bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to
developing potentially transformative gene therapies for severe genetic
and orphan diseases, today reported financial results and operational
highlights for the quarter ended September 30, 2013.
Financial Results
Revenues were $6.4 million during the quarter ended September 30, 2013
compared to $0.1 million for the quarter ended September 30, 2012 and
include amounts allocated to research and development services from the
Celgene collaboration.
Net cash provided by operating activities during the nine months ended
September 30, 2013 was $48.9 million. bluebird bio held $216.8 million
in cash and cash equivalents as of September 30, 2013.
Total operating expenses for the quarter ended September 30, 2013 were
$12.5 million as compared to $5.1 million for the same period in 2012.
bluebird bio reported a net loss of $6.1 million, or $0.26 per share,
for the quarter ended September 30, 2013, as compared to net income
applicable to common stockholders of $0.6 million, or $1.14 per share,
for the quarter ended September 30, 2012.
Recent Business Highlights:
-- In October bluebird bio announced the first patient was transplanted
in the Starbeam (ALD-102) study for childhood cerebral
adrenoleukodystrophy
-- In October bluebird bio joined the Russell 2000 Index
"bluebird continues to make solid progress on multiple fronts," stated
Nick Leschly, chief bluebird. "In October, we announced that the first
patient had been transplanted in the Starbeam study for CCALD, an
important step in advancing bluebird’s lentiviral gene therapy platform.
We look forward to announcing the first patient treated in our
LentiGlobin studies for the treatment of beta-thalassemia in the months
ahead.”
Calendar Year 2013 Anticipated Milestones:
-- Announce the first patient transplanted with LentiGlobin for beta
thalassemia major
-- Attend the Deutsche Bank BioFest conference on December 2nd,
2013
About bluebird bio, Inc.
bluebird bio is a clinical-stage company committed to developing
potentially transformative gene therapies for severe genetic and orphan
diseases. bluebird bio has two clinical-stage programs in development.
The most advanced product candidate, Lenti-D, is in a recently-initiated
phase 2/3 study for the treatment of childhood cerebral
adrenoleukodystrophy (CCALD), a rare, hereditary neurological disorder
affecting young boys. The next most advanced product candidate,
LentiGlobin, is currently in a phase 1/2 study in France for the
treatment of beta-thalassemia major and severe sickle cell disease. A
second phase 1/2 study with LentiGlobin in the United States has been
initiated for the treatment of beta-thalassemia major.
bluebird bio also has an early-stage chimeric antigen receptor-modified
T cell (CAR-T) program for oncology in partnership with Celgene
Corporation.
bluebird bio has operations in Cambridge, Massachusetts and Paris,
France. For more information, please visit www.bluebirdbio.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995, including
statements regarding the advancement of the Company’s clinical studies
and the timing of data announcement. Any forward-looking
statements in this press release 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, but are not
limited to, the risk of cessation or delay of any of the ongoing or
planned clinical studies and/or our development of our product
candidates, the risk of a delay in the enrollment of patients in the
Company’s clinical studies, the risk that the results of previously
conducted studies involving similar product candidates will not be
repeated or observed in ongoing or future studies involving current
product candidates, the risk that our collaboration with Celgene will
not continue or will not be successful, and the risk that any one or
more of our product candidates will not be successfully developed and
commercialized. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause our actual results to
differ from those contained in the forward-looking statements, see the
section entitled "Risk Factors" in our quarterly report on Form 10-Q, as
well as discussions of potential risks, uncertainties, and other
important factors in our subsequent filings with the Securities and
Exchange Commission. All information in this press release is as
of the date of the release, and bluebird bio undertakes no duty to
update this information unless required by law.
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bluebird bio, Inc. Condensed Consolidated Statements
of Operations and Comprehensive Loss (unaudited) (in
thousands, except per share data)
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Three months ended
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Nine months ended
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September 30,
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September 30,
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2013
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2012
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2013
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2012
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Revenue:
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Collaboration revenue
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$
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6,251
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$
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-
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$
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13,542
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$
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-
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Research and license fees
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134
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85
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304
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255
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Total revenue
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6,385
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85
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13,846
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255
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Operating expenses:
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Research and development
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8,706
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3,501
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21,237
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10,713
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General and administrative
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3,836
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1,608
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9,441
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4,302
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Total operating expenses
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12,542
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5,109
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30,678
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15,015
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Loss from operations
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(6,157
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(5,024
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(16,832
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(14,760
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)
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Other income (expense), net:
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Interest income
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11
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1
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21
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3
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Foreign currency gains
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33
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4
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11
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18
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Re-measurement of warrants
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-
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(22
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(440
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67
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Other income (expense), net
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44
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(17
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(408
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88
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Net loss
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$
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(6,113
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$
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(5,041
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$
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(17,240
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$
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(14,672
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Net (loss) income applicable to common stockholders - basic
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$
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(6,113
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$
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315
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$
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(17,240
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)
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$
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111
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Net (loss) income applicable to common stockholders - diluted
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$
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(6,113
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$
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632
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$
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(17,240
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)
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$
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243
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Net (loss) income per share applicable to common
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stockholders:
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Basic
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$
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(0.26
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)
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$
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1.15
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$
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(1.96
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$
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0.44
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Diluted
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$
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(0.26
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$
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1.14
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$
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(1.96
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$
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0.44
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Weighted-average number of common shares used
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in computing net (loss) income per share applicable to
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common stockholders:
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Basic
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23,623
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275
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8,786
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250
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Diluted
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23,623
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554
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8,786
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551
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bluebird bio, Inc. Condensed Consolidated Balance
Sheets (unaudited) (in thousands, except per
share data)
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September 30,
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December 31,
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2013
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2012
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Assets
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Current assets:
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Cash and cash equivalents
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$
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216,791
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$
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67,011
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Prepaid expenses and other current assets
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4,676
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773
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Total current assets
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221,467
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67,784
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Property and equipment, net
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5,392
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1,288
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Restricted cash
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1,403
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250
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Total assets
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$
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228,262
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$
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69,322
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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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$
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1,144
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$
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2,173
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Accrued expenses and other current liabilities
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5,006
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2,115
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Deferred revenue, current portion
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25,340
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340
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Total current liabilities
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31,490
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4,628
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Warrant liability
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-
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215
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Deferred rent, net of current portion
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2,529
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46
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Deferred revenue, net of current portion
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36,543
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340
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Total liabilities
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70,562
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5,229
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Convertible preferred stock
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-
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119,840
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Total stockholders' equity (deficit)
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157,700
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(55,747
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)
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Total liabilities, convertible preferred stock and stockholders'
equity (deficit)
|
|
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$
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228,262
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$
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69,322
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Copyright Business Wire 2013