form10q_06302008.htm
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 June 30, 2008
OR
[ ] TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the
transition period from _ to
Commission
file number 1-12830
BioTime,
Inc.
(Exact
name of registrant as specified in its charter)
California
|
94-3127919
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
1301
Harbor Bay Parkway, Suite 100
Alameda,
California 94502
(Address
of principal executive offices)
(510)
521-3390
(Registrant's
telephone number, including area code)
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.
:Yes 9
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 9 Accelerated filer 9
Non-accelerated filer 9
(Do not check if a smaller
reporting company) Smaller reporting company :
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
9Yes :No
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate the number of shares
outstanding of each of the issuer's classes of common stock, as of the latest
practicable date. 23,694,374 common shares, no par value, as of June
30, 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
|
|
June
30,
2008
(unaudited)
|
|
|
December
31, 2007
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
172,461 |
|
|
$ |
9,501 |
|
Accounts
receivable
|
|
|
4,095 |
|
|
|
3,502 |
|
Prepaid
expenses and other current assets
|
|
|
150,626 |
|
|
|
128,643 |
|
Total
current assets
|
|
|
327,182 |
|
|
|
141,646 |
|
|
|
|
|
|
|
|
|
|
Equipment,
net of accumulated depreciation of $588,318 and $585,765,
respectively
|
|
|
11,316 |
|
|
|
12,480 |
|
Advance
license fee and others
|
|
|
270,976 |
|
|
|
20,976 |
|
TOTAL
ASSETS
|
|
$ |
609,474 |
|
|
$ |
175,102 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$ |
623,065 |
|
|
$ |
480,374 |
|
Lines
of credit payable
|
|
|
1,924,156 |
|
|
|
716,537 |
|
Deferred
license revenue, current portion
|
|
|
293,070 |
|
|
|
261,091 |
|
Total
current liabilities
|
|
|
2,840,291 |
|
|
|
1,458,002 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Stock
appreciation rights compensation liability
|
|
|
52,603 |
|
|
|
13,151 |
|
Deferred
license revenue, net of current portion
|
|
|
1,630,122 |
|
|
|
1,740,702 |
|
Other
liabilities
|
|
|
7,347 |
|
|
|
9,636 |
|
Total
long-term liabilities
|
|
|
1,690,072 |
|
|
|
1,763,489 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
DEFICIT:
|
|
|
|
|
|
|
|
|
Common
shares, no par value, authorized 50,000,000 shares; issued and outstanding
23,694,374 and 23,034,374 shares at June 30, 2008 and December 31, 2007,
respectively
|
|
|
40,968,465 |
|
|
|
40,704,136 |
|
Contributed
capital
|
|
|
93,972 |
|
|
|
93,972 |
|
Accumulated
deficit
|
|
|
(44,983,326 |
) |
|
|
(43,844,497 |
) |
Total
shareholders' deficit
|
|
|
(3,920,889 |
) |
|
|
(3,046,389 |
) |
TOTAL
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
|
$ |
609,474 |
|
|
$ |
175,102 |
|
See
accompanying notes to the condensed consolidated financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended
|
|
|
Six
Months Ended
|
|
|
|
June
30, 2008
|
|
|
June
30, 2007
|
|
|
June
30, 2008
|
|
|
June
30, 2007
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
License
fees
|
|
$ |
67,725 |
|
|
$ |
47,065 |
|
|
$ |
133,908 |
|
|
$ |
93,499 |
|
Royalties
from product sales
|
|
|
341,153 |
|
|
|
163,676 |
|
|
|
650,053 |
|
|
|
362,940 |
|
Other
revenue
|
|
|
1,685 |
|
|
|
— |
|
|
|
7,620 |
|
|
|
— |
|
Total
revenues
|
|
|
410,563 |
|
|
|
210,741 |
|
|
|
791,581 |
|
|
|
456,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
(416,978 |
) |
|
|
(210,767 |
) |
|
|
(764,129 |
) |
|
|
(554,317 |
) |
General
