FORM
10-Q
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
(Mark
One)
[X] QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For the
quarterly period ended March 31, 2009
OR
[ ] TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For the
transition period from
to
Commission
file number
1-12830
BioTime,
Inc.
(
Exact
name of registrant as specified in its
charter)
California
|
94-3127919
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification
No.)
|
1301
Harbor Bay Parkway, Suite 100
Alameda,
California 94502
(Address
of principal executive offices)
(510)
521-3390
(Registrant's
telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90
days.
S
Yes
£
No
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of “large
accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule
12b-2 of the Exchange Act).
Large accelerated filer
£
Accelerated filer
£
Non-accelerated filer
£
(Do not check if a smaller reporting
company)
Smaller reporting
company
S
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
£
Yes
S
No
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate the number of shares
outstanding of each of the issuer's classes of common stock, as of the latest
practicable date. 25,889,693 common shares, no par value, as of April
23, 2009
.
PART
1--FINANCIAL INFORMATION
Statements made in this Report that are
not historical facts may constitute forward-looking statements that are subject
to risks and uncertainties that could cause actual results to differ materially
from those discussed. Such risks and uncertainties include but are
not limited to those discussed in this report under Item 1 of the Notes to
Financial Statements, and in BioTime's Annual Report on Form 10-K filed with the
Securities and Exchange Commission. Words such as “expects,” “may,” “will,”
“anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar
expressions identify forward-looking statements.
Item
1. Financial Statements
BIOTIME,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
ASSETS
|
|
March
31,
2009
(unaudited)
|
|
|
December
31, 2008
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
541,106
|
|
|
$
|
12,279
|
|
Prepaid
expenses and other current assets
|
|
|
109,277
|
|
|
|
96,595
|
|
Total
current assets
|
|
|
650,383
|
|
|
|
108,874
|
|
|
|
|
|
|
|
|
|
|
Equipment,
net of accumulated depreciation of $610,662 and $602,510,
respectively
|
|
|
100,719
|
|
|
|
105,607
|
|
Deferred
license fees
|
|
|
870,000
|
|
|
|
750,000
|
|
Deposits
|
|
|
75,002
|
|
|
|
70,976
|
|
TOTAL
ASSETS
|
|
$
|
1,696,104
|
|
|
$
|
1,035,457
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$
|
651,412
|
|
|
$
|
1,179,914
|
|
Lines
of credit payable, net
|
|
|
3,519,432
|
|
|
|
1,885,699
|
|
Deferred
license revenue, current portion
|
|
|
312,904
|
|
|
|
312,904
|
|
Total
current liabilities
|
|
|
4,483,748
|
|
|
|
3,378,517
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Stock
appreciation rights compensation liability
|
|
|
702,155
|
|
|
|
483,688
|
|
Deferred
license revenue, net of current portion
|
|
|
1,443,501
|
|
|
|
1,516,727
|
|
Deferred
rent, net of current portion
|
|
|
6,386
|
|
|
|
3,339
|
|
Total
long-term liabilities
|
|
|
2,152,042
|
|
|
|
2,003,754
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
(DEFICIT):
|
|
|
|
|
|
|
|
|
Common
shares, no par value, authorized 50,000,000 shares; issued and outstanding
25,416,562 and 25,076,798 shares at March 31, 2009 and December 31, 2008,
respectively
|
|
|
44,109,948
|
|
|
|
43,184,606
|
|
Contributed
capital
|
|
|
93,972
|
|
|
|
93,972
|
|
Accumulated
deficit
|
|
|
(49,143,606
|
)
|
|
|
(47,625,392
|
)
|
Total
shareholders' deficit
|
|
|
(4,939,686
|
)
|
|
|
(4,346,814
|
)
|
TOTAL
LIABILITIES AND SHAREHOLDERS' (DEFICIT)
|
|
$
|
1,696,104
|
|
|
$
|
1,035,457
|
|
See
accompanying notes to the condensed consolidated interim financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended
|
|
|
|
March
31, 2009
|
|
|
March
31, 2008
|
|
|
|
|
|
|
|
|
REVENUES:
|
|
|
|
|
|
|
License
fees
|
|
$
|
73,226
|
|
|
$
|
66,183
|
|
Royalties
from product sales
|
|
|
222,667
|
|
|
|
308,900
|
|
Other
revenue
|
|
|
850
|
|
|
|
5,935
|
|
Total
revenues
|
|
|
296,743
|
|
|
|
381,018
|
|
|
|
|
|
|
|
|
|
|
EXPENSES:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
(525,824
|
)
|
|
|
(347,151
|
)
|
General
and administrative
|
|
|
(682,174
|
)
|
|
|
(435,939
|
)
|
Total
expenses
|
|
|
(1,207,998
|
)
|
|
|
(783,090
|
)
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(911,255
|
)
|
|
|
(402,072
|
)
|
OTHER
INCOME/(EXPENSES):
|
|
|
|
|
|
|
|
|
Interest
expenses
|
|
|
(608,027
|
)
|
|
|
(76,521
|
)
|
Other
income
|
|
|
1,068
|
|
|
|
2,545
|
|
Total
other expenses, net
|
|
|
(606,959
|
)
|
|
|
(73,976
|
)
|
NET
LOSS
|
|
$
|
(1,518,214
|
)
|
|
$
|
(476,048
|
)
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
|
$
|
(0.06
|
)
|
|
$
|
(0.02
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND
DILUTED
|
|
|
25,303,963
|
|
|
|
23,042,945
|
|
See
accompanying notes to the condensed consolidated interim financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Three
months Ended
|
|
|
|
March 31,
2009
|
|
|
March 31,
2008
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(1,518,214
|
)
|
|
$
|
(476,048
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
8,152
|
|
|
|
1,230
|
|
Deferred license revenue
|
|
|
(73,226
|
)
|
|
|
(29,335
|
)
|
Amortization
of deferred finance cost on lines of credit
|
|
|
513,836
|
|
|
|
51,282
|
|
Amortization
of deferred consulting fees
|
|
|
32,793
|
|
|
|
–
|
|
Stock-based
compensation
|
|
|
31,538
|
|
|
|
39,364
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
(603
|
)
|
|
|
(6,552
|
)
|
Prepaid
expenses and other current assets
|
|
|
(30,153
|
)
|
|
|
19,974
|
|
Accounts
payable and accrued liabilities
|
|
|
(299,002
|
)
|
|
|
108,624
|
|
Interest
on lines of credit
|
|
|
87,580
|
|
|
|
21,183
|
|
Stock
appreciation rights compensation liability
|
|
|
218,467
|
|
|
|
–
|
|
Deferred
rent
|
|
|
3,047
|
|
|
|
29
|
|
Net
cash used in operating activities
|
|
|
(1,025,785
|
)
|
|
|
(270,249
|
)
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase
of equipment
|
|
|
(3,264
|
)
|
|
|
(1,389
|
)
|
Security
deposit
|
|
|
(4,026
|
)
|
|
|
–
|
|
Net
cash used in investing activities
|
|
|
(7,290
|
)
|
|
|
(1,389
|
)
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Repayment
of line of credit
|
|
|
(1,848
|
)
|
|
|
(5,392
|
)
|
Borrowings
under lines of credit
|
|
|
1,480,000
|
|
|
|
575,000
|
|
Issuance
of common shares for exercise of options
|
|
|
83,750
|
|
|
|
–
|
|
Net
cash provided by financing activities
|
|
|
1,561,902
|
|
|
|
569,608
|
|
|
|
|
|
|
|
|
|
|
NET
INCREASE IN CASH AND CASH EQUIVALENTS:
|
|
|
528,827
|
|
|
|
297,970
|
|
Cash
and cash equivalents at beginning of period
|
|
|
12,279
|
|
|
|
9,501
|
|
Cash
and cash equivalents at end of period
|
|
$
|
541,106
|
|
|
$
|
307,471
|
|
Supplemental
disclosure of cash flow statement
|
|
|
|
|
|
|
|
|
Cash
paid during the period for interest
|
|
$
|
6,430
|
|
|
$
|
4,057
|
|
SUPPLEMENTAL
SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Issuance
of stock related to line of credit agreement
|
|
$
|
93,024
|
|
|
$
|
(153,200
|
)
|
Common
shares issued for accounts payable
|
|
$
|
229,500
|
|
|
|
–
|
|
Common
shares issued for deferred license fees
|
|
$
|
120,000
|
|
|
|
–
|
|
Common
shares issued for line of credit conversion
|
|
$
|
52,911
|
|
|
|
–
|
|
Warrants
issued for services
|
|
$
|
14,719
|
|
|
|
–
|
|
Right
to exchange promissory notes for stock
|
|
$
|
299,900
|
|
|
|
–
|
|
See
accompanying notes to the condensed consolidated interim financial
statements.
