Foundation Medicine, Inc. (NASDAQ: FMI) today reported financial
and operating results for its third quarter ended September 30,
2017. Results and business highlights for the quarter included:
- Achieved third quarter revenue of $42.7
million, 45% year-over-year growth;
- Reported 17,474 clinical tests in the
third quarter, 50% year-over-year growth;
- Presented validation data for
FoundationOne CDx™ at the World Conference on Lung Cancer which
demonstrated high concordance with multiple FDA-approved companion
diagnostics across multiple solid tumor cancer types. FoundationOne
CDx is currently under the Parallel Review process with FDA and
CMS;
- Presented validation data for a novel
assay measuring tumor mutational burden in blood (bTMB) at the
European Society for Medical Oncology (ESMO) providing evidence
that response to immunotherapy can be predicted using a blood
sample. Based on these findings, the 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 to investigate bTMB as a non-invasive biomarker of response
to first-line atezolizumab in advanced NSCLC patients; and
- Published 19 manuscripts in
high-quality, peer-reviewed journals and delivered 21 podium and
poster talks at various medical and scientific meetings.
“Foundation Medicine made great progress in the third quarter as
evidenced by record revenue and clinical volume,” said Troy Cox,
chief executive officer of Foundation Medicine. “Our recent
accomplishments, including progress with the parallel review
process with FDA and CMS for FoundationOne CDx, expanding
relationships with our biopharma partners, and driving continued
innovation in our molecular information solutions pipeline with
bTMB, continue to position our company for further growth, and
competitive differentiation to transform cancer care.”
Foundation Medicine reported total revenue of $42.7 million in
the third quarter of 2017, compared to $29.4 million in the third
quarter of 2016. Revenue from biopharmaceutical customers was $29.6
million in the third quarter of 2017, compared to $20.7 million in
the third quarter of 2016. The results of 2,817 tests were reported
to biopharmaceutical customers in this year’s third quarter.
Revenue from clinical testing in the third quarter of 2017 was
$13.1 million, compared to $8.7 million in the third quarter of
2016. The company reported 17,474 tests to clinicians in the third
quarter of 2017, a 50% increase from the same quarter last year.
This number includes 14,398 FoundationOne® tests, 1,478
FoundationOne® Heme tests, 1,488 FoundationACT® tests, and 110
FoundationFocus™ CDxBRCA tests.
Total operating expenses for the third quarter of 2017 were
approximately $56.0 million, compared with $44.9 million for the
third quarter of 2016. The increase in operating expenses was
partially driven by investments in product development such as
FoundationOne CDx and bTMB, investments in the company’s technology
infrastructure, and certain non-recurring cash and non-cash
expenses.
Net loss was approximately $32.6 million in the third quarter of
2017, or a $0.90 loss per share. At September 30, 2017, the company
held approximately $76.8 million in cash, cash equivalents and
marketable securities.
Based on the new revenue reporting the company initiated last
quarter, Molecular Information Services revenue was $28.4 million,
including $13.1 million in revenue generated from our clinical
customers, and $15.3 million in revenue generated from our
biopharma customers during the third quarter. Pharma Research and
Development Services revenue was $14.3 million.
2017 Outlook
Foundation Medicine’s business and financial outlook for 2017 is
the following:
- The company expects 2017 revenue will
be in the range of $135 million to $145 million.
- The company is increasing clinical
volume guidance and now expects to deliver between 64,000 and
66,000 clinical tests in 2017.
- The company expects 2017 operating
expenses will be in the range of $215 million and $225
million.
- The company expects to advance its
comprehensive genomic profiling assay, FoundationOne CDx, through
the FDA and CMS Parallel Review process with a decision anticipated
in the fourth quarter of 2017.
- The company expects to continue
reimbursement progress and pursue additional coverage decisions for
its CGP assays.
Conference Call and Webcast Details
The company will conduct a conference call today, Wednesday,
November 1st at 4:30 p.m. Eastern Time to discuss its financial
performance for the 2017 third quarter and other business
activities, including matters related to future performance. To
access the conference call via phone, dial 1-877-270-2148 from the
United States or dial 1-412-902-6510 internationally. 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 FoundationOne CDx™ and FoundationFocus™
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, the timing of product
development, and the expansion of reimbursement progress, including
any changes to any earlier guidance; the benefits provided by
a FDA-approved and CMS-covered FoundationOne CDx and progress
with the Parallel Review process with FDA and CMS; the
scope and timing of any approval of FoundationOne CDx 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 use of any funds from its credit
facility. 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 CDx as a medical device or that CMS does not
decide to offer FoundationOne CDx as a covered benefit
under Medicare; the FDA or CMS is delayed in the
completion of the Parallel Review process; the company's 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 Balance
Sheets
(In thousands)
(unaudited)
September 30, December 31, 2017
2016 Assets Current assets: Cash and cash equivalents
$ 76,814 $ 63,617 Marketable securities — 79,402 Accounts
receivable 15,496 10,213 Inventory 10,400 10,438 Prepaid expenses
and other current assets 4,612 5,251 Total current
assets 107,322 168,921 Property and equipment, net 39,136 41,486
Restricted cash 2,305 1,395 Other assets 1,796 2,233
Total assets $ 150,559 $ 214,035
Liabilities and
stockholders’ equity Current liabilities: Accounts payable $
16,178 $ 11,898 Accrued expenses and other current liabilities
28,246 20,578 Deferred revenue 1,998 5,851 Current portion of
deferred rent 1,439 2,324 Total current liabilities
47,861 40,651 Other non-current liabilities 9,261 8,538
Indebtedness to Roche – non-current 30,000 — Total stockholders’
equity 63,437 164,846 Total liabilities and
stockholders’ equity $ 150,559 $ 214,035
FOUNDATION MEDICINE, INC.
Condensed Consolidated Statements of
Operations
(In thousands, except share and per share
data)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30, 2017
2016 2017 2016 Molecular information services
$ 28,368 $ 18,719 $ 79,763 $ 61,331 Pharma research and development
services
14,290 10,707
24,227 26,710
Total revenue 42,658 29,426 103,990 88,041 Costs and
expenses: Cost of molecular information services 19,128 15,946
58,727 39,291 Selling and marketing 16,556 14,654 50,107 42,928
General and administrative 17,001 13,012 49,926 34,739 Research and
development 22,399 17,238 68,657
49,194 Total costs and expenses 75,084
60,850 227,417 166,152
Loss from operations (32,426 ) (31,424 ) (123,427 ) (78,111
) Other (expense) income, net: Interest (expense) income, net (278
) 142 (132 ) 528 Other income 60 — 204
— Net loss $ (32,644 ) $ (31,282 ) $
(123,355 ) $ (77,583 ) Net loss per common share applicable
to common stockholders, basic and diluted $ (0.90 ) $ (0.90 ) $
(3.45 ) $ (2.24 ) Weighted-average common shares
outstanding, basic and diluted 36,086,169 34,949,785 35,726,711
34,701,013
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version on businesswire.com: http://www.businesswire.com/news/home/20171101006359/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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