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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
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California
|
|
94-3127919
|
|
(State or other jurisdiction of incorporation or organization)
|
|
(IRS Employer Identification No.)
|
|
Large accelerated filer
|
o
|
|
Accelerated filer
|
T
|
|
Non-accelerated filer
|
o
|
(Do not check if a smaller reporting company)
|
o
|
|
|
March 31, 2014
(unaudited)
|
December 31,
2013
|
||||||
|
|
|
|
||||||
|
ASSETS
|
|
|
||||||
|
CURRENT ASSETS
|
|
|
||||||
|
Cash and cash equivalents
|
$
|
6,637,834
|
$
|
5,495,478
|
||||
|
Inventory
|
236,588
|
178,694
|
||||||
|
Trade accounts and grants receivable, net
|
818,275 | 998,393 | ||||||
|
Prepaid expenses and other current assets
|
1,554,114
|
1,277,405
|
||||||
|
Total current assets
|
9,246,811
|
7,949,970
|
||||||
|
|
||||||||
|
Equipment, net
|
2,959,150
|
2,997,733
|
||||||
|
Deferred license and consulting fees
|
418,958
|
444,833
|
||||||
|
Deposits
|
428,827
|
129,129
|
||||||
|
Other long-term assets
|
56,062
|
-
|
||||||
|
Intangible assets, net
|
44,840,087
|
46,208,085
|
||||||
|
TOTAL ASSETS
|
$
|
57,949,895
|
$
|
57,729,750
|
||||
|
|
||||||||
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LIABILITIES AND EQUITY
|
||||||||
|
CURRENT LIABILITIES
|
||||||||
|
Accounts payable and accrued liabilities
|
$
|
5,443,063
|
$
|
6,722,624
|
||||
|
Deferred license and subscription revenue, current portion
|
177,594
|
235,276
|
||||||
|
Total current liabilities
|
5,620,657
|
6,957,900
|
||||||
|
|
||||||||
|
LONG-TERM LIABILITIES
|
||||||||
|
Deferred rent, net of current portion
|
28,054
|
35,997
|
||||||
|
Deferred tax liability, net
|
6,928,522
|
8,277,548
|
||||||
|
Other long-term liabilities
|
8,441
|
195,984
|
||||||
|
Total long-term liabilities
|
6,965,017
|
8,509,529
|
||||||
|
|
||||||||
|
Commitments and contingencies
|
||||||||
|
|
||||||||
|
EQUITY
|
||||||||
|
Preferred shares, no par value, authorized 2,000,000 shares as of March 31, 2014 and December 31, 2013; 70,000 and nil issued and outstanding as of March 31, 2014 and December 31, 2013, respectively
|
3,500,000
|
-
|
||||||
|
Common shares, no par value, authorized 125,000,000 shares as of March 31, 2014 and December 31, 2013; 69,617,329 issued and 59,071,192 outstanding as of March 31, 2014 and 67,412,139 issued and 56,714,424 outstanding at December 31, 2013
|
211,943,421
|
203,456,401
|
||||||
|
Contributed capital
|
93,972
|
93,972
|
||||||
|
Accumulated other comprehensive income/(loss)
|
(44,341
|
)
|
62,899
|
|||||
|
Accumulated deficit
|
(153,877,561
|
)
|
(145,778,547
|
)
|
||||
|
Treasury stock at cost: 10,546,137 and
10,697,715
shares at March 31, 2014 and at December 31, 2013, respectively
|
(42,372,546
|
)
|
(43,033,957
|
)
|
||||
|
Total shareholders' equity
|
19,242,945 |
14,800,768
|
||||||
|
Noncontrolling interest
|
26,121,276 |
27,461,553
|
||||||
|
Total equity
|
45,364,221
|
42,262,321
|
||||||
|
TOTAL LIABILITIES AND EQUITY
|
$
|
57,949,895
|
$
|
57,729,750
|
||||
|
Three Months Ended
|
||||||||
|
|
March 31, 2014
|
March 31, 2013
|
||||||
|
|
|
|
||||||
|
REVENUES:
|
|
|
||||||
|
License fees
|
$
|
294,504
|
$
|
349,824
|
||||
|
Royalties from product sales
|
97,886
|
107,599
|
||||||
|
Grant income
|
575,659
|
90,326
|
||||||
|
Sale of research products
|
98,586
|
66,724
|
||||||
|
Total revenues
|
1,066,635
|
614,473
|
||||||
|
|
||||||||
|
Cost of sales
|
(131,914
|
)
|
(182,749
|
)
|
||||
|
|
||||||||
|
Total revenues, net
|
934,721
|
431,724
|
||||||
|
|
||||||||
|
EXPENSES:
|
||||||||
|
Research and development
|
(8,405,393
|
)
|
(5,395,488
|
)
|
||||
|
General and administrative
|
(3,667,171
|
)
|
(3,416,145
|
)
|
||||
|
Total expenses
|
(12,072,564
|
)
|
(8,811,633
|
)
|
||||
|
Loss from operations
|
(11,137,843
|
)
|
(8,379,909
|
)
|
||||
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OTHER INCOME/(EXPENSES):
|
||||||||
|
Interest (expense)/income, net
|
(8,384
|
)
|
943
|
|||||
|
Loss on sale of fixed assets
|
(8,576
|
)
|
(1,523
|
)
|
||||
|
Other income/(expense), net
|
77,746
|
(28,056
|
)
|
|||||
|
Total other income/(expenses), net
|
60,786
|
(28,636
|
)
|
|||||
|
LOSS BEFORE INCOME TAX BENEFIT
