e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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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 September 30, 2005
OR
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o |
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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 registrant as specified in its charter)
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California
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94-3127919 |
(State or other jurisdiction of incorporation
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(IRS Employer |
or organization)
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Identification No.) |
6121 Hollis Street
Emeryville, California 94608
(Address of principal executive offices)
(510) 350-2940
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule
12b-2 of the Exchange Act). Yes o No þ
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. 17,871,450 common shares, no par value, as of October 27, 2005.
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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September 30, |
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2005 |
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December 31, |
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(unaudited) |
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2004 |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
175,564 |
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$ |
1,370,762 |
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Accounts receivable |
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255,953 |
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21,052 |
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Prepaid expenses and other current assets |
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109,202 |
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101,173 |
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Total current assets |
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540,719 |
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1,492,987 |
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EQUIPMENT, net of accumulated depreciation of $573,837 and $568,557,
respectively |
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7,272 |
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12,552 |
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DEPOSITS AND OTHER ASSETS |
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20,976 |
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16,050 |
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TOTAL ASSETS |
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568,967 |
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$ |
1,521,589 |
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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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$ |
235,210 |
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$ |
275,256 |
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DEFERRED LICENSE REVENUES |
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529,375 |
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601,563 |
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ROYALTY OBLIGATION |
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915,660 |
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300,000 |
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OTHER LONG
TERM LIABILITIES |
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2,594 |
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COMMITMENTS |
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SHAREHOLDERS EQUITY (DEFICIT): |
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Preferred shares, no par value, undesignated as to Series,
authorized 1,000,000 shares; none outstanding |
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Common shares, no par value, authorized 40,000,000 shares; issued
and outstanding 17,871,450 and 17,811,450, respectively |
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38,843,936 |
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38,718,197 |
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Contributed capital |
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93,972 |
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93,972 |
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Accumulated deficit |
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(40,051,780 |
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(38,467,399 |
) |
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Total shareholders equity (deficit) |
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(1,113,872 |
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344,770 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIT) |
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568,967 |
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$ |
1,521,589 |
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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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Nine Months Ended |
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September 30, |
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September |
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September 30, |
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September 30, |
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2005 |
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30, 2004 |
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2005 |
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2004 |
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REVENUE: |
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License fees |
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$ |
24,062 |
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$ |
25,173 |
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$ |
73,887 |
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$ |
54,049 |
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Royalties from product sales |
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128,829 |
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145,208 |
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442,877 |
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442,369 |
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Grant income |
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87,541 |
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164,026 |
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Total revenue |
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240,432 |
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170,381 |
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680,790 |
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496,418 |
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EXPENSES: |
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Research and development |
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(401,144 |
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(305,626 |
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(1,205,271 |
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(810,379 |
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General and administrative |
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(242,988 |
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(280,712 |
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(1,031,918 |
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(1,055,438 |
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Total expenses |
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(644,132 |
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(586,338 |
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(2,237,189 |
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(1,865,817 |
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INTEREST INCOME (EXPENSE)
AND OTHER: |
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(11,358 |
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13,415 |
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(27,982 |
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(1,118,353 |
) |
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Loss before income taxes |
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(415,058 |
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(402,542 |
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(1,584,381 |
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(2,487,752 |
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Foreign Taxes |
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(49,518 |
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(49,518 |
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NET LOSS |
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$ |
(415,058 |
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$ |
(452,060 |
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$ |
(1,584,381 |
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$ |
(2,537,270 |
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BASIC AND DILUTED LOSS PER
SHARE |
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$ |
(0.02 |
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$ |
(0.03 |
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$ |
(0.09 |
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$ |
(0.15 |
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COMMON AND EQUIVALENT
SHARES USED IN COMPUTING
BASIC AND DILUTED PER SHARE
AMOUNTS |
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17,871,450 |
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17,811,450 |
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17,864,564 |
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17,318,360 |
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See notes to condensed financial statements.
3
BIOTIME, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
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Nine months Ended |
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September 30, |
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2005 |
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2004 |
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OPERATING ACTIVITIES: |
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Net loss |
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$ |
(1,584,381 |
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$ |
(2,537,270 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
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Depreciation |
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5,280 |
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30,222 |
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Interest on royalty obligation |
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47,832 |
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Amortization of debt discount |
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1,012,921 |
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Stock-based compensation |
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85,616 |
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98,026 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(234,901 |
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(5,800 |
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Prepaid expenses and other current assets |
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(8,029 |
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73,985 |
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Deposits |
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(4,926 |
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Accounts payable and accrued liabilities |
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77 |
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(227,398 |
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Deferred revenue |
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(72,188 |
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216,701 |
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Other long-term liabilities |
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2,594 |
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Net cash used in operating activities |
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(1,763,026 |
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(1,338,613 |
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FINANCING ACTIVITIES: |
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Payment of debt |
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(1,850,000 |
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Issuance of common shares for cash |
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4,184,420 |
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Common shares placement costs |
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(162,453 |
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Increase in royalty obligation |
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697,828 |
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Payment on royalty obligation |
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(130,000 |
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Exercise of options |
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18,307 |
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Net cash provided by financing activities |
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567,828 |
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2,190,274 |
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INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
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(1,195,198 |
) |
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851,661 |
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Cash and cash equivalents at beginning of period |
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1,370,762 |
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717,184 |
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Cash and cash equivalents at end of period |
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$ |
175,564 |
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$ |
1,568,845 |
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NONCASH FINANCING AND INVESTING ACTIVITIES: |
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Conversion of debentures to common shares |
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$ |
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$ |
1,500,000 |
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Issuance of warrants to guarantors for
participation in the rights offer |
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82,500 |
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SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
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Cash paid for interest |
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$ |
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$ |
175,552 |
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Cash paid for income taxes |
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$ |
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$ |
49,518 |
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See notes to condensed financial statements.