and administrative
|
|
|
(532,358 |
) |
|
|
(293,772 |
) |
|
|
(968,297 |
) |
|
|
(711,552 |
) |
Total
expenses
|
|
|
(949,336 |
) |
|
|
(504,539 |
) |
|
|
(1,732,426 |
) |
|
|
(1,265,869 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(538,773 |
) |
|
|
(293,798 |
) |
|
|
(940,845 |
) |
|
|
(809,430 |
) |
Interest
expenses and other income
|
|
|
(124,007 |
) |
|
|
(50,279 |
) |
|
|
(197,983 |
) |
|
|
(88,509 |
) |
Net
Loss
|
|
$ |
(662,780 |
) |
|
$ |
(344,077 |
) |
|
$ |
(1,138,828 |
) |
|
$ |
(897,939 |
) |
Loss
per common share – basic and diluted
|
|
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding – basic and
diluted
|
|
|
23,694,374 |
|
|
|
22,828,879 |
|
|
|
23,368,660 |
|
|
|
22,788,518 |
|
See
accompanying notes to the condensed consolidated financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Six
Months Ended
|
|
|
|
June
30, 2008
|
|
|
June
30, 2007
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,138,828 |
) |
|
$ |
(897,939 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
2,553 |
|
|
|
3,233 |
|
Amortization
of deferred finance cost on lines of credit
|
|
|
128,220 |
|
|
|
11,997 |
|
Interest
on royalty obligation
|
|
|
– |
|
|
|
83,437 |
|
Interest
on lines of credit
|
|
|
21,895 |
|
|
|
6,370 |
|
Common
stock issued for services
|
|
|
43,500 |
|
|
|
– |
|
Stock-based
compensation
|
|
|
107,080 |
|
|
|
68,319 |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(593 |
) |
|
|
1,262 |
|
Prepaid
expenses and other current assets
|
|
|
890 |
|
|
|
1,371 |
|
Accounts
payable and accrued liabilities
|
|
|
133,491 |
|
|
|
59,774 |
|
Deferred
license revenue
|
|
|
(78,601 |
) |
|
|
(71,498 |
) |
Deferred
rent
|
|
|
6,911 |
|
|
|
1,678 |
|
Net
cash used in operating activities
|
|
|
(773,482 |
) |
|
|
(731,996 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Payments
of royalty fees
|
|
|
(250,000 |
) |
|
|
– |
|
Purchase
of equipment
|
|
|
(1,389 |
) |
|
|
(1,779 |
) |
Net
cash used in investing activities
|
|
|
(251,389 |
) |
|
|
(1,779 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Repayments
of line of credit
|
|
|
(12,169 |
) |
|
|
– |
|
Borrowings
under lines of credit
|
|
|
1,200,000 |
|
|
|
300,000 |
|
Net
cash provided by financing activities
|
|
|
1,187,831 |
|
|
|
300,000 |
|
|
|
|
|
|
|
|
|
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS:
|
|
|
162,960 |
|
|
|
(433,775 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
9,501 |
|
|
|
561,017 |
|
Cash
and cash equivalents at end of period
|
|
$ |
172,461 |
|
|
$ |
127,242 |
|
Supplemental
disclosure of cash flow statement
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$ |
55,510 |
|
|
$ |
– |
|
NON-CASH
FINANCING AND INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Issuance
of stock related to line of credit agreement
|
|
$ |
(153,200 |
) |
|
$ |
– |
|
Issuance
of stock related to outside services
|
|
$ |
(43,500 |
) |
|
$ |
– |
|
See
accompanying notes to the condensed consolidated financial
statements.
BIOTIME,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED 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 balance sheet as of June 30, 2008, the unaudited condensed
statements of operations for the three and six months ended June 30, 2008 and
2007, and the unaudited condensed statements of cash flows for the six months
ended June 30, 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 June 30, 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
and six months ended June 30, 2008 and 2007 are not necessarily indicative of
the operating results anticipated for the full year.
