Foundation Medicine (FMI) Tops Q3 EPS by 20c, Beats on Revenues; Offers FY17 Revenue Outlook

Foundation Medicine (NASDAQ: FMI) reported Q3 EPS of ($0.90), $0.20 better than the analyst estimate of ($1.10). Revenue for the quarter came in at $42.7 million versus the consensus estimate of $37.99 million.

2017 Outlook

Foundation Medicine’s business and financial outlook for 2017 is the following:

The company expects 2017 revenue will be in the range of $135 million to $145 million.

• The company is increasing clinical volume guidance and now expects to deliver between 64,000 and 66,000 clinical tests in 2017.
• The company expects 2017 operating expenses will be in the range of $215 million and $225 million.
• The company expects to advance its comprehensive genomic profiling assay, FoundationOne CDx, through the FDA and CMS Parallel Review process with a decision anticipated in the fourth quarter of 2017.
• The company expects to continue reimbursement progress and pursue additional coverage decisions for its CGP assays.

Highlights

• Achieved third quarter revenue of $42.7 million, 45% year-over-year growth;
• Reported 17,474 clinical tests in the third quarter, 50% year-over-year growth;
• Presented validation data for FoundationOne CDx™ at the World Conference on Lung Cancer which demonstrated high concordance with multiple FDA-approved companion diagnostics across multiple solid tumor cancer types. FoundationOne CDx is currently under the Parallel Review process with FDA and CMS;
• Presented validation data for a novel assay measuring tumor mutational burden in blood (bTMB) at the European Society for Medical Oncology (ESMO) providing evidence that response to immunotherapy can be predicted using a blood sample. Based on these findings, the bTMB assay is being integrated as part of Roche/Genentech’s prospective, randomized Phase III Blood First Assay Screening Trial (BFAST) as a companion diagnostic assay to investigate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients; and
• Published 19 manuscripts in high-quality, peer-reviewed journals and delivered 21 podium and poster talks at various medical and scientific meetings.

GUIDANCE:

Foundation Medicine sees FY2017 revenue of $135-145 million, versus the consensus of $141.33 million.

For earnings history and earnings-related data on Foundation Medicine (FMI) click here.

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