|
(11,077,057
|
)
|
(8,408,545
|
)
|
||||
|
|
||||||||
|
Income tax benefit
|
1,349,026
|
-
|
||||||
|
|
||||||||
|
NET LOSS
|
(9,728,031
|
)
|
(8,408,545
|
)
|
||||
|
|
||||||||
|
Net loss attributable to noncontrolling interest
|
1,629,017 |
689,282
|
||||||
|
|
||||||||
|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|
(8,099,014
|
)
|
(7,719,263
|
)
|
||||
|
|
||||||||
|
Foreign currency translation (loss)/gain
|
(104,590
|
)
|
148,437
|
|||||
|
Unrealized loss on available-for-sale securities, net
|
(2,650
|
)
|
-
|
|||||
|
|
||||||||
|
COMPREHENSIVE LOSS
|
$
|
(8,206,254
|
)
|
$
|
(7,570,826
|
)
|
||
|
|
||||||||
|
BASIC AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.14
|
)
|
$
|
(0.15
|
)
|
||
|
|
||||||||
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED
|
58,257,427
|
51,175,649
|
||||||
|
|
Three Months Ended
|
|||||||
|
|
March 31, 2014
|
March 31, 2013
|
||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
||||||
|
Net loss attributable to BioTime, Inc.
|
$
|
(8,099,014
|
)
|
$
|
(7,719,263
|
)
|
||
|
Adjustments to reconcile net loss attributable to BioTime, Inc. to net cash used in operating activities:
|
||||||||
|
Depreciation expense
|
256,945
|
113,356
|
||||||
|
Amortization of intangible assets
|
1,367,998
|
642,573
|
||||||
|
Amortization of deferred consulting fees
|
16,279
|
16,280
|
||||||
|
Amortization of deferred license fees
|
27,375
|
27,375
|
||||||
|
Amortization of deferred rent
|
(5,040
|
)
|
(2,222
|
)
|
||||
|
Amortization of deferred license, royalty and subscription revenues
|
(280
|
)
|
(42,996
|
)
|
||||
|
Amortization of stock-based prepaid rent
|
21,146
|
-
|
||||||
|
Net loss allocable to noncontrolling interest
|
(1,629,017
|
)
|
(689,282
|
)
|
||||
|
Stock-based compensation
|
801,554
|
691,946
|
||||||
|
Deferred income tax benefit
|
(1,349,026
|
)
|
-
|
|||||
|
Loss on sale or write-off of equipment
|
8,576
|
1,523
|
||||||
|
Deferred revenues
|
(57,402
|
)
|
-
|
|||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable, net
|
(24,441
|
)
|
(82,916
|
)
|
||||
|
Grant receivable
|
202,122
|
371,886
|
||||||
|
Inventory
|
(57,894
|
)
|
2,981
|
|||||
|
Prepaid expenses and other current assets
|
(375,224
|
)
|
(243,798
|
)
|
||||
|
Accounts payable and accrued liabilities
|
(1,276,211
|
)
|
(101,319
|
)
|
||||
|
Other long-term liabilities
|
(185,717
|
)
|
(7,806
|
)
|
||||
|
Net cash used in operating activities
|
(10,357,271
|
)
|
(7,021,682
|
)
|
||||
|
|
||||||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Purchase of equipment
|
(231,921
|
)
|
(496,128
|
)
|
||||
|
Security deposit paid, net
|
(299,697
|
)
|
(54,423
|
)
|
||||
|
Proceeds from the sale of equipment
|
4,000
|
-
|
||||||
|
Cash used in investing activities
|
(527,618
|
)
|
(550,551
|
)
|
||||
|
|
||||||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Employee options exercised
|
12,500
|
-
|
||||||
|
Director options exercised
|
46,000
|
-
|
||||||
|
Proceeds from issuance of common shares
|
8,182,559
|
11,699,340
|
||||||
|
Fees paid on sale of common shares
|
(212,046
|
)
|
(319,625
|
)
|
||||
|
Proceeds from sale of treasury shares
|
599,472
|
1,602,921
|
||||||
|
Proceeds from sale of preferred stock
|
3,500,000
|
-
|
||||||
|
Proceeds from sale of common shares of subsidiary
|
-
|
130,502
|
||||||
|
Net cash provided by financing activities
|
12,128,485
|
13,113,138
|
||||||
|
|
||||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
(101,240
|
)
|
5,463
|
|||||
|
|
||||||||
|
NET CHANGE IN CASH AND CASH EQUIVALENTS:
|
1,142,356
|
5,546,368
|
||||||
|
CASH AND CASH EQUIVALENTS:
|
||||||||
|
At beginning of the period
|
5,495,478
|
4,349,967
|
||||||
|
At end of the period
|
$
|
6,637,834
|
$
|
9,896,335
|
||||
|
|
||||||||
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
|
||||||||
|
Cash paid during the period for interest
|
$
|
8,472
|
$
|
-
|
||||
|
|
||||||||
|
SUPPLEMENTAL SCHEDULE OF NONCASH FINANCING AND INVESTING ACTIVITIES:
|
||||||||
|
Common shares issued for consulting services
|
$
|
-
|
$
|
77,280
|
||||
|
Common shares issued for rent
|
$
|
-
|
$
|
242,720
|
||||
|
|
||||||||
|
Subsidiary
|
Field of Business
|
BioTime
Ownership
|
Country
|
|
Asterias Biotherapeutics, Inc.
