Foundation Medicine Announces 2016 Second Quarter Results and Recent Highlights
- Achieved second quarter revenue of
$28.2 million , 26% year-over-year growth; - Reported 10,286 clinical tests in the second quarter, 16% year-over-year growth;
- Grew FoundationCORE™, the company's molecular information knowledgebase, to nearly 90,000 patient cases;
- Commercially launched FoundationACT™, the company's circulating tumor DNA (ctDNA) assay;
- Presented new data at the 2016 annual meeting of the
American Society of Clinical Oncology (ASCO) demonstrating that tumor mutational burden as measured by FoundationOne® may predict response to cancer immunotherapies in a broad range of solid tumors; - Published 23 manuscripts in high-quality, peer-reviewed journals and delivered 30 podium and poster talks at various medical and scientific meetings.
Revenue from clinical testing in the second quarter of 2016 was
The company reported 10,286 clinical tests in the second quarter of 2016, a 16% increase from the same quarter last year. This reported volume number includes 8,864 FoundationOne tests and 1,248 FoundationOne Heme tests.
"Foundation Medicine reported a strong second quarter highlighted by continued growth in our biopharma business and robust clinical volume growth," said
The company's molecular information knowledgebase, FoundationCORE, grew to nearly 90,000 patient cases. FoundationCORE is a unique asset and critical component of the value that
Total operating expenses for the second quarter of 2016 were approximately
Today,
Recent Enterprise Highlights
- Announced acceptance of FoundationOne for review as part of the Expedited Access Pathway program with
FDA and Parallel Review throughFDA and CMS. If approved, FoundationOne could be the firstFDA -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 toMedicare beneficiaries nationwide. http://www.businesswire.com/news/home/20160802006718/en/FoundationOne%C2%AE-Accepted-FDA-CMS-Parallel-Review-FDA - Announced the first strategic initiative under a master collaboration agreement with AstraZeneca to develop a novel companion diagnostic assay for Lynparza to support its global development program.
- Announced the release of a broad set of genomic profiles of adult cancers from FoundationCORE to the
National Cancer Institute in support of the National Cancer Moonshot and Precision Medicine initiatives.
2016 Outlook
Foundation Medicine's business and financial outlook for 2016 is the following:
- The company expects 2016 revenue will be in the range of
$110 to$120 million . - The company is increasing clinical volume guidance and now expects to deliver between 39,000 and 41,000 FoundationOne and FoundationOne Heme clinical tests in 2016.
- The company expects operating expenses will be in the range of
$175 and$185 million . - The company intends to expand upon reimbursement progress and work to drive additional coverage decisions.
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 benefits of our products to clinicians, payors and biopharmaceutical companies in the treatment of cancer and the recognition by physicians, payors 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 accelerated review of or approval of FoundationOne as a medical device by the
Condensed Consolidated Statements of Operations (In thousands, except share and per share data) (unaudited) | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
| | ||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||
Revenue | $ | 28,237 | $ | 22,458 | $ | 58,615 | $ | 41,753 | |||||||||
Costs and expenses: | |||||||||||||||||
Cost of revenue | 11,955 | 8,950 | 23,345 | 17,866 | |||||||||||||
Selling and marketing | 14,481 | 12,542 | 28,274 | 22,363 | |||||||||||||
General and administrative | 12,503 | 23,769 | 21,727 | 32,611 | |||||||||||||
Research and development | 18,500 | 10,256 | 31,956 | 18,944 | |||||||||||||
Total costs and expenses | 57,439 | 55,517 | 105,302 | 91,784 | |||||||||||||
Loss from operations | (29,202) | (33,059) | (46,687) | (50,031) | |||||||||||||
Other income: | |||||||||||||||||
Interest income | 208 | 9 | 386 | 16 | |||||||||||||
Total other income | 208 | 9 | 386 | 16 | |||||||||||||
Net loss | $ | (28,994) | $ | (33,050) | $ | (46,301) | $ | (50,015) | |||||||||
Net loss per common share applicable to common | $ | (0.84) | $ | (0.98) | $ | (1.34) | $ | (1.60) | |||||||||
Weighted-average common shares outstanding, basic and | 34,613,513 | 33,852,919 | 34,575,260 | 31,245,617 | |||||||||||||
Condensed Consolidated Balance Sheets (In thousands) (unaudited) | |||||||||
| | ||||||||
2016 | 2015 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 62,282 | $ | 117,763 | |||||
Marketable securities | 128,130 | 89,607 | |||||||
Accounts receivable, net | 12,448 | 7,765 | |||||||
Inventory | 10,160 | 7,992 | |||||||
Prepaid expenses and other current assets | 3,829 | 6,517 | |||||||
Total current assets | 216,849 | 229,644 | |||||||
Marketable securities | — | 24,939 | |||||||
Property and equipment, net | 41,211 | 41,333 | |||||||
Restricted cash | 1,395 | 1,395 | |||||||
Other assets | 2,160 | 678 | |||||||
Total assets | $ | 261,615 | $ | 297,989 | |||||
Liabilities and stockholders' equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 10,847 | $ | 10,469 | |||||
Accrued expenses and other current liabilities | 14,675 | 12,822 | |||||||
Deferred revenue | 4,926 | 4,459 | |||||||
Current portion of deferred rent | 2,209 | 2,146 | |||||||
Total current liabilities | 32,657 | 29,896 | |||||||
Other non-current liabilities | 9,350 | 10,404 | |||||||
Total stockholders' equity | 219,608 | 257,689 | |||||||
Total liabilities and stockholders' equity | $ | 261,615 | $ | 297,989 |
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