[March 17, 2014] |
|
BioTime Announces Fourth Quarter and Fiscal Year End 2013 Financial Results and Recent Corporate Accomplishments
ALAMEDA, Calif. --(Business Wire)--
BioTime, Inc. (NYSE MKT: BTX), today reported financial results for the
fourth quarter and year ended December 31, 2013 and highlighted its
fourth quarter and recent corporate accomplishments.
Fourth Quarter and Recent Highlighted Corporate Accomplishments
-
BioTime's subsidiary Asterias Biotherapeutics, Inc. completed the
acquisition of stem cell assets from Geron Corporation, including
patents and other intellectual property, biological materials,
reagents and equipment for the development of new therapeutic products
for regenerative medicine.
-
BioTime conducted a clinical safety study of Renevia™, a
biocompatible, implantable hyaluronan and collagen-based matrix for
cell delivery in human clinical applications, at The Stem Center in
Palma de Mallorca, Spain. Examinations of the subjects after they
received Renevia™ injections showed that Renevia™ was
well tolerated by all subjects with no serious adverse events or
subject withdrawals.
-
BioTime commenced the development of two new products based on our HyStem®
technology platform. The new products are unique
formulations utilizing some of the same cGMP components used in Renevia™.
The first of these new products is ReGlyde™, a cross-linked
thiol-modified hyaluronan hydrogel for the management and protection
of tendon injuries following surgical repair of the digital flexor or
extensor tendons of the hand. The second new product, Premvia™,
is a HyStem® hydrogel formulation of cross-linked
thiol-modified hyaluronan and thiol-modified gelatin for the
management of wounds including partial and full-thickness wounds,
ulcers, tunneled/undermined wounds, surgical wounds, and burns.
-
BioTime's subsidiary OncoCyte Corporation entered into a Sponsored
Research Agreement and a Material Transfer Agreement with The Wistar
Institute to collaboratively develop lung cancer diagnostic products.
OncoCyte scientists will analyze blood samples obtained from patients
in a Wistar clinical study to determine levels of tumor-associated
proteins found in the blood samples. The data obtained from the
samples received from Wistar's ongoing multi-center study may allow
OncoCyte to more rapidly develop a diagnostic test for lung cancer to
be marketed in the U.S. and other countries.
-
BioTime consolidated its research products business into a new ESI (News - Alert) BIO
division and a new ESI BIO branding program. The ESI BIO brand and
US-based operating division will now be BioTime's primary developer,
manufacturer and distributor of a growing portfolio of stem cell based
research products.
Financial Results
Revenue
For the quarter ended December 31, 2013, on a consolidated basis, total
revenue was $1.9 million, up $0.7 million from $1.2 million for the same
period one year ago. The increase in fourth quarter revenue is primarily
attributable to the accelerated amortization of the license fees from
our license agreement with Summit which was terminated in 2013.
For the full year 2013, total revenue, on a consolidated basis, was $4.4
million, up $0.5 million from $3.9 million in 2012. The increase in
annual revenue is primarily due to the same factors that contributed to
the increase in fourth quarter revenues. License revenue included
subscription and advertising revenues from LifeMap Sciences' online
database GeneCards® and accounted for approximately
$1.3 million and $0.8 million of total revenue as of December 31, 2013
and 2012, respectively.
Expenses
Operating expenses for the three months ended December 31, 2013 were
$13.5 million, compared to expenses of $8.1 million for the same period
of 2012. The increase in operating expenses is primarily attributable to
an increase in staffing, and the expansion of research and development
efforts, including additional expenses in the Renevia™ clinical
safety trial program, the development of OpRegen® by
BioTime's subsidiary Cell Cure Neurosciences, Ltd for the treatment of
dry age related macular degeneration, and the increased staffing
and operations of Asterias in connection with the Geron stem cell asset
acquisition. In addition, during the fourth quarter, Asterias recognized
$17.5 million of non-cash in-process research and development (IPR&D)
expense in connection with the consummation of its acquisition of assets
from Geron. IPR&D represents the value allocated by management to
incomplete research and development projects which Asterias acquired
from Geron and intends to continue. In accordance with applicable
accounting rules, that value was expensed rather than capitalized for
future amortization because the acquisition was accounted for an
acquisition of assets rather than an acquisition of a business.
