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 September 30, 2007
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 small business issuer as specified in its charter)
|
California
|
|
94-3127919
|
|
|
(State
or other jurisdiction of incorporation or organization)
|
|
(IRS
Employer Identification No.)
|
|
6121
Hollis Street
Emeryville,
California 94608
(Address
of principal executive offices)
(510)
350-2940
(Issuer's
telephone number)
Indicate
by check mark whether the issuer (1) 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. Yes x No ¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No x
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.
22,834,374 common shares, no par value, as of
November 9, 2007.
Transitional
Small Business Disclosure Format (Check one) Yes ¨ No
x
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
BALANCE SHEET
(unaudited)
ASSETS
|
|
September
30,
2007
|
|
CURRENT
ASSETS:
|
|
|
|
Cash
and cash equivalents
|
|
$ |
13,760
|
|
Accounts
receivable
|
|
|
4,909
|
|
Prepaid
expenses and other current assets
|
|
|
13,883
|
|
Total
current assets
|
|
|
32,552
|
|
|
|
|
|
|
EQUIPMENT,
net of accumulated depreciation of $585,047
|
|
|
8,504
|
|
DEPOSITS
AND OTHER ASSETS
|
|
|
20,976
|
|
TOTAL
ASSETS
|
|
$ |
62,032
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$ |
442,162
|
|
Current
portion of deferred license revenue
|
|
|
193,633
|
|
Lines
of credit payable
|
|
|
353,931
|
|
Other
current liabilities
|
|
|
1,296
|
|
Total
current liabilities
|
|
|
991,022
|
|
|
|
|
|
|
DEFERRED
LICENSE REVENUE – less current portion
|
|
|
1,143,674
|
|
ROYALTY
OBLIGATION
|
|
|
761,215
|
|
OTHER
LONG-TERM LIABILITIES
|
|
|
10,530
|
|
Total
long-term liabilities
|
|
|
1,915,419
|
|
|
|
|
|
|
COMMITMENTS
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
DEFICIT:
|
|
|
|
|
Preferred
shares, no par value, undesignated as to Series, authorized 1,000,000
shares; none outstanding
|
|
|
—
|
|
Common
shares, no par value, authorized 50,000,000 shares; issued and
outstanding
22,834,374
|
|
|
40,579,321
|
|
Contributed
capital
|
|
|
93,973
|
|
Accumulated
deficit
|
|
|
(43,517,703 |
) |
Total
shareholders' deficit
|
|
|
(2,844,409 |
) |
TOTAL
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
|
$ |
62,032
|
|
See
notes
to condensed interim financial statements.
BIOTIME,
INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended
|
|
|
Nine
Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30, 2007
|
|
|
September
30, 2006
|
|
|
September
30, 2007
|
|
|
September
30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVENUE:
|
|
|
|
|
|
|
|
|
|
|
|
|
License
fees
|
|
$ |
48,066
|
|
|
$ |
46,979
|
|
|
$ |
141,565
|
|
|
$ |
126,019
|
|
Royalties
from product sales
|
|
|
183,093
|
|
|
|
250,017
|
|
|
|
546,033
|
|
|
|
555,914
|
|
Total
revenue
|
|
|
231,159
|
|
|
|
296,996
|
|
|
|
687,598
|
|
|
|
681,933
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
(170,382 |
) |
|
|
(304,562 |
) |
|
|
(724,699 |
) |
|
|
(954,369 |
) |
General
and administrative
|
|
|
(216,443 |
) |
|
|
(301,924 |
) |
|
|
(927,877 |
) |
|
|
(1,139,305 |
) |
Total
expenses
|
|
|
(386,825 |
) |
|
|
(606,486 |
) |
|
|
(1,652,576 |
) |
|
|
(2,093,674 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTEREST
INCOME (EXPENSE) AND OTHER EXPENSES:
|
|
|
(57,825 |
) |
|
|
(30,545 |
) |
|
|
(146,452 |
) |
|
|
(74,325 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$ |
(213,491 |
) |
|
$ |
(340,035 |
) |
|
$ |
(1,111,430 |
) |
|
$ |
(1,486,066 |
) |
LOSS
PER COMMON SHARE – BASIC AND DILUTED
|
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.07 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE NUMBER OF COMMON SHARES – BASIC AND DILUTED
|
|
|
22,834,374
|
|
|
|
22,574,324
|
|
|
|
22,803,971
|
|
|
|
22,525,747
|
|
See
notes
to condensed interim financial statements.