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 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 financial statements include the
accounts of Embryome Sciences, Inc. (“Embryome Sciences”), a wholly-owned
subsidiary of BioTime. As of June 30, 2008, there was only one
significant transaction with respect to this subsidiary: a Product Production
and Distribution Agreement was executed with Lifeline Cell Technology, LLC, for
the production and marketing of embryonic progenitor cells or progenitor cell
lines, and products derived from those embryonic progenitor
cells. See
Note 4 to
the condensed consolidated financial statements. 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 financial statements have been prepared
assuming BioTime will continue as a going concern. At June 30, 2008,
BioTime had $172,461 of cash on hand and negative working capital of $2,513,109,
a shareholders’ deficit of $3,920,889 and an accumulated deficit of
$44,983,326. 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, reduce its operating costs, and succeed in generating more
revenue from its operations. The condensed consolidated 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 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 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.
Recently Adopted Accounting Pronouncements – On December
21, 2007, the SEC issued SAB No. 110, which amends SAB No. 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. The Company has concluded that its
historical share option exercise experience does not provide a reasonable basis
upon which to estimate the expected term due to the significant structural
changes in its business. Therefore, the Company will continue to use the
"simplified" method in developing its estimate of the expected term of "plain
vanilla" share options.
In
September 2006, the FASB issued FASB Statement No. 157, Fair Value Measurements
(“SFAS No. 157”), which defines fair value, establishes a framework for
measuring fair value under GAAP, and expands disclosures about fair value
measurements. SFAS No. 157 applies to other accounting pronouncements
that require or permit fair value measurements. The new guidance is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, and for interim periods within those fiscal
years. The Company adopted SFAS No. 157 during the quarter ended
March 31, 2008 which had no impact on its condensed balance sheets, condensed
statement of operations, condensed statement of stockholders' equity and cash
flows.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities.” SFAS No. 159 permits entities
to choose to measure many financial instruments, and certain other items, at
fair value. SFAS No. 159 was effective January 1, 2008. The adoption of
SFAS No. 159 did not have an impact on the consolidated financial statements
since the Company did not elect the fair value option for any of its existing
assets or liabilities.
Recently Issued Accounting
Pronouncements –
In May 2008, the Financial Accounting Standards Board ("FASB") issued FASB Staff
Position ("FSP") Emerging Issues Task Force ("EITF") No. 03-6-1, "Determining
Whether Instruments Granted in Share-Based Payment Transactions Are
Participating Securities" ("EITF 03-6-1"). EITF 03-6-1 addresses whether
instruments granted in share-based payment transactions, with rights to
dividends or dividend equivalents, are participating securities prior to vesting
and, therefore, need to be included in the earnings allocation in computing
earnings per share ("EPS") under the two-class method described in FASB
Statement No. 128, "Earnings per Share." Unvested share-based payment awards
that contain nonforfeitable rights to dividends or dividend equivalents (whether
paid or unpaid) are participating securities and shall be included in the
computation of EPS pursuant to the two-class method. In contrast, the right to
receive dividends or dividend equivalents that the holder will forfeit if the
award does not vest does not constitute a participation right. EITF 03-6-1 is
effective for financial statements issued for fiscal years beginning after
December 15, 2008, and interim periods within those fiscal years. All
prior-period EPS data presented shall be adjusted retrospectively (including
interim financial statements, summaries of earnings, and selected financial
data). Early adoption of EITF 03-6-1 is prohibited. The Company will adopt EITF
03-6-1 as of January 1, 2009, and does not currently believe that the adoption
will have a material impact on its consolidated financial
statements.