Operating expenses for the full year ended December 31, 2013 were $42.2
million, compared to $28.5 million for the full year ended December 31,
2012. The increase in operating expenses is primarily related to an
increase in staffing, the expansion of research and development efforts,
and transaction legal expenses. In addition, BioTime recognized $17.5
million of non-cash IPR&D expense in connection with Asterias'
acquisition of Geron's stem cell assets, as discussed above.
Net Loss
Net loss attributable to BioTime for the three months ended December 31,
2013 was $19.6 million or $0.35 per share, compared to a net loss of
$6.0 million or $0.12 per share for the same period in 2012. Net loss
attributable to BioTime for the full year ended December 31, 2013 was
$43.9 million or $0.81 per share, compared to a net loss of $21.4
million or $0.44 per share for the full year ended December 31, 2012.
Net loss for both the three months and the full year ended December 31,
2013 includes the $17.5 million of non-cash IPR&D expense described
above and $3.3 deferred income tax benefit. Net losses attributable to
BioTime include losses from BioTime majority owned subsidiaries based
upon BioTime's percentage ownership of those subsidiaries.
Balance Sheet and Subsequent Financing Events
Cash and cash equivalents, on a consolidated basis, totaled $5.5 million
as of December 31, 2013, compared with $4.3 million as of December 31,
2012.
Since January 1, 2014, BioTime and certain of its subsidiaries raised
approximately $8.6 million of additional equity capital through the sale
of BioTime common shares in "at-the-market" transactions through Cantor
Fitzgerald & Co. ("Cantor"), as sales agent. In addition, on March 4,
2014, BioTime raised $3.5 million of equity capital through the sale of
70,000 shares of a newly authorized Series A Convertible Preferred Stock
to private investors.
About BioTime
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime's focus is on pluripotent stem cell technology based on
human embryonic stem ("hES") cells and induced pluripotent stem ("iPS")
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime's
therapeutic and research products include a wide array of proprietary PureStem®
progenitors, HyStem® hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia™ (a HyStem®
product) as a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications. In addition,
BioTime has developed Hextend®, a blood plasma volume
expander for use in surgery, emergency trauma treatment and other
applications. Hextend® is manufactured and distributed
in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang
Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
-
Asterias Biotherapeutics, Inc. is a new subsidiary which has acquired
the stem cell assets of Geron Corporation, including patents and other
intellectual property, biological materials, reagents and equipment
for the development of new therapeutic products for regenerative
medicine.
-
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
-
Cell Cure Neurosciences Ltd. ("Cell Cure Neurosciences") is an
Israel-based biotechnology company focused on developing stem
cell-based therapies for retinal and neurological disorders, including
the development of retinal pigment epithelial cells for the treatment
of macular degeneration, and treatments for multiple sclerosis.
-
LifeMap Sciences, Inc. ("LifeMap Sciences") markets, sells and
distributes GeneCards®, the leading human gene
database, as part of an integrated database suite that also includes
the LifeMap Discovery® database of embryonic
development, stem cell research and regenerative medicine, and MalaCards,
the human disease database.
-
ES Cell International Pte Ltd., a Singapore private limited company,
developed clinical and research grade hES cell lines and plans to
market those cell lines and other BioTime research products in
over-seas markets as part of BioTime's ESI BIO Division.
-
BioTime Asia, Limited, a Hong Kong company, may offer and sell
products for research use for BioTime's ESI BIO Division.
-
OrthoCyte Corporation is developing therapies to treat orthopedic
disorders, diseases and injuries.
-
ReCyte Therapeutics, Inc. is developing therapies to treat a variety
of cardiovascular and related ischemic disorders, as well as products
for research using cell reprogramming technology.
Additional information about BioTime can be found on the web at www.biotimeinc.com.
