e10qsb
FORM 10-QSB
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2006
OR
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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)
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California
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94-3127919 |
(State or other jurisdiction of incorporation
or organization)
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(IRS Employer
Identification No.) |
6121 Hollis Street
Emeryville, California 94608
(Address of principal executive offices)
(510) 350-2940
(Issuers 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. Yesþ Noo
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
APPLICABLE ONLY TO CORPORATE ISSUERS:
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date. 22,574,374 common shares, no par value, as of May 9, 2006.
Transitional Small Business Disclosure Format (Check one) Yes o No þ
TABLE OF CONTENTS
PART 1FINANCIAL 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 BioTimes 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 SHEETS
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March 31, |
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2006 (unaudited) |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
1,089,146 |
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Accounts receivable |
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505,511 |
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Prepaid expenses and other current assets |
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141,979 |
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Total current assets |
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1,736,636 |
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EQUIPMENT, net of accumulated depreciation of $576,394 |
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4,715 |
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DEPOSITS AND OTHER ASSETS |
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20,976 |
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TOTAL ASSETS |
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$ |
1,762,327 |
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LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIT) |
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CURRENT LIABILITIES: |
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Accounts payable and accrued liabilities |
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$ |
296,614 |
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Current portion of deferred revenue |
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141,375 |
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Total Current Liabilities |
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437,989 |
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DEFERRED LICENSE REVENUES long term |
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1,417,953 |
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ROYALTY OBLIGATION |
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524,315 |
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OTHER LONG TERM LIABILITIES |
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6,484 |
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TOTAL LIABILITIES |
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2,386,741 |
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COMMITMENTS |
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SHAREHOLDERS DEFICIT: |
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Common shares, no par value, authorized 40,000,000 shares; issued
and outstanding 22,440,625 |
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40,301,453 |
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Contributed capital |
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93,972 |
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Accumulated deficit |
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(41,019,839 |
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Total shareholders deficit |
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(624,414 |
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TOTAL LIABILITIES AND SHAREHOLDERS DEFICIT |
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$ |
1,762,327 |
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See notes to condensed financial statements.
2
BIOTIME, INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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March 31, 2006 |
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March 31, 2005 |
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REVENUE: |
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License fees |
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$ |
35,802 |
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$ |
25,762 |
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Royalties from product sales |
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205,940 |
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165,321 |
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Total revenue |
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241,742 |
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191,083 |
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EXPENSES: |
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Research and development |
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(265,932 |
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(462,608 |
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General and administrative |
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(436,881 |
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(454,001 |
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Total expenses |
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(702,813 |
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(916,609 |
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INTEREST INCOME (EXPENSE) AND OTHER: |
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(17,116 |
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(1,064 |
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NET LOSS |
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$ |
(478,187 |
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$ |
(726,590 |
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BASIC AND DILUTED LOSS PER SHARE |
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$ |
(0.02 |
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$ |
(0.04 |
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COMMON AND EQUIVALENT SHARES USED IN
COMPUTING BASIC AND DILUTED PER SHARE
AMOUNTS |
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22,439,469 |
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17,851,450 |
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See notes to condensed financial statements.
3
BIOTIME, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
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Three months Ended |
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March 31, |
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2006 |
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2005 |
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OPERATING ACTIVITIES: |
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Net loss |
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$ |
(478,187 |
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$ |
(726,590 |
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Adjustments to reconcile net loss to net
cash used in operating activities: |
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Depreciation |
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1,464 |
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2,975 |
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Interest on royalty obligation |
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31,371 |
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8,877 |
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Stock-based compensation |
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32,006 |
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15,050 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(503,561 |
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Prepaid expenses and other current assets |
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(46,073 |
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26,768 |
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Accounts payable and accrued liabilities |
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(251,760 |
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37,987 |
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Deferred revenue |
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468,041 |
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(24,063 |
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Deferred rent |
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1,945 |
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Net cash used in operating activities |
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(744,754 |
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(658,996 |
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FINANCING ACTIVITIES: |
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Exercise of warrants |
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126 |
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Net cash provided by financing activities |
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126 |
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DECREASE IN CASH AND CASH
EQUIVALENTS |
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(744,628 |
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(658,996 |
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Cash and cash equivalents at beginning of
period |
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1,833,774 |
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1,370,762 |
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Cash and cash equivalents at end of period |
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$ |
1,089,146 |
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$ |
711,766 |
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See notes to condensed financial statements.
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4
BIOTIME, INC.
NOTES TO FINANCIAL STATEMENTS
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.
The condensed balance sheet as of March 31, 2006, the condensed statements of operations for
the three months ended March 31, 2006 and 2005 and the statements of cash flows for the three
months ended March 31, 2006 and 2005 have been prepared by BioTime without audit. In the opinion
of management, all adjustments (consisting only of normal recurring adjustments) necessary to
present fairly the financial position, results of operations, and cash flows at March 31, 2006 and
for all periods presented have been made. The results of operations for the three months ended
March 31, 2006 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. Certain previously
furnished amounts have been reclassified to conform with presentations made during the current
periods. It is suggested that these interim condensed financial statements be read in conjunction
with the annual audited financial statements and notes thereto included in BioTimes Form 10-K for
the year ended December 31, 2005.
