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, 2008
OR
o 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)
6121
Hollis Street
Emeryville,
California 94608
(Former
address, changed since last report)
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.
xYes o 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 o
|
|
Accelerated
filer o
|
|
|
|
Non-accelerated
filer o (Do
not check if a smaller reporting company)
|
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
o Yes xNo
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. 23,694,374 common shares,
no par value, as of May 13, 2008.
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,
2008
(unaudited)
|
|
|
December
31, 2007
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
307,471 |
|
|
$ |
9,501 |
|
Accounts
receivable
|
|
|
10,054 |
|
|
|
3,502 |
|
Prepaid
expenses and other current assets
|
|
|
210,588 |
|
|
|
128,643 |
|
Total
current assets
|
|
|
528,113 |
|
|
|
141,646 |
|
|
|
|
|
|
|
|
|
|
Equipment,
net of accumulated depreciation of $586,995 and $585,765,
respectively
|
|
|
12,639 |
|
|
|
12,480 |
|
Deposits
and other assets
|
|
|
20,976 |
|
|
|
20,976 |
|
TOTAL
ASSETS
|
|
$ |
561,728 |
|
|
$ |
175,102 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$ |
590,001 |
|
|
$ |
480,374 |
|
Lines
of credit payable
|
|
|
1,307,328 |
|
|
|
716,537 |
|
Deferred
license revenue, current portion
|
|
|
286,555 |
|
|
|
261,091 |
|
Total
current liabilities
|
|
|
2,183,884 |
|
|
|
1,458,002 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES: |
|
|
|
|
|
|
|
|
Stock
appreciation rights compensation liability
|
|
|
32,877 |
|
|
|
13,151 |
|
Deferred
license revenue, net of current portion
|
|
|
1,685,903 |
|
|
|
1,740,702 |
|
Deferred
rent, net of current portion
|
|
|
8,663 |
|
|
|
9,636 |
|
Total
long-term liabilities
|
|
|
1,727,443 |
|
|
|
1,763,489 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
DEFICIT:
|
|
|
|
|
|
|
|
|
Common
shares, no par value, authorized 50,000,000 shares; issued and outstanding
23,544,374 and 23,034,374 shares at March 31, 2008 and December 31, 2007,
respectively
|
|
|
40,876,976 |
|
|
|
40,704,136 |
|
Contributed
capital
|
|
|
93,972 |
|
|
|
93,972 |
|
Accumulated
deficit
|
|
|
(44,320,547 |
) |
|
|
(43,844,497 |
) |
Total
shareholders' deficit
|
|
|
(3,349,599 |
) |
|
|
(3,046,389 |
) |
TOTAL
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
|
$ |
561,728 |
|
|
$ |
175,102 |
|
See
accompanying notes to the condensed consolidated interim financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended
|
|
|
|
March
31, 2008
|
|
|
March
31, 2007
|
|
|
|
|
|
|
|
|
REVENUE:
|
|
|
|
|
|
|
License
fees
|
|
$ |
66,183 |
|
|
$ |
46,434 |
|
Royalties
from product sales
|
|
|
308,900 |
|
|
|
199,264 |
|
Other
revenue - Hextend
|
|
|
5,935 |
|
|
|
- |
|
Total
revenue
|
|
|
381,018 |
|
|
|
245,698 |
|
|
|
|
|
|
|
|
|
|
EXPENSES:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
(347,151 |
) |
|
|
(343,550 |
) |
General
and administrative
|
|
|
(435,939 |
) |
|
|
(417,780 |
) |
Total
expenses
|
|
|
(783,090 |
) |
|
|
(761,330 |
) |
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
|
(407,072 |
) |
|
|
(515,632 |
) |
|
|
|
|
|
|
|
|
|
INTEREST
EXPENSE AND OTHER INCOME:
|
|
|
(73,976 |
) |
|
|
(38,230 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$ |
(476,048 |
) |
|
$ |
(553,862 |
) |
LOSS
PER COMMON SHARE – BASIC AND DILUTED
|
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC AND
DILUTED
|
|
|
23,042,945 |
|
|
|
22,722,707 |
|
See
accompanying notes to the condensed consolidated interim financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Three
Months Ended
|
|
|
|
March
31, 2008
|
|
|
March
31, 2007
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(476,048 |
) |
|
$ |
(553,862 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
1,230 |
|
|
|
1,758 |
|
Amortization
of interest on lines of credit
|
|
|
49,175 |
|
|
|
– |
|
Interest
on royalty obligation
|
|
|
– |
|
|
|
39,749 |
|
Interest
on lines of credit
|
|
|
23,290 |
|
|
|
– |
|
Amortization
of debt issuance costs
|
|
|
– |
|
|
|
5,965 |
|
Stock-based
compensation
|
|
|
39,364 |
|
|
|
50,837 |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(6,552 |
) |
|
|
2,889 |
|
Prepaid
expenses and other current assets
|
|
|
19,974 |
|
|
|
(8,713 |
) |
Accounts
payable and accrued liabilities
|
|
|
108,624 |
|
|
|
117,343 |
|
Deferred
license revenue
|
|
|
(29,335 |
) |
|
|
(38,925 |
) |
Deferred
rent
|
|
|
29 |
|
|
|
1,001 |
|
Net
cash used in operating activities
|
|
|
(270,249 |
) |
|
|
(381,958 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase
of equipment
|
|
|
(1,389 |
) |
|
|
(1,779 |
) |
Net
cash used in investing activities
|
|
|
(1,389 |
) |
|
|
(1,779 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Repayment
of line of credit
|
|
|
(5,392 |
) |
|
|
– |
|
Borrowings
under lines of credit
|
|
|
575,000 |
|
|
|
100,000 |
|
Net
cash provided by financing activities
|
|
|
569,608 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS:
|
|
|
297,970 |
|
|
|
(283,737 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
9,501 |
|
|
|
561,017 |
|
Cash
and cash equivalents at end of period
|
|
$ |
307,471 |
|
|
$ |
277,280 |
|
Supplemental
disclosure of cash flow statement |
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$ |
4,057 |
|
|
|
– |
|
NON-CASH
FINANCING AND INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Issuance
of stock related to line of credit agreement
|
|
|
(153,200 |
) |
|
|
– |
|
See
accompanying notes to the condensed consolidated interim financial
statements.
