News Column

Foundation Medicine Announces 2014 Second Quarter Results and Recent Highlights

August 25, 2014

By a News Reporter-Staff News Editor at Clinical Trials Week -- Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for the quarter ended June 30, 2014 (see also Foundation Medicine, Inc.).

5,908 clinical tests reported, 263% year-over-year growth

Total revenue of $14.5 million, 145% year-over-year growth

Revenue from clinical testing of $9.4 million, 233% year-over-year growth

Continued commercial expansion, with 60% of tests reported to community oncologists

Knowledgebase of genomic data grew to over 21,000 patient cases

Foundation Medicine reported total revenue of $14.5 million in the second quarter of 2014, a 145% increase compared to $5.9 million in the second quarter of 2013 and a 27% increase compared to $11.5 million in the first quarter of 2014. Revenue from clinical testing in this year's second quarter was $9.4 million, a 233% increase compared to $2.8 million in the second quarter of 2013 and a 32% increase compared to $7.1 million in the first quarter of 2014.

The company reported 5,908 clinical tests in the second quarter of 2014, a 263% increase from the same quarter last year and a 26% increase from the 4,702 tests reported in this year's first quarter. This number includes 4,960 FoundationOneŽ tests and 948 FoundationOne Heme tests.

The company's clinical assays, FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, provide a fully informative genomic profile that identifies clinically actionable molecular alterations to help physicians match relevant targeted therapies and clinical trials with the underlying genomic drivers of a patient's cancer.

"We continued to gain commercial momentum in the second quarter, with strong growth in clinical test volumes and in the revenue contribution from our pharmaceutical industry partnerships," said Michael Pellini, M.D., president and chief executive officer of Foundation Medicine. "It was especially encouraging to see a large number of new abstracts and publications coming from our partnerships and from independent research efforts. These data further validate our comprehensive approach to clinical testing and also represent a growing base of evidence supporting the clinical utility of our tests, a key factor in the reimbursement equation for payors."

Total operating expenses for the second quarter of 2014 were $21.6 million, compared with $18.3 million for the first quarter of 2014. The second quarter increase in operating expenses was primarily driven by continued investment in commercial infrastructure and research and development.

Net loss was $13.8 million in the second quarter of 2014, or a $0.49 loss per share. At June 30, 2014, the company had $97.1 million in cash and cash equivalents.

"We remain focused on facilitating the practical utilization of our test findings in clinical care," said Vincent Miller, M.D., chief medical officer of Foundation Medicine. "Our critical role in the Lung-MAP trial and launch of FoundationOne Careline emphasize our commitment to patients and physicians and our efforts to improve access to FDA-approved therapies and other therapies under study in clinical trials." Recent Enterprise Highlights Updated version of FoundationOne launched: In August, the company launched an updated version of FoundationOne incorporating a number of enhancements. The latest version, the most comprehensive genomic profile validated for clinical use today, expands the reporting of potential therapeutic options available for patients and physicians. New York State approval: In July, the New York State Department of Health fully approved FoundationOne and FoundationOne Heme, an important regulatory milestone. FoundationOne CareLine: In June, the company expanded its partnership with the Patient Advocate Foundation to establish the FoundationOne CareLine, a personalized case management service offered to patients with cancer who have had a FoundationOne or FoundationOne Heme test and are facing challenges gaining access to certain prescribed targeted therapies. Data release highlights: In June, results from a new study conducted in partnership with Memorial Sloan Kettering Cancer Center (MSKCC) presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated that comprehensive genomic profiling of lung adenocarcinomas from patients with no or a light smoking history using FoundationOne identified potentially actionable alterations in approximately two-thirds of cases where previous extensive molecular testing on tumors was negative. Approximately one third of patients were matched to therapies in accordance with National Comprehensive Cancer Network (NCCN) treatment guidelines, and approximately one third were matched to clinical trials enrolling at MSKCC at the time of testing.

In May, additional new data, also presented at the 2014 ASCO Annual Meeting, demonstrated that FoundationOne identified genomic alterations that prompted physicians to change therapeutic decisions in 28% of patients tested as part of a prospective study conducted in the US Oncology network.

Keywords for this news article include: Cancer, Genetics, Oncology, Foundation Medicine Inc., Clinical Trials and Studies.

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Source: Clinical Trials Week

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