Significant Risks and Uncertainties- BioTimes 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 BioTimes products; BioTimes 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; BioTimes ability to obtain additional financing and
the terms of any such financing that may be obtained; BioTimes ability to negotiate favorable
licensing or other manufacturing and marketing agreements for its products; the availability of
ingredients used in BioTimes products; and the availability of reimbursement for the cost of
BioTimes products (and related treatment) from government health administration authorities,
private health coverage insurers and other organizations.
Liquidity - At March 31, 2006, BioTime had $1,089,146 cash on hand and a line of credit for
$43,600 (see note 3), from which no money has yet been drawn. However, BioTime needs additional
capital and greater revenues to continue its current operations, to complete clinical trials of
PentaLyteâ, 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
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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 September 30, 2007.
2. Significant Accounting Policies
Financial Statement Estimates - The preparation of financial statements in conformity with
generally accepted accounting principles 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 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 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 BioTimes 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.
Indemnification The following is a summary of BioTimes agreements that BioTime has
determined are within the scope of the Financial Accounting Standards Board (the FASB)
interpretation No. 45 (FIN 45), Guarantors Accounting and Disclosure Requirements for
Guarantees, including Indirect Guarantees of Indebtedness of Others an interpretation of FASB
Statements No. 5, 57 and 107 and rescission of FIN 34.
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Under its bylaws, BioTime has agreed to indemnify its officers and directors for certain
events or occurrences arising as a result of the officer or directors serving in such capacity.
The term of the indemnification period is for the officers or directors lifetime. The maximum
potential amount of future payments BioTime could be required to make under the indemnification
provisions contained in its bylaws is unlimited. However, BioTime has a directors and officers
liability insurance policy that limits its exposure and enables it to recover a portion of any
future amounts paid. As a result of its insurance policy coverage, BioTime believes the estimated
fair value of these indemnification agreements is minimal and has no liabilities recorded for these
agreements as of March 31, 2006.
Under its license agreements with Hospira, Inc. and CJ Corp., BioTime shall indemnify Abbott
(Hospiras predecessor in interest), Hospira, and/or CJ for any cost or expense resulting from any
third party claim or lawsuit arising from alleged patent infringement by Abbott, Hospira, or CJ
relating to actions covered by the applicable license agreement. Management believes that the
possibility of payments under the indemnification clauses by BioTime is remote. Therefore, BioTime
has not recorded a provision for potential claims as of March 31, 2006.
BioTime enters into indemnification provisions under (i) its agreements with other companies
in its ordinary course of business, typically with business partners, licensees, contractors,
hospitals at which clinical studies are conducted, and landlords and (ii) its agreements with
investors, investment bankers and financial advisers. Under these provisions BioTime generally
indemnifies and holds harmless the indemnified party for losses suffered or incurred by the
indemnified party as a result of BioTimes activities or, in some cases, as a result of the
indemnified partys activities under the agreement. These indemnification provisions often include
indemnifications relating to representations made by BioTime with regard to intellectual property
rights. These indemnification provisions generally survive termination of the underlying
agreement. In some cases, BioTime has obtained liability insurance providing coverage that limits
its exposure for indemnified matters. The maximum potential amount of future payments BioTime
could be required to make under these indemnification provisions is unlimited. BioTime has not
incurred material costs to defend lawsuits or settle claims related to these indemnification
agreements. As a result, BioTime believes the estimated fair value of these agreements is minimal.
Accordingly, BioTime has no liabilities recorded for these agreements as of March 31, 2006.
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 BioTimes 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).
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BioTime adopted SFAS 123(R) using the modified prospective transition method, which requires
the application of the accounting standard as of January 1, 2006, the first day of BioTimes fiscal
year 2006. BioTimes condensed consolidated financial statements as of and for the three months
ended March 31, 2006, reflect the impact of SFAS 123(R). In accordance with the modified
prospective transition method, the condensed consolidated financial statements for prior periods
have not been restated to reflect, and do not include, the impact of SFAS 123(R). Stock-based
compensation expense recognized under SFAS 123(R) for the three months ended March 31, 2006 was
$18,843 which consisted of stock-based compensation expense related to employee and director stock
options. As of March 31, 2006, total
unrecognized compensation costs related to unvested stock options was $48,619, which is expected to
be recognized as expense over a weighted average period of
approximately 0.80 years.
SFAS 123(R) requires companies to estimate the fair value of share-based payment awards on the
date of grant using an option-pricing model. The value of the portion of the award that is
ultimately expected to vest is recognized as expense over the requisite service periods in
BioTimes condensed consolidated statement of operations. Prior to adoption of SFAS 123(R),
BioTime accounted for stock-based awards to employees and directors using the intrinsic value
method in accordance with APB 25 as allowed under Statement of Financial Accounting Standard 123
Accounting for Stock-Based Compensation. Under the intrinsic value method, no stock-based
compensation expense had been recognized in BioTimes condensed consolidated statement of
operations, because the exercise price of BioTimes options granted to employees and directors
equaled or was greater than the fair market value of the underlying stock at the date of grant.