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 non-controlling 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 No. 141R requires
that acquisition-related costs be expensed as incurred. The
provisions of SFAS No. 141R will become effective for acquisitions completed on
or after January 1, 2009; however, the income tax provisions of SFAS No. 141R
will become effective as of that date for all acquisitions, regardless of the
acquisition date. SFAS No. 141R amends SFAS No. 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 No. 141R further amends SFAS No. 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, “Non-controlling 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.
Business Segments - The Company operates in
one segment and therefore segment information is not presented.
BioTime
has a revolving line of credit Agreement (the “Credit Agreement”) with certain
private lenders. In 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 was fully
amortized over the life of the Credit Agreement. The Credit Agreement
was subsequently amended to permit BioTime to borrow up to a total of
$2,500,000, and the maturity date of 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
$90,000 is included in prepaid expenses and other current assets as of June 30,
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 June
30, 2008, BioTime had drawn $1,825,000 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 June 30, 2008, BioTime had drawn $25,629
against this line. Interest is paid monthly on borrowings at a total rate equal
to the prime rate plus 3.99%; however, regardless of the prime rate, the
interest rate payable will at no time be less than 9.49%.
BioTime
also secured a line of credit from Advanta in November 2006, which allows for
borrowings up to $35,000; at June 30, 2008, BioTime had drawn $32,138 against
this line. Interest is payable on borrowings at a Variable Rate
Index, which will at no time be less than 8.25%.
The Company has accrued interest of
$41,389 as of June 30, 2008.
4.
License and Collaboration Agreements
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 fell under the guidance of Emerging Issues Task Force
(“EITF”) Issue No. 88-18, “Sales of Future Revenues.” EITF No. 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 No. 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 U.S. 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.
On January 3, 2008, BioTime
entered into a Commercial License and Option Agreement with Wisconsin Alumni
Research Foundation (“WARF”). The WARF license permits BioTime to use
certain patented and patent pending technology belonging to WARF, as well as
certain stem cell materials, for research and development purposes, and for the
production and marketing of products used as research tools, including in drug
discovery and development.
BioTime
will pay WARF a license fee of $225,000 in two installments. The
first installment, in the amount of $10,000, was paid and charged to operations
during February 2008. The remaining $215,000 is due on the earlier of
(i) thirty (30) days after BioTime raises $5,000,000 or more of new equity
financing, or (ii) January 3, 2009. A maintenance fee of $25,000 will
be due annually on January 3 of each year during the term of the
License.
BioTime
or Embryome Sciences will pay WARF royalties on the sale of products and
services using the technology or stem cells licensed from WARF. The
royalty will range from 2% to 4%, depending on the kind of products
sold. The royalty rate is subject to certain reductions if BioTime
also becomes obligated to pay royalties to a third party in order to sell a
product.
BioTime
will also pay WARF $25,000 toward reimbursement of the costs associated with
preparing, filing and maintaining the licensed WARF patents. That fee
is payable in two installments. The first installment of $5,000 was
paid and charged to operations during February 2008, and the remaining $20,000
is due on the earlier of (i) thirty (30) days after BioTime raises $5,000,000 or
more of new equity financing, or (ii) January 3, 2009.
On June
24, 2008, BioTime, along with its subsidiary, Embryome Sciences, entered into a
Product Production and Distribution Agreement with Lifeline Cell Technology, LLC
for the production and marketing of embryonic progenitor cells or progenitor
cell lines, and products derived from those embryonic progenitor
cells. The products developed under the agreement with Lifeline will
be produced and sold for research purposes, such as drug discovery and drug
development uses.
The
proceeds from the sale of products to certain distributors with which Lifeline
has a pre-existing relationship will be shared equally by Embryome Sciences and
Lifeline, after deducting royalties payable to licensors of the technology used,
and certain production and marketing costs. The proceeds from
products produced for distribution by both Embryome Sciences and Lifeline, and
products produced by one party at the request of the other party, will be shared
in the same manner. Proceeds from the sale of other products, which
are produced for distribution by one party, generally will be shared 90% by the
party that produced the product for distribution, and 10% by the other party
after deducting royalties payable to licensors of technology used. In
the case of the sale of these products, the party that produces the product and
receives 90% of the sales proceeds will bear all of the production and marketing
costs of the product.
