SECURITIES AND EXCHANGE COMMISSION
Form 10-Q
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(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, 2003 | ||
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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.
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California
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94-3127919 | |
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(State or other jurisdiction of
incorporation or organization) |
(IRS Employer Identification No.) |
935 Pardee Street
(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
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. 13,654,949 common shares, no par value, as of November 3, 2003.
PART 1 FINANCIAL INFORMATION
Statements made in this Report that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed. Such risks and uncertainties include but are not limited to those discussed in this report under Item 1 of the Notes to Financial Statements, and in 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
| September 30, | December 31, | |||||||
| 2003 | 2002 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
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CURRENT ASSETS
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Cash and cash equivalents
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$ | 1,181,535 | $ | 1,284,432 | ||||
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Prepaid expenses and other current assets
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38,285 | 97,686 | ||||||
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Total current assets
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1,219,820 | 1,382,118 | ||||||
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EQUIPMENT, Net of accumulated depreciation of
$516,771and $478,396
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64,338 | 102,713 | ||||||
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DEPOSITS AND OTHER ASSETS
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16,050 | 11,250 | ||||||
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TOTAL ASSETS
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$ | 1,300,208 | $ | 1,496,081 | ||||
| LIABILITIES AND SHAREHOLDERS DEFICIT | ||||||||
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CURRENT LIABILITIES
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Accounts payable and accrued liabilities
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$ | 249,701 | $ | 498,423 | ||||
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Debentures, net of discount of $895,846 and
$1,181,196
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2,454,154 | 2,168,804 | ||||||
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Total current liabilities
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2,703,855 | 2,667,227 | ||||||
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DEFERRED REVENUES
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421,875 | | ||||||
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COMMITMENTS
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SHAREHOLDERS DEFICIT:
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||||||||
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Preferred Shares, no par value, undesignated as
to Series, authorized 1,000,000 shares; none outstanding
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Common Shares, no par value, authorized
40,000,000 shares; issued and outstanding 13,654,949 and
13,490,101
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32,864,488 | 32,374,883 | ||||||
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Contributed Capital
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93,972 | 93,972 | ||||||
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Deficit accumulated during development stage
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(34,783,982 | ) | (33,640,001 | ) | ||||
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Total shareholders deficit
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(1,825,522 | ) | (1,171,146 | ) | ||||
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TOTAL LIABILITIES AND SHAREHOLDERS DEFICIT
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$ | 1,300,208 | $ | 1,496,081 | ||||
See notes to financial statements.
1
BIOTIME, INC.
| Three Months Ended | Nine Months Ended | |||||||||||||||||||
| Period from Inception | ||||||||||||||||||||
| September 30, | September 30, | September 30, | September 30, | (November 30, 1990) | ||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | to September 30, 2003 | ||||||||||||||||
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REVENUE:
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License fees
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$ | 14,063 | $ | | $ | 28,125 | $ | | $ | 2,528,125 | ||||||||||
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Royalties from product sales
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95,807 | 85,843 | 275,663 | 169,511 | 832,713 | |||||||||||||||
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Reimbursed regulatory fees
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| | | 34,379 | 34,379 | |||||||||||||||
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Total revenue
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109,870 | 85,843 | 303,788 | 203,890 | 3,395,217 | |||||||||||||||
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EXPENSES:
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Research and development
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(239,760 | ) | (251,994 | ) | (675,900 | ) | (856,038 | ) | (23,409,908 | ) | ||||||||||
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General and administrative
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(227,432 | ) | (151,446 | ) | (943,767 | ) | (773,480 | ) | (15,689,653 | ) | ||||||||||
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Total expenses
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(467,192 | ) | (403,440 | ) | (1,619,667 | ) | (1,629,518 | ) | (39,099,561 | ) | ||||||||||
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INTEREST EXPENSE
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(288,603 | ) | (242,069 | ) | (775,484 | ) | (629,083 | ) | (1,885,012 | ) | ||||||||||
