BioTime, Inc. (NYSE MKT: BTX) today reported financial results
for the quarter and year ended December 31, 2014, and highlighted
its fourth quarter and recent corporate accomplishments.
“In 2014, BioTime and its subsidiaries built strong momentum in
advancing the development of therapeutic and diagnostic products
that address unmet medical needs with large market potential,” said
Dr. Michael D. West, CEO of BioTime. “Over the next 12 months, we
will be focused on advancing many of these programs in the clinic
and we expect to achieve additional business milestones as well.
BioTime and its subsidiaries are looking forward to announcing
results from early cohorts of OpRegen® for dry age-related macular
degeneration and AST-OPC1 for complete cervical spinal cord injury,
completing enrollment of the Renevia™ pivotal clinical trial and
the commercialization of one or more of the PanC-Dx™ cancer
screening diagnostics. To help us capitalize on these near-term
opportunities, we have broadened our capabilities by building a
management team and Board of Directors with relevant experience and
expertise in the clinical development and commercialization of
biopharmaceutical products. On the financial front, we have a solid
balance sheet and believe that BioTime and its subsidiaries have
sufficient financial resources to fund their operations at least
through 2015.”
Fourth Quarter and Recent Highlights
BioTime, Inc.
- In November 2014, BioTime received
authorization to begin its Renevia™ pivotal clinical trial in HIV-
associated lipoatrophy, a disorder that occurs in almost half of
the approximately three million people on antiretroviral therapy in
the U.S. and Europe. In the trial, Renevia™ is being tested as a
delivery matrix for the patient’s own fat-derived cells and
injected into portions of the patient’s face where there is
lipoatrophy in order to promote facial tissue reconstruction. The
first patient was treated in this trial in February 2015.
- In December 2014, BioTime strengthened
its Board of Directors with the appointment of Angus C. Russell,
former Chief Executive Officer of Shire plc, which is a leading
global specialty biopharmaceutical company. The appointment of Mr.
Russell followed the recent appointments to the board of Steve
Cartt and Mike Mulroy, who were among the top executives of
Questcor Pharmaceuticals.
- In December 2014, BioTime appointed Adi
Mohanty as Chief Operating Officer, bringing proven leadership in
biopharmaceutical product development and commercialization to the
company. Mr. Mohanty is a former executive of Shire with
significant experience in biopharmaceutical product development,
manufacturing, and commercialization and a background in
regenerative medicine.
Asterias Biotherapeutics, Inc.
- In February 2015, Asterias raised $5.5
million through the sale of shares of its Series A common
stock.
- In March 2015, Asterias Biotherapeutics
(NYSE MKT: AST) initiated patient enrollment for its Phase 1/2a
clinical trial of its product, AST-OPC1 (oligodendrocyte progenitor
cells), in complete cervical spinal cord injury.
Cell Cure Neurosciences Ltd.
- In October 2014, the U.S. Food and Drug
Administration (FDA) cleared Cell Cure's Investigational New Drug
(IND) application to initiate the Phase 1/2a clinical trial of
OpRegen® in patients with the severe form of age-related macular
degeneration with geographic atrophy. In February 2015, the
OpRegen® Phase 1/2a clinical trial opened at Hadassah University
Medical Center in Jerusalem, Israel. Patient enrollment is expected
to begin shortly. OpRegen® consists of high purity retinal pigment
epithelial cells derived from human embryonic stem cells using a
proprietary directed differentiation method.
LifeMap Solutions, Inc.
- In March 2015, the Icahn School of
Medicine at Mount Sinai (“Mount Sinai”) launched a large-scale
medical research study of asthma that uses the new ResearchKit
software framework developed by Apple to enable individuals who
suffer from asthma to participate in the study right from their
iPhone using an Asthma Health app developed by Mount Sinai in
conjunction with LifeMap Solutions. The Asthma Health App is
designed to facilitate asthma patient education and
self-monitoring, promote positive behavioral changes, and reinforce
adherence to treatment plans according to current asthma
guidelines. The study tracks symptom patterns in an individual and
potential triggers for these exacerbations so that researchers can
learn new ways to personalize asthma treatment. The Asthma Health
app was highlighted by Apple during its senior management public
presentation of new products on March 9, 2015 and is displayed on
Apple’s website and is available as a free download on the Apple
App Store.
OncoCyte Corporation
- OncoCyte completed enrollment in the
initial clinical study of its urine-based PanC-Dx™ diagnostic
product for bladder cancer. The goal of this clinical study was to
assess the performance of OncoCyte’s proprietary diagnostic
technology in detecting the most common type of bladder cancer,
urothelial carcinoma (previously designated transitional cell
carcinoma).
