- Achieved third quarter revenue of $29.4 million, 16% year-over-year growth;
- Reported 11,627 clinical tests in the third quarter, 45% year-over-year growth;
- Grew FoundationCORE ™, the company's molecular information knowledgebase, to nearly 100,000 patient cases;
- Announced acceptance of FoundationOne ® for Parallel Review by FDA and CMS. If approved, FoundationOne could be the first FDA-approved comprehensive genomic profiling (CGP) assay to incorporate multiple companion diagnostics to support precision medicine in oncology and would be offered as a covered benefit to Medicare beneficiaries nationwide;
- Added new immunotherapy clinical markers, Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI), to FoundationOne and FoundationOne Heme to help guide personalized immunotherapy-based treatment plans;
- Published an additional 17 manuscripts in high-quality, peer-reviewed journals and delivered six podium and poster presentations at various medical and scientific meetings providing further evidence for the clinical impact of integrating CGP into routine cancer care;
- Expanded patient access to CGP through Palmetto, the Medicare Administrative Contractor in North Carolina, who broadened a Local Coverage Determination, covering CGP for all stage IIIB and IV non-small cell lung cancer (NSCLC) patients at diagnosis by removing a patient's smoking status as a coverage factor.
Revenue from clinical testing in the third quarter of 2016 was $8.7 million, compared to $13.7 million in the third quarter of 2015. The decrease was 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 payments for testing in other indications.The company reported 11,627 clinical tests in the third quarter of 2016, a 45% increase from the same quarter last year. This reported volume number includes 9,398 FoundationOne tests, 1,325 FoundationOne Heme tests and 904 FoundationACT ™ tests. "Foundation Medicine delivered another solid quarter highlighted by strong biopharma revenue and record clinical testing volume," said Michael Pellini, M.D., chief executive officer of Foundation Medicine. "We believe our progress on building distinct, yet synergistic clinical and biopharma businesses, developing applications that enable patient access to therapies and clinical trials, aggressively working towards reimbursement coverage and payment for our comprehensive genomic profiling assays and pursuing parallel review with FDA and CMS for FoundationOne will drive continued growth and value creation." The company's molecular information knowledgebase, FoundationCORE, grew to nearly 100,000 patient cases at the end of the third quarter. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers. The increasing scale and breadth of this high quality, clinically relevant oncology data set derived from the company's testing platform continues to enhance clinical practice and help enable improved outcomes for patients. Total operating expenses for the third quarter of 2016 were approximately $44.9 million compared with $35.6 million for the third quarter of 2015. Net loss was approximately $31.3 million in the third quarter of 2016, or a $0.90 loss per share. At September 30, 2016, the company held approximately $167.9 million in cash, cash equivalents and marketable securities.
Recent Enterprise Highlights
- Announced a collaboration with Sarah Cannon Research Institute (SCRI) in which SCRI will utilize Foundation Medicine's full suite of assays to accelerate patient enrollment into clinical trials and facilitate data sharing across its network in the U.S.
- Selected as the molecular information provider of choice by The Leukemia & Lymphoma Society for its landmark Beat AML Master Trial, a prospective study aimed at delivering a precision medicine approach to treat newly diagnosed Acute Myeloid Leukemia patients.
- Announced the election of life sciences leader, Michael R. Dougherty, to its Board of Directors and the Board's Audit Committee. Mr. Dougherty joins as an independent director and fills an existing vacancy on the Board.
- The company continues to expect 2016 revenue will be in the range of $110 to $120 million.
- The company is increasing the bottom-end of its clinical volume guidance range and now expects to deliver between 40,000 and 41,000 FoundationOne and FoundationOne Heme clinical tests in 2016.
- The company continues to expect operating expenses will be in the range of $175 and $185 million.
|FOUNDATION MEDICINE, INC.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Costs and expenses:|
|Cost of revenue||15,946||10,370||39,291||28,236|
|Selling and marketing||14,654||14,267||42,928||36,630|
|General and administrative||13,012||9,199||34,739||41,810|
|Research and development||17,238||12,174||49,194||31,118|
|Total costs and expenses||60,850||46,010||166,152||137,794|
|Loss from operations||(31,424||)||(20,611||)||(78,111||)||(70,642||)|
|Other income (expense):|
|Total other income (expense)||142||15||528||31|
|Net loss per common share applicable to common stockholders, basic and diluted||$||(0.90||)||$||(0.60||)||$||(2.24||)||$||(2.19||)|
|Weighted-average common shares outstanding, basic and diluted||34,949,785||34,347,593||34,701,013||32,290,972|
|FOUNDATION MEDICINE, INC.|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||77,847||$||117,763|
|Accounts receivable, net||13,718||7,765|
|Prepaid expenses and other current assets||2,973||6,517|
|Total current assets||196,535||229,644|
|Property and equipment, net||42,041||41,333|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||22,263||12,822|
|Current portion of deferred rent||2,250||2,146|
|Total current liabilities||38,969||29,896|
|Other non-current liabilities||8,971||10,404|
|Total stockholders' equity||194,376||257,689|
|Total liabilities and stockholders' equity||$||242,316||$||297,989|