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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
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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California
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94-3127919
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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Large accelerated filer
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o
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Accelerated filer
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x
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Non-accelerated filer
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o
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(Do not check if a smaller reporting company)
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Smaller reporting company
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o
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Item 1.
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Financial Statements
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September 30, 2012
(unaudited)
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December 31,
2011
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||
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ASSETS
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CURRENT ASSETS
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Cash and cash equivalents
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$
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7,830,347
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$
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22,211,897
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Inventory
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56,968
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51,174
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Prepaid expenses and other current assets
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1,861,407
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2,692,303
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Total current assets
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9,748,722
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24,955,374
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Equipment, net
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1,251,083
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1,347,779
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Deferred license and consulting fees
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712,981
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843,944
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Deposits
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67,889
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63,082
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Intangible assets, net
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21,089,661
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18,619,516
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TOTAL ASSETS
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$
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32,870,336
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$
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45,829,695
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LIABILITIES AND EQUITY
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CURRENT LIABILITIES
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Accounts payable and accrued liabilities
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$
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2,162,390
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$
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2,681,111
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Deferred grant income
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55,710
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261,777
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Deferred license and subscription revenue, current portion
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354,703
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203,767
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Total current liabilities
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2,572,803
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3,146,655
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LONG-TERM LIABILITIES
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Deferred license revenue, net of current portion
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790,146
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899,551
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Deferred rent, net of current portion
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60,462
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66,688
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Other long term liabilities
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235,330
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258,620
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Total long-term liabilities
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1,085,938
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1,224,859
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Commitments and contingencies
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EQUITY
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Preferred Shares, no par value, authorized 1,000,000 shares; none issued
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Common shares, no par value, authorized 75,000,000 shares; 50,868,932 issued, and 49,162,758 outstanding at September 30, 2012 and 50,321,962 issued, and 49,035,788 outstanding at December 31, 2011
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120,905,891
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115,144,787
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Contributed capital
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93,972
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93,972
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Accumulated other comprehensive income
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(197,384
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)
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(122,749
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)
