Foundation Medicine Announces 2017 Fourth Quarter and Year-End Results, Recent Highlights and 2018 Outlook
- Fourth quarter revenue of $48.9 million, 70% year-over-year growth;
- Full year 2017 revenue of $152.9 million, 31% year-over-year growth;
- 20,044 clinical tests reported in the fourth quarter, 57% year-over-year growth;
- 67,375 clinical tests reported in 2017, 54% year-over-year growth;
-
Received approval from the
U.S. Food & Drug Administration (FDA) under the parallel review process for FoundationOne CDx, the first broad comprehensive genomic profiling test for all solid tumors incorporating multiple companion diagnostics. Simultaneously, theCenters for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx; - Entered into new and expanded biopharma collaborations for molecular information solutions including companion diagnostics, molecular profiling, data insights, and biomarker discovery, validation and development such as tumor mutational burden (TMB) and tumor mutational burden in blood (bTMB); and
- Published 95 peer-reviewed manuscripts in top medical and scientific journals and presented 141 podium talks and posters at scientific and medical meetings.
"Foundation Medicine's 2017 results and achievements, including record
revenue and clinical volume and the landmark
Revenue from biopharmaceutical companies was
Revenue from clinical testing was
Based on the new revenue reporting the company initiated during 2017,
Molecular Information Services revenue was
Total operating expenses for the fourth quarter of 2017 were
approximately $59.9 million compared with $47.1 million for the fourth
quarter of 2016. For the full year, operating expenses were $228.6
million, compared to $173.9 million in 2016. Net loss was $38.1
million in the fourth quarter of 2017, or
Cash and cash equivalents at December 31, 2017 was approximately $71.4
million, including
2018 Outlook
- The company expects 2018 revenue will be in the range of $200 million to $220 million.
- The company expects to deliver between 90,000 and 100,000 clinical tests in 2018.
- The company expects operating expenses will be in the range of $250 million to $260 million in 2018.
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, and the incurrence of operating
expenses in 2018; the benefits provided by a FDA-approved and
CMS-covered FoundationOne CDx; and the 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 company's 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
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| Three Months Ended | Twelve Months Ended | ||||||||||||||||||||||
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| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||||||
| Molecular information services | $ | 37,390 |
$ |
20,417 |
$ |
117,153 |
$ | 81,748 | |||||||||||||||
| Pharma research and development services | 11,523 | 8,407 | 35,750 | 35,117 | |||||||||||||||||||
| Total revenue | 48,913 | 28,824 | 152,903 | 116,865 | |||||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||
| Cost of molecular information services | 26,543 | 17,457 | 85,270 | 56,748 | |||||||||||||||||||
| Selling and marketing | 16,620 | 15,023 | 66,727 | 57,951 | |||||||||||||||||||
| General and administrative | 20,414 | 13,872 | 70,340 | 48,611 | |||||||||||||||||||
| Research and development | 22,852 | 18,177 | 91,509 | 67,371 | |||||||||||||||||||
| Total costs and expenses | 86,429 | 64,529 | 313,846 | 230,681 | |||||||||||||||||||
| Loss from operations | (37,516 | ) | (35,705 | ) | (160,943 | ) | (113,816 | ) | |||||||||||||||
| Other (expense) income, net: | |||||||||||||||||||||||
| Interest (expense) income, net | (595 | ) | 182 | (727 | ) | 624 | |||||||||||||||||
| Other income | — | (86 | ) | 204 | — | ||||||||||||||||||
| Net loss | $ | (38,111 | ) |
$ |
(35,609 |
) | $ (161,466 | ) | $ | (113,192 | ) | ||||||||||||
| Net loss per common share applicable to common stockholders, basic and diluted | $ | (1.05 | ) |
$ |
(1.02 |
) |
$ |
(4.50 |
) | $ | (3.25 | ) | |||||||||||
| Weighted-average common shares outstanding, basic and diluted | 36,325,659 | 35,072,320 | 35,877,678 | 34,794,347 | |||||||||||||||||||
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| 2017 | 2016 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 71,404 | $ | 63,617 | |||||
| Marketable securities | — | 79,402 | |||||||
| Accounts receivable | 30,126 | 10,213 | |||||||
| Inventory | 13,171 | 10,438 | |||||||
| Prepaid expenses and other current assets | 9,118 | 5,251 | |||||||
| Total current assets | 123,819 | 168,921 | |||||||
| Property and equipment, net | 41,119 | 41,486 | |||||||
| Restricted cash | 2,305 | 1,395 | |||||||
| Other assets | 1,760 | 2,233 | |||||||
| Total assets | $ | 169,003 | $ | 214,035 | |||||
| Liabilities and stockholders' equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 21,926 | $ | 11,898 | |||||
| Accrued expenses and other current liabilities | 36,745 | 20,578 | |||||||
| Deferred revenue | 5,954 | 5,851 | |||||||
| Current portion of deferred rent | 1,818 | 2,324 | |||||||
| Total current liabilities | 66,443 | 40,651 | |||||||
| Other non-current liabilities | 10,892 | 8,538 | |||||||
|
Indebtedness to |
60,000 | — | |||||||
| Total stockholders' equity | 31,668 | 164,846 | |||||||
| Total liabilities and stockholders' equity | $ | 169,003 | $ | 214,035 | |||||
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