Veracyte, Inc. Announces Fourth Quarter and Full-Year 2013 Financial Results, Provides 2014 Financial Outlook
"We experienced strong revenue gains in 2013, driven by growing physician adoption of our Afirma Thyroid FNA Analysis, combined with increased payer coverage and reimbursement for our Afirma Gene Expression Classifier (GEC). We saw increases in fine needle aspiration (FNA) sample volumes and cash collections during the fourth quarter, which is traditionally our strongest quarter," said
Recent Business Highlights
- Announced a positive medical coverage policy from Cigna for the Afirma GEC in December, followed by
EmblemHealth in February, bringing the total number of covered lives for the Afirma GEC to over 120 million. - Obtained required registrations and, in
Europe , a CE mark for the Afirma GEC collection kit to enable introduction of the Afirma GEC in select countries, upon positive reimbursement decisions. - Expanded our internal sales force by more than 50%.
- Initiated the pilot launch of our Afirma Malignancy Classifiers at approximately a dozen clinical sites.
- Received our second patent on the Afirma GEC.
Additional Fourth Quarter and Full-Year 2013 Financial Results
- Cash and cash equivalents as of
December 31, 2013 , totaled$71.2 million , which includes proceeds from the company's initial public offering. - The company received 14,059 thyroid nodule FNA samples during the fourth quarter of 2013, compared to 9,303 FNA samples during the same period in 2012, an increase of 51%.
- Total FNAs received in 2013 were 49,670, compared to 25,890 total FNAs received in 2012, a year-over-year increase of 92%. Afirma GEC tests continued to be performed at a rate of approximately 20% of FNA samples received.
- Operating expenses for the fourth quarter of 2013 were
$12.6 million , compared with operating expenses of$9.6 million for the comparable period in 2012. Cost of revenue was$3.5 million for the fourth quarter of 2013, compared with$2.6 million for the comparable period in 2012. - Operating expenses for full-year 2013 were
$45.1 million , compared with operating expenses of$30.6 million in 2012. Cost of revenue was$12.6 million for full-year 2013, compared with$7.6 million for full-year 2012. - Net loss for the fourth quarter of 2013 was
$5.9 million , or$0.42 per common share, compared with a net loss of$4.8 million , or$7.27 per common share, for the same period in 2012. - Net loss for full-year 2013 was
$25.6 million , or$6.15 per common share, compared with a net loss of$18.6 million , or$28.68 per common share, for 2012.
2014 Financial Outlook
- FNA volumes of 76,000 to 83,000
- Revenue of
$38 million to$43 million
Conference Call Details
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to future revenue levels and FNA volumes; the company's expectations regarding accelerating growth and the drivers of growth; the company's expectations regarding the timing of the planned launch of the Afirma Malignancy Classifiers; the company's belief that it is on track in advancing product development efforts in its next clinical indication in pulmonology; and the company's intent to expand its molecular cytology business into other clinical areas. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited
operating history and history of losses; our ability to increase usage of and reimbursement for Afirma, and any future products we may develop; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our test; laws and regulations applicable to our business, including potential regulation by the
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Statements of Operations and Comprehensive Loss | ||||||||||||
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(In thousands, except share and per share amounts) | ||||||||||||
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Three Months Ended |
Year Ended | |||||||||||
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December 31, |
December 31, |
December 31, |
December 31, | |||||||||
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(Unaudited) |
(Unaudited) |
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Revenue |
$ |
6,838 |
$ |
4,457 |
$ |
21,884 |
$ |
11,628 | ||||
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Operating expenses: |
||||||||||||
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Cost of revenue |
3,471 |
2,600 |
12,607 |
7,584 | ||||||||
|
Research and development |
1,870 |
1,721 |
7,810 |
6,608 | ||||||||
|
Selling and marketing |
3,931 |
3,055 |
12,540 |
8,447 | ||||||||
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General and administrative |
3,328 |
2,197 |
12,100 |
7,918 | ||||||||
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Total operating expenses |
12,600 |
9,573 |
45,057 |
30,557 | ||||||||
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Loss from operations |
(5,762) |
(5,116) |
(23,173) |
(18,929) | ||||||||
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Interest income |
5 |
1 |
5 |
2 | ||||||||
|
Interest expense |
(102) |
— |
(233) |
— | ||||||||
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Other income (expense), net |
(33) |
278 |
(2,179) |
278 | ||||||||
|
Net loss and comprehensive loss |
$ |
(5,892) |
$ |
(4,837) |
$ |
(25,580) |
$ |
(18,649) | ||||
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Net loss per common share, basic and diluted |
$ |
(0.42) |
$ |
(7.27) |
$ |
(6.15) |
$ |
(28.68) | ||||
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Shares used to compute net loss per common share, basic and diluted |
13,944,239 |
665,306 |
4,158,664 |
650,333 | ||||||||
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Condensed Balance Sheets | ||
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(In thousands, except share and per share amounts) | ||
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As of December 31, | ||
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2013 |
2012 | |
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(Unaudited) |
(1) | |
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Assets |
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Current assets: |
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Cash and cash equivalents |
|
|
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Accounts receivable |
1,143 |
569 |
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Supplies inventory |
2,567 |
1,050 |
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Prepaid expenses and other current assets |
1,477 |
710 |
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Restricted cash |
- |
50 |
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Total current assets |
76,407 |
16,381 |
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Property and equipment, net |
2,952 |
2,446 |
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Restricted cash |
118 |
118 |
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Other assets |
153 |
122 |
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Total assets |
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Liabilities, Convertible Preferred Stock, and Stockholders' Equity (Deficit) |
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Current liabilities: |
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Accounts payable |
|
|
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Accrued liabilities |
7,594 |
4,020 |
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Deferred Genzyme co‑promotion fee |
2,500 |
2,500 |
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Preferred stock liability |
- |
583 |
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Total current liabilities |
15,388 |
8,991 |
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Long-term debt, net of current portion |
4,899 |
- |
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Deferred rent, net of current portion |
286 |
61 |
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Deferred Genzyme co‑promotion fee, net of current portion |
2,614 |
5,114 |
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Total liabilities |
23,187 |
14,166 |
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Convertible preferred stock |
- |
63,372 |
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Total stockholders' equity (deficit) |
56,443 |
(58,471) |
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Total liabilities, convertible preferred stock, and stockholders' equity (deficit) |
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(1) |
The condensed balance sheet at |
Media:
650-380-4413
Tracy.Morris@Veracyte.com
Investors:
212-213-0006
akolhatkar@burnsmc.com
SOURCE
News Provided by Acquire Media