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 June 30, 2013.
Financial Results
Revenues were $6.3 million during the quarter ended June 30, 2013
compared to $0.1 million for the quarter ended June 30, 2012 and include
amounts allocated to research and development services from the Celgene
collaboration.
Net cash provided by operating activities during the six months ended
June 30, 2013 was $57.8 million. bluebird bio held $228.8 million in
cash and cash equivalents as of June 30, 2013.
Total operating expenses for the quarter ended June 30, 2013 were $10.5
million as compared to $4.7 million for the same period in 2012.
bluebird bio reported a net loss of $4.6 million, or $2.13 per share,
for the quarter ended June 30, 2013, as compared to a net loss of $4.6
million, or $23.21 per share, for the quarter ended June 30, 2012.
Recent Operational Highlights:
-
Completed an initial public offering raising approximately $104.9
million, net of underwriting discounts and commissions and estimated
offering expenses
-
Initiated the HGB-205 study with LentiGlobin for the treatment of beta
thalassemia major and severe sickle cell disease patients
-
Strengthened our Board of Directors with two additions, Wendy Dixon,
Ph.D. and David Schenkein, M.D.
-
Signed a multi-year collaboration with Celgene Corporation focused on
the development of modified chimeric antigen receptor (CAR) T cells
for the treatment of cancer
"bluebird has made substantial progress during the first half of 2013
both operationally and in the clinic," stated Nick Leschly, Chief
bluebird. "In June, we completed our initial public offering,
strengthening our balance sheet and attracting a number of new
shareholders. We are now focused on initiating two additional clinical
trials in the second half of 2013, including our phase 2/3 CCALD study
with Lenti-D."
Calendar Year 2013 Anticipated Milestones:
-
Initiate the HGB-204 study with LentiGlobin for the treatment of beta
thalassemia major in mid-2013
-
Initiate the ALD-102 study with Lenti-D for the treatment of childhood
cerebral adrenoleukodystrophy (CCALD) in late 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 expected to enter a
phase 2/3 study in late 2013 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 is expected to initiate in the
United States in mid-2013 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,
San Francisco, California 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 our clinical trials. 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 trials and/or our development of our
product candidates, 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.
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Condensed Consolidated Statements of Operations
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(unaudited)
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(in thousands, except per share data)
|
|
|
|
|
|
|
Three months ended
|
|
Six months ended
|
|
|
|
|
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June 30,
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June 30,
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|
|
|
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
|
|
|
$
|
6,249
|
|
|
$
|
-
|
|
|
$
|
7,291
|
|
|
$
|
-
|
|
Research and license fees
|
|
|
|
|
|
85
|
|
|
|
85
|
|
|
|
170
|
|
|
|
170
|
|
Total revenue
|
|
|
|
|
|
6,334
|
|
|
|
85
|
|
|
|
7,461
|
|
|
|
170
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
7,247
|
|
|
|
3,354
|
|
|
|
12,531
|
|
|
|
7,212
|
|
General and administrative
|
|
|
|
|
|
3,281
|
|
|
|
1,331
|
|
|
|
5,605
|
|
|
|
2,694
|
|
Total operating expenses
|
|
|
|
|
|
10,528
|
|
|
|
4,685
|
|
|
|
18,136
|
|
|
|
9,906
|
|
Loss from operations
|
|
|
|
|
|
(4,194
|
)
|
|
|
(4,600
|
)
|
|
|
(10,675
|
)
|
|
|
(9,736
|
)
|
Other (expense) income, net:
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
|
7
|
|
|
|
1
|
|
|
|
10
|
|
|
|
2
|
|
Foreign currency gains (losses)
|
|
|
|
|
|
3
|
|
|
|
6
|
|
|
|
(22
|
)
|
|
|
14
|
|
Re-measurement of warrants
|
|
|
|
|
|
(399
|
)
|
|
|
30
|
|
|
|
(440
|
)
|
|
|
89
|
|
Other (expense) income, net
|
|
|
|
|
|
(389
|
)
|
|
|
37
|
|
|
|
(452
|
)
|
|
|
105
|
|
Net loss
|
|
|
|
|
$
|
(4,583
|
)
|
|
$
|
(4,563
|
)
|
|
$
|
(11,127
|
)
|
|
$
|
(9,631
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of net loss to net loss applicable to common
stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
$
|
(4,583
|
)
|
|
$
|
(4,563
|
)
|
|
$
|
(11,127
|
)
|
|
$
|
(9,631
|
)
|
Accretion and dividends on convertible preferred stock
|
|
|
|
|
|
-
|
|
|
|
(1,285
|
)
|
|
|
-
|
|
|
|
(2,570
|
)
|
Net loss applicable to common stockholders
|
|
|
|
|
$
|
(4,583
|
)
|
|
$
|
(5,848
|
)
|
|
$
|
(11,127
|
)
|
|
$
|
(12,201
|
)
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss per share applicable to common stockholders--basic and
diluted
|
|
|
|
|
$
|
(2.13
|
)
|
|
$
|
(23.21
|
)
|
|
$
|
(8.94
|
)
|
|
$
|
(51.48
|
)
|
Weighted-average number of common shares used in net loss per
share applicable to common stockholders--basic and diluted
|
|
|
|
|
|
2,151
|
|
|
|
252
|
|
|
|
1,244
|
|
|
|
237
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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bluebird bio, Inc.
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Condensed Consolidated Balance Sheets
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(unaudited)
|
(in thousands)
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
|
|
2013
|
|
2012
|
Assets
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
$
|
228,847
|
|
$
|
67,011
|
|
Prepaid expenses and other current assets
|
|
|
|
|
|
1,679
|
|
|
773
|
|
Total current assets
|
|
|
|
|
|
230,526
|
|
|
67,784
|
|
Property and equipment, net
|
|
|
|
|
|
2,515
|
|
|
1,288
|
|
Restricted cash
|
|
|
|
|
|
1,503
|
|
|
250
|
|
Total assets
|
|
|
|
|
$
|
234,544
|
|
$
|
69,322
|
|
|
|
|
|
|
|
|
|
Liabilities, convertible preferred stock, and stockholders'
equity (deficit)
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
|
$
|
1,609
|
|
$
|
2,173
|
|
Accrued expenses and other current liabilities
|
|
|
|
|
|
3,409
|
|
|
2,115
|
|
Deferred revenue, current portion
|
|
|
|
|
|
25,340
|
|
|
340
|
|
Total current liabilities
|
|
|
|
|
|
30,358
|
|
|
4,628
|
|
Warrant liability
|
|
|
|
|
|
-
|
|
|
215
|
|
Deferred rent, net of current portion
|
|
|
|
|
|
38
|
|
|
46
|
|
Deferred revenue, net of current portion
|
|
|
|
|
|
42,878
|
|
|
340
|
|
Total liabilities
|
|
|
|
|
|
73,274
|
|
|
5,229
|
|
Convertible preferred stock
|
|
|
|
|
|
-
|
|
|
119,840
|
|
Stockholders' equity (deficit)
|
|
|
|
|
|
161,270
|
|
|
(55,747
|
)
|
Total liabilities, convertible preferred stock and stockholders'
equity (deficit)
|
|
|
|
|
$
|
234,544
|
|
$
|
69,322
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Copyright Business Wire 2013