BIOTIME,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
1. Organization,
Basis of Presentation, and Summary of Select Significant Accounting
Policies
General
- BioTime is a
biotechnology company engaged in two areas of biomedical research and product
development. First, BioTime has historically developed blood plasma
volume expanders, and related technology for use in surgery, emergency trauma
treatment and other applications. Second, BioTime’s regenerative
medicine business is operated through its wholly owned subsidiary,
Embryome Sciences, Inc
. Regenerative
medicine refers to therapies based on human embryonic stem (“hES”) cell
technology that are designed to rebuild cell and tissue function lost due to
degenerative disease or injury. These novel stem cells provide a
means of manufacturing every cell type in the human body and therefore show
considerable promise for the development of a number of new therapeutic
products. BioTime is focusing its current efforts in the regenerative medicine
field on the development and sale of advanced human stem cell products and
technology that can be used by researchers at universities and other
institutions, at companies in the bioscience and biopharmaceutical industries,
and at other companies that provide research products to companies in those
industries. These research-only markets generally can be marketed without
regulatory (FDA) approval, and are therefore relatively near-term business
opportunities when compared to therapeutic products. BioTime’s
operating revenues have been derived almost exclusively from royalties and
licensing fees related to the sale of its plasma volume expander products,
primarily Hextend®. BioTime began to make its first stem cell
research products available during 2008 but has not yet generated significant
revenues in that business segment. BioTime’s ability to generate
substantial operating revenue depends upon its success in developing and
marketing or licensing its plasma volume expanders and stem cell products and
technology for medical and research use.
The
unaudited condensed consolidated interim balance sheet as of March 31, 2009, the
unaudited condensed consolidated interim statements of operations for the three
months ended March 31, 2009 and 2008, and the unaudited condensed consolidated
interim statements of cash flows for the three months ended March 31, 2009 and
2008 have been prepared by BioTime’s management in accordance with the
instructions from the Form 10-Q and Article 8-03 of Regulation
S-X. In the opinion of management, all adjustments (consisting only
of normal recurring adjustments) necessary to present fairly the financial
position, results of operations, and cash flows at March 31, 2009 and for all
interim periods presented have been made. The balance sheet as of
December 31, 2008 is derived from the Company's audited financial statements as
of that date. The results of operations for the three months ended
March 31, 2009 are not necessarily indicative of the operating results
anticipated for the full year of 2009.
Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been
condensed or omitted as permitted by regulations of the Securities and Exchange
Commission (“SEC”) except for the condensed consolidated balance sheet as of
December 31, 2008, which was derived from audited financial
statements. Certain previously furnished amounts have been
reclassified to conform with presentations made during the current
periods. It is suggested that these condensed consolidated interim
financial statements be read in conjunction with the annual audited financial
statements and notes thereto included in BioTime's Form 10-K for the year ended
December 31, 2008.
Principles of Consolidation –
The accompanying condensed consolidated interim financial statements
include the accounts of Embryome Sciences, Inc., a wholly-owned subsidiary of
BioTime. All material intercompany accounts and transactions have
been eliminated in consolidation. The condensed consolidated interim
financial statements are presented in accordance with accounting principles
generally accepted in the United States and with the accounting and reporting
requirements of Regulation S-X of the SEC.
Certain Significant Risks and
Uncertainties
- BioTime’s operations are subject to a number of factors
that can affect its operating results and financial condition. Such factors
include but are not limited to the following: the results of clinical trials of
BioTime’s pharmaceutical products; BioTime’s ability to obtain United States
Food and Drug Administration and foreign regulatory approval to market its
pharmaceutical products; BioTime’s ability to develop new stem cell research
products and technologies; competition from products manufactured and sold or
being developed by other companies; the price and demand for BioTime products;
BioTime’s ability to obtain additional financing and the terms of any such
financing that may be obtained; BioTime’s ability to negotiate favorable
licensing or other manufacturing and marketing agreements for its products; the
availability of ingredients used in BioTime’s products; and the availability of
reimbursement for the cost of BioTime’s pharmaceutical products (and related
treatment) from government health administration authorities, private health
coverage insurers and other organizations.
Use of Estimates
- The
preparation of unaudited condensed consolidated interim financial statements in
conformity with accounting principles generally accepted in the United States of
America requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the unaudited condensed consolidated interim
financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those
estimates.
Effect of recent accounting
pronouncements
- On April 9, 2009, the Financial Accounting Standards
Board (“FASB”) issued FSP FAS 157-4, “Determining Fair Value When the Volume and
Level of Activity for the Asset or Liability Have Significantly Decreased and
Identifying Transactions That Are Not Orderly”. This FASB FSP provides
additional guidance for estimating fair value in accordance with FASB Statement
No. 157, “Fair Value Measurements”, when the volume and level of activity for
the asset or liability have significantly decreased. This FSP also includes
guidance on identifying circumstances that indicate a transaction is not
orderly. This FSP will be effective for interim and annual reporting periods
ending after June 15, 2009, and will be applied prospectively. BioTime does not
anticipate that this FSP will have any material impact upon its preparation of
its financial statements.
On April
1, 2009, the FASB issued FSP FAS 141(R)-1, “Accounting for Assets and
Liabilities Assumed in a Business Combination That Arise from Contingencies”.
This FASB FSP amends and clarifies FASB Statement No. 141 (revised 2007),
“Business Combinations”, to address application issues raised by preparers,
auditors, and members of the legal profession on initial recognition and
measurement, subsequent measurement and accounting, and disclosure of assets and
liabilities arising from contingencies in a business combination. This FSP will
be effective for assets or liabilities arising from contingencies in business
combinations for which the acquisition date is on or after the beginning of the
first annual reporting period beginning on or after December 15, 2008. BioTime
does not anticipate that this FSP will have any material impact upon its
preparation of its financial statements.
On April
9, 2009, the FASB issued FSP FAS 115-2 and FAS 124-2, “Recognition and
Presentation of Other-Than-Temporary Impairments”. This FSP amends the
other-than-temporary impairment guidance in U.S. GAAP for debt securities to
make the guidance more operational and to improve the presentation and
disclosure of other-than-temporary impairments on debt and equity securities in
the financial statements. This FSP does not amend existing recognition and
measurement guidance related to other-than-temporary of equity securities. This
FSP will be effective for interim and annual reporting periods ending after June
15, 2009. BioTime does not anticipate that this FSP will have any material
impact upon its preparation of its financial statements.
On April
9, 2009, the FASB issued FSP FAS 107-1 and APB 28-1, “Interim Disclosures about
Fair Value of Financial Instruments”. This FSP amends FASB Statement No. 107,
“Disclosures about Fair Value of Financial Instruments”, to require disclosures
about fair value of financial instruments for interim reporting periods of
publicly traded companies as well as in annual financial statements. This FSP
also amends APB Opinion No. 28, “Interim Financial Reporting”, to require those
disclosures in summarized financial information at interim reporting periods.
This FSP will be effective for interim reporting periods ending after June 15,
2009. BioTime does not anticipate that this FSP will have any material impact
upon its preparation of its financial statements.
In
January 2009, the FASB issued FSP EITF 99-20-1, “Amendments to the Impairment
Guidance of EITF Issue No. 99-20”. This FSP amends the impairment guidance in
EITF issue No. 99-20, “Recognition of Interest Income and Impairment on
Purchased Beneficial Interests and Beneficial Interests That Continue to Be Held
by a Transferor in Securitized Financial Assets”, to achieve more consistent
determination of whether an other-than-temporary impairment has occurred. This
FSP also retains and emphasizes the objective of an other-than-temporary
impairment assessment and the related disclosure requirements in FASB Statement
No. 115, “Accounting for Certain Investments in Debt and Equity Securities”, and
other related guidance. This FSP will be effective for interim and annual
reporting periods ending after December 15, 2009, and will be applied
prospectively. BioTime does not anticipate that this FSP will have any material
impact upon its preparation of its financial statements.