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OTHER INCOME
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1,007,945 | (19,198 | ) | 1,029,902 | (13,742 | ) | 2,912,725 | |||||||||||||
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Income (Loss) before income taxes
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362,020 | (578,864 | ) | (1,061,461 | ) | (2,068,453 | ) | (34,676,631 | ) | |||||||||||
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INCOME TAXES
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| | (82,520 | ) | | (82,520 | ) | |||||||||||||
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NET INCOME (LOSS)
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$ | 362,020 | $ | (578,864 | ) | $ | (1,143,981 | ) | $ | (2,068,453 | ) | $ | (34,759,151 | ) | ||||||
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BASIC INCOME (LOSS) PER SHARE
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$ | 0.03 | $ | (0.05 | ) | $ | (0.08 | ) | $ | (0.18 | ) | |||||||||
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DILUTED INCOME (LOSS) PER SHARE
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$ | 0.03 | $ | (0.05 | ) | $ | (0.08 | ) | $ | (0.18 | ) | |||||||||
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COMMON SHARES USED IN COMPUTING BASIC INCOME
(LOSS) PER SHARE
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13,654,949 | 12,289,705 | 13,581,236 | 11,815,101 | ||||||||||||||||
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COMMON AND EQUIVALENT SHARES USED IN COMPUTING
DILUTED INCOME (LOSS) PER SHARE
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13,720,583 | 12,289,705 | 13,581,236 | 11,815,101 | ||||||||||||||||
See notes to financial statements.
2
BIOTIME, INC.
CONDENSED STATEMENTS OF CASH FLOWS
| Nine Months Ended | |||||||||||||
| September 30, | Period from Inception | ||||||||||||
| (November 30, 1990) | |||||||||||||
| 2003 | 2002 | to September 30, 2003 | |||||||||||
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OPERATING ACTIVITIES:
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Net loss
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$ | (1,143,981 | ) | $ | (2,068,453 | ) | $ | (34,759,151 | ) | ||||
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Adjustments to reconcile net loss to net cash
used in operating activities:
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Deferred Revenue
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| | (1,000,000 | ) | |||||||||
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Depreciation
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38,375 | 49,339 | 523,312 | ||||||||||
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Amortization of debt discount
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525,079 | 311,197 | 1,194,599 | ||||||||||
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Cost of donation warrants
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| | 552,000 | ||||||||||
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Stock-based compensation
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114,730 | 77,922 | 1,356,427 | ||||||||||
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Changes in operating assets and liabilities:
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Prepaid expenses and other current assets
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59,401 | 44,950 | (38,286 | ) | |||||||||
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Deposits and other assets
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| | (11,250 | ) | |||||||||
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Accounts payable/accrued liabilities
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(200,472 | ) | (31,310 | ) | 297,949 | ||||||||
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Deferred revenue
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421,875 | | 1,421,875 | ||||||||||
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Other
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(4,800 | ) | | (4,800 | ) | ||||||||
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Net cash used in operating activities
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(189,793 | ) | (1,616,355 | ) | (30,467,325 | ) | |||||||
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INVESTING ACTIVITIES:
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Sale of investments
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| | 197,400 | ||||||||||
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Purchase of short-term investments
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| | (9,946,203 | ) | |||||||||
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Redemption of short-term investments
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| | 9,946,203 | ||||||||||
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Purchase of equipment and furniture
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(571,224 | ) | |||||||||||
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Net cash used in investing activities
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(373,824 | ) | |||||||||||
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FINANCING ACTIVITIES:
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Loans/ Debentures
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| | 2,350,000 | ||||||||||
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Borrowings under line of credit
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| | 1,000,000 | ||||||||||
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Issuance of preferred shares for cash
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| | 600,000 | ||||||||||
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Preferred shares placement costs
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| | (125,700 | ) | |||||||||
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Issuance of common shares for cash
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| 2,075,119 | 25,776,851 | ||||||||||
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Common shares placement costs
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| (282,373 | ) | (2,526,946 | ) | ||||||||
