"The third quarter of 2014 was another productive quarter for bluebird
bio," said
Third Quarter 2014 and Recent Business Highlights:
--
Transplanted our first subject with sickle cell disease using our
LentiGlobin BB305 product candidate in the HGB-205 study
--
-- Two presentations accepted at the 56th Annual Meeting of
the
- Two subjects with beta-thalassemia major and enrolled in the HGB-205 study remain transfusion independent at days 180 and 90 post-transplant
- One subject in the Northstar Study observed monthly increases in beta-T87Q-globin levels following infusion out to month three
- We plan to provide clinical data on at least three subjects enrolled in the Northstar Study
--
Anticipated 2014 Milestones:
-- Present further clinical
results in beta-thalassemia major from our HGB-205 and Northstar Studies
at ASH
Financial Results:
bluebird bio held
Total revenue was
Total operating expenses for the three months ended
bluebird bio reported a net loss of
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, the
Starbeam 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 two phase 1/2 studies, one in the US (the
Northstar Study) and one in
bluebird bio also has an early-stage chimeric antigen receptor-modified
T cell (CAR-T) program for oncology in collaboration with
bluebird bio has operations in
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 Company’s financial condition and results of operations and the
advancement of, and anticipated milestones related to the Company’s
product candidates and clinical studies, and anticipated milestones for
2014. Any 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, 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
Availability of other information about bluebird bio
Investors
and others should note that we communicate with our investors and the
public using our company website (www.bluebirdbio.com),
our investor relations website (http://www.bluebirdbio.com/investor-splash.html),
including but not limited to investor presentations and FAQs,
bluebird bio, Inc. | ||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss Data | ||||||||||||
(unaudited) | ||||||||||||
(in thousands, except per share data) | ||||||||||||
Three months ended |
Nine months ended |
|||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||
Revenue: | ||||||||||||
Collaboration revenue | $ | 6,250 | $ | 6,251 | $ | 18,750 | $ | 13,542 | ||||
Research and license fees | 115 | 134 | 285 | 304 | ||||||||
Total revenue | 6,365 | 6,385 | 19,035 | 13,846 | ||||||||
Operating expenses: | ||||||||||||
Research and development | 16,649 | 8,706 | 42,043 | 21,237 | ||||||||
General and administrative | 6,648 | 3,836 | 17,924 | 9,441 | ||||||||
Change in fair value of contingent consideration | 78 | — | 78 | — | ||||||||
Total operating expenses | 23,375 | 12,542 | 60,045 | 30,678 | ||||||||
Loss from operations | (17,010 | ) | (6,157 | ) | (41,010 | ) | (16,832 | ) | ||||
Other income (expense), net | (20 | ) | 44 | 48 | (408 | ) | ||||||
Loss before income taxes | (17,030 | ) | (6,113 | ) | (40,962 | ) | (17,240 | ) | ||||
Benefit from income taxes | — | — | 11,797 | — | ||||||||
Net loss | $ | (17,030 | ) | $ | (6,113 | ) | $ | (29,165 | ) | $ | (17,240 | ) |
Net loss per share - basic and diluted: | $ | (0.61 | ) | $ | (0.26 | ) | $ | (1.14 | ) | $ | (1.96 | ) |
Weighted-average number of common shares used
in computing net loss per share - basic and diluted: |
28,115 | 23,623 | 25,593 | 8,786 | ||||||||
bluebird bio, Inc. | |||||||||
Condensed Consolidated Balance Sheets Data | |||||||||
(unaudited) | |||||||||
(in thousands, except par value amounts) | |||||||||
September 30, 2014 |
December 31, 2013 |
||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 89,603 | $ | 206,279 | |||||
Marketable securities | 125,771 | — | |||||||
Deferred tax assets | 3,106 | 693 | |||||||
Prepaid expenses and other current assets | 4,840 | 5,015 | |||||||
Total current assets | 223,320 | 211,987 | |||||||
Marketable securities | 48,446 | — | |||||||
Property and equipment, net | 14,978 | 10,920 | |||||||
Intangible assets, net | 29,159 | — | |||||||
Goodwill | 13,128 | — | |||||||
Restricted cash and other non-current assets | 1,162 | 1,483 | |||||||
Total assets | $ | 330,193 | $ | 224,390 | |||||
Liabilities and stockholders' equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 3,641 | $ | 4,359 | |||||
Accrued expenses and other current liabilities | 9,677 | 5,175 | |||||||
Deferred revenue, current portion | 25,206 | 25,340 | |||||||
Total current liabilities | 38,524 | 34,874 | |||||||
Deferred rent, net of current portion | 8,724 | 6,740 | |||||||
Deferred revenue, net of current portion | 11,458 | 30,208 | |||||||
Contingent consideration, net of current portion | 6,166 | — | |||||||
Deferred tax liabilities | 3,106 | 693 | |||||||
Other non-current liabilities | 323 | 208 | |||||||
Total liabilities | 68,301 | 72,723 | |||||||
Stockholders' equity: | |||||||||
Common stock, $0.01 par value, 125,000 shares authorized; 28,702
and 23,940 shares |
287 | 239 | |||||||
Additional paid-in capital | 389,519 | 250,103 | |||||||
Accumulated other comprehensive loss | (74 | ) | — | ||||||
Accumulated deficit | (127,840 | ) | (98,675 | ) | |||||
Total stockholders' equity | 261,892 | 151,667 | |||||||
Total liabilities and stockholders' equity | $ | 330,193 | $ | 224,390 | |||||
Source: bluebird bio, Inc.
Investor Relations:
Richard E. T. Smith, Ph.D., 339-499-9382
bluebird
bio, Inc.
or
Media Contact:
Dan Budwick,
973-271-6085
Pure Communications, Inc.