Stock-based compensation expense recognized during the period is based on the value of the
portion of share-based payment awards that is ultimately expected to vest during the period.
Stock-based compensation expense recognized in BioTimes condensed consolidated statement of
operations for the three months ended March 31, 2006 includes compensation expense for share-based
payment awards granted prior to but not yet vested as of December 31, 2005 based on the grant date
fair value estimated in accordance with the pro forma provisions of SFAS 123, as well as
compensation expense for the share-based payment awards granted subsequent to December 31, 2005
based on the grant date fair value estimated in accordance with the provisions of SFAS 123(R).
Compensation expense for all share-based payment awards granted on or prior to December 31, 2005
will continue to be recognized using the same vesting attribution, vested graded or straight-line
method, while compensation expense for all share-based payment awards granted subsequent to
December 31, 2005 will be recognized using the straight-line method of expense attribution. As
stock-based compensation expense recognized in the condensed consolidated statement of operations
for the first quarter 2006 is based on awards ultimately expected to vest, it has been reduced for
estimated forfeitures. SFAS 123 (R) requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. In
the proforma disclosures required under SFAS 123 for the periods prior to fiscal 2006, BioTime
accounted for forfeitures as they occurred.
SFAS 123(R) requires the cash flows resulting from the tax benefits resulting from tax
deductions in excess of the compensation cost recognized for those options to be classified as
financing cash flows. Due to BioTimes loss position, there were no such tax benefits during the
three months ended March 31, 2006. Prior to the adoption of Statement SFAS 123(R) those
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benefits would have been reported as operating cash flows had BioTime received any tax benefits related to
stock option exercises.
Upon adoption of SFAS 123 (R), BioTime has continued to utilize the Black-Scholes Merton
option pricing model which was previously used for BioTimes proforma disclosures under SFAS 123.
BioTimes determination of fair value of share-based payment awards on the date of grant using an
option-pricing model is affected by BioTimes stock price as well as assumptions regarding a number
of highly complex and subjective variables. These variables include, but are not limited to, BioTimes 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 managements opinion, the
existing valuation models may not provide an accurate measure of the fair value of BioTimes
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.
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 is 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 borrowers 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
line of credit is collateralized by a security interest in BioTimes right to receive royalty and
other payments under the license agreement with Hospira. The market value of BioTime common shares
was $0.38 per common share on April 12, 2006, valuing the shares at $38,000. No funds have yet been
drawn on this line of credit.
BioTime also has an available line of credit from American Express, which allows for
borrowings up to $43,600; no funds have yet been drawn from this line of credit. Should any such
money be drawn, 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.
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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 BioTimes development cost of
Hextend and PentaLyte. In June 2005, following BioTimes approval of Summits 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 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
BioTimes 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 Summits 8% share
of BioTimes U.S. PentaLyte sales plus Summits 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. BioTimes 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
10
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% 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 $31,371 and $8,877 of interest expense on the long-term royalty
obligation during the three months ended March 31, 2006 and March 31, 2005, respectively.
5. Shareholders Deficit
During December 2005, BioTime completed a subscription rights offer (the 2005 Rights Offer)
through which BioTime raised gross proceeds of $1,787,144 through the sale of 4,467,862 common
shares and 4,467,862 warrants. The common shares and warrants were sold as units consisting of
one common share and one warrant for $0.40 per unit. Each warrant entitles the holder to purchase
one common share for $2.00 per share and will expire on October 31, 2010. BioTime may redeem the
warrants by paying $.05 per warrant if the closing price of the common shares on any national
securities exchange or the Nasdaq Stock Market exceeds 200% of the exercise price of the warrants
for any 20 consecutive trading days.
Certain persons acted as guarantors of the 2005 Rights Offer under a Standby Purchase
Agreement pursuant to which they agreed to purchase up to 4,467,862 units if the subscription
rights were not fully exercised. In consideration for their agreement, BioTime paid the guarantors
$132,000 in cash and issued to them warrants to purchase 600,000 common shares, which were
accounted for as costs of the equity financing. The $132,000 was included in accounts payable and
accrued expenses as of December 31, 2005. Total cash costs for the Rights Offer, which were
recorded as a reduction of the proceeds received, were $379,984. The warrants issued to the
guarantors have the same terms as the warrants BioTime sold in the 2005 Rights Offer. The market
price of all warrants issued in the 2005 Rights Offer was $0.05 on the closing date.