BIOTIME,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
1. Organization
General - BioTime, Inc.
(“BioTime”) was organized November 30, 1990 as a California corporation. BioTime
is a biomedical organization which is engaged in the research and development of
synthetic plasma expanders, blood volume substitute solutions, and organ
preservation solutions, for use in surgery, trauma care, organ transplant
procedures, and other areas of medicine. In October 2007, BioTime
announced its entry into the field of regenerative medicine by initiating the
development of advanced human stem cell products and technology for diagnostic,
therapeutic and research use. Regenerative medicine refers to
therapies based on human embryonic stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. Human embryonic stem cells are the first human cells ever
discovered that are capable of infinite cell division while possessing the
potential to differentiate into all of the cell types of the human body.
Stem cells may also have commercial uses in screening for the discovery of
experimental new drugs.
The
unaudited condensed interim balance sheet as of March 31, 2008, the unaudited
condensed interim statements of operations for the three months ended March 31,
2008 and 2007, and the unaudited condensed interim statements of cash flows for
the three months ended March 31, 2008 and 2007 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, 2008 and for all interim periods presented have been
made. The balance sheet as of December 31, 2007 is derived from the
Company's audited financial statements as of that date. The results
of operations for the three months ended March 31, 2008 are not necessarily
indicative of the operating results anticipated for the full year of
2008.
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 except for the condensed consolidated balance sheet as of December
31, 2007, 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-KSB for the year ended December 31, 2007
Principles of Consolidation –
The accompanying condensed consolidated interim financial statements
include the accounts of Embryome Sciences, Inc., a wholly-owned subsidiary of
BioTime. As of March 31, 2008, there was no financial activity with
respect to this subsidiary. All intercompany accounts and
transactions have been eliminated in consolidation.
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.
Liquidity and Going Concern -
The accompanying unaudited condensed consolidated interim financial statements
have been prepared assuming BioTime will continue as a going concern. At
March 31, 2008, BioTime had $307,471 of cash on hand and negative working
capital of $1,655,771, a shareholders’ deficit of $3,349,599 and an accumulated
deficit of $44,320,547. BioTime will continue to need additional
capital and greater revenues to continue its current operations and to continue
to conduct its product development and research programs. Sales of additional
equity securities could result in the dilution of the interests of present
shareholders. BioTime is also continuing to seek new agreements with
pharmaceutical companies to provide product and technology licensing fees and
royalties. The availability and terms of equity financing and new
license agreements are uncertain. The unavailability or inadequacy of
additional financing or future revenues to meet capital needs could force
BioTime to modify, curtail, delay or suspend some or all aspects of its planned
operations. To mitigate these factors, management has instituted a
cost-cutting plan which included a reduction in discretionary general and
administrative expenses such as public relations. Additionally, in
October 2007 and again in March 2008, BioTime’s line of credit for working
capital was increased and the maturity date was extended (see Note
3). BioTime will continue to seek additional financing or capital as
well as additional licensing revenues from its current and future
patents. In view of the matters described above, BioTime’s continued
operations are dependent on its ability to raise additional capital, obtain
additional financing, and succeed in generating more revenue from its
operations. The condensed consolidated interim financial statements
do not include any adjustments relating to the recoverability and classification
of recorded asset amounts and classification of liabilities should BioTime
be unable to continue as a going concern.
2. Summary
of Select Significant Accounting Policies
Financial Statement 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.
Revenue Recognition – BioTime
complies with the Securities and Exchange Commission’s (“SEC”) Staff Accounting
Bulletin (“SAB”) No. 101, Revenue Recognition, as amended by SAB No. 104.
Royalty and license fee revenues consist of product royalty payments and fees
under license agreements and are recognized when earned and reasonably
estimable. BioTime recognizes revenue in the quarter in which the
royalty report is received rather than the quarter in which the sales took
place, as it does not have sufficient sales history to accurately predict
quarterly sales. Up-front nonrefundable fees where BioTime has no
continuing performance obligations are recognized as revenues when collection is
reasonably assured. In situations where continuing performance
obligations exist, up-front nonrefundable fees are deferred and amortized
ratably over the performance period. If the performance period cannot
be reasonably estimated, BioTime amortizes nonrefundable fees over the life of
the contract until such time that the performance period can be more reasonably
estimated. Milestones, if any, related to scientific or technical
achievements are recognized in income when the milestone is accomplished if (a)
substantive effort was required to achieve the milestone, (b) the amount of the
milestone payment appears reasonably commensurate with the effort expended and
(c) collection of the payment is reasonably assured.
BioTime
also defers costs, including finders’ fees, which are directly related to
license agreements for which revenue has been deferred. Deferred
costs are charged to expense proportionally and over the same period that
related deferred revenue is recognized as revenue. Deferred costs are
net against deferred revenues in BioTime’s balance sheet.
