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 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 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.
BioTime, Inc.Lesley Stolz, PhD, 510-521-3390, ext 367Executive
Vice President, Corporate Developmentlstolz@biotimemail.comorJudith
Segall, 510-521-3390, ext 301jsegall@biotimemail.com
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Brooklyn ImmunoTherapeut... (AMEX:BTX)
Historical Stock Chart
From Apr 2023 to Apr 2024