During April 1998, BioTime entered into a financial advisory services agreement with Greenbelt
Corp., 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. Expenses of $24,413 and $37,550 relating to the term of the agreement were
recognized during the three months ended March 31, 2006 and March 31, 2005, respectively. 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 will pay Greenbelt a cash fee of $90,000 and will issue Greenbelt 200,000 common
shares. The common shares will be issued as follows: 150,000 shares on January 2, 2007 for
services rendered through
11
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 will be payable as follows:
$30,000 on January 2, 2007, $30,000 on April 2, 2007, and $30,000 on October 1, 2007; provided,
that BioTime may defer either or both of the cash payments that would otherwise be due on January
2, 2007 and April 2, 2007 until a date that BioTime may determine, but not later than October 1,
2007. If BioTime elects to defer either or both cash payments, BioTime will issue to Greenbelt 30,000 additional
common shares for each deferred payment within ten business days after the date on which the deferred cash payment was
originally due.
Activity related to the Greenbelt agreement is presented in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance |
|
Add: |
|
|
|
|
|
|
|
|
|
Less: |
|
Balance |
|
|
included in |
|
Cash- |
|
Add: Stock- |
|
|
|
|
|
Value of |
|
included in |
|
|
Accounts |
|
based |
|
based |
|
|
|
|
|
stock- |
|
Accounts |
|
|
Payable at |
|
expense |
|
expense |
|
Less:Cash |
|
based |
|
Payable at |
|
|
January 1 |
|
accrued |
|
accrued |
|
payments |
|
payments |
|
March 31, |
|
|
|
2006 |
|
$ |
65,138 |
|
|
|
11,250 |
|
|
|
13,163 |
|
|
|
(0 |
) |
|
|
(31,388 |
) |
|
$ |
58,163 |
|
2005 |
|
$ |
112,950 |
|
|
|
22,500 |
|
|
|
15,050 |
|
|
|
(45,000 |
) |
|
|
(60,400 |
) |
|
$ |
45,100 |
|
During the three months ended March 31, 2006 and 2005, BioTime issued to Greenbelt 101,250 and
40,000 common shares, respectively, valued at $31,388 and $60,400.
During the three months ended March 31, 2006, 63 warrants were exercised for proceeds of $126.
6. Licensing Agreement
On March 24, 2006, BioTime entered into a license agreement with Summit to develop Hextend and
PentaLyte in the Peoples Republic of China, and Taiwan. Summit paid BioTime $500,000 in May 2006
as the initial consideration for the China and Taiwan license. At March 31, 2006, BioTime had a receivable of $500,000 for this amount. BioTime has recorded this amount as deferred revenue which will be amortized over the remaining life of the underlying patents. 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 sublicensee 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 20,000,000 yen 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. Net Income (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 months ended March 31, 2006 and
2005, options to purchase 1,509,664 and 1,211,164, common shares, respectively, and
12
warrants to purchase 8,169,909 and 3,153,191 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. Valuation and Expense Information under SFAS 123(R)
During 1992,
BioTime adopted the 1992 Stock Option Plan (the 1992 Plan). Options
granted under the 1992 Plan expire five to ten years from the date of grant and may be fully
exercisable immediately, or may be exercisable according to a schedule or conditions specified by
the Board of Directors or the Option Committee. As of March 31, 2006, options to purchase 285,500
shares had been granted and were outstanding at exercise prices ranging from $1.55 to $11.75 under
the 1992 Plan. At March 31, 2006, no options were available for future grants under the 1992 Plan.
During 2002 BioTime adopted a new stock option plan (the 2002 Plan). The 2002 Plan was
amended during December 2004 to increase the number of shares available for the issuance of
options. Under the 2002 Plan, BioTime has reserved 2,000,000 common shares for issuance under
options granted to eligible persons. No options may be granted under the 2002 Plan more than ten
years after the date the 2002 Plan was adopted by the Board of Directors, and no options granted
under the 2002 Plan may be exercised after the expiration of ten years from the date of grant.
Under the 2002 Plan, options to purchase common shares may be granted to employees, directors and
certain consultants at prices not less than the fair market value at date of grant for incentive
stock options and not less than 85% of fair market value for other stock options. These options
expire five to ten years from the date of grant and may be fully exercisable immediately, or may be
exercisable according to a schedule or conditions specified by the Board of Directors or the
Compensation Committee. The 2002 Plan also permits BioTime to sell common shares to employees
subject to vesting provisions under restricted stock agreements that entitle BioTime to repurchase
unvested shares at the employees cost upon the occurrence of specified events, such as termination
of employment. BioTime may permit employees or consultants, but not executive officers or
directors, who purchase stock under restricted stock purchase agreements to pay for their shares by
delivering a promissory note that is secured by a pledge of their shares. Under the 2002 Plan, as
of March 31, 2006, BioTime had granted to certain employees, consultants, and directors, options to
purchase a total of 1,124,164 common shares at exercise prices ranging from $0.34 to $4.00 per
share; and had 834,836 options available for future grants.