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Accumulated deficit
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(95,860,758
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)
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(80,470,009
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)
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Treasury stock at cost: 1,706,174 shares at September 30, 2012 and 1,286,174 shares at December 31, 2011
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(8,001,762
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)
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(6,000,000
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)
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Total shareholders' equity
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16,939,959
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28,646,001
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Non-controlling interest
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12,271,636
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12,812,180
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Total equity
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29,211,595
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41,458,181
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TOTAL LIABILITIES AND EQUITY
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$
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32,870,336
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$
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45,829,695
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Three Months Ended
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Nine Months Ended
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||||||||||
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September 30,
2012
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September 30,
2011
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September 30,
2012
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September 30,
2011
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REVENUES:
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License fees
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$
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337,633
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$
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54,900
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$
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549,521
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$
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201,589
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Royalties from product sales
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133,946
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176,027
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407,803
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569,257
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Grant income
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441,630
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746,426
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1,518,086
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1,605,612
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Sale of research products
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90,342
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184,217
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217,380
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405,981
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Total revenues
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1,003,551
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1,161,570
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2,692,790
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2,782,439
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Cost of sales
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(169,734
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)
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(18,516
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(273,916
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)
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(58,808
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)
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Total revenues, net
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833,817
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1,143,054
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2,418,874
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2,723,631
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EXPENSES:
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||||
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Research and development
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(4,545,470
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)
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(3,488,121
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)
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(13,323,410
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)
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(9,756,443
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)
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General and administrative
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(2,234,905
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)
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(1,887,298
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)
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(7,037,807
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)
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(6,193,383
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)
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Total expenses
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(6,780,375
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)
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(5,375,419
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)
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(20,361,217
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)
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(15,949,826
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)