BIOTIME,
INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Nine
months Ended
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,111,430 |
) |
|
$ |
(1,486,066 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
4,115
|
|
|
|
5,383
|
|
Interest
on royalty obligation
|
|
|
129,458
|
|
|
|
101,416
|
|
Amortization
of debt issuance costs
|
|
|
18,162
|
|
|
|
11,393
|
|
Lines
of credit payable
|
|
|
13,931
|
|
|
|
—
|
|
Stock-based
compensation
|
|
|
74,043
|
|
|
|
77,211
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
2,268
|
|
|
|
(5,966 |
) |
Prepaid
expenses and other current assets
|
|
|
18,454
|
|
|
|
71,053
|
|
Deposits
|
|
|
—
|
|
|
|
—
|
|
Accounts
payable and accrued liabilities
|
|
|
69,945
|
|
|
|
(240,768 |
) |
Deferred
revenue
|
|
|
(104,836 |
) |
|
|
389,362
|
|
Other
long-term liabilities
|
|
|
412
|
|
|
|
4,578
|
|
Net
cash used in operating activities
|
|
|
(885,478 |
) |
|
|
(1,072,404 |
) |
|
|
|
|
|
|
|
|
|
Cash
used in investing activities, purchase of equipment
|
|
|
(1,779 |
) |
|
|
(5,943 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Borrowings
under lines of credit
|
|
|
340,000
|
|
|
|
—
|
|
Exercise
of options
|
|
|
—
|
|
|
|
126
|
|
Net
cash provided by financing activities
|
|
|
340,000
|
|
|
|
126
|
|
|
|
|
|
|
|
|
|
|
DECREASE
IN CASH AND CASH EQUIVALENTS:
|
|
|
(547,257 |
) |
|
|
(1,078,221 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
561,017
|
|
|
|
1,833,774
|
|
Cash
and cash equivalents at end of period
|
|
$ |
13,760
|
|
|
$ |
755,553
|
|
|
|
|
|
|
|
|
|
|
NONCASH
FINANCING AND INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Issuance
of shares to secure line of credit
|
|
$ |
—
|
|
|
$ |
38,000
|
|
See
notes
to condensed interim financial statements.
BIOTIME,
INC.
NOTES
TO THE CONDENSED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
1. Description
of Organization and Liquidity
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 September 30, 2007, the
unaudited condensed interim statements of operations for the three and nine
months ended September 30, 2007 and 2006 and the unaudited condensed interim
statements of cash flows for the nine months ended September 30, 2007 and
2006
have been prepared by BioTime’s management in accordance with the instructions
from the Form 10-QSB and Item 310(b) of Regulation S-B. 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 September 30, 2007 and for all interim periods
presented have been made. The results of operations for the three and nine
months ended September 30, 2007 are not necessarily indicative of the operating
results anticipated for the full year of 2007.
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. Certain previously furnished amounts have been
reclassified to conform with presentations made during the current
periods. It is suggested that these condensed 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, 2006.
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 products; BioTime’s ability to
obtain United States Food and Drug Administration and foreign regulatory
approval to market its products; competition from products manufactured and
sold
or being developed by other companies; the price of 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 products (and related treatment) from
government health administration authorities, private health coverage insurers
and other organizations.
Liquidity
and Going Concern- The accompanying unaudited condensed interim financial
statements have been prepared assuming BioTime will continue as a going
concern. At September 30, 2007, BioTime had $13,760 cash and cash equivalents
on
hand and lines of credit for $573,600 (see Note 3), from which $340,000 had
been drawn at September 30, 2007. BioTime also had negative working capital
of $958,470, a shareholders' deficit of $2,844,409, and an accumulated
deficit of $43,517,703. BioTime needs additional capital and greater
revenues to continue its current operations, and to conduct its planned 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, suspend, or possibly discontinue some or all aspects of its planned
operations. Management believes that its projected rate of spending, which
includes possible spending cuts, cash on hand, anticipated royalties from
the
sale of Hextend®, licensing
fees,
and available revolving lines of credit, will allow BioTime to operate
through March 31, 2008. These conditions raise substantial doubt
about BioTime's ability to continue as a going concern. The accompanying
unaudited condensed interim financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
2. Summary
of Select Significant Accounting Policies
Financial
Statement Use of Estimates - The preparation of unaudited condensed 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 interim financial statements and the reported amounts of revenues
and
expenses during the reporting period. Actual results could differ
from those estimates.
Revenue
recognition – Royalty and license fee revenues consist of product royalty
payments and fees under license agreements and are recognized when
earned. Up-front, non-refundable 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, non-refundable fees are deferred and amortized ratably over
the
performance period. If the performance period cannot be reasonably
estimated, BioTime amortizes non-refundable 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 unaudited condensed interim balance
sheet.
BioTime
recognizes royalty revenues in the quarter in which the sales report is
received, rather than the quarter in which the sales took place, as BioTime
does
not have sufficient sales history to accurately predict quarterly
sales.
Grant
income is recognized as revenue when earned.
Stock-based
Compensation - On January 1, 2006, BioTime adopted Statement of Financial
Accounting Standard (“SFAS”) 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 Securities and Exchange Commission issued Staff Accounting Bulletin No.
107
(“SAB107”) relating to SFAS 123(R), 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 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. See Note 8 for additional
information.
