Foundation Medicine Announces 2014 Fourth Quarter and Year-End Results, Recent Highlights and 2015 Outlook
- 7,233 clinical tests reported in the fourth quarter -- 93% year-over-year growth
$18.7 millionrevenue in the fourth quarter -- 93% year-over-year growth
- 24,271 clinical tests reported in 2014 -- 167% annual growth
$61.1 millionrevenue in 2014 -- 111% annual growth
- FoundationCORE™, Foundation Medicine's knowledgebase of genomic data, grew to approximately 35,000 clinical cases
- Launched ICE 2™, the latest version of the company's Interactive Cancer Explorer®, including a new feature called PatientMatch™
The company reported total revenue of
The company reported 7,233 clinical tests in the fourth quarter of 2014, a 93% increase from the fourth quarter of 2013 and a 13% increase from the third quarter of 2014. This clinical test number includes 6,216 FoundationOne® tests and 1,017 FoundationOne Heme tests. An additional 2,009 tests were reported to pharmaceutical partners in the fourth quarter of 2014. For the full year, the company reported 24,271 clinical tests compared to 9,095 tests in 2013. The 2014 number includes 20,555 FoundationOne tests and 3,716 FoundationOne Heme tests.
Revenue from pharmaceutical partners was
"Commercial execution and growth rates were strong across both our
clinical and pharma customers in the fourth quarter, highlighting the
broad adoption of our comprehensive genomic profiling approach," said
The company's knowledgebase of molecular information, FoundationCORE, grew to approximately 35,000 clinical cases across a wide spectrum of cancers. FoundationCORE is an asset being utilized by biopharma customers through direct data product relationships and by physicians through the PatientMatch feature of ICE 2. The company believes the increasing scale of FoundationCORE will play an essential role in enhancing clinical practice efficiency and enabling improved outcomes for patients.
Total operating expenses for the fourth quarter of 2014 were
In January, the company and Roche agreed to enter into a strategic R&D
collaboration and commercialization arrangements, and Roche agreed to
$250 millioninvestment in Foundation Medicine. The complete transaction is subject to Roche's acquisition of at least 52.4% and up to 56.3% of the company's outstanding shares on a fully diluted basis and the satisfaction of other closing conditions.
- In December, the company launched ICE 2, the newest version of its Interactive Cancer Explorer physician portal, including a new tool called PatientMatch.
In December, the company commenced a strategic collaboration with
Flatiron Healthto develop a proprietary cloud-based information platform combining genomic and clinical treatment and outcomes data.
In December, molecular diagnostics veteran
David J. Dalyjoined the company as its chief commercial officer.
- Throughout the fourth quarter, clinical data was presented supporting the use of FoundationOne and FoundationOne Heme in solid and hematologic cancers, including non-small cell lung, breast, upper gastrointestinal, multiple myeloma and lymphoma.
In November, broad reimbursement coverage for FoundationOne and
FoundationOne Heme was announced by
- In November, the NCCN published updates to its Clinical Practice Guidelines in Oncology that endorse broader molecular profiling for non-small cell lung cancer.
- The company expects to report between 43,000 and 47,000 clinical tests in 2015.
The company anticipates 2015 revenue will be in the range of
$105- $115 millionassuming completion of the Roche transaction in the second quarter of 2015.
The company expects operating expenses in the range of
$128to $138 million.
- The company expects to launch a cell-free DNA test in 2015.
Conference Call and Webcast Details
The company will conduct a conference call today,
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the ability of the
Roche collaboration to strengthen Foundation Medicine's business; the
ability of FoundationCORE to affect clinical practice and patient
outcomes; the number of tests to be conducted, the generation of
revenue, and the incurrence of operating expenses in 2015; the launch of
a cell-free DNA assay test; the planned completion of the collaboration
In connection with the proposed transactions,
Consolidated Statements of Operations
(In thousands, except share and per share data)
Three Months Ended
|Costs and expenses:|
|Cost of revenue||8,022||4,204||27,434||11,659|
|Selling and marketing||8,244||4,602||28,997||12,326|
|General and administrative||8,976||7,512||27,302||21,865|
|Research and development||7,839||6,834||30,629||24,901|
|Total costs and expenses||33,081||23,152||114,362||70,751|
|Loss from operations||(14,401||)||(13,490||)||(53,283||)||(41,761||)|
|Other income (expense):|
|Interest income (expense), net||1||(33||)||(42||)||(235||)|
|Other income (expense), net||1,103||432||1,103||(948||)|
|Total other income (expense), net||1,104||399||1,061||(1,183||)|
|Net loss||$ (13,297||)||$ (13,091||)||$ (52,222||)||$||(42,944||)|
|Accretion of redeemable convertible preferred stock||—||—||—||(139||)|
|Net loss applicable to common stockholders||$ (13,297||)||$ (13,091||)||$ (52,222||)||$||(43,083||)|
|Net loss per common share applicable to common stockholders, basic and diluted||
|Weighted-average common shares outstanding, basic and diluted||28,165,590||27,504,773||27,954,327||9,294,730|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||72,080||$||124,293|
|Prepaid expenses and other current assets||2,865||992|
|Total current assets||89,648||133,310|
|Property and equipment, net||21,015||22,104|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||7,414||5,168|
|Current portion of deferred rent||1,429||1,167|
|Current portion of notes payable||—||1,499|
|Total current liabilities||16,446||15,759|
|Other non-current liabilities||9,323||9,798|
|Total stockholders' equity||86,169||131,711|
|Total liabilities and stockholders' equity||$||111,938||$||157,268|
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