|
Research, development and commercialization of human therapeutic products from stem cells potentially in the fields of neurology, oncology, orthopedics, and cardiology
|
71.6%
|
USA
|
|
ES Cell International Pte Ltd
|
Stem cell products for research, including clinical grade cell lines
produced under cGMP
|
100%
|
Singapore
|
|
OncoCyte Corporation
|
Cancer diagnostics
|
75.3%
|
USA
|
|
OrthoCyte Corporation
|
Orthopedic diseases, including chronic back pain and osteoarthritis
|
100%
|
USA
|
|
Cell Cure Neurosciences Ltd.
|
Age-related macular degeneration
Multiple sclerosis
Parkinson’s disease
|
62.5%
|
Israel
|
|
ReCyte Therapeutics, Inc.
|
Vascular disorders, including cardiovascular-related diseases, ischemic conditions, vascular injuries
Stem cell-derived endothelial and cardiovascular related progenitor cells for research, drug testing, and therapeutics
|
94.8%
|
USA
|
|
BioTime Asia, Limited
|
Stem cell products for research
|
81%
|
Hong Kong
|
|
LifeMap Sciences, Inc.
|
Genetic, disease, and stem cell databases
|
73.2%
|
USA
|
|
LifeMap Sciences, Ltd.
|
Stem cell database
|
(1)
|
Israel
|
| LifeMap Solutions, Inc. | Mobile health software | (1) | USA |
| (1) | LifeMap Sciences, Ltd. and LifeMap Solutions, Inc. are wholly-owned subsidiaries of LifeMap Sciences, Inc. |
|
|
March 31, 2014
(unaudited)
|
December 31,
2013
|
||||||
|
Equipment, furniture and fixtures
|
$
|
4,645,077
|
$
|
4,431,586
|
||||
|
Accumulated depreciation
|
(1,685,927
|
)
|
(1,433,853
|
)
|
||||
|
Equipment, net
|
$
|
2,959,150
|
$
|
2,997,733
|
||||
|
|
March 31, 2014
(unaudited)
|
December 31,
2013
|
||||||
|
Intangible assets
|
$
|
54,719,918
|
$
|
54,719,918
|
||||
|
Accumulated amortization
|
(9,879,831
|
)
|
(8,511,833
|
)
|
||||
|
Intangible assets, net
|
$
|
44,840,087
|
$
|
46,208,085
|
||||
|
Year Ended
|
Deferred License
|
|||
|
December 31,
|
Fees
|
|||
|
2014
|
$
|
83,615
|
||
|
2015
|
111,000
|
|||
|
2016
|
111,000
|
|||
|
2017
|
111,000
|
|||
|
Thereafter
|
111,843
|
|||
|
Total
|
$
|
528,458
|
||
|
|
March 31, 2014
(unaudited)
|
December 31,
2013
|
||||||
|
Accounts payable
|
$
|
2,527,330
|
$
|
3,887,950
|
||||
|
Accrued bonuses
|
229,905
|
600,000
|
||||||
|
Other accrued liabilities
|
2,685,828
|
2,234,674
|
||||||
|
|
$
|
5,443,063
|
$
|
6,722,624
|
||||
|
Consideration transferred to BioTime:
|
|
|||
|
Asterias Series B shares
|
$
|
52,164,568
|
||
|
Warrants to purchase Asterias Series B shares
|
2,012,481
|
|||
|
Excess of contributed assets’ value over consideration
|
4,800,063
|
|||
|
Total consideration issued
|
$
|
58,977,112
|
||
|
|
||||
|
Assets transferred by BioTime:
|
||||
|
BioTime common shares, at fair value
|
$
|
34,985,163
|
||
|
BioTime Warrants, at fair value
|
18,276,406
|
|||
|
Cancellation of outstanding obligation to BioTime
|
5,000,000
|
|||
|
Investment in affiliates, at cost
|
415,543
|
|||
|
Geron asset acquisition related transaction costs paid by BioTime
|
300,000
|
|||
|
Total assets transferred
|
$
|
58,977,112
|
||
|
Consideration paid to Geron:
|
|
|||
|
Asterias Series A shares, net of share issuance costs of $541,800
|
$
|
15,121,222
|
||
|
Obligation to distribute BioTime Warrants
|
18,276,406
|
|||
|
Transaction and other costs
|
1,519,904
|
|||
|
Total consideration paid
|
$
|
34,917,532
|
||
|
Assets acquired from Geron (preliminary allocation):
|
||||
|
Patents and other intellectual property rights related to hES cells
|
$
|
29,017,009
|
||
|
Deferred tax liability arising from difference in book versus tax basis on Geron intangible assets acquired
|
(11,558,243
|
)
|
||
|
IPR&D expensed upon acquisition
|
17,458,766
|
|||
|
Total assets and in-process research and development acquired
|
$
|
34,917,532
|
||
|
|
Three Months Ended March 31,
|
|||||||
|
|
2014
|
2013
|
||||||
|
|
(Unaudited)
|
(Unaudited)
|
||||||
|
Revenues, net
|
$
|
934,721
|
$
|
493,705
|
||||
|
|
||||||||
|
Net loss available to common shareholders
|
$
|
(8,099,014
|
)
|
$
|
(
22,572,852
|
)
|
||
|
|
||||||||
|
Net loss per common share – basic and diluted
|
$
|
(0.14
|
)
|
$
|
(
0.38
|
)
|
||
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
Subsidiary
|
Field of Business
|
BioTime
Ownership
|
Country
|
|
Asterias Biotherapeutics, Inc.
