FORM 10-Q
Washington, D.C. 20549
(Mark One)
| [ü] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE | |
| SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2003
OR
| [ ] | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE |
| SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-12830
BioTime, Inc.
| California (State or other jurisdiction of incorporation or organization) |
94-3127919 (IRS Employer Identification No.) |
935 Pardee Street
Berkeley, California 94710
(Address of principal executive offices)
(510) 845-9535
(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 [X] No[ ]
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. 13,590,101 common shares, no par value, as of May 13, 2003.
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.
(A Development Stage Company)
CONDENSED BALANCE SHEETS (Unaudited)
| March 31, | December 31, | |||||||
| 2003 | 2002 | |||||||
ASSETS |
||||||||
CURRENT ASSETS |
||||||||
Cash and cash equivalents |
$ | 723,519 | $ | 1,284,432 | ||||
Accounts receivable |
510,579 | | ||||||
Prepaid expenses and other current assets |
86,883 | 97,686 | ||||||
Total current assets |
1,320,981 | 1,382,118 | ||||||
EQUIPMENT, Net of accumulated depreciation of $493,098 and $478,396,
respectively |
88,011 | 102,713 | ||||||
DEPOSITS AND OTHER ASSETS |
11,250 | 11,250 | ||||||
TOTAL ASSETS |
$ | 1,420,242 | $ | 1,496,081 | ||||
LIABILITIES AND SHAREHOLDERS DEFICIT |
||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable and accrued liabilities |
$ | 428,753 | $ | 498,423 | ||||
DEBENTURES, net of discount of $1,041,236 and $1,181,196,
respectively |
2,308,764 | 2,168,804 | ||||||
DEFERRED REVENUES |
450,000 | | ||||||
COMMITMENTS |
||||||||
SHAREHOLDERS DEFICIT: |
||||||||
Preferred Shares, no par value, undesignated as to Series,
authorized 1,000,000 shares; none outstanding |
| | ||||||
Common Shares, no par value, authorized 40,000,000 shares; issued and
outstanding shares; 13,590,101 and 13,490,101, respectively |
32,529,883 | 32,374,883 | ||||||
Contributed Capital |
93,972 | 93,972 | ||||||
Deficit accumulated during development stage |
(34,391,130 | ) | (33,640,001 | ) | ||||
Total shareholders deficit |
(1,767,275 | ) | (1,171,146 | ) | ||||
TOTAL LIABILITIES AND SHAREHOLDERS DEFICIT |
$ | 1,420,242 | $ | 1,496,081 | ||||
See notes to condensed financial statements.
2
BIOTIME, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended | Period from Inception | ||||||||||||
| March 31, | (November 30, 1990) to | ||||||||||||
| 2003 | 2002 | March 31, 2003 | |||||||||||
REVENUE: |
|||||||||||||
License fee |
$ | | $ | | $ | 2,500,000 | |||||||
Royalty from product sales |
96,622 | 57,235 | 653,672 | ||||||||||
Reimbursed regulatory fees |
| | 34,379 | ||||||||||
Total revenue |
96,622 | 57,235 | 3,188,051 | ||||||||||
EXPENSES: |
|||||||||||||
Research and development |
(224,536 | ) | (260,571 | ) | (22,958,544 | ) | |||||||
General and administrative |
(337,768 | ) | (331,407 | ) | (15,083,654 | ) | |||||||
Total expenses |
(562,304 | ) | (591,978 | ) | (38,042,198 | ) | |||||||
INTEREST INCOME (EXPENSE) AND
OTHER: |
(205,447 | ) | (171,665 | ) | 567,848 | ||||||||
Loss before income taxes |
(671,129 | ) | (706,408 | ) | (34,286,299 | ) | |||||||
INCOME TAXES |
(80,000 | ) | | (80,000 | ) | ||||||||
NET LOSS |
$ | (751,129 | ) | $ | (706,408 | ) | $ | (34,366,299 | ) | ||||
BASIC AND DILUTED LOSS PER SHARE |
$ | (0.06 | ) | $ | (0.06 | ) | |||||||
COMMON AND EQUIVALENT SHARES
USED IN COMPUTING PER SHARE
AMOUNTS: |
|||||||||||||
BASIC AND DILUTED |
13,564,545 | 11,627,872 | |||||||||||
See notes to condensed financial statements.