Recently
Adopted Accounting Standard
In
July 2006, the FASB issued
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (“FIN
48”). FIN 48 creates a single accounting and disclosure model for
uncertain tax positions, provides guidance on the minimum threshold that
a tax
uncertainty is required to meet before it can be recognized in the financial
statements, and applies to all tax positions taken by a company, both those
deemed to be routine as well as those for which there may be a high degree
of
uncertainty. FIN 48 establishes a two-step approach for evaluating tax
positions. The first step - recognition - occurs when a company
concludes (based solely on the technical aspects of the tax matter) that
a tax
position is more likely than not to be sustained on examination by a taxing
authority. The second step - measurement - is only considered after
step one has been satisfied, and measures any tax benefit at the largest
amount
that is deemed more likely than not to be realized upon ultimate settlement
of
the uncertainty. Tax positions that fail to qualify for initial
recognition are recognized in the first subsequent interim period that they
meet
the more likely than not standard, when they are resolved through negotiation
or
litigation with the taxing authority, or upon the expiration of the statute
of
limitations. Derecognition of a tax position previously recognized
would occur when a company subsequently concludes that a tax position no
longer
meets the more likely than not threshold of being sustained. FIN 48
also significantly expands the financial statement disclosure requirements
relating to uncertain tax positions. FIN 48 is effective for fiscal
years beginning after December 15, 2006. Differences
between the amounts recognized in the balance sheet prior to adoption and
the
amounts recognized in the balance sheet after adoption will be accounted
for as
a cumulative effect adjustment to the beginning balance of retained
earnings. BioTime does not believe that the adoption of FIN 48 will
have a material effect on its condensed interim financial
statements.
Recently
Issued Accounting Standards
In
September 2006, the FASB issued
SFAS 157, “Fair Value Measurements,” which defines fair
value, establishes a framework for measuring fair value, and requires
additional disclosures about fair value measurements. SFAS 157 is effective
for fiscal years beginning after November 15, 2007. BioTime is currently
evaluating the effect, if any, that the adoption of SFAS 157 will have on
its condensed interim financial statements.
In
February 2007, the FASB issued SFAS 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 159 applies to reporting periods beginning after November 15, 2007.
BioTime
is currently evaluating the effect, if any, that the adoption of SFAS 159
will have on its condensed interim financial statements.
3. Lines
of Credit
In
April 2006, BioTime entered into a Revolving Line of Credit Agreement (the
“Credit Agreement”) with Alfred D. Kingsley, Cyndel & Co., Inc., and George
Karfunkel, investors in BioTime, under which BioTime may borrow up to $500,000
for working capital purposes at an interest rate of 10% per annum. The
maturity date of the Credit Agreement was the earlier of
(i) October 31, 2007 or (ii) such date on which the borrower
shall have received an aggregate of $600,000 through (A) the sale of
capital stock, (B) the collection of licensing fees, signing fees,
milestone fees, or similar fees in excess of $1,000,000 under any present
or
future agreement pursuant to which the borrower grants one or more licenses
to
use the borrower’s patents or technology, (C) funds borrowed from other
lenders, or (D) any combination of sources under clauses (A) through
(C). Under the Credit Agreement, BioTime will prepay, and the credit line
will be reduced by, any funds received prior to the maturity date from those
sources discussed above. In consideration for making the line of credit
available, BioTime issued to the investors a total of 99,999 common shares.
The market value of BioTime common shares was $0.38 per common share on
April 12, 2006, valuing the shares at $38,000. The line of
credit is collateralized by a security interest in BioTime’s right to receive
royalty and other payments under the license agreement with Hospira. During
the nine months ended September 30, 2007, BioTime drew $300,000 under this
line.
BioTime
also has an available line of credit from American Express, which allows
for
borrowings up to $43,600. During the nine months ended September 30, 2007,
BioTime drew $40,000 under this line, interest will be payable 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 line of credit will not expire unless terminated by one of
the parties.
BioTime
also secured a line of credit from Advanta in November 2006, which allows
for
borrowings up to $30,000; the entire amount was drawn from this line of credit
in October 2007. Interest will be payable on borrowings at a Variable Rate
Index, which will at no time be less than 8.25% per annum.
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 development 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 fall under the guidance
of the
FASB’s Emerging Issues Task Force (“EITF”) 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 meets
one
of the factors whereby BioTime has significant continuing involvement in
the
generation of the cash flows due to the investor. 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
Pharmaceutical Co., Ltd (“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 and Summit
agreement, Summit paid 40% of the initial agreement execution amount, $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 sublicense during the fourth quarter of 2005, at which time BioTime
prepared an estimate of the future cash flows, and determined that Summit
will
earn a majority of its return on investment from its agreement with Maruishi,
and not the 8% of BioTime’s U.S. PentaLyte sales. Considering this,
the imputed $770,000 obligation to Summit is viewed for accounting purposes
as a
royalty obligation which will 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 $593,390 paid
by Maruishi to Summit for the sublicense 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. The balance of the license fees received by BioTime is still
being treated as a long-term royalty obligation for financial accounting
purposes under EITF 88-18. Interest on the long-term royalty
obligation is accrued monthly, using the effective interest method beginning
October 2005, at the rate of 25.2% per annum, which BioTime has determined
is the appropriate interest rate when the future cash flows from the transaction
are considered. Prior to October 2005, BioTime was accruing interest
at a rate of 12% per annum based upon its incremental borrowing rate because
the
effective interest rate derived from future “deemed payments” could not be
reasonably estimated. The effective interest rate will be evaluated
annually, or when events occur that have significantly affected the estimate
of
future cash flows. BioTime has recorded $129,458 and $101,416 of
interest expense on the long-term royalty obligation during the nine months
ended September 30, 2007 and September 30, 2006, respectively.