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|||
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Loss from operations
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(5,946,558
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)
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(4,232,365
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)
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(17,942,343
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)
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(13,226,195
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)
|
|
OTHER INCOME/(EXPENSES):
|
|
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||
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Interest income/(expense), net
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5,624
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2,911
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17,321
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19,705
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||
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Gain/(loss) on sale of fixed assets
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(1,451
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)
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(6,246
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)
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(4,997
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)
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|
|
(6,246)
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|
Other income/(expense), net
|
|
|
18,766
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|
|
(919
|
)
|
|
|
(223,899
|
)
|
|
|
223,944
|
||
|
Total other income/(expenses), net
|
|
$
|
22,939
|
|
$
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(4,254
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)
|
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$
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(211,575
|
)
|
|
$
|
237,403
|
||
|
NET LOSS
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|
|
(5,923,619
|
)
|
|
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(4,236,619
|
)
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(18,153,918
|
)
|
|
|
(12,988,792
|
)
|
|
Less: Net loss attributable to the noncontrolling interest
|
|
|
965,605
|
|
|
|
498,993
|
|
|
|
2,763,169
|
|
|
|
1,833,943
|
|
|
|
|
|
|
|
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|
|
|
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|
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|
|||
|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|
|
$
|
(4,958,014
|
)
|
|
$
|
(3,737,626
|
)
|
|
$
|
(15,390,749
|
)
|
|
$
|
(11,154,849
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
Foreign currency translation gain/(loss)
|
|
|
(15,777
|
)
|
|
|
696,661
|
|
|
|
(74,635
|
)
|
|
|
(901,881
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
COMPREHENSIVE NET LOSS
|
|
$
|
(4,973,791
|
)
|
|
$
|
(3,040,965
|
)
|
|
$
|
(15,465,384
|
)
|
|
$
|
(12,056,730
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
BASIC AND DILUTED LOSS PER COMMON SHARE
|
|
$
|
(0.10
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.23
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED
|
|
|
49,291,177
|
|
|
|
48,896,973
|
|
|
|
49,196,804
|
|
|
|
48,681,879
|
|
|
Nine Months Ended
|
||||||||
|
September 30,
2012
|
September 30,
2011
|
|||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net loss attributable to BioTime, Inc.
|
$
|
(15,390,749
|
)
|
$
|
(11,154,849
|
)
|
||
|
Adjustments to reconcile net loss attributable to BioTime, Inc. to net cash used in operating activities:
|
||||||||
|
Depreciation expense
|
283,637
|
260,646
|
||||||
|
Amortization of intangible asset
|
1,764,382
|
1,626,476
|
||||||
|
Amortization of deferred license, royalty and subscription revenues
|
(220,764
|
)
|
(186,035
|
)
|
||||
|
Amortization of deferred grant income
|
(261,777
|
)
|
(261,777
|
)
|
||||
|
Amortization of deferred consulting fees
|
582,186
|
582,186
|
||||||
|
Amortization of deferred license and royalty fees
|
82,129
|
82,125
|
||||||
|
Amortization of deferred rent
|
(8,143
|
)
|
32,403
|
|||||
|
Stock-based compensation
|
986,769
|
828,395
|
||||||
|
Options issued as independent director compensation
|
454,366
|
427,516
|
||||||
|
Reduction in receivables from the reversal of revenues
|
205,926
|
—
|
||||||
|
Write-off of security deposit
|
(3,634
|
)
|
—
|
|||||
|
Write off of expired inventory
|
—
|
1,510
|
||||||
|
Loss on sale/write-off of fixed assets
|
4,997
|
6,502
|
||||||
|
Net loss allocable to noncontrolling interest
|
(2,763,169
|
)
|
(1,833,943
|
)
|
||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable, net
|
(459,555
|
)
|
(25,272
|
)
|
||||
|
Grant receivable
|
584,744
|
256,714
|
||||||
|
Inventory
|
(5,794
|
)
|
21,154
|
|||||
|
Prepaid expenses and other current assets
|
140,220
|
(320,893)
|
||||||
|
Accounts payable and accrued liabilities
|
(699,155
|
)
|
(331,072
|
)
|
||||
|
Other long term liabilities
|
(16,686
|
)
|
(31,741
|
)
|
||||
|
Deferred grant income
|
56,630
|
271,655
|
||||||
|
Net cash used in operating activities
|
(14,683,440
|
)
|
(9,748,300
|
)
|
||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Purchase of equipment
|
(205,135
|
)
|
(780,524
|
)
|
||||
|
Payment of license fee
|
—
|
(1,500
|
)
|
|||||
|
Cash paid, net of cash acquired for assets
|
—
|
(246,850
|
)
|
|||||
|
Cash acquired in connection with merger
|
292,387
|
5,908
|
||||||
|
Proceeds from the sale of fixed assets
|
4,500
|
—
|
||||||
|
Security deposit (paid)/received
|
(529
|
)
|
250
|
|||||
|
Net cash provided by/(used) in investing activities
|
91,223
|
(1,022,716
|
)
|
|||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds from the exercise of stock options from employees
|
286,552
|
106,153
|
||||||
|
Proceeds from the exercise of stock options from directors
|
—
|
112,328
|
||||||
|
Proceeds from the exercise of stock options from outside consultant
|
—
|
4,700
|
||||||
|
Proceeds from the exercise of warrants
|
—
|
425,000
|
||||||
|
Proceeds from the sale of common shares of subsidiary
|
—
|
3,213,500
|
||||||
|
Net cash provided by financing activities
|
286,552
|
3,861,681
|
||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
(75,885
|
)
|
(185,291
|
)
|
||||
|
NET CHANGE IN CASH AND CASH EQUIVALENTS:
|
(14,381,550
|
)
|
(7,094,626
|
)
|
||||
|
Cash and cash equivalents at beginning of period
|
22,211,897
|
33,324,924
|
||||||
|
Cash and cash equivalents at end of period
|
$
|
7,830,347