Grant
income is recognized as revenue when earned.
Stock-based Compensation - On
January 1, 2006, BioTime adopted Statement of Financial Accounting Standards
(“SFAS”) No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123(R)”) which
requires the measurement and recognition of compensation expense for all
share-based payment awards made to directors and employees including employee
stock options based on estimated fair values. SFAS 123(R) supersedes BioTime's
previous accounting using the intrinsic value method under Accounting Principles
Board Opinion (“APB”) No. 25, “Accounting for Stock Issued to Employees” for
periods beginning in fiscal 2006. In March 2005, the SEC issued SAB No. 107,
“Valuation of Share-Based Payment Arrangements for Public Companies”, which
provides supplemental implementation guidance for SFAS 123(R). BioTime has
applied the provisions of SAB 107 in its adoption of SFAS
123(R). Upon adoption of SFAS 123 (R), BioTime has continued to
utilize the Black-Scholes-Merton option pricing model which was previously used
for BioTime's proforma disclosures under SFAS No. 123. BioTime's determination
of fair value of share-based payment awards on the date of grant using an
option-pricing model is affected by BioTime's stock price as well as assumptions
regarding a number of highly complex and subjective variables. These variables
include, but are not limited to, BioTime's expected stock price volatility over
the term of the awards, and the actual and the projected employee stock options
exercise behaviors. The expected term of options granted is derived from
historical data on employee exercises and post-vesting employment termination
behavior. The risk-free rate is based on the U.S Treasury rates in effect during
the corresponding period of grant. Because changes in the subjective assumptions
can materially affect the estimated value, in management's opinion, the existing
valuation models may not provide an accurate measure of the fair value of
BioTime's employee stock options. Although the fair value of employee stock
options is determined in accordance with SFAS 123(R) and SAB 107 using an
option-pricing model, that value may not be indicative of the fair value
observed in a willing buyer/willing seller market transaction.
Recently Adopted
Accounting Pronouncements – On
December 21, 2007, the SEC issued SAB 110, which amends SAB 107 to allow for the
continued use of the simplified method to estimate the expected term in valuing
stock options beyond December 31, 2007. The simplified method can
only be applied to certain types of stock options for which sufficient exercise
history is not available.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements,”
which defines fair value, establishes a framework for measuring fair value,
and requires additional disclosures about fair value measurements. SFAS No. 157
is effective for fiscal years beginning after November 15,
2007.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities.” SFAS 159 permits entities to
choose to measure many financial instruments, and certain other items, at
fair value. SFAS No. 159 applies to reporting periods beginning after
November 15, 2007.
Recently Issued Accounting Pronouncements - In
December 2007, the FASB issued SFAS No. 141R (revised 2007), "Business Combinations" (SFAS
No. 141R), which replaces SFAS No. 141. SFAS No. 141R establishes the
principles and requirements for how an acquirer: (i) recognizes and measures in
its financial statements the identifiable assets acquired, the liabilities
assumed, and any noncontrolling interest in the acquiree; (ii) recognizes and
measures the goodwill acquired in the business combination or a gain from a
bargain purchase; and (iii) determines what information to disclose to enable
users of the financial statements to evaluate the nature and financial effects
of the business combination. Additionally, SFAS 141R requires that
acquisition-related costs be expensed as incurred. The provisions of
SFAS 141R will become effective for acquisitions completed on or after January
1, 2009; however, the income tax provisions of SFAS 141R will become effective
as of that date for all acquisitions, regardless of the acquisition
date. SFAS 141R amends SFAS 109, to require the acquirer to
recognize changes in the amount of its deferred tax benefits recognizable due to
a business combination either in income from continuing operations in the period
of the combination or directly in contributed capital, depending on the
circumstances. SFAS 141R further amends SFAS 109 and FIN 48, to
require, subsequent to a prescribed measurement period, changes to
acquisition-date income tax uncertainties to be reported in income from
continuing operations and changes to acquisition-date acquiree deferred tax
benefits to be reported in income from continuing operations or directly in
contributed capital, depending on the circumstances. BioTime is
currently evaluating the impact SFAS No. 141R will have on its future business
combinations.
In
December 2007, the FASB issued SFAS No. 160, "Noncontrolling Interests in
Consolidated Financial Statements—An Amendment of ARB No. 51" (SFAS No.
160). SFAS No. 160 establishes new accounting and reporting standards
for the non-controlling interest in a subsidiary and for the deconsolidation of
a subsidiary. SFAS No. 160 is effective for fiscal years beginning on
or after December 15, 2008. BioTime does not believe the adoption of
this statement will have a material effect on its financial position, results of
operations, and cash flows.
In March
2008, the FASB issued SFAS No. 161, Disclosures about Derivative
Instruments and Hedging Activities—An Amendment of FASB Statement No. 133
(SFAS No. 161). SFAS No. 161 applies to all derivative
instruments and related hedged items accounted for under FASB Statement No. 133,
Accounting for Derivative
Instruments and Hedging Activities. It requires entities to
provide greater transparency about (a) how and why an entity uses derivative
instruments, (b) how derivative instruments and related hedged items are
accounted for under Statement No. 133 and its related interpretations, and (c)
how derivative instruments and related hedged items affect an entity’s financial
position, results of operations, and cash flows. SFAS No. 161 is
effective for fiscal years and interim periods beginning after November 15,
2008. BioTime does not believe the adoption of this statement will
have a material effect on the results of operations or financial
condition.
