Foundation Medicine Announces 2014 Second Quarter Results and Recent Highlights

Posted by Samantha Powell on August 12th, 2014 |

Foundation Medicine, Inc. (NASDAQ:FMI) today reported financial and operating results for the quarter ended June 30, 2014.
— 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 FoundationOne(R) 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.

— In May, results from a study conducted by Foundation Medicine
presented at the 2014 ASCO Annual Meeting demonstrated that
FoundationOne detected nearly 50% more ALK (anaplastic lymphoma
kinase) rearrangements than detected by FISH (fluorescence in situ
hybridization) in lung carcinoma patients. These FISH-negative
patients with ALK rearrangements detected by FoundationOne could
benefit from crizotinib, an approved inhibitor of ALK.

— Clinical trial updates:

— In July, the company partnered with the Addario Lung Cancer
Medical Institute and Bonnie J. Addario Lung Cancer Foundation to
launch the Genomics of Young Lung Cancer clinical trial, a first
of its kind, multi-center, international prospective study. This
study aims to better inform treatment decisions in young adults
with lung cancer by leveraging FoundationOne.

— In June, a unique public-private collaboration among the National
Cancer Institute, part of the National Institutes of Health, SWOG
Cancer Research, Friends of Cancer Research, the Foundation for
the National Institutes of Health, five pharmaceutical companies,
and Foundation Medicine initiated the Lung Cancer Master Protocol
(Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven
clinical trial for patients with advanced squamous cell lung
cancer. Since launch, the first patient samples have been received,
and in July, the program announced its expansion to an additional
169 locations throughout the U.S. in addition to the 85 locations
that have been participating since the initial launch.

2014 Outlook

The company confirmed its prior guidance for 2014, including:

— Reported clinical tests in the range of 22,000 and 25,000;
— Revenue in the range of $52 to $58 million; and
— The introduction of new features for the Interactive Cancer Explorer(TM)
physician portal, including outcomes collection capabilities, in the
second half of 2014.

Conference Call and Webcast Details

The company will conduct a conference call today, Tuesday, August 12(th) at 4:30 p.m. Eastern Time to discuss our financial performance for the second quarter and other business activities, including matters related to future performance. To access the conference call via phone, dial 1-855-420-0652 from the United States and Canada, or dial 1-484-365-2939 internationally, and for either number reference Foundation Medicine and provide the passcode 68469471. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website for two weeks following the call.

About Foundation Medicine

Foundation Medicine (NASDAQ: FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. 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 to identify the molecular alterations in a patient’s cancer to help physicians in matching them with relevant targeted therapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine(R) and FoundationOne(R) are registered trademarks and Interactive Cancer Explorer(TM) is a trademark of Foundation Medicine, Inc.

Date: 8/12/14
Outlet Full Name: Wall Street Journal
Author: Dan Budwick

http://online.wsj.com/article/PR-CO-20140812-911626.html

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