|
Research, development and commercialization of human therapeutic products from stem cells potentially in the fields of neurology, oncology, orthopedics, and cardiology
|
71.6%
|
USA
|
|
ES Cell International Pte Ltd
|
Stem cell products for research, including clinical grade cell lines
produced under cGMP
|
100%
|
Singapore
|
|
OncoCyte Corporation
|
Cancer diagnostics
|
75.3%
|
USA
|
|
OrthoCyte Corporation
|
Orthopedic diseases, including chronic back pain and osteoarthritis
|
100%
|
USA
|
|
Cell Cure Neurosciences Ltd.
|
Age-related macular degeneration
Multiple sclerosis
Parkinson’s disease
|
62.5%
|
Israel
|
|
ReCyte Therapeutics, Inc.
|
Vascular disorders, including cardiovascular-related diseases, ischemic conditions, vascular injuries
Stem cell-derived endothelial and cardiovascular related progenitor cells for research, drug testing, and therapeutics
|
94.8%
|
USA
|
|
BioTime Asia, Limited
|
Stem cell products for research
|
81%
|
Hong Kong
|
|
LifeMap Sciences, Inc.
|
Genetic, disease, and stem cell databases
|
73.2%
|
USA
|
|
LifeMap Sciences, Ltd.
|
Stem cell database
|
(1)
|
Israel
|
| LifeMap Solutions, Inc. | Mobile health software | (1) | USA |
| (1) | LifeMap Sciences, Ltd. and LifeMap Solutions, Inc. are wholly-owned subsidiaries of LifeMap Sciences, Inc. |
|
|
|
Three Months Ended
March 31,
|
|||||||
|
Company
|
Program
|
2014
|
2013
|
||||||
|
Asterias
|
hESC-based cell therapeutic programs
|
30.9
|
%
|
3.6
|
%
|
||||
|
BioTime and ESI
|
PureStem
®
hEPCs, cGMP hES cell lines,
and related research products
|
9.8
|
%
|
12.8
|
%
|
||||
|
BioTime
|
PureStem
®
technology
|
0.0
|
%
|
3.7
|
%
|
||||
|
BioTime
|
Hydrogel therapeutic products and
HyStem
®
research
|
15.6
|
%
|
21.6
|
%
|
||||
|
OncoCyte
|
Cancer diagnostics
|
11.1
|
%
|
13.1
|
%
|
||||
|
OrthoCyte
|
Orthopedic therapeutics
|
2.7
|
%
|
4.6
|
%
|
||||
|
ReCyte Therapeutics
|
Cardiovascular therapeutics
|
5.2
|
%
|
5.8
|
%
|
||||
|
BioTime
|
Hextend
®
|
0.1
|
%
|
0.4
|
%
|
||||
|
BioTime Asia
|
Stem cell products for research
|
0.0
|
%
|
0.2
|
%
|
||||
|
Cell Cure Neurosciences
|
A
ge related macular degeneration (
OpRegen
®
and
OpRegen
®
-Plus
), and neurological disease therapeutics
|
15.0
|
%
|
23.2
|
%
|
||||
|
LifeMap Sciences
|
Database development and sales
|
9.3
|
%
|
11.0
|
%
|
||||
|
BioTime
|
High Content Screening
|
0.3
|
%
|
-
|
|||||
|
|
Three Months Ended
March 31,
|
$ Increase/
|
% Increase/
|
|||||||||||||
|
|
2014
|
2013
|
(Decrease)
|
(Decrease)
|
||||||||||||
|
License fees
|
$
|
294,504
|
$
|
349,824
|
$
|
(55,320
|
)
|
(15.8
|
)%
|
|||||||
|
Royalty from product sales
|
97,886
|
107,599
|
(9,713
|
)
|
(9.0
|
)%
|
||||||||||
|
Grant income
|
575,659
|
90,326
|
485,333
|
537.3
|