3. Lines
of Credit
BioTime
has a revolving line of credit Agreement (the “Credit Agreement”) with certain
private lenders. In March 2008, the Credit Agreement was amended
twice. In the first amendment, the line of credit was increased from
$1,000,000 to $1,100,000, and BioTime agreed to issue to the new lender 10,000
common shares in return for making the additional credit available; the market
value for those shares was $3,200 on the date of issue, and that cost is being
amortized over the life of the Credit Agreement. Unamortized cost of
$1,745 is included in prepaid expenses and other current assets as of March
31, 2008. The Credit Agreement was subsequently amended to permit BioTime to
borrow up to a total of $2,500,000, and the maturity date of the revolving line
of credit was extended to November 15, 2008. The loans may become payable
prior to the maturity date if BioTime receives an aggregate of $4,000,000
through (A) the sale of capital stock, (B) the collection of license fees,
signing fees, milestone fees, or similar fees (excluding royalties) in excess of
$2,500,000 under any present or future agreement pursuant to which BioTime
grants one or more licenses to use its patents or technology, (C) funds borrowed
from other lenders, or (D) any combination of sources under clauses (A) through
(C).
In
consideration for making the additional credit available and for extending the
maturity date of outstanding loans, BioTime agreed to issue the lenders one
common share for each $5 principal amount of their loan
commitment. In total, 500,000 shares were issuable on March 31, 2008;
those shares had a market value of $150,000 on that date, and the cost is being
amortized over the life of the Credit Agreement. Unamortized cost of $149,348 is
included in prepaid expenses and other current assets as of March 31,
2008.
The
lenders have been given the right to exchange their line of credit promissory
notes for BioTime’s common shares at a price of $1.00 per share, and/or for
common stock of BioTime’s subsidiary, Embryome Sciences, Inc., at a price of
$2.00 per share.
At March
31, 2008, BioTime had drawn $1,200,000 under the Credit Agreement.
BioTime
also obtained a line of credit from American Express in August 2004, which
allows for borrowings up to $43,600; at March 31, 2008, BioTime had drawn
$30,519 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%.
The Company has accrued interest of $41,809 as of March 31,
2008.
BioTime
also secured a line of credit from Advanta in November 2006, which allows for
borrowings up to $35,000; at March 31, 2008, BioTime had drawn the entire
$35,000 against this line. Interest is payable on borrowings at a
Variable Rate Index, which will at no time be less than 8.25%.
4.
Royalty Obligation
In
December 2004, BioTime entered into an agreement with Summit Pharmaceuticals
International Corporation (“Summit”) to co-develop Hextend and PentaLyte for the
Japanese market. Under the agreement, BioTime received $300,000 in
December 2004, $450,000 in April 2005, and $150,000 in October
2005. The payments represent a partial reimbursement of BioTime’s
development cost of Hextend and PentaLyte. In June 2005, following
BioTime’s approval of Summit’s business plan for Hextend, BioTime paid to Summit
a one-time fee of $130,000 for their services in preparing the
plan. The agreement states that revenues from Hextend and PentaLyte
in Japan will be shared between BioTime and Summit as follows: BioTime 40% and
Summit 60%. Additionally, BioTime will pay Summit 8% of all net
royalties received from the sale of PentaLyte in the United States.
The
accounting treatment of the payments from Summit falls under the guidance of
Emerging Issues Task Force (“EITF”) Issue No. 88-18, “Sales of Future
Revenues.” EITF 88-18 addresses the accounting treatment when an
enterprise (BioTime) receives cash from an investor (Summit) and agrees to pay
to the investor a specified percentage or amount of the revenue or a measure of
income of a particular product line, business segment, trademark, patent, or
contractual right. The EITF reached a consensus on six independent factors that
would require reclassification of the proceeds as debt. BioTime met
one of the factors: BioTime was determined to have had significant continuing
involvement in the generation of the cash flows to the investor due to BioTime’s
supervision of the Phase II clinical trials of PentaLyte. As a
result, BioTime initially recorded the net proceeds from Summit to date of
$770,000 as long-term debt to comply with EITF 88-18 even though BioTime is not
legally indebted to Summit for that amount.
In July
2005, Summit sublicensed the rights to Hextend in Japan to
Maruishi. In consideration for the license, Maruishi agreed to pay
Summit a series of milestone payments: Yen 70,000,000, (or $593,390 based on
foreign currency conversion rates at the time) upon executing the agreement, Yen
100,000,000 upon regulatory filing in Japan, and Yen 100,000,000 upon regulatory
approval of Hextend in Japan. Consistent with the terms of the
BioTime-Summit agreement, Summit paid 40% of that amount, or $237,356, to
BioTime during October 2005. BioTime does not expect the regulatory
filing and approval milestones to be attained for several years.
The
initial accounting viewed the potential repayment of the $770,000 imputed debt
to come only from the 8% share of US PentaLyte revenues generated by BioTime and
paid to Summit. BioTime first became aware of the terms of the
Maruishi and Summit agreement during the fourth quarter of 2005, prepared an
estimate of the future cash flows, and determined that Summit would earn a
majority of their return on investment from their agreement with Maruishi, and
not the 8% of BioTime’s U.S. PentaLyte sales. Considering this, the
$770,000 was viewed as a royalty obligation which would be reduced by Summit’s
8% share of BioTime’s U.S. PentaLyte sales plus Summit’s 60% share of
Japanese revenue. Accordingly, BioTime recorded the entire amount
paid by Maruishi to Summit for the sublicense of $593,390 as deferred revenue,
to be amortized over the remaining life of the patent through
2019. BioTime’s 40% share of this payment was collected in October
2005 and the remaining 60% share was recorded as a reduction of the long-term
royalty obligation of BioTime to Summit. Interest on the long-term
royalty obligation was accrued monthly using the effective interest method
beginning October 2005, using a rate of 25.2% per annum, which BioTime had
determined was the appropriate interest rate when the future cash flows from the
transaction were considered.