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(Concluded) |
4
BIOTIME, INC.
NOTES TO FINANCIAL STATEMENTS
1. Organization
General - BioTime, Inc. (the Company) was organized November 30, 1990 as a California
corporation. The Company 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 September 30, 2005, the condensed statements of operations
for the three and nine months ended September 30, 2005 and 2004 and the statements of cash flows
for the nine months ended September 30, 2005 and 2004 have been prepared by the Company 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 September 30, 2005 and for all periods presented have been made. The balance sheet as of
December 31, 2004 is derived from the Companys audited financial statements as of that date. The
results of operations for the nine months ended September 30, 2005 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. These
interim condensed financial statements should be read in conjunction with the annual audited
financial statements and notes thereto included in the Companys Form 10-K for the year ended
December 31, 2004.
Significant Risks and Uncertainties- The Companys 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 the Companys products; the
Companys 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 Company products; the Companys ability to obtain
additional financing and the terms of any such financing that may be obtained; the Companys
ability to negotiate favorable licensing or other manufacturing and marketing agreements for its
products; the availability of ingredients used in the Companys products; and the availability of
reimbursement for the cost of the Companys products (and related treatment) from government health
administration authorities, private health coverage insurers and other organizations.
Liquidity - At September 30, 2005, BioTime had $175,564 cash on hand and a line of credit
through American Express in the amount of $43,600, from which no money has yet been drawn. During
October the Company received approximately $397,000 under its agreement with Summit. Of that
amount, $150,000 represents a scheduled payment from Summit under
5
BioTimes agreement with them, while the remaining approximately $247,000 represents the
Companys 40% share of a non-refundable payment from a prospective licensee in connection with a
license agreement for the Japanese market that is being negotiated by Summit. BioTime also expects
to receive $242,124 in royalty payments from Hospira in November. However, the Company 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. The Company 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 the Company
to modify, curtail, delay, suspend, or possibly discontinue some or all aspects of its planned
operations. In order to preserve capital, the Company has already introduced a cost-cutting plan,
including voluntary decreases in salaries and decreases in discretionary spending. With this plan
in place, management believes its existing cash, along with anticipated license fees and royalties,
and the minimum rights offer proceeds, will be sufficient to allow the Company to operate through
March 31, 2007 (see Note 8). Should the Company be unable to complete the rights offer for any
reason, it would have a material adverse effect on the Companys ability to continue its planned
operations.
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
the Company 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, the Company 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.
The Company also defers costs, including finders fees, which are directly related to license
agreements for which revenue has been deferred. Deferred costs reduce revenue proportionally and
over the same period that related deferred revenue is recognized. Deferred costs are net against
deferred revenues in the Companys balance sheet.
6
The Company recognizes royalty revenues in the quarter in which the sales report is received,
rather than the quarter in which the sales took place, as the Company 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 the Companys agreements that the Company 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.
Under its bylaws, the Company 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 the Company could be required to make under the indemnification
provisions contained in its bylaws is unlimited. However, the Company 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, the Company believes the
estimated fair value of these indemnification agreements is minimal and has no liabilities recorded
for these agreements as of September 30, 2005.
Under the License Agreement and the CJ Agreement, BioTime shall indemnify Abbott, Hospira,
and/or CJ for any cost or expense resulting from any third party claim or lawsuit arising from
alleged patent infringement, as defined, by Abbott, Hospira, or CJ relating to actions covered by
the License Agreement or the CJ Agreement, respectively. Management believes that the possibility
of payments under the indemnification clauses by the Company is remote. Therefore, the Company has
not recorded a provision for potential claims as of September 30, 2005.
The Company 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 the
Company generally indemnifies and holds harmless the indemnified party for losses suffered or
incurred by the indemnified party as a result of the Companys 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 the Company with regard to
intellectual property rights. These indemnification provisions generally survive termination of the
underlying agreement. In some cases, the Company has obtained liability insurance providing
coverage that limits its exposure for indemnified matters. The maximum potential amount of future
payments the Company could be required to make under these indemnification provisions is unlimited.
The Company has not incurred material costs to defend lawsuits or settle claims related to these
indemnification agreements. As a result, the Company believes the estimated fair value of these
agreements is minimal. Accordingly, the Company has no liabilities recorded for these agreements as
of September 30, 2005.
7
Comprehensive Income (Loss) - Statement of Financial Accounting Standards (SFAS) No. 130,
Reporting Comprehensive Income, establishes standards for reporting and displaying comprehensive
income and its components (revenues, expenses, gains, and losses) in a full set of general-purpose
financial statements. Comprehensive loss was the same as net loss for all periods presented.
Stock-based Compensation - The Company has elected to continue to follow the intrinsic value
method in accounting for its stock-based employee compensation arrangement as defined by Accounting
Principles Board Opinion (APB) No. 25, Accounting for Stock Issued to Employees.