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. The
agreement has been renewed each subsequent year ending March 31. For
the twelve months ending March 31, 2006, BioTime agreed to pay Greenbelt
$45,000
in cash and issue 135,000 common shares. During April 2006, BioTime
paid the remaining $45,000 obligation under the agreement for the twelve
months
ended March 31, 2006 and issued 33,750 common
shares. During March 2006, the board of directors approved
the renewal of the agreement with Greenbelt for the 12 months ending March
31,
2007. BioTime agreed to pay Greenbelt a cash fee of $90,000 and issue
Greenbelt 200,000 common shares. The common shares were issued as
follows: 150,000 shares on January 2, 2007 for services rendered through
December 31, 2006, and 50,000 shares on April 2, 2007 for services rendered
from
January 1, 2007 through March 31, 2007. The cash fee was payable as follows:
$30,000 on January 2, 2007, $30,000 on April 2, 2007, and $30,000 on October
1,
2007. However, BioTime elected to exercise its right to defer the
cash payments that would otherwise have been due on January 2, 2007, and
on
April 2, 2007. Under the terms of the Greenbelt agreement, BioTime
issued 60,000 additional common shares as consideration for the deferral
of the
cash payments. An expense of $33,000, reflecting the value of the
shares issued, has been recorded for the nine months ended September 30,
2007 in
the unaudited condensed statements of operations.
Activity
related to the Greenbelt agreement is presented in the table below
(unaudited):
|
|
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 September 30,
|
|
2007
|
|
$ |
108,000
|
|
|
$ |
22,500
|
|
|
$ |
62,500
|
|
|
$ |
(0 |
) |
|
$ |
(103,000 |
) |
|
$ |
90,000
|
|
2006
|
|
$ |
65,138
|
|
|
$ |
56,250
|
|
|
$ |
33,487
|
|
|
$ |
(45,000 |
) |
|
$ |
(43,875 |
) |
|
$ |
66,000
|
|
During
the nine months ended September
30, 2007 and 2006, the Company issued to Greenbelt 110,000 and 135,000 common
shares, respectively, valued at $62,500 and $43,875, respectively.
During
the nine months ended September
30, 2006, 63 warrants were exercised for proceeds of $126.
6.
Licensing Agreement
On
March 24, 2006, BioTime entered into a licensing agreement with Summit to
develop Hextend and PentaLyte in the People’s Republic of China, and Taiwan.
Summit paid BioTime $500,000 in May, 2006 as the initial
consideration for the China and Taiwan license. BioTime also will be
entitled to receive 50% of the royalties and any milestone payments received
by
Summit from any third-party sublicense, excluding the first payment made
by a
sublicense upon execution of an agreement with Summit. Summit has
entered a sublicense agreement with Maruishi for Hextend and PentaLyte in
China
and Taiwan. Milestone payments of Yen 20,000,000 are payable by Maruishi
when the first new drug application for Hextend is filed and when the first
clinical study of PentaLyte begins under the sublicense.
7.
Loss Per Share
Basic
earnings (loss) per share excludes dilution and is computed by dividing net
income (loss) by the weighted average number of common shares outstanding
during
the period. Diluted earnings (loss) per share reflects the potential
dilution from securities and other contracts which are exercisable or
convertible into common shares. For the three and nine months ended
September 30, 2007 and 2006, options to purchase 1,691,664 and 1,419,644
common
shares, respectively, and warrants to purchase 7,847,867 and 7,847,867 common
shares, respectively, were excluded from the computation of earnings (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.
8.
Stock-Based Compensation
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 related to employee and director
stock options awards for the three and nine months ended September 30, 2007,
which was allocated as follows (unaudited):
Stock-based
compensation expense:
|
|
Three
Months Ended September 30, 2007 (under
SFAS123(R))
|
|
|
Nine
Months Ended September 30, 2007 (under
SFAS123(R))
|
|
|
Three
Months Ended September 30, 2006 (under
SFAS123(R))
|
|
|
Nine
Months Ended September 30, 2006 (under
SFAS123(R))
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and Administrative
|
|
$ |
5,723
|
|
|
$ |
29,243
|
|
|
$ |
7,913
|
|
|
$ |
43,724
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in operating expense
|
|
|
5,723
|
|
|
|
29,243
|
|
|
|
7,913
|
|
|
|
43,724
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
stock-based compensation expense
|
|
$ |
5,723
|
|
|
$ |
29,243
|
|
|
$ |
7,913
|
|
|
$ |
43,724
|
|
For
all
applicable periods, 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).
