Foundation Medicine Announces 2016 Third Quarter Results and Recent Highlights
Achieved third quarter revenue of
$29.4 million, 16% year-over-year growth;
- Reported 11,627 clinical tests in the third quarter, 45% year-over-year growth;
- Grew FoundationCORE™, the company's molecular information knowledgebase, to nearly 100,000 patient cases;
Announced acceptance of FoundationOne® for Parallel Review
FDAand CMS. If approved, FoundationOne could be the first FDA-approved comprehensive genomic profiling (CGP) assay to incorporate multiple companion diagnostics to support precision medicine in oncology and would be offered as a covered benefit to Medicarebeneficiaries nationwide;
- Added new immunotherapy clinical markers, Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI), to FoundationOne and FoundationOne Heme to help guide personalized immunotherapy-based treatment plans;
- Published an additional 17 manuscripts in high-quality, peer-reviewed journals and delivered six podium and poster presentations at various medical and scientific meetings providing further evidence for the clinical impact of integrating CGP into routine cancer care;
Expanded patient access to CGP through Palmetto, the
MedicareAdministrative Contractor in North Carolina, who broadened a Local Coverage Determination, covering CGP for all stage IIIB and IV non-small cell lung cancer (NSCLC) patients at diagnosis by removing a patient's smoking status as a coverage factor.
Revenue from clinical testing in the third quarter of 2016 was
The company reported 11,627 clinical tests in the third quarter of 2016, a 45% increase from the same quarter last year. This reported volume number includes 9,398 FoundationOne tests, 1,325 FoundationOne Heme tests and 904 FoundationACT™ tests.
"Foundation Medicine delivered another solid quarter highlighted by
strong biopharma revenue and record clinical testing volume," said
The company's molecular information knowledgebase, FoundationCORE, grew
to nearly 100,000 patient cases at the end of the third quarter.
FoundationCORE is a unique asset and critical component of the value
Total operating expenses for the third quarter of 2016 were
Recent Enterprise Highlights
Announced a collaboration with
Sarah Cannon Research Institute(SCRI) in which SCRI will utilize Foundation Medicine's full suite of assays to accelerate patient enrollment into clinical trials and facilitate data sharing across its network in the U.S.
Selected as the molecular information provider of choice by
The Leukemia & Lymphoma Societyfor its landmark Beat AML Master Trial, a prospective study aimed at delivering a precision medicine approach to treat newly diagnosed Acute Myeloid Leukemia patients.
Announced the election of life sciences leader,
Michael R. Dougherty, to its Board of Directors and the Board's Audit Committee. Mr. Dougherty joins as an independent director and fills an existing vacancy on the Board.
Foundation Medicine's business and financial outlook for 2016 is the following:
The company continues to expect 2016 revenue will be in the range of
$110to $120 million.
- The company is increasing the bottom-end of its clinical volume guidance range and now expects to deliver between 40,000 and 41,000 FoundationOne and FoundationOne Heme clinical tests in 2016.
The company continues to expect operating expenses will be in the
$175and $185 million.
Conference Call and Webcast Details
The company will conduct a conference call today,
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the benefits of our
products to clinicians, payers and biopharmaceutical companies in the
treatment of cancer and the recognition by physicians, payers and
patients of the differentiating characteristics of our tests; the number
of tests to be conducted, the generation of revenue, and the incurrence
of operating expenses in 2016, including any changes to earlier
guidance; expectations of continued growth or competitive
differentiation; any approval of FoundationOne as a medical device by
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended||Nine Months Ended|
|Costs and expenses:|
|Cost of revenue||15,946||10,370||39,291||28,236|
|Selling and marketing||14,654||14,267||42,928||36,630|
|General and administrative||13,012||9,199||34,739||41,810|
|Research and development||17,238||12,174||49,194||31,118|
|Total costs and expenses||60,850||46,010||166,152||
|Loss from operations||(31,424||)||(20,611||)||(78,111||)||(70,642||)|
|Other income (expense):|
|Total other income (expense)||142||15||528||31|
|Net loss per common share applicable to common stockholders, basic and diluted||$||(0.90||)||$||(0.60||)||$||(2.24||)||$||(2.19||)|
|Weighted-average common shares outstanding, basic and diluted||34,949,785||34,347,593||34,701,013||32,290,972|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||77,847||$||117,763|
|Accounts receivable, net||13,718||7,765|
|Prepaid expenses and other current assets||2,973||6,517|
|Total current assets||196,535||229,644|
|Property and equipment, net||42,041||41,333|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||22,263||12,822|
|Current portion of deferred rent||2,250||2,146|
|Total current liabilities||38,969||29,896|
|Other non-current liabilities||8,971||10,404|
|Total stockholders' equity||194,376||257,689|
|Total liabilities and stockholders' equity||$||242,316||$||297,989|
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