Had compensation cost for employee options granted under the Companys option plans been
determined based on the fair value at the grant dates, as prescribed in SFAS No. 123, Accounting
for Stock-Based Compensation, the Companys net loss and pro forma net loss per share would have
been as follows:
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|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
Net loss as reported |
|
$ |
(415,058 |
) |
|
$ |
(452,060 |
) |
|
$ |
(1,584,381 |
) |
|
$ |
(2,537,270 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deduct: Stock-based
compensation
determined under
fair value method
for awards, net of
applicable tax
effects |
|
|
(44,729 |
) |
|
|
(38,639 |
) |
|
|
(135,379 |
) |
|
|
(153,828 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(459,787 |
) |
|
$ |
(490,699 |
) |
|
$ |
(1,719,760 |
) |
|
$ |
(2,691,098 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per common
share as reported |
|
$ |
(0.02 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma basic and
diluted loss per
common share |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Recently issued accounting standards In December 2004, the FASB revised and retitled
SFAS No. 123R, Share-Based Payment. SFAS No. 123R establishes standards for the accounting of
transactions in which an entity exchanges its equity instruments for goods or services, primarily
focusing on accounting for transactions where an entity obtains employee services in share-based
payment transactions. SFAS No. 123R requires a public entity to measure the cost of employee
services received in exchange for an award of equity instruments, including stock options, based on
the grant-date fair value of the award and to recognize it as compensation expense over the period
the employee is required to provide service in exchange for the award, usually the vesting period.
SFAS No. 123R is effective as of the first fiscal year that begins on or after June 15, 2005. The
Company will adopt the provisions of SFAS No. 123R on January 1, 2006. Management is currently
assessing the impact of adopting SFAS No. 123R.
8
3. Debentures
In August 2001, the Company issued $3,350,000 of debentures to an investor group. Interest on
the debentures was payable at an annual rate of 10% and was payable semi-annually. Investors who
purchased the debentures also received warrants to purchase a total of 525,688 common shares at an
exercise price of $6.37. The warrants expired on August 1, 2004.
During April 2003, holders of $2,750,000 principal amount of the debentures granted BioTime a
pay in kind right allowing (but not requiring) BioTime to make interest payments in common shares
instead of cash for the interest payments due during August 2003 and February 2004 (the PIK
Right). BioTime retained the right to pay the interest due in cash. Each debenture holder who
agreed to grant BioTime the PIK Right received a three-year warrant entitling the holder to
purchase BioTime common shares for $1.50 per share. The number of shares covered by the warrants
is the amount of debenture interest due in August 2003 and February 2004 divided by the $1.50
exercise price. Warrants to purchase a total of 226,595 common shares, inclusive of the 40,799
warrants granted to Alfred Kingsley discussed below, were issued.
The warrants will expire on April 1, 2006, and will not be exercisable thereafter. The
warrants will be redeemable by BioTime, at BioTimes option, at $0.05 per warrant share if the
closing price of the common shares on a national stock exchange or the average bid price as quoted
in the Nasdaq Stock Market exceeds 200% of the exercise price for 20 consecutive trading days. All
prices and share amounts will be adjusted for any stock splits, reverse splits, recapitalization,
or similar changes to the common shares.
During April 2003, Mr. Kingsley agreed with BioTime that if BioTime exercised the PIK right,
he would have provided BioTime with the cash required to pay the interest due on any debentures
held by persons who did not grant BioTime the PIK Right. In consideration of his agreement to do
so, BioTime issued to Mr. Kingsley a warrant for 40,799 additional common shares, which is the
amount of warrants that would have been issued had the debenture holders who did not grant BioTime
the PIK Right, instead agreed to do so. BioTime, Inc. chose not to exercise the right to pay
interest in stock and paid all interest on the debentures in cash.
During February 2004, the Company eliminated its $3,350,000 of debenture indebtedness by using
a portion of the proceeds of its 2003 Rights Offer (see Note 5) to repay $1,850,000 of debentures
in cash, and by issuing a total of 1,071,428 common shares and 535,712 common share purchase
warrants in exchange for $1,500,000 of debentures held by certain persons who acted as
Participating Debenture Holders under the Standby Purchase Agreement described in Note 5. As the
fair value of the consideration of $3,781,786 given to the debenture holders exceeded the carrying
value of the debentures, BioTime recognized interest expense of $1,106,786 relative to the cost
incurred on the extinguishment of the debentures. The components of this charge are as follows:
(1) a $664,608 charge for unamortized discount of the warrants issued to the debenture holders at
the time they acquired the debentures; (2) a $265,000 charge for fees consisting of $100,000 of
cash and 500,000 common share purchase warrants, bearing the same terms as those sold in the 2003
Rights Offer described in Note 5 and determined to have a fair value of $0.33 per warrant, received
by the Participating Debenture
9
Holders under the Standby Purchase Agreement; and (3) a $176,786 charge for the excess of the
fair value of the 1,071,428 common shares and 535,712 warrants over the $1,500,000 face value of
debentures exchanged. The common shares and warrants were valued at the AMEX closing prices on
February 4, 2004.
4. Royalty Obligation
In December 2004, BioTime entered into an agreement with a pharmaceutical partner 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 received an additional $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 this co-developers business plan for
Hextend, BioTime paid to the co-developer a one-time fee of $130,000 for their services in
preparing the plan. Revenues from Hextend and PentaLyte in Japan will be shared between BioTime
and the co-developer as follows: BioTime (40%) and the co-developer (60%). Additionally, BioTime
will pay the co-developer 8% of all net royalties received from the sale of PentaLyte in the United
States.
The accounting treatment of the payments of $900,000 from the co-developer falls under the
guidance of Emerging Issues Task Force 88-18 (EITF 88-18), Sales of Future Revenues. EITF
88-18 addresses the accounting treatment when an enterprise (BioTime) receives cash from an
investor (the pharmaceutical co-developer) 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 Emerging Issues Task Force reached a consensus on six
independent factors that would require reclassification of the proceeds as debt. As BioTime meets
one of the factors whereby BioTime has significant continuing involvement in the generation of the
cash flows due to the investor, BioTime has recorded the net proceeds from the co-developer of
$620,000 as well as amounts due to BioTime for revenues received by the co-developer in Japan of
approximately $247,000 as long-term debt as of September 30, 2005. During October 2005 the Company
received approximately $247,000 as its 40% share of a non-refundable payment from a prospective
licensee in connection with a license agreement for the Japanese market that is being negotiated by
the co-developer. BioTime will reduce the debt principal and accrued interest as the royalty
payments on U.S. sales of PentaLyte are made. Interest on the debt will accrue monthly using the
effective interest method beginning January 2005 and total interest will be adjusted based on the
periodic adjustments made on the overall expected royalty. BioTime determined that interest should
be accrued at a rate of 12% per annum for the nine months ended September 30, 2005, resulting in
interest expense associated with the royalty obligation to the co-developer of $47,832 for that
nine-month period.