%
|
|||||||||||
|
Sales of research products and services
|
98,586
|
66,724
|
31,862
|
47.8
|
%
|
|||||||||||
|
Total revenues
|
1,066,635
|
614,473
|
452,162
|
73.6
|
%
|
|||||||||||
|
Cost of sales
|
(131,914
|
)
|
(182,749
|
)
|
(50,835
|
)
|
(27.8
|
)%
|
||||||||
|
Total revenues, net
|
934,721
|
431,724
|
502,997
|
116.5
|
%
|
|||||||||||
|
|
Three Months Ended
March 31,
|
$ Increase/
|
% Increase/
|
|
|||||||||||||
|
|
2014
|
2013
|
(Decrease)
|
(Decrease)
|
|
||||||||||||
|
Research and development expenses
|
$
|
(8,405,393
|
)
|
$
|
(5,395,488
|
)
|
$
|
3,009,905
|
55.8
|
%
|
|
||||||
|
General and administrative expenses
|
(3,667,171
|
)
|
(3,416,145
|
)
|
251,026
|
7.3
|
%
|
|
|||||||||
|
Interest (expense)/income
|
(8,384
|
)
|
943
|
9,327
|
989.1
|
%
|
|
||||||||||
|
Other income/(expense)
|
77,746
|
(28,056
|
)
|
105,802
|
377.1
|
%
|
|
||||||||||
|
|
Three Months Ended
March 31,
|
||||||||
|
Company
|
Program
|
2014
|
2013
|
||||||
|
Asterias
|
hESC-based cell therapeutic programs
|
$
|
2,599,146
|
$
|
193,444
|
||||
|
BioTime and ESI
|
PureStem
®
hEPCs, cGMP hES cell lines,
and related research products
|
823,451
|
691,611
|
||||||
|
BioTime
|
PureStem
®
technology
|
-
|
199,447
|
||||||
|
BioTime
|
Hydrogel therapeutic products and
HyStem
®
research
|
1,315,231
|
1,163,340
|
||||||
|
OncoCyte
|
Cancer diagnostics
|
929,725
|
704,917
|
||||||
|
OrthoCyte
|
Orthopedic therapeutics
|
224,716
|
249,954
|
||||||
|
ReCyte Therapeutics
|
Cardiovascular therapeutics
|
433,408
|
313,615
|
||||||
|
BioTime
|
Hextend
®
|
12,160
|
21,633
|
||||||
|
BioTime Asia
|
Stem cell products for research
|
-
|
8,565
|
||||||
|
Cell Cure Neurosciences
|
OpRegen
®
,
OpRegen
®
-Plus
, and neurological disease therapeutics
|
1,261,054
|
1,252,917
|
||||||
|
LifeMap Sciences
|
Database development and sales
|
781,424
|
596,045
|
||||||
|
BioTime
|
High Content Screening
|
25,078
|
-
|
||||||
|
|
Principal Payments Due by Period
|
||||||||||||||||||||
|
Contractual Obligations
(1)
|
Total
|
Less Than
1 Year
|
1-3 Years
|
4-5 Years
|
After
5 Years
|
||||||||||||||||
|
|
|
||||||||||||||||||||
|
Operating leases
(2)
|
$
|
|
12,026,101
|
$
|
|
940,963
|
$
|
|
3,243,018
|
$
|
|
2,579,280
|
$
|
|
5,262,840
|
||||||
|
|
(1)
|
This table does not include payments to key employees that could arise if they were involuntary terminated or if their employment terminated following a change in control.
|
|
|
(2)
|
Includes the lease of our principal office and laboratory facilities in Alameda, California, and leases of the offices and laboratory facilities of our subsidiaries Asterias, ESI, LifeMap Sciences, and Cell Cure Neurosciences.
|
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
|
Item 4.