The
weighted-average estimated fair value of stock options granted during the
nine
months ended September 30, 2007 and 2006 was $0.57 and $0.25 per share,
respectively, using the Black-Scholes Merton model with the following
weighted-average assumptions:
|
|
Nine
Months Ended September 30, 2007
|
|
|
Nine
Months Ended September 30, 2006
|
|
|
|
|
|
|
|
|
Expected
lives in years
|
|
|
5
|
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
Risk
free interest rates
|
|
|
4.51 |
% |
|
|
4.79 |
% |
|
|
|
|
|
|
|
|
|
Volatility
|
|
|
102 |
% |
|
|
93 |
% |
|
|
|
|
|
|
|
|
|
Dividend
yield
|
|
|
0 |
% |
|
|
0 |
% |
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.
9.
Subsequent Event
In
October 2007, BioTime amended its Revolving Line of Credit Agreement (See
Note 3). The amendment increases the line of credit to $1,000,000,
and increases the interest rate to 12% per annum. The maturity date of the
amended Credit Agreement is the earlier of (i) April 30, 2008 or
(ii) such date on which the borrower shall have received an aggregate of
$2,000,000 through (A) the sale of capital stock, (B) the collection
of licensing fees, signing fees, milestone fees, or similar fees in excess
of
$1,000,000 under any present or future agreement pursuant to which the borrower
grants one or more licenses to use the borrower’s patents or technology,
(C) funds borrowed from other lenders, or (D) any combination of
sources under clauses (A) through (C). In consideration for amending
the line of credit, on October 17, 2007, BioTime issued to the investors
a total
of 200,000 common shares, which had a value on that date of $106,000. The
line of credit is collateralized by a security interest in BioTime’s right to
receive royalty and other payments under the license agreement with
Hospira.
Item
2. Management's Discussion and Analysis or Plan of
Operation.
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Overview
Since
its
inception in November 1990, BioTime has 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. Our ability to generate substantial
operating revenue depends upon our success in developing and marketing or
licensing our plasma volume expanders and organ preservation solutions and
technology for medical use.
On
October 10, 2007, Michael D. West, Ph.D. became BioTime's new Chief Executive
Officer. Dr. West will help spearhead BioTime's 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. 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.
We
plan
to focus on near-term commercialization opportunities presented by stem cell
research programs. We believe that the development of products for
use in stem cell research provides an opportunity to commercialize products
more
quickly, using less capital, than developing therapeutic
products. Our plan is to market to companies and academic researchers
in the stem cell industry some of the tools they need to attain their
goals.
We
plan
to launch three kinds of research products in the next two years. The
first product is a commercial embryome database that will provide a map that
researchers may use to navigate the complexities of human development and
to
identify the many hundreds of cell types coming from hES cells. Like
the field of "genomics," where companies mapped the human DNA, we believe
that
there is an important need for a map of the human "embryome" in stem cell
research. This map would take the form of a relational data base 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. We plan to launch this
web-based database in late 2007 or the early part of 2008.
We
also
plan to develop growth and differentiation factors, and hope to launch the
first
of these products beginning in 2008. In order to manufacture specific
cell types from hES cells, researchers need to use factors that signal to
hES
cells to become a desired cell type. We may market these reagents
from a new BioTime website.
The
third
category of near-term products that we plan to develop are purification ligands
useful to researchers in purification and quality control analysis of products
in regenerative medicine. We hope to be able to launch the first of
these products in 2009.
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 September 30, 2007 consist of royalties on sales
made
by Hospira and CJ during the period beginning April 1, 2007 and ending June
30,
2007. Royalty revenues recognized for that three-month period were
$183,093, a 27% decrease from the $250,017 of royalty revenue during the
same
period last year. The decrease in royalties reflects a decline in
sales predominantly 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 $230,646 from Hospira during November 2007, based on
Hextend sales during the three months ended September 30,
2007. Royalties decreased 39% from royalty revenues of
$377,564 received during the same period last year. The decrease
in royalties is due to slower sales to the United States Armed
Forces. This revenue will be reflected in our financial statements
for the fourth quarter of 2007.
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. Clinical trials of PentaLyte in the United States may
take longer and may be more costly than the Hextend clinical trials, which
cost
approximately $3,000,000. The Food and Drug Administration (“FDA”)
permitted us to proceed directly into a Phase III clinical trial of Hextend
involving only 120 patients because the active ingredients in Hextend had
already been approved for use in plasma expanders by the FDA in other products.
Because PentaLyte contains a starch (pentastarch) that has not been approved
by
the FDA for use in a plasma volume expander (although pentastarch is approved
in
the US for use in certain intravenous solutions used to collect certain blood
cell fractions), we had to complete Phase I and Phase II clinical trials
of
PentaLyte. A subsequent Phase III trial may involve more patients
than the Hextend trials, and we do not know yet the actual scope or cost
of the
clinical trials that the FDA will require for PentaLyte or the other products
we
are developing.