|
$
|
26,230,298
|
||||
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
|
||||||||
|
Cash paid during the period for interest
|
$
|
315
|
$
|
1,073
|
||||
|
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:
|
||||||||
|
Common shares acquired in connection with investment in subsidiary as part of Share Exchange and Contribution Agreement
|
$
|
2,001,762
|
$
|
—
|
||||
|
Common shares issued in connection with investment in subsidiary
|
$
|
—
|
$
|
6,000,000
|
||||
|
Common shares issued in connection with the purchase of assets
|
$
|
—
|
$
|
2,300,000
|
||||
|
Common shares issued as part of merger
|
$
|
1,802,684
|
$
|
2,600,000
|
||||
|
Warrants issued as part of merger
|
$
|
—
|
$
|
954,879
|
||||
|
Subsidiary
|
|
BioTime Ownership
|
|
Country
|
|
ReCyte Therapeutics, Inc. (formerly Embryome Sciences, Inc.)
|
|
95.15%
|
|
USA
|
|
OncoCyte Corporation
|
|
75.3%
|
|
USA
|
|
OrthoCyte Corporation
|
|
100%
|
|
USA
|
|
ES Cell International Pte. Ltd.
|
|
100%
|
|
Singapore
|
|
BioTime Asia, Limited
|
|
81%
|
|
Hong Kong
|
|
Cell Cure Neurosciences Ltd.
|
|
53.6% (1)
|
|
Israel
|
|
LifeMap Sciences, Inc.
|
|
77.1% (2)
|
|
USA
|
|
LifeMap Sciences, Ltd.
|
|
(3)
|
|
Israel
|
|
BioTime Acquisition Corporation
|
|
96.7%
|
|
USA
|
|
(1)
|
Cell Cure Neurosciences has agreed to issue additional ordinary shares to BioTime in exchange for BioTime common shares which will increase BioTime’s ownership, directly and through ESI, to approximately 62.6%. See Note 11.
|
|
(2)
|
LifeMap Sciences, Inc. has agreed to issue additional shares of its common stock to certain investors which will reduce BioTime’s ownership 73.2%. See Note 9.
|
|
(3)
|
LifeMap Sciences, Ltd. is a wholly-owned subsidiary of LifeMap Sciences, Inc.
|
|
|
|
September 30, 2012
(unaudited)
|
|
|
December 31,
2011
|
|
||
|
Equipment, furniture and fixtures
|
|
$
|
2,062,655
|
|
|
$
|
1,900,090
|
|
|
Accumulated depreciation
|
|
|
(811,572
|
)
|
|
|
(552,311
|
)
|
|
Equipment, net
|
|
$
|
1,251,083
|
|
|
$
|
1,347,779
|
|
|
|
|
September 30, 2012
(unaudited)
|
|
|
December 31,
2011
|
|
||
|
Intangible assets
|
|
$
|
25,664,015
|
|
|
$
|
21,429,488
|
|
|
Accumulated amortization
|
|
|
(4,574,354
|
)
|
|
|
(2,809,972
|
)
|
|
Intangible assets, net
|
|
$
|
21,089,661
|
|
|
$
|
18,619,516
|
|
|
|
|
September 30, 2012
(unaudited)
|
|
|
December 31,
2011
|
|
||
|
Accounts payable
|
|
$
|
708,961
|
|
|
$
|
1,118,112
|
|
|
Accrued bonuses
|
|
|
—
|
|
|
|
583,620
|
|
|
Other accrued liabilities
|
|
|
1,453,429
|
|
|
|
979,379
|
|
|
|
|
$
|
2,162,390
|
|
|
$
|
2,681,111
|
|
|
Components of the purchase price:
|
|
|
|
|
|
BioTime common shares
|
|
$
|
1,802,684
|
|
|
LifeMap common shares
|
|
|
2,462,521
|
|
|
Total purchase price
|
|
$
|
4,265,205
|
|
|
|
|
|
|
|
|
Preliminary allocation of purchase price:
|
|
|
|
|
|
Assets acquired and liabilities assumed:
|
|
|
|
|
|
Cash
|
|
$
|
292,387
|
|
|
Other current assets
|
|
|
311,118
|
|
|
Intangible assets
|
|
|
4,234,526
|
|
|
Current liabilities
|
|
|
(294,572
|
)
|
|
Cash distributable to sellers
|
|
|
(278,254
|
)
|
|
Net assets acquired
|
|
$
|
4,265,205
|
|
|
|
|
Nine Months Ended
September 30
,
|
|
|||||
|
|
|
2012
|
|
|
2011
|
|
||
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
||
|
Revenues, net
|
|
$
|
2,984,436
|
|
|
$
|
3,285,531
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common shareholders
|
|
$
|
(15,288,233
|
)
|
|
$
|
(11,031,976
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted
|
|
$
|
(0.31
|
)
|
|
$
|
(0.23
|
)
|
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
Subsidiary
|
Field of Business
|
BioTime
Ownership
|
Country
|
|
ES Cell International Pte. Ltd.
|
Stem cell products for research, including clinical grade cell lines produced under cGMP
|
100%
|
Singapore
|
|
OncoCyte Corporation
|
Diagnosis and treatment of cancer
|
75.3%
|
USA
|
|
OrthoCyte Corporation
|
Orthopedic diseases, including osteoarthritis
|
100%
|
USA
|
|
Cell Cure Neurosciences Ltd.
|
Age-related macular degeneration
Multiple sclerosis
Parkinson’s disease
|
53.6% (1)
|
Israel
|
|
ReCyte Therapeutics, Inc.
(formerly Embryome Sciences, Inc.)
|
Blood and vascular diseases including coronary artery disease
Endothelial progenitor cells and iPS cell banking
|
95.15%
|
USA
|
|
BioTime Asia, Limited
|
Ophthalmologic, skin, musculo-skeletal system, and hematologic diseases for Asian markets.
Stem cell products for research
|
81%
|
Hong Kong
|
|
LifeMap Sciences, Inc.
|
Searchable online databases for research in the fields of biotechnology, pharmaceutical development, and life sciences
|
77.1% (2)
|
USA
|
|
LifeMap Sciences, Ltd.
|
Development of the LifeMap database and therapeutics discovery activities
|
(3)
|
Israel
|
|
BioTime Acquisition Corporation
|
Explore opportunities to acquire assets and businesses in the field of stem cells and regenerative medicine
|
96.7%
|
USA
|
|
(1)
|
Cell Cure Neurosciences has agreed to issue additional ordinary shares to BioTime in exchange for BioTime common shares which will increase BioTime’s ownership, directly and through ESI, to approximately 62.6%. See Note 11 to the Condensed Consolidated Interim Financial Statements.
|
|
(2)
|
LifeMap Sciences, Inc. has agreed to issue additional shares of its common stock to certain investors which will reduce BioTime’s ownership 73.2%. See Note 9 to the Condensed Consolidated Interim Financial Statements.
|
|
(3)
|
LifeMap Sciences, Ltd. is a wholly-owned subsidiary of LifeMap Sciences, Inc.
|
|
Company
|
Program
|
Status
|
|
BioTime(1) and ESI
|
ACTCellerate™
cell lines/growth media/reagent kits for stem cell research
GMP hES cell lines
|
Nearly 300 products for stem cell research are now being offered, including
ACTCellerate™
hEPCs,
ESpan™
cell line optimal growth media, and reagent cell differentiation kits. We plan to add additional cell lines, growth media, and differentiation kits with characterization of new hEPCs
ESI has developed and offers for sale GMP hES cell lines for research purposes. Six ESI hES cell lines have been approved by the NIH for use in federally funded research.
|
|
BioTime(1)
|
CIRM-funded research project addressing the need for industrial-scale production of purified therapeutic cells (2)
|
Conducted long-term stability studies of hEPCs using commercial-type culture processes to demonstrate phenotypic stability and genotypic stability during culture expansion.
Attempting to define a molecular signature of cell surface markers that would be unique to a given hEPC cell line to permit development of reagents to those markers that can be used to purify the target hEPCs intended for therapy.