3
BIOTIME, INC.
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
(unaudited)
| Three Months Ended | Period from Inception | ||||||||||||
| March 31, | (November 30, 1990) to | ||||||||||||
| 2003 | 2002 | March 31, 2003 | |||||||||||
OPERATING ACTIVITIES: |
|||||||||||||
Net loss |
$ | (751,129 | ) | $ | (706,408 | ) | $ | (34,366,299 | ) | ||||
Adjustments to reconcile net loss to net
cash used in operating activities: |
|||||||||||||
Depreciation |
14,702 | 16,861 | 499,639 | ||||||||||
Amortization of debt discount |
139,960 | 93,479 | 809,480 | ||||||||||
Cost of Donation - warrants |
| | 552,000 | ||||||||||
Stock-based compensation |
38,750 | 58,703 | 1,396,697 | ||||||||||
Changes in operating assets and liabilities: |
|||||||||||||
Accounts receivable |
(510,579 | ) | | (510,579 | ) | ||||||||
Prepaid expenses and other current assets |
10,803 | (8,209 | ) | (86,884 | ) | ||||||||
Deposits |
| | (11,250 | ) | |||||||||
Accounts payable and accrued liabilities |
46,580 | (119,704 | ) | 428,751 | |||||||||
Deferred revenue |
450,000 | | 450,000 | ||||||||||
Net cash used in operating activities |
(560,913 | ) | (665,278 | ) | (30,838,445 | ) | |||||||
INVESTING ACTIVITIES: |
|||||||||||||
Sale of investments |
| | 197,400 | ||||||||||
Purchase of short-term investments |
| | (9,946,203 | ) | |||||||||
Redemption of short-term investments |
| | 9,946,203 | ||||||||||
Purchase of equipment and furniture |
| | (571,224 | ) | |||||||||
Net cash used in investing activities |
| | (373,824 | ) | |||||||||
FINANCING ACTIVITIES: |
|||||||||||||
Warrants and debentures |
| | 2,350,000 | ||||||||||
Borrowings |
| | 1,000,000 | ||||||||||
Issuance of preferred shares for cash |
| | 600,000 | ||||||||||
Preferred shares placement costs |
| | (125,700 | ) | |||||||||
Issuance of common shares for cash |
| | 25,776,851 | ||||||||||
Common shares placement costs |
| | (2,526,946 | ) | |||||||||
Net proceeds from exercise of common share
options and warrants |
| | 5,011,589 | ||||||||||
Contributed capital - cash |
| | 77,547 | ||||||||||
Dividends paid on preferred shares |
| | (24,831 | ) | |||||||||
Repurchase of common shares |
| | (202,722 | ) | |||||||||
Net cash provided by financing activities |
| | 31,935,788 | ||||||||||
INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS |
(560,913 | ) | (665,278 | ) | 723,519 | ||||||||
At beginning of period |
1,284,432 | 1,652,748 | | ||||||||||
At end of period |
$ | 723,519 | $ | 987,470 | $ | 723,519 | |||||||
| See notes to condensed financial statements. | (Continued) |
4
BIOTIME, INC.
