMS; and strategies for achieving Medicare coverage
decisions at the local or national level and new and expanded
coverage from third-party payers. 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 our universal companion
diagnostic assay as a medical device or that CMS does not decide to
offer our universal companion diagnostic assay 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
revenue, test or operating expense projections may turn out to be
inaccurate because of the preliminary nature of the forecasts; the
company's expectations and beliefs regarding the future conduct and
growth of the company'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 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. 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.
- Financial Tables to Follow -
FOUNDATION MEDICINE,
INC. Condensed Consolidated Statements of Operations(In
thousands, except share and per share data)(unaudited)
Three Months Ended March 31,
2017
2016
Revenue
$
26,328
$ 30,378 Costs and expenses: Cost of revenue
18,017
11,390 Selling and marketing
16,436
13,793 General and administrative
15,277
9,224 Research and development
23,285
13,456 Total costs and expenses
73,015
47,863 Loss from operations
(46,687)
(17,485) Interest income (expense), net
90
178 Other income
144
— Net loss
$
(46,453)
$ (17,307 ) Net loss per common share applicable to common
stockholders, basic and diluted
$
(1.31)
$ (0.50) Weighted-average common shares outstanding, basic
and diluted
35,426,296
34,537,007
FOUNDATION MEDICINE,
INC.Condensed Consolidated Balance Sheets(In
thousands)(unaudited)
March 31, December
31, 2017 2016 Assets Current assets: Cash
and cash equivalents $ 49,075 $ 63,617 Marketable securities 49,976
79,402 Accounts receivable, net 10,728 10,213 Inventory 10,349
10,438 Prepaid expenses and other current assets 5,338
5,251 Total current assets 125,466 168,921 Property and
equipment, net 39,553 41,486 Restricted cash 1,395 1,395 Other
assets 2,140 2,233 Total assets $ 168,554 $ 214,035
Liabilities and stockholders’ equity Current
liabilities: Accounts payable $ 10,427 $ 11,898 Accrued expenses
and other current liabilities 19,240 20,578 Deferred revenue 2,278
5,851 Current portion of deferred rent 2,418 2,324
Total current liabilities 34,363 40,651 Other non-current
liabilities 7,874 8,538 Total stockholders’ equity 126,317
164,846 Total liabilities and stockholders’ equity $ 168,554
$ 214,035
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version on businesswire.com: http://www.businesswire.com/news/home/20170509006343/en/
Foundation Medicine, Inc.Media Contact:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor
Contact:Kimberly Brown,
617-418-2215ir@foundationmedicine.com
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