Mapping cell surface protein expression directly on hEPCs using large collections of commercially available antibodies and have begun testing those antibodies as affinity reagents for purifying target hEPCs.
Identifying peptide reagents that show specificity for cell surface targets on hEPCs and could thus be used directly as affinity reagents.
|
|
BioTime(1) and OrthoCyte (4)
|
Biocompatible hydrogels that mimic the human extracellular matrix
|
Demonstrated that those cell lines can be combined with BioTime's
Renevia™
matrices to formulate a combination product for treating cartilage deficits.
Developed
Extralink
®
,
PEGgel™
, and
HyStem
®
hydrogel products for basic laboratory research use
Conducted pre-clinical development of
Renevia™
as an implantable cell delivery device
Conducted toxicology studies of
Renevia™
in the brains of laboratory mice. Results show no difference in reactive astrocytes, macrophages/microglia, neuronal number or blood vessel structure between saline controls and
Renevia™.
There was no evidence of granulomata or foreign body reaction around either saline or
Renevia™
injection sites.
Two U.S. patents issued on hydrogels
|
|
OncoCyte (3)
|
Vascular endothelial cells that can be engineered to deliver a toxic payload to the developing blood vessels of a tumor
|
Developed a derivation protocol that can reproducibly produce populations of endothelial cells with levels of purity and efficiency above those reported in the published literature.
Established broad range of support assays to monitor and measure vascular endothelial cell differentiation process.
Initiated in vivo experiments monitoring incorporation of endothelial cells into developing mouse vasculature and into the developing vasculature of human tumor xenografts.
Completed initial development of a toxic payload transgene system which can be induced at the site of tumors to destroy cancer cells.
|
|
|
Genetic markers for cancer diagnosis
|
Demonstrated that many of the same genes associated with the normal growth of embryonic stem cells are abnormally reactivated by cancer cells. Based on this finding, and utilizing its proprietary algorithms, OncoCyte has discovered and filed patent applications on over 100 novel cancer-associated genes.
Initiated development of
PanC-DX
™, a novel blood-based diagnostic screening test designed to detect the presence of multiple cancer types with superior accuracy
|
|
Company
|
Program
|
Status
|
|
OrthoCyte (4)
|
Cartilage repair using embryonic progenitor cells
|
Identified several cell lines that displayed molecular markers consistent with the production of definitive human cartilage.
Confirmed chondrogenic potential in joint defects in rat models of osteoarthritis.
|
|
ReCyte Therapeutics
|
Therapeutic products for cardiovascular and blood diseases utilizing its proprietary
ReCyte™
iPS technology.
|
Evaluating effects of telomere length on growth potential of iPS cells and iPS-derived progenitor lines.
Through BioTime, formed a collaboration with researchers at Cornell Weill Medical College to derive clinical vascular endothelium for the treatment of age-related vascular disease.
Demonstrated the feasibility of producing highly purified product using
ACTCellerate™
technology.
|
|
BioTime
|
Hextend
®
– Blood plasma volume expanders
|
Hextend
®
is currently marketed to hospitals and physicians in the USA and Korea. Activities include complying with all regulatory requirements and promotional activities.
|
|
BioTime Asia
|
Distributing
ACTCellerate™
hEPC lines growth media and reagents
|
Initial sales of cell lines, growth media, and differentiation kits, to customers in Asia.
|
|
Cell Cure
Neurosciences (5)
|
OpRegen™
and
OpRegen-Plus™
for treatment of age related macular degeneration
|
Conducted animal model studies to establish proof of concept.
Developed directed differentiation as efficient method for short culture period to produce a supply of retinal pigment epithelial cells.
Granted Teva Pharmaceutical Industries, Ltd. an option to complete clinical development of, and to manufacture, distribute, and sell,
OpRegen™
and
OpRegen-Plus™.
|
|
LifeMap (6)
|
Online, searchable databases
|
Marketing searchable, integrated, database products, including:
·
GeneCards
®
, a database of human genes that provides concise genomic, transcriptomic, genetic, proteomic, functional and disease related information, on all known and predicted human genes;
·
MalaCards
, a database of human diseases that is based on the
GeneCards
®
platform and contains computerized “cards” classifying information relating to a wide array of human diseases; and
·
PanDaTox
, an innovative, recently developed, searchable database that can aid in the discovery of new antibiotics and biotechnologically beneficial products.