BioTime
has a Revolving Line of Credit Agreement (the “Credit Agreement”) with certain
private lenders that is collateralized by a security interest in BioTime’s right
to receive royalty and other payments under its license agreement with Hospira,
Inc. BioTime may borrow up to $3,500,000 under the Credit
Agreement. Following an amendment to the Credit Agreement in April
2009, the maturity date of this Revolving Line of Credit has been extended to
December 1, 2009 with respect to $2,669,282 in principal amount of
loans. BioTime repaid $223,834 of principal and accrued interest on
loans that matured on April 15, 2009 and were not extended. In
addition, certain lenders exercised their right to exchange $572,404 of
principal and accrued interest on loans for an aggregate of 381,605 BioTime
common shares.
BioTime
may borrow up to an additional $830,718 under its Revolving Line of Credit if
BioTime elects to do so and is able to obtain additional loan commitments from
its current lenders or from new lenders.
Lenders
who agreed to extend the maturity date of their outstanding loans will receive
from BioTime a number of common shares having an aggregate market value
(based on closing price of the shares on the OTC-BB) equal to six percent (6%)
of the lender’s loan commitment, as consideration for the extension of the term
of their loans. BioTime issued 91,526 common shares to those
lenders. BioTime will issue additional common shares on the same
basis to any lenders who provide additional loan commitments under
the Revolving Line of Credit.
Lenders
who extended the maturity date of their line of credit promissory notes, and any
new lenders who make additional loan commitments, will have the right to
exchange their promissory notes for BioTime common shares and for shares of
Embryome Sciences, Inc. common stock. Promissory notes that were
exchangeable for BioTime common shares at a price of $1.25 per share and
Embryome Sciences common stock at a price of $2.25 per share until April 15,
2009, may now be exchanged for BioTime common shares at $1.50 per share and for
Embryome Sciences common stock at $2.75 per share until the extended maturity
date, December 1, 2009. Promissory notes that were exchangeable for
BioTime common shares at a price of $1.50 and Embryome Sciences common stock at
$2.50 until April 15, 2009, may now be exchanged for BioTime common shares at
$1.75 per share and Embryome Sciences common stock at $3.00 per share until the
extended maturity date. Promissory notes issued for new loan
commitments will be exchangeable for BioTime common shares at a price of $2.00
per share, and for Embryome Sciences common stock at $3.50 per share until
December 1, 2009. The foregoing per share exchange prices are subject
to proportional adjustment in the event of a stock split, reverse stock split,
or similar event.
During
the quarter ended March 31, 2009, BioTime drew $1,480,000 under the Credit
Agreement. BioTime recognized as part of its interest expense an
imputed cost arising from the right of Credit Agreement lenders to exchange
their promissory notes for BioTime common shares at a discounted price.
BioTime determined the total imputed cost to be $299,900 of which $232,801 was
charged to interest during the three months ended March 31, 2009, and
the remaining portion of which will be charged as interest during the remaining
term of the promissory notes.
BioTime
also obtained a line of credit from American Express in August 2004, which
allows for borrowings up to $25,300; at March 31, 2009, BioTime had drawn
$20,751 against this line. Interest is paid monthly on borrowings at a total
rate equal to the prime rate plus 3.99%; however, regardless of the prime rate,
the interest rate payable will at no time be less than 9.49%.
BioTime
also secured a line of credit from Advanta in November 2006, which allows for
borrowings up to $35,000; at March 31, 2009, BioTime had drawn $31,253 against
this line. Interest is payable on borrowings at a Variable Rate
Index, which will at no time be less than 8.25%.
The Company has accrued interest of
$159,196 as of March 31, 2009.
3.
Deferred License
Fees
In February 2009, BioTime’s wholly owned subsidiary, Embryome Sciences, Inc.,
entered into a Stem Cell Agreement with Reproductive Genetic Institute
(“RGI”). In partial consideration of the rights and licenses granted
to Embryome Sciences, Inc., by RGI, BioTime issued to RGI 32,259 common shares
of BioTime stock, which was equal to $50,000 worth of such common shares on the
Effective Date of the Stem Cell Agreement.
In March
2009, BioTime amended its license agreement with the Wisconsin Alumni Research
Foundation (“WARF”). The amendment increased the license fee from
$225,000 to $295,000, of which $225,000 is payable in cash and $70,000 was
payable by delivering BioTime common shares having a market value of $70,000 as
of March 2, 2009. The amendment extends until March 2, 2010 the dates
for payment of the $215,000 balance of the cash license fee and $20,000 in
remaining reimbursement of costs associated with preparing, filing and
maintaining the Licensed Patents by WARF to January 3, 2010. The
commencement date for payment of the annual $25,000 license maintenance fee has
also been extended to March 2, 2010.
4. Issuance
of Common Shares
Shareholders' deficit increased by a total of $925,342, changing from
$43,184,608 at December 31, 2008 to $44,109,948 at March 31, 2009. This
increase was due to issuances of BioTime common shares for accounts payable
related to consulting services and license fees totaling $349,500, to issuances
of BioTime common shares for new funds received during the quarter in the amount
of $93,024 and debt converted to equity in the amount of $52,911 in accordance
with the Credit Agreement, to FAS 123R valuation of options and warrants vested
during the quarter for a total value of $46,257, to $299,900 arising from the
right of Credit Agreement lenders to exchange promissory notes for common
shares, and to options being exercised at a total value of
$83,750.
5.
Loss Per Share
Basic
loss per share excludes dilution and is computed by dividing net loss by the
weighted average number of common shares outstanding during the
period. Diluted loss per share reflects the potential dilution from
securities and other contracts which are exercisable or convertible into common
shares. For the three months ended March 31, 2009 and 2008, options
to purchase 3,440,832 and 3,283,332 common shares, respectively, and warrants to
purchase 7,847,867 and 7,847,867 common shares, respectively, were excluded from
the computation of loss per share as their inclusion would be
antidilutive. As a result, there is no difference between basic and
diluted calculations of loss per share for all periods presented.
6. Subsequent
Events
In April
2009, the California Institute of Regenerative Medicine (“CIRM”) awarded BioTime
a $4,721,706 grant for a stem cell research project related to its ACTCellerate™
embryonic stem cell technology. BioTime’s grant project is titled
“Addressing the Cell Purity and Identity Bottleneck through Generation and
Expansion of Clonal Human Embryonic Progenitor Cell Lines.” The
overall objective of the research project is to generate tools useful in
applying ACTCellerate™ technology to the manufacture of patient-specific
therapeutic products.
CIRM will provide funding
for this research project over a period of three years, with approximately
$1,600,000 expected to be available during the first 12
months. BioTime expects that the first funds will be available some
time during the summer of 2009 and that work on the project will be ready to
begin upon the receipt of funding.
In May
2009, BioTime received royalties in the amounts of $329,809 and $19,112 from
Hospira and CJ CheilJedang Corp. (“CJ”), respectively. These amounts
are based on sales of Hextend made by Hospira and CJ in the first quarter of
2009, and will be reflected in BioTime’s condensed consolidated interim
financial statements for the second quarter of 2009.
On May
13, 2009, BioTime raised $4,000,000 of equity capital through the sale of
2,200,000 common shares and 2,200,000 stock purchase warrants to two private
investors. The warrants entitle the investors to purchase additional
common shares at an exercise price of $2.00 per share. The warrants
will expire on October 31, 2010 and may not be exercised after that
date. The investors were also given the right to purchase, in the
aggregate, an additional 2,200,000 common shares and a like number of warrants
for an additional $4,000,000 on or before July 14, 2009. The shares
and warrants were sold to the investors in reliance upon an exemption from
registration under Section 4.2 of the Securities Act of 1933, as amended (the
“Securities Act”). BioTime has agreed to file a registration
statement to register the warrants and shares issuable upon the exercise of the
warrants for sale under the Securities Act. BioTime has also agreed
to permit the investors to include the common shares they purchase in any future
registration statements that BioTime may file after May 15, 2010, subject to
certain limitations.