- Two abstracts, summarizing clinical
studies of OncoCyte’s PanC-Dx™ diagnostic products for bladder and
breast cancer, were accepted for poster presentation at the
American Association for Cancer Research (AACR) Annual Meeting
being held April 18-22, 2015.
- OncoCyte appointed William Annett to
its Board of Directors, bringing extensive experience within the
biotechnology and diagnostics industry to the board. Mr. Annett is
a former senior executive of Genentech and Accenture, has been CEO
of six organizations, has been a successful entrepreneur, and has
substantial diagnostics experience.
Fourth Quarter Financial Results
Total revenue, on a consolidated basis, for the fourth quarter
of 2014 was $1.9 million, approximately the same as last year's
fourth quarter total revenue. Operating expenses, on a consolidated
basis, for the fourth quarter of 2014 were $16.1 million, compared
to 2013 operating expenses of $13.5 million net of certain in
process research and development expenses (IPR&D) charged in
the fourth quarter of 2013 in connection with Asterias’ acquisition
of intangible assets from Geron Corporation. Research and
development (R&D) expenses for the fourth quarter of 2014 were
$11.3 million, compared to $9.2 million in the same quarter of the
prior year. The increase in R&D expenses is largely
attributable to an additional $1.9 million in amortization of
intangible assets, the ramp-up of the Asterias and LifeMap
Solutions product development programs, and expenses of the
OncoCyte and Renevia™ clinical trial programs. General and
administrative (G&A) expenses for the fourth quarter of 2014
were $4.8 million, compared to $4.3 million in the third quarter of
2013.
Net loss attributable to BioTime for the three months ended
December 31, 2014 was $10.6 million. For the fourth quarter of
2013, net loss was $19.6 million, including $17.5 million of
IPR&D expense. On a per share basis, net loss for the fourth
quarter of 2014 narrowed to $0.14 per share, compared to $0.35 per
share for the fourth quarter of 2013. The decrease in net loss is
primarily attributed to the $17.5 million of IPR&D expense
incurred during 2013. Net losses for the fourth quarter of 2013 and
2014 reflect net income tax benefits of $2.2 and $3.3 million,
respectively. Net loss attributable to BioTime includes losses from
BioTime majority owned subsidiaries based upon BioTime’s percentage
ownership of those subsidiaries.
Full Year Financial Results
Total consolidated revenue for the full year of 2014 increased
to $5.2 million, up $0.8 million or 18%, from the year ago period.
The increase in revenue is primarily attributable to an increase in
grant revenue, partially offset by a decrease in license fees.
Operating expenses, on a consolidated basis, for the full year of
2014 were $55.1 million, compared to $42.2 million for the full
year of 2013 excluding $17.5 million of IPR&D incurred in the
fourth quarter of 2013 as described above. R&D expenses for the
full year of 2014 were $37.5 million, compared to $26.6 million for
the full year of 2013. The increase in R&D expenses is
generally attributable to the amortization of intangible assets
acquired by Asterias from Geron Corporation and BioTime in October
2013, and the other factors that contributed to the increase during
the fourth quarter. In addition, OncoCyte’s clinical trial work to
develop its PanC-Dx™ cancer diagnostics and BioTime’s continued
clinical development of Renevia™ also contributed to the increase
in R&D expense. G&A expenses for the full year of 2014 were
$17.6 million, compared to $15.6 million for the full year of
2013.
Net loss attributable to BioTime for the full year of 2014
narrowed to $36.4 million. For the full year 2013, net loss was
$43.9 million, including $17.5 million of IPR&D expense. Net
loss for 2014 and 2013 reflect deferred income tax benefits of $7.4
million and $3.3 million, respectively. On a per share basis, net
loss for the full year ended December 31, 2014 narrowed to $0.55
per share, compared to $0.81 per share for the full year of 2013.
The decrease in net loss is primarily attributable to the $17.5
million of IPR&D expense incurred during 2013. Net loss
attributable to BioTime includes losses from BioTime’s majority
owned subsidiaries based upon BioTime’s percentage ownership of
those subsidiaries.
Cash and cash equivalents, on a consolidated basis, totaled
$29.5 million as of December 31, 2014, compared to $5.5 million as
of December 31, 2013. The cash on hand at December 31, 2014
includes $4.4 million held by Asterias and other subsidiaries. In
January 2015, Asterias received their second payment in the amount
of $2.3 million from the California Institute for Regenerative
Medicine (CIRM) under a grant award for Asterias’ AST-OPC1
development program, and during February 2015 Asterias raised an
additional $5.5 million through the sale of shares of its Series A
common stock. Cash and cash equivalents, on a consolidated basis
excluding Asterias was $26.4 million as of December 31, 2014. Cash
used in operations excluding Asterias was $27.3 million for full
year 2014.
