Foundation Medicine Announces 2018 First Quarter Results and Recent Highlights
- Posted revenue of $52.8 million, 101% year-over-year growth;
- Reported 21,861 clinical tests, 57% year-over-year growth;
- Achieved broad
Medicare coverage through a final National Coverage Determination (NCD) from theCenters for Medicare and Medicaid Services (CMS) for FoundationOne CDx™ across all solid tumors for eligible stage III and stage IV cancer patients; - Launched FoundationOne CDx, the first
FDA approved comprehensive genomic profiling assay for all solid tumors incorporating multiple companion diagnostics; - Announced that an expanded version of FoundationACT®, which will include an expanded gene set and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB), was granted Breakthrough Device designation (formerly Expedited Access Pathway) by the
FDA ; - Announced a comprehensive gene expression profiling (GEP) program which leverages deep expertise in DNA and RNA sequencing to support precision oncology clinical research and development and identification of novel genomic and expression-based biomarkers for personalized cancer therapies;
- Partnered with
Chugai Pharmaceutical Co. to commercialize the company’s CGP tests inJapan , including the filing by Chugai of an application with the Ministry of Health, Labour and Welfare (MHLW) for approval of FoundationOne CDx inJapan ; - Announced a partnership with
Roche andDIAN Diagnostics , a leading NGS diagnostics laboratory inChina , to integrate Foundation Medicine’s CGP assays into clinical patient care in mainlandChina ; and - Published 22 peer-reviewed manuscripts in medical and scientific journals and presented 35 podium talks and posters at scientific and medical meetings.
“Foundation Medicine delivered another strong quarter. Compared to the same quarter last year, we doubled revenue over last year and reported record clinical volume,” stated Troy Cox, chief executive officer of Foundation Medicine. “Just four months into the year, we’ve made meaningful progress on our strategic priorities for 2018, including the achievement of
First Quarter | |||||||||||
($ in millions) | 2018 | 2017 | % Change | ||||||||
Molecular Information Services | |||||||||||
Clinical | $ | 18.8 | $ | 11.6 | 62 | % | |||||
Pharma | 27.8 | 9.5 | 193 | % | |||||||
Total Molecular Information Services | 46.6 | 21.1 | 121 | % | |||||||
Pharma R&D Services | 6.2 | 5.2 | 19 | % | |||||||
Total Revenue | $ | 52.8 | $ | 26.3 | 101 | % | |||||
Revenue from clinical testing in the first quarter of 2018 grew 62% year over year and was driven by increasing clinical volume. The company reported 21,861 clinical tests in the first quarter of 2018, a 57% increase from the same quarter last year. This number includes 17,685 FoundationOne® tests, 2,005 FoundationOne®Heme tests, 2,123 FoundationACT® tests, and 48 FoundationFocus™ CDx BRCA tests.
Molecular Information Services revenue from biopharmaceutical companies was very strong and was driven by clinical study sample testing. The company reported 7,184 tests to biopharmaceutical customers in the first quarter of 2018 compared to 1,802 tests in the first quarter of 2017.
Total operating expenses for the first quarter of 2018 were $62.0 million compared with $55.0 million for the first quarter of 2017. Net loss was $37.4 million in the first quarter of 2018, or
Cash and cash equivalents at March 31, 2018 was approximately $60.3 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 the company’s 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, including any changes to any earlier guidance; the scope and timing of any approval of the company’s new liquid biopsy assay as a medical device by the
FOUNDATION MEDICINE, INC. | |||||||||
Three Months Ended March 31, | |||||||||
2018 | 2017 | ||||||||
Revenue: | |||||||||
Molecular information services | $ | 31,943 | $ | 15,594 | |||||
Related-party molecular information services from Roche | 14,648 | 5,504 | |||||||
Pharma research and development services | 4,782 | 1,087 | |||||||
Related-party pharma research and development services from Roche | 1,467 | 4,143 | |||||||
Total revenue | 52,840 | 26,328 | |||||||
Costs and expenses: | |||||||||
Cost of molecular information services | 21,279 | 17,117 | |||||||
Cost of related-party molecular information services from Roche | 5,948 | 900 | |||||||
Selling and marketing | 17,480 | 16,436 | |||||||
General and administrative | 20,695 | 15,277 | |||||||
Research and development | 23,859 | 23,285 | |||||||
Total costs and expenses | 89,261 | 73,015 | |||||||
Loss from operations | (36,421 | ) | (46,687 | ) | |||||
Other (expense) income, net: | |||||||||
Interest (expense) income, net | (994 | ) | 90 | ||||||
Other income | — | 144 | |||||||
Net loss | $ | (37,415 | ) | $ | (46,453 | ) | |||
Net loss per common share applicable to common stockholders, basic and diluted | $ | (1.02 | ) | $ | (1.31 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 36,792,980 | 35,426,296 | |||||||
FOUNDATION MEDICINE, INC. | |||||||
Three Months Ended March 31, | |||||||
2018 | 2017 | ||||||
Clinical: | |||||||
Molecular information services | $ | 15,589 | $ | 10,649 | |||
Related-party molecular information services from Roche | 3,198 | 970 | |||||
Total clinical revenue | $ | 18,787 | $ | 11,619 | |||
Pharma: | |||||||
Molecular information services | $ | 16,354 | $ | 4,945 | |||
Related-party molecular information services from Roche | 11,450 | 4,534 | |||||
Pharma research and development services | 4,782 | 1,087 | |||||
Related-party pharma research and development services from Roche | 1,467 | 4,143 | |||||
Total pharma revenue | $ | 34,053 | $ | 14,709 | |||
|
| ||||||
Total revenue | $ | 52,840 | $ | 26,328 | |||
FOUNDATION MEDICINE, INC. | |||||||
March 31, 2018 | December 31, 2017 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 60,293 | $ | 71,404 | |||
Accounts receivable | 32,222 | 19,967 | |||||
Receivable due from Roche | 9,099 | 10,159 | |||||
Inventory | 16,411 | 13,171 | |||||
Prepaid expenses and other current assets | 13,003 | 9,118 | |||||
Total current assets | 131,028 | 123,819 | |||||
Property and equipment, net | 41,607 | 41,119 | |||||
Restricted cash | 2,305 | 2,305 | |||||
Other assets | 2,225 | 1,760 | |||||
Total assets | $ | 177,165 | $ | 169,003 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 25,865 | $ | 21,926 | |||
Accrued expenses and other current liabilities | 22,393 | 36,745 | |||||
Deferred revenue | 2,867 | 2,212 | |||||
Roche related-party deferred revenue | 4,801 | 3,742 | |||||
Current portion of deferred rent | 1,836 | 1,818 | |||||
Total current liabilities | 57,762 | 66,443 | |||||
Other non-current liabilities | 10,507 | 10,892 | |||||
Indebtedness to Roche – non-current | 90,000 | 60,000 | |||||
Total stockholders’ equity | 18,896 | 31,668 | |||||
Total liabilities and stockholders’ equity | $ | 177,165 | $ | 169,003 | |||
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Source:
Foundation Medicine
Media Contact:
Lee-Ann Murphy, 617-245-3077
pr@foundationmedicine.com
or
Investor Contact:
Kimberly Brown, 617-418-2215
ir@foundationmedicine.com