On January 1, 2006 BioTime adopted SFAS 123(R), which requires the measurement and recognition
for all share-based payment awards made to BioTimes 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 months ended March 31, 2006, which was allocated as
follows:
|
|
|
|
|
|
|
Three Months Ended March |
|
|
|
31, 2006 (under SFAS |
|
|
|
123(R)) |
|
Stock-based compensation expense: |
|
|
|
|
|
|
|
|
|
Research and Development |
|
$ |
|
|
General and Administrative |
|
|
18,843 |
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense included in
operating expense |
|
|
18,843 |
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
|
18,843 |
|
|
|
|
|
The following table compares the net loss and basic and diluted loss per share for the three
months ended March 31, 2006 and March 31, 2005 as if the fair value recognition provision of SFAS
123(R) had been applied for both periods as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, 2006 |
|
|
March 31, 2005 |
|
Net income (loss)as
reported for the prior
period (1) |
|
|
N/A |
|
|
$ |
(726,590 |
) |
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense related to
employee stock options
(2) |
|
|
(18,843 |
) |
|
|
(44,842 |
) |
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, 2006 |
|
|
March 31, 2005 |
|
Net income (loss),
including the effect of
stock-based compensation
expense (3) |
|
$ |
(478,187 |
) |
|
$ |
(771,432 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
shareas reported for the
prior period (1)
Basic and diluted |
|
|
|
|
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, including the
effect of stock-based
compensation expense
(3) |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.02 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
(1) |
|
Net loss and net loss per share prior to fiscal 2006 did
not include stock-based compensation expense for employee
stock options under SFAS 123 because BioTime did not adopt
the recognition provisions of SFAS 123.
|
|
(2) |
|
Stock-based compensation expense prior to fiscal 2006 is
calculated based on the pro forma application of SFAS 123.
|
|
(3) |
|
Net income and net income per share prior to fiscal 2006
represents pro forma information based on SFAS 123. |
Prior to the adoption of SFAS 123(R), 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.
The weighted-average estimated fair value of stock options granted during the three months
ended March 31, 2006 and 2005 was $0.25 and $0.84 per share, respectively, using the Black-Scholes
Merton model with the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Three Months Ended |
|
|
March 31, 2006 |
|
March 31, 2005 |
Expected lives in years |
|
|
5 |
|
|
|
5 |
|
Risk free interest rates |
|
|
4.79 |
% |
|
|
4.67 |
% |
Volatility |
|
|
93.00 |
% |
|
|
79.30 |
% |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
14
For options granted prior to 2006 and valued in accordance with SFAS 123, the expected life
and the expected volatility of the stock options were based upon historical data. Forfeitures of
employee stock options were accounted for on an as-incurred basis.
General Option Information
A
summary of all option activity for the three months ended March 31, 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options available |
|
|
Number of |
|
|
Weighted Average |
|
|
|
for grant |
|
|
Shares |
|
|
Exercise Price |
|
Outstanding, December 31, 2005 |
|
|
887,336 |
|
|
|
1,477,164 |
|
|
$ |
3.31 |
|
Granted |
|
|
(52,500) |
|
|
|
52,500 |
|
|
|
0.34 |
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited/expired |
|
|
|
|
|
|
(20,000) |
|
|
|
7.25 |
|
|
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2006 |
|
|
834,836 |
|
|
|
1,509,664 |
|
|
$ |
3.16 |
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes significant ranges of outstanding and exercisable options
as of March 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
|
|
|
|
Options Exercisable |
|
|
|
|
|
|
|
|
Weighted Avg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Range of |
|
|
|
|
|
Contractual Life |
|
|
Weighted Avg. |
|
|
Aggregate Intrinsic |
|
|
|
|
|
|
Weighted Avg. |
|
|
Aggregate Intrinsic |
|
Exercise Prices |
|
Number Outstanding |
|
|
(yrs) |
|
|
Exercise Price |
|
|
Value |
|
|
Number Exercisable |
|
|
Exercise Price |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.34-3.00 |
|
|
905,164 |
|
|
|
3.32 |
|
|
$ |
1.86 |
|
|
$ |
2,625 |
|
|
|
730,164 |
|
|
$ |
1.91 |
|
|
$ |
750 |
|
4.00-6.00 |
|
|
530,000 |
|
|
|
1.05 |
|
|
|
4.28 |
|
|
|
|
|
|
|
530,000 |
|
|
|
4.28 |
|
|
|
|
|
7.25-11.75 |
|
|
74,500 |
|
|
|
2.47 |
|
|
|
10.93 |
|
|
|
|
|
|
|
74,500 |
|
|
|
10.93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.34-$11.75 |
|
|
1,509,664 |
|
|
|
2.56 |
|
|
$ |
3.16 |
|
|
$ |
2,625 |
|
|
|
1,434,664 |
|
|
$ |
3.36 |
|
|
$ |
750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value in the preceding table represents the total pretax
intrinsic value, based on BioTimes closing stock price of $0.39 as of March 31, 2006, which would
have been received by the option holders had all option holders exercised their options as of that
date. The total number of in-the-money options exercisable as of March 31, 2006 was 15,000.
