On May 9, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for its first quarter ended March 31, 2017 (Press release, Foundation Medicine, MAY 9, 2017, View Source [SID1234518946]). Results and business highlights for the quarter included: Schedule your 30 min Free 1stOncology Demo! Reported 13,933 clinical tests in the first quarter, 55% year-over-year growth;
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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) by Palmetto GBA, the company’s Medicare Administrative Contractor in North 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 Medicare and a collaboration with Bristol-Myers Squibb in the critical field of immuno-oncology," said Troy Cox, chief executive officer of Foundation Medicine. "Importantly, we believe we are on track to achieve our 2017 business objectives, including advancing our universal companion diagnostic assay through the FDA and CMS parallel review process to a decision during the second half of this year."
Foundation Medicine reported total revenue of $26.3 million in the first quarter of 2017, compared to $30.4 million in the first quarter of 2016. Total revenue declined year over year due to an expected decrease in first quarter biopharmaceutical revenue related to the timing of various research and development projects with its biopharma partners. Revenue from biopharmaceutical customers was $14.7 million in the first quarter of 2017 compared to $20.2 million in the first quarter of 2016. The results of 1,802 tests were reported to biopharmaceutical customers in this year’s first quarter.
Clinical revenue returned to year over year growth, partially driven by the receipt of Medicare payment for FoundationOne under Palmetto’s NSCLC LCD. Revenue from clinical testing in the first quarter of 2017 was $11.6 million, compared to $10.2 million in the first quarter of 2016.
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 $55.0 million compared with $36.5 million for the first quarter of 2016. The increase in operating expenses was partially driven by investments related to the development of the company’s universal companion diagnostic assay. Net loss was approximately $46.5 million in the first quarter of 2017, or a $1.31 loss per share. At March 31, 2017, the company held approximately $99.1 million in cash, cash equivalents and marketable securities.
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.