5. Shareholders Equity (Deficit)
During January 2004, BioTime completed a subscription rights offer (the 2003 Rights Offer)
through which the Company raised gross proceeds of $3,584,420 through the sale of
10
2,560,303 common shares and 1,280,073 warrants. Following the completion of the 2003 Rights Offer,
the Company raised an additional $600,000 by selling an additional 428,571 common shares and
214,284 warrants under a Standby Purchase Agreement to certain persons who acted as Guarantors of
the 2003 Rights Offer. The common shares and warrants were sold as units for $1.40 per unit.
Each unit consisted of one common share and one-half of a warrant. Each full warrant entitles the
holder to purchase one common share for $2.00 per share and will expire on January 14, 2007.
However, upon completion of the new subscription rights offer described in note 8, the expiration
date of the warrants will be extended to October 31, 2010. BioTime may redeem the warrants by
paying $.05 per warrant if the closing price of the common shares on a national securities exchange
or the average bid price as quoted in the Nasdaq Stock Market exceeds 200% of the exercise price of
the warrants for any 20 consecutive trading days.
In consideration for their agreement to purchase up to $2,250,000 of units if the subscription
rights were not fully exercised, under the Standby Purchase Agreement the Company paid the
Guarantors $50,000 in cash and issued to them warrants to purchase 250,000 common shares, which
were accounted for as costs of the equity financing. Total estimated cash costs of the 2003 Rights
Offer, which were recorded as a reduction of the proceeds received, were $351,518. Also, the
Company paid the Participating Debenture Holders $100,000 in cash and issued to them warrants to
purchase 500,000 common shares, which were included in the computation of the cost on
extinguishments of the debentures (See Note 3). The warrants issued to the Guarantors and
Participating Debenture Holders have the same terms as the warrants the Company sold in the 2003
Rights Offer.
Additionally, the Company issued a total of 1,071,428 common shares and 535,712 common share
purchase warrants in exchange for $1,500,000 of debentures held by the Participating Debenture
Holders (See Note 3).
The 2003 Rights Offer triggered the anti-dilution provisions contained in various warrants
previously issued by the Company. The resulting change in the exercise prices of the warrants was
small, and did not significantly change the fair market value of the warrants. Under these
anti-dilution provisions, the number of shares issuable upon the exercise of the warrants increased
by a total of 15,169 shares. The Company recognized a total charge to interest expense of $6,135
relative to the adjustments of the exercise prices and the number of shares issuable upon the
exercise of the warrants.
Options to purchase 60,000 common shares were granted to consultants in 1999, and vest upon
achievement of certain milestones. During the first quarter of 2004, the Company accelerated the
vesting of these options so that all were fully vested as of March 31, 2004. During the three
months ended March 31, 2004, expense of $8,276 was incurred for these options and recorded as a
research and development expense. No further expense was recorded after March 31, 2004.
On August 8, 2005, the Board of Directors granted options to purchase 100,000 common shares to
outside consultants at an exercise price of $2.00. The options vested immediately upon grant and
were valued at $41,540 using the Black-Scholes options pricing model and the following assumptions:
stock price $0.80, historical volatility 83.55, risk free rate of return
11
4.28%, and dividend yield of zero and contractual term of 5 years. The value of these options
is reflected in the statement of operations as follows: $29,078 as a component of research and
development expense and $12,462 as a component of general and administrative expense.
During April 1998, the Company 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 the Company. The agreement has been renewed each subsequent year ending March
31. For the twelve months ended March 31, 2004, the Company paid Greenbelt $90,000 in cash and
issued 80,000 common shares. For the twelve months ending March 31, 2005, the Company paid
Greenbelt $90,000 in cash and agreed to issue 60,000 common shares. During April 2005, 20,000
common shares relating to the twelve months ended March 31, 2005 were issued. The agreement with
Greenbelt has been renewed for the 12 months ending March 31, 2006. BioTime will pay Greenbelt a
cash fee of $45,000 due on April 3, 2006, and will issue them 135,000 common shares as follows:
101,250 shares on January 2, 2006 for services rendered through December 31, 2005, and 33,750
shares on April 3, 2006 for services rendered from January 1, 2006 through March 31, 2006.
Activity related to the Greenbelt agreement is presented in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance |
|
|
Balance |
|
Add: |
|
|
|
|
|
|
|
|
|
Less: |
|
included in |
|
|
included in |
|
Cash- |
|
Add: Stock- |
|
|
|
|
|
Value of |
|
Accounts |
|
|
Accounts |
|
based |
|
based |
|
|
|
|
|
stock- |
|
Payable at |
|
|
Payable at |
|
expense |
|
expense |
|
Less: Cash |
|
based |
|
September |
|
|
January 1 |
|
accrued |
|
accrued |
|
payments |
|
payments |
|
30, |
2005 |
|
$ |
112,950 |
|
|
$ |
45,000 |
|
|
$ |
45,275 |
|
|
$ |
(67,500 |
) |
|
$ |
(84,200 |
) |
|
$ |
51,525 |
|
2004 |
|
$ |
105,300 |
|
|
$ |
67,500 |
|
|
$ |
72,400 |
|
|
$ |
(67,500 |
) |
|
$ |
(122,800 |
) |
|
$ |
54,900 |
|
During the nine months ended September 30, 2005 and 2004, the Company issued to Greenbelt
60,000 and 80,000 common shares, respectively, valued at $84,200 and $122,800.