Accuracy of Fair Value Estimates
BioTime uses third-party party analyses to assist in developing the assumptions used to
determine fair value of share-based payment awards granted. BioTimes determination of the fair
value of share-based payment awards on the date of grant using an option-pricing model is affected
by BioTimes stock price as well as assumptions regarding a number of highly complex and subjective
variables. The variables include, but are not limited to BioTimes 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
managements opinion, the existing valuation models may not provide an accurate measure of the fair
value of BioTimes 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 Events
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 is 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 borrowers 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 line of credit is collateralized by a security
interest in BioTimes right to receive royalty and other payments under the license agreement with
Hospira. The market value of BioTime common shares was $0.38 per common share on April 12, 2006,
valuing the shares at $38,000. No funds have yet been drawn on this line of credit.
On April 3, 2006, BioTime issued 33,750 common shares in conjunction with the 2005 Greenbelt
agreement.
15
Item 2. Managements Discussion and Analysis or Plan of Operation.
MANAGEMENTS 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.
Most of our research and development efforts 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 Peoples Republic of China, and Taiwan. Summit has entered into
sublicenses with Maruishi Pharmaceutical Co., Ltd. (Maruishi) to obtain regulatory approval,
manufacture, and market Hextend in Japan and Hextend and PentaLyte in China and Taiwan.
Under our license agreements, Hospira and CJ will report sales of Hextend and pay us the
royalties and license fees due on account of such sales after the end of each calendar quarter. We
recognize such revenues in the quarter in which the sales report is received, rather than the
quarter in which the sales took place.
Revenues for the three months ended March 31, 2006 consist of royalties on sales made by
Hospira during the period beginning October 1, 2005 and ending December 31, 2005. Royalty
revenues recognized for that three-month period were $205,940, a 25% increase from the $165,321 of
royalty revenue during the same period last year. Licensee sales to hospitals increased while
sales to the United States Armed Forces declined during the period.
Hextend has been purchased by the Armed Forces through intermittent large volume orders, and
is part of the Tactical Combat Casualty Care protocol. This protocol is published in the 2005
military edition of PHTLS: Basic and Advanced Prehospital Trauma Life Support by The National
Association of Emergency Medical Technicians in cooperation with The American College of Surgeons.
We expect to receive royalties from Hospira and CJ during May 2006, based on
Hextend sales during the three months ended March 31, 2006. This revenue will be reflected in our financial statements for the
second quarter of 2006. In addition, we received $500,000 from Summit in May 2006 as the initial
consideration for its China and Taiwan license.
16
Hextend has become the standard plasma volume expander at a number of prominent teaching
hospitals and leading medical centers. We believe that as Hextend use proliferates within the
leading US hospitals, other smaller hospitals will follow their lead contributing to sales growth.
We are conducting a Phase II clinical trial of PentaLyte in which PentaLyte is being 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 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 a
Phase I clinical trial of PentaLyte, and we are now conducting a Phase II clinical trial. We
expect our Phase II trial will cost approximately an additional $350,000. 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.
If Hospira obtains a license to manufacture and market PentaLyte under our License Agreement
with them, they would reimburse us for all our direct costs incurred in developing PentaLyte.
Hospiras decision whether to license PentaLyte would follow the completion of our Phase II trial.
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.
17
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. Through December 31, 2005, $184,186 of the grant funds had
been paid to us. The time period for drawing down the remainder of the grant funds was extended
for another year, running through March 31, 2007.
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
patients 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 complete the development of PentaLyte and HetaCool and enter
into commercial license agreements for those products and 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.
18
Stock-based Compensation Expense
On January 1, 2006, we adopted Statement of Financial Accounting Standard 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 our directors and employees
including employee stock options based on estimated fair values. Stock based compensation expense
recognized under SFAS 123(R) for the three months ended March 31, 2006 was $18,843 which consisted
of stock-based compensation expense related to employee and director stock option grants.
We adopted SFAS 123(R) using the modified prospective transition method, which requires the
application of the accounting standard as of January 1, 2006, the first day of our fiscal year
2006. Our condensed consolidated financial statements as of and for the three months ended March
31, 2006, reflect the impact of SFAS 123(R). In accordance with the modified prospective
transition method, the condensed consolidated financial statements for prior periods have not been
restated to reflect, and do not include, the impact of SFAS 123(R). As of March 31, 2006, total
unrecognized compensation costs related to unvested stock options was $48,619, which is expected to
be recognized as expense over a weighted average period of
approximately 0.80 years.
Upon adoption of SFAS 123(R), we began estimating the value of employee stock options on the
date of grant using the Black-Scholes Merton model. Prior to the adoption of SFAS 123(R), the
value of each employee stock options was estimated on the date of grant using the Black-Scholes
Merton model for the purpose of the pro forma financial information in accordance with SFAS 123.