About BioTime
BioTime, Inc., a pioneer in regenerative medicine, is a
clinical-stage biotechnology company. BioTime and its subsidiaries
are leveraging their industry-leading experience in pluripotent
stem cell technology and a broad intellectual property portfolio to
facilitate the development and use of cell-based therapies and gene
marker-based molecular diagnostics for major diseases and
degenerative conditions for which there presently are no cures. The
lead clinical programs of BioTime and its subsidiaries include:
OpRegen®, currently in a Phase I/IIa trial for the treatment of the
dry form of age-related macular degeneration; AST-OPC1, currently
in a Phase I/IIa trial for spinal cord injuries; Renevia™,
currently in a pivotal trial in Europe as an injectable matrix for
the engraftment of transplanted cells to treat HIV-related
lipoatrophy; and PanC-Dx™ cancer diagnostics, which are completing
initial clinical studies for bladder, breast, and lung cancer.
AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage.
BioTime’s subsidiaries include: publicly-traded Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem
cell-based therapies in neurology and oncology, including AST-OPC1
and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem
cell-based therapies for retinal and neurological disorders,
including OpRegen®; OncoCyte Corporation, developing PanC-Dx™
cancer diagnostics; LifeMap Sciences, Inc., developing and
marketing an integrated on-line database resource for biomedical
and stem cell research; LifeMap Solutions, Inc., a subsidiary of
LifeMap Sciences, developing mobile health (mHealth) products; ES
Cell International Pte Ltd, which has developed cGMP compliant
human embryonic stem cell lines that are being marketed by BioTime
for research purposes under the ESI BIO branding program; OrthoCyte
Corporation, developing therapies to treat orthopedic disorders,
diseases and injuries; and ReCyte Therapeutics, Inc., developing
therapies to treat a variety of cardiovascular and related ischemic
disorders.
BioTime common stock is traded on the NYSE MKT under the symbol
BTX. For more information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube,
and Google+.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for BioTime and its
subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements. Any statements
that are not historical fact (including, but not limited to
statements that contain words such as “will,” “believes,” “plans,”
“anticipates,” “expects,” “estimates”) should also be considered to
be forward-looking statements. Forward-looking statements involve
risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products, uncertainty in the results of clinical trials or
regulatory approvals, need and ability to obtain future capital,
and maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the business of BioTime and
its subsidiaries, particularly those mentioned in the cautionary
statements found in BioTime's Securities and Exchange Commission
filings. BioTime disclaims any intent or obligation to update these
forward-looking statements.
To receive ongoing BioTime corporate communications, please
click on the following link to join our email alert list:
http://news.biotimeinc.com.
BIOTIME, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE
SHEETS December 31,
December 31, 2014 2013 ASSETS
CURRENT ASSETS Cash and cash equivalents $ 29,486,909 $ 5,495,478
Trade accounts and grants receivable, net 1,041,856 1,115,209
Inventory 266,022 178,694 Landlord receivable 377,981 - Prepaid
expenses and other current assets 1,231,789 1,160,589
Total current assets 32,404,557 7,949,970 Equipment, net
2,857,846 2,997,733 Deferred license and consulting fees 336,833
444,833 Deposits 443,289 129,129 Other long term assets 9,985 -
Intangible assets, net 38,848,396 46,208,085 TOTAL
ASSETS $ 74,900,906 $ 57,729,750
LIABILITIES AND
SHAREHOLDERS' EQUITY CURRENT LIABILITIES Accounts payable and
accrued liabilities $ 6,803,173 $ 6,722,624 Capital lease
liability, current portion 57,500 - Related party convertible debt,
net of discount 60,237 - Deferred license and subscription revenue,
current portion 208,357 235,276 Total current
liabilities 7,129,267 6,957,900 LONG-TERM
LIABILITIES Deferred tax liabilities, net 4,514,362 8,277,548
Deferred rent liabilities, net of current portion 97,280 35,997
Lease liability 377,981 - Capital lease, net of current portion