The
products will be produced using technology and stem cell lines licensed from
WARF, technology developed by Embryome Sciences, technology developed by
Lifeline, and technology licensed from Advanced Cell Technology,
Inc. WARF and Advanced Cell Technology will receive royalties from
the sale of the products developed using their licensed technology and stem
cells.
BioTime
and Embryome Sciences paid Lifeline $250,000, included in advanced license fee
and others, to facilitate their product production and marketing
efforts. Embryome Sciences will be entitled to recover that amount
from the share of product sale proceeds that otherwise would have been allocated
to Lifeline.
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 total fee of $135,000 in cash and
will issue a total of 300,000 common shares. BioTime issued 150,000
common shares to Greenbelt on April 1, 2008, and will issue 75,000 common shares
on October 1, 2008, and 75,000 common shares on January 2, 2009. The
cash fee is 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. In accordance with these
provisions, BioTime did elect to defer the July 1, 2008 payment until January 2,
2009, and as such, will issue 30,000 additional common shares to Greenbelt when
that cash payment is made.
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 June 30,
|
2008
|
$90,000
|
$67,500
|
$43,500
|
$(0)
|
$(43,500)
|
$157,500
|
2007
|
$108,000
|
$22,500
|
$62,500
|
$(0)
|
$(103,000)
|
$90,000
|
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 and six months ended June 30, 2008 and 2007,
options to purchase 3,653,332 and 1,691,644 common shares, respectively, and
warrants to purchase 7,847,867 common shares in both years 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.
Subsequent Events
BioTime received royalties in the
amount of $341,391 from Hospira in August 2008 and in the amount of $24,143 from
CJ CheilJedang Corp. in July 2008. These amounts are based on sales
of Hextend made by Hospira in the second quarter of 2008, and will be reflected
in BioTime’s consolidated financial statements for the third quarter of
2008.
On July
10, 2008, BioTime’s subsidiary Embryome Sciences entered into a
License
Agreement
with Advanced Cell Technology, Inc. (“ACT”) under which Embryome Sciences
acquired exclusive world-wide rights to use ACT’s “ACTCellerate” technology for
methods to accelerate the isolation of novel cell strains from pluripotent stem
cells. The licensed rights include pending patent applications,
know-how, and existing cells and cell lines developed using the
technology.
Embryome
Sciences has paid ACT a $250,000 license fee and will pay an 8% royalty on sales
of products, services, and processes that utilize the licensed
technology. Once a total of $1,000,000 of royalties has been paid, no
further royalties will be due.
ACT
may reacquire royalty free, world wide licenses to use the technology for
retinal pigment epithelial cells, hemangioblasts, and myocardial cells, on an
exclusive basis, and for hepatocytes, on a non-exclusive basis, for human
therapeutic use. ACT will pay Embryome Sciences $5,000 for each
license that it elects to reacquire.
Embryome
Sciences has also now begun marketing cell growth media called ESpanTM
in collaboration with Lifeline Cell Technology, LLC. These growth
media are designed for the growth of human embryonic progenitor
cells. In addition, Embryome Sciences is developing a product called
ESpyTM
cell lines, which will be derivatives of hES cells that send beacons of light in
response to the activation of particular genes. The ESpy™ cell lines
will be developed in conjunction with Lifeline using the ACTCellerate technology
licensed from ACT and other technology sublicensed from Lifeline.
Also on
July 10, 2008, BioTime sent out new draw requests totaling $225,000 under its
current Credit Agreement. At the date of filing of this report, BioTime has
received all funds so requested.