Item
2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF
FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Overview
We are a
biotechnology company engaged in two areas of biomedical research and product
development. First, we historically have developed blood plasma
volume expanders, and related technology for use in surgery, emergency trauma
treatment and other applications. Our lead blood plasma expander
product, Hextend
®
, is a
physiologically balanced intravenous solution used in the treatment of
hypovolemia. Hypovolemia is a condition caused by low blood volume,
often from blood loss during surgery or from injury. Hextend
maintains circulatory system fluid volume and blood pressure and keeps vital
organs perfused during surgery and trauma care.
Our
regenerative medicine business is operated through our wholly owned subsidiary
Embryome Sciences,
Inc
. Regenerative medicine refers to therapies based on human
embryonic stem (“hES”) cell technology that are designed to rebuild cell and
tissue function lost due to degenerative disease or injury. These
novel stem cells provide a means of manufacturing every cell type in the human
body and therefore show considerable promise for the development of a number of
new therapeutic products. We are focusing our current efforts in the
regenerative medicine field on the development and sale of advanced human stem
cell products and technology that can be used by researchers at universities and
other institutions, at companies in the bioscience and biopharmaceutical
industries, and at other companies that provide research products to companies
in those industries. These research-only markets generally can be marketed
without regulatory (FDA) approval, and are therefore relatively near-term
business opportunities when compared to therapeutic products. We may also
initiate development programs for human therapeutic applications should it be
determined that it is practical to raise the required capital or partner with a
third party on terms acceptable to the company.
Our
operating revenues have been derived almost exclusively from royalties and
licensing fees related to the sale of our plasma volume expander products,
primarily Hextend. We began to make our first stem cell research
products available during 2008 but we have not yet generated significant
revenues in that business segment. Our ability to generate
substantial operating revenue depends upon our success in developing and
marketing or licensing our plasma volume expanders and stem cell products and
technology for medical and research use.
Stem
Cells and Products for Regenerative Medicine Research
We are
conducting our stem cell business through our new, wholly-owned subsidiary,
Embryome Sciences, Inc. (“Embryome Sciences”). We plan to focus our
initial efforts in the regenerative medicine field on the development and sale
of advanced human stem cell products and technology for diagnostic, therapeutic
and research use. Regenerative medicine refers to therapies based on
human embryonic stem (“hES”) cell technology that are designed to rebuild cell
and tissue function lost due to degenerative disease or injury. Our
initial marketing efforts will be directed to researchers at universities and
other institutions, to companies in the bioscience and biopharmaceutical
industries, and to other companies that provide research products to companies
in those industries.
Embryome Sciences has already
introduced its first stem cell research products, and is implementing plans to
develop additional research products over the next two years. Our
first products include a relational database, available at our website
embryome.com, that will permit researchers to chart the cell lineages of human
development, the genes expressed in those cell types, and antigens present on
the cell surface of those cells that can be used in
purification. This database will provide the first detailed map of
the embryome, thereby aiding researchers in navigating the complexities of human
development and in identifying the many hundreds of cell types coming from
embryonic stem cells.
Embryome Sciences is also now marketing
cell growth media called ESpan
TM
in
collaboration with Lifeline Cell Technology, LLC. These growth media
are designed for the growth of human embryonic progenitor
cells. Additional new products that Embryome Sciences has targeted
for development are ESpy
TM
cell lines, which will be derivatives of hES cells that send beacons of light in
response to the activation of particular genes. The ESpy™ cell lines
will be developed in conjunction with Lifeline using the ACTCellerate™
technology licensed from Advanced Cell Technology, Inc., and other technology
sublicensed from Lifeline. Embryome Sciences also plans to bring to
market other new growth and differentiation factors that will permit researchers
to manufacture specific cell types from embryonic stem cells, and purification
tools useful to researchers in quality control of products for regenerative
medicine. As new products are developed, they will become available
for purchase on embryome.com.
We are in
the process of launching our first products for stem cell
research. We cannot predict the amount of revenue that the new
products we offer might generate.
In April
2009, the California Institute of Regenerative Medicine (“CIRM”) awarded us a
$4,721,706 grant for a stem cell research project related to our ACTCellerate™
technology. Our grant project is titled “Addressing the Cell Purity
and Identity Bottleneck through Generation and Expansion of Clonal Human
Embryonic Progenitor Cell Lines.” The overall objective of the
research project is to generate tools useful in applying ACTCellerate™
technology to the manufacture of patient-specific therapeutic products.
CIRM will provide funding
for this research project over a period of three years, with approximately
$1,600,000 expected to be available during the first 12 months. We
expect that the first funds will be available some time during the summer of
2009 and that work on the project will be ready to begin upon the receipt of
funding.
Hextend
®
and
PentaLyte
®
are registered
trademarks of BioTime, Inc., and ESpan
TM
and
Espy
TM
are
trademarks of Embryome Sciences, Inc.
Plasma
Volume Expander Products
Our
principal product, Hextend, is a physiologically balanced blood plasma volume
expander, for the treatment of hypovolemia. Hextend is being
distributed in the United States by Hospira, Inc. and in South Korea by CJ
CheilJedang Corp. (“CJ”) under exclusive licenses from us. Summit
Pharmaceuticals International Corporation (“Summit”) has a license to develop
Hextend and PentaLyte in Japan, the People’s Republic of China, and
Taiwan. Summit has entered into sublicenses with Maruishi
Pharmaceutical Co., Ltd. (“Maruishi”) to obtain regulatory approval,
manufacture, and market Hextend in Japan, and Hextend and PentaLyte in China and
Taiwan. However, Maruishi has informed Summit that Maruishi wishes to
pursue discussions that might lead to a termination of their
sublicense. Summit has informed us that if the Maruishi sublicense is
terminated, Summit will seek a replacement sublicensee.
Hextend
has become the standard plasma volume expander at a number of prominent teaching
hospitals and leading medical centers and is part of the Tactical Combat
Casualty Care protocol. We believe that as Hextend use proliferates
within the leading U.S. hospitals, other smaller hospitals will follow their
lead, contributing to sales growth.
We have
completed a Phase II clinical trial of PentaLyte in which PentaLyte was used to
treat hypovolemia in cardiac surgery. Our ability to commence and
complete additional clinical studies of PentaLyte depends on our cash resources
and the costs involved, which are not presently determinable as we do not know
yet the actual scope or cost of the clinical trials that the FDA will require
for PentaLyte.
Results
of Operations
Revenues
Under our
license agreements, Hospira and CJ will report sales of Hextend and pay us the
royalties and license fees due on account of such sales after the end of each
calendar quarter. We recognize such revenues in the quarter in which
the sales report is received, rather than the quarter in which the sales took
place.
Our royalty revenues for the three
months ended March 31, 2009 consist of royalties on sales of Hextend made by
Hospira and CJ during the period beginning October 1, 2008 and ending December
31, 2008. Royalty revenues recognized for that three-month period
were $222,667, a 28% decrease from the $308,900 of royalty revenue during the
same period last year. The decrease in royalties reflects a decrease
in sales both to hospitals and to the United States Armed
Forces. Purchases by the Armed Forces generally take the form of
intermittent, large volume orders, and cannot be predicted with
certainty.
We
recognized $73,226 and $66,183 of license fees from CJ and Summit during the
three months ended March 31, 2009 and the three months ended March 31, 2008,
respectively. Full recognition of license fees has been deferred, and
is being recognized over the life of the contract, which has been estimated to
last until approximately 2019 based on the current expected life of the
governing patent covering our products in Korea and Japan. See Notes
2 and 4 to the condensed interim financial statements.
We
received royalties of $329,809 from Hospira and $19,112 from CJ during May 2009
based on sales of Hextend during the three months ended March 31,
2009. This revenue will be reflected in our financial statements for
the fourth quarter of 2008. For the same period last year, we
received royalties of $341,153 from Hospira and $16,085 from
CJ. Royalties from CJ were included in license fees during prior
accounting periods.
Operating
Expenses
Research
and development expenses were $525,824 for the three months ended March 31,
2009, compared to $347,151 for the three months ended March 31,
2008. This increase is primarily attributable to an increase of
$94,834 in rent, an increase of $60,361 in salaries allocated to research and
development, an increase of $16,905 in payroll fees and taxes allocated to
research and development expense, and an increase of $29,655 in expenditures
made to cover laboratory expenses and supplies. These increases were
offset to some extent by a decrease of $12,975 in insurance costs allocated to
research and development, a decrease of $5,958 in utilities allocated to
research and development expense, and a decrease of $10,326 in expenditures made
for research consultants. Research and development expenses include
laboratory study expenses, salaries, rent, insurance, and consultants’
fees.