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, 2013
|
|
December 31, 2012
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
CURRENT ASSETS
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
5,495,478
|
|
|
$
|
4,349,967
|
|
Inventory
|
|
|
178,694
|
|
|
|
55,316
|
|
Prepaid expenses and other current assets
|
|
|
2,275,798
|
|
|
|
2,774,196
|
|
Total current assets
|
|
|
7,949,970
|
|
|
|
7,179,479
|
|
|
|
|
|
|
|
|
Equipment, net
|
|
|
2,997,733
|
|
|
|
1,348,554
|
|
Deferred license and consulting fees
|
|
|
444,833
|
|
|
|
669,326
|
|
Deposits
|
|
|
129,129
|
|
|
|
64,442
|
|
Intangible assets, net
|
|
|
46,208,085
|
|
|
|
20,486,792
|
|
TOTAL ASSETS
|
|
$
|
57,729,750
|
|
|
$
|
29,748,593
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
CURRENT LIABILITIES
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
6,722,624
|
|
|
$
|
3,989,962
|
|
Deferred license and subscription revenue, current portion
|
|
|
235,276
|
|
|
|
400,870
|
|
Total current liabilities
|
|
|
6,957,900
|
|
|
|
4,390,832
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES
|
|
|
|
|
|
|
Deferred license revenue, net of current portion
|
|
|
-
|
|
|
|
768,678
|
|
Deferred rent, net of current portion
|
|
|
35,997
|
|
|
|
57,214
|
|
Deferred tax liability, net
|
|
|
8,277,548
|
|
|
|
-
|
|
Other long term liabilities
|
|
|
195,984
|
|
|
|
237,496
|
|
Total long-term liabilities
|
|
|
8,509,529
|
|
|
|
1,063,388
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY
|
|
|
|
|
|
|
Preferred Shares, no par value, authorized 2,000,000 and 1,000,000
shares respectively, as of December 31, 2013 and 2012; none issued
|
|
|
-
|
|
|
|
-
|
|
Common shares, no par value, authorized 125,000,000 and 75,000,000
shares respectively as of December 31, 2013 and 2012; 67,412,139
issued and 56,714,424 outstanding as of December 31, 2013 and
51,183,318 issued and 49,383,209 outstanding at December 31, 2012
|
|
|
203,456,401
|
|
|
|
119,821,243
|
|
Contributed capital
|
|
|
93,972
|
|
|
|
93,972
|
|
Accumulated other comprehensive income/(loss)
|
|
|
62,899
|
|
|
|
(59,570
|
)
|
Accumulated deficit
|
|
|
(145,778,547
|
)
|
|
|
(101,895,712
|
)
|
Treasury stock at cost: 10,697,715 and 1,800,109 shares at December
31, 2013 and 2012, respectively
|
|
|
(43,033,957
|
)
|
|
|
(8,375,397
|
)
|
Total shareholders' equity
|
|
|
14,800,768
|
|
|
|
9,584,536
|
|
Noncontrolling interest
|
|
|
27,461,553
|
|
|
|
14,709,837
|
|
Total equity
|
|
|
42,262,321
|
|
|
|
24,294,373
|
|
TOTAL LIABILITIES AND EQUITY
|
|
$
|
57,729,750
|
|
|
|
29,748,593
|
|
|
BIOTIME, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended (unaudited)
|
|
Year Ended
|
|
|
December 31, 2013
|
|
December 31, 2012
|
|
December 31, 2013
|
|
December 31, 2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
License fees
|
|
$
|
1,123,331
|
|
|
$
|
350,477
|
|
|
$
|
2,218,174
|
|
|
$
|
899,998
|
|
Royalties from product sales
|
|
|
75,270
|
|
|
|
133,878
|
|
|
|
366,775
|
|
|
|
541,681
|
|
Grant income
|
|
|
632,103
|
|
|
|
704,372
|
|
|
|
1,573,329
|
|
|
|
2,222,458
|
|
Sale of research products
|
|
|
61,781
|
|
|
|
33,810
|
|
|
|
276,058
|
|
|
|
251,190
|
|
Total revenues
|
|
|