Plans to also market
·
LifeMap Discovery™
, a database of embryonic development, stem cell research and regenerative medicine; and
·
BioTime research products.
|
|
|
|
|
Amount
|
|
Percent
|
||||||||||
|
Company
|
Program
|
|
2012
|
|
|
2011
|
|
2012
|
|
|
2011
|
||||
|
BioTime, ReCyte Therapeutics,
and ESI
|
ACTCellerate
hEPCs, GMP hES cell lines, and related research products
|
|
$
|
2,057,859
|
|
|
$
|
2,458,649
|
|
15.4
|
%
|
|
25.2
|
%
|
|
|
BioTime
|
CIRM sponsored ACTCellerate technology
|
|
$
|
794,632
|
|
|
$
|
1,363,363
|
|
6.0
|
%
|
|
14.0
|
%
|
|
|
BioTime and OrthoCyte(1)
|
Hydrogel products and
HyStem
®
research
|
|
$
|
2,560,964
|
|
|
$
|
400,030
|
|
19.2
|
%
|
|
4.1
|
%
|
|
|
OncoCyte
|
Cancer therapy and diagnostics
|
|
$
|
2,252,071
|
|
|
$
|
1,663,869
|
|
16.9
|
%
|
|
17.0
|
%
|
|
|
OrthoCyte
|
Orthopedic therapy
|
|
$
|
679,166
|
|
|
$
|
650,393
|
|
5.1
|
%
|
|
6.7
|
%
|
|
|
ReCyte Therapeutics
|
IPS and vascular therapy
|
|
$
|
971,572
|
|
|
$
|
265,350
|
|
7.3
|
%
|
|
2.7
|
%
|
|
|
BioTime
|
HyStem
®
|
|
$
|
266,652
|
|
|
$
|
247,571
|
|
2.0
|
%
|
|
2.5
|
%
|
|
|
BioTime Asia
|
Stem cell products for research
|
|
$
|
109,807
|
|
|
$
|
145,149
|
|
0.8
|
%
|
|
1.5
|
%
|
|
|
Cell Cure Neurosciences
|
OpRegen™
,
OpRegen-Plus™
, and neurological disease therapies
|
|
$
|
2,409,095
|
|
|
$
|
2,283,475
|
|
18.1
|
%
|
|
23.4
|
%
|
|
|
LifeMap
|
Database development
|
|
$
|
1,221,592
|
|
|
$
|
278,594
|
|
9.2
|
%
|
|
2.9
|
%
|
|
|
(1)
|
OrthoCyte transferred its
HyStem
®
product line and related research to BioTime during January 2012.
|
|
|
|
Amount
|
|
Percent
|
|||||||||||
|
Company
|
|
2012
|
|
|
2011
|
|
2012
|
|
|
2011
|
|||||
|
BioTime
|
|
$
|
3,264,699
|
|
|
$
|
2,719,755
|
|
46.4
|
% |
|
|
43.9
|
%
|
|
|
BAC
|
$
|
32,308
|
$
|
—
|
0.5
|
% |
0.0
|
||||||||
|
BioTime Asia
|
|
$
|
799,098
|
|
|
$
|
802,951
|
|
11.3
|
% |
|
|
13.0
|
%
|
|
|
Cell Cure Neurosciences*
|
|
$
|
525,450
|
|
|
$
|
436,790
|
|
7.5
|
% |
|
|
7.0
|
%
|
|
|
ESI*
|
|
$
|
392,411
|
|
|
$
|
363,670
|
|
5.6
|
% |
|
|
5.9
|
%
|
|
|
LifeMap
|
|
$
|
909,518
|
|
|
$
|
236,713
|
|
12.9
|
% |
|
|
3.8
|
%
|
|
|
OncoCyte
|
|
$
|
511,614
|
|
|
$
|
505,308
|
|
7.3
|
% |
|
|
8.2
|
%
|
|
|
OrthoCyte
|
|
$
|
304,867
|
|
|
$
|
769,650
|
|
4.3
|
% |
|
|
12.4
|
%
|
|
|
ReCyte Therapeutics
|
|
$
|
297,842
|
|
|
$
|
358,546
|
|
4.2
|
% |
|
|
5.8
|
%
|
|
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
|
Item 4.
|
Controls and Procedures
|
|
Item 1.
|
Controls and Procedures
|
|
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 $13,323,410 during the nine months ended September 30, 2012, and $13,699,691, $8,191,314, and $3,181,729 during the fiscal years ended December 31, 2011, 2010, and 2009, respectively.