|
Controls and Procedures
|
| Item 1. | Legal Proceedings. |
| Item 1A. | Risk Factors |
| · | We are attempting to develop new medical products and technologies. |
| · | Many of our experimental products and technologies have not been applied in human medicine and have only been used in laboratory studies in vitro or in animals. These new products and technologies might not prove to be safe and efficacious in the human medical applications for which they were developed. |
| · | The experimentation we are doing is costly, time consuming, and uncertain as to its results. We incurred research and development expenses amounting to $8,405,393, during the three months ended March 31, 2014, and $26,609,423, $18,116,688, and $13,699,691 during the fiscal years ended December 31, 2013, 2012, and 2011, respectively, excluding $17,458,766 charged as in process research and development expenses during 2013 in accordance with ASC 805-50 on account of Asterias’ acquisition of certain assets f rom Geron. See Note 8 to condensed consolidated interim financial statements. |
| · | If we are successful in developing a new technology or product, refinement of the new technology or product and definition of the practical applications and limitations of the technology or product may take years and require the expenditure of large sums of money. Future clinical trials of new therapeutic products, particularly those products that are regulated as drugs or biological, will be very expensive and will take years to complete. We may not have the financial resources to fund clinical trials on our own and we may have to enter into licensing or collaborative arrangements with larger, well-capitalized pharmaceutical companies in order to bear the cost. Any such arrangements may be dilutive to our ownership or economic interest in the products we develop, and we might have to accept a royalty payment on the sale of the product rather than receiving the gross revenues from product sales. |
| · | Asterias will use the stem cell assets that it has acquired from Geron for the research and development of products for regenerative medicine. Asterias’ research and development efforts will involve substantial expense, including but not limited to hiring additional research and management personnel, and possibly the rent of additional research or manufacturing space that will add to our losses on a consolidated basis for the near future. |
| · | Asterias has become a public company. As a public company, Asterias will incur costs associated with audits of its financial statements, filing annual, quarterly, and other periodic reports with the SEC, holding annual shareholder meetings, listing its common shares for trading, and public relations and investor relations. These costs will be in addition to those incurred by BioTime for similar purposes. |
| · | As a developer of therapeutic products derived from hES or iPS cells, Asterias will face substantially the same kind of risks that affect our business, as well as the risks related to our industry generally. |
| · | The success of our business of selling products for use in stem cell research depends on the growth of stem cell research, without which there may be no market or only a very small market for our products and technology. The likelihood that stem cell research will grow depends upon the successful development of stem cell products that can be used to treat disease or injuries in people or that can be used to facilitate the development of other therapeutic products. The growth in stem cell research also depends upon the availability of funding through private investment and government research grants. |
| · | There can be no assurance that any safe and efficacious human medical applications will be developed using stem cells or related technology. |
| · | Government-imposed bans, restrictions and religious, moral, and ethical concerns with respect to use of embryos or hES cells in research and development could have a material adverse effect on the growth of the stem cell industry, even if research proves that useful medical products can be developed using hES cells. |
| · | Hextend ® is presently the only plasma expander product that we have on the market, and it is being sold only in the U.S. and South Korea. The royalty revenues that we have received from sales of Hextend ® have not been sufficient to pay our operating expenses. This means that we need to successfully develop and market or license additional products and earn additional revenues in sufficient amounts to meet our operating expenses. |
| · | We are also bringing our first stem cell research products to the market, but there is no assurance that we will succeed in generating significant revenues from the sale of those products. |
| · | Sales of Hextend ® have already been adversely impacted by the availability of other products that are commonly used in surgery and trauma care and sell at low prices. |
| · | In order to compete with other products, particularly those that sell at lower prices, our products will have to provide medically significant advantages. |
| · | Physicians and hospitals may be reluctant to try a new product due to the high degree of risk associated with the application of new technologies and products in the field of human medicine. |
| · | Competing products are being manufactured and marketed by established pharmaceutical companies. For example, B. Braun presently markets Hespan ® , an artificial plasma volume expander, and Hospira and Teva sell a generic equivalent of Hespan ® . Hospira also markets Voluven ® , a plasma volume expander containing a 6% low molecular weight hydroxyethyl starch in saline solution. |
| · | Competing products for the diagnosis and treatment of cancer are being manufactured and marketed by established pharmaceutical companies, and more cancer diagnostics and therapeutics are being developed by those companies and by other smaller biotechnology companies. Other companies, both large and small, are also working on the development of stem cell based therapies for the same diseases and disorders that are the focus of the research and development programs of our subsidiaries. |
| · | There also is a risk that our competitors may succeed at developing safer or more effective products that could render our products and technologies obsolete or noncompetitive. |
| · | We plan to continue to incur substantial research and product development expenses, largely through our subsidiaries, and we and our subsidiaries will need to raise additional capital to pay operating expenses until we are able to generate sufficient revenues from product sales, royalties, and license fees. |
| · | It is likely that additional sales of equity or debt securities will be required to meet our short-term capital needs, unless we receive substantial revenues from the sale of our new products or we are successful at licensing or sublicensing the technology that we develop or acquire from others and we receive substantial licensing fees and royalties. |
| · | Sales of additional equity securities by us or our subsidiaries could result in the dilution of the interests of present shareholders. |