The determination of the fair value of share-based payment awards on the date grant using an option
pricing model is affected by our stock price as well assumptions regarding a number of highly
complex and subjective variables. These variables include, but are not limited to, the expected
stock price volatility over the term of the awards, and actual and projected employee stock option
exercise behaviors. The use of a Black-Scholes Merton model requires the use of extensive actual
employee exercise behavior data and the use of a number of complex assumptions including expected
volatility, risk-free interest rate and expected dividend yields. The weighted-average estimated
value of employee stock options granted during the three months ended March 31, 2006 was $0.25 per
share using the Black-Scholes Merton model with the following weighted average assumptions:
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, 2006 |
Expected lives in years |
|
|
5 |
|
Risk free interest rates |
|
|
4.79 |
% |
Volatility |
|
|
93.00 |
% |
Dividend yield |
|
|
0 |
% |
The fair value of each option award is estimated on the date of grant using the Black-Scholes
Merton option valuation model with the weighted average assumption for volatility,
19
expected term and risk-free rate. The expected term of options grants 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. The expected
volatility is a blended rate based on both the historical volatility of our stock price and the
volatility of certain peer company stock prices.
As stock-based compensation expense recognized in the condensed consolidated statement of
operations for the first quarter of fiscal 2006 is based on awards ultimately expected to vest,
estimated forfeitures have been accounted for. SFAS 123 (R) requires forfeitures to be estimated
at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates. Forfeitures were estimated based on historical experience.
If factors change and we employ different assumptions in the application of SFAS 123(R) in
future periods, the compensation expense that we record under SFAS 123(R) may differ significantly
from what we have recorded in the current period.
Results of Operations
Revenues
During the three months
ended March 31, 2006, we recognized $35,292 of license fee revenues
related to our agreements with CJ and Summit. The CJ license fee of $800,000, net of the finders 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
BioTimes products in Korea. See Note 2 to the condensed financial statements.
For the three months ended March 31, 2006, we recognized $205,940 in royalty revenue, whereas
we recognized $165,321 for the three months ended March 31, 2005. This increase of 25% in
royalties is attributable to an increase in product sales by Hospira. During the period, sales to
hospitals increased while sales to the United States Armed Forces declined, reflecting the fact
that the Armed Forces purchases Hextend in intermittent large volume orders.
Operating Expenses
Research and development expenses were $265,932 for the three months ended March 31, 2006,
compared to $462,608 for the three months ended March 31, 2005. This decrease is chiefly
attributable to a $196,401 decrease in outside research, as payments made in the prior year to
initiate our phase II clinical trial for PentaLyte were not repeated this year. Research and
development expenses include clinical trails expenses, laboratory study expenses, salaries, ongoing
prosecution of regulatory applications in the United States, and consultants fees.
General and administrative expenses decreased to $436,881 for the three months ended March 31,
2006 from $454,001 for the three months ended March 31, 2005. Several changes in various general
and administrative expense accounts acted to almost completely offset each other. An increase in
patent expense of $22,541 was offset by a $23,596 decrease in investor
20
relations expense, as we cut spending in that area. Also, an increase of approximately $28,000 in accounting fees was offset by
a $29,168 decrease in general and administrative consulting expenses. The bulk of the remaining
overall change was due to a decrease in legal expense of approximately $22,000.
Interest and Other Income
For the three months ended March 31, 2006, we incurred net interest and other expense of
$17,116, compared to expense of $1,064 for the three months ended March 31, 2005. This increase in
expense is due to higher interest expense associated with our imputed royalty obligation under our
license agreement with Summit, offset by higher interest income, due to larger cash balances and
higher microcannula sales.
Income Taxes
During the three months ended March 31, 2006, 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
During December 2005, we completed a new subscription rights offer under which we raised gross
proceeds of $1,787,144 through the sale of 4,467,862 common shares and warrants (the 2005 Rights
Offer). See Note 5 to the financial statements.
We have entered into agreements with Summit to develop Hextend and PentaLyte in Japan, the
Peoples 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, 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 is 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 borrowers 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 line of credit is collateralized by a security interest in BioTimes right to receive
royalty and other payments under the license agreement with Hospira.
21
The market value of BioTime common shares was $0.38 per common share on April 12, 2006, valuing the shares at $38,000. No
funds have yet been drawn on this line of credit.
The
major components of our net cash used in operations of approximately $745,000 in the first
quarter of 2006 are our net loss of $478,000, along with a $252,000
reduction in accounts payable and accrued expenses.
At our projected rate of spending, which includes possible spending cuts, we expect that our
cash on hand, anticipated royalties from the sale of Hextend, licensing fees, and our available
revolving line of credit will allow us to operate through September 30, 2007.
We will need to obtain additional equity capital from time to time in the future, as long as
the fees we receive from licensing our products to pharmaceutical companies, profits from sales of
our products, and royalty revenues are not sufficient to fund our operations. Sales of additional
equity securities could result in the dilution of the interests of present shareholders. 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.
We have no contractual obligations as of March 31, 2006, 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 $10,488 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 March 31, 2006 that materially affected or that could reasonably likely materially affect our
internal controls over financial reporting.
22
PART II OTHER INFORMATION
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During January 2006, we issued 101,250 common shares, and during April 2006, we issued 33,750
common shares, to Greenbelt Corp., our financial advisor, as compensation for services rendered
during the period April 1, 2005 through March 31, 2006 under the terms of a previously reported
agreement.
