Foundation Medicine Announces 2017 Second Quarter Results and Recent Highlights
-
Achieved second quarter revenue of
$35.0 million , 24% year-over-year growth; - Reported 15,924 clinical tests in the second quarter, 55% year-over-year growth;
-
Submitted the final module to the
FDA in June for FoundationOne CDx™ as part of the Parallel Review process withFDA and CMS; -
Presented new data at the 2017 annual meeting of the
American Society of Clinical Oncology (ASCO) which continues to validate the clinical utility of Comprehensive Genomic Profiling (CGP) in guiding treatment towards targeted therapy, immunotherapy and clinical trials; - Announced a collaboration with 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 NCI-Match (Molecular Analysis for Therapy Choice) study; and, - Published 29 manuscripts in high-quality, peer-reviewed journals and delivered 49 podium and poster talks at various medical and scientific meetings.
"Foundation Medicine delivered a strong second quarter, highlighted by
record clinical volume and total revenue, increased adoption of our
molecular information solutions by both clinicians and biopharma
partners, and importantly, improved cancer care for the patients we
serve," said
Revenue from clinical testing in the second quarter of 2017 was
Total operating expenses for the second quarter of 2017 were
approximately
The company will now be reporting revenue in two components:
On
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 61,000 and 64,000 clinical tests in 2017.
-
The company is increasing operating expenses and now expects they will
be in the range of
$215 million and$225 million . -
The company expects to advance its pan-cancer universal companion
diagnostic 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 made in 2016 and pursue additional coverage decisions for its CGP assays.
Conference Call and Webcast Details
The company will conduct a conference call today,
About
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 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 our universal companion diagnostic
assay 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 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
- Financial Tables to Follow -
Condensed Consolidated Balance Sheets (In thousands) (unaudited) |
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2017 | 2016 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 36,532 | $ | 63,617 | |||||
Marketable securities | 34,985 | 79,402 | |||||||
Accounts receivable, net | 17,727 | 10,213 | |||||||
Inventory | 8,922 | 10,438 | |||||||
Prepaid expenses and other current assets | 5,102 | 5,251 | |||||||
Total current assets | 103,268 | 168,921 | |||||||
Property and equipment, net | 38,713 | 41,486 | |||||||
Restricted cash | 2,305 | 1,395 | |||||||
Other assets | 2,080 | 2,233 | |||||||
Total assets | $ | 146,366 | $ | 214,035 | |||||
Liabilities and stockholders' equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 15,175 | $ | 11,898 | |||||
Accrued expenses and other current liabilities | 25,269 | 20,578 | |||||||
Deferred revenue | 5,668 | 5,851 | |||||||
Current portion of deferred rent | 1,384 | 2,324 | |||||||
Total current liabilities | 47,496 | 40,651 | |||||||
Other non-current liabilities | 9,354 | 8,538 | |||||||
Total stockholders' equity | 89,516 | 164,846 | |||||||
Total liabilities and stockholders' equity | $ | 146,366 | $ | 214,035 |
Condensed Consolidated Statements of Operations (In thousands, except share and per share data) (unaudited) |
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Three Months Ended | Six Months Ended | |||||||||||||||
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2017 | 2016 | 2017 | 2016 | |||||||||||||
Molecular information services | $ | 30,297 | $ | 22,683 | $ | 51,395 | $ | 42,612 | ||||||||
Pharma research and development services | 4,707 | 5,554 | 9,937 | 16,003 | ||||||||||||
Total revenue | 35,004 | 28,237 | 61,332 | 58,615 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of molecular information services | 21,582 | 11,955 | 39,599 | 23,345 | ||||||||||||
Selling and marketing | 17,115 | 14,481 | 33,551 | 28,274 | ||||||||||||
General and administrative | 17,648 | 12,503 | 32,925 | 21,727 | ||||||||||||
Research and development | 22,973 | 18,500 | 46,258 | 31,956 | ||||||||||||
Total costs and expenses | 79,318 | 57,439 | 152,333 | 105,302 | ||||||||||||
Loss from operations | (44,314) | (29,202) | (91,001) | (46,687) | ||||||||||||
Other income: | ||||||||||||||||
Interest income | 56 | 208 | 146 | 386 | ||||||||||||
Other income | — | — | 144 | — | ||||||||||||
Net loss | $ |
(44,258) |
$ |
(28,994) |
$ | (90,711) | $ |
(46,301) |
||||||||
Net loss per common share applicable to common stockholders, basic and diluted | $ |
(1.24) |
$ |
(0.84) |
$ |
(2.55) |
$ |
(1.34) |
||||||||
Weighted-average common shares outstanding, basic and diluted | 35,660,430 | 34,613,513 | 35,544,003 | 34,575,260 |
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