General and administrative expenses
increased to $682,174 for the three months ended March 31, 2009, from $435,939
for the three months ended March 31, 2008. This increase
is primarily
attributable to an increase of $198,741 in stock appreciation rights
compensation liability expenses, an increase of $41,953 in accounting fees, an
increase of $28,067 in expenses related to outside services, an increase of
$21,900 in travel and entertainment expenses, an increase of $13,030 in investor
and public relations expenses, an increase of $11,899 in stock-based expense and
allocated to general and administrative costs, and an increase of $17,708 in
rent allocated to general and administrative costs. These increases
were offset in part by a decrease of $53,570 in general and administrative
consulting fees, a decrease of $35,369 in legal fees, and a decrease of $11,320
in patent costs.
Interest
and Other Income (Expense)
For the three months ended March 31,
2009, we incurred a total of $608,027
of
interest expense, compared to interest expense of $76,521
for
the three months ended March 31, 2008.
Income
Taxes
During the three months ended March 31,
2009 and 2008, there were no Federal and state income taxes, since BioTime
has substantial net operating loss carryovers and has provided a 100%
valuation allowance for any deferred taxes.
Liquidity
and Capital Resources
The major
components of our net cash used in operations of approximately $1,026,000 in the
three months ended March 31, 2009 can be summarized as follows: net loss of
approximately $1,518,000 was reduced by non-cash expenses of approximately
$822,000 resulting in the cash loss of approximately $696,000 and increased a
reduction in working capital of approximately $330,000
At March
31, 2009, we had $541,106 cash and cash equivalents on hand, and lines of credit
for $3,575,000 from which $3,481,982 had been drawn.
We have a
Revolving Line of Credit Agreement (the “Credit Agreement”) with certain private
lenders that is collateralized by a security interest in our right to receive
royalty and other payments under our license agreement with
Hospira. We may borrow up to $3,500,000 under the Credit
Agreement. Following an amendment to the Credit Agreement in April
2009, the maturity date of our Revolving Line of Credit has been extended to
December 1, 2009 with respect to $2,669,282 in principal amount of
loans. We repaid $223,834 of principal and accrued interest on loans
that matured on April 15, 2009 and were not extended. In addition,
certain lenders exercised their right to exchange $572,404 of principal and
accrued interest on loans for an aggregate of 381,605 of our common
shares. These transactions will be reflected in our condensed
consolidated interim financial statements for the quarter ending June 30,
2009.
We may
borrow up to an additional $830,718 under our Revolving Line of Credit if we
elect to do so and are able to obtain additional loan commitments from our
current lenders or from new lenders.
Lenders
who agreed to extend the maturity date of their outstanding loans will receive
from us a number of common shares having an aggregate market value (based on
closing price of the shares on the OTC-BB) equal to six percent (6%) of the
lender’s loan commitment, as consideration for the extension of the term of
their loans. In April 2009, we issued 91,526 common shares to those
lenders. We will issue additional common shares on the same basis to
any lenders who provide additional loan commitments under our revolving line of
credit.
Lenders
who extended the maturity date of their line of credit promissory notes, and any
new lenders who make additional loan commitments, will have the right to
exchange their promissory notes for our common shares and for shares of Embryome
Sciences, Inc. common stock. Promissory notes that were exchangeable
for our common shares at a price of $1.25 per share and Embryome Sciences common
stock at a price of $2.25 per share until April 15, 2009, may now be exchanged
for our common shares at $1.50 per share and for Embryome Sciences common stock
at $2.75 per share until the extended maturity date, December 1,
2009. Promissory notes that were exchangeable for our common shares
at a price of $1.50 and Embryome Sciences common stock at $2.50 until April 15,
2009, may now be exchanged for our common shares at $1.75 per share and Embryome
Sciences common stock at $3.00 per share until the extended maturity
date. Promissory notes issued for new loan commitments will be
exchangeable for BioTime common shares at a price of $2.00 per share, and for
Embryome Sciences common stock at $3.50 per share until December 1,
2009. The foregoing per share exchange prices are subject to
proportional adjustment in the event of a stock split, reverse stock split, or
similar event.
We also
obtained a line of credit from American Express in August 2004, which allows for
borrowings up to $25,300; at March 31, 2009, we had drawn $20,751 against this
line. See Note 3 to the condensed interim financial statements for
additional information.
We also
secured a line of credit from Advanta in November 2006, which allows for
borrowings up to $35,000; at March 31, 2009, we had drawn $31,253 against this
line. See Note 3 to the condensed interim financial statements for
additional information.
In April
2009, CIRM awarded us a $4,721,706 grant for a stem cell research project
related to our ACTCellerate™ technology. CIRM will provide funding
for this research project over a period of three years, with approximately
$1,600,000 expected to be available during the first 12 months. We
expect that the first funds will be available some time during the summer of
2009 and that work on the project will be ready to begin upon the receipt of
funding.
On May
13, 2009, we raised $4,000,000 of equity capital through the sale of 2,200,000
common shares and 2,200,000 stock purchase warrants to two private
investors. The warrants entitle the investors to purchase additional
common shares at an exercise price of $2.00 per share. The warrants
will expire on October 31, 2010 and may not be exercised after that
date. The investors were also given the right to purchase, in the
aggregate, an additional 2,200,000 common shares and a like number of warrants
for an additional $4,000,000 on or before July 14, 2009.
Since
inception, we have primarily financed our operations through the sale of equity
securities, licensing fees, royalties on product sales by our licensees, and
borrowings. The amount of license fees and royalties that may be
earned through the licensing and sale of our products and technology, the timing
of the receipt of license fee payments, and the future availability and terms of
equity financing, are uncertain. Although we have recently been
awarded a research grant from CIRM for a particular project, we must finance our
other research and operations with funding from other sources. The
unavailability or inadequacy of financing or revenues to meet future capital
needs could force us to modify, curtail, delay or suspend some or all aspects of
our planned operations. Sales of additional equity securities could
result in the dilution of the interests of present shareholders.
We have
no contractual obligations as of March 31, 2009, with the exception of two
facilities lease agreements. We currently have a fixed,
non-cancelable operating lease on our office and laboratory facilities in
Emeryville, California (the “Emeryville lease”). Under the Emeryville
lease, we are committed to make payments of $11,127 per month, increasing 3%
annually, plus our pro rata share of operating costs for the building and office
complex, through May 31, 2010. In April 2008, we entered into a
sublease of approximately 11,000 square feet of office and research laboratory
spaced at 1301 Harbor Bay Parkway, in Alameda, California (the “Alameda
sublease”). We have now moved our headquarters to this new
facility. The Alameda sublease will expire on November 30,
2010. Base monthly rent was $22,000 during 2008, and will be $22,600
during 2009, and $23,340 during 2010. In addition to base rent, we
will pay a pro rata share of real property taxes and certain costs related to
the operation and maintenance of the building in which the subleased premises
are located.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
We did not hold any market risk
sensitive instruments as of March 31, 2009, December 31, 2008, or March 31,
2008.
Item
4T. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
It is
management’s responsibility to establish and maintain adequate internal control
over all financial reporting pursuant to Rule 13a-15 under the Securities
Exchange Act of 1934 (the “Exchange Act”). Our management, including
our principal executive officer, our principal operations officer, and our
principal financial officer, have reviewed and evaluated the effectiveness of
our disclosure controls and procedures as of a date within ninety (90) days of
the filing date of this Form 10-Q quarterly report. Following this
review and evaluation
,
management collectively determined that our disclosure controls and
procedures are effective to ensure that information required to be disclosed by
us in reports that we file or submit under the Exchange Act (i) is recorded,
processed, summarized and reported within the time periods specified in SEC
rules and forms, and (ii) is accumulated and communicated to management,
including our chief executive officer, our chief operations officer, and our
chief financial officer, as appropriate to allow timely decisions regarding
required disclosure.