6. 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 reflect the potential dilution from securities and other contracts which
are exercisable or convertible into common shares. For the three and nine months ended September
30, 2005 and 2004, options to purchase 1,352,164 and 1,278,832, common shares, respectively, and
warrants to purchase 3,153,191 common shares, 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.
12
7. Lease Agreement
During the second quarter, the Company entered into a five-year lease for its new corporate
headquarters. The Company moved to its new Emeryville, California location in June 2005.
Remaining minimum annual lease payments for the next five years under the new lease are as follows:
|
|
|
|
|
Year |
|
Minimum lease payments |
|
2005 |
|
$ |
31,464 |
|
2006 |
|
|
128,058 |
|
2007 |
|
|
131,900 |
|
2008 |
|
|
135,857 |
|
2009 |
|
|
139,933 |
|
|
|
|
|
|
|
$ |
567,212 |
|
|
|
|
|
8. Subsequent Event
On October 27, 2005, BioTime commenced a new subscription rights offer under which it will
distribute subscription rights Rights to the holders of its common shares entitling each holder
to subscribe for and purchase one Unit for every five Rights held at a price of $0.50 per Unit.
Each Unit will consist of one new common share and one warrant to purchase an additional common
share. The subscription price for the Units is $0.50 per Unit. Each warrant will entitle the
holder to purchase one common share for $2.00 per share and will expire on October 31, 2010. The
rights offer will expire on November 30, 2005. Shareholders who exercise all of their rights in
full will be entitled to the additional privilege of subscribing for and purchasing any Units left
over by rights holders who fail to exercise their rights, plus up to 1,787,145 Units to cover
over-subscriptions, subject to certain limitations and subject to allocation. A group of private
investors has agreed to purchase any Units that remain unsold at the conclusion of the new rights
offer, excluding Units that the Company has authorized to issue to fill over-subscription. BioTime
will raise at least $1,787,145 through the new rights offer, before deducting expenses of the
rights offer which BioTime estimates will be approximately $292,000. Should the Company be unable
to complete the rights offer for any reason, it would have a material adverse effect on the
Companys ability to continue its planned operations. During October 2005, BioTime received
approximately $397,000 under its agreement with Summit. Of that amount, $150,000 represents a
scheduled payment from Summit under the Companys agreement with them, while the remaining
approximately $247,000 represents BioTimes 40% share of a non-refundable payment from a
prospective licensee in connection with a license agreement for the Japanese market that is being
negotiated by Summit. The Company also expects to receive $242,124 in royalty payments from
Hospira in November 2005.
13
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
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. During 1997 we granted Abbott Laboratories (Abbott) an exclusive
license to sell Hextend in the United States and Canada, along with a right to obtain licenses to
manufacture and sell other BioTime products. Abbott has completed a spin-off of a substantial
portion of its hospital products business into a new company called Hospira, Inc. Abbott has
assigned to Hospira its license to manufacture and market Hextend.
During March 2003, we granted to CJ Corp. (CJ) an exclusive license to manufacture and sell
Hextend and PentaLyte in South Korea (the CJ Agreement). CJ commenced sales of Hextend during
the first quarter of 2005. CJ is also responsible for obtaining the regulatory approvals required
to manufacture and market PentaLyte, including conducting any clinical trials that may be required,
and will bear all related costs and expenses.
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, as we do not have sufficient sales history to accurately
predict quarterly sales.
Revenues for the three months ended September 30, 2005 consist of royalties on sales made
by Hospira during the period beginning April 1, 2005 and ending June 30, 2005. Royalty revenues recognized for that three-month period were $128,829, an 11% decrease from the $145,208
of royalty revenue during the same period last year due to a decline in sales to the U.S. Armed Forces, partially offset by an increase in hospital sales. The Armed Forces purchase
Hextend through intermittent, large volume orders, which makes it difficult to predict sales to them in subsequent quarters.
14
During July 2005, Hospira appointed a new marketing manager of infusion therapy with more than a decade of experience
in hospital product sales. We expect to receive royalties of $242,124 from Hospira in November 2005, based on Hextend sales during the three month period beginning July 1, 2005
and ending September 30, 2005. This revenue will be reflected in our financial statements for the fourth quarter of 2005. A portion of the royalty amount, $73,489, represents
a payment from Hospira to preserve certain rights under their license. The balance of the royalty payment, $168,635, was based upon sales of Hextend and represents a 15%
increase from royalty revenues of $147,148 received during the same period last year. The increase is primarily due to a large increase in hospital sales which was more
than sufficient to offset reduced sales to the U.S. Armed Forces.
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 and accelerate sales growth.
We have entered into an agreement with Summit Pharmaceuticals International Corporation to
develop Hextend and PentaLyte for the Japanese market. Under the agreement, we received $300,000
in December 2004, $450,000 in April 2005 and $150,000 in October 2005. The payments represent a
partial reimbursement of our development cost of Hextend and PentaLyte. We and Summit do not plan
to manufacture and market Hextend and PentaLyte ourselves. Instead, we will seek to license
manufacturing and marketing rights to a third party such as a pharmaceutical company. During
October 2005 we received approximately $247,000 as our 40% share of a non-refundable payment from a
prospective licensee in connection with a license agreement for the Japanese market that is being
negotiated by Summit. The definitive terms of the license agreement have not been finalized.
