Foundation Medicine Announces 2015 Fourth Quarter and Year-End Results, Recent Highlights and 2016 Outlook
Fourth quarter revenue of
$26.1 million, 39% year-over-year growth;
- 8,286 clinical tests reported in the fourth quarter, 15% year-over-year growth;
Full year 2015 revenue of
$93.2 million, 53% year-over-year growth;
- 32,998 clinical tests reported in 2015, 36% year-over-year growth;
Improving patient access to comprehensive genomic profiling by signing
a national agreement with
United Healthcarefor FoundationOne® in metastatic non-small cell lung cancer. Additionally, Palmetto GBA, a Medicare Administrative Contractor (MAC), announced a final local coverage determination for comprehensive genomic profiling in a subset of patients with non-small cell lung cancer;
- Broadening molecular information solutions with the addition of PatientMatchTM, GeneKitTM and SmartTrialsTM; and,
- Expanding FoundationCORE™ molecular information knowledgebase to more than 68,000 cases.
The company reported total revenue of $26.1 million in the fourth quarter of 2015, compared to $18.7 million in the fourth quarter of 2014. Revenue from clinical testing in the fourth quarter of 2015 was $12.0 million, compared to $10.3 million in the fourth quarter of 2014. Total revenue for the year ended December 31, 2015 was $93.2 million, compared to $61.1 million in 2014.
The company reported 8,286 clinical tests, which includes 7,382 FoundationOne® tests and 904 FoundationOne Heme tests, in the fourth quarter of 2015, a 15% increase from the total reported clinical tests in fourth quarter of 2014. An additional 3,104 tests were reported to pharmaceutical partners in the fourth quarter of 2015. The company reported 32,998 clinical tests, which includes 29,076 FoundationOne tests and 3,922 FoundationOne Heme tests, for the full year 2015, a 36% increase compared to the total reported clinical tests in 2014.
Revenue from pharmaceutical partners was $14.1 million in the fourth
quarter, representing a 68% increase from the same period in 2014 and a
20% increase from the third quarter of 2015. For the full year, revenue
from pharmaceutical partners was
The company's cancer knowledgebase, FoundationCORE, grew to more than 68,000 clinical cases. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers.
Total operating expenses for the fourth quarter of 2015 were approximately $34.0 million compared with $25.1 million for the fourth quarter of 2014. For the full year, operating expenses were $143.5 million, compared to $86.9 million in 2014. Net loss was $19.0 million in the fourth quarter of 2015, or a $0.55 loss per share, and net loss for the full year was $89.6 million, or a $2.73 loss per share. At December 31, 2015, the company held approximately $232.3 million in cash, cash equivalents and marketable securities.
Initiated a prospective clinical study with
Horizon Healthcare Servicesand Clinical Outcomes Tracking Analysis (COTA) to measure changes in survival benefit and total cost savings achieved among patients with previously untreated metastatic non-small cell lung cancer who undergo comprehensive genomic profiling with FoundationOne.
- Announced a collaboration agreement with Mirati Therapeutics to develop a companion diagnostic test using the FoundationOne platform for Mirati's kinase inhibitor, glesatinib.
- Launched a circulating tumor DNA (ctDNA) assay to biopharmaceutical partners. The Company is on track to launch its ctDNA assay, FoundationACT™, to its clinical customers during the first quarter of 2016.
- Throughout the fourth quarter, the Company presented clinical data at seven medical conferences, including four podium presentations and 20 posters, to further support its commercial and reimbursement strategies.
The company expects 2016 revenue will be in the range of
$110to $120 million.
- The company expects to deliver between 37,000 and 40,000 FoundationOne and FoundationOne Heme clinical tests in 2016.
The company expects operating expenses will be in the range of
$175and $185 million.
- The company plans to expand its offering of molecular information products with the commercial launch of its ctDNA assay in the first quarter 2016.
- The company expects to expand upon reimbursement progress made in 2015 and drive additional coverage decisions.
Conference Call and Webcast Details
The company will conduct a conference call today, Tuesday, February 23rd at 4:30
p.m. Eastern Time to discuss its financial performance for the fourth
quarter and year ended
Cautionary Note Regarding Forward-Looking Statements for
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the benefits of our
products to clinicians, payers and biopharmaceutical companies in the
treatment of cancer; the number of tests to be conducted, the generation
of revenue, and the incurrence of operating expenses in 2016; the timing
of launching new products, including a ctDNA assay; and payer support
for comprehensive genomic profiling, including coverage decisions by
Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended||Year Ended|
|Costs and expenses:|
|Cost of revenue||11,195||8,022||39,431||27,434|
|Selling and marketing||12,400||8,244||49,030||28,997|
|General and administrative||8,804||8,976||50,614||27,302|
|Research and development||12,765||7,839||43,883||30,629|
|Total costs and expenses||45,164||33,081||182,958||114,362|
|Loss from operations||(19,113||)||(14,401||)||(89,755||)||(53,283||)|
|Other income (expense):|
|Interest income (expense), net||93||1||124||(42||)|
|Other income (expense), net||—||1,103||—||1,103|
|Total other income (expense), net||93||1,104||124||1,061|
|Net loss||$||(19,020||)||$ (13,297||)||$ (89,631||)||$||(52,222||)|
|Net loss per common share applicable to common stockholders, basic and diluted||$||(0.55||)||$ (0.47||)||$ (2.73||)||$||(1.87||)|
|Weighted-average common shares outstanding, basic and diluted||34,454,183||28,165,590||32,836,219||27,954,327|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||117,763||$||72,080|
|Accounts receivable, net||7,765||9,894|
|Prepaid expenses and other current assets||6,517||2,865|
|Total current assets||229,644||89,648|
|Property and equipment, net||41,333||21,015|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||12,822||7,414|
|Current portion of deferred rent||2,146||1,429|
|Total current liabilities||29,896||16,446|
|Other non-current liabilities||10,404||9,323|
|Total stockholders' equity||257,689||86,169|
|Total liabilities and stockholders' equity||$||297,989||$||111,938|
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