Changes
in Internal Controls
There
were no changes in our internal control over financial reporting that occurred
during the period covered by this Quarterly Report on Form 10-Q that have
materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
PART
II - OTHER INFORMATION
Item
2. Unregistered Sale of Equity Securities and Use of
Proceeds
We issued the following
securities without registration under the Securities Act of 1933, as amended
(the “Securities Act”), in reliance upon the exemption provided by Section 4(2)
thereunder
.
During February 2009, we issued 32,259 common shares to a licensor as a license
fee for certain stem cell lines that we acquired.
During March 2009 we issued 33,019 common shares to a licensor of certain
patents as part of a license fee.
In April 2009, we issued 473,131 common shares under the terms of our Credit
Agreement to certain lenders who exercised their right to exchange principal and
accrued interest on loans or to extend the date for repayment of their
outstanding loan amounts.
On May 13, 2009, we raised $4,000,000 of equity capital through the sale of
2,200,000 common shares and 2,200,000 stock purchase warrants to two private
investors.
Item
5. Other Information
On May
13, 2009, we raised $4,000,000 of equity capital through the sale of 2,200,000
common shares and 2,200,000 stock purchase warrants to two private
investors. The warrants entitle the investors to purchase additional
common shares at an exercise price of $2.00 per share. The warrants
will expire on October 31, 2010 and may not be exercised after that
date. The investors were also given the right to purchase, in the
aggregate, an additional 2,200,000 common shares and a like number of warrants
for an additional $4,000,000 on or before July 14, 2009.
We may
redeem the warrants by paying $.01 per warrant if the closing price of our
common shares on any national securities exchange or the Nasdaq Stock Market
exceeds 200% of the exercise price of the warrants for any 20 consecutive
trading days. The redemption date will abate, if the closing price or
average bid price of our common shares does not equal or exceed 120% of the
exercise price of the warrants on the redemption date and each of the five
trading days immediately preceding the redemption date. However, we
will have the right to redeem the warrants at a future date if the market price
of the common shares again exceeds 200% of the exercise price for 20 consecutive
trading days, as described above. In addition, we may not redeem the
warrants unless a registration statement with respect to the warrants and
underlying common shares is effective under the Securities Act.
We have agreed to file a registration statement to register the warrants and
shares issuable upon the exercise of the warrants for sale under the Securities
Act. We have also agreed to permit the investors to include the
common shares they purchase in any future registration statements that we may
file after May 15, 2010, subject to certain limitations.
We
believe that the $4,000,0000 received from the sale of the shares and warrants,
when coupled with our expected royalty revenues and the funds from our CIRM
grant, will be sufficient to finance our operations with an expanded research
and development program for at least 12 to 18 months. If the
investors exercise their right to purchase up to $4,000,000 of additional shares
and warrants by July 14, 2009, we would have additional capital to expand our
research and development program and to finance our operations for a longer
period of time. In determining to sell the shares and warrants to
address our capital needs at this time, our board of directors considered the
range of prices at which our common shares and warrants have traded over the
past 30 days, our cost of financing through our revolving line of credit,
including the interest rate and the prices at which lenders have exchanged their
promissory notes for our common shares, the difficult conditions prevailing in
the capital markets, and the alternatives available to us for
financing. Based on these considerations our board of directors
concluded that the sale of the shares and warrants provided the best available
alternative for us to secure capital for the near future, without excessive
dilution of the interests of our shareholders.
The shares and warrants were sold to
Broadwood Partners, L.P. and George Karfunkel. Broadwood Partners,
L.P. beneficially owned more than 10% of our common shares prior to the
transaction, and Mr. Karfunkel now beneficially owns more than 10% of our common
shares as a result of the transaction.
Item
6. Exhibits
Exhibit
Numbers
|
|
Description
|
3.1
|
|
Articles
of Incorporation.†
|
|
|
|
3.2
|
|
Amendment
of Articles of Incorporation.***
|
|
|
|
3.3
|
|
By-Laws,
As Amended.#
|
|
|
|
4.1
|
|
Specimen
of Common Share Certificate.+
|
|
|
|
4.2
|
|
Form
of Warrant Agreement between BioTime, Inc. and American Stock Transfer
& Trust Company++
|
|
|
|
4.3
|
|
Form
of Amendment to Warrant Agreement between BioTime, Inc. and American Stock
Transfer & Trust Company. +++
|
|
|
|
4.4
|
|
Form
of Warrant+++
|
|
|
|
4.5
|
|
Warrant
Agreement between BioTime, Inc., Broadwood Partners, L.P., and George
Karfunkel ~~
|
|
|
|
4.6
|
|
Form
of Warrant ~~
|
|
|
|
10.1
|
|
Intellectual
Property Agreement between BioTime, Inc. and Hal
Sternberg.+
|
|
|
|
10.2
|
|
Intellectual
Property Agreement between BioTime, Inc. and Harold
Waitz.+
|
|
|
|
10.3
|
|
Intellectual
Property Agreement between BioTime, Inc. and Judith
Segall.+
|
|
|
|
10.4
|
|
Intellectual
Property Agreement between BioTime, Inc. and Steven
Seinberg.*
|
|
|
|
10.5
|
|
Agreement
between CMSI and BioTime Officers Releasing Employment Agreements, Selling
Shares, and Transferring Non-Exclusive License.+
|
|
|
|
10.6
|
|
Agreement
for Trans Time, Inc. to Exchange CMSI Common Stock for BioTime, Inc.
Common Shares.+
|
|
|
|
10.7
|
|
2002
Stock Option Plan, as amended.##
|
|
|
|
10.8
|
|
Exclusive
License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a
request for confidential treatment).###
|
|
|
|
|
|
|
10.9
|
|
Modification
of Exclusive License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a request for
confidential treatment).^
|
|
|
|
10.10
|
|
Exclusive
License Agreement between BioTime, Inc. and CJ Corp.**
|
|
|
|
10.11
|
|
Hextend
and PentaLyte Collaboration Agreement between BioTime, Inc. and Summit
Pharmaceuticals International Corporation.‡
|
|
|
|
10.12
|
|
Lease
dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D
Associates ‡‡
|
|
|
|
10.13
|
|
Addendum
to Hextend and PentaLyte Collaboration Agreement Between BioTime Inc. And
Summit Pharmaceuticals International Corporation‡‡‡
|
|
|
|
10.14
|
|
Amendment
to Exclusive License Agreement Between BioTimeInc. and Hospira,
Inc.††
|
|
|
|
10.15
|
|
Hextend
and PentaLyte China License Agreement Between BioTime, Inc. and Summit
Pharmaceuticals International Corporation.†††
|
|
|
|
10.16
|
|
Revolving
Credit Line Agreement between BioTime, Inc, Alfred D. Kingsley, Cyndel
& Co., Inc., and George Karfunkel, dated April 12,
2006.††††
|
|
|
|
10.17
|
|
Security
Agreement executed by BioTime, Inc., dated April 12,
2006.††††
|
|
|
|
10.18
|
|
Form of Revolving Credit Note of
BioTime, Inc. in the principal amount of $
166,666.67 dated April 12,
2006.††††
|
|
|
|
10.19
|
|
First
Amended and Restated Revolving Line of Credit Agreement, dated October 17,
2007. ####
|
|
|
|
10.20
|
|
Form
of Amended and Restated Revolving Credit Note. ####
|
|
|
|
10.21
|
|
Form
of Revolving Credit Note. ####
|
|
|
|
10.22
|
|
First
Amended and Restated Security Agreement, dated October 17, 2007.
####
|
|
|
|
10.23
|
|
Employment
Agreement, dated October 10, 2007, between BioTime, Inc. and Michael
D. West.++++
|
|
|
|
10.24
|
|
Commercial
License and Option Agreement between BioTime and Wisconsin Alumni Research
Foundation.****
|
|
|
|
10.25
|
|
Second
Amended and Restated Revolving Line of Credit Agreement, dated February
15, 2008.‡‡‡‡
|
|
|
|
10.26
|
|
Form
of Amended and Restated Revolving Credit
Note.‡‡‡‡
|
|
|
|
10.27
|
|
Second
Amended and Restated Security Agreement, dated February 15,
2008.‡‡‡‡
|
|
|
|
10.28
|
|
Third
Amended and Restated Revolving Line of Credit Agreement, March 31,
2008.~
|
|
|
|
10.29
|
|
Third
Amended and Restated Security Agreement, dated March 31,
2008.~
|
|
|
|
10.30
|
|
Sublease
Agreement between BioTime, Inc. and Avigen, Inc.++++
|
|
|
|
10.31
|
|
License,
Product Production, and Distribution Agreement, dated June 19, 2008, among
Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc.