On July
31, 2008, BioTime’s Board of Directors elected Dr. Robert N. Butler as a
director. Dr. Butler is the President and CEO of the U.S. branch of the
International Longevity Center (ILC), a policy research and education center. He
is also a Professor of Geriatrics at Mount Sinai Medical Center and Co-Chair of
the Alliance for Health and the Future of the International Longevity Center,
which focuses on Europe. He is a physician, gerontologist, psychiatrist, and
Pulitzer-Prize winning author who is perhaps best known for his advocacy of the
medical and social needs and rights of the elderly and his research on healthy
aging and the dementias.
In
consideration of Dr. Butler joining BioTime’s Board of Directors, the company
granted him options to purchase 25,000 common shares under its 2002 Stock Option
Plan, as amended, at an exercise price of $ 0.68, which was the closing price of
the common shares on the OTC Bulletin Board on the date of grant. The option
grant is subject to shareholder approval of an amendment increasing the number
of shares available under the Option Plan. The options granted are presently
exercisable with respect to 15,000 shares, and will vest and thereby become
exercisable for the remaining 10,000 shares in equal monthly installments on the
last day of each calendar month, through December 2008, for which Dr. Butler
completes a month of service on the Board of Directors.
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.
Plasma
Volume Expander Products
Our
principle product, Hextend, is a physiologically balanced blood plasma volume
expander, for the treatment of hypovolemia. Hextend is being
distributed in the United States by Hospira, Inc. and in South Korea by CJ
CheilJedang Corp. (“CJ”) under exclusive licenses from us. Summit
Pharmaceuticals International Corporation (“Summit”) has a license to develop
Hextend and PentaLyte in Japan, the People’s Republic of China, and
Taiwan. Summit has entered into sublicenses with Maruishi
Pharmaceutical Co., Ltd. (“Maruishi”) to obtain regulatory approval,
manufacture, and market Hextend in Japan, and Hextend and PentaLyte in China and
Taiwan.
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.
Under our
license agreements, Hospira and CJ will report sales of Hextend and pay us the
royalties and license fees due on account of such sales after the end of each
calendar quarter. We recognize such revenues in the quarter in which
the sales report is received, rather than the quarter in which the sales took
place.
Our
royalty revenues for the three months ended June 30, 2008 consist of royalties
on sales of Hextend made by Hospira and CJ during the period beginning January
1, 2008 and ending March 31, 2008. Royalty revenues recognized for
that three-month period were $341,153, a 108% increase from the $163,676 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 $341,391 from Hospira during August 2008, based on
Hextend sales during the three months ended June 30, 2008. This
represents an 86% increase from royalty revenues of $183,093 received
during the same period last year. The increase in royalties is due to
increased sales to the United States Armed Forces. This revenue will
be reflected in our financial statements for the third quarter of
2008.
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.
Stem
Cells and Products for Regenerative Medicine Research
We are
conducting our stem cell business through our new, wholly-owned subsidiary,
Embryome Sciences, Inc. (“Embryome Sciences”). We plan to focus our
initial efforts in the regenerative medicine field on the development and sale
of advanced human stem cell products and technology for diagnostic, therapeutic
and research use. Regenerative medicine refers to therapies based on
human embryonic stem (“hES”) cell technology that are designed to rebuild cell
and tissue function lost due to degenerative disease or injury. Our
initial marketing efforts will be directed to researchers at universities and
other institutions, to companies in the bioscience and biopharmaceutical
industries, and to other companies that provide research products to companies
in those industries.
Embryome Sciences has already
introduced its first stem cell research products, and is implementing plans to
develop additional research products over the next two years. Our
first products include a relational database, available at our website
embryome.com, that will permit researchers to chart the cell lineages of human
development, the genes expressed in those cell types, and antigens present on
the cell surface of those cells that can be used in
purification. This database will provide the first detailed map of
the embryome, thereby aiding researchers in navigating the complexities of human
development and in identifying the many hundreds of cell types coming from
embryonic stem cells.