|
|
|
●
|
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.
|
|
|
●
|
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 pharmaceutical 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 human embryonic stem 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 human embryonic stem cells.
|
|
|
●
|
Hextend
®
is presently the only plasma expander product that we have on the market, and it is being sold only in the United States 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 will receive additional license fees and royalties if our licensees are successful in marketing
Hextend
®
and
PentaLyte
®
in Japan, Taiwan, and China, but they have not yet obtained the regulatory approvals required to begin selling those products.
|
|
|
●
|
We are also beginning to bring 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/McGaw presently markets
Hespan
®
, an artificial plasma volume expander, and Hospira and Baxter International, Inc. manufacture and 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.
|
|
|
●
|
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 September 30, 2012, we had
$
7,830,347 of cash and cash equivalents on hand. There can be no assurance that we or our subsidiaries will be able to raise additional 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 some laboratory research and development work unless our cash resources increase through a growth in revenues or additional equity investment or borrowing.
|
|
|
●
|
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 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 drug 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.
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A product that is approved may be subject to restrictions on use.
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The FDA can recall or withdraw approval of a product if problems arise.
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We will face similar regulatory issues in foreign countries.
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Government-imposed restrictions with respect to the use of embryos or human embryonic stem cells in research and development could limit our ability to conduct research and develop new products.
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Government-imposed bans, restrictions on the use of embryos or hES cells in the United States and abroad could generally constrain stem cell research, thereby limiting the market and demand for our products. During March 2009, President Obama lifted certain restrictions on federal funding of research involving the use of hES cells, and in accordance with President Obama’s Executive Order, the National Institutes of Health (“NIH”) has adopted new guidelines for determining the eligibility of hES cell lines for use in federally funded research. The central focus of the proposed guidelines is to assure that hES cells used in federally funded research were derived from human embryos that were created for reproductive purposes, were no longer needed for this purpose, and were voluntarily donated for research purposes with the informed written consent of the donors. The hES cells that were derived from embryos created for research purposes rather than reproductive purposes, and other hES cells that were not derived in compliance with the guidelines, are not eligible for use in federally funded research.
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California law requires that stem cell research be conducted under the oversight of a stem cell research oversight committee (“SCRO”). Many kinds of stem cell research, including the derivation of new hES cell lines, may only be conducted in California with the prior written approval of the SCRO. A SCRO could prohibit or impose restrictions on the research that we plan to do.
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The use of hES cells gives rise to religious, moral, and ethical issues regarding the appropriate means of obtaining the cells and the appropriate use and disposal of the cells. These considerations could lead to more restrictive government regulations or could generally constrain stem cell research, thereby limiting the market and demand for our products.
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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.
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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.
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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.
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We have filed patent applications for technology that we have developed, and we have obtained licenses for a number of patent applications covering technology developed by others, that we believe will be useful in producing new products, and which we believe may be of commercial interest to other companies that may be willing to sublicense the technology for fees or royalty payments. In the future, we may also file additional new patent applications seeking patent protection for new technology or products that we develop ourselves or jointly with others. However, there is no assurance that any of our licensed patent applications, or any patent applications that we have filed or that we may file in the future covering our own technology, either in the United States or abroad, will result in the issuance of patents.
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In Europe, the European Patent Convention prohibits the granting of European patents for inventions that concern “uses of human embryos for industrial or commercial purposes.” The European Patent Office is presently interpreting this prohibition broadly, and is applying it to reject patent claims that pertain to human embryonic stem cells. However, this broad interpretation is being challenged through the European Patent Office appeals system. As a result, we do not yet know whether or to what extent we will be able to obtain patent protection for our human embryonic stem cell technologies in Europe.
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The recent Supreme Court decision in
Mayo Collaborative Services v. Prometheus Laboratories, Inc.
, will need to be considered in determining whether certain diagnostic methods can be patented, since the Court denied patent protection for the use of a mathematical correlation of the presence of a well-known naturally occurring metabolite as a means of determining proper drug dosage. Our subsidiary OncoCyte is developing
PanC-Dx™
as a cancer diagnostic test, based on the presence of certain genetic markers for a variety of cancers. Because
PanC-Dx™
combines an innovative methodology with newly discovered compositions of matter, we are hopeful that this Supreme Court decision will not preclude the availability of patent protection for OncoCyte’s new product. However, like other developers of diagnostic products, we are evaluating this new Supreme Court decision and are waiting to see if the United States Patent and Trademark Office will issue any new guidelines for the patenting of products that test for biological substances.