Item 5. Other Information
We
plan to hold our next annual meeting of shareholders on July 24, 2006. Shareholders who
intend to present a proposal for action at our 2006 Annual Meeting of Shareholders must notify the
our management of such intention by notice received at our principal executive offices not later
than June 9, 2006 for such proposal to be included in our proxy statement and form of proxy
relating to such meeting.
Item 6. Exhibits and Reports on Form 8-K
|
|
|
Exhibit |
|
|
Numbers |
|
Description |
3.1
|
|
Articles of Incorporation, as Amended |
|
|
|
3.2
|
|
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.* |
23
|
|
|
Exhibit |
|
|
Numbers |
|
Description |
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. (Incorporated by reference to BioTimes
Form 10-K for the year ended December 31, 2005) |
|
|
|
10.19
|
|
Security Agreement executed by BioTime, Inc., dated April 12, 2006. (Incorporated by
reference to BioTimes Form 10-K for the year ended December 31, 2005) |
|
|
|
10.20
|
|
Form of Revolving Credit Note of BioTime, Inc. in the principal amount of $166,666.67 dated
April 12, 2006. |
|
|
|
31
|
|
Rule 13a-14(a)/15d-14(a) Certification ++++ |
24
|
|
|
Exhibit |
|
|
Numbers |
|
Description |
32
|
|
Section 1350 Certification ++++ |
Incorporated by reference to BioTimes 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 BioTimes Form 8-K, filed April 24, 1997.
^ Incorporated by reference to BioTimes Form 10-Q for the quarter ended June 30, 1999.
* Incorporated by reference to BioTimes Form 10-K for the year ended December 31, 2001.
** Incorporated by reference to BioTimes Form 10-Q for the quarter ended June 30, 2002.
***Incorporated by reference to BioTimes Form 10-K/A-1 for the year ended December 31, 2002.
Incorporated by reference to BioTimes 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 BioTimes Form 8-K filed December 20, 2005.
Incorporated by reference to BioTimes Form 8-K filed January 13, 2006
25
Incorporated by reference to BioTimes Form 8-K filed March 30, 2006
Incorporated by reference to BioTimes Form 10-K for the year ended December 31, 2005.
++++Filed herewith
26
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BIOTIME, INC.
|
|
|
|
|
|
|
|
Date: May 15, 2006 |
/s/Judith Segall
|
|
|
Judith Segall |
|
|
Vice-President Operations
Member, Office of the President* |
|
|
|
|
|
Date: May 15, 2006 |
/s/Hal Sternberg
|
|
|
Hal Sternberg |
|
|
Vice-President Research
Member, Office of the President* |
|
|
|
|
|
Date: May 15, 2006 |
/s/Harold Waitz
|
|
|
Harold Waitz |
|
|
Vice-President Regulatory Affairs
Member, Office of the President* |
|
|
|
|
|
Date: May 15, 2006 |
/s/Steven A. Seinberg
|
|
|
Steven A. Seinberg |
|
|
Chief Financial Officer |
|
|
|
|
|
* |
|
The Office of the President is comprised of the three above-referenced executive officers of
BioTime who collectively exercise the powers of the Chief Executive Officer |
27
|
|
|
Exhibit |
|
|
Numbers |
|
Description |
3.1
|
|
Articles of Incorporation, as Amended |
|
|
|
3.2
|
|
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.*** |
28
|
|
|
Exhibit |
|
|
Numbers |
|
Description |
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. (Incorporated by reference to BioTimes
Form 10-K for the year ended December 31, 2005) |
|
|
|
10.19
|
|
Security Agreement executed by BioTime, Inc., dated April 12, 2006. (Incorporated by
reference to BioTimes Form 10-K for the year ended December 31, 2005) |
|
|
|
10.20
|
|
Form of Revolving Credit Note of BioTime, Inc. in the principal amount of $166,666.67 dated
April 12, 2006. |
|
|
|
31
|
|
Rule 13a-14(a)/15d-14(a) Certification ++++ |
|
|
|
32
|
|
Section 1350 Certification ++++ |
Incorporated by reference to BioTimes 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.
29
## 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 BioTimes Form 8-K, filed April 24, 1997.
^ Incorporated by reference to BioTimes Form 10-Q for the quarter ended June 30, 1999.
* Incorporated by reference to BioTimes Form 10-K for the year ended December 31, 2001.
** Incorporated by reference to BioTimes Form 10-Q for the quarter ended June 30, 2002.
***Incorporated by reference to BioTimes Form 10-K/A-1 for the year ended December 31, 2002.
Incorporated by reference to BioTimes 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 BioTimes Form 8-K filed December 20, 2005.
Incorporated by reference to BioTimes Form 8-K filed January 13, 2006
Incorporated by reference to BioTimes Form 8-K filed March 30, 2006
Incorporated by reference to BioTimes Form 10-K for the year ended December 31, 2005.
++++Filed herewith
30