Foundation Medicine Announces 2014 First Quarter Results and Recent Highlights
Company Drives 25% Growth in Clinical Tests Reported Compared to 2013 Fourth Quarter
The company's clinical assays, FoundationOne® for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, provide a fully informative genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies and clinical trials.
"The first quarter was a strong start to 2014 for
Total operating expenses for the first quarter of 2014 were
Net loss was
Recent Enterprise Highlights
-
At the 2014 American Society of Clinical Oncology (ASCO) Annual
Meeting in June,
Foundation Medicine expects to present 18 abstracts, which the company authored or co-authored. -
In April, the company announced the expansion of its ongoing
collaboration with Clovis Oncology to include development of a novel
companion diagnostic test to identify ovarian cancer patients most
likely to respond to rucaparib, an investigational therapy under
development by Clovis, and to submit an application to the
FDA for Premarket Approval (PMA) of the test. -
In April, new clinical data highlighting FoundationOne and
FoundationOne Heme were presented by
Foundation Medicine and its collaborators at theAmerican Association of Cancer Research (AACR) Annual Meeting 2014. - In February, data were published in The Oncologist suggesting that FoundationOne may be used to inform targeted treatment options for patients with intrahepatic cholangiocarcinoma (ICC) - a form of primary liver cancer that is increasing in incidence, typically associated with poor prognosis and often approached with systemic chemotherapy used in other gastrointestinal cancers.
- In January, the company extended and expanded its ongoing collaboration with Novartis to provide molecular information and comprehensive genomic profiling analysis in support of many of Novartis' clinical oncology programs.
-
In January, the discovery of a high incidence of ERBB2 (HER2)
extracellular domain alterations in patients with micropapillary
urothelial carcinoma (MPUC) using FoundationOne was published in
Clinical Cancer Research , suggesting that anti-ERBB2 targeted therapies may be potential treatment options for patients with this aggressive form of bladder cancer.
2014 Outlook
The company confirmed its guidance for 2014, including:
- Reported clinical tests in the range of 22,000 and 25,000;
-
Revenue in the range of
$52 to$58 million ; - The introduction of an updated version of FoundationOne with an expanded set of genes for solid tumors in the first half of 2014; and
- The introduction of new features for the Interactive Cancer Explorer™ physician portal, including outcomes collection capabilities, in the second half of 2014.
Conference Call and Webcast Details
The company will conduct a conference call today,
About
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 adoption of
FoundationOne and FoundationOne Heme, potential targeted therapy
treatment options for patients with identified alterations, the number
of reported tests to be conducted and the generation of revenue in 2014,
and the introduction of new versions and features to FoundationOne and
the Interactive Cancer Explorer. 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 that Foundation Medicine's test or
revenue projections may turn out to be inaccurate because of the
preliminary nature of the forecasts; that the launch of an updated
version of FoundationOne or the introduction of new features to the
Interactive Cancer Explorer are delayed, discontinued or substantially
changed; that FoundationOne Heme and any subsequent products may never
achieve sustained and significant commercial adoption; the company's
expectations and beliefs regarding the future conduct and growth of
Foundation Medicine's business and the markets in which we operate;
delays or denials in obtaining coverage and reimbursement decisions for
FoundationOne, FoundationOne Heme and subsequent products; the
inability of
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Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (unaudited) |
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| Three Months Ended | ||||||
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| 2014 | 2013 | |||||
| Revenue |
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| Costs and expenses: | ||||||
| Cost of revenue | 5,291 | 2,378 | ||||
| Selling and marketing | 5,690 | 1,811 | ||||
| General and administrative | 5,700 | 3,150 | ||||
| Research and development | 6,915 | 4,982 | ||||
| Total costs and expenses | 23,596 | 12,321 | ||||
| Loss from operations | (12,141 | ) | (7,121 | ) | ||
| Other income (expense): | ||||||
| Interest expense, net | (25 | ) | (76 | ) | ||
| Other expense, net | — | (6 | ) | |||
| Total other expense, net | (25 | ) | (82 | ) | ||
| Net loss | $ (12,166 | ) | $ (7,203 | ) | ||
| Accretion of redeemable convertible preferred stock | — | (50 | ) | |||
| Net loss applicable to common stockholders | $ (12,166 | ) | $ (7,253 | ) | ||
|
Net loss per common share applicable to common stockholders, basic and diluted |
$ (0.44 | ) | $ (2.56 | ) | ||
|
Weighted-average common shares outstanding, basic and diluted |
27,733,717 | 2,834,832 | ||||
| Comprehensive loss | $ (12,166 | ) | $ (7,253 | ) | ||
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Consolidated Condensed Balance Sheets (In thousands) (unaudited) |
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| 2014 | 2013 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 110,308 | $ | 124,293 | |||
| Accounts receivable | 7,960 | 6,262 | |||||
| Inventory | 2,973 | 1,763 | |||||
| Prepaid expenses and other current assets | 1,256 | 992 | |||||
| Total current assets | 122,497 | 133,310 | |||||
| Property and equipment, net | 22,277 | 22,104 | |||||
| Restricted cash | 1,725 | 1,725 | |||||
| Other assets | 121 | 129 | |||||
| Total assets | $ | 146,620 | $ | 157,268 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 5,245 | $ | 7,007 | |||
| Accrued expenses and other current liabilities | 7,506 | 5,168 | |||||
| Deferred revenue | 807 | 918 | |||||
| Current portion of deferred rent | 1,167 | 1,167 | |||||
| Current portion of notes payable | 1,058 | 1,499 | |||||
| Total current liabilities | 15,783 | 15,759 | |||||
| Other non-current liabilities | 10,502 | 9,798 | |||||
| Total stockholders' equity | 120,335 | 131,711 | |||||
| Total liabilities and stockholders' equity | $ | 146,620 | $ | 157,268 | |||
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