During
April 2007, Hospira declined an opportunity to commercialize PentaLyte® under
the terms we
offered. Hospira will continue to manufacture and sell
Hextend® under
its License Agreement with us, and we will offer other pharmaceutical companies
the opportunity to license 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.
We
are
also continuing to develop solutions for low temperature
surgery. Once a sufficient amount of data from successful low
temperature surgery has been compiled, we plan to seek permission to use
Hextend
as a complete replacement for blood under near-freezing
conditions. We currently plan to market Hextend for complete blood
volume replacement at very low temperatures under the registered trademark
“HetaCool®”
after FDA approval is obtained, although the time frame for such approval
is
presently uncertain.
We
have
been awarded a $299,990 research grant by the National Heart, Lung, and Blood
Institute division of the National Institutes of Health (“NIH”) for use in the
development of HetaCool. We are using the grant to fund a project
entitled “Resuscitating Blood-Substituted Hypothermic Dogs” at the Texas Heart
Institute in Houston under the guidance of Dr. George V. Letsou. Dr.
Letsou is Associate Professor of Surgery and Director of the Heart Failure
Center at the University of Texas Medical School in Houston,
Texas. We were granted $149,994 for the project during 2004 and
$149,996 during 2005. We have received $240,352 of the grant funds
through September 30, 2007. The time period for drawing down the
remainder of the grant funds was extended for another year, running through
March 31, 2008.
BioTime
scientists believe the HetaCool program has the potential to produce a product
that could be used in very high fluid volumes (50 liters or more per procedure
if HetaCool were used as a multi-organ donor preservation solution or to
temporarily replace substantially all of the patient’s circulating blood volume)
in cardiovascular surgery, trauma treatment, and organ
transplantation. However, the cost and time to complete the
development of HetaCool, including clinical trials, cannot presently be
determined.
Until
such time as we are able to successfully commercialize any of the various
projected regenerative medicine products and can complete the development
of
PentaLyte and HetaCool and enter into commercial license agreements for those
products and additional foreign commercial license agreements for Hextend,
we
will depend upon royalties from the sale of Hextend by Hospira and CJ as
our
principal source of revenues.
The
amount and pace of research and development work that we can do or sponsor,
and
our ability to commence and complete clinical trials required to obtain FDA
and
foreign regulatory approval of products, depends 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 registered trademarks of BioTime.
Results
of Operations
Revenues
During
the three months ended September 30, 2007, we recognized $48,066 of license
fee
revenues related to our license agreements with CJ and
Summit. The CJ license fee of $800,000, net of the finder’s fees, has
been deferred and is being recognized as revenue over the life of the contract,
which has been estimated to be approximately eight years based on the current
expected life of the governing patent covering BioTime’s products in
Korea. A portion of the proceeds received by Summit from Maruishi in
conjunction with the sublicense of Hextend have also been deferred and are
being
amortized under the same terms as the CJ revenues. See Notes 2 and 4 to the
unaudited condensed interim financial statements for additional
information.
For
the
three months ended September 30, 2007, we recognized $183,093 in royalty
revenue, whereas we recognized $250,017 for the three months ended September
30,
2006. This decrease of 27% in royalties is attributable to a decrease
in product sales by Hospira, and reflects a decline in sales predominantly
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.
Operating
Expenses
Research
and development expenses were $170,382 for the three months ended September
30,
2007, compared to $304,562 for the three months ended
September 30, 2006. This decrease is chiefly attributable
to a $65,184 decrease in outside research expenses following the completion
of
our PentaLyte clinical trial, a $22,112 decrease in salaries allocated to
research and development expense, a $29,006 decrease in insurance costs
allocated to research and development expense, and a decrease of $24,144
in
scientific consulting costs. For the nine months ended September 30,
2007, research and development expenses totaled $724,699, compared to $954,369
for the nine months ended September 30, 2006. This
decrease is due primarily to a decrease of $85,802 in outside research expenses
following the completion of our PentaLyte clinical trial, a decrease of $30,652
in salaries allocated to research and development expense, a decrease of
$83,151
in insurance costs allocated to research and development expense, and a decrease
of $44,343 in fees paid to scientific consultants; these decreases were offset
to some extent by a $27,456 increase in payroll taxes and expenses allocated
to
research and development expense. Research and development
expenses include clinical trial expenses, laboratory study expenses, salaries,
ongoing prosecution of regulatory applications in the United States, and
consultants’ fees.
General
and administrative expenses decreased to $216,443 for the three months ended
September 30, 2007 from $301,924 for the three months ended September 30,
2006. The major components of this decrease were a
decrease of $47,070 in fees paid to general and administrative consultants,
a
decrease of $25,652 in salaries allocated to general and administrative expense,
a decrease of $16,009 in accounting expenses, and a decrease of $10,350 in
outside services; these decreases were offset to some extent by an increase
of
$15,510 in legal fees. For the nine months ended September 30, 2007,
general and administrative expenses totaled $927,877, compared to $1,139,305
for
the nine months ended September 30, 2006. This decrease is due
primarily to a decrease of $48,278 in general and administrative consulting
fees, a decrease of $19,642 in salaries allocated to general and administrative
expense, a decrease of $20,788 in insurance costs allocated to general and
administrative expense, a decrease of $34,480 in printing costs, a decrease
of
$28,984 in legal fees, and a decrease of $28,925 in investor relations costs;
these decreases were somewhat offset by an increase of $13,103 in patent
expenses.