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
(unaudited)
| Three Months Ended | Period from Inception | |||||||||||||||
| March 31, | (November 30, 1990) to | |||||||||||||||
| 2003 | 2002 | March 31, 2003 | ||||||||||||||
NONCASH FINANCING AND
INVESTING ACTIVITIES: |
||||||||||||||||
Issuance of common shares
in exchange for shares of
common stock of Cryomedical
Sciences, Inc. in a stock-for-stock
transaction |
$ | | $ | | $ | 197,400 | ||||||||||
Conversion of line of credit to debentures |
| | 840,878 | |||||||||||||
Issuance of Warrants for private
placement costs |
| | 163,583 | |||||||||||||
Issuance of Warrants related to debenture
financing and line of credit agreement |
| | 1,911,106 | |||||||||||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW
INFORMATION: |
||||||||||||||||
Cash paid for interest |
$ | 168,877 | $ | | $ | 492,329 | ||||||||||
Cash paid for income taxes |
| | | |||||||||||||
| See notes to condensed financial statements. | (Concluded) |
5
BIOTIME, INC.
(A Development Stage Company)
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, 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 March 31, 2003, the condensed statements of operations for the three months ended March 31, 2003 and 2002 and the period from inception (November 30, 1990) to March 31, 2003, and the statements of cash flows for the three months ended March 31, 2003 and 2002 and the period from inception (November 30, 1990) to March 31, 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 March 31, 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 ended March 31, 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 $34,366,299 from inception to March 31, 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.
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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 March 31, 2003, BioTime had $723,519 of cash on hand, and has implemented cost savings and expenditure limitation measures. The Company has also received approximately $370,000 from a new licensing agreement in April. 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 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. However, management believes its existing cash, along with license fees receivable and anticipated royalties, is sufficient to allow the Company to operate through March 31, 2004.
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 have been 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
7
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 March 31, 2003 include royalties on sales made by Abbott during the three months ended December 31, 2002. Royalties on sales made during the first quarter of 2003 will not be recognized by the Company until the second 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.
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 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
8
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 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 March 31, 2003.
Under the License Agreement and the CJ Agreement, BioTime shall indemnify Abbott 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 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 March 31, 2003.
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 hold 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 March 31, 2003.
Comprehensive 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.
9
Recently issued accounting standards
Costs associated with Exit or Disposal Activities - On July 30, 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities. SFAS No. 146 requires companies to recognize costs associated with exit or disposal activities when they are incurred rather than at the date of a commitment to an exit or disposal plan. Examples of costs covered by the standard include lease termination costs and certain employee severance costs that are associated with a restructuring, discontinued operation, plant closing or other exit or disposal activity. SFAS No. 146 is to be applied prospectively to exit or disposal activities initiated after December 31, 2002. Adoption of SFAS No. 146 did not have a material impact on the financial statements.
Guarantors accounting and disclosure requirements for guarantees - In November 2002, the FASB Issued FASB interpretation (FIN) No. 45, Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others. FIN No. 45 requires a guarantor to recognize, at the inception of a qualified guarantee, a liability for the fair value of the obligation undertaken in issuing the guarantee. FIN No. 45 is effective on a prospective basis for qualified guarantees issued or modified after December 31, 2002. Adoption of this Interpretation did not have a material impact on the Companys financial condition or results of operations.
Stock-based compensation - transition and disclosure - In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based Compensation - Transition and Disclosure, which amended SFAS No. 123, Accounting for Stock-Based Compensation. The new standard provides alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. Additionally, the statement amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in the annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. This statement is effective for financial statements for fiscal years ending after December 15, 2002. 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:
| Three Months Ended March 31, | ||||||||
| 2003 | 2002 | |||||||
Net loss as reported |
$ | (751,129 | ) | $ | (706,408 | ) | ||
Deduct: Stock-based compensation determined
under fair value method for awards, net of tax |
(118,940 | ) | (25,819 | ) | ||||
Pro forma net loss |
$ | (870,069 | ) | $ | (732,227 | ) | ||
10
| Three Months Ended March 31, | ||||||||
| 2003 | 2002 | |||||||
Basic and diluted loss per common share as
reported |
$ | (0.06 | ) | $ | (0.06 | ) | ||
Pro forma basic and diluted loss per common share |
$ | (0.06 | ) | $ | (0.06 | ) | ||
Consolidation of variable interest entities - In January 2003, the FASB issued Interpretation No. 46, Consolidation of Variable Interest Entities (FIN 46) which requires the consolidation of variable interest entities, as defined. FIN 46 is applicable to financial statements to be issued by the Company after 2002; however, disclosures are required currently if the Company expects to consolidate any variable interest entities. Adoption of this standard did not have a material effect on its financial statements.