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Net proceeds from exercise of common share
options and warrants
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86,896 | | 5,098,485 | ||||||||||
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Contributed capital cash
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| | 77,547 | ||||||||||
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Dividends paid on preferred shares
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| | (24,831 | ) | |||||||||
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Repurchase Common Shares
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| | (202,722 | ) | |||||||||
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Net cash provided by financing activities
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86,896 | 1,792,746 | 32,022,684 | ||||||||||
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INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS
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(102,897 | ) | 176,391 | 1,181,535 | |||||||||
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CASH AND CASH EQUIVALENTS:
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At beginning of period
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1,284,432 | 1,652,748 | | ||||||||||
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At end of period
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$ | 1,181,535 | $ | 1,829,139 | $ | 1,181,535 | |||||||
3
CONDENSED STATEMENTS OF CASH FLOWS (Continued)
| Nine Months Ended | ||||||||||||
| September 30, | Period from Inception | |||||||||||
| (November 30, 1990) | ||||||||||||
| 2003 | 2002 | to September 30, 2003 | ||||||||||
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NONCASH FINANCING AND INVESTING ACTIVITIES:
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Receipt of contributed equipment
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| | $ | 16,425 | ||||||||
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Issuance of common shares in exchange for shares
of common stock of Cryomedical Sciences, Inc. in a
stock-for-stock transaction
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| | $ | 197,400 | ||||||||
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Issuance of warrants for private placement costs
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| $ | 163,583 | $ | 163,583 | |||||||
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Issuance of warrants related to debenture
financing and Line of Credit agreement
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$ | 239,729 | $ | 60,390 | $ | 2,150,835 | ||||||
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Issuance of warrants related to debenture
financing and Line of Credit Agreement
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| | $ | 1,911,106 | ||||||||
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Conversion of Line of Credit to debentures, net
of deferred financing fees
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| | $ | 840,878 | ||||||||
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SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
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Cash paid for interest
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$ | 335,000 | $ | 336,730 | $ | 658,452 | ||||||
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Cash paid for income taxes
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$ | 82,520 | | $ | 82,520 | |||||||
See notes to condensed financial statements.
4
BIOTIME, INC.
1. Organization
General BioTime, Inc. (the Company) was organized November 30, 1990 as a California corporation. The Company is a biomedical organization, currently in the development stage, 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, 2003, the condensed statements of operations and cash flows for the three months ended September 30, 2003 and 2002 and for the nine months ended September 30, 2003 and 2002, and the period from inception (November 30, 1990) to September 30, 2003, 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, 2003 and for all periods presented have been made. The balance sheet as of December 31, 2002 is derived from the Companys audited financial statements as of that date. The results of operations for the three months and nine months ended September 30, 2003 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 the Companys Form 10-K/ A-1 for the year ended December 31, 2002.
Development Stage Enterprise Since inception, the Company has been engaged in research and development activities in connection with the development of synthetic plasma expanders, blood volume substitute solutions and organ preservation products. The Company has limited operating revenues and has incurred net losses of $34,759,151 from inception to September 30, 2003. The successful completion of the Companys product development program and, ultimately, achieving profitable operations is dependent upon future events including maintaining adequate capital to finance its future development activities, obtaining regulatory approvals for the products it develops and achieving a level of revenues adequate to support the Companys cost structure.
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, 2003, BioTime had $1,181,535 of cash on hand, and has implemented cost savings and expenditure limitation measures. Included in cash on hand are proceeds from an upfront fee of approximately $370,000, net of Korean taxes withheld, from a new licensing agreement signed in April, as well as $1,000,000 from a key man life insurance policy (See Note 6). However, the Company needs additional capital and greater revenues to continue its current operations, to begin clinical trials of PentaLyte®, and to conduct its planned product development and research programs. Sales of additional equity securities could
5
NOTES TO FINANCIAL STATEMENTS (Continued)
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 August 2004, debentures of $3.35 million are payable by the Company. In order to retire the debentures, and to raise additional operating capital, the Company has filed a registration statement with the Securities and Exchange Commission for a subscription rights offer and an offer to exchange common shares and warrants for $1,500,000 of debentures. See Note 7.
