Foundation Medicine Announces 2015 Second Quarter Results and Recent Highlights
Year-over-Year Revenues Grow 55%; FoundationCORE™ Expands to More Than 50,000 Patient Cases; Guidance Updated for 2015
- 8,846 clinical tests reported in the second quarter, 50% year-over-year growth;
Second quarter revenue of
$22.5 million, 55% year-over-year growth;
Second quarter revenue from biopharmaceutical customers of
$10.0 million, 97% year-over-year growth;
- FoundationCORE™ molecular information knowledgebase grew to over 50,000 patient cases;
Updated full-year 2015 revenue guidance to a range of
$85to $95 million, and full-year 2015 reported clinical test volumes to a range of 35,000 to 38,000.
The company reported 8,846 clinical tests in the second quarter of 2015, a 50% increase from the same quarter last year and a 13% increase from this year's first quarter. This number includes 7,809 FoundationOne® tests and 1,037 FoundationOne® Heme tests. The results of an additional 1,451 tests were also reported to biopharmaceutical customers in this year's second quarter.
Revenue from biopharmaceutical customers grew to
"Foundation Medicine delivered 16% quarter-over-quarter revenue growth
demonstrating that our commercial team continues to leverage a portfolio
of differentiated products for both our clinical and biopharmaceutical
clients and partners," said
The company's cancer knowledgebase, FoundationCORE, grew to more than
50,000 clinical cases. FoundationCORE is a unique asset and critical
component of the value that
Total operating expenses for the second quarter of 2015 were
Recent Enterprise Highlights
Foundation Medicineannounced the initiation of a large, multi-center clinical study to validate and support the anticipated commercial launch of its novel, circulating tumor DNA (ctDNA) assay to advance precision medicine in oncology.
HealthChoice Oklahoma and one additional regional payer in Southern
Californiaeach enacted broad, pan-cancer coverage policies for FoundationOne and FoundationOne Heme for their members.
Palmetto GBA, a Medicare Administrative Contractor (MAC) with expertise in molecular diagnostics, issued a final local coverage determination on July 6th for comprehensive genomic profiling in a subset of patients with non-small cell lung cancer.
Foundation Medicineand IMS Health announced a collaboration to advance the understanding and effectiveness of precision medicine for treating cancer. The collaboration associates claims, electronic medical records and biomarker data at the anonymized patient level with FoundationCORE to improve cancer care by better connecting patients to the right targeted therapies at the right time.
Foundation Medicineand its collaborators presented 22 oral and poster presentations at the 2015 American Society of Clinical Oncology(ASCO) Annual Meeting, including promising clinical outcomes underscoring the importance of integrating comprehensive genomic profiling into clinical oncology care.
In May, new clinical data presented at the 3rd
Biennial Pediatric Neuro-Oncology Basic and Translational Research Conferencedemonstrated that FoundationOne identified a high frequency of clinically relevant genomic alterations in pediatric gliomas that informed treatment decisions and, in some, cases, resulted in promising outcomes.
- The company expects to report between 35,000 and 38,000 clinical tests in 2015.
The company anticipates 2015 revenue will be in the range of
$85to $95 million.
The company expects operating expenses in the range of
$128to $138 million, plus an additional $14.4 millionone-time advisor fee expense recognized in the second quarter related to the closing of the Rochestrategic collaboration.
- The company expects to launch a circulating tumor DNA (ctDNA) test for its biopharmaceutical partners by year-end, and a commercial ctDNA assay for clinical testing in 2016.
Conference Call and Webcast Details
The company will conduct a conference call today,
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
FoundationOne and FoundationOne Heme to physicians and patients in the
treatment of cancer; the number of tests to be conducted, the generation
of revenue, and the incurrence of operating expenses in 2015; the
expansion of our business with biopharmaceutical partners; the ability
of FoundationCORE to affect clinical practice and patient outcomes; the
objectives, timeline, design and results of a clinical study to validate
the company's ctDNA assay; payer support for comprehensive genomic
profiling, including coverage decisions by
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|Costs and expenses:|
|Cost of revenue||8,950||6,619||17,866||11,910|
|Selling and marketing||12,542||7,170||22,363||12,860|
|General and administrative||23,769||5,825||32,611||11,525|
|Research and development||10,256||8,645||18,944||15,560|
|Total costs and expenses||55,517||28,259||91,784||51,855|
|Loss from operations||(33,059)||(13,763)||(50,031)||
|Other income (expense):|
|Total other income (expense), net||9||
Net loss per common share applicable to common
Weighted-average common shares outstanding, basic and
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||
|Accounts receivable, net||14,136||9,894|
|Prepaid expenses and other current assets||5,675||2,865|
|Total current assets||289,549||89,648|
|Property and equipment, net||30,971||21,015|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||10,752||7,414|
|Current portion of deferred rent||1,908||1,429|
|Total current liabilities||22,144||16,446|
|Other non-current liabilities||11,092||9,323|
|Total stockholders' equity||289,564||86,169|
|Total liabilities and stockholders' equity||
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