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The preparation and filing of patent applications, and the maintenance of patents that are issued, may require substantial time and money.
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A patent interference proceeding may be instituted with the United States Patent and Trademark Office (“U.S. PTO”) 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 PTO will 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 PTO’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.
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Oppositions to the issuance of patents may be filed under European patent law and the patent laws of certain other countries. As with the U.S. PTO 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.
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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.
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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.
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In addition to interference proceedings, the U.S. PTO 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.
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The market price of our shares, like that of the shares of many biotechnology companies, has been highly volatile.
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The price of our 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.
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Similarly, prices of our 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.
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The failure of our earnings to meet analysts’ expectations could result in a significant rapid decline in the market price of our common shares.
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Item 2.
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Unregistered Sales of Equity Securities and Use of Proceeds.
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Item 3.
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Default Upon Senior Securities.
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Item 4.
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Mine Safety Disclosures
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Item 5.
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Other Information.
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Item 6.
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Exhibits
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Exhibit
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Numbers
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Description
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2.1
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|
Agreement and Plan of Merger, dated April 19, 2012, by and among XenneX, Inc., LifeMap Sciences, Inc., BioTime, Inc. and the stockholders of XenneX, Inc. named therein. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment) (1)
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3.1
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Articles of Incorporation with all amendments. (2)
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3.2
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By-Laws, As Amended. (3)
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4.1
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Share Exchange and Contribution Agreement, dated July 24, 2012, among LifeMap Sciences, Inc., Alfred D. Kingsley, and Greenway Partners, L.P. (4)
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10.1
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Exclusive License Agreement, dated February 15, 2006, between Glycosan BioSystems, Inc. and the University of Utah Research Foundation, as amended.*
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10.2
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Amendment to Share Exchange and Contribution Agreement, dated September 28, 2012, by and among LifeMap Sciences, Inc., Alfred D. Kingsley, and Greenway Partners, L.P.*
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10.3
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Share Purchase Agreement, dated November 1, 2012, between Cell Cure Neurosciences, Ltd. and BioTime, Inc.*
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31
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Rule 13a-14(a)/15d-14(a) Certification.*
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32
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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)
|
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended March 31, 2012.
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(2)
|
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended September 30, 2009.
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(3)
|
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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(4)
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Incorporated by reference to Registration Statement on Form S-3, File Number 333-182964 filed with the Securities and Exchange Commission on July 31, 2012.
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*
|
Filed herewith
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|
BIOTIME, INC.
|
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Date: November 9, 2012
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/s/ Michael D. West
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Michael D. West
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Chief Executive Officer
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Date: November 9, 2012
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/s/ Peter S. Garcia
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Peter S. Garcia
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Chief Financial Officer
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Exhibit
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|
Numbers
|
|
Description
|
|
|
|
|
|
2.1
|
|
Agreement and Plan of Merger, dated April 19, 2012, by and among XenneX, Inc., LifeMap Sciences, Inc., BioTime, Inc. and the stockholders of XenneX, Inc. named therein. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment) (1)
|
|
|
|
|
|
3.1
|
|
Articles of Incorporation with all amendments. (2)
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3.2
|
|
By-Laws, As Amended. (3)
|
|
|
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4.1
|
|
Share Exchange and Contribution Agreement, dated July 24, 2012, among LifeMap Sciences, Inc., Alfred D. Kingsley, and Greenway Partners, L.P.(4)
|
|
|
|
|
|
|
Exclusive License Agreement, dated February 15, 2006, between Glycosan BioSystems, Inc. and the University of Utah Research Foundation, as amended.*
|
|
|
|
|
|
|
|
Amendment to Share Exchange and Contribution Agreement, dated September 28, 2012, by and among LifeMap Sciences, Inc., Alfred D. Kingsley, and Greenway Partners, L.P.*
|
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|
Share Purchase Agreement, dated November 1, 2012, between Cell Cure Neurosciences, Ltd. and BioTime, Inc.*
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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
|
|
|
|
|
|
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 *
|
|
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101.DEF
|
|
XBRL Taxonomy Extension Definition Document *
|
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(1)
|
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended March 31, 2012
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(2)
|
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended September 30, 2009.
|
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(3)
|
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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(4)
|
Incorporated by reference to Registration Statement on Form S-3, File Number 333-182964 filed with the Securities and Exchange Commission on July 31, 2012.
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*
|
Filed herewith
|
|
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 |
|---|