Interest
and Other Income (Expense)
For
the three months ended September
30, 2007, we incurred net interest and other expense of $57,825, compared
to
expense of $30,545 for the three months ended September 30,
2006. This increase in expense is due to higher interest expense
associated with our imputed royalty obligation under our license agreement
with
Summit. For the nine months ended September 30, 2007, we incurred net
interest and other expense of $146,452, compared to expense of $74,325 for
the
nine months ended September 30, 2006. This overall net increase in expense
is due to a reduction in interest income due to lower cash balances in 2007,
coupled with an increase of approximately $50,000 in interest expense due
to
compounding on our imputed royalty obligation under our license agreement
with
Summit and increased interest expense associated with our lines of
credit.
Income
Taxes
During
the three months ended September 30, 2007, we incurred no foreign withholding
taxes and no income 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 $885,000 in
the
nine months ended September 30, 2007 can be summarized as follows: inflows
of
approximately $584,000 from royalty revenues from the sale of Hextend, offset
by
total cash based research and development costs of approximately $638,000,
and
total cash based general and administrative costs of approximately
$831,000.
Our
net
cash used in operating activities during the nine months ended September
30,
2007 was $885,478, compared to $1,072,404 used during the nine months ended
September 30, 2006. Our net cash provided by financing activities for
the nine months ended September 30, 2007 was $340,000 from borrowings on
lines
of credit, compared to $126 provided by exercise of warrants during the nine
months ended September 30, 2006.
At
September 30, 2007, we had $13,760 cash and cash equivalents on hand and
lines
of credit for $573,600 from which $340,000 had been drawn.
We
have
entered into agreements with Summit to develop Hextend and PentaLyte in Japan,
the People’s Republic of China, and Taiwan. Summit has sublicensed to
Maruishi the right to manufacture and market Hextend in Japan, and the right
to
manufacture and market Hextend and PentaLyte in China and
Taiwan. Summit paid us $500,000 in May 2006 as the initial
consideration for the China and Taiwan license.
In
April 2006, we entered into a Revolving Line of Credit Agreement (the
“Credit Agreement”) with Alfred D. Kingsley, Cyndel & Co., Inc., and George
Karfunkel, investors in BioTime, under which allowed us to borrow up to $500,000
for working capital purposes at an interest rate of 10% per annum.
On October 17, 2007, we amended the Credit Agreement to
increase the line of credit to $1,000,000 and extended the maturity date
to
April 30, 2008. In conjunction with the Amendment to the Credit
Agreement, Broadwood Partners, L.P. became a lender, and the portion of the
loan
advanced by Cyndel & Co., Inc. was paid off. Loans under the line
of credit will bear interest at 12% per annum. The line of credit is
collateralized by a security interest in our right to receive royalty and
other
payments under our License Agreement with Hospira, Inc. The line of
credit may mature prior to April 30, 2008 if we receive an aggregate of
$2,000,000 through the sale of capital stock, the collection of licensing
fees,
signing fees, milestone fees, or similar fees in excess of $1,000,000, and
funds
borrowed from other lenders. In consideration for amending the Credit
Agreement, on October 17, 2007, we issued the lenders 200,000 common shares,
which had a value of $106,000. As of September 30, 2007, we had drawn
$300,000 under the Credit Agreement.
We
also
have a $43,600 line of credit from American Express. As of September
30, 2007, we had drawn $40,000 under this line of credit. See Note 3
to the unaudited condensed 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 September 30, 2007, with the exception of
a
fixed, non-cancelable operating lease on our office and laboratory facilities
in
Emeryville, California. Under this 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.
Item
3. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, including our principal executive officers and our principal
financial officer, have reviewed and evaluated our disclosure controls and
procedures as of the end of the period covered by this quarterly report on
Form
10-QSB. Following this review and evaluation, management has
collectively determined that our disclosure controls and procedures were
effective as of the end of the period covered by this quarterly report on
Form
10-QSB.
Changes
in Internal Controls
There
were no changes in our internal controls over financial reporting during
the
quarter ended September 30, 2007 that materially affected or that could
reasonably likely materially affect our internal controls over financial
reporting.
PART
II - OTHER INFORMATION
Item
2. Unregistered Sale of Equity Securities and Use of
Proceeds.
In
conjunction with the amendment of
our Revolving Line of Credit Agreement, on October 17, 2007, we issued the
lenders 200,000 common shares. The shares were issued without
registration under the Securities Act of 1933, as amended, pursuant to the
exemption provided in Section 4(2) thereunder.