3. DEBENTURES
In August 2001, the Company issued $3,350,000 of debentures to an investor group. As part of the $3,350,000 debenture issuance, Alfred D. Kingsley, an investor and consultant to the Company, agreed to convert the $1,000,000 outstanding balance under a one year Revolving Line of Credit Agreement (the Credit Agreement) to $1,000,000 of debentures and purchased an additional $500,000 of debentures for cash. On the date of the conversion of the Credit Agreement to the debentures, the Credit Agreement was terminated, and no additional borrowings are available under that Credit Agreement. Interest on the debentures is payable at an annual rate of 10% and is payable semi-annually. The principal amount of the debentures is due on August 1, 2004. BioTime may prepay the debentures, in whole or in part, at any time without premium or penalty. Under the terms of the debentures, BioTime has agreed to restrict its quarterly cash payments for operating expenses to not more than $450,000 (excluding interest payable on the debentures) plus the amount of cash revenue (excluding interest and dividends) it collects for the quarter. To the extent BioTimes expenditures during any quarter are less than $450,000 over its revenues, it may expend the difference in one or more subsequent quarters. This spending restriction will expire when the Company obtains at least $5,000,000 in cash through sales of equity securities or pays off the debenture indebtedness in full. The Company has also agreed not to pay any cash dividends on or to redeem or repurchase any of its common shares outstanding until it has paid off the debentures in full.
Investors who purchased the debentures also received warrants to purchase a total of 515,385 common shares at an exercise price of $6.50. The warrants expire on August 1, 2004. The total fair value of the warrants of $1,596,124 was determined using the Black-Scholes option pricing model with the following assumptions: contractual life of 3 years; risk-free interest rate of 4.04%; volatility of 88%; and no dividends during the expected term. Of the $3,350,000 of proceeds, $1,596,124 and the unamortized portion ($159,122) of the fair value of a warrant issued in connection with the Credit Agreement was allocated to the warrants. The portion of the proceeds allocated to the debentures is being accreted to interest expense over the term of the debentures using the effective interest rate method. The Company has the right to call the warrants for redemption at a redemption price of $0.01 per share if the closing price of the
11
Companys common shares equals or exceeds 150% of the exercise price for fifteen consecutive trading days.
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 223,331 common shares were issued.
The warrants will expire in three years and will not be exercisable thereafter. The warrants will be redeemable by BioTime at $0.05 per warrant share if the closing price of the common shares on the American Stock Exchange exceeds 200% of the exercise price for 20 consecutive trading days.
If BioTime actually elects to pay interest in stock instead of cash, the common shares issued on the interest payment date will be valued at the lower of (a) $1.20 or (b) 80% of the average closing price of BioTime common shares on the AMEX for the 10 trading days prior to the interest payment date, but not less than $0.80 per share.
BioTime granted registration rights for the warrants and shares on substantially the same terms as the registration rights covering the warrants issued when the debentures were originally sold. All prices and share amounts will be adjusted for any stock splits, reverse splits, recapitalization, or similar changes to the common shares.
Alfred Kingsley has agreed with BioTime that if BioTime exercises the PIK right he will provide 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 39,999 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. When Mr. Kingsley provides BioTime with the cash to pay the interest due, he will receive the number of shares that the debenture holders would have received had they accepted stock in lieu of cash interest payments.