In 2007,
BioTime completed its Phase II trials of PentaLyte, however was unable to find a
suitable licensing agreement for the product. At this time, BioTime
has deemed the continuation of the clinical trials necessary to bring this
product to market to be a significantly lower priority than it had been in the
past. Correspondingly, it is less likely that proceeds from the 8% of
PentaLyte U.S. sales will be sufficient to pay down the Summit Royalty
Obligation prior to the expiration of the patents. As a result of
this change in accounting estimates, BioTime has reevaluated treatment of this
transaction. The transaction no longer meets any of the factors that
require it to fall under the guidance from EITF 88-18. Consequently,
BioTime has reclassified the royalty obligation to deferred revenue and is
amortizing it over the remaining life of the underlying patents.
5. Shareholders’
Deficit
During April 1998, BioTime entered into
a financial advisory services agreement with Greenbelt Corp. ("Greenbelt"), a
corporation controlled by Alfred D. Kingsley and Gary K. Duberstein, who are also shareholders of BioTime. BioTime agreed
to indemnify Greenbelt and its officers, affiliates,
employees, agents, assignees, and controlling person from any liabilities
arising out of or in connection with actions taken on BioTime's behalf under the
agreement. The agreement was renewed annually through March 31,
2007. BioTime paid Greenbelt $90,000 in cash and issued 200,000
common shares for the twelve months ending March 31,
2007. Greenbelt permitted BioTime to defer paying
certain cash fees until October 2007. In return for allowing the
deferral, Greenbelt was issued an additional 60,000 common
shares by BioTime.
On March
31, 2008, BioTime entered into an amendment to its financial adviser agreement
with Greenbelt, renewing that agreement through December 31, 2008. Under
the amendment, BioTime will pay Greenbelt a fee of $135,000 in cash and 300,000
common shares. The shares shall be issued as follows: 150,000 shares
on April 1, 2008, and 75,000 shares on October 1, 2008, and January 2,
2009. The cash fee will be payable in three equal installments of
$45,000 each on July 1, 2008, October 1, 2008, and January 2,
2009. BioTime may elect to defer until January 2, 2009 the cash
payments due on July 1, 2008 and October 1, 2008, and if it does so, BioTime
will issue to Greenbelt 30,000 additional common shares for each payment
deferred.
The
agreement will terminate on December 31, 2008, unless BioTime or Greenbelt
terminates it on an earlier date. In the event of an early
termination, BioTime will pay Greenbelt a pro rata portion of the cash and
shares earned during the calendar quarter in which the agreement terminated,
based upon the number of days elapsed.
Activity
related to the Greenbelt agreement is presented in the table below:
|
|
Balance
included in Accounts Payable at January 1,
|
|
|
Add:
Cash-based
expense accrued
|
|
|
Add:
Stock-based
expense accrued
|
|
|
Less:
Cash
payments
|
|
|
Less:
Value
of stock-based payments
|
|
|
Balance
included in Accounts Payable at March 31,
|
|
2008
|
|
$ |
90,000 |
|
|
$ |
33,750 |
|
|
$ |
21,750 |
|
|
$ |
(0 |
) |
|
$ |
(0 |
) |
|
$ |
145,500 |
|
2007
|
|
$ |
108,000 |
|
|
$ |
22,500 |
|
|
$ |
44,800 |
|
|
$ |
(0 |
) |
|
$ |
(40,500 |
) |
|
$ |
134,800 |
|
6.
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, 2008 and 2007, options to
purchase 3,283,332 and 1,691,664 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.
7.
Stock-Based Compensation under SFAS 123(R)
On
January 1, 2006, BioTime adopted SFAS 123(R), which requires the measurement and
recognition for all share-based payment awards made to BioTime’s employees and
directors including employee stock options. The following table
summarizes stock-based compensation expense under SFAS 123R related to employee
and director stock options awards for the three months ended March 31, 2008 and
2007, which was allocated as follows:
|
|
Three Months Ended March 31, 2008
|
|
|
Three Months Ended March 31,
2007
|
|
Stock-based
compensation expense:
|
|
|
|
|
|
|
General
and Administrative
|
|
$ |
19,638 |
|
|
$ |
6,037 |
|
Stock
appreciation rights
|
|
|
19,726 |
|
|
|
– |
|
Stock-based
compensation expense included in operating expense
|
|
|
39,364 |
|
|
|
6,037 |
|
Total
stock-based compensation expense
|
|
$ |
39,364 |
|
|
$ |
6,037 |
|
The value
of each employee and director stock option was estimated on the date of grant
using the Black-Scholes-Merton model for the purpose of the pro-forma financial
disclosures in accordance with SFAS 123(R).
No
options were granted during the three months ended March 31,
2008. The weighted-average estimated fair value of stock
options vested during the three months ended March 31, 2007 was $0.25 per
share, using the Black-Scholes-Merton model with the following weighted-average
assumptions:
|
|
Three Months Ended March 31,
2007
|
Expected
lives (in years)
|
|
5
|
Risk
free interest rate
|
|
3.89%
|
Volatility
|
|
78.34%
|
Dividend
yield
|
|
0%
|
Forfeiture
rate
|
|
0%
|
For
options granted prior to 2006 and valued in accordance with SFAS No. 123, the
expected life and the expected volatility of the stock options were based upon
historical data. Forfeitures of employee stock options were accounted
for on an as-incurred basis.