1,892,485
|
|
|
|
1,222,537
|
|
|
|
4,434,336
|
|
|
|
3,915,327
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
(222,422
|
)
|
|
|
(160,355
|
)
|
|
|
(792,659
|
)
|
|
|
(434,271
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues, net
|
|
|
1,670,063
|
|
|
|
1,062,182
|
|
|
|
3,641,677
|
|
|
|
3,481,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
(9,220,014
|
)
|
|
|
(4,793,278
|
)
|
|
|
(26,609,423
|
)
|
|
|
(18,116,688
|
)
|
Acquired in-process research and development
|
|
|
(17,458,766
|
)
|
|
|
-
|
|
|
|
(17,458,766
|
)
|
|
|
-
|
|
General and administrative
|
|
|
(4,284,726
|
)
|
|
|
(3,327,238
|
)
|
|
|
(15,558,674
|
)
|
|
|
(10,365,045
|
)
|
Total expenses
|
|
|
(30,963,506
|
)
|
|
|
(8,120,516
|
)
|
|
|
(59,626,863
|
)
|
|
|
(28,481,733
|
)
|
Loss from operations
|
|
|
(29,293,443
|
)
|
|
|
(7,058,334
|
)
|
|
|
(55,985,186
|
)
|
|
|
(25,000,677
|
)
|
OTHER INCOME/(EXPENSES):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense)/income, net
|
|
|
(2,611
|
)
|
|
|
2,062
|
|
|
|
(578
|
)
|
|
|
19,383
|
|
Gain/(loss) on sale of fixed assets
|
|
|
-
|
|
|
|
(93,811
|
)
|
|
|
5,120
|
|
|
|
(6,856
|
)
|
Other income/(expense), net
|
|
|
(39,665
|
)
|
|
|
(1,859
|
)
|
|
|
(209,177
|
)
|
|
|
(317,710
|
)
|
Total other income/(expenses), net
|
|
|
(42,276
|
)
|
|
|
(93,608
|
)
|
|
|
(204,635
|
)
|
|
|
(305,183
|
)
|
LOSS BEFORE INCOME TAX BENEFIT
|
|
|
(29,335,719
|
)
|
|
|
(7,151,942
|
)
|
|
|
(56,189,821
|
)
|
|
|
(25,305,860
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefit
|
|
|
3,280,695
|
|
|
|
-
|
|
|
|
3,280,695
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET (News - Alert) LOSS
|
|
|
(26,055,024
|
)
|
|
|
(7,151,942
|
)
|
|
|
(52,909,126
|
)
|
|
|
(25,305,860
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to the noncontrolling interest
|
|
|
6,442,710
|
|
|
|
1,116,988
|
|
|
|
9,026,291
|
|
|
|
3,880,157
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. (1)
|
|
$
|
(19,612,314
|
)
|
|
$
|
(6,034,954
|
)
|
|
$
|
(43,882,835
|
)
|
|
$
|
(21,425,703
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation gain/(loss)
|
|
|
(64,841
|
)
|
|
|
137,814
|
|
|
|
119,469
|
|
|
|
63,179
|
|
Unrealized gain on available-for-sale securities, net
|
|
|
-
|
|
|
|
-
|
|
|
|
3,000
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE NET LOSS (2)
|
|
$
|
(19,677,155
|
)
|
|
$
|
(5,897,140
|
)
|
|
$
|
(43,760,366
|
)
|
|
$
|
(21,362,524
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE (1)
|
|
$
|
(0.35
|
)
|
|
$
|
(0.12
|
)
|
|
$
|
(0.81
|
)
|
|
$
|
(0.44
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND
DILUTED
|
|
|
56,245,189
|
|
|
|
49,263,968
|
|
|
|
54,226,219
|
|
|
|
49,213,687
|
|
(1) Basic and diluted loss per common share is calculated using "Net
loss attributable to BioTime, Inc."
|
|
|
(2) Comprehensive net loss includes foreign currency translation
loss of $64,841 and gain of $119,469 for the three and twelve months
ended December 31, 2013, respectively and translation gain of
$137,814 and $63,179 for the same periods in the prior year,
respectively 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.
|
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