31,290 - Other long term liabilities 27,961 195,984
Total long-term liabilities 5,048,874 8,509,529
Commitments and contingencies SHAREHOLDERS' EQUITY
Preferred shares, no par value, authorized 2,000,000 shares as of
December 31, 2014 and 2013; 70,000 and none issued and outstanding
as of December 31, 2014 and 2013, respectively 3,500,000 - Common
shares, no par value, authorized 125,000,000 shares as of December
31, 2014 and 2013; 83,121,698 issued and 78,227,756 outstanding as
of December 31, 2014 and 67,412,139 issued and 56,714,424
outstanding as of December 31, 2013 234,842,998 203,456,401
Contributed capital 7,145 93,972 Accumulated other comprehensive
income 185,835 62,899 Accumulated deficit (182,190,207)
(145,778,547) Treasury stock at cost: 4,893,942 and
10,697,715 shares at December 31, 2014 and 2013, respectively
(19,889,788) (43,033,957) BioTime, Inc. shareholders'
equity 36,455,983 14,800,768 Non-controlling interest
26,266,782 27,461,553 Total shareholders' equity
62,722,765 42,262,321 TOTAL LIABILITIES AND SHAREHOLDERS'
EQUITY $ 74,900,906 $ 57,729,750
BIOTIME, INC. AND
SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
Three Months Ended December 31
(unaudited) Years Ended December 31, 2014 2013 2014 2013
REVENUES: License fees $ 292,120 $ 1,123,331 $ 1,172,860 $
2,218,174 Royalties from product sales 75,945 75,270 397,751
366,775 Grant income 1,443,331 632,103 3,296,832 1,573,329
Sale of research products and services
76,139 61,781 375,761
276,058 Total revenues 1,887,535 1,892,485 5,243,204
4,434,336 Cost of sales (222,972 ) (222,422 )
(837,052 ) (792,659 ) Gross Profit 1,664,563 1,670,063
4,406,152 3,641,677
OPERATING EXPENSES: Research and
development (11,277,256 ) (9,220,014 ) (37,532,624 ) (26,609,423 )
Acquired in-process research and development - (17,458,766 ) -
(17,458,766 ) General and administrative (4,791,898 )
(4,284,726 ) (17,556,102 ) (15,558,674 ) Total
operating expenses (16,069,154 ) (30,963,506 )
(55,088,726 ) (59,626,863 ) Loss from operations
(14,404,591 ) (29,293,443 ) (50,682,574 )
(55,985,186 )
OTHER EXPENSES: Interest expense, net (57,939
) (2,611 ) (88,496 ) (578 ) (Loss)/gain on sale or write off of
fixed assets (217 ) - (8,926 ) 5,120 Other expense, net
(513,505 ) (39,665 ) (374,715 ) (209,177 )
Total other expenses, net (571,661 ) (42,276 ) (472,137 ) (204,635
) LOSS BEFORE INCOME TAX BENEFITS (14,976,252 ) (29,335,719
) (51,154,711 ) (56,189,821 ) Deferred income tax benefit
2,200,634 3,280,695 7,375,611
3,280,695 NET LOSS (12,775,618 )
(26,055,024 ) (43,779,100 ) (52,909,126 ) Net loss
attributable to the noncontrolling interest
2,208,081 6,442,710 7,367,440
9,026,291
NET LOSS ATTRIBUTABLE TO
BIOTIME, INC. (1) $ (10,567,537 ) $ (19,612,314 ) $
(36,411,660 ) $ (43,882,835 ) Dividends on preferred shares
(2) (52,789 ) - (86,827 ) -
NET LOSS ATTRIBUTABLE TO BIOTIME,
INC. COMMON SHAREHOLDERS (10,620,326 )
(19,612,314 ) (36,498,487 ) (43,882,835 )
Foreign currency translation gain/(loss) 337,253 (64,841 ) 124,949
119,469 Unrealized (loss)/gain on available-for-sale securities
(727 ) - (2,013 ) 3,000
COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON
SHAREHOLDERS BEFORE PREFERRED
STOCK DIVIDEND(2)
$ (10,231,011 ) $ (19,677,155 ) $ (36,288,724 ) $ (43,760,366 )
BASIC AND DILUTED NET LOSS PER COMMON SHARE (1) $ (0.14 ) $
(0.35 ) $ (0.55 ) $ (0.81 ) WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING: BASIC AND DILUTED 77,957,943
56,245,189 66,466,714
54,226,219 (1) Basic and diluted loss per common
share is calculated using "Net loss attributable to BioTime, Inc.
common shareholders." (2) Comprehensive loss includes
foreign currency translation gain of $337,253 and $124,949 for the
three and twelve months ended December 31, 2014, respectively and
translation loss of $64,841 and gain of $119,469 for the same
periods in the prior year, respectively which arise entirely from
the translation of foreign subsidiary financial information for
consolidation purposes and therefore not used in the calculation of
basic and diluted loss per common share. Comprehensive loss does
not include dividends on preferred shares.
BioTime, Inc.Judith Segall, 510-521-3390, ext
301jsegall@biotimemail.comorInvestor Contact:EVC Group, Inc.Gregory
Gin, 862-236-0673ggin@evcgroup.comJim
Dawson, 646-445-4800jdawson@evcgroup.comDoug Sherk,
415-652-9100dsherk@evcgroup.com
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