4. SHAREHOLDERS DEFICIT
Options to purchase 60,000 common shares were granted to consultants in 1999, and vest upon achievement of certain milestones. At March 31, 2003, 23,000 options had vested and 37,000 had not vested. During the three months ended March 31, 2003, remeasurement of these options did not yield a change in their fair value. Accordingly, no expense was incurred during this period. At March 31, 2002, 5000 options had vested, and 55,000 options had not vested. During
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the three months ended March 31, 2002, the Company recorded a benefit of $31,687 as a result of the remeasurement of such options. The benefit recognized on these options during the three months ended March 31, 2002 was recorded as an offset to research and development 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 year and expired on March 31, 2003. Under the Agreement, the Company issued to Greenbelt 40,000 common shares in four quarterly installments of 10,000 each for the twelve months ended March 31, 2002. For the twelve months ending March 31, 2003, the Company agreed to pay Greenbelt $60,000 in cash and issue 100,000 common shares. At December 31, 2002, $131,250 was included in accounts payable related to services rendered through December 31, 2002. During the first quarter of 2003, this obligation was settled through the payment of $15,000 and issuance of 75,000 common shares. The Company recorded expense of $53,750 related to services rendered by Greenbelt under this agreement for the three months ended March 31, 2003. On March 31, 2003, the Company issued 25,000 shares valued at $38,750 ($1.55 per share) in accordance with the agreement leaving an unpaid balance of $15,000 included in accounts payable. This obligation was settled through the payment of cash in April 2003.
5. NET LOSS PER SHARE
Basic earnings (loss) per share excludes dilution and is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted earnings (loss) per share reflects the potential dilution from securities and other contracts which are exercisable or convertible into common shares. For the three months ended March 31, 2003 and March 31, 2002, options to purchase 910,033 and 473,201 common shares, and warrants to purchase 725,078 and 880,714 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.
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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, the Company has been engaged primarily in research and development activities which have culminated in the commercial launch of Hextend®, its lead product, and a clinical trial of PentaLyte®. The Companys operating revenues have been generated primarily from licensing fees and royalties, including $2,500,000 of licensing fees received from Abbott Laboratories for the right to manufacture and market Hextend® in the United States and Canada. As a result of the developmental nature of its business and the limited sales of its product, since the Companys inception in November 1990 it has incurred $34,366,299 of losses. During the first three months of 2003 the Company had an operating loss of $751,129. The Companys ability to generate substantial operating revenue depends upon its success in developing and marketing or licensing its plasma volume expanders and organ preservation solutions and technology for medical use.
Most of the Companys research and development efforts have been devoted to the Companys first three blood volume replacement products: Hextend®, PentaLyte®, and HetaCool. By testing and bringing all three products to the market, BioTime believes it can increase its 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 and tissue transplant surgery, BioTime may also create new market niches for its product line.
The Companys first product, Hextend®, is a physiologically balanced blood plasma volume expander, for the treatment of hypovolemia. Hypovolemia is a condition caused by low blood volume, often from blood loss during surgery or from injury. Hextend® maintains circulatory system fluid volume and blood pressure and keeps vital organs perfused during surgery. Hextend® is being sold in the United States by Abbott Laboratories under an exclusive license from the Company. Abbott also has the right to sell Hextend® in Canada, where it was approved for sale and product launch is expected shortly. Abbott also has a right to obtain licenses to manufacture and sell other BioTime products in the United States and Canada, and BioTime would receive additional license fees if those options are exercised, in addition to royalties on subsequent sales of those products.
During March 2003, BioTime granted to CJ Corp. 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 license fee of $500,000, less 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 within 30 days after an
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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.
BioTime has retained all rights to manufacture, sell or license Hextend®, PentaLyte®, HetaCool, and other products in all other countries. BioTime and certain pharmaceutical companies are discussing and negotiating potential manufacturing, distributing and marketing agreements for BioTime products in the rest of the world.
Under its License Agreement