Foundation Medicine Announces 2016 First Quarter Results and Recent Highlights
- Achieved first quarter revenue of
$30.4 million , 57% year-over-year growth; - Reported 8,985 clinical tests in the first quarter, 14% year-over-year growth;
- Grew the FoundationCORE™ molecular information knowledgebase, now approaching 80,000 patient cases;
- Presented analytic validation of FoundationACT™, the company's circulating tumor DNA (ctDNA) assay;
- Publicly-released a broad pediatric data set from FoundationCORE for research purposes to enable precision medicine;
- Published 9 manuscripts in high-quality, peer-reviewed journals and delivered 41 podium and poster talks at various medical and scientific meetings.
The company reported 8,985 clinical tests in the first quarter of 2016, a 14% increase from the same quarter last year. This number includes 7,957 FoundationOne® tests and 1,028 FoundationOne® Heme tests.
Revenue from biopharmaceutical customers more than doubled year-over-year to
"Foundation Medicine delivered a solid first quarter highlighted by strong revenue growth and healthy clinical volume," said
The company's molecular information knowledgebase, FoundationCORE, grew to nearly 80,000 patient cases. FoundationCORE is a unique asset and critical component of the value that
Total operating expenses for the first quarter of 2016 were approximately
Recent Enterprise Highlights
- Launched FoundationACT, the company's ctDNA assay to clinical customers. FoundationACT was developed with the same rigorous analytical validation standards as FoundationOne and FoundationOne Heme, and is the third clinical product launch by the company in just four years.
- Announced an agreement with AstraZeneca to develop novel companion diagnostic assays to enable physicians to identify patients most likely to benefit from targeted medicines within AstraZeneca's oncology pipeline.
- Expanded the company's
U.S. laboratory footprint to include a second site atResearch Triangle Park inNorth Carolina . When operational, the company expects this new facility will support continued innovation and expansion of its product portfolio, provide important lab redundancies, increase operational flexibility, and broaden commercial opportunities.
2016 Outlook
Foundation Medicine's business and financial outlook for 2016 remains unchanged:
- The company expects 2016 revenue will be in the range of
$110 to$120 million . - The company expects to deliver between 37,000 and 40,000 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 expects to expand upon reimbursement progress made in 2015 and 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, 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; the expansion of the company's laboratory operations to a new facility in
| Consolidated Statements of Operations (In thousands, except share and per share data) (unaudited) | ||||||||
|
| ||||||||
| Three Months Ended | ||||||||
| | ||||||||
| 2016 | 2015 | |||||||
| Revenue | $ | 30,378 | $ | 19,295 | ||||
| Costs and expenses: | ||||||||
| Cost of revenue | 11,390 | 8,916 | ||||||
| Selling and marketing | 13,793 | 9,821 | ||||||
| General and administrative | 9,224 | 8,842 | ||||||
| Research and development | 13,456 | 8,688 | ||||||
| Total costs and expenses | 47,863 | 36,267 | ||||||
| Loss from operations | (17,485 | ) | (16,972 | ) | ||||
| Other income: | ||||||||
| Interest income | 178 | 7 | ||||||
| Total other income | 178 | 7 | ||||||
| Net loss | $ | (17,307 | ) | $ | (16,965 | ) | ||
| Net loss per common share applicable to common stockholders, basic and diluted | $ | (0.50 | ) | $ | (0.59 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 34,537,007 | 28,609,345 | ||||||
| Condensed Consolidated Balance Sheets (In thousands) (unaudited) | |||||||
| | | ||||||
| 2016 | 2015 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 86,058 | $ | 117,763 | |||
| Marketable securities | 127,441 | 89,607 | |||||
| Accounts receivable, net | 10,569 | 7,765 | |||||
| Inventory | 6,743 | 7,992 | |||||
| Prepaid expenses and other current assets | 5,088 | 6,517 | |||||
| Total current assets | 235,899 | 229,644 | |||||
| Marketable securities | — | 24,939 | |||||
| Property and equipment, net | 41,104 | 41,333 | |||||
| Restricted cash | 1,395 | 1,395 | |||||
| Other assets | 2,155 | 678 | |||||
| Total assets | $ | 280,553 | $ | 297,989 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 8,518 | $ | 10,469 | |||
| Accrued expenses and other current liabilities | 14,290 | 12,822 | |||||
| Deferred revenue | 2,027 | 4,459 | |||||
| Current portion of deferred rent | 2,184 | 2,146 | |||||
| Total current liabilities | 27,019 | 29,896 | |||||
| Other non-current liabilities | 9,801 | 10,404 | |||||
| Total stockholders' equity | 243,733 | 257,689 | |||||
| Total liabilities and stockholders' equity | $ | 280,553 | $ | 297,989 | |||
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