Embryome Sciences is also now marketing
cell growth media called ESpanTM
in collaboration with Lifeline Cell Technology, LLC. These growth
media are designed for the growth of human embryonic progenitor
cells. Additional new products that Embryome Sciences has targeted
for development are ESpyTM
cell lines, which will be derivatives of hES cells that send beacons of light in
response to the activation of particular genes. The ESpy™ cell lines
will be developed in conjunction with Lifeline using the ACTCellerate technology
licensed from ACT and other technology sublicensed from
Lifeline. Embryome Sciences also plans to bring to market other new
growth and differentiation factors that will permit researchers to manufacture
specific cell types from embryonic stem cells, and purification tools useful to
researchers in quality control of products for regenerative
medicine. As new products are developed, they will become available
for purchase on embryome.com.
We are in
the process of launching our first products for stem cell research, and did not
have stem cell products on the market during the first quarter of
2008. We cannot predict the amount of revenue that the new products
we offer might generate.
Hextend®,
PentaLyte®, and HetaCool® are registered trademarks of BioTime, Inc., and
ESpanTM and
EspyTM
are trademarks of Embryome Sciences, Inc.
Results
of Operations
We
incurred a net loss of $662,780 during the three months, and a net loss of
$1,138,828 during the six months, ended June 30, 2008. 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.
Revenues
For the
three months ended June 30, 2008, we recognized $341,153 in royalty revenue,
whereas we recognized $163,676 for the three months ended June 30,
2007. This increase of 108% 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 $67,725 and $47,065 of license fees from CJ and Summit during the
three months ended June 30, 2008 and the three months ended June 30, 2007,
respectively. These licensing fee amounts were received in earlier
accounting periods, but 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 financial statements.
Operating
Expenses
Research
and development expenses were $416,978 for the three months ended June 30, 2008,
compared to $210,767 for the three months ended June 30, 2007. This
increase is primarily attributable to a $66,927 increase in salaries allocated
to research and development, an increase of $21,268 in payroll fees and taxes
allocated to research and development expense, an increase of $14,193 in
insurance costs allocated to research and development expense, an increase of
$32,771 in expenditures made to cover laboratory expenses and supplies, and an
increase of $56,101 in rent costs allocated to research and development
expense. Research and development expenses were $764,129 for the six
months ended June 30, 2008, compared to $554,317 for the six months ended June
30, 2007. This increase is primarily attributable to a $106,280
increase in salaries allocated to research and development, an increase of
$41,973 in payroll fees and taxes allocated to research and development expense,
an increase of $29,122 in insurance costs allocated to research and development
expense, an increase of $71,714 in expenditures made to cover laboratory
expenses and supplies, and an increase of $58,207 in rent costs allocated to
research and development expense; these increases were offset to some
extent
by a
decrease of $108,766 in expenses paid for outside research. Research
and development expenses include laboratory study expenses, salaries, and
consultants’ fees.
General
and administrative expenses increased to $532,358 for the three months ended
June 30, 2008, from $293,772 for the three months ended June 30,
2007. This increase is primarily
attributable to an increase of $50,232 in stock-based expense allocated to
general and administrative costs, an increase of $21,766 in legal fees, an
increase of $35,281 in travel and entertainment expenses, an increase of $8,160
in expenses related to outside services, an increase of $29,964 in accounting
fees, an increase of $25,414 in office expenses, an increase of $14,025 in rent
costs allocated to general and administrative expense, and an increase of
$40,260 in general and administrative consulting fees. General and
administrative expenses increased to $968,297 for the six months ended June 30,
2008, from $711,552 for the six months ended June 30, 2007. This
increase is
primarily attributable to an increase of $83,560 in stock-based expense
allocated to general and administrative costs, an increase of $71,023 in legal
fees, an increase of $56,645 in travel and entertainment expenses, an increase
of $13,730 in expenses related to outside services, an increase of $15,000 in
licensing fees, an increase of $28,815 in office expenses, an increase of
$14,551 in rent costs allocated to general and administrative expense, an
increase of $21,699 in payroll fees and taxes allocated to general and
administrative expense, and an increase of $28,460 in general and administrative
consulting fees; these increases were offset to some extent by a decrease of
$30,009 in accounting fees, and by a decrease of $36,529 in patent
expenses.