Fair
Value Estimates
BioTime
uses third-party analyses to assist in developing the assumptions used to
determine fair value of share-based payment awards granted. BioTime’s
determination of the fair value of share-based payment awards on the date of
grant using an option-pricing model is affected by BioTime’s stock price as well
as assumptions regarding a number of highly complex and subjective
variables. The variables include, but are not limited to BioTime’s
expected stock price volatility over the term of the awards, and the actual and
projected employee stock option exercise behaviors. Because changes
in the subjective assumptions can materially affect the estimated value, in
management’s opinion, the existing valuation models may not provide an accurate
measure of the fair value of BioTime’s employee stock
options. Although the fair value of employee stock options is
determined in accordance with SFAS 123(R) and SAB 107 using an option-pricing
model, that value may not be indicative of the fair value observed in a willing
buyer/willing seller market transaction.
8. Fair
Value Measurement
Effective January 1, 2008, the Company
implemented SFAS No. 157, Fair
Value Measurement, for its financial assets and liabilities that are
re-measured and reported at fair value at each reporting period, and
non-financial assets and liabilities that are re-measured and reported at fair
value at least annually. In accordance with the provisions of FASB Staff
Position No. FAS 157-2, Effective Date of FASB Statement No.
157, the Company has elected to defer implementation of SFAS No. 157 as
it relates to its non-financial assets and non-financial liabilities that are
recognized and disclosed at fair value in the financial statements on a
nonrecurring basis until January 1, 2009. The Company is evaluating the impact,
if any, this standard will have on its non-financial assets and
liabilities.
The adoption
of SFAS No. 157 to the Company’s financial assets and liabilities and
non-financial assets and liabilities that are re-measured and reported at fair
value at least annually did not have an impact on the Company’s financial
results. The following table presents information about the Company’s assets and
liabilities that are measured at fair value on a recurring basis as of March 31,
2008, and indicates the fair value hierarchy of the valuation techniques the
Company utilized to determine such fair value. In general, fair values
determined by Level 1 inputs utilize quoted prices (unadjusted) in active
markets for identical assets or liabilities. Fair values determined by Level 2
inputs utilize data points that are observable such as quoted prices, interest
rates and yield curves. Fair values determined by Level 3 inputs are
unobservable data points for the asset or liability, and includes situations
where there is little, if any, market activity for the asset or
liability:
|
|
|
|
|
Quoted
Price in Active Markets
|
|
|
Significant
Other Observable Inputs
|
|
|
Significant
Unobservable Inputs
|
|
Description
|
|
March
31, 2008
|
|
|
(Level
1)
|
|
|
(Level
2)
|
|
|
(Level
3)
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
|
307,471 |
|
|
|
307,471 |
|
|
|
- |
|
|
|
- |
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lines
of Credit
|
|
|
1,307,328 |
|
|
|
1,307,328 |
|
|
|
- |
|
|
|
- |
|
The fair values of the Company’s cash and cash equivalents and lines of credit
are determined through market, observable and corroborated sources.
The carrying amounts reflected in the condensed consolidated balance sheets for
other current assets and other current liabilities approximate fair value due to
their short-term maturities
9.
Subsequent Events
BioTime
and its wholly-owned subsidiary Embryome Sciences, Inc., have signed a letter of
intent with International Stem Cell Corporation and its wholly-owned subsidiary
Lifeline Cell Technology (“Lifeline”) to jointly produce and distribute a wide
array of research products from human embryonic stem cell
technology. Pursuant to this anticipated collaboration, BioTime paid
$250,000 to Lifeline in installments of $100,000 and $150,000 on April 1, 2008
and April 2, 2008, respectively. The proposed collaboration with
Lifeline is subject to the execution of a definitive agreement, and should such
an agreement fail to be executed, the $250,000 will be returned to
BioTime.
In April
2008, BioTime 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 sublease will expire on November 30, 2010, but
BioTime has an early termination right that permits it to terminate the sublease
on July 31, 2008. Base monthly rent will be $22,000 during 2008,
$22,600 during 2009, and $23,340 during 2010. In addition to base
rent, BioTime 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.
In April
2008, BioTime received royalties in the amount of $341,153 from
Hospira. This amount is based on sales of Hextend made by Hospira in
the first quarter of 2008, and will be reflected in BioTime’s condensed
consolidated interim financial statements for the second quarter of
2008.
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
Since our
inception in November 1990, we have been engaged primarily in research and
development activities, which have culminated in the commercial launch of
Hextend®, our
lead product, and a clinical trial of PentaLyte®. Our
operating revenues have been generated primarily from licensing fees and from
royalties on the sale of Hextend. During October 2007, we entered the
field of regenerative medicine where we plan to develop stem cell related
products and technology for diagnostic, therapeutic and research
use. Our ability to generate substantial operating revenue depends
upon our success in developing and marketing or licensing our plasma volume
expanders, stem cell products, and organ preservation solutions and technology
for medical and research use.
On
October 10, 2007, Michael D. West, Ph.D. became our new Chief Executive
Officer. Dr. West is helping to spearhead our entry into the field of
regenerative medicine by initiating the development 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. To
further these ends, in December 2007, we created a new, wholly-owned subsidiary
called Embryome Sciences, Inc.