Item
6. Exhibits
Exhibit
Numbers |
Description |
|
|
3.1
|
Articles
of Incorporation, as Amended †
|
|
|
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
|
Warrant
Agreement, dated March 27, 2002, between BioTime, Inc. and Alfred
D.
Kingsley*
|
|
|
10.11
|
Warrant
for the Purchase of Common Shares, dated August 12, 2002, issued
to
Ladenburg Thalmann & Co. Inc.**
|
|
|
10.12
|
Exclusive
License Agreement between BioTime, Inc. and CJ Corp.***
|
|
|
10.13
|
Hextend
and PentaLyte Collaboration Agreement between BioTime, Inc. and
Summit
Pharmaceuticals International Corporation‡
|
|
|
10.14
|
Lease
dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D
Associates ‡‡
|
|
|
10.15
|
Addendum
to Hextend and PentaLyte Collaboration Agreement between BioTime,
Inc. and
Summit Pharmaceuticals International Corporation‡‡‡
|
|
|
10.16
|
Amendment
to Exclusive License Agreement Between BioTime, Inc. and Hospira,
Inc.††
|
|
|
10.17
|
Hextend
and PentaLyte China License Agreement between BioTime, Inc. and
Summit
Pharmaceuticals International Corporation†††
|
|
|
10.18
|
Revolving
Credit Line Agreement between BioTime, Inc, Alfred D. Kingsley,
Cyndel
& Co., Inc., and George Karfunkel, dated April 12,
2006. ††††
|
|
|
10.19
|
Security
Agreement executed by BioTime, Inc., dated April 12, 2006.
††††
|
|
|
10.20
|
Form
of Revolving Credit Note of BioTime, Inc. in the principal amount
of
$166,666.67 dated April 12, 2006. ††††
|
|
|
10.21
|
First
Amended and Restated Revolving Line of Credit Agreement, dated
October 17,
2007. ####
|
|
|
10.22
|
Form
of Amended and Restated Revolving Credit Note. ####
|
|
|
10.23
|
Form
of Revolving Credit Note. ####
|
|
|
10.24
|
First
Amended and Restated Security Agreement, dated October 17, 2007.
####
|
|
|
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-Q for the quarter ended June 30,
2002.
***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-QSB for the quarter ended June
30, 2006.
####
Incorporated by reference to BioTime’s Form 8-K filed October 18,
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:
November 14, 2007
|
|
/s/
Michael D. West
|
|
|
Michael
D. West
|
|
|
Chief
Executive Officer
|
|
|
|
|
|
|
Date:
November 14, 2007
|
|
/s/
Steven A. Seinberg
|
|
|
Steven
A. Seinberg
|
|
|
Chief
Financial Officer
|
Exhibit
Numbers
|
Description
|
|
|
3.1
|
Articles
of Incorporation, as Amended †
|
|
|
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
|
Warrant
Agreement, dated March 27, 2002, between BioTime, Inc. and Alfred
D.
Kingsley*
|
|
|
10.11
|
Warrant
for the Purchase of Common Shares, dated August 12, 2002, issued
to
Ladenburg Thalmann & Co. Inc.**
|
10.12
|
Exclusive
License Agreement between BioTime, Inc. and CJ Corp.***
|
|
|
10.13
|
Hextend
and PentaLyte Collaboration Agreement between BioTime, Inc. and
Summit
Pharmaceuticals International Corporation‡
|
|
|
10.14
|
Lease
dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D
Associates ‡‡
|
|
|
10.15
|
Addendum
to Hextend and PentaLyte Collaboration Agreement between BioTime,
Inc. and
Summit Pharmaceuticals International Corporation‡‡‡
|
|
|
10.16
|
Amendment
to Exclusive License Agreement Between BioTime, Inc. and Hospira,
Inc.††
|
|
|
10.17
|
Hextend
and PentaLyte China License Agreement between BioTime, Inc. and
Summit
Pharmaceuticals International Corporation†††
|
|
|
10.18
|
Revolving
Credit Line Agreement between BioTime, Inc, Alfred D. Kingsley,
Cyndel
& Co., Inc., and George Karfunkel, dated April 12,
2006. ††††
|
|
|
10.19
|
Security
Agreement executed by BioTime, Inc., dated April 12, 2006.
††††
|
|
|
10.20
|
Form
of Revolving Credit Note of BioTime, Inc. in the principal amount
of
$166,666.67 dated April 12, 2006. ††††
|
|
|
10.21
|
First
Amended and Restated Revolving Line of Credit Agreement, dated
October 17,
2007. ####
|
|
|
10.22
|
Form
of Amended and Restated Revolving Credit Note. ####
|
|
|
10.23
|
Form
of Revolving Credit Note. ####
|
|
|
10.24
|
First
Amended and Restated Security Agreement, dated October 17, 2007.
####
|
|
|
|
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-Q for the quarter ended June 30,
2002.
***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-QSB for the quarter ended June
30, 2006.
####
Incorporated by reference to BioTime’s Form 8-K filed October 18,
2007.
++++Filed
herewith
29