Foundation Medicine Announces 2016 Fourth Quarter and Year-End Results, Recent Highlights and 2017 Outlook
- Fourth quarter revenue of $28.8 million, 11% year-over-year growth;
- Full year 2016 revenue of $116.9 million, 25% year-over-year growth;
- 12,788 clinical tests reported in the fourth quarter, 54% year-over-year growth;
- 43,686 clinical tests reported in 2016, 32% year-over-year growth;
- Received
FDA approval of FoundationFocus™ CDxBRCA as a companion diagnostic for Rubraca™ (rucaparib) for the treatment of women with ovarian cancer. FoundationFocus is the first next generation sequencing companion diagnostic approved by theFDA and marks important progress towards the development of the company's universal pan-cancer companion diagnostic assay; - Made progress in expanding patient access to comprehensive genomic profiling (CGP) through Palmetto, a
Medicare administrative contractor inNorth Carolina , who issued draft Local Coverage Determinations covering CGP at initial diagnosis for advanced or metastatic melanoma, colorectal cancer and ovarian cancer patients; - Together with
Flatiron Health , launched a clinico-genomic database containing information on 20,000 patients designed to help researchers and biopharmaceutical companies accelerate the development of targeted therapies and immunotherapies to treat cancer; and, - Increased FoundationCORE™, the company's molecular information database, to more than 100,000 clinical cases.
"Since its inception just six years ago,
The company reported total revenue of $28.8 million in the fourth quarter of 2016, compared to $26.1 million in the fourth quarter of 2015. Total revenue for the year ended December 31, 2016 was $116.9 million, compared to $93.2 million in 2015.
Revenue from biopharmaceutical partners was $19.0 million in the fourth quarter, representing a 35% increase from the same period in 2015. For the full year, revenue from biopharmaceutical partners was $78.8 million, a 79% increase from
Revenue from clinical testing in the fourth quarter of 2016 was $9.8 million, compared to $12.0 million in the fourth quarter of 2015. For the full year, revenue from clinical testing was
The company reported 12,788 clinical tests, which includes 10,108 FoundationOne tests, 1,407 FoundationOne Heme tests and 1,273 FoundationACT™ tests, in the fourth quarter of 2016, a 54% increase from the total reported clinical tests in the fourth quarter of 2015. An additional 1,860 tests were reported to biopharmaceutical partners in the fourth quarter of 2016. The company reported 43,686 clinical tests, which includes 36,327 FoundationOne tests, 5,008 FoundationOne Heme tests and 2,351 FoundationACT tests, for the full year 2016, a 32% increase compared to the total reported clinical tests in 2015.
Total operating expenses for the fourth quarter of 2016 were approximately $47.1 million compared with $34.0 million for the fourth quarter of 2015. For the full year, operating expenses were $173.9 million, compared to $143.5 million in 2015. Net loss was $35.6 million in the fourth quarter of 2016, or a $1.02 loss per share, and net loss for the full year was $113.2 million, or a $3.25 loss per share. At December 31, 2016, the company held approximately $143.0 million in cash, cash equivalents and marketable securities.
2017 Outlook
- The company expects 2017 revenue will be in the range of $135 million to $145 million.
- The company expects to deliver between 53,000 and 56,000 clinical tests in 2017.
- The company expects operating expenses will be in the range of $205 million to $215 million.
- The company expects to advance its universal, pan-cancer companion diagnostic assay through the
FDA and CMS Parallel Review process with a decision in the second half of 2017. - The company expects to expand upon reimbursement progress made in 2016 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 physicians, biopharmaceutical companies, payers and patients in the treatment of cancer and personalized cancer care; the generation of revenue, the number of tests to be conducted, and the incurrence of operating expenses in 2017; the benefits provided by a
| ||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||
(In thousands, except share and per share data) | ||||||||||||
(unaudited) | ||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||
| | |||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||
Revenue | $ | 28,824 | $ | 26,051 | $ | 116,865 | $ | 93,203 | ||||
Costs and expenses: | ||||||||||||
Cost of revenue | 17,457 | 11,195 | 56,748 | 39,431 | ||||||||
Selling and marketing | 15,023 | 12,400 | 57,951 | 49,030 | ||||||||
General and administrative | 13,872 | 8,804 | 48,611 | 50,614 | ||||||||
Research and development | 18,177 | 12,765 | 67,371 | 43,883 | ||||||||
Total costs and expenses | 64,529 | 45,164 | 230,681 | 182,958 | ||||||||
Loss from operations | (35,705) | (19,113) | (113,816) | (89,755) | ||||||||
Other income (expense): | ||||||||||||
Interest income (expense), net | 96 | 93 | 624 | 124 | ||||||||
Total other income (expense), net | 96 | 93 | 624 | 124 | ||||||||
Net loss | $ | (35,609) | $ | (19,020) | $ | (113,192) | $ | (89,631) | ||||
Net loss per common share applicable to common stockholders, basic and diluted | $ | (1.02) | $ | (0.55) | $ | (3.25) | $ | (2.73) | ||||
Weighted-average common shares outstanding, basic and diluted | 35,072,320 | 34,454,183 | 34,794,347 | 32,836,219 | ||||||||
| ||||||
Condensed Consolidated Balance Sheets | ||||||
(In thousands) | ||||||
(unaudited) | ||||||
| | |||||
2016 | 2015 | |||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 63,617 | $ | 117,763 | ||
Marketable securities | 79,402 | 89,607 | ||||
Accounts receivable, net | 10,213 | 7,765 | ||||
Inventory | 10,438 | 7,992 | ||||
Prepaid expenses and other current assets | 5,251 | 6,517 | ||||
Total current assets | 168,921 | 229,644 | ||||
Marketable securities | — | 24,939 | ||||
Property and equipment, net | 41,486 | 41,333 | ||||
Restricted cash | 1,395 | 1,395 | ||||
Other assets | 2,233 | 678 | ||||
Total assets | $ | 214,035 | $ | 297,989 | ||
Liabilities and stockholders' equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 11,898 | $ | 10,469 | ||
Accrued expenses and other current liabilities | 20,578 | 12,822 | ||||
Deferred revenue | 5,851 | 4,459 | ||||
Current portion of deferred rent | 2,324 | 2,146 | ||||
Total current liabilities | 40,651 | 29,896 | ||||
Other non-current liabilities | 8,538 | 10,404 | ||||
Total stockholders' equity | 164,846 | 257,689 | ||||
Total liabilities and stockholders' equity | $ | 214,035 | $ | 297,989 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20170222006448/en/
Media Contact:
pr@foundationmedicine.com
or
Investor Contact:
ir@foundationmedicine.com
Source:
News Provided by Acquire Media