^^
|
|
|
|
10.32
|
|
License
Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and
Advanced Cell Technology, Inc. ^^
|
|
|
|
10.33
|
|
License
Agreement, dated August 15, between Embryome Sciences, Inc. and Advanced
Cell Technology, Inc. ^^^
|
|
|
|
10.34
|
|
Sublicense
Agreement, dated August 15, between Embryome Sciences, Inc. and Advanced
Cell Technology, Inc. ^^^
|
|
|
|
10.35
|
|
Fourth
Amendment of Revolving Line of Credit Agreement.^^^
|
|
|
|
10.36
|
|
Fourth
Amendment of Security Agreement.^^^
|
|
|
|
10.37
|
|
Stem
Cell Agreement, dated February 23, 2009, between Embryome Sciences, Inc.
and Reproductive Genetics Institute. ^^^^
|
|
|
|
10.38
|
|
First
Amendment of Commercial License and Option Agreement, dated March 11,
2009, between BioTime and Wisconsin Alumni Research Foundation.
^^^^
|
|
|
|
10.39
|
|
Employment
Agreement, dated October 10, 2007, between BioTime, Inc. and Robert
Peabody. ^^^^
|
|
|
|
10.40
|
|
Fifth
Amendment of Revolving Line of Credit Agreement, dated April 15,
2009.‡‡‡‡‡
|
|
|
|
10.41
|
|
Form
of Amendment of Revolving Credit Note. ‡‡‡‡‡
|
|
|
|
10.42
|
|
Fifth
Amendment of Security Agreement, dated April 15, 2009.
‡‡‡‡‡
|
|
|
|
10.43
|
|
Stock
and Warrant Purchase Agreement between BioTime, Inc. and George Karfunkel
~~
|
|
|
|
10.44
|
|
Stock
and Warrant Purchase Agreement between BioTime, Inc. and Broadwood
Partners, L.P. ~~
|
|
|
|
10.45
|
|
Registration
Rights Agreement between BioTime, Inc., Broadwood Partners, L.P. and
George Karfunkel. ~~
|
|
|
|
31
|
|
Rule
13a-14(a)/15d-14(a) Certification~~
|
|
|
|
32
|
|
Section
1350 Certification~~
|
|
|
|
†
|
Incorporated
by reference to BioTime’s Form 10-K for the fiscal year ended June 30,
1998.
|
|
|
+
|
Incorporated
by reference to Registration Statement on Form S-1, File Number 33-44549
filed with the Securities and Exchange Commission on December 18, 1991,
and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities
and Exchange Commission on February 6, 1992 and March 7, 1992,
respectively.
|
|
|
#
|
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.
|
|
|
++
|
Incorporated
by reference to Registration Statement on Form S-2, File Number
333-109442, filed with the Securities and Exchange Commission on October
3, 2003, and Amendment No.1 thereto filed with the Securities and Exchange
Commission on November 13, 2003.
|
|
|
+++
|
Incorporated
by reference to Registration Statement on Form S-2, File Number
333-128083, filed with the Securities and Exchange Commission on September
2, 2005.
|
|
|
##
|
Incorporated
by reference to Registration Statement on Form S-8, File Number 333-101651
filed with the Securities and Exchange Commission on December 4, 2002 and
Registration Statement on Form S-8, File Number 333-122844 filed with the
Securities and Exchange Commission on February 23,
2005.
|
|
|
###
|
Incorporated
by reference to BioTime’s Form 8-K, filed April 24,
1997.
|
|
|
^
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended June 30,
1999.
|
|
|
*
|
Incorporated
by reference to BioTime’s Form 10-K for the year ended December 31,
2001.
|
|
|
**
|
Incorporated
by reference to BioTime’s Form 10-K/A-1 for the year ended December 31,
2002.
|
|
|
‡
|
Incorporated
by reference to BioTime’s Form 8-K, filed December 30,
2004.
|
|
|
‡‡
|
Incorporated
by reference to Post-Effective Amendment No. 3 to Registration Statement
on Form S-2 File Number 333-109442, filed with the Securities and Exchange
Commission on May 24, 2005.
|
|
|
‡‡‡
|
Incorporated
by reference to BioTime’s Form 8-K, filed December 20,
2005.
|
|
|
††
|
Incorporated
by reference to BioTime’s Form 8-K, filed January 13,
2006.
|
|
|
†††
|
Incorporated
by reference to BioTime’s Form 8-K, filed March 30,
2006.
|
|
|
††††
|
Incorporated
by reference to BioTime’s Form 10-K for the year ended December 31,
2005.
|
|
|
***
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended June 30,
2006.
|
|
|
****
|
Incorporated
by reference to BioTime’s Form 8-K, filed January 9,
2008.
|
|
|
‡‡‡‡
|
Incorporated
by reference to BioTime’s Form 8-K, filed March 10,
2008.
|
|
|
~
|
Incorporated
by reference to BioTime’s Form 8-K filed April 4, 2008.
|
|
|
++++
|
Incorporated
by reference to BioTime’s Form 10-KSB for the year ended December 31,
2007.
|
|
|
^^
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended June 30,
2008.
|
|
|
^^^
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended September 30,
2008.
|
|
|
^^^^
|
Incorporated
by reference to BioTime’s Form 10-K for the year ended December 31,
2008.
|
|
|
‡‡‡‡‡
|
Incorporated
by reference to BioTime’s Form 8-K filed April 17,
2009.
|
|
|
~~
|
Filed
herewith
|
|
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
BIOTIME,
INC.
|
|
|
|
|
|
Date: May
14, 2009
|
/s/
Michael D. West
|
|
Michael
D. West
|
|
Chief
Executive Officer
|
|
|
|
|
Date: May
14, 2009
|
/s/
Steven A. Seinberg
|
|
Steven
A. Seinberg
|
|
Chief
Financial Officer
|
Exhibit
Numbers
|
|
Description
|
3.1
|
|
Articles
of Incorporation.†
|
|
|
|
3.2
|
|
Amendment
of Articles of Incorporation.***
|
|
|
|
3.3
|
|
By-Laws,
As Amended.#
|
|
|
|
4.1
|
|
Specimen
of Common Share Certificate.+
|
|
|
|
4.2
|
|
Form
of Warrant Agreement between BioTime, Inc. and American Stock Transfer
& Trust Company++
|
|
|
|
4.3
|
|
Form
of Amendment to Warrant Agreement between BioTime, Inc. and American Stock
Transfer & Trust Company. +++
|
|
|
|
4.4
|
|
Form
of Warrant+++
|
|
|
|
4.5
|
|
Warrant
Agreement between BioTime, Inc., Broadwood Partners, L.P., and George
Karfunkel ~~
|
|
|
|
4.6
|
|
Form
of Warrant ~~
|
|
|
|
10.1
|
|
Intellectual
Property Agreement between BioTime, Inc. and Hal
Sternberg.+
|
|
|
|
10.2
|
|
Intellectual
Property Agreement between BioTime, Inc. and Harold
Waitz.+
|
|
|
|
10.3
|
|
Intellectual
Property Agreement between BioTime, Inc. and Judith
Segall.+
|
|
|
|
10.4
|
|
Intellectual
Property Agreement between BioTime, Inc. and Steven
Seinberg.*
|
|
|
|
10.5
|
|
Agreement
between CMSI and BioTime Officers Releasing Employment Agreements, Selling
Shares, and Transferring Non-Exclusive License.+
|
|
|
|
10.6
|
|
Agreement
for Trans Time, Inc. to Exchange CMSI Common Stock for BioTime, Inc.