| · | At March 31, 2014, we had $6,637,834 of cash and cash equivalents on hand. There can be no assurance that we or our subsidiaries will be able to raise funds on favorable terms or at all, or that any funds raised will be sufficient to permit us or our subsidiaries to develop and market our products and technology. Unless we and our subsidiaries are able to generate sufficient revenue or raise additional funds when needed, it is likely that we will be unable to continue our planned activities, even if we make progress in our research and development projects. |
| · | We may have to postpone or limit the pace of our research and development work and planned clinical trials of our product candidates unless our cash resources increase through a growth in revenues or additional equity investment or borrowing. |
| · | hES derived therapeutic cells have only been produced on a small scale and not in quantities and at levels of purity and viability that will be needed for wide scale commercialization. If we are successful in developing products that consist of hES cells or other cells or products derived from hES or other cells, we will need to develop, alone or in collaboration with one or more pharmaceutical companies or contract manufacturers, technology for the commercial production of those products. |
| · | Our hES cell or other cell based products are likely to be more expensive to manufacture on a commercial scale than most other drugs on the market today. The high cost of manufacturing a product will require that we charge our customers a high price for the product in order to cover our costs and earn a profit. If the price of our products is too high, hospitals and physicians may be reluctant to purchase our products, especially if lower priced alternative products are available, and we may not be able to sell our products in sufficient volumes to recover our costs of development and manufacture or to earn a profit. |
| · | We will have to conduct expensive and time-consuming clinical trials of new products. The full cost of conducting and completing clinical trials necessary to obtain FDA and foreign regulatory approval of a new product cannot be presently determined, but could exceed our current financial resources. |
| · | Clinical trials and the regulatory approval process for a pharmaceutical or cell-based product can take several years to complete. As a result, we will incur the expense and delay inherent in seeking FDA and foreign regulatory approval of new products, even if the results of clinical trials are favorable. |
| · | Data obtained from preclinical and clinical studies is susceptible to varying interpretations that could delay, limit, or prevent regulatory agency approvals. Delays in the regulatory approval process or rejections of an application for approval of a new product may be encountered as a result of changes in regulatory agency policy. |
| · | Because the therapeutic products we are developing with hES and iPS technology involve the application of new technologies and approaches to medicine, the FDA or foreign regulatory agencies may subject those products to additional or more stringent review than drugs or biologicals derived from other technologies. |
| · | A product that is approved may be subject to restrictions on use. |
| · | The FDA can recall or withdraw approval of a product if problems arise. |
| · | We will face similar regulatory issues in foreign countries. |
| · | delays in securing clinical investigators or trial sites for our clinical trials; |
| · | delays in obtaining IRB and other regulatory approvals to commence a clinical trial; |
| · | slower than anticipated rates of patient recruitment and enrollment, or failing to reach the targeted number of patients due to competition for patients from other trials; |
| · | limited or no availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third party payors for the use of agents used in our clinical trials; |
| · | negative or inconclusive results from clinical trials; |
| · | unforeseen side effects interrupting, delaying or halting clinical trials of our product candidates and possibly resulting in the FDA or other regulatory authorities denying approval of our product candidates; |
| · | unforeseen safety issues; |
| · | uncertain dosing issues; |
| · | approval and introduction of new therapies or changes in standards of practice or regulatory guidance that render our clinical trial endpoints or the targeting of our proposed indications obsolete; |
| · | inability to monitor patients adequately during or after treatment or problems with investigator or patient compliance with the trial protocols; |
| · | inability to replicate in large controlled studies safety and efficacy data obtained from a limited number of patients in uncontrolled trials; |
| · | inability or unwillingness of medical investigators to follow our clinical protocols; and |
| · | unavailability of clinical trial supplies. |
| · | Our success will depend in part on our ability to obtain and enforce patents and maintain trade secrets in the United States and in other countries. If we are unsuccessful at obtaining and enforcing patents, our competitors could use our technology and create products that compete with our products, without paying license fees or royalties to us. |
| · | The preparation, filing, and prosecution of patent applications can be costly and time consuming. Our limited financial resources may not permit us to pursue patent protection of all of our technology and products throughout the world. |
| · | Even if we are able to obtain issued patents covering our technology or products, we may have to incur substantial legal fees and other expenses to enforce our patent rights in order to protect our technology and products from infringing uses. We may not have the financial resources to finance the litigation required to preserve our patent and trade secret rights. |
| · | The preparation and filing of patent applications, and the maintenance of patents that are issued, may require substantial time and money. |
| · | A patent interference proceeding may be instituted with the USPTO for patents or applications filed before March 16, 2013 when more than one person files a patent application covering the same technology, or if someone wishes to challenge the validity of an issued patent. At the completion of the interference proceeding, the USPTO may determine which competing applicant is entitled to the patent, or whether an issued patent is valid. Patent interference proceedings are complex, highly contested legal proceedings, and the USPTO’s decision is subject to appeal. This means that if an interference proceeding arises with respect to any of our patent applications, we may experience significant expenses and delay in obtaining a patent, and if the outcome of the proceeding is unfavorable to us, the patent could be issued to a competitor rather than to us. |
| · | After March 16, 2013 a derivation proceeding may be instituted by the USPTO or an inventor alleging that a patent or application was derived from the work of another inventor. |
| · | Post Grant Review under the new America Invents Act will make available after March 16, 2013 opposition-like proceedings in the United States. As with the USPTO interference proceedings, Post Grant Review proceedings will be very expensive to contest and can result in significant delays in obtaining patent protection or can result in a denial of a patent application. |