Our new
subsidiary plans to launch several kinds of stem cell research products in the
next two years. One such product is a commercial database that 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. This map of
the human and mouse embryome will take the form of a relational database that
would 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.. When the new embryome
database is operational, Embryome Sciences will provide researchers access to it
through an internet website. Embryome Sciences plans to launch this
web-based database in the second quarter of 2008. The new website may
also be used to market stem cell research products developed by Embryome
Sciences and by other companies.
In order
to manufacture specific cell types from embryonic stem cells, researchers need
to use factors that induce those cells to become a desired cell
type. Embryome Sciences plans to develop growth and differentiation
factors that can do this, and hopes to launch the first of these products
beginning in 2008.
Another
category of near-term embryomics products that Embryome Sciences will pursue, to
be launched beginning in 2009, is a line of purification tools useful to
researchers in quality control of products for regenerative
medicine.
We, and
our wholly-owned subsidiary Embryome Sciences, Inc., have signed a letter of
intent with International Stem Cell Corporation and its wholly-owned subsidiary
Lifeline Cell Technology (“Lifeline”) to jointly produce and distribute a wide
array of research products from human embryonic stem cell
technology. Embryome Sciences and Lifeline intend to jointly
manufacture products serving the complex needs of this industry, including cells
and related products that will allow researchers to identify and study the
thousands of cell types that can be made from hES cells. Among these
planned products are ESpyTM
cell lines, consisting of complex derivatives of hES cells that
send beacons of light in response to the activation of particular
genes. The progenitor cell lines will be produced and distributed in
joint efforts utilizing Embryome Science’s proprietary “Embryomics™” technology,
its future Embryome.com online database, and technology and approved hES cell
lines licensed from the Wisconsin Alumni Research Foundation
(“WARF”). Lifeline will contribute its manufacturing and quality
control expertise, the use of its facilities, and use of Lifeline’s
technologies. The proposed collaboration with Lifeline is subject to
the execution of a definitive agreement.
Our
ability to commercialize our planned stem cell research products is dependent
upon the success of our research and development program, and our ability to
obtain the capital needed for the financing of that program.
Most of
our research and development efforts to date have been devoted to our first
three blood volume replacement products: Hextend, PentaLyte, and HetaCool®. By
testing and bringing all three products to the market, we can increase our
market share by providing the medical community with solutions to match
patients’ needs. By developing technology for the use of HetaCool in
low temperature surgery, trauma care, and organ transplant surgery, we may also
create new market segments for our product line.
Our first
product, Hextend, is a physiologically balanced blood plasma volume expander,
for the treatment of hypovolemia. Hextend is being distributed in the
United States and Canada by Hospira, Inc. and in South Korea by CJ Corp. (“CJ”)
under exclusive licenses from us. Hospira also has the right to
obtain regulatory approval and market Hextend in Latin America and
Australia. 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.
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.
Revenues
for the three months ended March 31, 2008 consist of royalties on sales made by
Hospira and CJ during the period beginning October 1, 2007 and ending December
31, 2007. Royalty revenues recognized for that three-month period
were $308,900, a 55% increase from the $199,264 of royalty revenue during the
same period last year. The increase in royalties reflects an increase
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
received royalties of $341,153 from Hospira during April 2008, based on Hextend
sales during the three months ended March 31, 2008. Royalties
increased 108% from royalty revenues of $163,676 received during the same
period last year. The increase in royalties is due to increased sales
both to hospitals and to the United States Armed Forces. This revenue
will be reflected in our condensed consolidated interim financial statements for
the second quarter of 2008.
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.
Plasma
volume expanders containing pentastarch have been approved for use in certain
foreign countries including Canada, certain European Union countries, and
Japan. The regulatory agencies in those countries may be more willing
to accept applications for regulatory approval of PentaLyte based upon clinical
trials smaller in scope than those that may be required by the
FDA. This would permit us to bring PentaLyte to market overseas more
quickly than in the United States, provided that suitable licensing arrangements
can be made with multinational or foreign pharmaceutical companies to obtain
financing for clinical trials and manufacturing and marketing
arrangements.
Although
we plan to launch our first products for stem cell research during 2008 and
2009, we cannot predict the amount of revenue that those products might
generate. We will depend upon royalties from the sale of Hextend by
Hospira and CJ as our principal source of revenues for the near
future. Those royalty revenues will be supplemented by any revenues
that we may receive from our stem cell research products, and by license fees if
we enter into new commercial license agreements for our products.
The
amount and pace of research and development work that we can do or sponsor, and
our ability to commence and complete the clinical trials that are required in
order for us to obtain FDA and foreign regulatory approval of products, depend
upon the amount of money we have. Future research and clinical study
costs are not presently determinable due to many factors, including the inherent
uncertainty of these costs and the uncertainty as to timing, source, and amount
of capital that will become available for these projects. We have
already curtailed the pace of our product development efforts due to the limited
amount of funds available, and we may have to postpone further laboratory and
clinical studies, unless our cash resources increase through growth in revenues,
the completion of licensing agreements, additional equity investment, borrowing,
or third party sponsorship.
Because
our research and development expenses, clinical trial expenses, and production
and marketing expenses will be charged against earnings for financial reporting
purposes, management expects that there will be losses from operations in the
near term.
Hextend®,
PentaLyte®, and HetaCool® are our registered trademarks.
Results
of Operations
Revenues
For the
three months ended March 31, 2008, we recognized $308,900 in royalty revenue,
whereas we recognized $199,264 for the three months ended March 31,
2007. This increase of 55% in royalties is attributable to an
increase in product sales by Hospira, and reflects an increase in sales both to
hospitals and to the United States Armed Forces.