Common Shares.+
|
|
|
|
10.7
|
|
2002
Stock Option Plan, as amended.##
|
|
|
|
10.8
|
|
Exclusive
License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a
request for confidential treatment).###
|
|
|
|
10.9
|
|
Modification
of Exclusive License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a request for
confidential treatment).^
|
|
|
|
10.10
|
|
Exclusive
License Agreement between BioTime, Inc. and CJ Corp.**
|
|
|
|
10.11
|
|
Hextend
and PentaLyte Collaboration Agreement between BioTime, Inc. and Summit
Pharmaceuticals International Corporation.‡
|
|
|
|
10.12
|
|
Lease
dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D
Associates ‡‡
|
|
|
|
10.13
|
|
Addendum
to Hextend and PentaLyte Collaboration Agreement Between BioTime Inc. And
Summit Pharmaceuticals International Corporation‡‡‡
|
|
|
|
10.14
|
|
Amendment
to Exclusive License Agreement Between BioTimeInc. and Hospira,
Inc.††
|
|
|
|
10.15
|
|
Hextend
and PentaLyte China License Agreement Between BioTime, Inc. and Summit
Pharmaceuticals International Corporation.†††
|
|
|
|
10.16
|
|
Revolving
Credit Line Agreement between BioTime, Inc, Alfred D. Kingsley, Cyndel
& Co., Inc., and George Karfunkel, dated April 12,
2006.††††
|
|
|
|
10.17
|
|
Security
Agreement executed by BioTime, Inc., dated April 12,
2006.††††
|
|
|
|
10.18
|
|
Form of Revolving Credit Note of
BioTime, Inc. in the principal amount of $
166,666.67 dated April 12,
2006.††††
|
|
|
|
10.19
|
|
First
Amended and Restated Revolving Line of Credit Agreement, dated October 17,
2007. ####
|
|
|
|
10.20
|
|
Form
of Amended and Restated Revolving Credit Note. ####
|
|
|
|
10.21
|
|
Form
of Revolving Credit Note. ####
|
|
|
|
10.22
|
|
First
Amended and Restated Security Agreement, dated October 17, 2007.
####
|
|
|
|
10.23
|
|
Employment
Agreement, dated October 10, 2007, between BioTime, Inc. and Michael
D. West.++++
|
|
|
|
10.24
|
|
Commercial
License and Option Agreement between BioTime and Wisconsin Alumni Research
Foundation.****
|
|
|
|
10.25
|
|
Second
Amended and Restated Revolving Line of Credit Agreement, dated February
15, 2008.‡‡‡‡
|
|
|
|
10.26
|
|
Form
of Amended and Restated Revolving Credit
Note.‡‡‡‡
|
|
|
|
10.27
|
|
Second
Amended and Restated Security Agreement, dated February 15,
2008.‡‡‡‡
|
|
|
|
10.28
|
|
Third
Amended and Restated Revolving Line of Credit Agreement, March 31,
2008.~
|
|
|
|
10.29
|
|
Third
Amended and Restated Security Agreement, dated March 31,
2008.~
|
|
|
|
10.30
|
|
Sublease
Agreement between BioTime, Inc. and Avigen, Inc.++++
|
|
|
|
10.31
|
|
License,
Product Production, and Distribution Agreement, dated June 19, 2008, among
Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc.
^^
|
|
|
|
10.32
|
|
License
Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and
Advanced Cell Technology, Inc. ^^
|
|
|
|
10.33
|
|
License
Agreement, dated August 15, between Embryome Sciences, Inc. and Advanced
Cell Technology, Inc. ^^^
|
|
|
|
10.34
|
|
Sublicense
Agreement, dated August 15, between Embryome Sciences, Inc. and Advanced
Cell Technology, Inc. ^^^
|
|
|
|
10.35
|
|
Fourth
Amendment of Revolving Line of Credit Agreement.^^^
|
|
|
|
10.36
|
|
Fourth
Amendment of Security Agreement.^^^
|
|
|
|
10.37
|
|
Stem
Cell Agreement, dated February 23, 2009, between Embryome Sciences, Inc.
and Reproductive Genetics Institute. ^^^^
|
|
|
|
10.38
|
|
First
Amendment of Commercial License and Option Agreement, dated March 11,
2009, between BioTime and Wisconsin Alumni Research Foundation.
^^^^
|
|
|
|
10.39
|
|
Employment
Agreement, dated October 10, 2007, between BioTime, Inc. and Robert
Peabody. ^^^^
|
|
|
|
10.40
|
|
Fifth
Amendment of Revolving Line of Credit Agreement, dated April 15,
2009.‡‡‡‡‡
|
|
|
|
10.41
|
|
Form
of Amendment of Revolving Credit Note. ‡‡‡‡‡
|
|
|
|
10.42
|
|
Fifth
Amendment of Security Agreement, dated April 15, 2009.
‡‡‡‡‡
|
|
|
|
10.43
|
|
Stock
and Warrant Purchase Agreement between BioTime, Inc. and George Karfunkel
~~
|
|
|
|
10.44
|
|
Stock
and Warrant Purchase Agreement between BioTime, Inc. and Broadwood
Partners, L.P. ~~
|
|
|
|
10.45
|
|
Registration
Rights Agreement between BioTime, Inc., Broadwood Partners, L.P. and
George Karfunkel. ~~
|
|
|
|
31
|
|
Rule
13a-14(a)/15d-14(a) Certification~~
|
|
|
|
32
|
|
Section
1350 Certification~~
|
|
|
|
†
|
Incorporated
by reference to BioTime’s Form 10-K for the fiscal year ended June 30,
1998.
|
|
|
+
|
Incorporated
by reference to Registration Statement on Form S-1, File Number 33-44549
filed with the Securities and Exchange Commission on December 18, 1991,
and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities
and Exchange Commission on February 6, 1992 and March 7, 1992,
respectively.
|
|
|
#
|
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.
|
|
|
++
|
Incorporated
by reference to Registration Statement on Form S-2, File Number
333-109442, filed with the Securities and Exchange Commission on October
3, 2003, and Amendment No.1 thereto filed with the Securities and Exchange
Commission on November 13, 2003.
|
|
|
+++
|
Incorporated
by reference to Registration Statement on Form S-2, File Number
333-128083, filed with the Securities and Exchange Commission on September
2, 2005.
|
|
|
##
|
Incorporated
by reference to Registration Statement on Form S-8, File Number 333-101651
filed with the Securities and Exchange Commission on December 4, 2002 and
Registration Statement on Form S-8, File Number 333-122844 filed with the
Securities and Exchange Commission on February 23,
2005.
|
|
|
###
|
Incorporated
by reference to BioTime’s Form 8-K, filed April 24,
1997.
|
|
|
^
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended June 30,
1999.
|
|
|
*
|
Incorporated
by reference to BioTime’s Form 10-K for the year ended December 31,
2001.
|
|
|
**
|
Incorporated
by reference to BioTime’s Form 10-K/A-1 for the year ended December 31,
2002.
|
|
|
‡
|
Incorporated
by reference to BioTime’s Form 8-K, filed December 30,
2004.
|
|
|
‡‡
|
Incorporated
by reference to Post-Effective Amendment No. 3 to Registration Statement
on Form S-2 File Number 333-109442, filed with the Securities and Exchange
Commission on May 24, 2005.
|
|
|
‡‡‡
|
Incorporated
by reference to BioTime’s Form 8-K, filed December 20,
2005.
|
|
|
††
|
Incorporated
by reference to BioTime’s Form 8-K, filed January 13,
2006.
|
|
|
†††
|
Incorporated
by reference to BioTime’s Form 8-K, filed March 30,
2006.
|
|
|
††††
|
Incorporated
by reference to BioTime’s Form 10-K for the year ended December 31,
2005.
|
|
|
***
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended June 30,
2006.
|
|
|
****
|
Incorporated
by reference to BioTime’s Form 8-K, filed January 9,
2008.
|
|
|
‡‡‡‡
|
Incorporated
by reference to BioTime’s Form 8-K, filed March 10,
2008.
|
|
|
~
|
Incorporated
by reference to BioTime’s Form 8-K filed April 4, 2008.
|
|
|
++++
|
Incorporated
by reference to BioTime’s Form 10-KSB for the year ended December 31,
2007.
|
|
|
^^
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended June 30,
2008.
|
|
|
^^^
|
Incorporated
by reference to BioTime’s Form 10-Q for the quarter ended September 30,
2008.
|
|
|
^^^^
|
Incorporated
by reference to BioTime’s Form 10-K for the year ended December 31,
2008.
|
|
|
‡‡‡‡‡
|
Incorporated
by reference to BioTime’s Form 8-K filed April 17,
2009.
|
|
|
~~
|
Filed
herewith
|
|
|
23