Research
and development expenses and general and administrative expenses for the three
months and six months ended June 30, 2008 increased over the same periods in
2007 due primarily to our entry into the fields of stem cell research and
regenerative medicine.
Interest
and Other Income (Expense)
For the three months ended June 30,
2008, we incurred a total of $124,821 of
net interest expense, compared to net interest expense of $50,279 for
the three months ended June 30, 2007. For the six months ended June
30, 2008, we incurred a total of $200,443 of
net interest expense, compared to net interest expense of $88,509 for
the six months ended June 30, 2007.
Income
Taxes
During the three months ended June 30,
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 $773,000 in the
six months ended June 30, 2008 can be summarized as follows: net loss of
approximately $1,139,000 was reduced by non-cash expenses of approximately
$303,000, resulting in the cash loss of approximately $836,000 which was partly
funded with a net overall change in current assets and current liabilities of
approximately $63,000.
At June
30, 2008, we had $172,461 cash and cash equivalents on hand, and lines of credit
for $2,578,600, from which $1,882,767 had been drawn. On July 10,
2008, our subsidiary Embryome Sciences entered into a License Agreement with
Advanced Cell Technology, Inc. (“ACT”) under which Embryome Sciences acquired
exclusive world-wide rights to use ACT’s “ACTCellerate” technology for methods
to accelerate the isolation of novel cell strains from pluripotent stem
cells. We have paid ACT a $250,000 license fee. Also on
July 10, 2008, we sent out new draw requests totaling $225,000 under our current
Revolving Line of Credit Agreement. At the date of filing of this
report, we have received all funds so requested. See Note 7 to the
condensed consolidated financial statements for additional
information.
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 June 30, 2008, we had drawn $25,629 against this
line. See Note 3 to the condensed consolidated 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 June 30, 2008, we had drawn $32,138 against this
line. See Note 3 to the condensed consolidated 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 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 plasma volume expander 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.
We have
no contractual obligations as of June 30, 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. We plan to sublet our Emeryville
facility if we are able to find a suitable subtenant. In April 2008,
we entered into a sublease of approximately 11,000 square feet of office and
research laboratory spaced at 1301 Harbor Bay Parkway, in Alameda, California
(the “Alameda sublease”). We have now moved our headquarters to this
new facility. The Alameda sublease will expire on November 30,
2010. Base monthly rent 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 June 30, 2008, December 31, 2007, or June 30,
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
April 2008 we issued a total of 150,000 common shares to our financial advisor
under the terms of our Financial Advisor 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.
Our Board of Directors has set
Thursday, October 30, 2008, at 10:00 a.m. as the date of our next annual meeting
of shareholders. Any shareholder who desires to submit a proposal for
consideration and approval by the shareholders at the annual meeting and who
wishes to have that proposal included in our proxy statement under SEC Rule
14a-8, must submit their proposal to us no later than September 1,
2008. Any proposal received from a shareholder after that date will
not be included in our proxy statement, and notice of the proposal will be
considered untimely under SEC Rule 14a-5(e)(2).
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. +++
|
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.++++
10.31
|
License,
Product Production, and Distribution Agreement, dated June 19, 2008, among
Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc.
^^
|
10.32
|
License
Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and
Advanced Cell Technology, Inc. ^^
|
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: August
14, 2008
|
/s/
Michael D. West
|
|
Michael
D. West
|
|
Chief
Executive Officer
|
|
|
|
|
Date: August
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. +++
|
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.++++
10.31
|
License,
Product Production, and Distribution Agreement, dated June 19, 2008, among
Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc.
^^
|
10.32 License
Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and Advanced
Cell Technology, Inc. ^^
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
30