We
recognized $66,183 and $46,434 of license fees from CJ and Summit during the
three months ended March 31, 2008 and the three months ended March 31, 2007,
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 consolidated interim financial statements.
Operating
Expenses
Research
and development expenses were $347,151 for the three months ended March 31,
2008, compared to $343,550 for the three months ended March 31,
2007. This increase is primarily attributable to a $39,353
increase in salaries allocated to research and development, an increase of
$21,628 in payroll fees and taxes allocated to research and development expense,
an increase of $14,928 in insurance costs allocated to research and development
expense, and an increase of $38,943 in expenditures made to cover laboratory
expenses and supplies; these increases were offset to some extent by a decrease
of $108,766 in expenditures made for outside research. Research and
development expenses include laboratory study expenses, salaries, and
consultants’ fees.
General
and administrative expenses increased to $435,939 for the three months ended
March 31, 2008, from $417,780 for the three months ended March 31,
2007. This increase is primarily
attributable to an increase of $33,328 in stock-based expense allocated to
general and administrative costs, an increase of $49,257 in legal fees, an
increase of $21,364 in travel and entertainment expenses, an increase of $5,504
in investor and public relations expenses, an increase of $5,570 in expenses
related to outside services, and an increase of $15,000 in technology licensing
fees. These increases were offset in part by a decrease of $11,800 in
general and administrative consulting fees, a decrease of $59,974 in accounting
fees, and a decrease of $40,037 in patent costs.
Interest
and Other Income (Expense)
For the
three months ended March 31, 2008, we incurred a total of $73,976 of
net interest expense, compared to net interest expense of $38,230 for
the three months ended March 31, 2007.
Income
Taxes
During
the three months ended March 31, 2008, we incurred no foreign withholding
taxes. With respect to Federal and state income taxes, our effective
income tax rate differs from the statutory rate due to the 100% valuation
allowance established for our deferred tax assets, which relate primarily to net
operating loss carryforwards, as realization of such benefits is not deemed to
be likely.
Liquidity
and Capital Resources
The major
components of our net cash used in operations of approximately $270,000 in the
three months ended March 31, 2008 can be summarized as follows: net loss of
approximately $476,000 was reduced by non-cash expenses of approximately
$113,000, resulting in the cash loss of approximately $363,000, which was partly
funded with change in working capital of approximately $93,000.
At March
31, 2008, we had $307,471 cash and cash equivalents on hand, and lines of credit
for $2,578,600 from which $1,265,519 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 $2,500,000 under the Credit
Agreement. The maturity date of revolving line of credit loans is
November 15, 2008 but the loans may become payable prior to the maturity date if
we receive an aggregate of $4,000,000 through (A) the sale of capital stock, (B)
the collection of license fees, signing fees, milestone fees, or similar fees
(excluding royalties) in excess of $2,500,000 under any present or future
agreement pursuant to which we grant one or more licenses to use its patents or
technology, (C) funds borrowed from other lenders, or (D) any combination of
sources under clauses (A) through (C).
The
lenders have been given the right to exchange their line of credit promissory
notes for our common shares at a price of $1.00 per share, and/or for common
stock of our subsidiary, Embryome Sciences, Inc., at a price of $2.00 per
share.
We also
obtained a line of credit from American Express in August 2004, which allows for
borrowings up to $43,600; at March 31, 2008, we had drawn $30,519 against this
line. See Note 3 to the condensed consolidated 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, 2008, we had drawn the entire $35,000
against this line. See Note 3 to the condensed consolidated interim
financial statements for additional information.
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. 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, 2008, 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, but
we have an early termination right that permits us to terminate the sublease on
July 31, 2008. Base monthly rent will be $22,000 during 2008, $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, 2008, December
31, 2007, or March 31, 2007.
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.
During
March 2008 we agreed to issue a total of 510,000 common shares to
our lenders under the terms of our Credit Agreement. These shares
were issued in reliance upon an exemption from registration under Section
4(2) of the Securities Act of 1933, as amended.
Item
5. Other Information.
We do not presently have
enough independent directors to constitute our Nominating
Committee. Accordingly, the Board of Directors, as a whole,
will consider nominees proposed by shareholders; provided that they notify the
Board in writing at least 120 days before the date of the next annual meeting,
and they and the nominee provide the Board with all information that the Board
may reasonably request regarding the nominee no later than 90 days prior to the
annual meeting. The Board has not set any specific minimum
qualifications that a prospective nominee would need in order to be recommended
by the Board or to serve on the Board. Rather, in evaluating any new
nominee or incumbent director, the Board will consider whether the particular
person has the management, financial, scientific, and industry knowledge,
skills, experience, and expertise needed to manage our affairs in light of the
skills, experience and expertise of the other members of the Board as a
whole. The Board will also consider whether including a prospective
director on the Board will result in a Board composition that complies with (a)
applicable state corporate laws, (b) applicable federal and state securities
laws, and (c) the rules of the SEC and any stock exchange on which our shares
may be listed.
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+++
|
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 BioTime Inc. 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.++++
|
|
|
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.
^^ 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, 2008
|
/s/
Michael D. West
|
|
Michael
D. West
|
|
Chief
Executive Officer
|
|
|
|
|
Date:
May 14, 2008
|
/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+++
|
|
|
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 BioTime Inc. 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.++++
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification^^
|
|
|
|
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.
^^ Filed
herewith