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
estimate that the Phase II trial will cost approximately $1,000,000. 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 our direct costs incurred in developing PentaLyte.
Hospiras decision whether to license PentaLyte would follow the completion of our Phase II trial.
15
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.
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 have received $184,186 of the grant
funds through September 30, 2005, including $87,541 in the current quarter.
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.
16
Because our research and development expenses, clinical trial expenses, and production and
marketing expenses will be charged against earnings for financial reporting purposes, management
expects that there will be losses from operations in the near term.
Hextend®, PentaLyte®, and HetaCool® are registered trademarks of BioTime.
Results of Operations
Revenues
During the three months ended September 30, 2005, we recognized $24,062 of license fees
received from CJ during previous fiscal periods, and for the nine months ended September 30, 2005,
we recognized $73,887 of license fees received from CJ during previous fiscal periods. 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 the Companys products in
Korea. See Note 2 to the condensed financial statements.
For the three months ended September 30, 2005, we recognized $128,829 in royalty revenue,
whereas we recognized $145,208 for the three months ended September 30, 2004. This decrease of 11%
in royalties is attributable to a decrease in product sales to the United States Armed Forces
during the period, partially offset by an increase in hospital sales. The Armed Forces purchase Hextend through intermittent, large volume orders,
which makes it difficult to predict sales to them in subsequent quarters. For the nine months
ended September 30, 2005, we recognized $442,877 in royalty revenue, compared to the $442,369 we
recognized for the nine months ended September 30, 2004. The essentially flat progression of
royalties is due to the aforementioned decrease in product sales to the Armed Forces, which was only partially offset
by an increase in hospital sales.
Operating Expenses
Research
and development expenses were $401,144 for the three months ended September 30, 2005,
compared to $305,626 for the three months ended September 30, 2004. This increase is chiefly
attributable to a $110,902 increase in outside research essentially all due to the ongoing
PentaLyte clinical study, an increase in rent expense allocated to research and development of
$18,115, and a $20,234 increase in insurance costs allocated to research and development due to
requirements of the PentaLyte clinical study. These increases were offset to some extent by a
$52,073 decrease in salaries allocated to research and development due to cost-cutting measures
implemented during the second quarter of 2005. For the nine months ended September 30, 2005,
research and development expenses totaled $1,205,271, compared to $810,379 for the nine months
ended September 30, 2004. This increase is due primarily to an increase of $375,100 in outside
research expenses due to the PentaLyte study, an increase of $16,944 in rent allocated to research
and development, and an increase of $78,315 in insurance costs arising from the PentaLyte study.
These increases were somewhat offset by a decrease of
17
$72,341 in salaries allocated to research and development. Research and development expenses
include clinical study and laboratory study expenses, salaries, ongoing prosecution of regulatory
applications, and consultants fees.
General and
administrative expenses decreased to $242,988 for the three months ended September
30, 2005 from $280,712 for the three months ended September 30, 2004. This decrease is chiefly
attributable to a decrease of $28,698 in salaries allocated to general and administrative work due
to cost-cutting measures implemented during the second quarter of 2005, a decrease of $19,988 in
investor relations expenses, and a decrease of $20,744 in legal fees. These decreases were
somewhat offset by an increase of $24,240 in general and administrative consulting fees, and an
increase of $10,561 in accounting expenses. For the nine months ended September 30, 2005, general
and administrative expenses totaled $1,031,918, compared to $1,055,438 for the nine months ended
September 30, 2004. This decrease is due primarily to a decrease of $24,942 in depreciation
expense, a decrease of $12,508 in investor/public relations expenses, a decrease of $20,891 in
legal fees, a decrease of $12,714 in outside services expenses, a decrease of $16,372 in printing
expenses, and a decrease of $36,808 in patent and trademark expenses. These decreases were
somewhat offset by an increase of $27,612 in general and administrative consulting expenses, an
increase of $35,076 in accounting expenses, and an increase of $30,446 in office expenses.
Interest and Other Income
For the three months ended September 30, 2005, we incurred a total of $11,358 of net interest
expense, compared to net interest income of $13,415 for the three months ended September 30, 2004.
The difference is attributable to the interest expense accrued on the royalty obligation during the
current period. For the nine months ended September 30, 2005, we incurred a total of $27,982 of
net interest expense, while we incurred a total of $1,118,353 of net interest expense for the nine
months ended September 30, 2004. This difference is attributable to the fact that we incurred more
than $1.1 million in interest expense in the first quarter of 2004 when we retired our outstanding
long-term debt in full. See Notes 3 and 4 to the condensed financial statements.
Income Taxes
During the three and nine months ended September 30, 2005, we incurred no foreign withholding
taxes, while for the three and nine months ended September 30, 2004, we incurred $49,518 in foreign
withholding taxes. This difference was due to our receipt of a $300,000 license fee from CJ in the
third quarter of 2004. 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
18
Since inception, we have primarily financed our operations through the sale of equity
securities, licensing fees, and borrowings. During January 2004, we completed a rights offer (the
2003 Rights Offer) through which we raised gross proceeds of $3,584,420 through the sale of
2,560,303 common shares and 1,280,073 warrants. Following the completion of the 2003 Rights Offer,
we raised an additional $600,000 by selling an additional 428,571 common shares and 214,284
warrants under a Standby Purchase Agreement. During February 2004, we eliminated $3,350,000 of
debenture indebtedness by using a portion of the proceeds of the 2003 Rights Offer to repay
$1,850,000 of debentures in cash, and by issuing a total of 1,071,428 common shares and 535,712
common share purchase warrants in exchange for $1,500,000 of debentures held by certain persons who
acted as Participating Debenture Holders under the Standby Purchase Agreement. See Note 3 to the
condensed financial statements.