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. Such management estimates include certain accruals. Actual results could differ from those estimates.
Revenue recognition In April 1997, BioTime and Abbott Laboratories (Abbott) entered into an Exclusive License Agreement (the License Agreement) under which BioTime granted to Abbott an exclusive license to manufacture and sell BioTimes proprietary blood plasma volume expander solution Hextend® in the United States and Canada for certain therapeutic uses.
Under the License Agreement, Abbott paid the Company $2,500,000 of license fees based upon achievement of specified milestones. Such fees were recognized as revenue as the milestones were achieved. Up to $37,500,000 of additional license fees will be payable based upon annual net sales of Hextend at the rate of 10% of annual net sales if annual net sales exceed $30,000,000 or 5% if annual net sales are between $15,000,000 and $30,000,000.
Abbotts obligation to pay license fees on sales of Hextend will expire on the earlier of January 1, 2007 or, on a country by country basis, when all patents protecting Hextend in the applicable country expire or any third party obtains certain regulatory approvals to market a generic equivalent product in that country.
In addition to the license fees, Abbott will pay the Company a royalty on annual net sales of Hextend. The royalty rate will be 5% plus an additional .22% for each increment of $1,000,000 of annual net sales, up to a maximum royalty rate of 36%. Abbotts obligation to pay royalties on sales of Hextend will expire in the United States or Canada when all patents protecting Hextend in the applicable country expire and any third party obtains certain regulatory approvals to market a generic equivalent product in that country.
The Company recognizes such 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. Revenues for the three months ended September 30, 2003 include royalties on sales made by Abbott during the three months ended June 30, 2003. Royalties on sales made during the third quarter of fiscal year 2003 will not be recognized by the Company until the fourth quarter of fiscal year 2003.
Abbott has agreed that the Company may convert Abbotts exclusive license to a non-exclusive license or may terminate the license outright if certain minimum sales and royalty payments are not met. In order to terminate the license outright, BioTime would pay a termination fee in an amount ranging from the milestone payments made by Abbott to an amount equal to three times prior year net sales, depending upon when termination occurs. Management believes that the probability of payments of any termination fee by the Company is remote.
6
NOTES TO FINANCIAL STATEMENTS (Continued)
Research and product license fees are generally deferred and recognized over the life of the contract unless the license period has commenced, the technology has been delivered, and all other performance conditions have been met. If all of these conditions are met, any remaining deferred revenue would then be recognized.
During March 2003, BioTime granted to CJ Corp. (CJ) an exclusive license to manufacture and sell Hextend and PentaLyte in South Korea (the CJ Agreement). Under the CJ Agreement, CJ agreed to pay the Company a license fee of $800,000, payable in two installments. The first installment of $500,000, less $80,000 of Korean taxes withheld, was paid to the Company during April 2003. In connection with this agreement, the Company paid a finders fee of $50,000 to an unrelated third party. The Company has not completed the development of PentaLyte, for which additional clinical trials in the United States are being planned. As the expected completion date of the clinical trials is uncertain, the license fee of $500,000, net of the $50,000 finders fee, has been deferred and will be 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. The remaining $300,000 is payable to the Company within 30 days after an application for regulatory approval to manufacture and market Hextend is filed in Korea. In addition to the license fees, CJ will pay the Company a royalty on sales of the licensed products. The royalty will range from $1.30 to $2.60 per 500 ml unit of product sold, depending upon the price approved by Koreas National Health Insurance, but CJ Corp. will have to obtain regulatory approval before sales can begin. CJ will be responsible for obtaining the regulatory approvals required to manufacture and market Hextend and PentaLyte, including conducting any clinical trials that may be required, and will bear all related costs and expenses.
Indemnification In November 2002, the Financial Accounting Standards Board (the FASB) issued FASB interpretation (FIN) No. 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. The following is a summary of the Companys agreements that the Company has determined are within the scope of FIN 45.
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 Compa