On February 22, 2017 Foundation Medicine (NASDAQ:FMI) reported financial and operational results for the fourth quarter and year ended December 31, 2016 (Press release, Foundation Medicine, FEB 22, 2017, View Source [SID1234517808]). Highlights for the quarter and year included:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 the FDA 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 in North 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, Foundation Medicine has established itself as the clear leader in molecular information and precision medicine in oncology," stated Troy Cox, chief executive officer of Foundation Medicine. "We believe 2017 will be a year of continued growth and value creation particularly as we progress through Parallel Review of FoundationOne with FDA and CMS and simultaneously collaborate with healthcare providers, payers and biopharma partners to apply our molecular information to accelerate personalized cancer care."
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 $44.0 million in 2015. These increases in revenue from biopharmaceutical partners highlight the company’s continued leading and broadening role within targeted oncology drug development.
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 $38.1 million, compared to $49.2 million in 2015. The decreases were driven by various factors, the most significant of which was the transition in-network with a large national payer for stage IV NSCLC testing, which resulted in the termination of out of network payments for testing in other indications.
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