At September 30, 2005,
we had $175,564 of cash on hand. During October 2005, we received
approximately $397,000 under our agreement with Summit. Of that amount, $150,000 represents a
scheduled payment from Summit under our agreement with them, while the remaining approximately
$247,000 represents our 40% share of a non-refundable payment from a prospective licensee in
connection with a license agreement for the Japanese market that is being negotiated by Summit. We
also expect to receive $242,124 in royalty payments from Hospira in November, 2005.
On October 27, 2005, we commenced a new subscription rights offer under which we will
distribute subscription rights Rights to the holders of BioTime common shares entitling each
holder to subscribe for and purchase one Unit for every five Rights held at a price of $0.50 per
Unit. Each Unit will consist of one new common share and one warrant to purchase an additional
common share. The subscription price for the Units is $0.50 per Unit. Each warrant will entitle
the holder to purchase one common share for $2.00 per share and will expire on October 31, 2010.
The rights offer will expire on November 30, 2005. Shareholders who exercise all of their rights
in full will be entitled to the additional privilege of subscribing for and purchasing any Units
left over by rights holders who fail to exercise their rights, plus up to 1,787,145 Units to cover
over-subscriptions, subject to certain limitations and subject to allocation. A group of private
investors has agreed to purchase any Units that remain unsold at the conclusion of the new rights
offer, excluding Units that we have authorized to issue to fill over-subscription. We will raise
at least $1,787,145 through the new rights offer, before deducting expenses of the rights offer
which we estimate will be $292,000. Should the Company be unable to complete the rights offer for
any reason, it would have a material adverse effect on the Companys ability to continue its
planned operations.
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. We need additional
capital and greater revenues to continue our current operations, to complete clinical trials of
PentaLyte, and to conduct our planned product development and research programs. Sales of
additional equity securities could result in the dilution of the interests of present shareholders.
We are also continuing to seek new agreements with pharmaceutical companies to provide us with
additional product and technology licensing fees and royalties. The amount of license fees and
royalties that may be earned through the licensing and sale of our products and
19
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. Management believes our existing cash, along with
anticipated license fees and royalties, and the minimum rights offer proceeds, will be sufficient
to allow us to operate through March 31, 2007.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The Company did not hold any market risk sensitive instruments as of September 30, 2005,
December 31, 2004, or September 30, 2004.
Item 4. 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 a date within
ninety (90) days of the filing date of this Form 10-Q quarterly report. Following this review and
evaluation, management has collectively determined that our disclosure controls and procedures are
sufficient to ensure that material information relating to BioTime with respect to the period
covered by this report was made known to them.
Changes in Internal Controls
There were no significant changes to our internal controls or in other factors that could
significantly affect these controls subsequent to the date of the review by our Chief Executive
Officers and Chief Financial Officer.
20
PART II OTHER INFORMATION
Item 6. Exhibits
|
|
|
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++ |
|
|
|
4.3
|
|
Form of Warrant Agreement between BioTime, Inc. and American Stock Transfer & Trust Company++ |
|
|
|
4.4
|
|
Form of Amendment to Warrant Agreement between BioTime, Inc. and American Stock Transfer &
Trust Company. +++ |
|
|
|
4.5
|
|
Form of Subscription Certificate+++ |
|
|
|
10.1
|
|
Lease Agreement dated July 1, 1994 between the Registrant and Robert and Norah Brower,
relating to principal executive offices of the Registrant.* |
|
|
|
10.2
|
|
Intellectual Property Agreement between BioTime, Inc. and Hal Sternberg.+ |
|
|
|
10.3
|
|
Intellectual Property Agreement between BioTime, Inc. and Harold Waitz.+ |
|
|
|
10.4
|
|
Intellectual Property Agreement between BioTime, Inc. and Judith Segall.+ |
|
|
|
10.5
|
|
Intellectual Property Agreement between BioTime, Inc. and Steven Seinberg.** |
|
|
|
10.6
|
|
Agreement between CMSI and BioTime Officers Releasing Employment Agreements, Selling Shares,
and Transferring Non-Exclusive License.+ |
|
|
|
10.7
|
|
Agreement for Trans Time, Inc. to Exchange CMSI Common Stock for BioTime, Inc. Common
Shares.+ |
|
|
|
10.8
|
|
2002 Stock Option Plan, as amended.## |
|
|
|
10.9
|
|
Addenda to Lease Agreement between BioTime, Inc. and Donn Logan. |
21
|
|
|
Exhibit |
|
|
Numbers |
|
Description |
|
|
|
10.10
|
|
Exclusive License Agreement between Abbott Laboratories and BioTime, Inc. (Portions of this
exhibit have been omitted pursuant to a request for confidential treatment).### |
|
|
|
10.11
|
|
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).^^^ |
|
|
|
10.12
|
|
Warrant Agreement, dated March 27, 2001, between BioTime, Inc. and Alfred D. Kingsley |
|
|
|
10.13
|
|
Form of Series 2001-A 10% Debenture due August 1, 2004 |
|
|
|
10.14
|
|
Warrant Agreement between BioTime, Inc. and Purchasers of Series 2001-A Debentures |
|
|
|
10.15
|
|
Warrant Agreement, dated March 27, 2002, between BioTime, Inc. and Alfred D. Kingsley** |
|
|
|
10.16
|
|
Warrant for the Purchase of Common Shares, dated August 12, 2002, issued to Ladenburg
Thalmann & Co. Inc.*** |
|
|
|
10.17
|
|
Exclusive License Agreement between BioTime, Inc. and CJ Corp.**** |
|
|
|
10.18
|
|
Warrant Agreement, dated April 9, 2003, between BioTime, Inc. and certain holders of Series
2001-A Debentures**** |
|
|
|
10.19
|
|
Addendum to Lease, dated March 12, 2004, between BioTime, Inc. as lessee, and Donn Logan and
Marcy Li Wong as lessor |
|
|
|
10.20
|
|
Lease dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D Associates |
|
|
|
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. |
22
|
|
|
++ |
|
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 BioTimes Form 10-K for the fiscal year ended June 30, 1994. |
|
^ |
|
Incorporated by reference to BioTimes Form 10-Q for the quarter ended March 31, 1997. |
|
## |
|
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 10-Q for the quarter ended March 31, 1999. |
|
|
|
Incorporated by reference to BioTimes Form 10-K for the year ended December 31, 1999. |
|
### |
|
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 the Companys Form 10-K for the year ended December 31, 2000. |
|
|
|
Incorporated by reference to BioTimes Form 10-Q for the quarter ended June 30, 2001. |
|
** |
|
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 10-K for the year ended December 31, 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 |
|
|
|
Filed herewith |
23
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BIOTIME, INC.
