CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine (NASDAQ:FMI) today reported financial and operational results for the fourth quarter and year endedDecember 31, 2016. Highlights for the quarter and year included:

Since its inception just six years ago, Foundation Medicine has established itself as the clear leader in molecular information and precision medicine in oncology, statedTroy Cox, chief executive officer ofFoundation 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 millionin the fourth quarter of 2016, compared to$26.1 millionin the fourth quarter of 2015. Total revenue for the year endedDecember 31, 2016was$116.9 million, compared to$93.2 millionin 2015.

Revenue from biopharmaceutical partners was$19.0 millionin 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 millionin 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 millionin 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 FoundationOnetests, 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 millioncompared with$34.0 millionfor the fourth quarter of 2015. For the full year, operating expenses were$173.9 million, compared to$143.5 millionin 2015. Net loss was$35.6 millionin the fourth quarter of 2016, or a$1.02loss per share, and net loss for the full year was$113.2 million, or a$3.25loss per share. AtDecember 31, 2016, the company held approximately$143.0 millionin cash, cash equivalents and marketable securities.

2017 Outlook

Conference Call and Webcast Details

The company will conduct a conference call today, Wednesday, February 22nd at 4:30 p.m. Eastern Time to discuss its financial performance for the fourth quarter and year ended December 31, 2016 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 61272791. 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 companys 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 companys 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 patients unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies 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 http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicineand FoundationOneare registered trademarks, and FoundationACT, FoundationFocusand FoundationCOREare trademarks, of Foundation Medicine, Inc.

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 benefits of our products to physicians, biopharmaceutical companies, payers and patients in the treatment of cancer and personalized cancer care; the generation of revenue, the number of tests to be conducted, and the incurrence of operating expenses in 2017; the benefits provided by a FDA-approved and CMS-covered version of FoundationOne and progress with the Parallel Review process with FDA and CMS; the scope and timing of any approval of FoundationOne as a medical device by theFDAand any coverage decision by CMS; and strategies for achieving Medicare coverage decisions at the local or national level and new and expanded coverage from third-party payers. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks thattheFDA does not approve FoundationOne as a medical device or that CMS does not decide to offer FoundationOne as a covered benefit under Medicare; theFDAor CMS is delayed in the completion of the Parallel Review process; the companys new facilities in North Carolina and Germany do not facilitate the companys ability to achieve it business objectives; the companys distribution partner outside the United States is not able to achieve market penetration in new and existing markets as quickly or as extensively as projected; Foundation Medicine's relationships withthird-party or government payers do not increase or expand; Foundation Medicine is unable to sustain or grow relationships with biopharmaceutical partners; the companys revenue, test or operating expense projections may turn out to be inaccurate because of the preliminary nature of the forecasts; the company's expectations and beliefs regarding the future conduct and growth of the company's business are inaccurate; Foundation Medicineis unable to achieve profitability, to compete successfully, to manage its growth, or to develop its molecular information platform; and the risks described under the caption "Risk Factors" in Foundation Medicine's Annual Report on Form 10-K for the year endedDecember 31, 2015, which is on file with theSecurities and Exchange Commission, as well as other risks detailed in Foundation Medicine's subsequent filings with theSecurities and Exchange Commission. All information in this press release is as of the date of the release, andFoundation Medicineundertakes no duty to update this information unless required by law.

FOUNDATION MEDICINE, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(unaudited)

(35,705)

(19,113)

(113,816)

(89,755)

$

(19,020)

$

(113,192)

$

(89,631)

$

(1.02)

$

(0.55)

$

(3.25)

$

(2.73)

FOUNDATION MEDICINE, INC.

Condensed Consolidated Balance Sheets

(In thousands)

(unaudited)

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Foundation Medicine Announces 2016 Fourth Quarter and Year-End Results, Recent Highlights and 2017 Outlook - Business Wire (press release)