| · | Oppositions to the issuance of patents may be filed under European patent law and the patent laws of certain other countries. As with the USPTO interference proceedings, these foreign proceedings can be very expensive to contest and can result in significant delays in obtaining a patent or can result in a denial of a patent application. |
| · | We might not be able to obtain any additional patents, and any patents that we do obtain might not be comprehensive enough to provide us with meaningful patent protection. |
| · | There will always be a risk that our competitors might be able to successfully challenge the validity or enforceability of any patent issued to us. |
| · | In addition to interference proceedings, the USPTO can re-examine issued patents at the request of a third party seeking to have the patent invalidated. This means that patents owned or licensed by us may be subject to re-examination and may be lost if the outcome of the re-examination is unfavorable to us. As of September 16, 2012 our patents may be subject to inter partes review (replacing the inter partes reexamination proceeding), a proceeding in which a third party can challenge the validity of one of our patents. |
| · | The market price of our common shares, like that of the shares of many biotechnology companies, has been highly volatile. |
| · | The price of our common shares may rise rapidly in response to certain events, such as the commencement of clinical trials of an experimental new drug, even though the outcome of those trials and the likelihood of ultimate FDA approval remain uncertain. |
| · | Similarly, prices of our common shares may fall rapidly in response to certain events such as unfavorable results of clinical trials or a delay or failure to obtain FDA approval. |
| · | The failure of our earnings to meet analysts’ expectations could result in a significant rapid decline in the market price of our common shares. |
| · | Changes in the price of our common shares will affect the price at which our warrants may trade. |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
| Item 3. | Default Upon Senior Securities |
| Item 4. | Mine Safety Disclosures |
| Item 5. | Other Information |
|
Exhibits
|
|
Exhibit
|
|
|
Numbers
|
Description
|
|
|
|
|
3.1
|
Articles of Incorporation with all amendments.(1)
|
|
|
|
|
3.2
|
By-Laws, As Amended. (2)
|
|
|
|
|
4.1
|
Specimen of Series A Convertible Preferred Stock Certificate (3)
|
|
|
|
|
4.2
|
Certificate of Determination of Series A Convertible Preferred Stock (3)
|
|
|
|
|
10.1
|
Preferred Stock Purchase Agreement, dated March 4, 2014, between BioTime and certain investors (3)
|
|
|
|
|
10.2
|
Option Agreement, dated March 4, 2014, between BioTime and certain investors (3)
|
|
|
|
|
10.3
|
Amendment No. 1 to
Controlled Equity Offering
SM
Sales Agreement, dated March 26, 2014, between BioTime, Inc. and Cantor Fitzgerald & Co (4)
|
|
|
|
|
31
|
Rule 13a-14(a)/15d-14(a) Certification.*
|
|
|
|
|
32
|
Section 1350 Certification.*
|
|
|
|
|
101
|
Interactive Data File
|
|
|
|
|
101.INS
|
XBRL Instance Document *
|
|
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema *
|
|
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase *
|
|
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase *
|
|
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase *
|
|
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Document *
|
|
(1)
|
Incorporated by reference to BioTime’s Annual Report on Form 10-K/A-1 for the year ended December 31, 2013 filed with the Securities and Exchange Commission on April 29, 2014
|
|
(2)
|
Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively.
|
|
(3)
|
Incorporated by reference to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 5, 2014
|
|
(4)
|
Incorporated by reference to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 26, 2014
|
|
*
|
Filed herewith
|
|
|
BIOTIME, INC.
|
|
|
|
|
|
|
Date: May 12, 2014
|
/s/ Michael D. West
|
|
|
|
Michael D. West
|
|
|
|
Chief Executive Officer
|
|
|
Date: May 12, 2014
|
/s/ Robert W. Peabody
|
|
|
|
Robert W. Peabody
|
|
|
|
Chief Financial Officer
|
|
|
Exhibit
|
|
|
Numbers
|
Description
|
|
|
|
|
3.1
|
Articles of Incorporation with all amendments.(1)
|
|
|
|
|
3.2
|
By-Laws, As Amended. (2)
|
|
|
|
|
4.1
|
Specimen of Series A Convertible Preferred Stock Certificate (3)
|
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4.2
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Certificate of Determination of Series A Convertible Preferred Stock (3)
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10.1
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Preferred Stock Purchase Agreement, dated March 4, 2014, between BioTime and certain investors (3)
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10.2
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Option Agreement, dated March 4, 2014, between BioTime and certain investors (3)
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10.3
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Amendment No. 1 to
Controlled Equity Offering
SM
Sales Agreement, dated March 26, 2014, between BioTime, Inc. and Cantor Fitzgerald & Co (4)
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Rule 13a-14(a)/15d-14(a) Certification.*
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Section 1350 Certification.*
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101
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Interactive Data File
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101.INS
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XBRL Instance Document *
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101.SCH
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XBRL Taxonomy Extension Schema *
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase *
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101.LAB
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XBRL Taxonomy Extension Label Linkbase *
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101.PRE
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XBRL Taxonomy Extension Presentation Linkbase *
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101.DEF
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XBRL Taxonomy Extension Definition Document *
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(1)
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Incorporated by reference to BioTime’s Annual Report on Form 10-K/A-1 for the year ended December 31, 2013 filed with the Securities and Exchange Commission on April 29, 2014
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(2)
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Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively.
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(3)
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Incorporated by reference to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 5, 2014
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(4)
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Incorporated by reference to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 26, 2014
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*
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Filed herewith
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No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|