Foundation Medicine Announces 2017 First Quarter Results and Recent Highlights
- Reported 13,933 clinical tests in the first quarter, 55% year-over-year growth;
- Reported first quarter revenue of
$26.3 million which included payment for FoundationOne® for patients with non-small cell lung cancer (NSCLC) under a Local Coverage Determination (LCD) byPalmetto GBA , the company's Medicare Administrative Contractor inNorth Carolina ; - Announced a collaboration agreement with Bristol-Myers Squibb in the area of immuno-oncology (IO). BMS will leverage FMI's molecular information platform to identify predictive biomarkers across multiple tumor types in patients enrolled in clinical trials investigating BMS' cancer immunotherapies;
- Published 27 manuscripts in high-quality, peer-reviewed journals and delivered 37 podium and poster talks at various medical and scientific meetings; and,
- Increased FoundationCORE™, the company's molecular information database, to more than 125,000 clinical cases.
"Foundation Medicine achieved several milestones this quarter that extend our leadership in molecular information, including strong growth in clinical volume, payment from
Clinical revenue returned to year over year growth, partially driven by the receipt of
The company reported 13,933 tests to clinicians in the first quarter of 2017, a 55% increase from the same quarter last year. This number includes 11,005 FoundationOne® tests, 1,284 FoundationOne® Heme tests, 1,355 FoundationACT® tests, and 289 FoundationFocus™ CDxBRCA tests.
Total operating expenses for the first quarter of 2017 were approximately
2017 Outlook
Foundation Medicine's business and financial outlook for 2017 remains unchanged:
- 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 and$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 for its CGP assays.
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, the incurrence of operating expenses and the expansion of reimbursement progress; the benefits provided by a FDA-approved and CMS-covered version of FoundationOne and progress with the Parallel Review process with FDA and CMS; the scope and timing of any approval of our universal companion diagnostic assay as a medical device by the FDA and any coverage decision by CMS; and strategies for achieving Medicare coverage decisions at the local or national level and new and expanded coverage from third-party payers. 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 FDA does not approve our universal companion diagnostic assay as a medical device or that CMS does not decide to offer our universal companion diagnostic assay as a covered benefit under Medicare; the FDA or CMS is delayed in the completion of the Parallel Review process; the company's new 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
- Financial Tables to Follow -
| | ||||||||
| Three Months Ended | ||||||||
| | ||||||||
| 2017 | 2016 | |||||||
| Revenue | $ | 26,328 | $ | 30,378 | ||||
| Costs and expenses: | ||||||||
| Cost of revenue |
| 18,017 | 11,390 | |||||
| Selling and marketing |
| 16,436 | 13,793 | |||||
| General and administrative |
| 15,277 | 9,224 | |||||
| Research and development |
| 23,285 | 13,456 | |||||
| Total costs and expenses |
| 73,015 | 47,863 | |||||
| Loss from operations |
| (46,687) | (17,485) | |||||
| Interest income (expense), net |
| 90 | 178 | |||||
| Other income |
| 144 | — | |||||
| Net loss | $ | (46,453) | $ | (17,307 ) | ||||
| Net loss per common share applicable to common stockholders, basic and diluted | $ | (1.31) | $ | (0.50) | ||||
| Weighted-average common shares outstanding, basic and diluted |
| 35,426,296 | 34,537,007 | |||||
|
| |||||||||
| | | ||||||||
| 2017 | 2016 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 49,075 | $ | 63,617 | |||||
| Marketable securities | 49,976 | 79,402 | |||||||
| Accounts receivable, net | 10,728 | 10,213 | |||||||
| Inventory | 10,349 | 10,438 | |||||||
| Prepaid expenses and other current assets | 5,338 | 5,251 | |||||||
| Total current assets | 125,466 | 168,921 | |||||||
| Property and equipment, net | 39,553 | 41,486 | |||||||
| Restricted cash | 1,395 | 1,395 | |||||||
| Other assets | 2,140 | 2,233 | |||||||
| Total assets | $ | 168,554 | $ | 214,035 | |||||
| Liabilities and stockholders' equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 10,427 | $ | 11,898 | |||||
| Accrued expenses and other current liabilities | 19,240 | 20,578 | |||||||
| Deferred revenue | 2,278 | 5,851 | |||||||
| Current portion of deferred rent | 2,418 | 2,324 | |||||||
| Total current liabilities | 34,363 | 40,651 | |||||||
| Other non-current liabilities | 7,874 | 8,538 | |||||||
| Total stockholders' equity | 126,317 | 164,846 | |||||||
| Total liabilities and stockholders' equity | $ | 168,554 | $ | 214,035 | |||||
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