|
|
|
|
|
|
|
|
Date: November 14, 2005 |
/s/ Judith Segall
|
|
|
Judith Segall |
|
|
Vice-President Operations
Member, Office of the President* |
|
|
|
|
|
|
Date: November 14, 2005 |
/s/ Hal Sternberg
|
|
|
Hal Sternberg |
|
|
Vice-President Research
Member, Office of the President* |
|
|
|
|
|
|
Date: November 14, 2005 |
/s/ Harold Waitz
|
|
|
Harold Waitz |
|
|
Vice-President Regulatory Affairs
Member, Office of the President* |
|
|
|
|
|
|
Date: November 14, 2005 |
/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 the
Company who collectively exercise the powers of the Chief Executive Officer
24
|
|
|
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++ |
|
|
|
4.3
|
|
Form of Warrant Agreement between BioTime, Inc. and American Stock Transfer & Trust Company++ |
|
|
|
4.4
|
|
Form of Amendment to Warrant Agreement between BioTime, Inc. and American Stock Transfer &
Trust Company. +++ |
|
|
|
4.5
|
|
Form of Subscription Certificate+++ |
|
|
|
10.1
|
|
Lease Agreement dated July 1, 1994 between the Registrant and Robert and Norah Brower,
relating to principal executive offices of the Registrant.* |
|
|
|
10.2
|
|
Intellectual Property Agreement between BioTime, Inc. and Hal Sternberg.+ |
|
|
|
10.3
|
|
Intellectual Property Agreement between BioTime, Inc. and Harold Waitz.+ |
|
|
|
10.4
|
|
Intellectual Property Agreement between BioTime, Inc. and Judith Segall.+ |
|
|
|
10.5
|
|
Intellectual Property Agreement between BioTime, Inc. and Steven Seinberg.** |
|
|
|
10.6
|
|
Agreement between CMSI and BioTime Officers Releasing Employment Agreements, Selling Shares,
and Transferring Non-Exclusive License.+ |
|
|
|
10.7
|
|
Agreement for Trans Time, Inc. to Exchange CMSI Common Stock for BioTime, Inc. Common
Shares.+ |
|
|
|
10.8
|
|
2002 Stock Option Plan, as amended.## |
|
|
|
10.9
|
|
Addenda to Lease Agreement between BioTime, Inc. and Donn Logan. |
|
|
|
10.10
|
|
Exclusive License Agreement between Abbott Laboratories and BioTime, Inc. (Portions of this
exhibit have been omitted pursuant to a request for confidential treatment).### |
|
|
|
10.11
|
|
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).^^^ |
25
|
|
|
Exhibit |
|
|
Numbers |
|
Description |
|
|
|
10.12
|
|
Warrant Agreement, dated March 27, 2001, between BioTime, Inc. and Alfred D. Kingsley |
|
|
|
10.13
|
|
Form of Series 2001-A 10% Debenture due August 1, 2004 |
|
|
|
10.14
|
|
Warrant Agreement between BioTime, Inc. and Purchasers of Series 2001-A Debentures |
|
|
|
10.15
|
|
Warrant Agreement, dated March 27, 2002, between BioTime, Inc. and Alfred D. Kingsley** |
|
|
|
10.16
|
|
Warrant for the Purchase of Common Shares, dated August 12, 2002, issued to Ladenburg
Thalmann & Co. Inc.*** |
|
|
|
10.17
|
|
Exclusive License Agreement between BioTime, Inc. and CJ Corp.**** |
|
|
|
10.18
|
|
Warrant Agreement, dated April 9, 2003, between BioTime, Inc. and certain holders of Series
2001-A Debentures**** |
|
|
|
10.19
|
|
Addendum to Lease, dated March 12, 2004, between BioTime, Inc. as lessee, and Donn Logan and
Marcy Li Wong as lessor |
|
|
|
10.20
|
|
Lease dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D Associates |
|
|
|
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. |
|
* |
|
Incorporated by reference to BioTimes Form 10-K for the fiscal year ended June 30, 1994. |
26
|
|
|
^ |
|
Incorporated by reference to BioTimes Form 10-Q for the quarter ended March 31, 1997. |
|
## |
|
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 10-Q for the quarter ended March 31, 1999. |
|
|
|
Incorporated by reference to BioTimes Form 10-K for the year ended December 31, 1999. |
|
### |
|
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 the Companys Form 10-K for the year ended December 31, 2000. |
|
|
|
Incorporated by reference to BioTimes Form 10-Q for the quarter ended June 30, 2001. |
|
** |
|
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 10-K for the year ended December 31, 2003 |
|
|
|
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 |
|
|
|
Filed herewith |
27